苦参素葡萄糖注射液治疗药物性肝病临床研究

Clinical observation on kurorinone in the treatment of drug-induced liver disease

目的:通过观察苦参素葡萄糖注射液治疗药物性肝病(DILD)临床表现及肝功能异常的变化,探讨其治疗DILD的疗效和安全性。方法:68例患者随机分为治疗组35例,苦参素葡萄糖注射液600 mg(100 mL)静脉滴注;对照组33例,硫普罗宁200 mg加入10%葡萄糖液250 mL静脉滴注,均为q.d,用药30 d。治疗前后分别观察症状和体征、肝功能及B超检测肝脾大小。结果:两组病人治疗后临床症状、肝功能均有改善。对SB、ALT、GCT、ALP的降低及ALB的升高较对照组明显(P<0.05),对AST和LDH的降低两组间无差异。治疗组总有效率显著高于对照组(P<0.0 5)。结论:苦参素葡萄糖注射液在药物性肝病的治疗中,对肝功能的恢复有明显作用,而且安全,可作为目前治疗DILD的理想药物。

Objective: To observe the changes of clinical situation and liver function of the drug-induced liver disease (DILD) treated by kurorinone, and to discuss the curative efficacy and safety of kurorinone. Methods: 68 patients with DILD were randomized into either therapy group (35 cases, kurorinone 600mg(100mL) daily for 30d) or control group (33 cases, tiopronin 200mg daily for 30d). The efficacy and safety were evaluated with clinical, biochemical parameters and the size of liver and spleen. Results: After treatment, the clinical sign and biochemical parameters were improved in both groups. The SB, ALT, GGT and ALP were debased remarkedly than those of control group (P<0.05). ALB was higher than that of control group (P<0.05 ).There was no difference of AST and LDH between groups. The total efficiency was significantly higher in therapy group than that in control group (P<0.05). Conclusion: The kurorinone, with a good tolerance and safety, has a sound efficacy in the improvement of clinical signs and hepatic functions of DILD patients. It is a good drug to treat DILD at present.