背景:骨康胶囊已在中国用作治疗原发性骨质疏松症(POP)的补充和替代药物(CAM)。本研究的主要目的是评估骨康胶囊在POP患者中的临床有效性和安全性。方法:在包括PubMed在内的多个学术数据库中进行了系统的搜索,WebofScience,科克伦图书馆,中国国家知识基础设施,重庆贵宾信息,和万方数据库确定研究骨康胶囊治疗POP的随机对照试验。筛选过程,数据提取,方法质量评估由两名评审员独立进行。使用RevMan5.3软件进行统计分析。通过OPF的组合进行亚组分析。根据是否合并OPF进行亚组分析。Stata12.0用于敏感性和偏倚分析。结果:评估了19项研究,包括1804名参与者。结果发现,与对照组相比,总有效率(RR=1.26,95%CI,1.20,1.33),医学结果研究简表36[RR=1.26,95%CI(1.20,1.33)],腰椎骨密度(BMD)(SMD=0.77,95%CI,0.48,1.07),股骨颈骨密度[SMD=0.84,95%CI(0.53,1.14)],骨康胶囊实验组的沃德三角骨密度(SMD=0.64,95%CI,0.44,0.85)较高。与对照组相比,骨折愈合时间(SMD=-2.14,95%CI,-2.45,-1.84),血清中骨特异性碱性磷酸酶(BALP)水平(SMD=-2.00,95%CI,-2.83,-1.17),骨康胶囊实验组血清抗酒石酸酸性磷酸酶5b(TRACP-5b)水平(SMD=-2.58,95%CI,-3.87,-1.29)较低。试验组与对照组血清骨组织蛋白(BGP)水平(SMD=-0.22,95%CI,-1.86,1.43)及不良事件(RR=0.80,95%CI,0.40,1.63)无差异。结论:骨康胶囊,作为POP管理的CAM,展示了提高BMD和生活质量的潜力,加快OPF的愈合时间,降低BALP和TRACP-5b的水平,在不增加不良事件的情况下提高总有效率。系统审查注册:https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42023477774,PROSPEROCRD42023477774。
Background: Gukang Capsule has been used as a complementary and alternative medicine (CAM) for the treatment of primary osteoporosis (POP) in
China. The primary aim of this study was to assess the clinical effectiveness and safety of Gukang Capsule in POP patients. Methods: A systematic search was conducted across multiple academic databases including PubMed, Web of science, Cochrane Library,
China National Knowledge Infrastructure, Chongqing VIP Information, and Wanfang database to identify randomized controlled trials investigating the Gukang Capsule in the treatment of POP. The screening process, data extraction, and assessment of methodological quality were conducted independently by two reviewers. Statistical analysis was performed using the Rev Man 5.3 software. Subgroup analysis was carried out through the combination of OPF. Subgroup analysis was performed according to whether OPF were combined. Stata 12.0 was used for sensitivity and bias analysis. Results: Nineteen studies were assessed that included 1804 participants. It was found that compared with the control group, the total effective rate (RR = 1.26, 95% CI, 1.20, 1.33), the Medical Outcomes Study Short-form 36 [RR = 1.26, 95% CI(1.20, 1.33)], the bone mineral density (BMD) of lumbar vertebra (SMD = 0.77, 95% CI, 0.48, 1.07), the BMD of femoral neck [SMD = 0.84, 95% CI(0.53, 1.14)], and the BMD of Ward\'s triangle (SMD = 0.64, 95% CI, 0.44, 0.85) of the Gukang Capsule experimental group were higher. Compared with the control group, the fracture healing time (SMD = -2.14, 95% CI, -2.45, -1.84), the bone specific alkaline phosphatase (BALP) levels in serum (SMD = -2.00, 95% CI, -2.83, -1.17), the tartrate resistant acid phosphatase 5b (TRACP-5b) levels in serum (SMD = -2.58, 95% CI, -3.87, -1.29) of the Gukang Capsule experimental group were lower. The bone glaprotein (BGP) levels in serum (SMD = -0.22, 95% CI, -1.86, 1.43) and the adverse events (RR = 0.80, 95% CI, 0.40, 1.63) of the experimental group and the control group have no difference. Conclusion: Gukang Capsule, as a CAM for the management of POP, exhibits the potential to enhance BMD and quality of life, expedite the healing time of OPF, diminish levels of BALP and TRACP-5b, and improve the total effective rate without increasing the adverse events. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023477774, PROSPERO CRD42023477774.