注射用谷胱甘肽对慢性病毒性肝炎和中毒性肝炎病人疗效及安全性的临床研究

The Clinical Studies on the Safety and Efficacy of Glutathione for Injection for Patients with Chronic Viral and Toxic Hepatitis

目的评价注射用谷胱甘肽对慢性病毒性肝炎和中毒性肝炎病人的临床疗效及安全性。方法122例病毒性肝炎和中毒性肝炎患者随机分为两组,治疗组61例,iv谷胱甘肽1200mg,qd,对照组61例,iv门冬氨酸钾镁3支(每支10ml),qd,开放组42例,iv谷胱甘肽1200mg,qd,疗程4周。结果4周后,治疗组食欲不振、乏力、肝区疼痛、腹胀及黄疸显著减轻(P<0.01)。ALT由(485.91±442.65)U·L-1降到(54.30±39.72)U·L-1(P<0.01);AST由(262.95±288.71)U·L-1下降到(39.68±28.68)U·L-1(P<0.01);总有效率为86.89%。对照组与治疗组类似,总有效率为81.97%(P>0.05)。2组均未发现明显的不良反应。注射用谷胱甘肽治疗的103例,总有效率为92.23%。结论注射用谷胱甘肽治疗病毒性肝炎和中毒性肝炎是安全、有效的。

Aim To evaluate the clinical safety and effcacy of glutathione for injection for patients with chronic viraland toxic hepatitis. Methods The 122 patients with chronic viral and toxic hepatitis were selected and randomly dividedinto the treatment group and control group. In the treatment group, patients were intravenous injected with glutathione forinjection 1 200mg qd; in the control group, patients were intravenous injected with potassimn-magnesium aspartate 10ml×3 qd, for 4 weeks. Patients in the open group were administerd with the same drug as the treatment group, Results After 4weeks, in the treatment group, inappetence, debility, liver pain, windy and jaundice significantly decreased （ P 〈 0.01 ）.ALT from （485.91 ± 442.65 ） U·L^-1 decreased to （54.30 ± 39.72） U·L^-1 （ P 〈 0.01 ）. AST from （262.95 ± 288.71 ）U·L^-1 decreased to （39.68 ± 28.68） U·L^-1 （ p 〈 0.01 ）, the clinical efficacy was 86.89 %. The control group （81.97%）resembled the treatment group in clinical efficacy（ P 〉 0.05）.Severe drug reactions of both groups were not discovered. Among the 103 Patients treated with glutathione the clinical efficacy was 92.23 %. Conclusion This result suggests that glutathione for injection is a safe and effective treatment for chronic viral and toxic hepatitis.