目的 系统评价腰痛宁胶囊治疗腰腿痛的有效性与安全性。方法 计算机检索CNKI、VIP、万方以及中国科学引文数据库，全面收集腰痛宁胶囊治疗腰腿痛随机对照试验（randomized control trials，RCT），由两名研究者独立筛选文献，录入数据，并对文献方法学进行质量评价，运用Review Manager 5.3软件进行Meta分析。结果 本研究共纳入11项RCT，1 200例患者，腰痛宁组为599例，对照组为601例。Meta分析结果显示，腰痛宁胶囊治疗腰腿痛有效率优于对照组（OR=4.13，95% CI[2.90，5.88]），P<0.000 01，差异有统计学意义；腰痛宁胶囊的剂量和疗程对VAS疼痛评分的改善上均优于对照组（SMD=-1.22，95% CI[-1.71，-0.73]），P<0.000 01，（SMD=-2.09，95% CI[-2.14，-2.04]），P<0.000 01差异有统计学意义；JOA功能评分的改善上优于对照组（SMD=6.78，95% CI[5.21，8.26]），P<0.000 01，差异有统计学意义。结论 腰痛宁胶囊可以有效改善腰腿痛患者的腰部活动功能和临床症状，且减轻疼痛程度与其疗程和剂量呈正相关。但受纳入样本量及观察指标等都可能导致出现偏倚的原因，期待更多的研究者能进行多中心、大样本、设计实验科学完整的研究来评估腰痛宁胶囊治疗腰腿痛的有效性和安全性。

Objective To systematic evaluate the efficacy and safety of Yaotongning Capsule in the treatment of lumbago and leg pain. Methods The databases of CNKI, VIP, Wanfang and Chinese science citation were searched by computer, and the randomized controlled trials of Yaotongning Capsule in the treatment of lumbago and leg pain were collected. Two researchers independently selected literatures, entered data, and evaluated the quality of literature methodology. Review Manager 5.3 software was used for Meta analysis. Results This study included 11 RCTs, 1 200 patients, 599 cases in Yaotongning group and 601 cases in control group. Meta analysis showed that the effective rate of Yaotongning Capsule in the treatment of lumbocrural pain was better than that of the control group (OR=4.13, 95% CI[2.90, 5.88]), P<0.000 01; The improvement of VAS pain score of Yaotongning Capsule was better than that of the control group (SMD=-1.22, 95% CI[-1.71, -0.73]), P<0.000 01, (SMD=-2.09, 95% CI[-2.14, -2.04]). The improvement of JOA function score was better than that of the control group (SMD=6.78, 95% CI[5.21, 8.26]), P<0.000 01, the difference was statistically significant. Conclusion Yaotongning Capsule can effectively improve the lumbar activity function and clinical symptoms of patients with lumbocrural pain, and the degree of pain relief is positively correlated with the course of treatment and dose. However, the included sample size and observation indicators may lead to bias. It is expected that more researchers can conduct multi center, large sample, scientific and complete research to evaluate the efficacy and safety of Yaotongning Capsule in the treatment of lumbocrural pain.

R28;R274

国家中医药管理局“全国名老中医药专家仇湘中传承工作室建设项目”（国中医药人教发[2016]42号）；长沙市科技计划项目（kq1907119，kq1901066）