Method and system for evaluating curative effect of oral neifen' anpian combined with acupoint sticking for insomnia of heart-kidney disharmony type

Abstract

This invention belongs to the field of clinical efficacy evaluation technology, specifically relating to a method and system for evaluating the efficacy of oral antisleep granules combined with acupoint application in treating insomnia of the heart-kidney disharmony type. The method includes the following steps: selecting subjects to form an observation group and a control group; the control group receiving oral zopiclone tablets; the observation group receiving the same treatment as the control group, combined with oral antisleep granules and acupoint application; observing and comparing indicators: comparing the indicators of the control group before and after treatment with those of the observation group before and after treatment to obtain the efficacy difference between the two groups. The indicators include: a Traditional Chinese Medicine (TCM) syndrome score, where a scale is used to score difficulty falling asleep, shallow sleep with easy awakening / difficulty falling back asleep after waking, early awakening, and lower back and knee weakness. The efficacy evaluation method and system of this application can evaluate the efficacy of oral antisleep granules combined with acupoint application in treating insomnia of the heart-kidney disharmony type.

Description

Technical Field

[0001] The present invention belongs to the technical field of clinical efficacy evaluation, and specifically relates to an efficacy evaluation method and system for treating insomnia of the type of disharmony between the heart and the kidney by taking Ansui Granules orally combined with acupoint application. Background Art

[0002] Insomnia is a sleep disorder characterized by persistent difficulty in falling asleep, sleep maintenance disorder or early awakening, and resulting in impaired daytime function. According to the definition of the "International Classification of Sleep Disorders (Third Edition)" (ICSD-3), a course of disease ≥ 3 months and the appearance of symptoms ≥ 3 times per week can be diagnosed as chronic insomnia.

[0003] Epidemiological studies show that the incidence of chronic sleep disorders in the adult population in China has exceeded 50%. Clinical findings show that persistent insomnia not only causes neuropsychological function damage, but also induces secondary mood disorders mainly manifested by anxiety and depressive symptoms, and the risk of self-harm is significantly increased in severe cases.

[0004] Modern medical treatment mainly uses benzodiazepines and non-benzodiazepines. The short-term efficacy is clear, but long-term use is likely to cause drug dependence, daytime sleepiness and cognitive function decline. Some patients even show varying degrees of central inhibition or respiratory inhibition reactions, and there is an urgent need to explore a safer and more effective alternative plan. Traditional Chinese medicine theory classifies insomnia into the category of "insomnia", and the type of disharmony between the heart and the kidney is an important syndrome type, and the treatment should nourish the kidney and soothe the heart, calm the mind and tranquilize the spirit.

[0005] In recent years, the combination of traditional Chinese medicine compound and external treatment methods has attracted much attention due to its multi-target regulation advantages. Ansui Granules is a commonly used proprietary Chinese medicine, which has the functions of regulating the heart and kidney, calming the mind and tranquilizing the spirit, and can be used for the treatment of insomnia of the type of disharmony between the heart and the kidney; Acupoint application, as a characteristic of traditional Chinese medicine external treatment, selects specific acupoints, and with the dual effects of drug transdermal absorption and meridian stimulation, can regulate the balance of the autonomic nervous system and has a definite curative effect on insomnia.

[0006] However, there is currently a lack of special research on the combined treatment of taking Ansui Granules orally and acupoint application for insomnia of the type of disharmony between the heart and the kidney. Based on this, this patent application aims to provide an evaluation method that can systematically evaluate the clinical efficacy of the combination of taking Ansui Granules orally and acupoint application for insomnia of the type of disharmony between the heart and the kidney. Summary of the Invention

[0007] The purpose of the present invention is to provide an evaluation method and system that can systematically evaluate the clinical efficacy of the combination of taking Ansui Granules orally and acupoint application for insomnia of the type of disharmony between the heart and the kidney.

