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<0.00001),腰椎骨密度(SMD=0.64,95%CI:0.46~0.83,P<0.00001)、股骨颈骨密度(MD=0.43,95%CI:0.30,0.56,P<0.00001)、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。
Objective To systematically evaluate the clinical efficacy of Chinese patent drugs combined with alendronate in the treatment of primary osteoporosis(POP).Methods The databases such as CNKI,Wanfang Data Knowledge Service Platform,Weipu Journal Database,Chinese Biomedical Literature Database(CBMdisc),the Cochrane Library,Pubmed,Science of Web(SCI)were searched.Search time was limited to 30 January,2020.All clinical randomized controlled studies of Chinese patent medicines combined with alendronate sodium were searched.The literature quality evaluation and meta-analysis were carried out by using Review Manager 5.0 software.Results A total of 25 research articles were included,of which only 3 were high-quality articles.Meta-analysis results showed that compared with alendronate alone,the total effective rate of Chinese patent drugs combined with alendronate in treating POP was significantly higher(OR=3.96,95%CI:3.03-5.17,P<0.00001),and the lumbar bone density(SMD=0.64,95%CI:0.46-0.83,P<0.00001),femoral neck bone density(SMD=0.43,95%CI:0.30-0.56,P<0.00001),the level of ALP(SMD=-1.40,95%CI:-2.63 to-0.16,P=0.03),typeⅠcollagen cross linked C-terminal peptide(CTX)(SMD=-1.13,95%CI:-1.71 to-0.55,P=0.0002),and the VAS score(MD=-1.78,95%CI:-2.96 to-0.61,P=0.003)were improved significantly.There was no significant difference on the adverse reactions between Chinese patent drugs combined with alendronate and alendronate alone(OR=0.84,95%CI:0.55-1.28,P=0.42).Conclusion Compared with alendronate alone,Chinese patent drug combined with alendronate has a significant clinical effect in the treatment on POP,and more high-quality clinical trials are still needed because of the publication bias in the included studies.
作者
张楚焌
孟欢
熊国辉
杨盼盼
谈荣珍
胡俊
付璐珩
张斌
袁忠
ZHANG Chu-jun;MENG Huan;XIONG Guo-hui;YANG Pan-pan;TAN Rong-zhen;HU Jun;FU Lu-heng;ZHANG Bin;YUAN Zhong(Department of Osteoporosis,Nanchang Hongdu Hospital of Traditional Chinese Medicine,Nanchang 330038,Jiangxi,CHINA;Beijing University of Chinese Medicine,Beijing100029,CHINA)
出处
《海南医学》
CAS
2020年第20期2699-2705,共7页
Hainan Medical Journal
基金
江西省卫生计生委中医药科研项目(编号:2017A164)。
