水飞蓟宾胶囊治疗抗精神病药物所致肝损伤多中心随机对照研究

目的观察水飞蓟宾胶囊、复方益肝灵及肝泰乐治疗抗精神病药物所致肝损伤的疗效与安全性。方法随机选择三家精神专科医院服用抗精神病药物出现肝功能异常的精神分裂症患者250例为研究对象,随机分为水飞蓟宾组、复方益肝灵组及肝泰乐组,比较3组患者治疗12周ALT、AST、TBil、GGT等指标的变化。结果水飞蓟宾组、复方益肝灵组及肝泰乐组总有效率分别为86.16%、90.00%和85.50%。3组患者治疗4、8、12周ALT、GGT、TBil水平差异均无统计学意义(P均0.05)。水飞蓟宾组治疗4周AST水平均低于复方益肝灵组及肝泰乐组,差异均有显著统计学意义(P均0.01)。水飞蓟宾组治疗8周AST水平均低于复方益肝灵组及肝泰乐组,差异均有统计学意义(P均0.05),而治疗12周AST水平差异均无统计学意义(P均0.05)。3组患者治疗12周肌酐(Cr)、尿素氮(BUN)及空腹血糖(GLU)差异均无统计学意义(P均0.05)。结论 3种药物均能有效治疗抗精神病药物所致肝损伤,且水飞蓟宾胶囊在治疗4周时降低转氨酶较快,改善程度优于其他两组。

Multicenter, randomized controlled study on effect of silymarin capsules on liver injury induced by antipsychotic drugs

Objective To evaluate the efficacy and safety of silibinin capsules, compound liver- benepitino remedy and glucurolactone on patients with hepatic injury induced by antipsychotic drugs. Methods Total of 250 schizophrenia patients with abnormal liver function after taking antipsychotics were selected randomly from three psychiatric hospitals. Those patients were divided into three groups randomly and received the treatment of silibinin capsules, compound liver-benepitino remedy and glucurolactone, respectively. ALT, AST, TBil, GGT in three groups after 12 weeks treatment of three medicines were compared. Results The total effective rate of silibinin capsules, compound liver-benepitino remedy and glucurolactone were 86.16%, 90% and 85.5%, respectively. The differences on the level ofALT, GGT and TBit among three groups were compared not statistically significant at 4th weeks, 8th weeks and 12th week （P 〉 0.05）. AST level in the group receiving silibinin was lower than that of other groups at 4th week, and the differences were statistically significant （P 〈 0.01）. AST level in the group of receiving silibinin was also lower than that of other groups at 8th week, and the differences were statistically significant （P 〈 0.05）. But there was no significant different on AST, Cr, BUN and GLU levels respectively at 12th week among the three groups （P 〉 0.05）. Conclusions All three medicines could be used in antipsychotic-induced hepatic lesion effectively. Silibinin capsules reduces AST level faster than other groups at 4th week, and the degree of improvement is better than other groups.