Effect evaluation method and system for treating PDPN through surgical decompression and application

Abstract

The invention discloses an effect evaluation method and system for treating painful diabetic peripheral neuropathy (PDPN) through surgical decompression and application, and belongs to the technical field of medical treatment. The effect evaluation method comprises the following steps: step 1, carrying out complete evaluation examination on a subject; 2, the subjects meeting the requirements after evaluation and examination in the step 1 are randomly distributed to an operation group and a non-operation group, and evaluation and examination of the subjects comprise medical history collection, physical examination, blood examination and electrophysiological examination. According to the effect evaluation method, an accurate and measurable evaluation method is established, namely, the effect of treating the PDPN through surgical decompression is evaluated by utilizing a random control test method, comprehensive evaluation of the PDPN is achieved, a patient can conveniently understand the specific effect of a treatment scheme, and therefore the curative effect of triple nerve decompression on the PDPN patient prompting nerve entrapment is achieved.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and specifically relates to an effect evaluation method, system and application of surgical decompression treatment for PDPN. Background Art

[0002] PDPN (painful diabetic peripheral neuropathy) is one of the most common complications of diabetes, affecting up to 50% of diabetic patients. The clinical manifestations of PDPN vary greatly, with lower limb involvement more common than upper limb involvement. Neuropathic pain is the most painful symptom of PDPN patients, seriously affecting their quality of life and being the main reason for them to seek medical treatment.

[0003] As one of the most common complications of diabetes, PDPN has become a global problem. Most patients with diabetic peripheral neuropathy have symptoms of pain, as well as related depression, anxiety and sleep disorders. Diabetic patients have different complications in different organ systems, and PDPN is no exception. Neuropathic symptoms can be divided into two types: hyperactivity and hypoactivity of the sensory nervous system, which are typically manifested as pain as an irritation symptom and numbness. PDPN is usually difficult to cure with conventional drugs and has great side effects. Since diabetic peripheral nerve compression often involves multiple nerves, triple nerve decompression is proposed to treat PDPN. However, the role of decompression surgery in the treatment of PDPN is still controversial. Therefore, an evaluation method is needed to comprehensively evaluate and understand the specific effects of the treatment plan.

[0004] The present invention aims to evaluate the therapeutic effect of triple nerve decompression on PDPN patients with nerve entrapment through a randomized controlled trial (RCT) design. Summary of the invention

[0005] The purpose of the present invention is to provide a method for evaluating the effect of surgical decompression in the treatment of PDPN to solve the problems existing in the above-mentioned background technology.

[0006] The purpose of this study was to determine the role of mechanical allodynia (MA) in predicting the prognosis of PDPN surgery, to quantify the analgesic medication regimen using a questionnaire, and to assess the sensory characteristics, psychological state, and quality of life of patients in order to comprehensively evaluate the effect of trigeminal nerve decompression in the treatment of PDPN patients.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] The present invention provides a method for evaluating the effect of surgical decompression in treating PDPN, the method comprising the following steps:

[0009] Step 1: Conduct a complete assessment of the subject, including history collection, physical examination, blood test, neuroelectrophysiological examination, and high-frequency neuroultrasound;

[0010] Step 2: The subjects who meet the requirements after the evaluation and examination in step 1 are randomly assigned to the surgical group and the non-surgical group for analysis.

[0011] In step one, the medical history collection includes the patient's basic information, diabetes course and blood sugar-lowering regimen, pain course and medication regimen, previous history of smoking and drinking, previous medical history, surgical history, clinical symptoms related to diabetic peripheral neuropathy, etc.

[0012] The basic information of the patient includes gender, age, height, weight (body mass index is further calculated), etc.

[0013] The glucose-lowering regimen includes drugs, dosage, duration of medication, etc.;

[0014] The medication regimen includes drugs, dosage, duration of medication, etc.

[0015] Among them, the clinical symptoms associated with diabetic peripheral neuropathy include tingling, burning pain, numbness, dry skin, cracked feet, foot infection, soreness and weakness, etc.

[0016] In the step 1, the physical examination includes vital signs and physical examination related to diabetic peripheral neuropathy;

[0017] Specifically, the physical examination includes superficial sensation (pain, touch, temperature), deep sensation (motion, position, vibration), complex sensation (positioning, two-point discrimination, pattern), reflexes (knee jerk, ankle jerk), etc.

[0018] In step 1, the blood tests include routine blood tests, routine coagulation tests, liver and kidney function, blood lipids, fasting blood sugar, glycosylated hemoglobin, etc.

[0019] In the step 1, the neuroelectrophysiological examination is performed using an electromyograph; it includes detecting the motor conduction velocity (NCV) and amplitude of the bilateral posterior tibial nerve and common peroneal nerve, and detecting the sensory nerve conduction velocity and amplitude of the bilateral deep peroneal nerve; wherein, the bilateral common peroneal nerve is mainly characterized by a decrease in the motor conduction velocity across the fibular head region, and the bilateral posterior tibial nerve is mainly characterized by a decrease in the motor conduction velocity across the medial malleolus, supplemented by observing the changes in amplitude (decline) of the bilateral posterior tibial nerve and common peroneal nerve, and the changes in the sensory nerve conduction velocity and amplitude (mainly decrease) of the bilateral deep peroneal nerve.

