壳脂胶囊治疗非酒精性脂肪肝的随机对照研究

摘要

Objective To evaluate the effect and side effects of Kezhi capsule in short-term treatment of nonalcoholic fatty liver disease (NAFLD). Methods 60 NAFLD cases of outpatients according to the inclusion criteria of were randomly assigned to two groups: the treated group-30cases with the prescription of Kezhi capsule , and the control group-30cases with the prescription of Xuezhikang. The treatment Course of taking Kezhi capusule (1.25 g, tid, po) and Xuezhikang(0.6 g, bid, po)was 24 weeks. Results After treatment in both groups we saw the significant decrease of the levels of ALT, AST, TC, TG, LDL-C, CREAT, BUN, BMI and TCM Syndromes scores, and the improvement of the ultrasonographic findings of liver steatosis. In the Xuezhikang group we saw higher decrease of TC and TG than the Kezhi capsule group with statistic difference (P < 0.05), while in Kezhi capsule group we saw higher decrease of BMI , TCM Syndromes scores and the improvement of the ultrasonographic findings of liver steatosis than the xuezhikang group with statistic difference (P < 0.05). Conclusions The results show that kezhi capsule is effective for the treatment of NAFLD without obvious side effects.%目的：观察壳脂胶囊治疗非酒精性脂肪肝（NAFLD）的临床疗效及安全性。方法：选择符合标准的非酒精性脂肪肝门诊患者60例，随机分为治疗组（壳脂胶囊组30例）及对照组（血脂康组30例），分别予壳脂胶囊1．25 g tid和血脂康0．6 g bid，疗程24周。结果：两组在降低天门冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）、总胆固醇（TC）、甘油三酯（TG）、低密度胆固醇（LDL-C）、肌酐（CREAT）、尿素氮（BUN）、体质量指数（BMI），症状积分，B 超影像学指标表现等方面均有显著疗效；其中血脂康组在降低 TC、TG 方面，优于壳脂胶囊组，差异有统计学意义（P＜0．05）；壳脂胶囊组在降低 BMI、症状疗效、B 超疗效等方面，优于血脂康组，差异有统计学意义（P＜0．05）。结论：壳脂胶囊治疗NAFLD有一定效果；且无明显不良反应。