摘要
综合评价金天格胶囊治疗绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的疗效与安全性。系统检索7个文献数据库,2位评价者独立检索、筛选文献、提取数据,纳入所有已完成的金天格胶囊治疗PMOP的随机对照试验。干预措施包括金天格胶囊与安慰剂对照以及常规治疗对比,金天格胶囊联合常规治疗对比常规治疗的研究亦被纳入。研究评价指标至少包括骨折、生活质量、日常生活能力、临床症状指标、死亡、不良事件/不良反应、骨密度、骨代谢检测指标中的1项。原始研究质量评价遵循Cochrane Handbook标准,采用Rev Man 5.2进行统计分析。共纳入7项随机对照试验,研究质量偏低。Meta分析显示与单纯常规治疗相比,金天格胶囊联合常规治疗在减轻疼痛方面改善更为明显(MD=-0.98,95%CI[-1.55,-0.41],P=0.000 8),并能够有效提高血钙水平(MD=0.05,95%CI[0.02,0.09],P=0.003),降低血清碱性磷酸酶水平方面更为明显(MD=-12.92,95%CI[-24.09,-1.75],P=0.02)。此外,中成药单用或者联合常规治疗安全性相对较好。金天格胶囊治疗PMOP具有一定疗效,但目前证据质量偏低,需要严谨设计随机对照试验,选择公认评价指标尤其是终点结局指标来进一步完善临床证据。
To systemically evaluate the efficacy and safety of Jintiange Capsules in the treatment of postmenopausal osteoporosis(PMOP).Seven literature databases were retrieved systematically,and two reviewers independently searched and screened studies,extracted data,and included all the randomized controlled trials on Jintiange Capsules in the treatment of PMOP.Interventions included comparison of Jintiange Capsules with placebo and routine treatment,and the studies on Jintiange Capsules combined with routine treatment versus conventional treatment were also included.The evaluation indicators of the study included at least one of the followings:fracture,quality of life,daily living ability,clinical symptoms,death,adverse events/adverse reactions,bone density,and bone metabolism indexes.The original study quality evaluation was conducted by following the Cochrane Handbook standard and statistical analysis was performed by using Rev Man 5.2.A total of 7 randomized controlled trials were included and the study quality was low.Meta-analysis showed that as compared with conventional treatment alone,Jintiange Capsules combined with conventional treatment showed more obvious effects in pain relief(MD=-0.98,95% CI[-1.55,-0.41],P=0.000 8),increasing blood calcium levels(MD=0.05,95% CI[0.02,0.09],P=0.003) and lowering serum alkaline phosphatase levels(MD=-12.92,95% CI[-24.09,-1.75],P=0.02).In addition,the Chinese patent medicine alone or in combination with conventional treatment was relatively safe.In conclusion,Jintiange Capsules has a certain effect in treating PMOP,but the quality of evidence is low.It is necessary to conduct well designed randomized controlled trials and select recognized evaluation indicators,especially the end outcomes in order to further improve the clinical evidence.
作者
赵艺如
魏戌
姜俊杰
章轶立
王尚全
谢雁鸣
ZHAO Yi-ru;WEI Xu;JIANG Jun-jie;ZHANG Yi-li;WANG Shang-quan;XIE Yan-ming(Institute of Basic Research in Clinic Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2019年第1期186-192,共7页
China Journal of Chinese Materia Medica
基金
北京中医药科技发展资金项目(JJ2016-79)
中华中医药学会(2017-2019年度)青年人才托举工程项目(CACM-2017-QNRC2-A03)
关键词
金天格胶囊
绝经后骨质疏松症
证据
随机对照试验
系统评价
Jintiange Capsules
postmenopausal osteoporosis
evidence
randomized controlled trial
systemic review