[0020] The high-frequency nerve ultrasound is performed using a high-frequency ultrasound probe to detect the bilateral posterior tibial nerves and their plantar branches, the common peroneal nerve and its deep peroneal nerve branches, and observe nerve morphology, including the longitudinal fiber bundle morphology and the internal morphology of the cross-sectional nerves, and quantify the nerve cross-sectional length, short axis distance and area.

[0021] In the step 2, the evaluation criteria include inclusion criteria and exclusion criteria, etc.;

[0022] The inclusion criteria included: 1) diagnosed with type 2 diabetes according to the 1999 WHO diabetes diagnostic criteria; 2) aged between 40 and 70 years; 3) assessment of neuropathy: Michigan Diabetic Neuropathy Screening Scale (MNSI) greater than 2 points; 4) blood sugar control: fasting blood glucose less than 8 mmol / L, glycosylated hemoglobin less than 8%; 5) assessment of neuropathic pain: neuropathic pain symptoms distributed in the sensory distribution areas of the common peroneal nerve, posterior tibial nerve, and deep tibial nerve, the duration of pain symptoms was greater than 6 months, and the VAS score was greater than 4 points; 6) neuroelectrophysiological examination indicated abnormal nerve conduction velocity (greater than two standard deviations) in more than one nerve including the common peroneal nerve, posterior tibial nerve, or deep peroneal nerve;

[0023] Among them, the exclusion criteria include: 1) the presence of other injuries or medications that may cause peripheral neuropathy, such as pernicious anemia, hypothyroidism, lower limb vascular disease (absence or weakening of dorsalis pedis artery fluctuations, varicose veins, etc.); history of lower limb trauma or surgery; history of drug use such as vincristine, phenytoin sodium; history of heavy metal poisoning, etc.; 2) history of alcohol or drug addiction or abuse within 1 year of enrollment; 3) lumbar stenosis or discogenic neuropathy; 4) lower limb edema caused by various reasons; 5) patients with severe hemorrhagic diseases or bleeding tendencies; 6) patients with organ dysfunction such as heart, lung, liver, and kidney who are difficult to tolerate surgery or drugs, such as creatinine clearance ≤30mL / min; 7) patients whose compliance is affected by mental disorders and other factors; 8) rheumatic and rheumatoid diseases, etc.; 9) patients participating in other clinical trials.

[0024] In the step 2, the surgical group, the surgical group and the non-surgical group were all clinically evaluated using visual analog scale (VAS), two-point discrimination, Michigan Diabetic Neuropathy Screening Form (MNSI), Neuropathic Pain Rating Scale (DN4), Toronto Clinical Score, Hospital Anxiety and Depression Scale (HADS), SF-36 Quality of Life Assessment Scale, Quantitative Medication Score-III (MQS-III), neurophysiological examination, and high-frequency nerve ultrasound before and after surgery.

[0025] Specifically, the visual analog scale includes: asking the patient about the subjective pain level, with 0 being no pain and 10 being the most intolerable pain, and making a subjective score, as shown in the attachedFigure 4 shown.

[0026] Specifically, the two-point discrimination includes: measuring the two-point discrimination in three areas, namely, the dorsum of the foot (proximal end of the third toe), the medial plantar sole, and the lateral plantar sole, and repeating the measurement three times to obtain an average value.

[0027] Specifically, the Michigan Diabetic Neuropathy Screening Form (MNSI) includes a screening questionnaire and a physical examination; as shown in the attached Figure 5 and attached Figure 6 shown.

[0028] Specifically, the neuropathic pain assessment scale (DN4) includes: 10 yes / no questions, "yes" is 1 point, "no" is no point; Figure 7 shown.

[0029] Specifically, the Toronto clinical score includes: symptom score, reflex score and sensory test score, with the highest score being 19 points; Figure 8 shown.

[0030] Specifically, the Hospital Anxiety and Depression Scale includes: 14 items, 7 of which are for depression assessment and 7 for anxiety assessment; each item is scored on a 4-point scale, with the higher the score, the more severe the symptom; as shown in the attached Fig. 9 shown.

[0031] Specifically, the SF-36 quality of life assessment scale includes: physical function, physical role, bodily pain, general health status, energy, social function, emotional role, mental health, and health changes; Fig.10 shown.

[0032] Specifically, the third edition of the quantitative pain medication score (MQS-III) includes: obtaining a quantitative medication score (MQS score) by evaluating the drug (Drug), dose (mg / day) (Dose (mg / day)), weight (Detriment weight), and dosage level (Dosage level) to comprehensively quantify the use of prescription drugs for chronic non-malignant pain; as shown in the attached Fig.11 shown.

[0033] Specifically, the neuroelectrophysiological examination is performed by personnel with qualifications as neuroelectrophysiologists using neuroelectrophysiological examination equipment to perform neuroelectrophysiological examination on the posterior tibial nerve, common peroneal nerve and its branches of both lower limbs, including examination of nerve conduction velocity (NCV), compound muscle action potential (CMAP) and latency, especially examination of nerve conduction velocity of the posterior tibial nerve across the medial malleolus, the common peroneal nerve across the fibular head, and the deep peroneal nerve across the extensor pollicis brevis tendon.

