泼尼松龙与促肾上腺皮质激素治疗婴儿痉挛症有效性及安全性的meta分析

发布时间：2018-04-28 18:53

本文选题：婴儿痉挛症 + 泼尼松龙　；参考：《西南医科大学》2017年硕士论文

【摘要】：目的:对泼尼松龙与促肾上腺皮质激素(adrenocorticotropic hormone,ACTH)、小剂量泼尼松龙与大剂量泼尼松龙治疗婴儿痉挛症(Infantile spasms,IS)的有效性及安全性进行评价,以探讨泼尼松龙是否能够替代ACTH治疗IS以及泼尼松龙治疗IS的最佳治疗方案。方法:通过计算机检索Cochrane Library、Medline、Embase英文数据库以及中国知网、万方中文数据库,收集泼尼松龙与ACTH、小剂量泼尼松龙与大剂量泼尼松龙治疗IS的随机对照试验(Randomized controlled trial,RCT)。文献检索时间为建库时间至2016年12月。不限制语言。根据研究目的,制定纳入、排除标准,严格按照标准进行文献的筛选。由两名系统评价员按照标准,独立进行数据收集,并对纳入文献进行质量评估及异质性检验。应用Review Manager5.3软件进行统计分析。分类资料采用比值比(Odds Ratio,OR)及95%置信区间(Confidence interval,CI)进行统计分析。异质性检验无统计学异质性时,采用固定效应模型进行meta分析;存在统计学异质性时,使用随机效应模型进行meta分析,同时分析产生异质性的原因,按来源不同进行亚组分析。结果:共纳入4个RCT研究,合计406例患儿。其中泼尼松龙与ACTH比较部分,共纳入3个RCT研究,合计343例患儿。meta分析结果显示:1.泼尼松龙与ACTH治疗IS痉挛发作缓解率方面差异无统计学意义(OR:1.40,95%CI:[0.89,2.19],P=0.15);2.泼尼松龙与ACTH治疗IS脑电图(Electroencephalogram,EEG)高峰节律紊乱消失率方面差异无统计学意义(OR:0.83,95%CI:[0.17,4.07],P=0.82);3.不良反应发生率:泼尼松龙与ACTH在不良反应发生率方面差异无统计学意义(OR:1.22,95%CI:[0.97,1.54],P=0.09)。小剂量泼尼松龙与大剂量泼尼松龙比较部分,共纳入1个RCT研究,合计63例患儿。meta分析结果显示:1.小剂量泼尼松龙与大剂量泼尼松龙治疗IS痉挛发作缓解率方面差异有统计学意义(OR:0.31,95%CI:[0.11,0.91],P=0.03);2.小剂量泼尼松龙与大剂量泼尼松龙治疗IS EEG高峰节律紊乱消失率方面差异无统计学意义(OR:0.35,95%CI:[0.09,1.29],P=0.11);3.小剂量泼尼松龙与大剂量泼尼松龙治疗IS痉挛无复发患儿所占比例差异有统计学意义(OR:0.19,95%CI:[0.05,0.76],P=0.02)。4.不良反应:大小剂量泼尼松龙不良反应无明显差异。结论:meta分析结果提示:1.泼尼松龙与ACTH在治疗IS痉挛发作缓解率、EEG高峰节律紊乱消失率方面疗效相近,不良反应两组发生率相当。2.大剂量泼尼松龙在治疗IS痉挛发作缓解率、痉挛无复发患儿所占比例方面疗效优于小剂量泼尼松龙,EEG高峰节律紊乱消失率方面小剂量泼尼松龙与大剂量泼尼松龙疗效相近。不良反应两组发生率相当。目前有限的证据支持:泼尼松龙能够替代ACTH治疗IS,且以大剂量泼尼松龙效果更佳,其最佳治疗方案为起始剂量4mg/(kg.d)口服2周,并于接下来2周内逐渐减停。纳入的临床研究较少,仍需要更多相关的大样本临床研究对结果予以支持。
[Abstract]:Objective: to evaluate the efficacy and safety of prednisolone and adrenocorticotropic hormone (ACTH), low dose prednisolone and high dose prednisolone in the treatment of infantile spasmsISs. To explore whether prednisolone can replace ACTH in the treatment of is and whether prednisolone is the best treatment for is. Methods: the Cochrane Library Medlinebase English database and the Chinese database of Wanfang were searched. The randomized controlled trials of prednisolone and ACTH, low-dose prednisolone and high-dose prednisolone in the treatment of is were conducted. The time of document retrieval was from the time of building the database to December 2016. There is no restriction on language. According to the purpose of the study, the inclusion and exclusion criteria were formulated and the literature was screened strictly according to the criteria. According to the standard, two system evaluators collect data independently, and evaluate the quality and heterogeneity of the literature. The statistical analysis was carried out with Review Manager5.3 software. The classification data were statistically analyzed by odds ratio odds ratio (OR) and 95% confidence interval (CI). When there was no statistical heterogeneity, fixed effect model was used for meta analysis. When there was statistical heterogeneity, random effect model was used for meta analysis. At the same time, the causes of heterogeneity were analyzed and subgroup analysis was carried out according to different sources. Results: a total of 4 RCT studies were conducted. Prednisolone was compared with ACTH in 3 RCT studies. The results of meta analysis showed that the ratio of prednisolone to ACTH was 1. 1. There was no significant difference between prednisolone and ACTH in the remission rate of is spasm. There was no significant difference in the disappearance rate of peak rhythm disorder between prednisolone and ACTH in the treatment of is electroencephalogramma. There was no significant difference between prednisolone and ACTH in the disappearance of peak rhythm disorder. The incidence of adverse reactions: there was no significant difference between prednisolone and ACTH in the incidence of adverse reactions. A comparison of prednisolone with high dose prednisolone was conducted in a RCT study. The results of meta analysis in 63 cases showed that the ratio of prednisolone to prednisolone was 1: 1. There was significant difference between low dose prednisolone and high dose prednisolone in the remission rate of is spasm. There was no significant difference between low-dose prednisolone and high-dose prednisolone in the disappearing rate of peak rhythm disorder of is EEG. There was no significant difference in the rate of disappearance of peak rhythm disorder between low dose prednisolone and large dose prednisolone. There was no significant difference in the rate of disappearance of peak rhythm disorder between low dose prednisolone and high dose prednisolone. There was significant difference between low dose prednisolone and high dose prednisolone in the treatment of children with no recurrence of is spasm. Adverse reactions: there was no significant difference in adverse reactions between large and small doses of prednisolone. Conclusion: the result of the analysis of: meta indicates that the result of the analysis is: 1. The efficacy of prednisolone was similar to that of ACTH in treating the remission rate of is spasm and the disappearance rate of peak rhythm disorder. The therapeutic effect of high-dose prednisolone on the remission rate of is spasm and the proportion of children with no recurrence of spasm was better than that of low-dose prednisolone EEG peak rhythm disorder. The efficacy of low-dose prednisolone was similar to that of high-dose prednisolone. The incidence of adverse reactions was similar between the two groups. There is limited evidence to support that prednisolone can replace ACTH, and that prednisolone is more effective than prednisolone in the treatment of ISS. The best treatment is 4 mg / kg 路d prednisolone orally for 2 weeks, and then gradually decreases and stops in the next 2 weeks. Fewer clinical studies were included, and more large clinical studies were needed to support the results.
【学位授予单位】：西南医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R742.1

【参考文献】