Application of substance for detecting NLR in preparation of product for predicting PONV risk after lumbar surgery and research method

Abstract

The invention discloses application of a substance for detecting NLR in preparation of a product for predicting PONV risk after lumbar surgery and a research method, and relates to the technical field of biological medicine. The pre-operation NLR of the lumbar vertebra is greater than 2, and the NLRlt of the lumbar vertebra is greater than 1; 2, grouping the patients, comparing and analyzing the PONV appearing condition of the patients after the lumbar surgery, and discussing whether the NLR before the surgery is a marker of the PONV or not; besides, the influence of erector spine muscle plane block on NLR and PONV is further studied, a theoretical basis is provided for lumbar postoperative PONV risk prediction, evidence-based parameters are formulated for patients needing to prevent nausea and vomiting before an operation, and therefore the hospital cost is reduced, and the postoperative recovery speed of the patients is increased.

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to an application of a substance for detecting NLR in the preparation of a product for predicting PONV risk after lumbar surgery and a research method. Background Art

[0003] Postoperative nausea and vomiting (PONV) is one of the most common complications after surgery. PONV in patients undergoing lumbar spine surgery may lead to serious complications such as implant migration, aspiration, lung infection, and spinal cord injury. Although PONV is almost self-limited and not fatal, the incidence of dehydration, electrolyte imbalance, suture breakage, hypertension and bleeding, esophageal rupture, and life-threatening airway obstruction caused by PONV is significantly increased. PONV can lead to prolonged stay in the PACU and hospital, poor patient satisfaction, unplanned re-hospitalization, and increased hospital costs. Preventing and treating PONV is very important for patient outcomes and reducing medical costs. Therefore, it is very important to find clinically useful parameters for evaluating and predicting PONV. The first step in PONV prevention is to identify risk factors and high-risk patient groups. There are many anesthetic risk factors associated with PONV, including anesthetic technique, use of volatile anesthetics, use of nitrous oxide, duration of anesthesia, use of opioids, and type of surgery. Many factors are associated with PONV, and inflammation increases this risk. The neutrophil-to-lymphocyte ratio (NLR) is an inexpensive parameter for the diagnosis and follow-up of systemic inflammatory diseases. Although PONV prevention has been shown to increase healthcare costs, its costs are lower than those of treating PONV and associated complications. Therefore, developing evidence-based parameters to identify patients who require nausea and vomiting prevention preoperatively is important to reduce hospital costs. There is a relationship between the severity of hyperemesis gravidarum and NLR during pregnancy. However, few studies in the literature have explored the possible relationship between PONV and NLR.

[0004] Lumbar spine surgery is one of the most painful surgical procedures. Postoperative pain is acute pain, which is mainly caused by the body's stress response caused by surgical trauma and inflammation. Ultrasound-guided erector spinae plane block (ESPB) is a newly discovered local anesthesia technology that can block the dorsal and ventral branches of the thoracic and abdominal spinal nerves. It is currently mainly used for combined anesthesia and postoperative analgesia in thoracic surgery, abdominal surgery, breast surgery, urology surgery, bariatric surgery, and hip surgery. Ultrasound-guided erector spinae plane block can accurately locate and administer drugs based on visualization, has good analgesic effect, has little effect on the patient's systemic system, and has no obvious adverse reactions. However, it is currently rarely used in lumbar spine surgery. Recently, it has been reported that this technology can also be used in lumbar spine surgery, but the relationship between the preoperative neutrophil-to-lymphocyte ratio (NLR) and PONV in patients undergoing lumbar surgery and the effect of erector spinae plane block on NLR and PONV have not been reported. Summary of the invention

[0005] In view of the above-mentioned problems, the present invention aims to provide an application and research method of a substance for detecting NLR in the preparation of a product for predicting the risk of PONV after lumbar surgery, so as to study the relationship between the preoperative neutrophil-to-lymphocyte ratio (NLR) and PONV in patients undergoing lumbar surgery and the effect of erector spinae plane block on NLR and PONV.

