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作 者:沈洪 张声生[2] 王垂杰[3] 赵文霞[4] 叶柏 周滔[2] 李玉锋[3] 韩捷[4] 郑凯 顾培青 崔超[2] 邹建东 朱磊
机构地区:[1]南京中医药大学附属医院,南京市汉中路155号210029 [2]首都医科大学附属北京中医医院 [3]辽宁中医药大学附属医院 [4]河南中医学院第一附属医院
出 处:《中医杂志》2011年第13期1108-1111,共4页Journal of Traditional Chinese Medicine
基 金:"十一五"国家科技支撑计划(2006BAI04A14);国家自然科学基金资助项目(81072778)
摘 要:目的评价中药分期序贯治疗方案对轻中度溃疡性结肠炎(UC)的临床疗效。方法按照多中心、随机、对照、非劣效性研究设计,将4个临床中心的239例轻中度UC患者随机分为试验组及对照组,试验组分阶段予以清肠化湿方汤剂口服、灌肠方灌肠及清肠方汤剂口服,对照组口服美沙拉嗪肠溶片,疗程24周。记录治疗前及治疗后2、4、8、12、16、20和24周的症状积分,比较两组患者症状积分变化,评价临床疗效。结果 239例患者中,符合方案有效病例204例,试验组111例,对照组93例。治疗结束时,试验组症状总有效率87.4%,对照组症状总有效率84.9%,试验组的症状总有效率非劣效于对照组(P<0.05)。治疗前后症状积分比较,试验组在治疗第8周时对症状总积分的改善优于对照组(P<0.01),在第4周和第8周对腹胀和腹痛的改善分别优于对照组(P<0.05)。结论中药分期序贯治疗方案对轻中度UC患者的症状有明显改善作用,并能较快地诱导患者症状的缓解,尤其对腹胀、腹痛的改善早于西药治疗。Objective To evaluate the effect of stage sequential treatment of Chinese medicine on mild to moderate ulcerative colitis(UC).Methods A multi-central,randomized-controlled,and non-inferiority designed study was carried out.Totally 239 patients from four clinical centers with mild to moderate UC were randomized into study group and control group.The study group received the stage sequential treatment of Chinese medicine,i.e.,the decoction of Qingchang Huashi Recipe(Recipe for clearing intestine and dissolving damp)for oral taking,the decoction of Guanchang Recipe(Recipe for enema)for enema,and thedecoction of Qingchang Recipe(Recipe for clearing intestine)for oral taking.The control group received mesalazine enteric coated tablets for oral taking.The course of treatment was of 24 weeks.The symptom scores of before treatment and 2,4,8,12,16,20,24 weeks after treatment were recorded to compare the changes of two groups for evaluating the clinical effect.Results Of the 239 patients,204 cases were up to the treatment plan,111in the study group and 93 in the control group.At the end of the treatment,the total effective rate of the study group was 87.4%,while that of the control group was 84.9%,indicating that the former was not inferior to the latter(P0.05).In the comparison of difference of symptom scores between the two groups,the improvement in the total symptom score of the 8th week in the study group was better than that of the control group(P0.01),and the improvement in the abdominal distention and abdominal pain of the 4th and 8th weeks in the study group was better than that of the control group respectively(P0.05).Conclusion Stage sequential treatment of Chinese medicine could remarkably improve symptoms of mild to moderate UC patients,and could quickly induce symptom relief,especially the earlier improvement of abdominal distention and abdominal pain.
分 类 号:R259[医药卫生—中西医结合]
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