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硕士 专业 学位论文 论文题目 不同方案 静脉注射 丙种球蛋白治疗川崎病疗 效的 Meta 分析 研究生姓名 沈 勤 指导教师姓名 吕海涛 专 业 名 称 儿科学 研 究 方 向 小儿心血管 论文提交日期 2013 年 4 月 不同方案静脉注射丙种球蛋白治疗川崎病疗效的 Meta 分析 中文摘要 I 不同方案静脉注射 丙种球蛋白治疗 川崎病疗效的 Meta分析 中文摘要 第一部分: 静脉注射 丙种球蛋白不同剂量及用法治疗 川崎病疗效的 Meta 分析 目的: 评价 近 20年 静脉注射 丙种球蛋白( intravenous immunoglobulin, IVIG)不同剂量及用法 治疗川崎病( Kawasaki disease,KD) 临床疗效的 Meta分析。 方法: 制定检索策略、原始文献纳入及排除标准,检索 1993.3至 2013.3, MEDLINE、EMBASE、 PUBMED、 Cochrane图书馆、万方数据库、重庆维普( VIP)数据库及中国期刊全文数据库( China national knowledge infrastructure, CNKI)。纳入初始 静脉注射 丙种球蛋白不同剂量及用法对 川崎病患者 冠状动脉损害( coronary artery lesions,CALs)、丙种球蛋白 无反应者、 IVIG不良反应发生率、退热时间及治疗前后炎症指标如白细胞( White blood cell, WBC)、血沉( Erythrocyte sedimentation rate, ESR)、 C反应蛋白( C-reactive protein, CRP)的影响。并对纳入的相关文献进行质量评价。采用 Stata11.0对数据进行统计分析。 结果: 纳入 40 篇文献共包括 7932 例 KD 患者 ,研究中除了一篇为前瞻性研究外, 余均为回顾性研究,提取数据资料后进行统计分析 结果显示: 1) IVIG2g/(kg.d) 1d 与 1g/( kg.d) 2d比较, Meta分析结果示 : IVIG2g/(kg.d) 1d 的退热时间比 IVIG1g/( kg.d) 2d缩短 加权平均差值 (weighted mean difference, WMD)=-0.54, 95%可信区间( confidence interval, CI): -0.65 -0.44,差异有统计学意义;在急性期、亚急性期冠状动脉损害发生率方面 两种用法 无统计学 差异 优势比中文摘要 不同方案静脉注射丙种球蛋白治疗川崎病疗效的 Meta 分析 II (odds ratio, OR)=0.71, 1.07; 95%CI: 0.46 1.08,0.78 1.46。 2) IVIG2g/(kg.d) 1d 与 1g/( kg.d) 1d比较, Meta 分析结果示: IVIG2g/(kg.d) 1d 较 1g/( kg.d) 1d能更好地缩短 退 热时间 ( WMD=-0.11,95%CI: -0.16 -0.06)及降低治疗前后炎症反应指标( WBC、 ESR、 CRP) ,差异有统计学意义; 在 降低 冠状动脉损害 发生率 ( P=0.996, OR=1.12, 95%CI为 0.41-3.04)及不良反应发生率(P=0.997, OR=1.22, 95%CI为 0.81-1.83)方面 两种用法无统计学差异 。 3) IVIG2g/(kg.d) 1d 与 400mg/( kg.d) 4-5d 比较, Meta 分析结果示:IVIG2g/(kg.d) 1d 较 400mg/( kg.d) 4-5d 能更好降低冠状动脉损害发生率( OR=0.33, 95%CI: 0.27 0.41),缩短退热时间( WMD=-1.38,95%CI: -1.45 -1.32)及降低治疗前后炎症指标( WBC、 ESR、 CRP) ,差异有统计学意义 。 4) IVIG1g/(kg.d) 1d 与 400mg/( kg.d) 4-5d 比较, Meta 分析结果示:IVIG1g/(kg.d) 1d 较 400mg/( kg.d) 4-5d 能更好 降低 冠状动脉损害发生率( OR=0.39,95%CI: 0.25-0.60),缩短 退热时间( WMD=-0.95,95%CI: -1.01 -0.89),及降低 治疗 前后 炎症指标 ( WBC、 ESR、 CRP) ,差异有统计学意义; 在 不良反应发生率 方面 ( P=0.786)两者 无统计学差异 。 5) IVIG1g/(kg.d) 2d 与 400mg/( kg.d) 4-5d 比较, Meta 分析结果示:IVIG1g/(kg.d) 2d 较 400mg/( kg.d) 4-5d 更好 降低 冠状动 脉损害 发生率 (OR=0.60,95%CI:0.44-0.81)及缩短退热时间 (WMD=-1.25,95%CI: -1.34 -1.16),差异有统计学意义 。 结论: 1) IVIG 2g/(kg.d) 1d 与 IVIG 1g/(kg.d) 1d、 IVIG 1g/(kg.d) 2d 比较,三种用法在降低 冠状动脉损害发生率上无明显差异; 2) IVIG 2g/(kg.d) 1d 较 IVIG 400mg/( kg.d) 4-5d、 IVIG 1g/(kg.d) 1d、 IVIG 1g/(kg.d) 2d 更能有效 缩短退热时间, 降低 炎症指标( ESR、 CRP、 WBC); 3) IVIG 400mg/( kg.d) 4-5d 疗法 与 IVIG 2g/(kg.d) 1d 、 IVIG 1g/(kg.d) 1d、IVIG 1g/(kg.d) 2d 相比, 冠状动脉损害发生率 高 。 关键词: 川崎病; 静脉注射 丙种球蛋白; Meta 分析 不同方案静脉注射丙种球蛋白治疗川崎病疗效的 Meta 分析 中文摘要 III 第二部分: 静脉注射 丙种球蛋白联合糖皮质激素初始治疗 川崎病疗效的 Meta分析 目的 : 通过对近 20 年来 静脉注射 丙种球蛋白联合糖皮质激素与 单用静脉注射 丙种球蛋白两种方案治疗川崎病患儿疗效的 Meta 分析,以了解 IVIG 联合糖皮质激 素对冠状动脉损害及 IVIG 无反应者发生率的影响。 方法: 制定检索策略及原始文献纳入、排除标准,检索 1993.3-2013.3 MEDLINE、EMBASE、 PUBMED、 Cochrane 图书馆、万方数据库、 VIP 及 CNKI。纳入 初始治疗IVIG联合糖皮质激素 与 单用 IVIG对 川崎病患儿 冠状动脉损害、 丙种球蛋白无反应者、不良反应发生率及退热时间的影响 (阿司匹林 aspirin, ASA在两组中为基础用药) 。对纳入相关文献进行质量评价。采用 Stata11.0 对数据进行统计分析。计数资料采用OR 及 95%CI 进行分析 ,计量资料采用 WMD 及 95%CI 进行分析,并 进行发表偏倚评估。 