仙灵骨葆胶囊治疗原发性骨质疏松症随机对照试验的系统评价及Meta分析

Systemic evaluation and Meta-analysis of Xianling Gubao capsule in treatment of primary osteoporosis in randomized controlled trials

评价仙灵骨葆胶囊治疗骨质疏松症的有效性和安全性。检索中文和英文数据库共8个(均自建库至2017年2月),按照预先设定的纳入标准与排除标准筛选临床试验,应用风险评估工具进行研究质量评价,提取数据并运用Rev Man 5.3软件进行Meta分析。共检索到1 895篇文献,最终纳入54个研究,总样本数为5 030例,试验组2 543例和对照组2 487例。仙灵骨葆胶囊vs CT(常规治疗)的干预措施下,仙灵骨葆胶囊治疗OP,SOP有效率优于对照组,提高OP患者骨密度[MD=0.08,95%CI(0.06,0.10)]。仙灵骨葆胶囊+CT vs CT的干预措施下,仙灵骨葆胶囊治疗OP,PMOP,SOP疗效优于对照组,提高OP患者骨密度[MD=0.04,95%CI(0.03,0.05)],提高POP患者骨密度[MD=0.08,95%CI(0.05,0.10)],提高SOP患者骨密度[MD=0.06,95%CI(0.05,0.07)],减缓OP患者骨质疏松性疼痛[MD=-0.93,95%CI(-1.16,-0.70)],提高OP患者碱性磷酸酶[MD=7.53,95%CI(5.91,9.14)],提高OP患者血钙[MD=0.03,95%CI(0.01,0.06)],提高OP患者骨钙素的含量[MD=4.09,95%CI(3.20,4.98)],提高SOP患者血磷含量[MD=0.03,95%CI(0.00,0.05)]。研究中报告的不良反应主要以肝损伤和胃肠道症状为主。仙灵骨葆胶囊单用或与其他西药联合使用,在治疗骨质疏松症方面的疗效优于单用西药治疗。但由于纳入研究存在潜在偏倚,研究结论仍需要更多高质量随机对照试验以提高证据级别。

To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of osteoporosis （OP）. Eight Chinese and English databases were retrieved （from establishment to February 2017 ）, and clinical trials were screened according to the preset in- clusion criteria and exclusion criteria. Then risk assessment tools were used for quality evaluation of the studies, and data extraction and analysis were conducted by using RevMan 5.3 software for Meta-analysis. A total of 1 895 articles were retrieved, and finally 54 studies were included. The total sample number was 5 030, including 2 543 cases in experimental group and 2 487 cases in control group. As compared with CT （routine therapy） intervention, Xianling Gubao capsules showed higher SOP efficiency and improved bone mineral density in patients with OP [ MD = 0. 08, 95 % CI （ 0. 06, 0. 10 ） ]. As compared with control group, Xianling Gubao capsule ＋ CT showed higher efficiency in PMOP and SOP, increased bone mineral density in OP patients [ MD =0. 04, 95% CI （0. 03, 0. 05） ], POP patients [ MD =0.08, 95% CI （0.05, 0. 10） ], and SOP patients [ MD =0.06, 95% CI （0. 05, 0. 07） ], relieved os- teoporotic pain in OP patients [ MD = - 0.93,95 % CI （ - 1.16, - 0. 70）, increased alkaline pbosphatase level in OP patients [ MD = 7.53, 95% CI （5.91, 9. 14）, blood calcium in OP patients [ MD = 0.03, 95% CI （0.01, 0. 06） ], and osteocalcin level in OP pa-tients [MD =4.09, 95%CI （3.20, 4. 98） ], and increased serum phosphorus level in SOP patients [ MD =0. 03, 95% CI （0. 00, 0. 05） ]. The main adverse reactions reported were liver injury and gastrointestinal symptoms. Xianhng Gubao capsule alone or com- bined use with other medicines had better efficacy than western medicine alone in the treatment of osteoporosis. However, because of potential bias in the included studies, more high-quality randomized controlled trials would be needed to improve the level of evidence.