[0034] Specifically, the high-frequency nerve ultrasound is performed by an experienced ultrasound physician using a high-frequency (8-14MHz) ultrasound probe to examine the continuity and internal echo condition of the posterior tibial nerve and the common peroneal nerve, measure the anteroposterior diameter (D1) and transverse diameter (D2) of the nerve, and calculate the nerve cross-sectional area (CSA) of the common peroneal nerve and the posterior tibial nerve using the formula: S=π*(D1×D2 / 4); wherein D1 is the anteroposterior diameter of the nerve, D2 is the transverse diameter of the nerve, S is the cross-sectional area of ​​the nerve, and π is pi.

[0035] In the present invention, the above-mentioned clinical evaluation method comprehensively collects the clinical symptoms and signs of diabetic peripheral neuropathy in patients, systematically evaluates the severity of patients' neuropathy and its impact on psychology and quality of life, and uses neuroelectrophysiological examination and high-frequency nerve ultrasound to objectively evaluate the functionality and morphology of nerves.

[0036] In the present invention, the primary outcome of the effect evaluation method is measured by the 50% response rate, which is defined as the proportion of subjects whose average weekly visual analogue score of pain is reduced by at least 50% compared with the baseline after 6 months of treatment.

[0037] Furthermore, in step 2, the surgical group and the non-surgical group both took the first-line treatment for the PDPN including several drugs, including anticonvulsants (pregabalin or gabapentin), serotonin and norepinephrine reuptake inhibitors (SNRIs; duloxetine), tricyclic antidepressants (amitriptyline), etc.

[0038] The present invention also provides an effect evaluation system for surgical decompression treatment of PDPN, the effect evaluation system adopts the effect evaluation method as described above, and the effect evaluation system includes: evaluation examination of subjects, preoperative and postoperative examinations of subjects in the surgical group and examinations of subjects in the non-surgical group, evaluation of standards that meet the requirements, etc.

[0039] Specifically, the evaluation and examination of the subject includes medical history collection, physical examination, blood test, neuroelectrophysiological examination, and high-frequency neuroultrasound, and the specific contents are the same as those described in the effect evaluation method mentioned above.

[0040] Specifically, the preoperative and postoperative examinations of the surgical group subjects and the non-surgical group subjects included visual analog scale, two-point discrimination, Michigan Diabetic Neuropathy Screening Form (MNSI), Neuropathic Pain Assessment Scale (DN4), Toronto Clinical Score, Hospital Anxiety and Depression Scale (HADS), SF-36 Quality of Life Assessment Scale, Quantitative Analgesic Score - III (MQS-III), neuroelectrophysiological examination, and high-frequency nerve ultrasound, and the specific contents are the same as those described in the effect evaluation method mentioned above.

[0041] Specifically, the evaluation meets the requirements of the criteria including inclusion criteria, exclusion criteria, etc., and the specific contents are the same as those described in the effect evaluation method described above.

[0042] In the present invention, the effect of surgical decompression in the treatment of PDPN was comprehensively and systematically evaluated through questionnaire scale evaluation, specialist physical examination, and neuromorphological and functional evaluation. This is the first time that subjective scoring, neurological function examination and neuromorphological examination have been comprehensively used to establish a systematic early diagnosis, disease assessment system and postoperative evaluation system.

[0043] The present invention also provides a system for evaluating the effect of surgical decompression treatment of PDPN, the evaluation system comprising: a memory and a processor; a computer program is stored in the memory, and when the computer program is executed by the processor, the method described above is implemented.

[0044] The present invention also provides a prognosis prediction index for surgical decompression treatment of PDPN, wherein the prognosis prediction index is mechanical allodynia. This index is proposed for the first time and has academic and clinical innovation.

[0045] The present invention also provides the use of the effect evaluation method as described above, or the effect evaluation system as described above in the effect evaluation of surgical decompression treatment of PDPN.

[0046] The present invention also provides the use of the above-mentioned prognostic prediction index in the prognosis prediction of surgical decompression treatment of PDPN.

[0047] Compared with the prior art, the present invention has the following beneficial effects:

[0048] The method for evaluating the effect of surgical decompression in the treatment of PDPN of the present invention has established a set of accurate and measurable evaluation methods, and uses the method of randomized controlled trials to evaluate the therapeutic effect of decompression surgery, thereby achieving the ability to comprehensively evaluate PDPN and understand the specific effects of treatment plans, thereby achieving the efficacy of triple nerve decompression in patients with PDPN indicating nerve compression.

[0049] The present invention provides a method for evaluating the effect of surgical decompression in treating PDPN:

[0050] Results: Compared with the non-surgical group, the surgical group showed improvements in VAS and HADS levels, NCV, and CSA results (P<0.05). In the surgical subgroup, patients with positive MA signs showed improvements in pain, psychological status, NCV, and CSA (P<0.05), while patients without MA signs only observed improvements in pain, psychological status, and CSA (P<0.05), while NCV did not show statistically significant improvements (P>0.05). In addition, MA patients had better pain relief compared with non-MA patients (P<0.05).

