中国临床药学杂志

目的观察国产托拉塞米片在水肿性疾病中的利尿效果及安全性。方法采用随机、双盲、多中心对照研究方法。国产托拉塞米片与呋塞米片的用药剂量比为1∶2。结果共观察了214例肾病水肿、心力衰竭和肝硬化腹水患者,其中托拉塞米组106例,呋塞米组108例。用药前托拉塞米组和呋塞米组尿量分别为(1 067.1±514.5)和(1 111.8±528.0)mL.d-1(P=0.428),用药后d 3尿量即增至(1 714.7±760.4)和(1 566.0±643.3)mL.d-1(与用药前比较,P均<0.01);2组利尿有效率分别为90.0%和86.5%(P=0.443)。同时2组患者用药后体重、腹围也显著降低(P<0.05),心力衰竭患者在用药后心功能也得到一定程度改善。血清电解质紊乱是2组患者主要的不良事件,发生率分别达11.3%和10.2%,但没有见到严重不良事件发生。结论国产托拉塞米片治疗水肿性疾病利尿效果显著,不良反应较小,与呋塞米片无显著差异。

AIM To evaluate the efficacy and safety of torasemide tablet in edema diseases.METHODS A randomized, double-blind, controlled, multicenter clinical trial was conducted to compare the efficacy and safety of torasemide and furosemide tablets in 214 subjects with nephrotic syndrome,chronic heart failure, or ascites,repectively. The dose of furosemide was double time than that of torasemide.RESULTS There were 214 patients enrolled in the trial, and the numbers of torasemide group and furosemide group were 106 and 108 respectively. Before treatment, the urinary volume of torasemide group was comparable to furosemide group[(1 067.1±514.5) and (1 111.8±528.0)mL·d^-1,respectively,P=0.428];in the third day after treatment, the urinary volume increased to (1 714.7±760.4) and (1 566.0±643.3) mL·d^-1 respectively (vs pro-treatment,P<0.01). The total effective rate was 90.00% and (86.5%) in torasemide group and furosemide group respectively(P=0.443). The body mass and abdominal circumference also decreased significantly after the treatment in 2 groups. The heart function was improved after treatment in the patients of chronic heart failure. Electrolyte disturbances was the common adverse drug reaction in 2 groups, and the occurrence rates were 11.3% and 10.2% respectively in torasemide group and furosemide group.CONCLUSION Torasemide tablet is an effective and safe drug in treatment of edema diseases.