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纸质出版日期:2018
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冯卓, 韩昌鹏, 李盈, 等. 祛湿清肠方内服联合中药灌肠治疗轻中度活动期溃疡性结肠炎大肠湿热证临床观察[J]. 中国实验方剂学杂志, 2018,24(5):149-154.
FENG Zhuo, HAN Chang-peng, LI Ying, et al. Clinical Observation of Qushi Qingchang Recipe Combined with Chinese Medicine for Treating Mild-to-moderate Ulcerative Colitis with Syndrome of Dampness-heat in Large Intestine[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(5): 149-154.
冯卓, 韩昌鹏, 李盈, 等. 祛湿清肠方内服联合中药灌肠治疗轻中度活动期溃疡性结肠炎大肠湿热证临床观察[J]. 中国实验方剂学杂志, 2018,24(5):149-154. DOI: 10.13422/j.cnki.syfjx.2018050149.
FENG Zhuo, HAN Chang-peng, LI Ying, et al. Clinical Observation of Qushi Qingchang Recipe Combined with Chinese Medicine for Treating Mild-to-moderate Ulcerative Colitis with Syndrome of Dampness-heat in Large Intestine[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(5): 149-154. DOI: 10.13422/j.cnki.syfjx.2018050149.
目的:观察祛湿清肠方内服联合中药灌肠治疗轻中度活动期溃疡性结肠炎(ulcerative colitis,UC)大肠湿热证的临床疗效及安全性,同时考察外周血细胞因子白细胞介素-17(interleukin-17,IL-17),白细胞介素-6(interleukin-6,IL-6),白细胞介素-10(interleukin-10,IL-10),转化生长因子-β1(transforming growth factor-beta 1,TGF-β1)的变化。方法:70例轻中度活动期UC大肠湿热证患者随机分为观察组和对照组,各35例。观察组给予中药口服,配合中药灌肠。对照组给予美沙拉嗪肠溶片口服。两组疗程均为3个月。比较两组患者Truelove与Witts分度,Sutherland DAI活动指数,中医证候改善情况,缓解率及外周血细胞因子IL-17,IL-6,IL-10,TGF-β1水平,并监测用药安全性。结果:治疗后观察组脓便血次数少于对照组(P<0.05),红细胞沉降率(ESR)及C反应蛋白(CRP)水平显著低于对照组(P<0.01),脉搏、体温及血红蛋白无差异。两组Sutherland DAI积分无差异,医师评估情况积分,观察组高于对照组(P<0.05),排便次数、血便及内镜黏膜表现均无差异。观察组较对照组能更有效改善UC导致的临床症状(P<0.01)。对照组缓解率51.43%(18/35),观察组缓解率74.29%(26/35),观察组优于对照组(P<0.05)。观察组IL-17,IL-10水平显著低于对照组(P<0.01),TGF-β1水平低于对照组(P<0.05),IL-6水平无明显差异。观察组出现不良反应2例(恶心不适、肛周皮肤瘙痒),对照组出现不良反应3例(丙氨酸氨基转移酶升高至80 U ·L-1以上)。结论:祛湿清肠方内服联合中药灌肠治疗轻中度活动期UC大肠湿热证有效、安全,而且对症状的改善优于美沙拉嗪。
Objective:To observe the clinical effects and safety of Qushi Qingchang recipe for treating mild-to-moderate ulcerative colitis with syndrome of dampness-heat in large intestine
and investigate the changes in expression levels of cytokines interleukin (IL)-17
IL-6
IL-10 and transforming growth factor-beta 1 (TGF-β1) in peripheral blood. Method:The 70 patients with mild-to-moderate ulcerative colitis were assigned to experiment group (35 cases) and control group (35 cases) randomly. Patients in experiment group took Qushi Qingchang recipe orally
combined with Chinese medicine by gavage administration. Those in control group took mesalazine enteric-coated tablet. The treatment course was 3 months in both groups. The Truelove and Witts score
sutherland disease activity index and the remission rate were compared between two groups. Meanwhile
expressions of cytokines IL-17
IL-6
IL-10 and TGF-β1 in peripheral blood were compared and the medication safety was monitored. Result:By the end of the treatment
the frequency of hemafecia and mucosanguineous stools in experiment group was less than that in control group (P<0.05); erythrocyte sedimentation rate(ESR) and C-reactive protein(CRP) levels were significantly lower than those in control group (P<0.01)
but with no difference in body temperature
pulse
and hemoglobin. There was no difference between two groups in Sutherland DAI scores
and there were no differences in the number of defecation
bloody stool and endoscopic mucosal performance
but the score of physician evaluation index in experiment group was higher than that in control group (P<0.05). The experiment group can improve the clinical symptoms more effectively than control group (P<0.01). The remission rate was 51.43% (18/35) in control group
lower than 74.29% (26/35) in experiment group (P<0.05). The levels of IL-17 and IL-10 in experiment group were significantly lower than those in control group (P<0.01)
and the level of TGF-β1 was lower than that of the control group (P<0.05)
but there was no significant difference in the level of IL-6. Patients in experiment group had adverse reactions (nausea
perianal pruritus)
and 3 patients in control group had adverse reactions (ALT increased to more than 80 U·L-1. Conclusion:Qushi Qingchang recipe combined with herbal enema was effective and safe in treating mild-to-moderate ulcerative colitis with syndrome of dampness-heat in large intestine. Besides
its effect on improving the symptoms was better than that of mesalazine enteric-coated tablet.
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