老年人长期联合应用雷贝拉唑和氯吡格雷的安全性研究

The Safety of Long-term Combined Application of Rabeprazole and Clopidogrel in the Elderly

中文关键词: 老年人  质子泵抑制剂  氯吡格雷  安全性

英文关键词: the elderly  proton pump inhibitor  clopidogrel  safety

中文摘要:

      目的 评价老年人长期联合应用雷贝拉唑和氯吡格雷的安全性.方法 选取2002年1月-2012年6月服用氯吡格雷抗血小板治疗的老年患者,其中长期联合应用雷贝拉唑的设为联合组,未服用质子泵抑制剂的设为对照组,进行前瞻性随访.比较2组随访期间各种并发症和不良事件,包括慢性腹泻、肺部感染、消化道出血、骨折、主要心血管不良事件(MACE,包括心肌梗死、靶血管血运重建、脑卒中、心源性死亡)和全因死亡的发生,评价雷贝拉唑联合氯吡格雷与各种不良事件的相关危险度.结果 完成随访的388例联合组(男/女:255/133)与381例对照组(男/女:262/119)相比,联合组的消化道出血发生率较对照组降低(6.70％vs 12.86％),经多因素Cox回归分析对影响因素(如年龄、性别、吸烟史、体质指数、高血压、糖尿病、高脂血症、合并用药等)进行校正后,2组之间差异有统计学意义(adjustedhazard ratio AHR:0.76,95％CI:0.51～0.92,P＜0.01).2组的慢性腹泻(7.73％ vs 5.51％,AHR:1.43,95％CI:0.68 ～ 2.99)、肺部感染(18.81％ vs 16.01％,AHR:0.94,95％CI:0.45～3.73)、骨折(4.90％ vs 3.94％,AHR:0.91,95％CI:0.37～4.12)、MACE(19.32％ vs 17.59％,AHR:1.05,95％CI:0.42～2.56)和全因死亡(11.34％ vs 9.71％,AHR:1.18,95％CI:0.70～3.18)的发生率之间差异均无统计学意义(P＞0.05).结论 老年人长期联合应用雷贝拉唑和氯吡格雷没有增加腹泻、肺部感染、骨折、MACE和全因死亡的风险,能够降低消化道出血的发生率.

英文摘要:

      Objective To estimate the safety of long-term combined application of rabeprazole and clopidogrel in the elderly.Methods A prospective and retrospective follow-up study was carried out in elderly patients taking clopidogrel from January,2002 to June,2012,including the elderly with long-term combined application of clopidogrel and rabeprazole in combined group and the elderly with no application of proton pump inhibitors in control group;the occurrence of complications and side effects in the 2 groups were compared,including chronic diarrhea,pneumonia,gastrointestinal bleeding,fracture,major adverse cardiovascular events (MACE,such as myocardial infarction,target lesion revascularization,ischemic stroke and cardiac death) and the occurrence of all-cause death.Results The follow-up was completed in 388 patients in combined group (male/female:255/133) and 381 patients in control group (male/female:262/119);the occurrence of gastrointestinal bleeding in combined group was lower than that in control group (6.70％ vs 12.86％) and Cox regression analysis showed out a difference of statistical significance between the 2 groups (AHR:0.76,95％ CI:0.51-0.92,P＜0.01);There existed no significant difference between the 2 groups in the occurrence of chronic diarrhea (7.73％ vs 5.51％,AHR:1.43,95％ CI:0.68-2.99),pneumonia (18.81％ vs 16.01％,AHR:0.94,95％CI:0.45-3.73),fracture (4.90％ vs3.94％,AHR:0.91,95％CI:0.37-4.12),MACE (19.32％ vs 17.59％,AHR:1.05,95％CI:0.42-2.56) and all-cause death (11.34％ vs 9.71％,AHR:1.18,95 ％ CI:0.70-3.18).Conclusions The long-term combined application of rabeprazole and clopidogrel in elderly patients will not increase the risk of chronic diarrhea,pneumonia,gastrointestinal bleeding,fracture,MACE and all-cause death,and the occurrence of gastrointestinal bleeding may be reduced.