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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 the efficacy and safety of tiopronin in the treatment of acute and chronic hepatitis. Methods: A randomized, double-blind analog, positive drug parallel control test method. Tiopronin sodium 200 mg intravenous Qd, the control group with Cassirattin (tiopronin) 200 mg intravenous Qd. The course of treatment was 4 weeks, followed up for 4 weeks after drug withdrawal. Results: A total of 7 patients with acute hepatitis and 18 patients with chronic hepatitis were treated. In the acute hepatitis group, the rate of ALT decreased by 69.14 ± 39.23% and 68.23 ± 45.12% respectively in the experimental group and the control group at 4 weeks. The effective rate was 33.33% and the total effective rate was 100% in the experimental group. The effective rate in the control group was 25% and the total effective rate was 100 %, No significant difference between the two groups (P> 0.05). In the chronic hepatitis group, the rate of ALT decreased by 44.34 ± 53.41% and 35.01 ± 74.67% respectively in the experimental group and the control group at 4 weeks. The effective rate in the experimental group was 22.22%, the total effective rate was 77.78%, the effective rate in the control group was 11.11% and the total effective rate was 66.67 %, No significant difference between the two groups (P> 0.05). There was no adverse reaction in the acute hepatitis group, the incidence of adverse reactions in the chronic hepatitis group was 5.00% in the experimental group and the control group. Conclusion: Tiopronin has the effect of protecting the liver and reducing the enzyme. It is safe and effective in treating patients with acute and chronic hepatitis.