Clinical College of Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, Hubei, China.
College of Public Health, Wuhan University, Wuhan, Hubei, China.
BMJ Open. 2022 May 17;12(5):e054158. doi: 10.1136/bmjopen-2021-054158.
Osteoporosis (OP) is a prevalent skeletal disease with high mortality and morbidity, followed by acute and chronic back pain, severe spinal deformity and dysfunction. First-line drugs for OP work through antiresorptive or anabolic mechanisms. Although with good efficacy, these drugs still have certain limitations in clinical application due to delivery routes, medication cycles and cost issues. Nowadays, statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) appear to be potentially promising drugs for OP. Despite the controversy, previous studies have shown the efficacy of statins in treating OP. Other studies have further indicated that the therapeutic effect of OP in statin-treated patients is dose dependent. However, scientists have not yet reached a consensus on the use of statins for the treatment or which statin to choose first. This study aims to review the literature, ascertaining the relative efficacy and safety of statins for patients with OP using a Bayesian network meta-analysis.
We will systematically search the following databases: MEDLINE, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database, Chinese BioMedical Literature Database and preprint servers to include randomised controlled trials that compare different statins for treating OP. Primary outcomes are the incidence of overall fractures and bone mineral density changes. Secondary outcomes contain adverse effects and bone turnover markers. All items of this review will comply with the Cochrane Handbook, and the quality of evidence will be evaluated by Grading of Recommendations Assessment, Development and Evaluation. A traditional pairwise meta-analysis and the Bayesian network meta-analysis will be performed to compare the efficacy of different statins.
Ethical approval is not required since this is a protocol study for meta-analyses. Results will be submitted to a peer-reviewed journal.
CRD42021242619.
From database inception to February 2022.
骨质疏松症（OP）是一种常见的骨骼疾病，具有高死亡率和发病率，随后会出现急性和慢性背痛、严重的脊柱畸形和功能障碍。OP 的一线药物通过抗吸收或合成代谢机制发挥作用。尽管这些药物疗效良好，但由于给药途径、用药周期和成本问题，它们在临床应用中仍存在一定的局限性。如今，他汀类药物（3-羟基-3-甲基戊二酰辅酶 A 还原酶抑制剂）似乎是治疗 OP 的有前途的药物。尽管存在争议，但先前的研究表明他汀类药物治疗 OP 的疗效。其他研究还进一步表明，他汀类药物治疗患者的 OP 治疗效果与剂量有关。然而，科学家们尚未就他汀类药物治疗 OP 的使用或选择哪种他汀类药物达成共识。本研究旨在通过贝叶斯网状荟萃分析，回顾文献，确定他汀类药物治疗 OP 患者的相对疗效和安全性。
我们将系统地搜索以下数据库：MEDLINE、EMBASE、Web of Science、Cochrane 中央对照试验注册库、中国知识基础设施、万方数据库、中国科技期刊数据库、中国生物医学文献数据库和预印本服务器，以纳入比较不同他汀类药物治疗 OP 的随机对照试验。主要结局是总体骨折发生率和骨密度变化。次要结局包括不良反应和骨转换标志物。本综述的所有项目都将符合 Cochrane 手册，证据质量将通过推荐评估、制定和评价进行评估。将进行传统的两两荟萃分析和贝叶斯网状荟萃分析，以比较不同他汀类药物的疗效。
由于这是荟萃分析的方案研究，因此不需要伦理批准。结果将提交给同行评议的期刊。
PROSPERO 注册号：CRD42021242619。
从数据库成立到 2022 年 2 月。
