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目的 :初步观察昆明积大制药有限公司研制的国家四类新药古拉定 (注射用还原型谷胱甘肽 )对酒精性肝病的疗效。方法 :用TAD(意大利的注射用还原型谷胱甘肽 )作对照 ,共观察 5 0例 ,用隐藏的随机双盲法分为三组 ,验证组和对照组各 15例 ,开放组 2 0例。药物剂量、疗程相同。结果 :总有效率验证组为 80 .0 % ,对照组为 6 6 .7% ,开放组为 70 .0 % ,各组比较无显著性差异 (P =0 .6 95 1)。 3组均未见明显不良反应。结论 :验证药与对照药治疗酒精性肝病均效佳 ,疗效相近 ,使用安全 ,无严重副作用。
OBJECTIVE: To observe the curative effect of four kinds of new national drug Guladin (reduced glutathione for injection) on alcoholic liver disease developed by Kunming Jida Pharmaceutical Co., Ltd. Methods: TAD (Italian injection of reduced glutathione) as a control, observed a total of 50 cases, with a hidden randomized double-blind method divided into three groups, the validation group and the control group of 15 cases, the open group 20 example. Drug dosage, treatment the same. Results: The total effective rate was 80.0% in the validation group, 66.7% in the control group and 70.0% in the open group, with no significant difference between the groups (P = .6 951). No obvious adverse reactions were found in the three groups. Conclusion: Validation and control drugs are effective in treating alcoholic liver disease, with similar curative effect, safe use and no serious side effects.