[0051] Conclusion: MA is a reliable predictor of prognosis after PDPN surgery. This indicator is proposed for the first time and is academically and clinically innovative. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without paying any creative work.

[0053] Figure 1 A structural diagram of the potential interaction between the mechanical compression mechanism and metabolic inflammation of the present invention;

[0054] Figure 2 The trend of the visual analogue score of the subjects in the surgical group and the non-surgical group at different time points;

[0055] Figure 3 It is a structural diagram of the application results of the Hospital Anxiety and Depression Scale of the present invention between different groups (surgery group and non-surgery group);

[0056] Figure 4 It is a visual analogue scale (VAS) diagram in the present invention;

[0057] Figure 5 The figure is a screening questionnaire diagram of the Michigan Diabetic Neuropathy Screening Form (MNSI) of the present invention;

[0058] Figure 6 The physical examination chart of the Michigan Diabetic Neuropathy Screening Form (MNSI) of the present invention;

[0059] Figure 7 This is a diagram of the neuropathic pain assessment scale (DN4) in the present invention;

[0060] Figure 8 This is the Toronto clinical score chart in the present invention;

[0061] Fig. 9 It is a diagram of the Hospital Anxiety and Depression Scale (HADS) of the present invention;

[0062] Fig.10 This is the SF-36 quality of life assessment scale in the present invention;

[0063] Fig.11 This is the third edition of the quantitative scoring system for analgesics (MQS-III) in the present invention. DETAILED DESCRIPTION

[0064] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0065] The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.

[0066] In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limiting. Therefore, other examples of the exemplary embodiments may have different values.

[0067] The present invention relates to the field of medical technology, and specifically provides a method for evaluating the effect of surgical decompression treatment of PDPN, comprising: step one: performing a complete evaluation and examination on a subject; step two: randomly allocating the subjects who meet the requirements after the evaluation and examination in step one to a surgical group and a non-surgical group, wherein the evaluation of the subjects includes medical history collection, physical examination, blood test and electrophysiological examination; the present invention, for a method for evaluating the effect of surgical decompression treatment of PDPN, establishes a set of accurate and measurable evaluation methods, utilizes the method of randomized controlled trials to evaluate the therapeutic effect of decompression surgery, and achieves the ability to comprehensively evaluate PDPN and understand the specific effects of the treatment plan, thereby achieving the efficacy of triple nerve decompression on PDPN patients indicating nerve compression.

[0068] Example 1 A method for evaluating the effect of surgical decompression in the treatment of PDPN

[0069] In this embodiment, the effect evaluation method specifically includes the following steps:

[0070] Step 1: Conduct a complete assessment of the subject;

[0071] Step 2: Subjects who meet the requirements after evaluation and examination (inclusion and exclusion criteria are shown below) are randomly assigned to the surgical group and the non-surgical group for analysis;

[0072] In step one,

[0073] The present invention further specifically details that the subject's assessment includes history collection, physical examination, blood test, neuroelectrophysiological examination and high-frequency neuro-ultrasound;

[0074] The medical history collection includes the patient's basic information, including gender, age, height, weight (further calculation of body mass index), course of diabetes and hypoglycemic regimen (drugs, dosage, duration of medication), course of pain and medication regimen (drugs, dosage, duration of medication), previous history of smoking and drinking, previous medical history, surgical history, clinical symptoms related to diabetic peripheral neuropathy, such as tingling, burning pain, numbness, dry skin, cracked feet, foot infection, soreness and weakness, etc.

[0075] The physical examination includes vital signs, physical examination related to diabetic peripheral neuropathy, including superficial sensation (pain, touch, temperature), deep sensation (motion, position, vibration), complex sensation (positioning, two-point discrimination, pattern), reflexes (knee jerk, ankle jerk), etc.

[0076] The blood tests include routine blood tests, routine coagulation tests, liver and kidney function tests, blood lipids, fasting blood sugar, glycosylated hemoglobin, etc.

[0077] The neuroelectrophysiological examination: specifically, the electrophysiological index test was performed by two skilled technicians in an indoor environment of 25°C using an electromyograph (Medtronic, Denmark); specifically, the subjects were asked to relax their lower limbs in a supine position, with their skin temperature maintained above 32°C, and the conduction velocity (NCV) and amplitude of the bilateral posterior tibial nerve and common peroneal nerve were detected, and the sensory nerve conduction velocity and amplitude of the bilateral deep peroneal nerve were detected.

[0078] The high-frequency nerve ultrasound is performed using a high-frequency ultrasound probe to detect the bilateral posterior tibial nerves and their plantar branches, the common peroneal nerve and its deep peroneal nerve branches, and observe nerve morphology, including the longitudinal fiber bundle morphology and the internal morphology of the cross-sectional nerves, and quantify the nerve cross-sectional length, short axis distance and area.

