A randomized controlled clinical trial of Jianpi Qingre Shugan Huayu recipe to treat refractory ulcerative colitis
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摘要: [目的]观察自拟健脾清热疏肝化瘀方对难治型溃疡性结肠炎临床疗效。[方法]选取我院经确诊的病例84例,随机分为西药组和中药组,每组分别给予相应药物治疗8周。分别于治疗前、治疗1周、4周和8周进行各症状积分和总积分、临床综合疗效和肠黏膜病变评分进行测定;与治疗前及治疗8周进行SF-36积分测定;停药4周进行远期疗效评估。[结果]每项症状积分比较治疗8周脓血便及里急后重的症状,组间差异显著且有统计学意义(P<0.05),各组于治疗8周与本组治疗前比较差异均有统计学意义(P<0.01)。各症状积分及症状总积分比较,治疗8周组间比较差异有统计学意义(P<0.05)。各组于治疗8周与本组治疗前比较,差异均有统计学意义(P<0.01);临床综合疗效比较治疗后8周组间比较差异有统计学意义(P<0.05)。肠镜检查结果治疗后8周中药组肠镜检查结果明显好于西药组,差异有统计学意义(P<0.05)。SF-36积分比较:中药组在改善BP、VT、SF、MH方面优于西药组(P<0.05)。2组患者远期疗效比较:停药4周中药组复发或加重程度均少于或好于西药组,2组间比较差异有统计学意义(P<0.01)。[结论]中药治疗在临床症状及生活质量方面双相调节优于西药组,达到疾病治疗稳态。Abstract: [Objective] To study the clinical effects of self-made Jianpi Qingre Shugan Huayu Recipe in treating refractory ulcerative colitis.[Methods] Eighty-four patients were randomly divided into 2 groups and treated by western medicine and traditional Chinese medicine for 8 weeks respectively. Symptoms, clinical comprehensive therapeutic effect and intestinal mucosal lesion were determined before treatment, 1 week, 4 weeks and 8 weeks after the treatment. SF-36 was determined before treatment and after 8 weeks' treatment. Evaluation of long-term effect was implemented 4 weeks after drug withdrawal.[Results] There were significant differences between the two groups in pus and blood stool and tenesmus symptoms after 8 weeks treatment (P<0.05). There were also significant differences in each group compared with before treatment and after 8 weeks' treatment (P<0.01). The differences were statistically significant when comparing the single symptom score and overall symptom scores between the two groups after 8 weeks treatment (P<0.05). The same results were found in each group when comparing the single symptom score and overall symptom scores before and after the treatment. There was significant difference between the two groups in the clinical comprehensive therapeutic effects after 8 weeks' treatment (P<0.05). Colonoscopy results after 8 weeks treatment showed obviously better outcome in traditional Chinese medicine group than western medicine group (P<0.05). When comparing the SF-36, traditional Chinese medicine had better effects than western medicine in improving BP, VT, SF and MH (P<0.05). There was significant difference between the two groups in the long-term effects, with lower relapse rate or less severity after 4 weeks drugwithdrawl in traditional Chinese medicine group than the western medicine group (P<0.01).[Conclusion] Traditional Chinese medicine was better than western medicine in improving clinlcal symptoms, the quality of life and achieving the steady situation of disease treatment.
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Key words:
- Jianpi Qingre Shugan Huayu Recipe /
- refractory /
- ulcerative colitis /
- quality of life
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