硫普罗宁钠治疗急慢性肝炎的随机、双盲模拟、平行对照的临床研究  

A Randomized,Double-blind Controlled Clinical Study on Tiopronin Sodium in the Treatment of Acute and Chronic Hepatitis

作　　者：王丽春[1] 王颖[1] 滕芳菊[1] 张永辉[1] 陈立宇 冯萍[1] 

机构地区：[1]四川大学华西医院感染性疾病中心,四川成都610041

出　　处：《华西医学》2009年第9期2330-2333,共4页West China Medical Journal

摘　　要：目的:评价硫普罗宁钠治疗急慢性肝炎的有效性与安全性。方法:采用随机、双盲模拟、阳性药平行对照试验方法。硫普罗宁钠200 mg静滴Qd,对照组用凯西莱(硫普罗宁)200 mg静滴Qd。疗程均为4周,停药后随访4周。结果:共治疗急性肝炎患者7例,慢性肝炎患者18例。急性肝炎组:试验组与对照组4周末ALT下降率分别为69.14±39.23%及68.23±45.12%,试验组显效率33.33%,总有效率100%,对照组显效率25%,总有效率100%,两组疗效比较无显著性差异(P>0.05)。慢性肝炎组:试验组与对照组4周末ALT下降率分别为44.34±53.41%及35.01±74.67%,试验组显效率22.22%,总有效率77.78%,对照组显效率11.11%,总有效率66.67%,两组疗效比较无显著性差异(P>0.05)。急性肝炎组未见不良反应,慢性肝炎组中试验组及对照组不良反应发生率均为5.00%。结论:硫普罗宁钠具有保肝降酶作用,临床上用于治疗急慢性肝炎患者安全有效。Objective：To evaluate efficacy and safety of tiopronin sodium in the treatment of acute and chronic hepatitis.Methods：A randomized,double-blind,simulation,parallel-controlled method was carried out..The regimen for tiopronin sodium was 200mg intravenous Qd,for tiopronin 200mg intravenous Qd as control drug for four weeks accompanied with four weeks＇ follow up periods at the end of treatment.Results：A total of 7 patients were included in acute hepatitis group and 18 patients in chronic hepatitis group.Acute hepatitis group：decline rate of ALT in test group and control group was 69.14±39.23% and 68.23±45.12% separately at the end of 4th weeks.The significant effective rate and total effective rate were 33.33% and 100% in test group,25% and 100% in control group.Efficacy of the two groups showed no significant difference（P〉0.05）.Chronic hepatitis group：decline rate of ALT in test group and control group was 44.34 ±53.41% and 35.01 ±74.67% seperately at the end of 4th weeks.The significant effevtive rate and total effective rate were 22.22% and 77.78% in test group,11.11% and 66.67% in control group.Efficacy of the two groups showed no significant difference（P〉0.05）.No adverse reactions occurred in acute hepatitis group.Rate of adverse reactions was both 5% in test group and control group in chronic hepatitis group.Conclusion：Tiopronin sodium can protect liver and reduce level of transaminase.It is safe and effective in the treatment of acute and chronic hepatitis.

关 键 词：硫普罗宁钠 硫普罗宁 随机双盲对照 临床研究 

分 类 号：R575.1[医药卫生—消化系统]