| ObjectiveThe purpose of this study is to develop a normative,practical and authoritative expert consensus of integrated traditional Chinese and Western medicine for cervical spondylotic myelopathy by using Delphi method,in order to provide reference for clinical diagnosis and treatment.Meta-analysis will be used to evaluate the clinical efficacy of Chinese medicine on postoperative symptoms of cervical spondylotic myelopathy.A prospective randomized controlled clinical trial will be conducted to observe the efficacy and safety of Qishe pill in improving postoperative symptoms of cervical spondylotic myelopathy.MethodPart 1:To develop a consensus on the diagnosis and treatment of cervical spondylotic myelopathy with integrated traditional Chinese and Western medicine using Delphi method.Firstly,a project organization team was established to define the task and scope of the research,consult literatures,guidelines and books related to cervical spondylotic myelopathy,select valuable information related to the definition of the disease,diagnostic criteria,assessment scale,auxiliary examination,treatment plan and other relevant materials,and formulate questionnaires according to the content of the review.The team will select authoritative,professional and representative experts in the field of orthopedics.Team members to the selected experts’ questionnaire,statistics and analyzed the feedback from the questionnaire results,screening of high consistency of entries,delete mean is low,the coefficient of variation of the big items.For items that are controversial and unclear,multiple rounds of questionnaire survey are needed.When the opinions of experts reach a consensus,the survey can be completed,the preliminary draft can be summarized and analyzed,and the final draft of Expert Conconsensus on Diagnosis and Treatment of Integrated Traditional Chinese and Western Medicine for Cervical Spondylotic Myelopathy can be formed after expert review.Part 2:Meta-analysis of systematic evaluation of postoperative symptoms of cervical spondylotic myelopathy treated with traditional Chinese medicine.Pub Med,Cochrane Library,Embase,China National Knowledge Network(CNKI),China Master’s and Doctor’s Dissertions,and China Scientific and Technological Journal Database were searched by computer,and literatures with the purpose of clarifying the efficacy of traditional Chinese medicine in the intervention of postoperative symptoms of cervical spondylotic myelopathy were included.The retrieval time is from the self-built database to October 31,2020.Data such as publication year,author,study type,sample size,course of treatment,outcome index and adverse reactions were extracted.Jadad score was used to evaluate the literature quality,and Rev Man 5.3 software was used for statistical analysis to draw conclusions and evaluate the effectiveness and safety of traditional Chinese medicine in the intervention of postoperative symptoms of cervical spondylotic myelopathy.Part 3:A randomized controlled clinical trial of Qishe pill to improve postoperative symptoms of cervical spondylotic myelopathyAccording to the principle of prospective randomized controlled clinical trials,a total of 72 patients treated in Longhua Hospital and Changzheng Hospital from December 2019 to August 2020 who received anterior cervical decompression and fusion(ACDF)were randomly divided into treatment group and control group.The patients received conventional treatment after surgery.One week later,the treatment group was given Qishe pill,and the control group was given mecobalamin.The medication was taken for 3 weeks and stopped for 1 week as a course of treatment.Patients in both groups require 2 courses of treatment.Researchers were given training and evaluate the patients at the time of enrollment,2 months after treatment,4 months of follow-up,and 6 months of follow-up.The main outcome indicators included JOA,VAS,NDI index,10-s grip and release test,TCM syndrome score,and adverse reactions and postoperative complications were recorded.The aim is to investigate the efficacy and safety of Qishe Pill in treating postoperative symptoms of cervical spondylotic myelopathy.ResultPart 1:To develop a consensus on the diagnosis and treatment of cervical spondylotic myelopathy with integrated traditional Chinese and Western medicine using Delphi method.After literature review and pre-investigation,an expert consultation questionnaire consisting of 157 items were formed,including terms and definitions,pathogenesis and etiology of TCM,key points of diagnosis,treatment of integrated traditional Chinese and western medicine,analysis of postoperative complications and prognostic factors,and nursing care of integrated traditional Chinese and Western medicine.There are 45 experts involved in this study.A total of two rounds of questionnaire survey were conducted from October 25,2020 to February 28,2021.The first round of experts came from 37 hospitals in 20 provinces and cities,and the positive coefficient of experts was95.74%,Kendall coordination coefficient was 0.426.The second round of experts came from 28 hospitals in 17 provinces and cities.The positive coefficient of experts was88.89%,Kendall coordination coefficient was 0.461.The selection of experts has a wide range of regional representation,professionalism and authority.Expert positive coefficient and Kendall coordination coefficient are high,indicating the experts’ affirmation of the research content.Combined with existing literature research and experts’ feedback,the final draft of "Expert Consensus on Diagnosis and Treatment of Integrated Traditional Chinese and Western Medicine for Cervical Spondylotic Myelopathy" was finally established after demonstration and trial,which was in line with clinical practice and scientific standards.Part 2:Meta-analysis of systematic evaluation of postoperative symptoms of cervical