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他汀类药物治疗肺高血压的Meta分析
A meta-analysis of statins therapy for pulmonary hypertension
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DOI:
作者:
王珂,文莉,徐大春,李伟明,徐亚伟
WANG Ke, WEN Li, XU Dachun, LI Weiming, XU Yawei
作者单位:
同济大学附属第十人民医院心内科 同济大学附属上海市肺科医院肺循环科
Department of Cardiology, Shanghai Tenth People’s Hospital, Tongji University School of Medicine Department of Cardiopulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
关键词:
他汀,肺高血压,Meta分析,随机对照研究
Statins; Pulmonary Hypertension; Meta-analysis; Randomized controlled trials
摘要:
摘要 目的:系统评价他汀类药物(statins)治疗肺高血压(pulmonary hypertension, PH)患者的有效性和安全性。 方法:系统检索PubMed、CNKI、Web of Science和the Cochrane Central Register of Controlled Trials database等数据库,全面收集statins治疗PH患者的前瞻性、随机对照临床试验 (RCT)。按纳入排除标准筛选文献、提取资料和进行方法学质量评价。利用RevMan 5.04 软件进行Meta分析,采用标准化均数差 (SMD) 和相对危险度 (RR) 在随机或固定效应模式下合并统计量。主要分析PH患者statins治疗前后运动耐量(6分钟步行距离或Naughton步行时间)变化。另外,同时评价PH患者statins治疗前后肺动脉压力变化,以及药物不良反应和临床恶化事件发生率。并按照PH临床分类进行亚组分析。 结果:共纳入7个RCT,包括4个安慰剂对照试验和3个非安慰剂对照试验。共计684例PH患者,分为statins组 (n=340) 和对照组 (n=344)。Meta分析结果显示:(1)较对照组而言,statins能改善PH患者的运动耐量[SMD = 0.47, 95%CI (0.08,0.87), P = 0.02],主要是第三大类PH (即呼吸系统疾病相关性PH) 患者[SMD = 0.84, 95%CI (0.36, 1.33), P = 0.0006];(2)statins可降低PH患者肺动脉压力[SMD = -0.53, 95%CI (-0.95, -0.11), P = 0.01]。另外,(3)两组之间药物相关不良反应无统计学差异[RR = 1.08,95%CI (0.55, 2.09), P = 0.68];(4)临床恶化事件发生率也无明显统计学差异[RR = 0.84, 95%CI (0.55, 1.30), P = 0.44]。 结论:Statins可显著改善PH患者的运动耐量以及降低肺动脉压力。未来,仍需更多大型、随机双盲和对照临床研究来进一步证实statins治疗PH患者的临床疗效和安全性。
Abstract Objective: To evaluate the safety and efficacy of statins therapy in patients with pulmonary hypertension (PH). Methods: Literature published were search completely in the database including PubMed, CNKI, Web of Science and the Cochrane Central Register of Controlled Trials to collect the prospective randomized control trials (RCTs) of statin treatment on patients with PH. The studies were evaluated and screen strictly according to the inclusive and exclusive criteria. Meta-analysis was conducted by RevMan 5.04 software to evaluate the change in exercise capacity (as indicated by six minute walk distance), pulmonary arterial pressure, adverse events and clinical worsening. Standardized mean difference (SMD)/Risk ratio (RR) and 95% confidence interval (CI) were calculated using random-effect or fixed-effect model, depending on statistical heterogeneity. Subgroup analysis was conducted based on the clinical classification of pulmonary hypertension (PH). Results: Seven RCTs (4 placebo-controlled and 3 non-placebo-controlled trials) were included and a total of 684 patients with PH met the inclusion criteria. The meta-analysis demonstrated that in the statin therapy group, compared with control group, 1) exercise capacity was significantly improved in patients with PH[SMD = 0.47, 95%CI (0.08,0.87), P = 0.02],mainly in patients with PH associated with lung diseases and/or hypoxia [SMD = 0.84, 95%CI (0.36, 1.33), P = 0.0006]; 2) The pulmonary arterial pressure (PAP) was significantly decreased [SMD = -0.53, 95%CI (-0.95, -0.11), P = 0.01]. And, the drug-related adverse events were not significantly different between the two groups[RR = 1.08,95%CI (0.55, 2.09), P = 0.68]. There was no significant difference in clinical worsening between two groups [RR = 0.84, 95%CI (0.55, 1.30), P = 0.44]. Conclusion: Statin therapy has beneficial effects on PH, as measured by patients’ exercise capacity and pulmonary arterial pressure. Clearly, more large, randomized, double-blind, placebo-controlled studies are warranted to define the role of statin therapy in PH
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