标题：中成药联合阿仑膦酸钠治疗原发性骨质疏松症的Meta分析

      作者：张楚焌 1，孟欢 2，熊国辉 1，杨盼盼 1，谈荣珍 1，胡俊 1，付璐珩 1，张斌 1，袁忠 1    1.南昌市洪都中医院骨质疏松科，江西 南昌 330038；2.北京中医药大学，北京 100029

      卷次： 2020年31卷20期

      【摘要】 目的 系统评价中成药联合阿仑膦酸钠治疗原发性骨质疏松症(POP)的临床疗效。方法 计算机检索自建库至2020年1月发表在中国期刊全文数据库(CNKI)、万方数据知识服务平台、维普期刊数据库、中国生物医学文献数据库(CBMdisc)、The Cochrane Library、Pubmed、Science of Web (SCI)等中英文数据中所有上市中成药联合阿仑膦酸钠治疗POP的临床随机对照研究(RCT)文献。采用Review Manager 5.3软件进行系统评价及Meta分析。结果 共纳入25篇研究文献，其中仅3篇高质量文献。Meta分析结果显示，与阿仑膦酸钠组相比，中成药联合阿仑膦酸钠治疗POP的临床效率明显(OR=3.96，95%CI：3.03~5.17，P<0.000 01)，腰椎骨密度(SMD=0.64，95%CI：0.46~0.83，P<0.000 01)、股骨颈骨密度(MD=0.43，95%CI：0.30，0.56，P<0.000 01)、碱性磷酸酶(ALP) (SMD=-1.40，95%CI：-2.63~-0.16，P=0.03)、I型胶原交联C-末端肽(CTX) (SMD =-1.13，95%CI：-1.71~-0.55，P=0.0002)、VAS评分(SMD=-1.78，95%CI：-2.96~-0.61，P=0.003)均改善明显，不良反应发生率差异无统计学意义(OR=0.84，95%CI：0.55~1.28，P=0.42)。结论 与单用阿仑膦酸钠相比，中成药联合阿仑磷酸钠临床疗效显著，纳入研究存在发表偏移，仍需要更多高质量临床试验。
      【关键词】 阿仑膦酸钠；随机对照试验；系统评价；原发性骨质疏松症；中成药；Meta分析
      【中图分类号】 R681 【文献标识码】 A 【文章编号】 1003—6350（2020）20—2699—07

Clinical efficacy of Chinese patent medicine combined with alendronate in the treatment of primary osteoporosis:a meta-analysis.
ZHANG Chu-jun 1, MENG Huan 2, XIONG Guo-hui 1, YANG Pan-pan 1, TAN Rong-zhen 1, HU Jun 1, FULu-heng 1, ZHANG Bin 1, YUAN Zhong 1. 1. Department of Osteoporosis, Nanchang Hongdu Hospital of Traditional ChineseMedicine, Nanchang 330038, Jiangxi, CHINA; 2. Beijing University of Chinese Medicine, Beijing100029, CHINA
【Abstract】 Objective To systematically evaluate the clinical efficacy of Chinese patent drugs combined withalendronate in the treatment of primary osteoporosis (POP). Methods The databases such as CNKI, Wanfang DataKnowledge Service Platform, Weipu Journal Database, Chinese Biomedical Literature Database (CBMdisc), the Co-chrane Library, Pubmed, Science of Web (SCI) were searched. Search time was limited to 30 January, 2020. All clinicalrandomized controlled studies of Chinese patent medicines combined with alendronate sodium were searched. The litera-ture quality evaluation and meta-analysis were carried out by using Review Manager 5.0 software. Results A total of25 research articles were included, of which only 3 were high-quality articles. Meta-analysis results showed that com-pared with alendronate alone, the total effective rate of Chinese patent drugs combined with alendronate in treating POPwas significantly higher (OR=3.96, 95%CI: 3.03-5.17, P<0.000 01), and the lumbar bone density (SMD=0.64, 95%CI:0.46-0.83, P<0.000 01), femoral neck bone density (SMD=0.43, 95% CI: 0.30-0.56, P<0.000 01), the level of ALP(SMD=-1.40, 95%CI: -2.63 to -0.16, P=0.03), type Ⅰ collagen cross linked C-terminal peptide (CTX) (SMD=-1.13,95%CI: -1.71 to -0.55, P=0.000 2), and the VAS score (MD=-1.78, 95%CI: -2.96 to -0.61, P=0.003) were improvedsignificantly. There was no significant difference on the adverse reactions between Chinese patent drugs combined withalendronate and alendronate alone (OR=0.84, 95% CI: 0.55-1.28, P=0.42). Conclusion Compared with alendronatealone, Chinese patent drug combined with alendronate has a significant clinical effect in the treatment on POP, and morehigh-quality clinical trials are still needed because of the publication bias in the included studies.
      【Key words】 Alendronate; Randomized controlled trials; Systematic evaluation; Primary osteoporosis; Chinesepatent drug; Meta-analysis·荟萃分析·doi:10.3969/j.issn.1003-6350.2020.20.032基金项目：江西省卫生计生委中医药科研项目(编号：2017A164)