[0079] In step 2,

[0080] The surgical group, the surgical group and the non-surgical group were clinically evaluated before and after surgery using visual analog scale (VAS), two-point discrimination, Michigan Diabetic Neuropathy Screening Form (MNSI), Neuropathic Pain Rating Scale (DN4), Toronto Clinical Score, Hospital Anxiety and Depression Scale (HADS), SF-36 Quality of Life Assessment Scale, MQS-III, neuroelectrophysiological examination, and high-frequency nerve ultrasound.

[0081] The criteria for meeting the requirements of the assessment include inclusion criteria and exclusion criteria, where the inclusion criteria include: 1) diagnosed with type 2 diabetes according to the 1999 WHO diabetes diagnostic criteria; 2) aged between 40 and 70 years old; 3) assessment of neuropathy: Michigan Diabetic Neuropathy Screening Form (MNSI) greater than 2 points; 4) blood sugar control: fasting blood glucose less than 8mmol / L, glycosylated hemoglobin less than 8%; 5) assessment of neuropathic pain: neuropathic pain symptoms are distributed in the sensory distribution areas of the common peroneal nerve, posterior tibial nerve, and deep tibial nerve, the pain symptoms last for more than 6 months, and the VAS score is greater than 4 points; 6) neuroelectrophysiological examination indicates abnormal nerve conduction velocity (greater than two standard deviations) in more than one nerve including the common peroneal nerve, posterior tibial nerve or deep peroneal nerve. Exclusion criteria include: 1) patients with other injuries or medications that may cause peripheral neuropathy, such as pernicious anemia, hypothyroidism, lower limb vascular disease (absence or weakening of dorsalis pedis artery fluctuations, varicose veins, etc.); history of lower limb trauma or surgery; history of drug use such as vincristine, phenytoin sodium; history of heavy metal poisoning, etc.; 2) patients with alcohol or drug addiction or abuse within 1 year of enrollment; 3) patients with lumbar stenosis or discogenic neuropathy; 4) patients with lower limb edema caused by various reasons; 5) patients with severe hemorrhagic diseases or bleeding tendencies; 6) patients with organ dysfunction such as heart, lung, liver, and kidney who are difficult to tolerate surgery or medication, such as creatinine clearance ≤30mL / min; 7) patients whose compliance is affected by mental disorders and other factors; 8) patients with rheumatic and rheumatoid diseases, etc.; 9) patients participating in other clinical trials.

[0082] As can be seen from the above, the primary outcome will be measured by a 50% response rate, which is defined as the proportion of subjects whose pain visual analogue score (VAS) is reduced by at least 50% from baseline after 6 months of treatment. Follow-up will be conducted 1 week (W1), 1 month (M1), 3 months (M3), and 6 months (M6) after treatment, and VAS scores, two-point discrimination, and Toronto clinical scores will be performed to monitor changes in pain intensity, sensory changes, and improvements in neurological function. Follow-up will be conducted 3 months and 6 months after treatment, and neurophysiological, HADS, and SF-36 quality of life assessment scales will be evaluated.

[0083] The above operations produced the following results: the visual analogue scale (VAS), hospital anxiety and depression scale (HADS) scores, nerve conduction velocity (NCV), and high-frequency nerve ultrasound (nerve cross-sectional area, CSA) scores of the surgical group were significantly improved (P<0.05).

[0084] In the surgical subgroups grouped by the presence or absence of mechanical allodynia (MA), patients with positive MA signs showed improvements in pain, psychological status (anxiety, depression), NCV, and CSA (P<0.05), while patients without MA signs only showed improvements in pain, psychological status (anxiety, depression), and CSA (P<0.05), but no statistically significant improvement in NCV (P>0.05). In addition, MA patients had better pain relief compared with non-MA patients (P<0.05).

[0085] Specific data and results of this example:

[0086] A total of 192 subjects (patients) were included in this embodiment, and all subjects were diagnosed with PDPN according to the above inclusion and exclusion criteria, including 148 subjects in the surgical group (57 males and 91 females) and 44 subjects in the non-surgical group (20 males and 24 females). All subjects were followed up after treatment. During the follow-up period, 5 subjects in the surgical group and 2 subjects in the non-surgical group were ultimately excluded from the study due to loss of follow-up. After reviewing the medical history, the subjects in the surgical group and the non-surgical group were further divided into subgroups according to the presence or absence of mechanical allodynia (MA). The subjects underwent routine examinations in the department of the applicant at the time of enrollment (surgical group and non-surgical group) and follow-up examinations. MA signs were detected in 65 subjects in the surgical group and 19 subjects in the non-surgical group. Therefore, the subjects were divided into four subgroups. Table 1 summarizes the baseline characteristics of each group of subjects.

[0087] Table 1. Clinical characteristics of subjects in the four subgroups

[0088]

[0089] Data are shown as mean ± SD.

