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基于电子数据采集系统的川崎病602例回顾性分析

A retrospective analysis of 602 Kawasaki disease cases with electronic data capture system

摘要:

目的 评价电子数据采集系统(EDC)在川崎病大样本研究中的价值.方法 EDC与上海市儿童医院信息管理系统对接后,快速捕获川崎病住院患儿的所有信息,回顾性分析我院2007至2012年收治的602例川崎病患儿的临床资料,主要包括:年龄、性别、急性期临床症状、实验室检查、超声心动图及治疗方案等.比较川崎病合并冠状动脉病变(CAL)和无CAL、静脉注射丙种球蛋白(IVIG)耐受组和敏感组相关指标的差别;多因素Logistic回归分析川崎病相关高危因素;受试者工作曲线(ROC曲线)分析相关指标对IVIG治疗耐受的预测价值.结果 602例川崎病患儿中男391例,女211例,年龄1个月~11.7岁,中位年龄为2岁,CAL发生率为20.1% (121/602).CAL组(n=121)中唇及口腔改变(71.1%比88.6%,P=0.001)、趾端膜状蜕皮(28.1%比41.6%,P=0.021)和肛周皮肤脱屑(29.8%比38.9%,P=0.031)发生率明显低于无CAL组(n=481).IVIG耐受组CAL发生率(34.6%,9/26)显著高于IVIG敏感组(21.3%,112/525),差异有统计学意义(x2=3.86,P=0.05).IVIG耐受组与IVIG敏感组比较,男性(80.8%比63.4%,P=0.05),应用IVIG的时间[(6±2)比(8±5)d,P=0.009],红细胞沉降率[(81±2)比(66±30)mm/1 h,P=0.014],C反应蛋白[(107±51)比(87±52) mg/L,P=O.017],外周血血小板计数[(599±178)比(489±182)x 109/L,P=O.003],血红蛋白[(96±13)比(102±19) g/L,P=0.032]和血白蛋白[(34±6)比(37±6) g/L,P =0.020]差异均有统计学意义.多因素回归分析提示血丙氨酸氨基转移酶≥80 U/L是川崎病IVIG耐受的独立危险因素(OR =2.945,95% CI:1.267~6.843,P=0.012).ROC曲线对川崎病患儿IVIG治疗耐受的相关指标进行检测后发现:急性期C反应蛋白为104 mg/L时,敏感度为61.5%、特异度为62.7%,红细胞沉降率为106 mm/1 h时,敏感度为26.9%、特异度为93.6%,血小板为187×109/L时,敏感度为76.9%、特异度为53.1%.结论 EDC可以快速、准确捕获川崎病患儿的临床资料,便于该病的大样本研究,推广EDC于多家医院有助于国内川崎病的多中心研究.

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abstracts:

Objective To explore the value of electronic data capture (EDC) system in largesample size studies on Kawasaki disease(KD).Method The clinical data of 602 KD cases from 2007 to 2012 admitted to Shanghai Children's Hospital with EDC system connected with hospital information system (HIS) were retrospectively analyzed.Age,gender,acute symptoms,laboratory results,echocardiography,therapy were collected.The differences in parameters were compared between KD with and without coronary artery lesion (CAL).Furthermore,the difference between intravenous immunoglobulin (IVIG) resistant group and sensitive group were compared.Multi-factor logistic regression analyses were used to analyze the risk factors.The sensitivity and specificity of IVIG resistance parameters were detected with receiver operating characteristic curve (ROC) analysis.Result The male to female ratio of KD cases was 1.85:1.The median age of KD cases was 2.0 years (one month to 11.7 years old); 20.1% cases (121/602)exhibited CAL.Compared with KD without CAL (n =481),the incidence of bright red cracked lips (71.1% vs.88.6%,P =0.001),peeling of the skin of the toes (28.1% vs.41.6%,P =0.021) and perianal skin peeling (29.8% vs.38.9%,P =0.031) were statistically lower in KD with CAL (n =121).The incidence of CAL in KD IVIG resistant group was significantly higher than KD IVIG sensitive group (34.6%(9/26) vs.21.3%(112/525),P=0.05).Male ratio (80.8% vs.63.4%,P=0.05),time of IVIG ((6 ± 2) vs.(8 ± 5) d,P =0.009),erythrocyte sedimentation rate (ESR) ((81 ± 2) vs.(66 ± 30)mm/1 h,P=0.014),C-reactive protein ((107 ±51) vs.(87 ±52) mg/L,P=0.017),blood platelet ((599 ± 178) vs.(489 ± 182) × 109/L,P =0.003),hemoglobin ((96 ± 13) vs.(102 ± 19) g/L,P =0.032) and albumin ((34 ± 6) vs.(37 ± 6) g/L,P =0.020) were significantly different between IVIG resistant group and sensitive group.Logistic regression analysis showed that alanine aminotransferase (ALT)≥ 80 U/L was the independent risk factor of IVIG resistance (P =0.012).C-reactive protein =104 mg/L (sensitivity 61.5%,specificity 62.7%),ESR =106 mm/1 h (sensitivity 26.9%,specificity 93.6%) and blood platelet =187 × 109/L (sensitivity 76.9%,specificity 53.1%) of KD in acute phase were predictive for IVIG resistance with receiver operate characteristic curve analysis.Conclusion EDC system can acquire KD clinical data quickly and accurately.It is helpful for multicenter retrospective analysis of KD.

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作者: 谢利剑 [1] 周翠臻 [1] 王韧健 [1] 肖婷婷 [1] 沈捷 [1] 黄敏 [1]
期刊: 《中华儿科杂志》2015年53卷1期 34-39页 MEDLINEISTICPKUCSCD
栏目名称: 心血管疾病研究
DOI: 10.3760/cma.j.issn.0578-1310.2015.01.007
发布时间: 2015-01-30
基金项目:
上海市卫生局科研面上项目 上海市级医院适宜技术联合开发推广应用项目
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