[0008] The present invention claims an evaluation method that can systematically evaluate the clinical efficacy of the combination of taking Ansui Granules orally and acupoint application for insomnia of the type of disharmony between the heart and the kidney, including: Selecting test subjects to form an observation group and a control group, and the number of people in the observation group is the same as that in the control group; The control group received oral zopiclone tablets; the observation group received the same treatment as the control group, combined with oral administration of Anshui Chongji (a traditional Chinese medicine) and acupoint application. Observe and compare indicators: Compare the indicators of the control group before and after treatment with those of the observation group before and after treatment to obtain the difference in efficacy between the two groups. The indicators include: Traditional Chinese Medicine syndrome score. The TCM syndrome score is based on a scale developed according to the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)" to score difficulty falling asleep, light sleep and easy awakening / difficulty falling back asleep after waking up, early awakening, and soreness and weakness in the lower back and knees.

[0009] As a preferred technical solution, the indicators also include: functional scale scores, which include: Pittsburgh Sleep Quality Index, Insomnia Severity Index, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and Sleep Guidance Map.

[0010] As a preferred technical solution, the indicators also include: neurotransmitter indicators, clinical efficacy, and treatment safety.

[0011] As a preferred technical solution, the post-treatment indicator is one course of treatment and / or two courses of treatment. When the post-treatment indicator is one course of treatment and two courses of treatment, the efficacy of one course of treatment and the efficacy of two courses of treatment are compared to obtain the difference in efficacy between one course of treatment and two courses of treatment, and the optimal treatment plan is evaluated.

[0012] As a preferred technical approach, a telephone follow-up was conducted one month after the end of treatment. The PSQI scale and the TCM syndrome scoring scale were completed and compared with the efficacy before treatment, at the end of one course of treatment, and at the end of two courses of treatment to assess whether there was any rebound in efficacy after the end of treatment.

[0013] This application also discloses a clinical efficacy evaluation system for insomnia caused by heart-kidney disharmony, which combines oral administration and acupoint application, using the aforementioned method for evaluating the clinical efficacy of oral administration and acupoint application for insomnia caused by heart-kidney disharmony.

[0014] The method and system for evaluating the efficacy of oral antisleep powder combined with acupoint application in treating insomnia of the heart-kidney disharmony type, as described in this application, can evaluate the efficacy of oral antisleep powder combined with acupoint application in treating insomnia of the heart-kidney disharmony type, explore and evaluate the effectiveness and safety of comprehensive TCM therapy for insomnia, and provide new ideas for TCM clinical treatment of insomnia. Attached Figure Description

[0015] Figure 1 This is a flowchart illustrating the steps of the method for evaluating the efficacy of the oral sleep aid powder combined with acupoint application in treating insomnia of the heart-kidney disharmony type according to the present invention. Figure 2This is a flowchart illustrating the efficacy evaluation method for treating insomnia of the heart-kidney disharmony type using oral sleep aid powder combined with acupoint application according to the present invention. Detailed Implementation

[0016] Example 1, referring to Figure 1 and 2 : An evaluation method for systematically assessing the clinical efficacy of oral administration of a sleeping pill combined with acupoint application for insomnia due to heart-kidney disharmony includes: Subjects were selected to form an observation group and a control group, with the same number of subjects in both groups. This was a prospective randomized controlled trial, approved by the hospital's ethics committee. The sample size was calculated using PASS 15.0 software (α=0.05, β=0.2, effect size 0.35). A total of 120 patients with heart-renal disharmony type insomnia who met the criteria between January 2022 and January 2024 were included and randomly divided into an observation group and a control group, with 60 patients in each group. The observation group consisted of 28 males and 32 females; age ranged from 28 to 63 years, with a mean age of (45.32±5.17) years; disease duration ranged from 7 months to 3 years, with a mean duration of (14.61±2.33) months. The control group consisted of 26 males and 34 females; age ranged from 30 to 65 years, with a mean age of (46.10±5.12) years; disease duration ranged from 6 months to 3 years, with a mean duration of (14.65±2.37) months. Statistical analysis of the baseline data of the two groups showed no significant differences (P>0.05), indicating good balance between the groups and meeting the requirements for clinical control.

