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1.上海中医药大学 附属曙光医院,上海 201203
2.上海同济大学 附属养志康复医院,上海 201600
3.上海市第一人民医院 嘉定分院,上海 201803
顾思臻,在读博士,从事中西医结合防治炎症性肠病的临床及基础研究,E-mail:gusizhen@126.com
窦丹波,博士,主任医师,从事中西医结合诊治消化系统疾病工作,Tel:021-20256332,E-mail:doudanbo@126.com
收稿日期:2021-04-18,
网络出版日期:2021-07-06,
纸质出版日期:2021-09-05
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顾思臻,薛艳,张玉丽等.溃结通干预轻中度活动期溃疡性结肠炎的临床疗效[J].中国实验方剂学杂志,2021,27(17):106-111.
GU Si-zhen,XUE Yan,ZHANG Yu-li,et al.Clinical Efficacy of Kuijietong Against Mild to Moderate Active Ulcerative Colitis[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(17):106-111.
顾思臻,薛艳,张玉丽等.溃结通干预轻中度活动期溃疡性结肠炎的临床疗效[J].中国实验方剂学杂志,2021,27(17):106-111. DOI: 10.13422/j.cnki.syfjx.20211794.
GU Si-zhen,XUE Yan,ZHANG Yu-li,et al.Clinical Efficacy of Kuijietong Against Mild to Moderate Active Ulcerative Colitis[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(17):106-111. DOI: 10.13422/j.cnki.syfjx.20211794.
目的
2
溃结通(KJT)干预溃疡性结肠炎(UC)的临床疗效再评价。
方法
2
采用随机、对照的方法,总共纳入60例轻、中度活动期UC受试者,KJT组30例,柳氮磺胺吡啶(SASP)组30例。KJT组给予KJT颗粒(每日1剂,早晚分服),SASP组给予SASP(4 g/天,分4次口服),评价临床疗效。
结果
2
根据改良Mayo评分,KJT组的临床缓解率为46.7%(14/30),SASP组为40%(12/30),两组之间差异不具有统计学意义;KJT组临床有效率为83.3%(25/30),优于SASP组的60%(18/30)(
P
<
0.05);KJT组黏膜愈合率为36.7%(11/30),SASP组为30%(9/30),两组之间差异不具有统计学意义。在UC症状改善方面,KJT组大肠湿热证候积分改善优于SASP组(
P
<
0.05),而两组炎症性肠病生活质量评分(IBDQ)之间的差异不具有统计学意义。在理化指标方面,干预后KJT组血清红细胞沉降率(ESR)水平低于SASP组(
P
<
0.05),白细胞介素-10(IL-10)水平则高于SASP组(
P
<
0.05),而干预后两组C反应蛋白(CRP),肿瘤坏死因子-
α
(TNF-
α
),CD4
+
T细胞及调节性T(Treg)细胞水平之间的差异不具有统计学意义。干预中两组受试者均未发现明显不良反应,安全性较好。
结论
2
KJT干预轻中度活动期UC缓解不劣于SASP。
Objective
2
To re-evaluate the intervention effect of Kuijietong(KJT) on ulcerative colitis(UC).
Method
2
Sixty patients with mild-to-moderate UC in the active stage were enrolled and randomized into a KJT group (
n
=30) and a sulfasalazine (SASP) group (
n
=30). Patients in the KJT group were treated with KJT granules, one bag divided in two daily doses, once in the morning and once in the evening, while those in the SASP group received SASP, 1 g per time, four times per day. Then the clinical efficacy was evaluated.
Result
2
According to the modified Mayo score,the clinical remission rates of the KJT group and SASP group were determined to be 46.7% (14/30)and 40% (12/30),exhibiting no significant difference between the two groups (
P
>
0.05). The clinical effective rate of the KJT group was 83.3% (25/30),which was better than 60% (18/30) of the SASP group (
P
<
0.05). The mucosal healing rate in the KJT group was 36.7% (11/30), not significantly different from 30% (9/30) in the SASP group. In the alleviation of UC symptoms,the score of large intestine dampness heat syndrome in the KJT group was remarkably better than that in the SASP group (
P
<
0.05),but there was no significant difference in inflammatory bowel disease questionnaire (IBDQ) score between the two groups. In terms of physical and chemical indexes,serum erythrocyte sedimentation rate (ESR) in the KJT group after intervention was lower than that in the SASP group (
P
<
0.05),whereas the interleukin-10 (IL-10) level was higher(
P
<
0.05). The comparison between the two groups revealed no significant difference in C-reactive protein (CRP), tumor necrosis factor-
α
(TNF-
α
), CD4
+
T cells and regulatory T (Treg) cells after intervention. During the intervention,no obvious adverse reactions were found in the two groups,indicating good safety.
Conclusion
2
KJT is not inferior to SASP in relieving mild-to-moderate UC in the active stage.
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