中药改善原发性骨质疏松性腰背痛疗效及安全性的Meta分析

Effect and Safety of Chinese Herbal Medicine on Primary Osteoporosis with Low Back Pain:A Meta-Analysis

目的:运用Meta分析方法评价中药干预原发性骨质疏松性腰背痛的有效性和安全性。方法:检索Pubmed、Cochrane、EMBASE、Bio Med Central、VIP、CNKI、Sino Med及万方数据库,根据Cochrane中心制定的标准,由2位研究者独立评估纳入临床资料,并提取相关要素。采用Review manager 5.3软件进行Meta分析及质量评价。结果:最终纳入23项随机对照临床试验,共1 971例骨质疏松伴腰背疼痛患者。中药组与对照组比较,短期基本概念视觉模拟评分法(VAS)评分、腰椎骨密度(BMD)的加权均数差(WMD)[WMD=-1.06,95%CI(-1.49,-0.63),P<0.00001],[WMD=0.08,95%CI(0.02,0.13),P=0.005],均有统计学意义;中药组+对照组与对照组比较,短期、中期VAS评分[WMD=-1.70,95%CI(-2.18,-1.21),P<0.00001]、[WMD=-0.95,95%CI(-1.47,-0.43),P=0.0003],均有统计学意义,中期腰椎BMD[WMD=0.05,95%CI(0.00,0.09),P=0.04],有统计学意义;不良反应方面[WMD=-0.21,95%CI(-0.43,0.01),P=0.06],中药组与对照组无统计学意义。结论:中药能够有效缓解原发性骨质疏松症早期腰背部疼痛症状,提高腰椎BMD,同时,伴随的不良反应少,因此,可作为防治骨质疏松性腰背痛的一种有效、安全的干预手段。

Objective： To evaluate the effectiveness and safety of Chinese herbal medicine for primary osteoporosis by meta analysis. Methods： Randomized controlled clinical trials were searched from Pub Med,Cochrane,EMBASE,Bio Med Central,VIP,CNKI,Sino-Med,Wanfang database. Two researchers assessed eligible data and extracted relevant elements independently according to the standards of Cochrane center. Then effective data and quality were analyzed by Rev Man 5. 3 Software. Results： A total of23 randomized control clinical trials involving 1971 osteoporosis patients with pain were included. Traditional Chinese Medicine group（ TCM） were compared with the control group,and significant difference between VAS（ Visual Analogue Scale/Score） scores[WMD =-1. 06,95% CI（-1. 49,-0. 63）,P〈0. 00001] and BMD（ Bone mineral density） of lumbar spine [（ Weighted Mean Difference） WMD = 0. 08,95% CI（ 0. 02,0. 13）,P = 0. 005] in short-term were found. Compared with the control group,VAS scores of short and medium term[WMD =-1. 70,95% CI（-2. 18,-1. 21）,P〈0. 00001],[WMD =-0. 95,95% CI（-1. 47,-0. 43）,P = 0. 0003]could be significantly reduced in TCM combined with control group,and the level of BMD has statistical difference in medium term. There was no statistical difference in adverse reactions between the two groups [WMD =-0. 21,95% CI（-0. 43,0. 01）,P = 0. 06]. Conclusion： Chinese herbal medicine could effectively alleviated low back pain from primary osteoporosis in early stage,and improved the BMD of the lumbar spine. At the same time,there was little adverse reaction. So it can be taken as a effective and safe intervention for the treatment of osteoporosis with low back pain.