[0090] pain

[0091] The subjects in the surgical group had a significant reduction in pain within 6 months after surgery, and the pain severity continued to decrease for the next 2 years (P<0.05). In contrast, the mean VAS of the subjects in the non-surgical group remained at the same level (P>0.05). After 2 years of follow-up, the VAS scores of the subjects in the surgical group (2.3±1.6) were lower than those in the non-surgical group (7.9±0.8, P<0.05). In both surgical subgroups, the mean VAS of the subjects decreased significantly after surgery (P<0.05). In addition, at all postoperative test time points, the mean VAS of MA subjects (MA(+)) was significantly lower than that of non-MA subjects (MA(-)) (P<0.05). There was no significant difference between the two non-surgical subgroups (P>0.05), and the mean VAS of both non-surgical subgroups did not improve (P>0.05) ( Figure 2 ).

[0092] Mental state (anxiety, depression)

[0093] Most PDPN patients had varying degrees of anxiety and depression. The anxiety and depression scales of the surgical group subjects were significantly reduced 2 years after surgery (P<0.05); however, in the non-surgical group subjects, there was no significant change in anxiety or depression after 2 years (P>0.05). In the two surgical subgroups of subjects, the Hospital Anxiety and Depression Scale was significantly reduced 2 years after surgery (P<0.05). In contrast, there was no significant improvement in the two non-surgical subgroups after 2 years (P>0.05). Regarding the degree of improvement in the Hospital Anxiety and Depression Scale, there was no significant difference between the two surgical subgroups of subjects (P>0.05) ( Figure 3 ).

[0094] Nerve conduction velocity

[0095] At 24 months after surgery, the mean NCV of the surgical group subjects increased significantly compared with the preoperative level (P<0.05), while the mean NCV of the non-surgical group subjects remained almost unchanged after two years of follow-up (P>0.05). Among the four subgroups, only the mean NCV of the surgical group MA subjects improved (P<0.05). There were no statistically significant differences between the preoperative and postoperative NCV in the other three subgroups (P>0.05) (Table 2).

[0096] Table 2. Nerve conduction velocity (NCV) of PDPN subjects before and after surgery

[0097]

[0098] *24 months post-surgery.

[0099] #There was a significant difference between preoperative and postoperative (P<0.05).

[0100] Data are shown as mean ± SD.

[0101] High-frequency nerve ultrasonography

[0102] The spindle-shaped swelling of the nerve, intraneural hypoechoicity, and lack of intraneural parallel and linear structures are often seen in high-frequency nerve ultrasound images in most patients with PDPN. After nerve decompression surgery, the nerve structure was restored and the swelling subsided in most patients. As shown in Table 3, the CSA of the subjects in the surgical group became smaller after two years of follow-up (P<0.05), while the CSA of the subjects in the non-surgical group remained almost unchanged (P>0.05). Similarly, the subjects in both subgroups of the surgical group achieved recovery of CSA two years after surgery (P<0.05), and there was no statistically significant difference in the degree of improvement between the two subgroups (P>0.05). However, in both subgroups of the non-surgical group, there was almost no change in CSA during the follow-up period (P>0.05).

[0103] Table 3. Nerve cross-sectional area (CSA) of PDPN subjects before and after surgery

[0104]

[0105] *24 months post-surgery.

[0106] #There was a significant difference between preoperative and postoperative (P<0.05).

[0107] Data are shown as mean ± SD.

[0108] Conclusion: Mechanical allodynia (MA) is a reliable predictor of prognosis after PDPN surgery.

[0109] The present invention further specifically describes that the first-line treatment of PDPN includes several drugs, including anticonvulsants (pregabalin or gabapentin), serotonin and norepinephrine reuptake inhibitors (SNRIs; duloxetine) and tricyclic antidepressants (amitriptyline), which act on both the surgical and non-surgical groups.

[0110] Specifically, visual analogue scale (VAS), two-point discrimination, hospital anxiety and depression scale (HADS), nerve conduction velocity (NCV), and high-frequency nerve ultrasound (nerve cross-sectional area, CSA) were used for clinical evaluation before and after surgery.

[0111] From the above, we can see that Figure 2 As shown in the data, the VAS scores of the surgical group and the non-surgical group were significantly lower than those of the non-surgical group during the follow-up period. The surgical group and the non-surgical group were divided into two subgroups according to the presence or absence of mechanical allodynia (MA). The VAS scores of the four subgroups were lower than those of the two non-surgical groups. In the surgical group, the average postoperative VASs of the MA subjects (MA(+)) in the surgical group were lower than those of the non-MA subjects (MA(-)) in the surgical group (P<0.05), while there was no significant difference between the two non-surgical subgroups (P>0.05).

[0112] Subjects in the surgical group will undergo triple nerve decompression within 2 weeks after randomization. During the entire study period after surgery, if subjects still suffer from diabetic neuropathic pain, they are allowed to use analgesics, which will be carefully evaluated and differentiated from short-term postoperative incisional pain. As in previous studies, Dellon's triple nerve decompression of the posterior tibial nerve and the common and deep peroneal nerves of both lower limbs will be performed by the same senior surgeon under general anesthesia.

[0113] From the above, we can see that Figure 3 As shown:

[0114] 1. The HADS-A (anxiety rating) results of the surgical group and the non-surgical group showed that the score of the surgical group was lower than that of the non-surgical group 2 years after surgery (P<0.05). After 2 years, there was no significant change in the non-surgical group.

