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目的 用meta分析评价中国急性冠脉综合征患者启动高强度他汀治疗的安全性。方法 收集关于中国急性冠脉综合征患者早期高强度他汀治疗的随机对照临床试验(RCT),按照纳入与排除标准筛选文献,评价文献质量并提取有效数据,采用RavMan5.3进行meta分析。结果 共纳入相关研究19篇,包括2 749例患者。Meta分析结果显示:高强度他汀明显增加肌肉不良反应[OR=2.3,95%CI(1.24,4.28),P<0.01]和肝脏损伤[OR=2.10,95%CI(1.36,3.24),P<0.01],不增加肾脏损害[OR=0.67,95%CI(0.19,2.38),P=0.53]和消化道症状[OR=1.05,95%CI(0.58,1.93),P=0.72]。 结论 中国急性冠脉综合征患者使用高强度他汀治疗的安全性较常规剂量他汀低。
Objective To evaluate the safety of high-intensity statin therapy in patients with acute coronary syndrome in China by meta-analysis. Methods Randomized controlled trials (RCTs) on early high-intensity statin therapy in Chinese patients with acute coronary syndromes were collected and screened for literature based on inclusion and exclusion criteria. The quality of the literature was evaluated and validated data were extracted. RavMan 5.3 was used for meta-analysis. Results A total of 19 related studies were included, including 2 749 patients. Meta-analysis showed that high-intensity statin significantly increased muscular adverse reactions [OR = 2.3, 95% CI (1.24,4.28), P <0.01] and liver damage [OR = 2.10,95% CI (1.36,3.24, P < 0.01] and did not increase kidney damage [OR = 0.67,95% CI (0.19,2.38), P = 0.53] and gastrointestinal symptoms [OR = 1.05,95% CI (0.58,1.93), P = 0.72]. Conclusions The safety of high-intensity statin treatment for patients with acute coronary syndrome in China is lower than that of conventional dose statin.