乌梅丸口服结合中药灌肠治疗寒热错杂型溃疡性结肠炎

Wumei Pill Combined with Traditional Chinese Medicine Enema for Treatment of Cold and Hot Miscellaneous Ulcerative Colitis

目的探讨乌梅丸口服结合中药灌肠治疗寒热错杂型溃疡性结肠炎(Ulcerative Colitis,UC)的临床效果与安全性。方法选取2018年12月—2019年6月期间在中国中医科学院广安门医院(南区)肛肠科治疗的50例UC患者,随机分成两组,每组25例。对照组服用美沙拉嗪肠溶片,1.0 g/次,4次/d;治疗组采用乌梅丸口服结合中药灌肠,两组均连续治疗3~6个疗程。观察分析治疗后第12、24、48周的完全缓解(CR)率和总有效率,评估两组患者的不良反应和UC复发率。结果治疗第24周后,治疗组完全缓解率(CR)68.0%(17/25)明显高于对照组完全缓解率(CR)32.0%(8/25)(P<0.05);治疗第48周后,治疗组完全缓解率(CR)60.0%(15/25)、治疗总有效率68.0%(17/25)均明显高于对照组完全缓解率(CR)16.0%(4/25)、治疗总有效率24.0%(6/25),两组比较差异均有统计学意义(P<0.05)。两组患者的不良反应发生率比较差异无统计学意义(P>0.05)。治疗组复发率4.0%(1/25),对照组复发率24.0%(6/25),两组比较差异有统计学意义(P<0.05)。结论对于寒热错杂型UC患者,乌梅丸口服结合中药灌肠有效率高,复发率低,值得在临床推广应用。

Objective The purpose of this study was to investigate the clinical efficacy and safety of Wumei Pill combined with traditional Chinese medicine enema in the treatment of cold and hot mixed ulcerative colitis(UC).Methods This study included 50 patients with UC who underwent gastroenterology in our hospital from December 2018 to June 2019.They were randomized into 2 groups with 25 patients in each group.The control group took mesalazine enteric-coated tablets,1.0 g,four times a day.The treatment group used Wumei Pills orally combined with traditional Chinese medicine enema,and both groups were treated for 3 to 6 consecutive courses.The complete remission(CR)rate and effectiveness at 12,24,and 48 weeks after treatment were analyzed.In addition,the study also evaluated adverse events and UC recurrence rates in the two groups.Results After the 24 thweek of treatment,the complete remission rate(CR)(17/25)of 68.0%in the treatment group was significantly higher than that of the control group(CR)(8/25)32.0%(P<0.05);at the 48 th week of treatment Weeks later,the complete remission rate(CR)(15/25)of 60.0%in the treatment group and the total effective rate(17/25)of 68.0%in the treatment group were significantly higher than the complete remission rate(CR)(4/25)of 16.0%in the control group.The total effective rate of treatment(6/25)was 24.0%,and the difference between the two groups was statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups of patients(P>0.05).The recurrence rate of the treatment group was 4.0%(1/25)and that of the control group was 24.0%(6/25).The difference between the two groups was statistically significant(P<0.05).Conclusion For Chinese patients with cold-heat mixed UC,Wumei Pill combined with traditional Chinese medicine enema has high efficiency and low recurrence rate,which is worthy of clinical application.