spondylotic myelopathy treated with traditional Chinese medicine.A total of 681 literatures were retrieved,and 20 literatures were included after screening,all in Chinese.The total sample size was 1332 cases,including 669 cases in the treatment group and 663 cases in the control group.The results of the meta-analysis showed that compared with conventional postoperative treatment of cervical spondylotic myelopathy,the addition of traditional Chinese medicine could increase the clinical response rate [OR=2.86,95%CI,(1.97,4.13),P<0.00001],improve the postoperative JOA score [MD=1.19,95%CI,(0.92,1.47),P<0.00001],and increase the spinal cord function score by 40 points [MD=2.26,95%CI,(1.71,2.81),P<0.00001],decreasing NDI index [MD=-2.85,95%CI,(-4.33,-1.38),P<0.00001],and the differences in each index were statistically significant.The adverse reactions in the treatment group were mainly epigastric discomfort and diarrhea,which could be relieved by themselves after adjusting the method of consuming medication.Meta-analysis showed that the addition of traditional Chinese medicine can effectively improve postoperative symptoms of cervical spondylotic myelopathy with high safety.However,the quality of the included literature was low.In the future,multi-center,large-sample and high-quality randomized controlled clinical studies are needed to improve the level of evidence.Part 3:A randomized controlled clinical trial of Qishe pill to improve postoperative symptoms of cervical spondylotic myelopathyA total of 72 patients with CSM who received ACDF surgical treatment were included in this study.No cases dropped out from the treatment group and 1 case dropped out from the control group.There were no significant differences between the two groups in age,gender,course of disease,JOA,VAS,NDI index and 10-s grip and release test(P>0.05).The JOA scores of patients before and after treatment were compared within the group,and the differences at each time point were statistically significant(P<0.001).There was no statistically significant difference between the groups after 2 months of treatment(P=0.215),and there was statistically significant difference between the groups after 4 months and 6 months of follow-up(P<0.05).The motor function analysis of JOA score showed that there was a statistically significant difference within the group(P<0.05),there was no statistically significant difference among groups at each time point(P>0.05).Analysis of sensory function in JOA score showed that there was a statistically significant difference within the group(P<0.05),and there was no significant difference between groups after 2 months of treatment(P>0.05),the treatment group was better than the control group after 4 months and 6months follow-up,and the difference was statistically significant(P<0.05).The difference of VAS scores within the group before and after treatment was statistically significant(P<0.05),and there was no significant difference between groups at each time point(P>0.05).The difference of NDI index within the groups before and after treatment was statistically significant(P<0.05),and there was no significant difference between groups at each time point(P>0.05).The difference within the groups before and after 10-s grip and release test was statistically significant(P<0.05),there was statistically significant difference between the groups after 2 months of treatment(P=0.031),and there was no statistically significant difference between the groups after4 months and 6 months of follow-up(P>0.05).The difference within the group before and after 10-s grip and release test in healthy side was statistically significant(P<0.05),and there was no significant difference between groups at each time point(P>0.05).There was no significant difference in effective rate between the two groups(P=0.437).No serious adverse events occurred in the two groups.A few patients had discomfort such as abnormal sensation of throat,stomach distension and diarrhea,which could be relieved by themselves.ConclusionPart 1:To develop a consensus on the diagnosis and treatment of cervical spondylotic myelopathy with integrated traditional Chinese and Western medicine using Delphi method.Delphi method is a scientific and operable method.On the basis of inheriting the tradition and integrating modern researches,combining the opinions and suggestions of experts,a strict,standardized and scientific consensus of diagnostics experts of integrated traditional Chinese and Western medicine has been formulated,which is of great significance to the standardization and development of orthopedics,teaching and scientific research.Part 2:Meta-analysis of systematic evaluation of postoperative symptoms of cervical spondylotic myelopathy treated with traditional Chinese medicine.On the basis of conventional treatment,the addition of traditional Chinese medicine in postoperative patients with cervical spondylotic myelopathy can improve the effective rate,improve JOA score,spinal cord functional status 40 score,reduce NDI index,promote postoperative rehabilitation of patients with cervical spondylotic myelopathy,and can be popularized and applied in clinical practice.However,more high-quality,large-sample,multi-center randomized clinical trials are needed to raise the level of evidence from evidence-based practices.Part 3:A randomized controlled clinical trial of Qishe pill to improve postoperative symptoms of cervical spondylotic myelopathy.Qishe Pill can effectively improve the limb sensation and motor function after the operation of cervical spondylotic myelopathy,and reduce the pain degree and cervical dysfunction index of patients.Its clinical efficacy is not inferior to that of mecobalamine,especially for the improvement of limb sensation and functional activity of hand,which is effective and safe. |
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