清热化湿颗粒治疗大肠湿热证溃疡性结肠炎的临床观察:一项随机、前瞻性、双盲临床试验

Clinical observation of Qingre Huashi Granules in the treatment of ulcerative colitis with damp-heat syndrome:a randomized,prospective,double-blind clinical trial

目的:探讨清热化湿颗粒治疗大肠湿热证溃疡性结肠炎(UC)的临床疗效。方法:筛选入组轻、中度大肠湿热证UC患者120例,随机双盲分为单纯西药组(对照组)和中西医结合治疗组(观察组),每组60例。对照组给予美沙拉嗪,1 g/次,3次/d口服;观察组给予中药清热化湿颗粒联合美沙拉嗪口服。连续治疗30 d为1个治疗周期。评价2种用药方案的临床疗效有效率、疾病活动指数、结肠镜下肠黏膜组织学评分和安全性。结果:观察组的总有效率高于对照组,差异有统计学意义(93.33%vs 76.67%,P<0.05);治疗后2组UC患者的改良Mayo评分均较治疗前降低,且观察组评分低于对照组,差异有统计学意义(P<0.0001);治疗后2组的结肠镜下肠黏膜组织学评分(Geboes指数)均下降,且观察组评分低于对照组,差异有统计学意义(P<0.001);2组治疗前后血常规指标(白细胞计数、血红蛋白、血小板、中性粒细胞百分比)、肝肾功能指标(谷丙转氨酶、谷草转氨酶、血肌酐)和炎症水平(C反应蛋白、血沉)比较差异无统计学意义(P>0.05)。结论:清热化湿颗粒联合美沙拉嗪治疗大肠湿热证UC的疗效确切,可有效减轻患者肠黏膜病变程度,较单纯美沙拉嗪治疗有更好的临床疗效。

Objective To investigate the clinical efficacy of Qingre Huashi Granules in the treatment of ulcerative colitis(UC)with damp-heat syndrome.Methods A total of 120 mild to moderate UC patients with large intestine damp-heat syndrome were enrolled,and divided into control group and observation group randomly.The control group was treated with Mesalazine,the observation group was treated with Qingre Huashi Granules combined with Mesalazine.The treatment period lasted for one month.The clinical efficacy,the Mayo score,the histological score under colonoscopy,and blood indexes were recorded and compared between the two groups before and after treatment.Results The total effective rate of the observation group was 93.33%,which was higher than that of the control group(76.67%)with a statistical significance(P<0.05).Following treatment,both groups exhibited a decrease in the Mayo score;however,the observation group demonstrated a superior reduction in the Mayo score compared to the control group,and this difference was statistically significant(P<0.0001).The histological scores(Geboes index)were significantly decreased in both groups,but the observation group had lower scores than the control group,and this difference was statistically significant(P<0.001).Indicators of blood test(WBC,Hb、PLT),serum biochemical indexes(ALT,AST,SCr)and inflammatory factors(CRP,ESR)were also compared between the two groups,and the results showed no difference between the two groups(P>0.05).Conclusion The therapeutic efficacy of Qingre Huashi Granules combined with mesalazine in the treatment of UC with large intestine damp-heat syndrome is definitive,and they can effectively reduce the degree of intestinal mucosal lesions and exhibit superior clinical effectiveness compared to Mesalazine monotherapy.