[0017] The diagnostic criteria for the subjects were: According to the International Classification of Sleep Disorders (3rd Edition) (ICSD-3): 1) Chief complaint of difficulty falling asleep, difficulty maintaining sleep, or early awakening; 2) Symptoms ≥3 times per week for ≥3 months; 3) Impaired daytime function (e.g., fatigue, decreased attention); 4) Pittsburgh Sleep Quality Index (PSQI) score >7; 5) Exclusion of insomnia secondary to medication, physical illness, or other mental disorders. According to Traditional Chinese Medicine Internal Medicine, the syndrome is diagnosed as Heart-Kidney Disharmony Type: Chief symptoms include difficulty falling asleep, shallow sleep with frequent awakenings / difficulty falling back asleep, early awakening, and in severe cases, complete sleeplessness; Secondary symptoms include dry throat with little saliva, palpitations, lower back and knee weakness, night sweats, dizziness, tinnitus, flushed cheeks, irritability, mouth and tongue sores, constipation, seminal emission / impotence in men, and menstrual irregularities in women; Tongue and pulse characteristics: red tongue tip with little coating, thready and rapid pulse. Meeting 1 chief symptom + ≥2 secondary symptom groups + characteristic tongue and pulse characteristics.

[0018] The inclusion criteria for the subjects were: 1) Age 18-75 years; 2) Meets the above diagnostic criteria for insomnia and the diagnostic criteria for heart-kidney disharmony; 3) Duration of illness ≥ 4 weeks; 4) Has not used sedative-hypnotic drugs in the past week; 5) Signs informed consent form and voluntarily participates in the study; 6) Has basic communication skills and can cooperate with the scale assessment.

[0019] The exclusion criteria for the subjects are as follows: 1) Those with severe primary diseases involving multiple organ systems (circulatory / respiratory / liver and kidney / hematopoietic system); 2) Those with insomnia caused by systemic pathological conditions such as pain syndrome, infectious fever, airway hyperresponsiveness, etc.; 3) Those with insomnia related to medical interventions; 4) Those with sleep disorders induced by exogenous environmental disturbances; 5) Those with a history of mental diseases such as schizophrenia and bipolar disorder; 6) Pregnant / lactating women; 7) Those with alcoholism or drug abuse; 8) Those known to be allergic to the study drug; 9) Those who participated in other clinical trials within the past 3 months.

[0020] The criteria for subject dropout and exclusion are as follows: 1) Those who were lost to follow-up or withdrew on their own during the treatment; 2) Those who did not take the medicine according to the protocol; 3) Those who had serious adverse events and needed to terminate the treatment (such as anaphylactic shock); 4) Those who used other sedative drugs or received acupuncture treatment during the study; 5) Those with incomplete data records that affected the determination of the curative effect.

[0021] The treatment method for the subjects is as follows: The control group took 3.75 mg of Zopiclone Tablets (Qilu Pharmaceutical Co., Ltd., National Medicine Approval No. H10980162, specification: 3.75 mg) orally, 30 minutes before going to bed every night. One course of treatment was 4 weeks, and 2 consecutive courses of treatment were given (for a total of 8 weeks). The observation group was treated with Ansui Granules taken orally + acupoint application on the basis of the treatment of the control group: The drug composition included 10 g of fried Semen Ziziphi Spinosae, 10 g of Ophiopogon japonicus, 15 g of Pseudostellaria heterophylla, 15 g of Caulis Polygoni Multiflori, 5 g of Schisandra chinensis, 15 g of Salvia miltiorrhiza, etc. The drug was made into 10 g / bag granules through standardized processes such as raw material preparation, ingredient mixing, granulation, and drying. It was taken 2 times a day (1 bag each in the morning and 1 hour before going to bed), taken with warm water, and treated continuously for 8 weeks. For acupoint application, a total of 9 acupoints including bilateral Neiguan, Yongquan, Xinshu, Shenshu, and Mingmen were selected. The powder of Evodia rutaecarpa and magnetite powder were mixed in a ratio of 3:1, and the paste was prepared with white vinegar and applied to the acupoints. The dosage of each acupoint was about 1 g, once every other day, and each time was retained for 6 - 8 hours. Other sedative drugs were prohibited during the treatment, and the acupoint application was performed by professional nurses, and the treatment was continuous for 8 weeks.

