缬沙坦在血管紧张素转化酶抑制剂不能耐受患者中的多中心临床试验

Multicenter trial of valsartan in patients of being intolerant of angiotensin converting enzymes inhibitor

目的 :研究缬沙坦对因持续性干咳、血管神经性水肿、皮疹等不良反应被迫停用血管紧张素转化酶 (ACE)抑制剂的患者中的临床疗效。方法 :将 2 0 0例因持续性干咳、血管神经性水肿、皮疹等不良反应及肾功能不全 ,不能用ACE抑制剂的患者随机分为治疗组和对照组 ,各 10 0例。治疗组予缬沙坦 80mg,po ,qd ;对照组患者行常规治疗 :高血压患者用硝苯地平控释片、吲达帕胺、美托洛尔。 2组中心力衰竭患者用利尿剂、洋地黄等 ;急性心肌梗死患者行溶栓治疗 ,有肝、肾功能不全的患者亦行相应的治疗。 2组服药 4wk以上对比观察持续性干咳、血管神经性水肿、皮疹等的出现情况。垂直对比观察肝、肾功能的变化。同时观察血压的变化。结果 :治疗组未见持续性干咳、皮疹的患者 ,3例患者出现轻微咳嗽 ,未因此而停药 ;对照组有 2例轻微咳嗽的患者。用缬沙坦前后BUN ,Cr变化无显著性 ,肝功能损害未见加重 ,2例患者服缬沙坦后水肿加重。高血压患者用缬沙坦前和 2wk后的SBP分别是 (15 8± 17)mmHg(1mmHg =0 133kPa)和 (139± 14 )mmHg ,P <0 0 1;DBP分别是 (10 1± 14 )mmHg和 (86± 13)mmHg,P <0 0 1。但与对照组相比 ,差异无显著性。结论 :因干咳等被迫停用ACE抑制剂的患者服用缬沙坦是安全的 。

AIM: To evaluate the clinical application of the angiotensin Ⅱ receptor antagonist valsartan in patients who are intolerant of angiotensin converting enzymes (ACE) inhibitor because of its adverse drug reaction (ADR): persistent dry cough, angioneurotic edema, skin eruption ,etc. METHODS: A multicenter trial was performed. Two hundred patients with persistent dry cough or angioneurotic edema or skin eruption, caused by taking ACE inhibitor or with renal insufficiency were randomely divided into the valsartan treated group (n=100) and the control group (n=100). The patients in valsartan treated group, aged (55.4±8.7) a, were randomized to receive valsartan 80mg,po, qd for 4 wk or more. The symptoms of persistent dry cough, angioneurotic edema and skin eruption in valsartan group were compared with the control group. The blood of the patients was tested for renal function and liver function before valsartan treatment and 2 wk after treatment with valsartan. RESULTS: All of patients (valsartan treated group and control group) were free of persistent dry cough, skin eruption. Three patients in valsartan treated group presented symptoms of mild cough and 2 patients in control group. Blood urea nitrogen, creatinine and liver function had unchanged to time of 2 wk after treating the patients with valsartan. The edema got worse and the urine volume was diminished in 2 patients in valsartan treated group. CONCLUSION: Administration of valsartan is safe and effective in patients who are intolerant of ACE inhibitor because of its ADR.