中医药治疗股骨头坏死临床试验的系统评价

Systematic review on traditional Chinese medicine for osteonecrosis of the femoral head

目的:系统评价中医药治疗股骨头坏死的有效性和安全性。方法:计算机检索国内外多个文献数据库,并追索纳入文献的参考文献和相关文献。纳入中医药治疗股骨头坏死的随机对照试验,评价纳入研究的方法学质量,采用Cochrane协作网提供的RevMan 5.0软件对临床同质性研究进行Meta分析,反之进行描述性分析。结果:纳入10篇中医药治疗股骨头坏死的随机对照试验,共552例患者。因各研究采用不同的干预措施,故仅进行描述性分析。结果显示,7个研究报道了有效率,大多研究提示联合应用中医药疗法未能明显提高股骨头坏死的优良率。7个研究报道了优良率,少数研究提示联合应用中医药疗法可提高股骨头坏死的有效率。2个研究报道了影像学改善,提示联合应用中医药疗法亦未能提高股骨头坏死影像学改善。2个研究报道了功能评分,提示部分中医药疗法缓解疼痛、改善功能方面优于对照组。2个研究报告了安全性监测,较少出现不良反应,且多可自行缓解。结论:由于普遍低质量的随机对照试验,中医药治疗股骨头坏死的疗效目前尚无充分证据。潜在的疗效亟待设计严格的随机双盲对照试验予以证实。

Objective： To evaluate the effctiveness and safety of traditional Chinese medicine therapies（TCMT） for osteonecrosis of the femoral head（ONFH）.Methods： Several main databases were searched,and the references of the included studies were searched at the same time.Randomized controlled trials of TCMT for ONFH were included.The quality of trials was critically assessed.Meta-analysis was performed using RevMan 5.0 software if there was no significant heterogeneity.If heterogeneity existed among the studies,descriptive analysis was conducted.Results： 10 RCTs involving 552 patients were included.Because of different therapies in the treatment and control groups,the results of outcome were described separately.Efficiency was reported in 7 studies,which showed that combined TCMT had the same efficiency for ONFH with the controls.7 studies reported excellent rates,and 2 of the studies suggest that combined TCMT can improve the rates.Image were compared in 2 studies,suggesting that combined TCMT couldn’t improve the necrosis restoration and imaging score.2 studies reported function score,indicating some TCMT can improve the function compared to the control group.2 studies identified safety and showed TCMT had fewer adverse effects.And most adverse reactions were slight,could be self relieved.Conclusion： There is insufficient evidence for treatment of ONFH with TCMT due to the low methodological quality of the trials.Rigorously designed,randomized,double-blind,placebo-controlled trials are required.