[0006] In order to achieve the above objectives,

[0007] On the one hand, the present invention provides the use of a substance for detecting NLR in the preparation of a product for predicting the risk of PONV after lumbar surgery.

[0008] Specifically, NLR is the neutrophil-to-lymphocyte ratio.

[0009] Specifically, the substances for detecting NLR include substances for detecting the number of neutrophils and substances for detecting the number of lymphocytes.

[0010] Specifically, the detection range of NLR is NLR>2 and NLR<2.

[0011] On the other hand, the present invention also provides a research method for the application as described above, comprising the following steps:

[0012] S1: Before lumbar spine surgery, patients were divided into two groups according to their NLR values;

[0013] S2: Each group of patients was further divided into erector spinae plane block group and control group;

[0014] S3: After lumbar surgery, the parameters related to PONV were recorded in each group of patients;

[0015] S4: Comparative analysis of the parameter indicators of each group of patients.

[0016] Specifically, the parameter indicators related to PONV described in step S3 include: the patient's age, gender, height, weight, BMI, ASA grade and operation time; the consumption of anesthetic drugs during the operation and the total consumption of analgesics in the first 24 hours and the second 24 hours after the operation; the patient's nausea and vomiting scores in the PACU and the first 24 hours and the second 24 hours after the operation and the need for antiemetics; the VAS scores at rest and during exercise 2h, 4h, 6h, 8h, 12h, 24h, and 48h after the operation; the time of the first compression of the analgesic pump; the 24- and 48-hour flurbiprofen rescue analgesia rate and analgesia satisfaction score; the time of postoperative awakening and extubation; the incidence of side effects of opioids; and the presence of serum neutrophil extracellular traps NETs.

[0017] Specifically, the nausea and vomiting scores include: 0 points = no nausea, 1 point = nausea, 2 points = retching, and 3 points = vomiting.

[0018] Specifically, the VAS scoring criteria include: mild pain: 1-3 points, pain is tolerable and sleep is normal; moderate pain: 4-6 points, pain is unbearable and sleep is impossible; severe pain: 7-10 points, passive position.

[0019] Specifically, the postoperative satisfaction levels include: 0 point = dissatisfied, 1 point = average, 2 points = satisfied, and 3 points = very satisfied.

[0020] The beneficial effects of the present invention are:

[0021] 1. In the present invention, by studying the relationship between the patient's preoperative NLR and postoperative PONV, evidence-based parameters can be formulated for patients who need to prevent nausea and vomiting before surgery, thereby reducing hospital costs, improving the patient's postoperative recovery speed, shortening the patient's stay in the PACU and hospitalization time, accelerating the patient's postoperative recovery and improving the quality of life, reducing medical costs, reducing patient expenses, reducing the burden on families and society, and saving clinical medical resources.

[0022] 2. The research results of this invention can provide evidence-based basis for clinical practice, improve medical quality and enhance patient satisfaction. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The figure is a flow chart of the research method in the present invention.

[0024] Figure 2 This is a histogram of the comparison results of the number of patients with postoperative nausea and vomiting (PONV) in the two groups of patients in the present invention. DETAILED DESCRIPTION

[0025] In order to enable those skilled in the art to better understand the technical solution of the present invention, the research process of the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0026] 1. Research Objectives

[0027] ①Main research objectives: To explore whether preoperative NLR is a marker for PONV; the effect of erector spinae plane block on NLR and PONV.

[0028] ②Secondary research purpose: To investigate the effect of erector spinae plane block on analgesia and opioid dosage during spinal surgery.

[0029] 2. Observation indicators

[0030] 1. Main observation indicators

[0031] ① Nausea and vomiting and the need for antiemetics in the PACU and in the first and second 24 hours after surgery were recorded. Patients with a nausea and vomiting score of 1 or above (0 = no nausea, 1 = nausea, 2 = retching, 3 = vomiting) were treated with ondansetron as an antiemetic.

