胶体酒石酸铋剂联合美沙拉嗪治疗溃疡性结肠炎随机对照研究

A randomized controlled study of colloidal bismuth tartrate combined with mesalazine in the treatment of ulcerative colitis

目的研究胶体酒石酸铋剂联合美沙拉嗪治疗溃疡性结肠炎疗效与安全性。方法采用前瞻性、随机、开放、对照研究的试验方法,随机分为A、B两组,A组应用胶体酒石酸铋联合美沙拉嗪(胶体酒石酸铋胶囊,165 mg,每日4次,餐前半小时及睡前各1次,疗程4周,美沙拉嗪片1 g,每日3次,疗程8周)治疗,B组单纯应用美沙拉嗪疗(美沙拉嗪1 g,每日3次,疗程8周),观察2组腹泻症状缓解情况、临床总疗效、内镜下黏膜愈合率及不良反应。结果60例患者纳入研究,其中男性32例,女性28例,年龄18~65岁,病程6个月~4年,平均体重56.5 kg,直肠炎20例,左半结肠炎有40例,轻度25例,中度35例。两组患者基线期临床特征基本相似。腹泻症状缓解情况:与B组比较,A组患者腹泻症状恢复正常天数(7.1±4.8 vs.11.7±4.6)及黏液脓血便消失天数(8.9±5.6 vs.13.3±4.7)明显缩短(P<0.05)。临床总疗效:A组(临床缓解23例,临床应答5例,无效2例)显著优于B组(临床缓解14例,临床11例,无效5例)(P<0.05)。内镜下黏膜愈合率:A组为76.7%,B组46.7%(P<0.05)。不良反应:胃肠道反应情况:A组上腹部不适、胃灼热、恶心等反应例数(2例)少于B组(3例),未见其他不良反应,而B组则有水样大便次数增多、皮疹各1例不良反应。两组肝肾功能正常。结论胶体酒石酸铋联合美沙拉嗪治疗溃疡性结肠炎,可以快速缓解腹泻症状,提高临床疗效。

Objective To study the efficacy and safety of colloidal bismuth tartrate combined with mesalazine in the treatment of ulcerative colitis.Methods A prospective,randomized,open and controlled study was used in this study,which was randomly divided into two groups:group A and group B.Group A was treated with colloidal bismuth tartrate combined with mesalazine(colloidal bismuth tartrate capsule,165 mg,4 times a day,1 time half an hour before meal and 1 time before sleep,4 weeks of treatment,1 g mesalazine tablet,3 times a day,8 weeks of treatment).Group B was treated with mesalazine only(1 g mesalazine,3 times a day,8 weeks of treatment).The relief of diarrhea symptoms,the total clinical effect,the healing rate of mucosa under endoscopy and adverse reactions were observed.Results A total of 60 patients were included in the study,including 32 men and 28 women,aged 18-65 years,with a course of 6 months-4 years,an average weight of 56.5 kg,20 cases of proctitis,40 cases of left colitis,25 cases of mild colitis and 35 cases of moderate colitis.The clinical characteristics of the two groups were basically similar at baseline.Relief of diarrhea symptoms:compared with group B,the recovery time of diarrhea symptoms in group A[(7.1±4.8)days vs.(11.7±4.6)days]and the disappearance time of mucopurulent bloody stool(8.9±5.6)days vs.(13.3±4.7)days]were significantly shorter(P<0.05).Total clinical efficacy:group A(23 cases of clinical remission,5 cases of clinical response,2 cases of ineffectiveness)was significantly better than group B(14 cases of clinical remission,11 cases of clinical response,5 cases of ineffectiveness,P<0.05).Adverse reactions:gastrointestinal reactions:the number of cases of upper abdominal discomfort,heartburn,nausea and other reactions in group A(2 cases)was less than that in group B(3 cases),and no other adverse reactions were found,while in group B,increased frequency of watery stools was found in 1 case,and rash in 1 case.The liver and kidney function was normal in both groups.Conclusion Colloidal bismuth tartrate combined with mesalazine in the treatment of ulcerative colitis can quickly relieve diarrhea symptoms and improve clinical efficacy.