Meta-analysis of the Efficacy and Safety of Adjunctive Rosuvastatin for Dyslipidemia in Patients with Schizophrenia.

上海精神医学 Pub Date : 2018-02-25 DOI:10.11919/j.issn.1002-0829.217156

Wei Zheng, Wei Yang, Qing-E Zhang, Xin-Hu Yang, Dong-Bin Cai, Jin-Qing Hu, Gabor S Ungvari, Chee H Ng, Marc De Hert, Yu-Ping Ning, Yu-Tao Xiang

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引用次数: 3

Abstract

Background: Metabolic syndrome in patients with schizophrenia is a major health concern. The efficacy and safety of adjunctive rosuvastatin in treating dyslipidemia were controversial.

Aims: To assess the efficacy and safety of adjunctive rosuvastatin for dyslipidemia in patients with schizophrenia.

Methods: We systematically searched for relevant controlled clinical trials from the following databases: PubMed, PsycINFO, Cochrane Library, China Knowledge Network, WanFang Database and Chinese Biomedical Database up to September 28, 2017. Standardized mean difference (SMD) and risk ratio (RR) along with their 95% confidence intervals (CIs) were calculated. The quality of the included studies was assessed using the Cochrane risk of bias assessment tool. The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system recommendation grading method was used as the reference standard.

Results: Four studies (n=274) comparing rosuvastatin (n=138) and control (n=136) groups were identified and analyzed. Adjunctive rosuvastatin showed greater efficacy than control group in low density lipoprotein cholesterol (LDL-C) [4 trials, n=272, SMD: -1.31 (95%CI: -1.93, -0.70), I²=81%], total cholesterol (2 trials, n=164, SMD: -2.00 (95%CI: -2.79, -1.21); I²=76%) and triglycerides (2 trials, n=164, SMD: -1.05 (95%CI: -1.38, -0.72); I²=0%), but not in high density lipoprotein cholesterol (2 trials, n=164, SMD: 0.14 (95%CI: -0.16, 0.45); I²=0%). After removing one study without randomization for LDL-C, significance remained [3 trials, n=172, SMD:-1.07 (95%CI: -1.60, -0.53); I²=63%]. No significant group differences regarding body weight (3 trials, n=208, SMD: -0.40 (95%CI:-1.29, 0.49); I²=89%), body mass index (2 trials, n=164, SMD: -0.34 (95%CI: -1.23, 0.56); I²=87%), waist circumference (3 trials, n=208, SMD): -0.43 (95%CI: -1.31, 0.46); I²=89%), and fasting glucose (4 trials, n=272, SMD: -0.25 (95%CI: -0.65, 0.15); I²=62%) were observed. The adverse reactions and any cause discontinuation rate were similar between the groups. According to the GRADE approach, the evidence levels of main outcomes were rated as "very low" (35.3%) to "low" (64.7%). Of them, the primary outcome (LDL-C) was rated as "very low ".

Conclusions: The data available on the effectiveness and safety of adjunctive rosuvastatin in treating dyslipidemia for patients with schizophrenia is insufficient to come to a definitive interpretation about its efficacy and safety. Further high quality RCTs with extended treatment duration are warranted to confirm the findings.

Review registration: PROSPERO: CRD42017078230.

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辅助瑞舒伐他汀治疗精神分裂症患者血脂异常的疗效和安全性的meta分析。

背景:精神分裂症患者的代谢综合征是一个主要的健康问题。辅助瑞舒伐他汀治疗血脂异常的有效性和安全性存在争议。目的:评价瑞舒伐他汀辅助治疗精神分裂症患者血脂异常的有效性和安全性。方法:系统检索截至2017年9月28日的PubMed、PsycINFO、Cochrane图书馆、中国知识网、万方数据库和中国生物医学数据库的相关对照临床试验。计算标准化平均差(SMD)和风险比(RR)及其95%置信区间(ci)。采用Cochrane偏倚风险评估工具对纳入研究的质量进行评估。采用GRADE (Grades of Recommendation, Assessment, Development, and Evaluation)系统推荐评分方法作为参考标准。结果:4项研究(n=274)对瑞舒伐他汀组(n=138)和对照组(n=136)进行了鉴定和分析。辅助瑞舒伐他汀在降低低密度脂蛋白胆固醇(LDL-C)[4项试验，n=272, SMD: -1.31 (95%CI: -1.93， -0.70)， I2=81%]、总胆固醇(2项试验，n=164, SMD: -2.00 (95%CI: -2.79， -1.21);I2=76%)和甘油三酯(2项试验，n=164, SMD: -1.05 (95%CI: -1.38， -0.72);I2=0%)，但高密度脂蛋白胆固醇没有(2项试验，n=164, SMD: 0.14 (95%CI: -0.16, 0.45);I2 = 0%)。在剔除一项未随机化LDL-C的研究后，显著性仍然存在[3项试验，n=172, SMD:-1.07 (95%CI: -1.60， -0.53);I2 = 63%)。体重组间无显著差异(3项试验，n=208, SMD: -0.40 (95%CI:-1.29, 0.49);I2=89%)、体重指数(2项试验，n=164, SMD: -0.34 (95%CI: -1.23, 0.56);I2=87%)，腰围(3项试验，n=208, SMD): -0.43 (95%CI: -1.31, 0.46);I2=89%)，空腹血糖(4项试验，n=272, SMD: -0.25 (95%CI: -0.65, 0.15);I2=62%)。两组间不良反应及无原因停药率相似。根据GRADE方法，主要结局的证据水平被评为“非常低”(35.3%)至“低”(64.7%)。其中，主要结果(LDL-C)被评为“非常低”。结论:关于辅助瑞舒伐他汀治疗精神分裂症患者血脂异常的有效性和安全性的现有数据不足以对其有效性和安全性做出明确的解释。进一步的高质量随机对照试验延长了治疗时间，以证实研究结果。评审注册号:PROSPERO: CRD42017078230。

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上海精神医学

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