痹祺胶囊治疗腰椎间盘突出症的有效性及安全性的系统评价

Systematic evaluation of efficacy and safety of the Biqi capsules in the treatment of lumbar disc herniation

目的:系统评价痹祺胶囊治疗腰椎间盘突出症(Lumbar Disc Herniation,LDH)的有效性及安全性。方法:通过计算机检索中国知网、维普中文科技期刊、万方数据知识平台、PubMed、Embase、Web of science、Cochrane图书馆等数据库,搜集痹祺胶囊治疗LDH的随机对照试验,检索时限从建库初始至2022年1月。将符合纳排标准的相关文献纳入研究,提取相关数据并按Cochrane系统评价手册对文献进行质量评价,利用Review Manager 5.4软件对总有效率、视觉模拟评分法(Visual Analogue Scale,VAS)评分、日本骨科协会评估治疗分数(Japanese Orthopaedic Association,JOA)评分、症状量表及安全性指标进行Meta分析。结果:排除不符合纳入标准的文献后,最终纳入5篇文献,总样本量共532例,其中试验组和对照组均266例。Meta分析结果显示,试验组总有效率、JOA评分、症状量表(包括临床症状、工作生活能力、体征)总评分均显著高于对照组(P<0.05),VAS评分低于对照组(P<0.05)。两者在不良反应发生率方面的差异无统计学意义(P>0.05)。结论:痹祺胶囊治疗LDH总有效率高,在缓解疼痛、改善腰椎功能障碍方面具有优势,且不良反应较少,能更好地改善患者的生活工作质量。但是,受研究样本量少及文献质量较低等因素的影响,文章结果仍需更多大样本、多中心、高质量的随机对照试验来验证。

Objective:To evaluate the efficacy and safety of the Biqi capsules(痹祺胶囊)in the treatment of lumbar disc herniation systematically.Methods:Randomized controlled trials of the Biqi capsule in the treatment of lumbar disc herniation were retrieved from CNKI,VIP Chinese Science and Technology Journals,Wanfang Data Knowledge Platform,PubMed,Embase,Web of Science,Cochrane Library and other databases by computer.The retrieval period was from the establishment of the database to January 2022.The relevant literature that met the standardization criteria was included in the study,the relevant data was extracted,and the quality of the literature was evaluated by Cochrane systematic review manual.A meta-analysis of the total efficiency,Visual Analog Scale(VAS),Japanese Orthopaedic Association Evaluation Treatment Score(JOA),symptom scale and safety indexes was performed by Review Manager 5.4 software.Results:After excluding literature that did not meet the inclusion criteria,5 literatures were finally included,with a total sample size of 532 cases,including 266 cases in both the experimental group and the control group.The meta-analysis results showed that the total effective rate,JOA score,and the total score of symptom scale(including clinical symptoms,work and life ability,and signs)in the experimental group were significantly higher than those in the control group(P<0.05),and the VAS score in the experimental group was lower than that in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The Biqi capsule has a high total effective rate in the treatment of lumbar disc herniation.It has advantages in relieving pain and ameliorating lumbar dysfunction,with less adverse reactions,and can better improve the quality of life and work of patients.However,due to the small sample size and low literature quality,the results of this paper still need to be verified by more large-sample,multi-center and high-quality randomized controlled trials.