[0032] ②Record the neutrophil count and lymphocyte count on the first day after surgery, and calculate the neutrophil-to-lymphocyte ratio (NLR).

[0033] 2. Secondary observation index

[0034] ① The overall VAS score (visual pain analog scale) of the patients at rest and during movement at 2h, 6h, 12h, 24h, and 48h after surgery.

[0035] ② Record the intraoperative consumption of propofol and remifentanil, as well as the total consumption of analgesics in the first 24 hours and the second 24 hours after surgery.

[0036] ③Record the time of first compression of the analgesic pump; 24- and 48-hour analgesia satisfaction scores.

[0037] ④Record the time of postoperative awakening and extubation, postoperative PACU stay time, and postoperative discharge time.

[0038] ⑤Record the incidence of side effects of opioids such as dizziness and urinary retention.

[0039] ⑥Measure serum neutrophil extracellular traps (NETs) on the first day after surgery.

[0040] 3. Research Methods

[0041] 1. Trial population

[0042] Patients scheduled for posterior approach lumbar spine surgery under general anesthesia.

[0043] 2. Selection of inclusion and exclusion criteria

[0044] 2.1 Selection according to inclusion criteria:

[0045] ① Patients undergoing elective posterior approach lumbar spine surgery under general anesthesia in prone position;

[0046] ②ASA classification is I to II;

[0047] ③Age 18 to 80 years old;

[0048] ④Sign the informed consent form for this study.

[0049] 2.2 Selection of exclusion criteria:

[0050] ① Preoperative blood transfusion;

[0051] ②Uncontrolled systemic diseases;

[0052] ③ Gastrointestinal system diseases;

[0053] ④History of use of antiemetic and anticholinergic drugs;

[0054] ⑤ There are adverse reactions related to surgery;

[0055] ⑥ Severe spinal deformity;

[0056] ⑦ There is infection at the puncture site;

[0057] ⑧People with coagulation disorder;

[0058] ⑨ Long-term use of sedatives and analgesics before surgery;

[0059] ⑩Patients with mental illness or language communication disorders;

[0060] Allergic to ropivacaine;

[0061] Study participants who have participated in other clinical studies in the past 3 months;

[0062] History of previous lumbar surgery;

[0063] Subjectively unwilling to participate in this study;

[0064] 3. Grouping of research participants:

[0065] The NLR value was calculated preoperatively by dividing the number of neutrophils by the number of lymphocytes obtained from the complete blood count. The cutoff value of the NLR calculated preoperatively was accepted as 2, and the patients were divided into two groups according to the values ​​above and below 2, with 110 patients in each group. Patients with preoperative NLR < 2 were included in group A (n = 110); patients with preoperative NLR > 2 were included in group B (n = 110); according to the random number table method, group A was divided into erector spinae plane block group (EA group) (n = 55) and control group (CA group) (n = 55), and group B was divided into erector spinae plane block group (EB group) (n = 55) and control group (CB group) (n = 55).

[0066] 4. Criteria for early withdrawal / termination of the trial by study participants

[0067] A research participant withdraws from the trial when the enrolled research participant becomes unsuitable to continue the trial and the researcher decides that the research participant withdraws from the trial.

[0068] ① The researcher considers it necessary to stop the trial from the perspective of medical ethics.

[0069] ② Those who have serious adverse events (SAE) and are judged by the researchers to be unsuitable to continue the trial.

[0070] ③ The researcher judges that withdrawal from the study is in the best interests of the research participants.

[0071] ④Poor compliance of study participants, including the following situations:

[0072] a. Research participants fail to take medication and undergo examinations as prescribed;

[0073] b. The study participants use other drugs or foods that may affect the results of the effectiveness and safety trials;

[0074] c. The research participants have other behaviors that affect the test results;

[0075] d. Lost to follow-up (defined as at least three unsuccessful telephone calls on different dates). 4.2 Study participants voluntarily withdraw from the study.

