补肾类中成药治疗老年性骨质疏松症的随机对照试验系统评价

Systematic Review of Randomized Controlled Trials on Kidney-tonifying Chinese Patent Medicine in Treatment of Senile Osteoporosis

目的系统评价补肾类中成药治疗老年性骨质疏松症的疗效及安全性。方法检索中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)、万方数据库、Cochrane Library、Medline、EMbase、Web of Science和临床试验注册库,筛选补肾类中成药治疗老年性骨质疏松症的随机对照试验研究,根据Cochrane评价标准和工具进行评价,并使用Rev Man5.3软件进行Meta分析。结果补肾类中成药单用或联合西医常规治疗在提高老年性骨质疏松症患者临床疗效总有效率方面比西医常规治疗具有优势[RR=1.22,95%CI(1.08,1.37),I^2=57%,P=0.002;RR=1.12,95%CI(1.05,1.20),I^2=7%,P=0.0003];在提高血磷、血钙方面,仅部分研究显示具有一定疗效。5项研究报告了中成药组有消化道症状等不良反应,但无严重不良反应和不良事件。结论补肾类中成药治疗老年性骨质疏松症的总体疗效优于单纯西医常规治疗,安全性较好。

Objective To evaluate the efficacy and safety of kidney-tonifying Chinese patent medicine in treating senile osteoporosis. Methods CNKI,CBM,VIP,Wanfang Database,Cochrane Library,MEDLINE,EMbase,Web of Science and database of clinical trials were searched to look for randomized controlled trials on kidney-tonifying Chinese patent medicine in treating senile osteoporosis. The selected clinical trials were evaluated by Cochrane evaluation criteria and tools and analyzed with Rev Man 5. 3. Results The kidney-tonifying Chinese patent medicine alone or combined with conventional Western medicine were better than the control group in improving total effective rate [RR =1. 22,95% CI（1. 08,1. 37）,I^2= 57%,P = 0. 002; RR = 1. 12,95% CI（1. 05,1. 20）,I^2= 7%,P =0. 0003]. While only several trials showed the kidney-tonifying Chinese patent medicines could increase serum levels of phosphate and calcium. Five trials reported that adverse reactions such as digestive symptoms occurred in Chinese patent medicine group,but no serious adverse reactions or adverse events. Conclusion The overall efficacy of kidney-tonifying Chinese patent medicine seems better than that of conventional Western medicine alone in treating senile osteoporosis,with good safety.