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中药方剂作为股骨头坏死辅助治疗的随机对照试验系统评价与Meta分析

Chinese herbal medicine formulas as adjuvant therapy for osteonecrosis of the femoral head: A systematic review and meta-analysis of randomized controlled trials.

作者信息

Zhang Qingwen, Yang Fan, Chen Yaolong, Wang Haibin, Chen Delong, He Wei, Chen Peng

机构信息

First Affiliated Hospital First School of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China.

出版信息

Medicine (Baltimore). 2018 Sep;97(36):e12196. doi: 10.1097/MD.0000000000012196.

Abstract

BACKGROUND

Osteonecrosis of femoral head (ONFH) is a disabling clinical entity affecting mainly young adults. Although Chinese Herbal Medicine (CHM) has been widely used as an adjunct therapy for ONFH in China, its effectiveness is not well defined. The purpose of this systematic review is to assess the effectiveness of CHM as an adjunct therapy to core decompression (CD) for patients with ONFH.

METHODS

A systematic literature search was conducted in 10 electronic databases. Randomized controlled trials involving CHM and CD for ONFH were included. Two authors independently assessed the studies for inclusion and extracted the data. A meta-analysis was conducted to estimate the safety and efficacy of CHM as an adjunct therapy.

RESULTS

Twenty-three randomized controlled trials with 1815 participants were included. The formulas used in these studies were different and we only combined data of studies observing the same formulas. Patients treated with CHM additionally exhibited a better TER (total effective rate) compared with CD alone in different degree, with the risk ratio (RR) varies from 1.09 to 1.09. The Harris score and radiographic effective rate indicate a similar result, with the medicine (MD) varies from 17.35 to 14.94 and RR 1.40 to 1.27. The risk of side-effect was barely reported except only 2 study record that no complications were observed.

CONCLUSION

This systematic review indicated that CHM as adjunctive therapy may improve the effectiveness of CD. However, a firm conclusion could not be reached because of overall high risk of bias in most domains. Further studies of higher quality are required, and other benefits of CHM remain to be determined.

摘要

背景

股骨头坏死(ONFH)是一种主要影响年轻人的致残性临床病症。尽管中药在中国已被广泛用作ONFH的辅助治疗方法,但其有效性尚未明确界定。本系统评价的目的是评估中药作为ONFH患者核心减压(CD)辅助治疗的有效性。

方法

在10个电子数据库中进行了系统的文献检索。纳入了涉及中药和CD治疗ONFH的随机对照试验。两位作者独立评估纳入研究并提取数据。进行荟萃分析以评估中药作为辅助治疗的安全性和有效性。

结果

纳入了23项随机对照试验,共1815名参与者。这些研究中使用的方剂不同,我们仅合并了观察相同方剂的研究数据。与单独使用CD相比,接受中药治疗的患者在不同程度上还表现出更好的总有效率(TER),风险比(RR)在1.09至1.09之间变化。Harris评分和影像学有效率表明结果相似,药物差异(MD)在17.35至14.94之间,RR在1.40至1.27之间。除了仅有2项研究记录未观察到并发症外,几乎没有报告副作用风险。

结论

本系统评价表明,中药作为辅助治疗可能会提高CD的有效性。然而,由于大多数领域的总体偏倚风险较高,无法得出确凿的结论。需要进行更高质量的进一步研究,中药的其他益处仍有待确定。

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