[0076] According to the informed consent form, research participants have the right to withdraw from the trial midway, or research participants who have not withdrawn their informed consent but no longer accept medication and testing are lost to follow-up (also considered withdrawal, or dropout). The reasons for their withdrawal should be understood as much as possible and recorded.

[0077] 5. Adverse events

[0078] 5.1 Definition of Serious Adverse Event (SAE)

[0079] SAEs are defined as adverse medical events that meet any of the following criteria (af):

[0080] a. cause death;

[0081] b. Life-threatening (In the definition, life-threatening means that a seriously ill patient is at risk of death immediately, not that death may occur if the condition develops seriously in the future;

[0082] c. Leading to hospitalization or prolonged hospitalization;

[0083] A hospitalization or prolonged hospital stay is not reportable as an SAE if at least one of the following criteria is met:

[0084] - After admission, hospital stay is less than 12 hours;

[0085] - Pre-planned admission;

[0086] (e.g., elective or planned surgery scheduled before the first dose of study drug; or hospital admission is part of the study process);

[0087] - Hospitalization not related to AE (e.g., admission to a social welfare institution for temporary care).

[0088] However, it is important to emphasize that invasive treatments received during hospitalization may meet the criteria for a "significant medical event" and therefore need to be reported as an SAE based on clinical judgment.

[0089] d. Leading to significant or permanent disability / functional impairment, where disability means that a person's ability to perform normal life functions is substantially impaired (functional impairment does not include events of relatively minor medical importance, such as headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (such as ankle sprains).

[0090] e. Causes congenital malformations or birth defects: Newborns (fetuses) born (or aborted) to female study participants exposed to the drug or to the female partners of male study participants exposed to the drug have congenital malformations or birth defects.

[0091] f. Other important medical events: may not immediately result in death, endanger life, or lead to hospitalization / prolonged hospitalization, but based on medical judgment, these events may harm the study participants or require medical intervention to prevent the occurrence of one of the above situations.

[0092] 6. Blinding and emergency unblinding

[0093] 6.1 Block randomization

[0094] Patients were grouped by block randomization: the drug blinding was performed by specialists who were not directly involved in the clinical trial, and block randomization was used (the statistical software (SAS) generated a random number table);

[0095] 6.2 Blinding

[0096] This trial was of double-blind design, and the study participants and follow-up personnel were unaware of the group allocation.

[0097] ①The total random table is kept by the person responsible for statistics;

[0098] ② The drug was prepared by the researcher according to the total randomization table; the patient was followed up by a professionally trained anesthesia nurse after surgery;

[0099] ③ Unblinding by normal procedure: If no emergency occurs during the study, unblinding will be carried out according to normal procedures. After the end of the trial, after checking the CRF and signature, unblinding will be carried out to determine the grouping of the study participants, so as to conduct statistical analysis and evaluate the difference in efficacy between the experimental group and the control group.

[0100] ④ Emergency unblinding: Emergency unblinding can only be performed when the drugs used have an impact on the treatment or life safety of the research participants. The principal investigator should be notified and the unblinding should be performed based on the drug information used by the research participants provided in the emergency letter, and this should be noted on the CRF.

[0101] 7. Test procedures

[0102] 7.1 Management of Research Participants

[0103] ① Methods of recruiting research participants

[0104] Open recruitment, interviewed by researchers one day before surgery, and recruited patients who underwent elective posterior approach lumbar spine surgery under general anesthesia in the First Affiliated Hospital of Shandong First Medical University between July 2023 and July 2024;

[0105] ②Informed consent process

[0106] The researcher shall provide the research participants or their legal representatives with an easy-to-understand informed consent form approved by the ethics committee, and give the research participants or their legal representatives sufficient time to consider the study. The research participants shall not be enrolled before obtaining the signed written informed consent form from the research participants. During the research participants' participation, all updated versions of the informed consent form and written information will be provided to the research participants. The informed consent form should be kept for reference as an important document of the clinical trial.

