Short term efficacy of traditional Chinese medicine of clearing heat and dispelling dampness enema for ulcerative colitis
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摘要: [目的]评价清热除湿中药灌肠方对溃疡性结肠炎(UC)患者快速诱导缓解和改善症状的有效性。[方法]按照多中心、随机、对照临床研究设计,将5个临床中心的80例UC患者采用口服美沙拉嗪基础治疗联合清热除湿中药灌肠治疗(试验组)或者阳性对照药物柳氮磺吡啶栓纳肛治疗(对照组),疗程4周,比较2组患者快速诱导缓解率及症状改善情况。[结果]治疗结束时试验组缓解率为50.0%,对照组缓解率为40.0%,差异无统计学意义。试验组腹痛症状总有效率为94.3%,对照组为84.0%,差异有统计学意义(P<0.05),脓血便、腹泻、腹胀症状总有效率组间比较差异无统计学意义。试验组大肠湿热证证候临床总有效率为95.0%,对照组为88.6%,差异无统计学意义。[结论]清热除湿中药灌肠方联合美沙拉嗪口服能够使UC快速诱导缓解,能够有效改善症状,尤其对腹痛症状有良好的治疗效果。Abstract: [Objective] To evaluate the response of clearing heat and dispelling dampness enema for ulcerative colitis(UC).[Methods] According to the multi-center, randomized, controlled clinical study design, 80 patients with ulcerative colitis in the five centers were treated with mesalazine as basic treatment and Traditional Chinese medicine of enema treatment(treatment group) or sulfasalazine suppository treatment(control group) for 4 weeks, and compared with the remission rate and clinical curative effection of two groups.[Results] In the end of treatment, the remission rate of Traditional Chinese medicine treatment group was 50.0%;comparison group was 40.0%, indicating that the former was not inferior to the later.Evaluated TCM syndrome efficacy in two groups after treatment, abdominal pain symptom was statistically significant difference in which of the treatment group was 94.3% while the comparison group was 84.0%(P<0.05), and the rest symptoms had no statistically significant difference.Compared those two groups after treatment, the total symptom curative effect of treatment group was 95.0%, while comparison group 88.6%, there was no statistical significance.[Conclusion] Traditional Chinese Medicine of clearing heat and dispelling dampness enema combined oral mesalazine can make UC quickly induce remission, and had curative effect in improvement of symptoms, especially in abdominal pain.
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