摘要
目的观察复方甘草酸苷治疗抗精神病药物所致肝损害的疗效与安全性。方法 70例抗精神病药物引起药源性肝损害的患者随机分为2组:治疗组口服复方甘草酸苷片每次3片,tid,疗程2 mo,对照组不服用任何改善肝损害的药物。2组抗精神病药物均不停用。在基线和治疗1、2 mo末检测肝功能指标,观察躯体不适和不良反应。结果基线时2组丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总胆红素(TBIL)、γ-谷氨酰转肽酶(γ-GT)均无显著差异(P>0.05)。治疗2 mo后,治疗组对3项肝功能指标的总有效率与对照组比较有非常显著差异(ALT:100%vs.33%,AST:100%vs.20%,γ-GT:93%vs.25%,均P<0.01),TBIL的总有效率2组间无显著差异(90%vs.89%,P>0.05)。2组在治疗1、2 mo末的疗效均有非常显著差异(均P<0.01)。治疗组有1例出现轻度双下肢水肿,未发现其他不良反应。结论复方甘草酸苷治疗抗精神病药物引起的肝功能损害的疗效较好,安全性高。
AIM To evaluate the efficacy and safety of stronger neo-minophagen C（SNMC）in treating antipsychotic-induced hepatic lesion.METHODS Seventy patents with antipsychotic-induced hepatic lesion were randomly divided into two groups：the treatment group received 3 SNMC tablets,tid for two months and the control group received no medicine for hepatic lesion.All patients continued their antipsychotic treatment.The hepatic function indexes were tested before treatment and 1,2 months later,and the adverse reactions were observed at the same time.RESULTS At baseline there were no significant differences between the two groups on hepatic function indexes of ALT,AST,TBIL,and γ-GT.At the endpoint of two months,the treatment group had higher effective rate than the control group on the function indexes of ALT,AST,and γ-GT（100% vs.33%,100% vs.20%,93% vs.25%,respectively,all P 0.01）,while effective rate of TBIL had no significant difference between the two groups（90% vs.89%,P 0.05）.There were significant differences（P 0.01）in the curative effect between the two groups after 1 month or 2 months treatment.Only one patient in the treatment group had lower limb edema,other patients had not be reported any adverse reactions.CONCLUSION Oral SNMC showes good efficacy and safety for patients with antipsychotic-induced hepatic lesion.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2010年第12期895-898,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
国家科技部新药创制重大专项(2008ZX09312-003
2008ZX09312-014)
关键词
复方甘草酸苷
抗精神病药
药物性肝损害
随机对照试验
stronger neo-minophagen C
antipsychotic agents
drug-induced liver injury
randomized controlled trials
