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中药仙灵骨葆胶囊联合阿仑膦酸钠治疗原发性骨质疏松症的疗效与安全性:一项对20项随机对照试验的系统评价和Meta分析

The Efficacy and Safety of Chinese Herbal Medicine Xianling Gubao Capsule Combined With Alendronate in the Treatment of Primary Osteoporosis: A Systematic Review and Meta-Analysis of 20 Randomized Controlled Trials.

作者信息

Chen Jiaru, Zheng Junju, Chen Mangmang, Lin Shenglei, Lin Zhou

机构信息

Department of Orthopaedic Surgery, Wenzhou Central Hospital, Wenzhou, China.

出版信息

Front Pharmacol. 2021 Jul 16;12:695832. doi: 10.3389/fphar.2021.695832. eCollection 2021.

DOI:10.3389/fphar.2021.695832
PMID:34335260
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8322973/
Abstract

Herein, we purposed to evaluate the efficacy along with the safety of Xianling Gubao capsule (XLGB) combined with alendronate (ALE) for primary osteoporosis (POP) from the current literature. We carried out a search for electronic literature in the PubMed, Chinese National Knowledge Infrastructure, EMBASE, Wanfang Web of Science, Chinese Biomedical Literature Database, Cochrane Library, as well as Chinese VIP databases targeting articles published from inception to December 2020. Only randomized controlled trials (RCTs) were enrolled into the study. Alkaline phosphatase (ALP), visual analogue scale (VAS), serum phosphorus (S-P), bone gla protein (BGP), serum calcium (S-Ca) and bone mineral density (BMD) were the primary outcome variable. The total clinical effective rate along with the adverse drug reaction (ADR) were the secondary outcome variables. The meta-analysis was conducted using RevMan 5.3 and STATA 12.0. GRADE pro3.6.1 software was used for the assessment of evidence quality. Overall, 20 RCTs focusing on 1911 patients were enrolled into the study. Our meta-analysis demonstrated that XLGB combined with ALE remarkably increased BMD ( < 0.001), BGP ( < 0.001), S-Ca ( < 0.001), S-P ( < 0.001) and effective rate ( < 0.001) than ALE alone in patients with POP. Moreover, ALP ( < 0.001) and VAS ( < 0.001) were overtly by decreased XLGB. However, XLGB combined with ALE would not markedly increase the rate of ADR in contrast with ALE alone ( = 0.499). The results of our study demonstrated that XLGB is a potential candidate for OP treatment. We recommend that rigorous, as well as high-quality trials involving large samples sizes should be conducted to confirm our findings.

摘要

在此,我们旨在从现有文献中评估仙灵骨葆胶囊(XLGB)联合阿仑膦酸钠(ALE)治疗原发性骨质疏松症(POP)的疗效和安全性。我们在PubMed、中国知网、EMBASE、万方数据、Web of Science、中国生物医学文献数据库、Cochrane图书馆以及中文维普数据库中检索了从数据库建立至2020年12月发表的电子文献。纳入研究的仅为随机对照试验(RCT)。碱性磷酸酶(ALP)、视觉模拟评分法(VAS)、血清磷(S-P)、骨钙素(BGP)、血清钙(S-Ca)和骨密度(BMD)为主要结局变量。总临床有效率和药物不良反应(ADR)为次要结局变量。使用RevMan 5.3和STATA 12.0进行荟萃分析。采用GRADE pro3.6.1软件评估证据质量。总体而言,该研究纳入了20项针对1911例患者的RCT。我们的荟萃分析表明,与单独使用ALE相比,XLGB联合ALE可显著提高POP患者的BMD(<0.001)、BGP(<0.001)、S-Ca(<0.001)、S-P(<0.001)和有效率(<0.001)。此外,XLGB可显著降低ALP(<0.001)和VAS(<0.001)。然而,与单独使用ALE相比,XLGB联合ALE不会显著增加ADR发生率(=0.499)。我们的研究结果表明XLGB是治疗OP的潜在候选药物。我们建议应开展严格且高质量的大样本试验以证实我们的研究结果。

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