香砂六君子汤改善脾虚型溃疡性结肠炎缓解期慢性疲劳临床疗效观察

Clinical observation of Xiangsha Liujunzi decoction in improving chronic fatigue of spleen deficiency type ulcerative colitis in remission period

目的:观察香砂六君子汤改善脾虚型溃疡性结肠炎(UC)缓解期慢性疲劳的临床疗效及其安全性。方法:采用随机、对照、交叉的研究方法,在常规口服美沙拉嗪缓释颗粒的基础上,将50例脾虚型UC缓解期慢性疲劳患者随机分为A组(第1~4周服用香砂六君子汤)、B组(第5~8周服用香砂六君子汤)。在第4周、第8周进行改良Mayo评分,Chalder Fatigue Scale疲劳评分、Clinical Global Impression评分、SF-36生活质量机体功能评分、工作与社会适应量表评分、工作状态评价,观察其临床疗效及其安全性。结果:2组患者在Chalder Fatigue Scale疲劳评分、Clinical Global Impression评分、SF-36生活质量机体功能评分、工作与社会适应量表评分中均较干预前明显好转(P<0.05),2组受试者均未出现明显不良反应。结论:香砂六君子汤具有改善脾虚型UC缓解期慢性疲劳的临床疗效,值得临床推广。

Objective: To observe the clinical efficacy and safety of Xiangsha Liujunzi decoction in improving chronic fatigue in spleen deficiency type of Ulcerative colitis patients in remission period. Methods: A randomized, controlled, crossover trial was conducted to divide 50 cases of spleen-deficiency ulcerative colitis patients with chronic fatigue in remission period into group A(In 1-4 weeks, oral Xiangsha Liujunzi decoction) and group B(In 5-8 weeks, oral Xiangsha Liujunzi decoction). The Modified Mayo score, Chalder Fatigue Scale score, Clinical Global Impression, Work and Social adaptation Scale score, SF-36 body function score and safety test were conducted at week 4 and week 8. Results: The Modified Mayo score, Chalder Fatigue Scale score, Clinical Global Impression, Work and Social adaptation Scale score, SF-36 body function score were significantly improved compared with those before intervention(P<0.05). There were no significant adverse events occurred in these two groups. Conclusion: Xiangsha Liujunzi decoction has an exact clinical effect in improving chronic fatigue in spleen-deficiency ulcerative colitis patients in remission period.