[0022] The observation indexes of the subjects were compared: The indexes before and after treatment in the control group were compared with the indexes before and after treatment in the observation group to obtain the curative effect differences between the control group and the observation group.

[0023] The indicators include: Traditional Chinese Medicine syndrome score: a scale was developed based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" to score difficulty falling asleep, light sleep and easy awakening / difficulty falling back asleep after waking up, early awakening, and soreness and weakness of the waist and knees. ① Difficulty falling asleep: 0 points (none); 2 points (falls asleep in 30-60 minutes, ≤3 times / week); 4 points (falls asleep in 60-90 minutes, 4-5 times / week); 6 points (falls asleep in >90 minutes, ≥6 times / week); ② Light sleep and easy awakening / difficulty falling back asleep: 0 points (none); 2 points (wakes up once at night and falls back asleep quickly); 4 points (wakes up 2-3 times at night or takes >30 minutes to fall back asleep); 6 points (wakes up ≥4 times at night / cannot fall back asleep); ③ Early awakening: 0 points (none); 2 points (wakes up 30-60 minutes early); 4 points (wakes up 1-2 hours early); 6 points (wakes up ≥2 hours early and cannot fall back asleep); ④ Lower back and knee pain: 0 points (none); 1 point (occasionally occurs after exertion); 2 points (requires rest after activity); 3 points (persistent and affects mobility). 1.7.2 Functional Scale Scoring: 1) Pittsburgh Sleep Quality Index (PSQI): The PSQI includes 7 components, such as sleep quality, sleep onset time, and sleep duration. Each component is scored from 0 to 3, for a total score of 0 to 21. A higher score indicates poorer sleep quality. 2) Insomnia Severity Index (ISI): 7 items, each scored from 0 to 4, for a total score of 0 to 28. Severity levels: 0-7 (no insomnia), 8-14 (mild), 15-21 (moderate), 22-28 (severe). 3) Self-Rating Anxiety Scale (SAS): 20 items, scored from 1 to 4 ("never / occasionally" to "always"). The standard score is calculated by multiplying the total score by 1.25. A score ≥50 indicates anxiety. 4) Self-Rating Depression Scale (SDS): 20 items, scoring is the same as the SAS. A score ≥53 indicates depression.

[0024] The indicators included: Polysomnography (PSG): A Philips Respironics Alice 6LDx polysomnography system was used for continuous monitoring for 8 hours, from 10:00 PM to 6:00 AM the following day. Analysis was conducted independently by two blinded technicians using a 30-second frame method, dividing the sleep into wakefulness (W), N1, N2, N3, and REM sleep stages. Total sleep time (TST) (total duration of N1+N2+N3+REM), sleep latency (SL) (time from lights out to the first occurrence of N1 / N2 / N3 sleep), number of awakenings (WASO) (number of awakenings ≥15 seconds during sleep), and REM sleep percentage (REM sleep duration / TST × 100%).

[0025] The indicators included: neurotransmitter indicators: 5 mL of fasting venous blood was collected in the morning, anticoagulated with EDTA, and centrifuged at 4°C (3000 rpm × 15 min) to separate the plasma. Dopamine (DA) and serotonin (5-HT) were detected by high-performance liquid chromatography-electrochemical detection method, melatonin (MT) was detected by enzyme-linked immunosorbent assay (ELISA), and γ-aminobutyric acid (GABA) was detected by high-performance liquid chromatography-fluorescence detection method.