[0107] 7.2 Safety Evaluation Procedure (Assessment, Detection and Reporting of Adverse Events)

[0108] This study is an observational study. Clinical adverse events may occur during the treatment of the study participants. Once an adverse event (including major adverse events) occurs, the time of occurrence, clinical manifestations, treatment process and duration, outcome, and relationship with the drug of the adverse event should be recorded in detail on the case report form; if laboratory abnormalities occur, the study participants must be followed up until the test results return to normal, or to the level before medication, or it is determined that it is not related to the trial drug. In the event of a serious adverse event, the serious adverse event form should be filled in and reported to the ethics committee within 24 hours.

[0109] 7.3 Screening Period:

[0110] For patients undergoing posterior approach lumbar spine surgery under general anesthesia, one day before surgery, one researcher assessed whether the patients were eligible for inclusion in this study according to the inclusion and exclusion criteria. Participants who met the inclusion criteria signed informed consent after being fully informed of the study procedures, potential benefits and risks. NLR values ​​were calculated by dividing the number of neutrophils by the number of lymphocytes before surgery. The preoperatively calculated NLR cutoff value was accepted as 2, and patients were divided into two groups according to values ​​above and below 2, with 110 patients in each group. Patients with preoperative NLR < 2 were included in group A (n = 110); patients with preoperative NLR > 2 were included in group B (n = 110); according to the random number table method, group A was divided into erector spinae plane block group (EA group) (n = 55) and control group (CA group) (n = 55), and group B was divided into erector spinae plane block group (EB group) (n = 55) and control group (CB group) (n = 55). The drugs were configured by the researchers according to the random table, and the random grouping sequence was concealed using the envelope method. Before the operation, a dedicated anesthesia nurse would deliver the implementation plan in the envelope to the corresponding operating room.

[0111] ① Erector spinae plane block group (EA group + EB group): conventional anesthesia induction, followed by 0.5% ropivacaine (20 ml) ultrasound-guided erector spinae plane block (ESPB).

[0112] ②Control group (CA group + CB group): conventional anesthesia induction, after anesthesia induction, 0.9% saline (20ml) was injected into the erector spinae plane (ESPB) under ultrasound guidance.

[0113] 7.4 Observation Period:

[0114] The patient entered the operating room, routinely opened intravenous access, monitored non-invasive blood pressure (NIBP), electrocardiogram (ECG), blood oxygen saturation (SpO2), and underwent radial artery puncture and catheterization connected to the FloTrac sensor to monitor invasive BP. All patients received total intravenous anesthesia.

[0115] The patient was placed in a supine position and given oxygen and nitrogen by mask for 3 minutes before anesthesia induction: midazolam 0.02mg / kg, sufentanil 0.2-0.3ug / kg, propofol 1.5-2mg / kg, atracurium 0.6mg / kg. After the patient's eyelash reflex disappeared and the mandible relaxed, tracheal intubation was performed through a visual laryngoscope, and the tracheal tube was accurately positioned and fixed, and the anesthesia machine was connected for mechanical ventilation and respiratory parameters were adjusted.

[0116] After the patient was in the prone position, the appropriate lumbar level was identified by surface landmarks or ultrasound according to the scope of the surgical incision marked by the surgeon before the operation, and the skin at the puncture point was disinfected with iodine. The ultrasonic low-frequency convex array probe covered by a sterile sleeve was placed in the longitudinal parasagittal direction 3 cm outside the midline to identify the corresponding lumbar transverse process and the erector spinae and latissimus dorsi muscles covering its surface. The needle was inserted using the in-plane method. When the needle tip touched the transverse process bone, after aspiration without blood and gas, 2-3 mL of isotonic saline solution was injected for hydrodissection, and the correct position of the needle tip was confirmed. The local anesthetic was injected between the erector spinae and the transverse process. The diffusion of the local anesthetic between the fascia on the deep surface of the erector spinae could be observed by ultrasound. Among them, the EA group and the EB group were given 20 ml of 0.5% ropivacaine on each side of the lumbar transverse process surface before the operation, and the erector spinae plane (ESPB) block was performed on both sides; the CA group and the CB group were given 0.9% saline (20 ml) on each side before the operation under ultrasound guidance.

