骨松宝制剂治疗原发性骨质疏松症的系统评价与Meta分析  

Systematic review and Meta-analysis of Gusongbao preparation in treatment of primary osteoporosis

作　　者：陆洁航 李正言[1] 杜国庆[1] 张军[2] 王玉鹏 石金玉 廉由之 潘富伟 章振林[4] 詹红生[1] LU Jie-hang;LI Zheng-yan;DU Guo-qing;ZHANG Jun;WANG Yu-peng;SHI Jin-yu;LIAN You-zhi;PAN Fu-wei;ZHANG Zhen-lin;ZHAN Hong-sheng(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China;Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai 201999,China;Shanghai Sixth People′s Hospital Affiliated to Shanghai Jiao Tong University,Shanghai 200233,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]中国中医科学院望京医院,北京100102 [3]上海市宝山区中西医结合医院,上海201999 [4]上海交通大学附属第六人民医院,上海200233

出　　处：《中国中药杂志》2023年第11期3086-3096,共11页China Journal of Chinese Materia Medica

基　　金：国家中医药管理局《中成药治疗优势病种临床应用指南》标准化项目第三批子课题项目(SATCM-2015-BZ402-042);国家自然科学基金面上项目(82174403,82074466);詹红生全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号);上海市慢性筋骨病临床医学研究中心项目(20MC1920600)。

摘　　要：系统评价骨松宝制剂治疗原发性骨质疏松症(POP)的有效性和安全性,为临床实践提供重要依据。检索4个中文和4个英文数据库(均自建库至2022年5月31日),按照预设的纳入、排除标准筛选后,纳入骨松宝制剂治疗POP的随机对照试验(RCT),采用偏倚风险评估工具对原始文献进行质量评价,并用RevMan 5.3文献管理软件将提取的数据进行Meta分析。共检索到657篇文献,最终纳入15篇、16项研究,总样本量3292例,其中试验组1071例、对照组2221例。骨松宝制剂+常规治疗在提高腰椎(L2~L4)骨密度(MD=0.03,95%CI[0.02,0.04],P<0.00001)与股骨颈骨密度,降低腰背痛(MD=-1.69,95%CI[-2.46,-0.92],P<0.0001),提高临床有效率(RR=1.36,95%CI[1.21,1.53],P<0.00001)方面优于单纯常规治疗。骨松宝制剂在提高临床有效率(RR=0.95,95%CI[0.86,1.04],P=0.23)方面与同类中成药相当;在降低中医证候积分(MD=1.08,95%CI[0.44,1.71],P=0.0009),提高中医证候疗效(RR=0.89,95%CI[0.83,0.95],P=0.0004)方面不及同类中成药。骨松宝制剂单用或+常规治疗的不良反应发生率与同类中成药(RR=0.98,95%CI[0.57,1.69],P=0.94)或单纯常规治疗(RR=0.73,95%CI[0.38,1.42],P=0.35)相当,不良反应以胃肠道不适为主。结果表明,骨松宝制剂+常规治疗在升高腰椎(L2~L4)和股骨颈骨密度、降低腰背痛、提高临床有效率方面优于单纯常规治疗,其不良反应以胃肠道不适为主,皆为轻度。This study aims to provide evidence for clinical practice by systematically reviewing the efficacy and safety of Gusongbao preparation in the treatment of primary osteoporosis(POP).The relevant papers were retrieved from four Chinese academic journal databases and four English academic journal databases(from inception to May 31,2022).The randomized controlled trial(RCT)of Gusongbao preparation in the treatment of POP was included after screening according to the inclusion and exclusion criteria.The quality of articles was evaluated using risk assessment tools,and the extracted data were subjected to Meta-analysis in RevMan 5.3.A total of 657 articles were retrieved,in which 15 articles were included in this study,which involved 16 RCTs.A total of 3292 patients(1071 in the observation group and 2221 in the control group)were included in this study.In the treatment of POP,Gusongbao preparation+conventional treatment was superior to conventional treatment alone in terms of increasing lumbar spine(L2-L4)bone mineral density(MD=0.03,95%CI[0.02,0.04],P<0.00001)and femoral neck bone mineral density,reducing low back pain(MD=-1.69,95%CI[-2.46,-0.92],P<0.0001)and improving clinical efficacy(RR=1.36,95%CI[1.21,1.53],P<0.00001).Gusongbao preparation was comparable to similar Chinese patent medicines in terms of improving clinical efficacy(RR=0.95,95%CI[0.86,1.04],P=0.23).Gusongbao preparation was inferior to similar Chinese patent medicines in reducing traditional Chinese medicine syndrome scores(MD=1.08,95%CI[0.44,1.71],P=0.0009)and improving Chinese medicine syndrome efficacy(RR=0.89,95%CI[0.83,0.95],P=0.0004).The incidence of adverse reactions of Gusongbao preparation alone or combined with conventional treatment was comparable to that of similar Chinese patent medicines(RR=0.98,95%CI[0.57,1.69],P=0.94)or conventional treatment(RR=0.73,95%CI[0.38,1.42],P=0.35),and the adverse reactions were mainly gastrointestinal discomforts.According to the available data,Gusongbao preparation combined with conventional treatment is mo

关 键 词：骨松宝制剂 原发性骨质疏松症 随机对照试验 系统评价 META分析 

分 类 号：R580[医药卫生—内分泌]