摘要
目的 从循证医学角度评价国内 8种血管紧张素转换酶抑制剂 (普利类降压药 )对高血压患者的临床疗效、安全性、成本 效果、依从性及伦理学等。 方法 采用药物卫生技术评估方法 ,检索Medline、Cochrane图书馆、Embase和中国生物医学文献数据库 (CBMdisc)等数据库 ,疗效分析纳入系统评价、随机临床对照试验和交叉试验等 ;安全性和药物经济学分析同时纳入观察性研究。按国际评价标准严格评价文献 ,纳入高质量研究。 结果 8种普利类降压药的降压幅度与剂量呈正相关 ;任何一种普利类降压药与钙拮抗剂或利尿剂或受体阻滞剂联合应用 ,降压效果更佳 ;新型普利类降压药的作用强于依那普利和卡托普利。Meta 分析显示 ,谷 峰比值小于 5 0 %的有培哚普利、贝那普利和卡托普利。上述 8种普利类降压药均有关于心脏保护的研究证据。慢性心力衰竭 ,依那普利和卡托普利的高质量研究证据最多 ;赖诺普利、培哚普利、西拉普利和贝那普利仅观察了中间指标对心力衰竭的影响。心脏保护 ,福辛普利较卡托普利更安全 ,比依那普利效果好 ;赖诺普利优于卡托普利等均以替代指标进行比较。治疗心肌梗死 ,证据显示卡托普利和赖诺普利可降低急性期 (心肌梗死 3 6h内 )患者病死率 ;依那普利、卡托普利。
Objective To evaluate the clinical effectiveness, safety, cost-effectiveness of eight angiotensin converting enzyme inhibitors(ACEIs) in order to provide evidence for adjustment of Essential Drug List in China. Method Collecting all clinical trials by searching Medline, Cochrane Library, Embase and Chinese Biomedical Database and conducting critical appraisal. High quality randomized controlled trials and systematic reviews were included to assess the effectiveness of ACEIs. Non-randomized controlled trials were also included to evaluate the safety and cost-effectiveness. Results New generation of ACEIs are better than enalapril and captopril in antihypertension and endurance. Meta-analysis showed that T/P ratio was less than 50% in prindopril, benazepril and captopril. Enalapril and captopril had the most adequate evidence in the treatment of chronic heart failure. The effects of lisinopril, prindopril, benazepril and cilazapril positive influence on heart failure were assessed by surrogates. Captopril, lisinopril could reduce the total death rate of acute period (during 36 hours of AMI). Enalapril, captopril, ramipril and prindopril had the effect of heart protection in late period of AMI (3 days after AMI). Only ramipril, lisinopril and prindopril had evidence to support the protective effect on cerebral vessels. The available evidence, though not adequate, showed all the ACEIs except benazepril could diminish proteinuria and delay the renal failure. The new generations of ACEIs were similar in adverse reactions to enalapril and captopril, while incidences were lower than enalapril and captopril. Few evidence on cost-effectiveness of ACEIs were identified. The available evidence showed enalapril was cost-effective in treating heart failure. However, it compromised to lisinopril. The studies on ethics were not available. Conclusions It was difficult to generally rank the eight ACEIs according to available evidence. Not all eight ACEIs had adequate evidence in organs protection. It was suggested that clinicians
出处
《中国循证医学杂志》
CSCD
2004年第1期15-28,共14页
Chinese Journal of Evidence-based Medicine
基金
中国药物监督管理局资助