结果: 8 篇文献(共 1727 例 KD 患者 )最终纳入分析。均为英文文献,其中 4篇为随机对照试验( randomized controlled trial, RCT), 4 篇为回顾性对照研究。 Meta分析结果显示:( 1)初始治疗 IVIG 联合 糖皮质 激素组与 单用 IVIG 组在一月内及随访一月后冠状动脉损害发生率方面 ( P=0.008、 0.782, OR=0.75、 0.65, 95%CI:0.51-1.09、0.35-1.19) 无统计学差异 。( 2)初始治疗 IVIG 联 合 糖皮质 激素组较单用 IVIG 组退热时间 缩短 (OR=-1.07, 95%CI: -1.29-0.85),差异有统计学意义。( 3)初始治疗 IVIG联合 糖皮质 激素组较单用 IVIG 组 IVIG 无反应者的发生率 降低 ( OR=0.45, 95%CI:0.31 0.66) , 差异有统计学意义 。( 4)初始 治疗 IVIG 联合 糖皮质 激素组较单用 IVIG组在不良反应发生率方面 ( P=0.554)无统计学差异 ,甲基强的松龙 30mg/kg 单次静脉使用及强的松 2mg/(kg.d) 3d 口服无严重不良反应发生。 结论: 1)与单用 IVIG 治疗 KD 比较, 联合激素组有同样降低冠状动脉损害的作用,且能更快缩短退热时间; 2) 与单用 IVIG 治疗 KD 比较, 联合激素组不良反应发生率未增加; 3) 与单用 IVIG 治疗 KD 比较, 联合激素组 IVIG 无反应者发生率明显降低 。 中文摘要 不同方案静脉注射丙种球蛋白治疗川崎病疗效的 Meta 分析 IV 关键词: 川崎病;糖皮质激素; 静脉注射 丙种球蛋白; Meta 分析 作 者: 沈 勤 指导老师: 吕海涛不同方案静脉注射 丙种球蛋白治疗川崎病疗效的 Meta 分析 英文摘要 V Treatment of Kawasaki disease by different therapies of intravenous immunoglobulin: a Mata analysis of therapeutic effects Abstract Part I: A Meta-analysis on efficacy of different doses and usage of intravenous immunoglobulin treatment in Kawasaki disease Objective To assess the efficacy of different doses and usage of intravenous immunoglobulin in treatment of Kawasaki disease (KD). Methods We searched literature in the electronic databases including Medline, Pubmed, Wanfang, China national knowledge infrastructure, VIP and Cochrane Library from March 1993 to March 2013. Randomized clinical trials (RCT) on the early treatment of KD with intravenous immunoglobulin were included and assessed for clinical efficacy, Statistical analysis was performed by using State 11.0 software. Datas were combined for meta analysis using odds ratios (OR) for dichotomous data or weighted mean difference (WMD) for continuous data. Random effects statistical model or fixed effects model was used Results Forty studies involved 7932 cases were included.They were retrospective studies except an article for prospective study 1) The meta analysis of these studies revealed the duration of fever was shorter among patients who received IVIG 2g/(kg.d) in a single dose for one day compared with 1g/(kg.d) for continuous two days( WMD=-0.54, 95%CI: -0.65 -0.44) . However, there was no significant reduction in the incidence of coronary artery lesions (CALs) in the acute and subacute KD, (OR=0.71, 1.07; 95%CI: 0.46 1.08,0.78 1.46). 2) The meta analysis showed a significant reduction in duration of fever and WBC, ESR, CRP decreased more rapidly among patients who received IVIG 2g/kg in single dose for one day compared with 1g/(kg.d) for one day. However, there was no significant difference in the incidence of CALs( P=0.996, OR=1.12, 95%CI: 0.41-3.04) and adverse 英文摘要 不同方案静脉注射丙种球蛋白治疗川崎病疗效的 Meta 分析 VI reactions of IVIG(P=0.997, OR=1.22, 95%CI: 0.81-1.83). 