药用炭剂治疗慢性肾功能不全的随机对照多中心临床研究

Multicenter randomized controlled clinical trial of medicinal charcoal in the treatment of chronic renal insufficiency

目的观察国产药用炭剂片与胶囊(肠道毒素吸附剂)治疗慢性肾功能不全的疗效和安全性。方法用多中心临床对照试验,187例患者口服治疗8周,比较治疗前后血肌酐、尿素水平和临床症状评分,并评价其安全性; 对照药为包醛氧淀粉。结果肌酐:治疗有效率分别为炭片组:33．3％,炭胶囊组:33．3％,包醛氧淀粉组:29．4％。尿素:治疗有效率分别为炭片组: 50．0％,炭胶囊组:46．0％,包醛氧淀粉组:59．4％。经治疗后,3组患者临床症状评分较治疗前有显著改善。药用炭剂片、胶囊与包醛氧淀粉的药物不良反应发生率分别为4．8％,3．1％,1．5％。结论国产药用炭剂作为肠道吸附剂,用于治疗慢性肾功能不全安全、有效。

Objective To observe the efficacy and safety of domestic medicinal charcoal on chronic renal insufficiency. Methods The trial was conducted in multi - centers. One hundred and eighty - seven patients were randomized into three groups, one for domestic medicinal charcoal tablets, one for domestic medicinal charcoal capsules, and one for coated aldehyde oxystarch（control） which was used as control in this study. The levels of serum creatinine and urea were assayed before and after 8 - week treatment. The symptoms of the patients were also evaluated. Results The efficacy to serum creatinine was 33.3% , 33.3% and 29.4% for three groups respectively. As to urea, the results were 50.0% , 46.0% and 59.4%. All patients%ymptoms were improved significantly after treatment. The total incidence of adverse reaction were 4.8% ,3.1% in the trial（ tablet, capsule） groups and 1.5% in the control group. Conclusion The domestic medicinal charcoal was safe and efficient in the treatment of chronic renal insufficiency.