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背景几项有关贝特类药物对心血管风险作用的临床试验所报道的结果不一致,故本研究就有关贝特类药物对主要临床结果的作用进行系统性观察和荟萃分析。方法我们对联机医学文献分析与检索系统、医学文摘资料库和Cochrane图书馆(循证医学图书馆)1950年—2010年3月发表的试验进行系统性检索。仅纳入前瞻性随机对照试验(与安慰剂进行对照),且评价了贝特类药物对心血管结果的作用。然后用随机效应模型计算心血管相关风险减少情况,做出简要的评价。所分析的结果包括:严重心血管事件、冠状动脉事件、脑卒中、心力衰竭、冠状动脉重建术、全因死亡率、心血管死亡、非血管性死亡、猝死、新发蛋白尿和药物相关负性事件。结果共纳入18项临床试验,受试者45058例,其中2870例发生严重心血管事件,4552例发生冠状动脉事件,3880例死亡。贝特类药物治疗使严重心血管事件相对风险(RR)减少10%〔95% CI(0,18),P=0.048〕;冠状动脉事件RR减少13%〔95% CI(7,19),P<0.0001〕;但脑卒中无获益〔-3%,95% CI(-16,9),P=0.69〕。研究还发现贝特类药物治疗对全因死亡率〔0,95% CI(-8,7),P=0.92〕、心血管死亡率〔3%,95% CI(-7,12),P=0.59〕、猝死〔11%,(-6,26),P=0.19〕或非血管性死亡率〔-10%,95% CI(-21,0.5),P=0.063〕无影响。贝特类药物使尿蛋白进展风险减少14%〔95% CI(2,25);P=0.028〕。尽管血清肌酐浓度常升高〔1.99,95% CI(1.46,2.70),P<0.0001〕,贝特类药物并未显著增加药物相关严重负性事件〔RR=1.21,95% CI(0.91,1.61),P=0.19〕。结论贝特类药物通过预防冠状动脉事件的发生,使严重心血管事件的发生风险减少。或许对心血管事件高危个体及有血脂障碍者来说,贝特类药物起着重要作用。
Several background clinical reports on the role of fibrates in cardiovascular risk have reported inconsistent results, and systematic reviews and meta-analyzes of the effects of fibrates on the primary clinical outcomes were conducted in this study. Methods We systematically searched for trials published in the On-line Medical Literature Analysis and Retrieval System, the Medical Abstracts Library, and the Cochrane Library (The Evidence-Based Medicine Library) from 1950 to March 2010. Only prospective randomized controlled trials (compared with placebo) were included, and the effects of fibrates on cardiovascular outcomes were evaluated. Then use the random effects model to calculate the cardiovascular risk reduction and make a brief evaluation. The results analyzed included: Serious Cardiovascular Events, Coronary Events, Stroke, Heart Failure, Coronary Artery Reconstruction, All-cause Mortality, Cardiovascular Death, Non-vascular Death, Sudden Death, Neocrine and Drug-Related Negatives Sexual events. Results A total of 18 clinical trials were enrolled in the study, 45058 subjects, of which 2870 had severe cardiovascular events, 4552 had coronary events, and 3880 died. Fibrate treatment reduced the relative risk (RR) of major cardiovascular events by 10% (95% CI (0,18), P = 0.048) and 13% for coronary events (95% CI, P <.0001]; however, stroke was not benefit [-3%, 95% CI (-16,9), P = .69]. The study also found that all-cause mortality (0,95% CI (-8,7), P = 0.92], cardiovascular mortality [3%, 95% CI (-7,12), P = 0.59〕, sudden death (11%, (-6,26), P = 0.19) or non-vascular mortality 〔-10%, 95% CI (-21,0.5), P = 0.063〕. Fibrates reduced the risk of urinary protein progression by 14% (95% CI (2, 25); P = 0.028). Fibrates did not significantly increase the drug-related serious adverse events (RR = 1.21, 95% CI (0.91, 1.61, P <0.0001) despite a frequently elevated serum creatinine concentration of 1.99, 95% CI (1.46, 2.70) ), P = 0.19]. Conclusion Fibrates reduce the risk of serious cardiovascular events by preventing the occurrence of coronary events. Perhaps fibrates play an important role in individuals at high risk of cardiovascular events and those with dyslipidemia.