[0026] The indicators include: Clinical efficacy: based on the Pittsburgh Sleep Quality Index (PSQI) score change rate: Clinically cured: PSQI score decrease ≥80%, sleep duration and daytime function return to normal range (total nighttime sleep time ≥6.5h, feeling energetic after waking); Significantly effective: 50%≤PSQI score decrease rate <80%, significantly improved sleep quality (sleep time increase ≥3h, sleep latency shortened ≥50%); Effective: 25%≤PSQI score decrease rate <50%, sleep problems partially relieved (sleep time increase <3h, mild daytime sleepiness still present); Ineffective: PSQI decrease rate <25%, symptoms no improvement or worsening. (Number of clinically cured + significantly effective + effective cases / total number of cases) × 100% = total effective rate.

[0027] The indicators include: treatment safety: recording the occurrence of adverse reactions in two groups, mainly including nausea, diarrhea, dizziness, drowsiness, skin itching, dry mouth, etc.

[0028] SPSS 24.0 software was used to analyze the data for the above-mentioned observation indicators of the subjects. Continuous data were expressed as mean ± standard deviation (±s), and independent samples t-tests were used for comparisons between groups. Categorical data were expressed as n, % and analyzed using χ² tests. A p-value < 0.05 was considered statistically significant. The following control table was obtained:

[0029]

[0030]

[0031]

[0032]

[0033]

[0034] By comparing the data of the control group and the observation group in the table above, we can see that: The PSQI, SAS, SDS, and ISI scales were used to evaluate the sleep quality, anxiety and depression status, and overall health status of insomnia patients. The study showed that after treatment, the scores of PSQI, SAS, SDS, and ISI in the treatment group were significantly lower than those in the control group (P < 0.05), indicating that taking Ansui Granules orally combined with acupoint application can effectively improve the sleep efficiency of patients with insomnia of heart-kidney disharmony type, shorten the sleep latency, prolong the sleep time, reduce nocturnal awakening and dreaminess, and at the same time relieve daytime fatigue and mood disorders, and promote the recovery of social function. The scores of traditional Chinese medicine syndromes and the total effective rate in the observation group were better than those in the control group (P < 0.05), confirming that simple western medicine treatment has limited regulation of accompanying symptoms, while traditional Chinese medicine combined with acupoint application can improve physical discomfort symptoms through mechanisms such as regulating the functions of zang-fu organs and nourishing the official collaterals. PSG is an important indicator for evaluating the sleep quality of insomnia patients. In this study, after treatment, SL and WASO in both groups decreased, and those in the observation group were lower than those in the control group (P < 0.05); after treatment, TST and the proportion of REM sleep in both groups increased, and those in the observation group were higher than those in the control group (P < 0.05). It was confirmed that taking Ansui Granules orally combined with acupoint application can significantly improve the sleep quality of patients with insomnia of heart-kidney disharmony type. Monoamine neurotransmitters regulate the sleep-wake rhythm and are closely related to central functions such as sleep and mood. As a key inhibitory neurotransmitter, 5-HT was confirmed as the first sleep regulatory factor, and studies have confirmed that a decrease in its concentration can lead to a decrease in sleep efficiency and quality. DA, as a wakefulness-maintaining neurotransmitter, phosphorylation of its transporter at the Thr53 site can regulate the reuptake of DA during the wakefulness period. MT affects the sleep rhythm by regulating the biological clock, manifested as shortening the sleep latency and enhancing slow-wave sleep. GABA, as a cortical inhibitory factor, a decrease in its content can activate the excitability of the frontal cortex and interfere with sleep maintenance. In this study, after treatment, DA, 5-HT, MT, and GABA in both groups increased, and those in the observation group were higher than those in the control group (P < 0.05), confirming that the combined treatment plan can effectively regulate the neurotransmitter levels of patients with insomnia of heart-kidney disharmony type, which may be the key mechanism for inhibiting excessive wakefulness in insomnia patients, regulating the sleep structure, and improving the sleep quality. There was no significant difference in the incidence of adverse reactions between the two groups (P > appreciate that the steps before or after do not necessarily proceed in exact order. On the contrary, they can be processed in reverse order or simultaneously. Also, other operations can be added to these processes.

