Lancet：标准化儿科结肠炎治疗反应的临床和生物学预测因子(PROTECT):一项多中心初始队列研究

2019-04-03 不详网络

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由于缺乏以证据为基础的结果数据，目前导致新诊断为溃疡性结肠炎的儿童在制定治疗方案方面存在不确定性。本研究假设预处理的临床、转录组和微生物因素可以预测病程。

在初始队列研究中，我们从美国和加拿大的29个中心招募了4-17岁的儿童患者，均为新诊断为溃疡性结肠炎。患者最初收到标准化mesalazine或糖皮质激素,与预先设定的标准升级免疫调制剂(即thiopurines)或抗肿瘤坏死factor-α(TNFα)治疗。我们使用RNA测序来定义治疗前直肠基因表达，16S测序来表征直肠和粪便微生物群。主要结果是52周无皮质类固醇激素缓解，没有治疗以外的美沙拉嗪。我们使用每个协议群体的逻辑回归模型评估与主要结果相关的因素。该研究已在ClinicalTrials.gov网站注册，号码为NCT01536535。

研究显示，2012年7月10日至2015年4月21日，467名患者中，428名开始接受治疗，其中400名患者(93%)在52周时进行了评估，386名患者(90%)在没有违反协议的情况下完成了研究。400名参与者中有150人(38%)在第52周达到无皮质激素缓解，其中147人(98%)正在服用美沙拉嗪，3人(2%)没有服用任何药物。74(19%)的400升级到免疫调制剂,123 (31%)anti-TNFα疗法,25(6%)结肠切除术。低基线临床严重程度、高基线血红蛋白、第4周临床缓解与第52周无皮质激素缓解相关(n=386, logistic模型曲线下面积[AUC] 0·70,95% CI 0·65-0·75;特异性77%，95% CI 71-82)。在274名新诊断为溃疡性结肠炎的儿科患者的独立队列中，对基线严重程度和第4周缓解情况进行了验证。调整临床预测因子后，抗菌肽基因签名(优势比[OR] 0·57,95% CI 0·39-0·81;瘤胃球菌科的丰度(OR 1·43,1·02-2·00;p=0·04)，Sutterella (OR 0·81,0·65-1·00;p=0·05)与52周无皮质激素缓解独立相关。

研究发现，本研究结果支持最初的临床活动和4周的治疗反应的效用，以预测52周无皮质类固醇缓解单美沙拉嗪对儿童谁是新诊断为溃疡性结肠炎。个性化临床和生物学特征的开发有望为溃疡性结肠炎的治疗提供决策依据。

原始出处：

Prof Jeffrey S Hyams, Clinical and biological predictors of response to standardised paediatric colitis therapy (PROTECT): a multicentre inception cohort study

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2019-12-17 luoxiaog

#多中心#

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2019-11-14 108807375_62823139

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2019-04-09 howi

#Lancet#

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2019-05-04 一天没事干

很好的学习机会

63 0
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2019-10-20 shock_melon

#TEC#

41 0
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2019-04-05 宋威

#预测因子#

35 0
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2019-04-05 sunylz

#PRO#

32 0
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2019-04-05 12498c32m74暂无昵称

#生物学#

24 0

内科

外科

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