口服补肾类中成药治疗绝经后骨质疏松症有效性与安全性的网状Meta分析

Efficacy and safety of oral kidney-tonifying Chinese patent medicines in treatment of postmenopausal osteoporosis:A network Meta-analysis

目的采用网状Meta分析方法评价不同补肾类中成药治疗绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的有效性及安全性。方法运用计算机检索Web of Science、Cochrane Library、Embase、PubMed、维普(VIP)、万方(Wanfang)、中国知网(CNKI)、中国生物医学文献数据库(CBM),搜寻有关补肾类中成药治疗PMOP的随机对照试验(randomized controlled trial,RCT),检索时间为建库至2021年11月,对符合质量标准的研究采用Stata16.0和Review Manager 5.4软件进行分析。结果共检索出3246篇文献,最终纳入41个RCTs,包括13种干预措施和3699例患者。网状Meta分析结果表明,在改善有效性方面,中成药和常规化学药联用均优于常规化学药或其他中成药单独应用或二者联用,中成药单用的安全性更好。①在提高总有效率方面,最好的前3种治疗方案为仙灵骨葆胶囊+常规化学药(conventional western medicine,CWM)、右归丸+CWM、鹿角壮骨胶囊+CWM;②在降低视觉模拟评分(visual analogue scale,VAS)方面,最好的前3种治疗方案为鹿角壮骨胶囊+CWM、加味二仙颗粒+CWM、仙灵骨葆胶囊+CWM;③在提高腰椎骨密度方面,最好的前3种治疗方案为骨疏康胶囊+CWM、右归丸+CWM、鹿角壮骨胶囊+CWM;④在提高股骨颈骨密度方面,最好的前3种治疗方案为骨疏康胶囊+CWM、鹿角壮骨胶囊+CWM、知柏地黄丸+CWM;⑤在降低血清骨钙素方面,最好的前3种治疗方案为仙灵骨葆+CWM、左归丸+CWM、青娥丸+CWM;⑥在不良反应发生率方面,最安全的前3种治疗方案为仙灵骨葆胶囊、仙灵骨葆胶囊+CWM、鹿角壮骨胶囊+CWM。结论补肾类中成药联合CWM在治疗PMOP有效性方面均优于二者单独应用,每种中成药都有其独特的优势,但以具有续筋接骨功效的中成药效果更佳。在安全性方面,中成药联用或不联用CWM均优于CWM,仙灵骨葆胶囊可能是最安全的治疗方案。受纳入研究质量的限制,所得结论仍待进一步验证。

Objective To evaluate the efficacy and safety of different kidney-tonifying Chinese patent medicines in the treatment of postmenopausal osteoporosis(PMOP)by network Meta-analysis.Methods Web of Science,Cochrane Library,Embase,PubMed,VIP,Wanfang,CNKI and Chinese Biomedical Literature Database(CBM)were searched by computer for randomized controlled trials(RCTs)on related kidney-tonifying Chinese patent medicines in the treatment of postmenopausal osteoporosis.The retrieval time was from the establishment of the database to November 2021.Studies that met the quality criteria were analyzed using Stata16.0 software and Review Manager 5.4.Results A total of 3246 articles were retrieved and finally 41 RCTs involving 13 interventions and 3699 patients were included.The results of network Meta-analysis showed that:In terms of improving effectiveness,the combination of Chinese patent medicine and conventional western medicine(CWM)was better than CWM or other Chinese patent medicine alone or the combination of both,and the safety of Chinese patent medicine alone was better.①In terms of effective rate,the optimal first three interventions were Xianling Gubao Capsule(仙灵骨葆胶囊)+CWM,Yougui Pill(右归丸)+CWM,Lujiao Zhuanggu Capsule(鹿角壮骨胶囊)+CWM;②In terms of reducing VAS score,the optimal first three interventions were Lujiao Zhuanggu Capsule+CWM,Jiawei Erxian Granule(加味二仙颗粒)+CWM,Xianling Gubao Capsule+CWM;③In terms of improving lumbar bone density,the optimal first three interventions were Gushukang Capsule(骨疏康胶囊)+CWM,Yougui Pill+CWM,Lujiao Zhuanggu Capsule+CWM;④In terms of improving the bone density of the femoral neck,the optimal first three interventions were Gushukang Capsule+CWM,Lujiao Zhuanggu Capsule+CWM,Zhibai Dihuang Pill(知柏地黄丸)+CWM;⑤In terms of reducing serum osteocalcin,the optimal first three interventionss were Xianling Gubao+CWM,Zuogui Pill(左归丸)+CWM,Qing'e Pill(青娥丸)+CWM;⑥In terms of adverse reaction incidence,the safest top three treatment methods were Xianling Gubao Capsule,Xianling Gubao Capsule+CWM,Lujiao Zhuanggu Capsule+CWM.Conclusion The combination of kidney-tonifying Chinese patent medicines and CWM is better than single use in the treatment of PMOP.Each Chinese patent medicine has its own unique advantages,but the Chinese patent medicine with the effect of reinforcing tendons and bones was more effective.In terms of safety,Chinese patent medicine combined with or without CWM is superior to CWM,and Xianling Gubao Capsule may be the safest treatment method.Limited by the quality of the included studies,the conclusions obtained still need to be further verified.