[0035] Flowcharts are used in this application disclosure to illustrate the steps of the method according to the embodiments of this disclosure. It should be understood that the steps before or after do not necessarily proceed in exact order. On the contrary, they can be processed in reverse order or simultaneously. Also, other operations can be added to these processes.

[0036] Those skilled in the art will understand that all or part of the steps in the above methods can be implemented by a computer program instructing related hardware, and the program can be stored in a computer-readable storage medium, such as a read-only memory, a disk, or an optical disk. Optionally, all or part of the steps in the above embodiments can also be implemented using one or more integrated circuits. Accordingly, each module / unit in the above embodiments can be implemented in hardware or as a software functional module. This disclosure is not limited to any particular combination of hardware and software.

[0037] Unless otherwise defined, all terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. It should also be understood that terms such as those defined in a common dictionary should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and not as having an idealized or highly formalized meaning, unless expressly defined herein.

[0038] The foregoing description is intended to illustrate the present disclosure and should not be construed as limiting it. While several exemplary embodiments of the present disclosure have been described, those skilled in the art will readily understand that many modifications may be made to the exemplary embodiments without departing from the novel teachings and advantages of the present disclosure. Therefore, all such modifications are intended to be included within the scope of the present disclosure as defined by the claims. It should be understood that the foregoing description is intended to illustrate the present disclosure and should not be construed as limiting it to the specific embodiments disclosed, and modifications to the disclosed embodiments and other embodiments are intended to be included within the scope of the appended claims. The present disclosure is defined by the claims and their equivalents.

[0039] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0040] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A method for systematically evaluating the clinical efficacy of oral administration of a sleeping powder combined with acupoint application for insomnia due to heart-kidney disharmony, characterized in that, Includes the following steps: Subjects were selected to form an observation group and a control group, with the same number of subjects in both groups. The control group received oral zopiclone tablets; the observation group received the same treatment as the control group, combined with oral administration of Anshui Chongji (a traditional Chinese medicine) and acupoint application. Observe and compare indicators: Compare the indicators of the control group before and after treatment with those of the observation group before and after treatment to obtain the difference in efficacy between the two groups. The indicators include: Traditional Chinese Medicine syndrome score. The TCM syndrome score is a scale designed to score difficulty falling asleep, light sleep with easy awakening / difficulty falling back asleep after waking, early awakening, and soreness and weakness in the lower back and knees.

2. The evaluation method as described in claim 1, capable of systematically evaluating the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia due to heart-kidney disharmony, is characterized in that... The indicators also include: functional scale scores, PSG, neurotransmitter indicators, clinical efficacy indicators, and treatment safety indicators.

3. The evaluation method as described in claim 2, capable of systematically evaluating the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia due to heart-kidney disharmony, is characterized in that... The functional scale rating includes: Pittsburgh Sleep Quality Index; Insomnia Severity Index Scale; Anxiety Self-Rating Scale; Self-Rating Depression Scale.

4. The evaluation method as described in claim 2, capable of systematically evaluating the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia due to heart-kidney disharmony, is characterized in that... The PSG (Physical Sleep Monitoring System) was implemented using the Philips Respironics Alice 6LDx polysomnography system. The monitoring lasted for 8 consecutive hours from 10:00 PM to 6:00 AM the next day. The data was analyzed independently by two blind technicians using a 30-second frame method, divided into W, N1, N2, N3 and REM sleep stages. The total sleep time, sleep latency, number of awakenings and REM sleep percentage were recorded.

5. The evaluation method for systematically evaluating the clinical efficacy of oral administration of Anshui granules combined with acupoint application for insomnia due to heart-kidney disharmony, as described in any one of claims 1-4, is characterized in that... The method for selecting the test subjects is as follows: The sample size was calculated using PASS15.0 software. Patients with insomnia of the heart-kidney disharmony type who met the criteria were finally included and randomly divided into an observation group and a control group using a random number table. Statistical analysis showed that there were no significant differences in baseline data between the two groups, which met the requirements for clinical control.