[0117] Propofol (4-6mg / kg / h) and remifentanil (12-20ug / kg / h) were used for anesthesia maintenance, BIS40-60 was maintained, blood pressure and heart rate were maintained within the preoperative baseline range, and the increase did not exceed 20% of the baseline value. Atracurium was intermittently added according to the needs of the operation to maintain muscle relaxation. The infusion of anesthetic drugs was stopped 10 minutes before the end of the operation, and all patients were not given nonsteroidal anti-inflammatory drugs before skin incision and before the end of the operation. If the changes in blood pressure and heart rate during the perioperative period exceeded the values ​​in the operating room by 20%, the corresponding drugs (ephedrine 5mg or atropine 0.2mg or esmolol 20mg or nitroglycerin 0.5mg) were immediately given intravenous analgesia (PCIA) for 48h in all patients who were immediately turned on the intravenous analgesia pump at the end of the operation. The PCIA formula was 2ug / kg sufentanil + 16mg ondansetron + 0.9% saline to 100ml. The PCIA device travels at a speed of 2 ml / h, the additional dose is 2 ml, the lock time is 15 min, and there is no background dose. After the operation, the patient was sent to the postoperative recovery unit (PACU) for postoperative awakening. Finally, the patient was sent to the ward. If the patient's VAS score is ≥4 points in the resting state after surgery, the PCIA is pressed for analgesia. If the effect of PCIA is not good after two consecutive additional doses, 50 mg of flurbiprofen axetil is injected intravenously as an emergency analgesic, and the number of PCIA presses and the number of flurbiprofen axetil administered within 24 hours and 48 hours are recorded. Postoperative follow-up data were collected by a dedicated person.

[0118] 7.5 Records:

[0119] (1) The age, gender, height, weight, BMI, ASA grade and operation time of the two groups of patients were recorded;

[0120] (2) record the intraoperative consumption of propofol and remifentanil, etc., as well as the total consumption of analgesics in the first 24 h and the second 24 h after surgery;

[0121] (3) Nausea and vomiting in the PACU and within the first 24 hours and the second 24 hours after surgery, as well as the need for antiemetics, were recorded. Patients with a nausea and vomiting score of 1 or above (0 = no nausea, 1 = nausea, 2 = retching, 3 = vomiting) were treated with ondansetron as an antiemetic.

[0122] (4) Record the VAS scores at rest and during movement 2h, 4h, 6h, 8h, 12h, 24h, and 48h after surgery. The VAS scoring criteria are: no pain: 0 points; mild pain: 1-3 points (pain is tolerable and sleep is normal); moderate pain: 4-6 points (pain is unbearable and sleep is unbearable); severe pain: 7-10 points (passive position);

[0123] (5) Record the time of the first compression of the analgesic pump; the 24- and 48-hour flurbiprofen axetil rescue analgesia rate and analgesia satisfaction score, and the postoperative satisfaction level (0 means dissatisfied, 1 means fair, 2 means satisfied, and 3 means very satisfied);

[0124] (6) Record the time of postoperative awakening and extubation (extubation indications: when the patient recovers spontaneous breathing and the tidal volume is ≥7 mL / kg, swallowing reflex appears and can complete the commanded movements, and spontaneous breathing can maintain SpO2 not less than 90%), postoperative PACU stay time; postoperative discharge time;

[0125] (7) record the incidence of opioid side effects such as dizziness and urinary retention;