[0115] 2. HADS-D (depression rating) results of the surgical group and the non-surgical group. Similarly, the scores of the surgical group were lower 2 years after surgery (P<0.05), while there was no significant change in the non-surgical group;

[0116] 3. 4 Subgroup HADS-A results: The scores of both groups were lower than those of the non-surgical group 2 years after surgery (P<0.05). After 2 years, there was no significant change in the two non-surgical subgroups;

[0117] 4. HADS-D results of the 4 subgroups: 2 years after surgery, the scores of the two surgical subgroups were lower (P<0.05), while there was no significant change in the two non-surgical subgroups.

[0118] In summary, the present invention aims at a method for evaluating the effect of surgical decompression in the treatment of PDPN, establishes a set of accurate and measurable evaluation methods, and uses the method of randomized controlled trials to evaluate the therapeutic effect of decompression surgery.

[0119] Results: Compared with the non-surgical group, the surgical group showed improvements in VAS and HADS levels, NCV, and CSA results (P<0.05). In the surgical subgroup, subjects with positive MA signs showed improvements in pain, psychological status, NCV, and CSA (P<0.05), while subjects without MA signs only observed improvements in pain, psychological status, and CSA (P<0.05), while NCV did not show statistically significant improvements (P>0.05). In addition, MA subjects had superior pain relief compared with non-MA subjects (P<0.05).

[0120] Conclusion: Surgical decompression can help improve pain in patients with PDPN, restore nerve conduction velocity and peripheral nerve morphology, and improve related anxiety and depression symptoms. MA is a reliable predictor of prognosis after PDPN surgery.

[0121] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0122] As used in the present invention, the term "comprising" is an open expression, that is, including the contents specified in the present invention but not excluding other contents.

[0123] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0124] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A method for evaluating the effect of surgical decompression in the treatment of PDPN, characterized in that: The effect evaluation method comprises the following steps: Step 1: Conduct a complete assessment of the subject, including history collection, physical examination, blood test, neuroelectrophysiological examination, and high-frequency neuroultrasound; Step 2: The subjects who meet the requirements after the evaluation and examination described in step 1 are randomly assigned to the surgical group and the non-surgical group for analysis.

2. The effect evaluation method according to claim 1, characterized in that: In the step 1, The medical history collection includes the patient's basic information, diabetes course and glucose-lowering regimen, pain course and medication regimen, previous history of smoking and drinking, previous medical history, surgical history, and clinical symptoms related to diabetic peripheral neuropathy; and / or, The physical examination includes vital signs, physical examination related to diabetic peripheral neuropathy; and / or, The blood tests include blood routine, coagulation routine, liver and kidney function, blood lipids, fasting blood sugar, and glycosylated hemoglobin; The neuroelectrophysiological examination is performed using an electromyograph, which includes detecting the motor conduction velocity and amplitude of the bilateral posterior tibial nerve and common peroneal nerve, and detecting the sensory nerve conduction velocity and amplitude of the bilateral deep peroneal nerve; The high-frequency nerve ultrasound is performed using a high-frequency ultrasound probe, which includes detecting the bilateral posterior tibial nerves and their plantar branches, the common peroneal nerve and its deep peroneal nerve branches, observing the nerve morphology including the longitudinal fiber bundle morphology and the internal morphology of the cross-sectional nerve, and quantifying the nerve cross-sectional length, short axis distance and area.

3. The effect evaluation method according to claim 2, characterized in that: The patient's basic information includes gender, age, height, weight; and / or, The glucose-lowering regimen includes drugs, dosages, and duration of medication; and / or, The medication regimen includes drugs, dosage, and duration of medication; and / or, The clinical symptoms associated with diabetic peripheral neuropathy include tingling, burning pain, numbness, dry skin, cracked feet, foot infection, soreness and weakness; and / or, The physical examination includes superficial sensation, deep sensation, combined sensation, and reflexes; and / or, In the neuroelectrophysiological examination, the motor conduction velocity of the bilateral common peroneal nerves across the fibular head area was mainly decreased, and the conduction velocity of the bilateral posterior tibial nerves across the medial malleolus was mainly decreased, supplemented by observing the amplitude changes of the bilateral posterior tibial nerves, common peroneal nerves, and the conduction velocity and amplitude changes of the bilateral deep peroneal nerves.

4. The effect evaluation method according to claim 3, characterized in that: The superficial sensations include pain, touch, and temperature; and / or, The deep senses include motion sense, position sense, vibration sense; and / or, The composite sense includes positioning sense, two-point discrimination sense, and pattern sense; and / or, The reflexes include knee jerk and ankle jerk.

