托拉塞米注射液治疗水肿性疾病安全性和利尿效果研究

Efficacy and safety of torasemide injection in treatment of edema diseases

目的观察托拉塞米注射液在水肿性疾病中的利尿效果及安全性。方法采用随机、单盲、多中心对照研究方法。托拉塞米注射液与呋塞米注射液的用药剂量比为1∶2。结果共观察了219例肾病水肿、充血性心力衰竭和肝硬化腹水患者,其中托拉塞米组110例,呋塞米组109例。治疗前托拉塞米组和呋塞米组尿量分别为(1300郾09±509郾33)和(1472郾95±647郾88)ml/24h(P=0.03),用药后第1天尿量即分别增至(2091.96±859.76)和(2058.26±828.81)ml/24h(与用药前比较,均P<0.01)。托拉塞米组用药后尿量增加<30%11例,30%～50%24例,51%～80%29例,81%～100%7例,>100%39例;呋塞米组用药后尿量增加<30%31例,30%～50%35例,51%～80%14例,81%～100%12例,>100%27例。托拉塞米组有例在用药后发生一过性耳聋,自行缓1解,以后随访也无听力障碍;其余不良反应与呋塞米组均无差异。结论短期应用托拉塞米注射液治疗水肿性疾病利尿效果显著,副作用小,与呋塞米注射液无显著差异。

Objective To evaluate the efficacy and safety of torasemide injection in edema diseases. Methods A randomized, single-blind, controlled, multicenter clinical trial was conducted to compare the efficacy and safety between torasemide and furosemide in 219 subjects with nephrotic syndrome, renal failure, chronic heart failure, or ascites respectively. The dose of furosemide was twice as that of torasemide.Results There were 219 patients enrolled in the trial, and number of torasemide group and furosemide group was 110 and 109 respectively. Before treatment, the urinary volume of torasemide group was significantly lower than that of furosemide group [(1300.09±509.33) and (1472.95±647.88) ml/24 h, respectively, P=0.03]. First day after treatment, urinary volume increased to (2091.96±859.76) and (2058.26±828.81)ml/24 h respectively( vs pro-treatment, P<0.01). In torasemide group, there were 11 patients whose increasing urinary volume was less than 30%, 24 patients between 30% to 50%,29 patients between 51% to 80%,7 patients between 81% to 100%, 39 patients more than 100%. While in furosemide group, there were 31, 35, 14, 12 and 27 patients respectively in different increasing urinary volume. In all the patients, only one case suffered from transitory deaf and recovered without treatment. Conclusion Torasemide injectin is an effective and safety drug in short-term treatment of edema diseases.