[0126] (8) Determination of serum neutrophil extracellular traps (NETs): ① Use PicoGreen dsDNA Quan-titation Kits (Invitrogen, USA): Collect 5 ml of venous blood from all patients in a normal test tube, centrifuge and store the serum at -20°C for testing. ② Use TE buffer [1XTE (10mmol / L Tris-HCl, 1mmol / L EDTA, pH7.5)] to dilute PicoGreen at 1:200 to prepare the dye working solution and store it in the dark for use. ③Prepare the standard curve: add 1 mg of calf thymus DNA powder (Sigma, USA) to 1 ml of double distilled water to prepare a 1 mg / ml standard working solution; dilute the standard working solution with TE in multiple ratios; mix the gradient standard solution (using 1XTE as a blank control) with the dye working solution in a 1:1 ratio and place it at room temperature in the dark for 5 minutes to be tested; use the Modulusm single-tube multifunctional detector to detect the fluorescence value of each gradient standard solution, and use the fluorescence value corresponding to the concentration (ng / ml) of the standard solution as a linear regression equation to prepare the standard curve. ④After incubating the serum to be tested, mix it with the dye working solution in a 1:1 ratio and place it at room temperature in the dark for 5 minutes to measure its light value, and substitute the measured fluorescence value into the regression equation to calculate the NETs content (ng / ml).

[0127] 8. Data Processing

[0128] Data were entered by two persons using a random number table for coding. The original data materials were stored in the anesthesiology office. The data entry selected the protocol set. The cases that met the protocol requirements, had good compliance, and completed all the required collection requirements were saved on the data collector's computer and backed up.

[0129] Missing data or illogical data are solved by deleting cases with missing values ​​(simple deletion) or using missing value filling methods (mean interpolation, maximum likelihood estimation, or multiple interpolation, etc.).

[0130] All data were analyzed using SPSS 25.0 statistical software. For continuous variables such as VAS scores, if they conformed to normal distribution, they were expressed as mean ± standard deviation, and the independent sample t test was used to compare the differences between groups. If they did not conform to normal distribution, the Wilcoxon rank sum test was used to compare the differences between groups. For categorical variables such as gender, the chi-square test or Fisher's exact probability method was used to compare the differences between groups. For graded data such as vomiting degree, the Wilcoxon rank sum test was used to compare the differences between groups. Bilateral P < 0.05 was considered statistically significant.

[0131] 9. Test results

[0132] 9.1 Records of pre- and post-operative parameters of test subjects

[0133] The preoperative and postoperative index records of all test subjects are shown in Tables 1-7. It should be noted here that there were 220 patients in this study, and Tables 1-7 provide a complete statistical analysis of the conditions of different patients.

[0134] Table 1 Statistical results of patients 1-34

[0135]

[0136] Table 2 Statistical results of patients 35-68

[0137]

[0138] Table 3 Statistical results of patients 69-102

[0139]

[0140] Table 4 Statistical results of patients 103-136

[0141]

[0142] Table 5 Statistical results of patients 137-170

[0143]

[0144] Table 6 Statistical results of patients 171-204

[0145]

[0146] Table 7 Statistical results of patients 205-220

[0147]

[0148] A chi-square test was performed on the patient gender and NLR in the above data, and the results are shown in Table 8 below.

[0149] Table 8 Chi-square test results of patient gender and NLR

[0150]

[0151] Among the 220 patients, in the NLR < 2 group, females accounted for 52.7% and males accounted for 47.3%.

[0152] In the NLR>2 group, 46.4% were female and 53.6% were male.

[0153] Overall, the gender distribution was similar, but the chi-square test did not find significance (P value>0.05), indicating that there was no significant statistical relationship between gender and NLR grouping.

[0154] The results of the comparison of differences between the groups are shown in Tables 9 to 12 below.

