中国临床药学杂志

目的探讨柳氮磺吡啶联合布地奈德与中药灌肠治疗溃疡性直肠炎的疗效和安全性。方法 90例经肠镜检查确诊为溃疡性直肠炎的患者,随机分为3组,即柳氮磺吡啶联合布地奈德与中药灌肠(A)组、口服柳氮磺吡啶(B)组以及柳氮磺吡啶栓剂纳肛(C)组,疗程4周。评估3组患者治疗前后临床症状改善情况、起效时间、肠镜镜下黏膜恢复情况以及疾病活动程度的变化,记录治疗过程中出现的不良反应。结果 A、B、C组治疗方案起效时间分别为(4.37±1.38)d、(12.04±1.81)d及(7.83±1.47)d。A组起效时间短(P<0.01)且临床完全缓解率及总体有效率皆高于其余2组(P<0.01);直肠局部用药的患者不良反应发生率(3.33%)皆显著低于口服用药组(26.67%),P<0.01。结论溃疡性直肠炎治疗局部用药较口服疗效快,不良事件发生率较低。中西药联合应用灌肠效果较单独用药效果好,值得在临床上推广应用。

AIM To discuss the efficacy and safety of enema treatment with combination of sulfusalazine with budesonid and traditional Chinese medicine(TCM) in patients with ulcerative rectitis.METHODS Ninety patients of ulcerative rectitis diagnosed by colonoscopy were involved in the study.The patients were randomized into 3 groups.In the group A,patients were treated by enema with combination of sulfusalazine,budesonide and TCM.In the group B,patients were treated by oral sulfusalazine only and in the group C,patients were treated by topical administration of sulfusalazine in rectum.The improvement of clinical symptoms,the onset time,the recovery of intestinal mucosa and the degree of disease activity were included in the evaluation,which were taken from the 3 groups after four-week treatment.All adverse drug reactions during the treatment were recorded.RESULTS The onset time for the group A,B and C were(4.37±1.38)d,(12.04±1.81)d and(7.83±1.47)d,respectively.The group of enema with combination of TCM and western medicine had the shortest onset time(P<0.01) and a higer rate of complete remission and efficiency(P<0.01) as well.The incidence rate of adverse drug ractions was 3.33% in local application of medication in rectum,which was significantly lower than simple oral medication(26.67%,P<0.01).CONCLUSION Topical administration is a better option for ulcerative rectitis than oral treatment,which has shorter onset time and less adverse drug reactions.The enema treatment with combination of TCM and western medicine has more satisfactory effects than single medication,which deserves the clinical expansion.