6. The evaluation method as described in claim 5, capable of systematically evaluating the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia due to heart-kidney disharmony, is characterized in that... In the method for selecting the subjects, the Western medical diagnostic criteria for patients with insomnia due to heart-kidney disharmony are as follows: The patient's main complaint is difficulty falling asleep, sleep maintenance disorder, or early awakening. Symptoms occur ≥3 times per week and last ≥3 months; Impaired daytime function; Pittsburgh Sleep Quality Index score > 7; Exclude insomnia secondary to medication, physical illness, or other mental disorders.

7. The evaluation method as described in claim 6, capable of systematically evaluating the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia due to heart-kidney disharmony, is characterized in that... The selection method for the subjects, the TCM diagnostic criteria for patients with heart-kidney disharmony type insomnia are as follows: The syndrome is diagnosed as heart-kidney disharmony type: Primary symptoms: difficulty falling asleep, shallow sleep with easy awakening / difficulty falling back asleep after waking, early awakening, and in severe cases, sleeplessness throughout the night; Secondary symptoms: dry throat with little saliva, palpitations, soreness and weakness of the lower back and knees, night sweats, dizziness and tinnitus, flushed cheeks and hot flashes, mouth and tongue sores, constipation, seminal emission / impotence in men, and menstrual irregularities in women; red tongue tip with little coating, thready and rapid pulse, meeting 1 primary symptom + ≥2 secondary symptom group manifestations + characteristic tongue and pulse; The selection criteria for the subjects were as follows: Age 18-75; It meets the diagnostic criteria for insomnia and the diagnostic criteria for heart-kidney disharmony; The course of the disease is ≥4 weeks; No sedative-hypnotic drugs used in the past week; Sign an informed consent form and voluntarily participate in the research; Possesses basic communication skills and can cooperate with the assessment scale; The exclusion criteria in the selection method for the subjects are as follows: Patients with multiple organ system diseases and severe primary diseases; Insomnia caused by systemic pathological conditions such as pain syndrome, infectious fever, and airway hyperresponsiveness; Insomnia related to iatrogenic intervention; Individuals with sleep disorders induced by external environmental disturbances; Those with a history of comorbid mental illnesses such as schizophrenia or bipolar disorder; Pregnant / breastfeeding women; Alcoholics or drug abusers; Patients known to be allergic to the investigational drug; Participated in other clinical trials within the past 3 months; The selection criteria for test subjects are as follows: Those who were lost to follow-up or withdrew voluntarily during treatment; Those who fail to take medication as prescribed in the plan; Patients who require discontinuation of treatment due to serious adverse events; Those who used other sedatives or received acupuncture treatment during the study period; Incomplete data recording affects the assessment of treatment efficacy.

8. The evaluation method as described in claim 7, capable of systematically evaluating the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia due to heart-kidney disharmony, is characterized in that... The post-treatment indicators are defined as one course of treatment and / or two courses of treatment.

9. The evaluation method for systematically evaluating the clinical efficacy of oral administration of Anshui granules combined with acupoint application for insomnia due to heart-kidney disharmony, as described in any one of claims 1-8, is characterized in that... When the post-treatment indicators are one course of treatment and two courses of treatment, the efficacy of one course of treatment and the efficacy of two courses of treatment are compared to determine the difference in efficacy between the two courses. One month after the end of treatment, a telephone follow-up is conducted, and the PSQI scale and the Traditional Chinese Medicine syndrome scoring scale are completed. The results are compared with those before treatment, at the end of one course of treatment, and at the end of two courses of treatment to assess whether there is any rebound in efficacy after the treatment ends.

10. An evaluation system capable of systematically evaluating the clinical efficacy of oral administration of a sleeping powder combined with acupoint application for insomnia due to heart-kidney disharmony, characterized in that, The evaluation method described in any one of claims 1-9, which can systematically evaluate the clinical efficacy of combined oral administration of Anshui granules and acupoint application for insomnia of the heart-kidney disharmony type, is adopted.

Images