[0155] Table 9 Cross-tabulation of differences between groups

[0156]

[0157] Table 10 Results of chi-square test for differences between groups

[0158]

[0159] Table 11 Mean results of patient data in different groups

[0160] Vanable Group I (NLR<2) Group II (NLR>2) P Value preoperative PCT 0.06±0.021 0.06±0.056 0.431 preoperative ESR 10.68±7.97 10.99±9.29 0.795 preoperative CRP 16.48±29.90 20.03±20.45 0.622 preoperative Hb 135.79±14.20 135.97±15.13 0.927 Postoperative PCT 0.20±0.375 0.36±0.828 0.173 Postoperative ESR 28.29±23.45 26.89±23.01 0.684 Postoperative CRP 37.21±32.07 48.79±53.54 0.096 Postoperative Hb 119.05±18.35 116.53±17.37 0.302 Age, yr 59.23±12.80 60.70±12.79 0.394

[0161] Table 12 Comparison of the number of patients with PONV in the two groups

[0162]

[0163] The comparison of the number of patients with postoperative nausea and vomiting (PONV) in the two groups is shown in the attached histogram. Figure 2 shown.

[0164] From the above table 9-12 and attached Figure 2 It can be concluded that the probability of PONV in patients with NLR>2 is significantly higher than that in patients with NLR<2. NLR may be a predictive factor for PONV.

[0165] There were no significant differences in preoperative Hb, ESR, CRP, and PCT and postoperative Hb, ESR, Age, yr between the two groups (P value>0.05). The P values ​​of postoperative CRP and PCT were close to statistical significance (CRP: P=0.096), and the sample size needs to be further expanded to explore possible differences. The overall data showed that the differences in these indicators between NLR groups were not significant.

[0166] The incidence of PONV was 20.0% in group 1 and 47.3% in group 2. The incidence of PONV was significantly higher in group 2 than in group 1 (P<0.001). By further verifying the association between NLR>2 and PONV, NLR>2 can be used as a potential predictor of postoperative nausea and vomiting, thereby helping to formulate perioperative management strategies.

[0167] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. Application of substances for detecting NLR in the preparation of products for predicting the risk of PONV after lumbar surgery.

2. The use according to claim 1, characterized in that: NLR is the neutrophil-to-lymphocyte ratio.

3. The use according to claim 2, characterized in that: Substances for detecting NLR include substances for detecting the number of neutrophils and substances for detecting the number of lymphocytes.

4. The use according to claim 3, characterized in that: The detection range of NLR is NLR>2 and NLR<2.

5. The research method of application according to any one of claims 1 to 4, characterized in that: The following steps are involved: S1: Before lumbar spine surgery, patients were divided into two groups according to their NLR values; S2: Each group of patients was further divided into erector spinae plane block group and control group; S3: After lumbar surgery, the parameters related to PONV were recorded in each group of patients; S4: Comparative analysis of the parameter indicators of each group of patients.

6. The research method according to claim 5, characterized in that: The parameter indicators related to PONV described in step S3 include: the patient's age, gender, height, weight, BMI, ASA grade and operation time; the intraoperative anesthetic consumption and the total analgesic consumption in the first 24 hours and the second 24 hours after surgery; the patient's nausea and vomiting scores in the PACU and the first 24 hours and the second 24 hours after surgery, and the need for antiemetics; the VAS scores at rest and during exercise 2h, 4h, 6h, 8h, 12h, 24h, and 48h after surgery; the time of the first compression of the analgesic pump; the 24- and 48-hour flurbiprofen rescue analgesia rate and analgesia satisfaction score; the postoperative awakening and extubation time; the incidence of side effects of opioids; and the presence of serum neutrophil extracellular traps NETs.

7. The research method according to claim 6, characterized in that: Nausea and vomiting scores included: 0 = no nausea, 1 = nausea, 2 = retching, and 3 = vomiting.

8. The research method according to claim 6, characterized in that: The VAS scoring criteria include: mild pain: 1-3 points, pain is tolerable and sleep is normal; moderate pain: 4-6 points, pain is unbearable and sleep is impossible; severe pain: 7-10 points, passive position.

9. The research method according to claim 6, characterized in that: The postoperative satisfaction scores included: 0 = dissatisfied, 1 = average, 2 = satisfied, and 3 = very satisfied.

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