六味地黄丸治疗绝经后骨质疏松症疗效和安全性的Meta分析

Clinical efficacy and safety of Liuwei Dihuang Wan(六味地黄丸) for treatment of postmenopausal osteoporosis:a meta-analysis

目的:系统评价六味地黄丸治疗绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的疗效和安全性。方法:应用计算机检索中国知网、万方数据库、维普网、Cochrane Library、PubMed中有关六味地黄丸治疗PMOP的随机对照试验文献,检索时限均为2012年5月31日至2022年2月31日。治疗组干预措施为口服六味地黄丸(或以六味地黄丸为基础适当加减),对照组干预措施为口服西药,2组均可联合其他相同的治疗措施。经文献检索、文献筛选、数据提取及偏倚风险评价后,采用RevMan5.3软件对治疗后疼痛视觉模拟量表(visual analogue scale,VAS)评分、治疗后L_(2)~L_(4)骨密度、治疗后血清碱性磷酸酶(alkaline phosphatase,ALP)含量及并发症发生率进行Meta分析,并采用漏斗图进行发表偏倚分析。结果:共纳入10项随机对照试验,涉及1102例患者,治疗组和对照组各551例。Meta分析结果显示,治疗组治疗后疼痛VAS评分、血清ALP含量和并发症发生率均低于对照组[MD=-1.03,95%CI(-1.29,-0.77),P=0.000;MD=-18.02,95%CI(-32.61,-3.43),P=0.020;OR=0.45,95%CI(0.23,0.90),P=0.020],治疗后L_(2)~L_(4)骨密度高于对照组[MD=0.06,95%CI(0.02,0.09),P=0.003]。基于治疗后L_(2)~L_(4)骨密度的发表偏倚分析结果显示,5项研究的分布不完全对称,不排除存在发表偏倚的可能。结论:现有的证据表明,六味地黄丸治疗PMOP的疗效和安全性均优于西药治疗。

Objective:To systematically review the clinical outcomes and safety of oral application of Liuwei Dihuang Wan(六味地黄丸,LWDHW)for treatment of postmenopausal osteoporosis(PMOP).Methods:All the randomized controlled trial(RCT)articles about oral application of LWDHW for treatment of PMOP included from May 31,2012 to February 31,2022 were retrieved from the China National Knowledge Internet,Wanfang Database,Vip Database,Cochrane Library and PubMed through computer.The patients in treatment group were treated with oral application of LWDHW or modified LWDHW,while the ones in control group with oral application of Western medicines.Other same therapies could be used in patients of the 2 groups.The articles were retrieved and screened and the information was extracted independently by two researchers according to the inclusion and exclusion criteria,and if any disagreement was found between them,discussion was conducted with another researcher for making a final decision.The bias risk of research in the articles was evaluated by using Cochrane bias risk assessment tools,and then a Meta-analysis on posttreatment pain visual analogue scale(VAS)score,posttreatment bone mineral density(BMD)of lumbar vertebrae from L2 to L4,posttreatment serum level of alkaline phosphatase(ALP)and complication incidence was conducted by using RevMan5.3 software,furthermore,the publication bias was analyzed by using funnel plot.Results:Ten articles(1102 patients)were included in the final analysis,551 patients in each group.The results of Meta-analysis revealed that the posttreatment pain VAS score,posttreatment serum level of ALP and complication incidence were lower,while the posttreatment BMD of lumbar vertebrae from L 2 to L4 was higher in treatment group compared to control group(MD=-1.03,95%CI(-1.29,-0.77),P=0.000;MD=-18.02,95%CI(-32.61,-3.43),P=0.020;OR=0.45,95%CI(0.23,0.90),P=0.020;MD=0.06,95%CI(0.02,0.09),P=0.003).Publication bias was analyzed according to funnel plot drawned based on posttreatment BMD of lumbar vertebrae from L2 to L4,and the asymmetrical funnel plot demonstrated that there might be publication bias.Conclusion:Available evidences suggest that the clinical curative effects and safety of LWDHW are better than that of Western medicines in treatment of PMOP.