南方医科大学学报

南方医科大学学报 ›› 2016, Vol. 36 ›› Issue (09): 1186-.

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云南白药辅助治疗溃疡性结肠炎的开放随机对照研究

赵文珍，刁娜，谷艺修，朱小彤，李明松   

  • 出版日期:2016-09-20 发布日期:2016-09-20

Efficacy of Yunnan Baiyao as an adjuvant treatment for active ulcerative colitis: an open-label randomized controlled study

  • Online:2016-09-20 Published:2016-09-20

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摘要： 目的研究云南白药在活动期溃疡性结肠炎（UC）诱导缓解中的作用。方法将221例活动期UC患者按照完全随机化的 方法分为云南白药组和对照组，随访26周，记录患者诱导缓解的时间，以及诱导缓解前后血清学指标（WBC、HGB、PLT、CRP） 的改变，进行统计分析综合评价云南白药对于UC患者辅助治疗作用。结果221例活动期UC患者中有78例患者应用云南白 药辅助治疗。云南白药组中位缓解时间为9周（95% CI：8.293-9.707），明显少于对照组（13周，95% CI：11.855-14.145），差异具 有统计学意义（P<0.001）。病变范围、病情活动度、治疗方案分组下云南白药组与对照组中位缓解时间分别为：E1、E2、E3组为 7、11周（P=0.09），10、13周（P=0.04），9、14周（P<0.001）；轻、中、重度活动组为9、10周（P=0.568），9、14周（P<0.001），11、20周（P= 0.001）；美沙拉嗪、激素、类克组为9、12周（P<0.001），9、13周（P=0.001），7、14周（P=0.04）。COX比例风险回归模型分析可知， 云南白药为活动期UC患者诱导缓解治疗的保护因素，应用云南白药辅助治疗的患者诱导缓解时间将缩短2.283倍（95% CI： 1.697-3.070，P<0.001）。结论对于活动期UC患者，在标准治疗的基础上，辅以云南白药治疗，可以缩短患者诱导缓解的时间， 早期缓解症状，提高生活质量。

Abstract: Objective To investigate the efficacy of Yunnan Baiyao (YNBY) as an adjuvant treatment of active ulcerative colitis. Methods A total of 221 patients with active ulcerative colitis were randomized into YNBY group (78 cases) and control group (143 cases). The patients were followed up for 26 weeks and time of remission and serological data (WBC, HGB, PLT, and CRP) were recorded. Results The patients receiving YNBY as an adjuvant therapy had a median remission time of 9 weeks (95% CI: 8.293-9.707), significantly shorter than that of 13 weeks (95% CI: 11.855-14.145) in the control patients (P<0.001). According to the extent of the lesion, both YNBY group and control group were classified into E1, E2 and E3 subgroups, and the median remission time was 7 versus 11 weeks in E1 subgroups (P=0.09), 10 versus 13 weeks in E2 subgroups (P=0.04), and 9 versus 14 weeks in E3 subgroups (P<0.001). According to the disease severity, the patients in YNBY group and control group had a median remission time of 9 versus 10 weeks in mild cases (P=0.568), 9 versus 14 weeks in moderate cases (P<0.001), and 11 versus 20 weeks in severe cases (P=0.001). According to the standard treatment received, the median remission time in YNBY group and control group was 9 versus 12 weeks in those receiving mesalazine (P<0.001), 9 versus 13 weeks in those receiving corticosteroid (P=0.001), and 7 versus 14 weeks in those receiving infliximab (P=0.04). Cox proportional hazards regression analysis showed that YNBY was a protective factor for disease remission. The remission time was shortened by 2.283 times (95% CI: 1.69-3.070, P<0.001) in patients having YNBY as an adjuvant treatment compared to the control group. Conclusion Patients with active ulcerative colitis can benefit from YNBY as an adjuvant treatment, which shortens the time of disease remission, relieves the symptoms and improves the quality of life of the patients.