3) The meta analysis showed a significant reduction in the incidence of coronary artery lesions( OR=0.33, 95%CI: 0.27 0.41) , as well as the reduction in duration of fever ( WMD=-1.38,95%CI: -1.45 -1.32) and WBC, ESR, CRP decreased more rapidly among patients who received IVIG 2g/kg in single dose for one day compared with 400mg/(kg.d) for four or five days. 4) The meta analysis of 1g/kg in a single dose versus 400mg/kg for four or five days showed significant reduction in the incidence of CALs( OR=0.39,95%CI: 0.25-0.60) , as well as the decrease of WBC, ESR, CRP and the duration of fever( WMD=-0.95,95%CI:-1.01 -0.89) .The comparison showed no significant difference of adverse reactions of IVIG 5) The meta analysis of 1g/kg for two days versus 400mg/kg for four or five days showed significant reduction in the incidence of CALs(OR=0.60, 95%CI:0.44-0.81), as well as the reduction in duration of fever(WMD=-1.25,95%CI: -1.34 -1.16) Conclusion 1) There were no significant difference in CALs occurence among the primary intravenous immunoglobulin treatments with 1 g/kg for 2 days, 1 g/kg and 2 g /kg in a single use in Kawasaki disease. 2) The intravenous immunoglobulin treatment at the dose of 2 g / kg for single use significantly reduced the fever duration, and decreased the inflammatory indicators, such as ESR, CRP, WBC. 3) The intravenous immunoglobulin treatments with 400mg/kg for 4-5 days had a highest incidence of coronary artery lesions. Key words Kawasaki disease ; intravenous immunoglobulin ; Meta analysis 不同方案静脉注射 丙种球蛋白治疗川崎病疗效的 Meta 分析 英文摘要 VII Part II A meta-analysis on the efficacy of intravenous immunoglobulin combinded with corticosteroid for initial treatment in Kawasaki disease Objective To investigate the efficacy of intravenous immunoglobulin combinded with corticosteroid in Kawasaki Disease compared with intravenous immunoglobulin singal therapy. Methods All studies were obtained by a systematic search in PUBMED, MEDLINE, Cochrane Library, EMBASE, WANFANG, CNKI and VIP database form March 1993 to March 2013. A set of inclusion and exclusion criteria selected the studies for analysis. Datas were combined for meta analysis using the pooled relative risk (RR) for CALs, retreatments with IVIG and adverse events and the weighted mean difference( WMD) for the antifebrile time. Studies that satisfied the test for homogeneity were subjected to further analysis and were investigated quality assessment. Hypothese testing was conducted to determine the statistical significance of the calculated difference in this compared treatment group. Stata 11.0 software was used to perform the statistical analysis. Results 8 studies involved 1727 cases were included (4 randomized controlled trials and 4 comparative studies). 1)The incidence of CALs was not different between IVIG in addition to corticosteroid and IVIG groups with 1 month or 1 month post-treatment (P=0.008、 0.782, OR=0.75、0.65, 95%CI:0.51-1.09、 0.35-1.19). 2) The duration of fever was shorter in the IVIG combined with corticosteroid group than in the group of IVIG alone (OR=-1.07, 95%CI: -1.29-0.85). 3) Meta analysis showed a significant reduction in the rates of re

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