5. The effect evaluation method according to claim 1, characterized in that: In the step 2, The surgical group, the surgical group, and the non-surgical group were clinically evaluated using visual analog scale (VAS), two-point discrimination, Michigan Diabetic Neuropathy Screening Form (MNSI), Neuropathic Pain Rating Scale (DN4), Toronto Clinical Score, Hospital Anxiety and Depression Scale (HADS), SF-36 Quality of Life Assessment Scale, Quantitative Medication Score-III (MQS-III), neurophysiological examination, and high-frequency nerve ultrasound before and after surgery; and / or, The criteria for meeting the requirements after the evaluation and examination include inclusion criteria and exclusion criteria; wherein, the inclusion criteria are: 1) diagnosed with type 2 diabetes according to the 1999 WHO diabetes diagnostic criteria; 2) aged between 40 and 70 years old; 3) assessment of neuropathy: Michigan Diabetic Neuropathy Screening Scale (MNSI) greater than 2 points; 4) blood sugar control: fasting blood sugar less than 8mmol / L, glycosylated hemoglobin less than 8%; 5) assessment of neuropathic pain: neuropathic pain symptoms are distributed in the sensory distribution areas of the common peroneal nerve, posterior tibial nerve, and deep tibial nerve, the pain symptoms last for more than 6 months, and the VAS score is greater than 4 points; 6) neuroelectrophysiology Examinations indicated abnormal nerve conduction velocity (greater than two standard deviations) in more than one nerve including the common peroneal nerve, posterior tibial nerve or deep peroneal nerve; the exclusion criteria were: 1) the presence of other injuries or medication history that may cause peripheral neuropathy; history of lower limb trauma or surgery; history of drug use; history of heavy metal poisoning; 2) history of alcohol or drug addiction or abuse within 1 year of enrollment; 3) lumbar stenosis or discogenic neuropathy; 4) lower limb edema caused by various reasons; 5) patients with severe hemorrhagic diseases or bleeding tendencies; 6) patients with heart, lung, liver, and kidney dysfunction who are unable to tolerate surgery or medication; 8) rheumatic and rheumatoid diseases; 9) patients participating in other clinical trials.

6. The effect evaluation method according to claim 5, characterized in that: The visual analog scale includes: asking the patient about the subjective pain level, with 0 being no pain and 10 being the most intolerable pain, and making a subjective score; and / or, The two-point discrimination sense: the two-point discrimination sense is measured in three areas: the dorsum of the foot (proximal end of the third toe), the medial plantar sole, and the lateral plantar sole, and the average value is taken after three repetitions; and / or, The Michigan Diabetic Peripheral Neuropathy Screening Form includes: a screening questionnaire and a physical examination; and / or, the neuropathic pain assessment scale includes: 10 yes / no questions, with "yes" being 1 point and "no" being no point; and / or, The Toronto Clinical Score includes: symptom score, reflex score and sensory test score, with the maximum score being 19 points; and / or, The Hospital Anxiety and Depression Scale includes: 14 items, 7 of which are for depression and 7 for anxiety; each item is scored on a 4-point scale, with the higher the score, the more severe the symptom; and / or, The SF-36 quality of life assessment scale includes: physical function, physical role, bodily pain, general health, energy, social function, emotional role, mental health, health changes; and / or, The third edition of the MQS-III includes: a quantitative drug score obtained by evaluating drugs, doses, weights, and dose levels to comprehensively quantify the use of prescription drugs for chronic non-malignant pain; and / or, The neuroelectrophysiological examination is performed by personnel with neuroelectrophysiology qualifications using neuroelectrophysiology examination equipment to perform neuroelectrophysiological examinations on the posterior tibial nerve, common peroneal nerve and its branches of both lower limbs, including examinations of nerve conduction velocity, compound muscle action potential and latency, in particular, examinations of nerve conduction velocity at the posterior tibial nerve across the medial malleolus, at the common peroneal nerve across the fibular head, and at the deep peroneal nerve across the extensor pollicis brevis tendon; and / or, The high-frequency nerve ultrasound is performed by an experienced ultrasound physician using a high-frequency ultrasound probe to examine the continuity and internal echo condition of the posterior tibial nerve and the common peroneal nerve, measure the anteroposterior diameter and transverse diameter of the nerve, and calculate the nerve cross-sectional area of ​​the common peroneal nerve and the posterior tibial nerve using the formula: S=π*(D1×D2 / 4), where D1 is the anteroposterior diameter of the nerve, D2 is the transverse diameter of the nerve, S is the nerve cross-sectional area, and π is pi.

7. The effect evaluation method according to claim 1, characterized in that: The primary outcome of the efficacy assessment method was measured as the 50% responder rate, which was defined as the proportion of subjects with at least a 50% reduction in the mean weekly visual analogue scale for pain from baseline after 6 months of treatment.

8. The effect evaluation method according to claim 1, characterized in that: In the step 2, the surgical group and the non-surgical group also took the first-line treatment drugs for PDPN including anticonvulsants, serotonin and norepinephrine reuptake inhibitors, and tricyclic antidepressants.

9. A system for evaluating the effect of surgical decompression treatment of PDPN, characterized in that: include: A memory and a processor; a computer program is stored in the memory, and when the computer program is executed by the processor, the method according to any one of claims 1 to 8 is implemented.

10. Use of the effect evaluation method according to any one of claims 1 to 8 or the effect evaluation system according to claim 9 in the effect evaluation of surgical decompression treatment of PDPN.

11. A prognosis prediction index for surgical decompression treatment of PDPN, characterized in that: The prognostic predictor is mechanical allodynia.

12. Use of the prognostic prediction index according to claim 11 in predicting the prognosis of surgical decompression treatment of PDPN.

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