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潑尼松龍與促腎上腺皮質(zhì)激素治療嬰兒痙攣癥有效性及安全性的meta分析

發(fā)布時(shí)間:2018-04-28 18:53

  本文選題:嬰兒痙攣癥 + 潑尼松龍。 參考:《西南醫(yī)科大學(xué)》2017年碩士論文


【摘要】:目的:對(duì)潑尼松龍與促腎上腺皮質(zhì)激素(adrenocorticotropic hormone,ACTH)、小劑量潑尼松龍與大劑量潑尼松龍治療嬰兒痙攣癥(Infantile spasms,IS)的有效性及安全性進(jìn)行評(píng)價(jià),以探討潑尼松龍是否能夠替代ACTH治療IS以及潑尼松龍治療IS的最佳治療方案。方法:通過計(jì)算機(jī)檢索Cochrane Library、Medline、Embase英文數(shù)據(jù)庫以及中國知網(wǎng)、萬方中文數(shù)據(jù)庫,收集潑尼松龍與ACTH、小劑量潑尼松龍與大劑量潑尼松龍治療IS的隨機(jī)對(duì)照試驗(yàn)(Randomized controlled trial,RCT)。文獻(xiàn)檢索時(shí)間為建庫時(shí)間至2016年12月。不限制語言。根據(jù)研究目的,制定納入、排除標(biāo)準(zhǔn),嚴(yán)格按照標(biāo)準(zhǔn)進(jìn)行文獻(xiàn)的篩選。由兩名系統(tǒng)評(píng)價(jià)員按照標(biāo)準(zhǔn),獨(dú)立進(jìn)行數(shù)據(jù)收集,并對(duì)納入文獻(xiàn)進(jìn)行質(zhì)量評(píng)估及異質(zhì)性檢驗(yàn)。應(yīng)用Review Manager5.3軟件進(jìn)行統(tǒng)計(jì)分析。分類資料采用比值比(Odds Ratio,OR)及95%置信區(qū)間(Confidence interval,CI)進(jìn)行統(tǒng)計(jì)分析。異質(zhì)性檢驗(yàn)無統(tǒng)計(jì)學(xué)異質(zhì)性時(shí),采用固定效應(yīng)模型進(jìn)行meta分析;存在統(tǒng)計(jì)學(xué)異質(zhì)性時(shí),使用隨機(jī)效應(yīng)模型進(jìn)行meta分析,同時(shí)分析產(chǎn)生異質(zhì)性的原因,按來源不同進(jìn)行亞組分析。結(jié)果:共納入4個(gè)RCT研究,合計(jì)406例患兒。其中潑尼松龍與ACTH比較部分,共納入3個(gè)RCT研究,合計(jì)343例患兒。meta分析結(jié)果顯示:1.潑尼松龍與ACTH治療IS痙攣發(fā)作緩解率方面差異無統(tǒng)計(jì)學(xué)意義(OR:1.40,95%CI:[0.89,2.19],P=0.15);2.潑尼松龍與ACTH治療IS腦電圖(Electroencephalogram,EEG)高峰節(jié)律紊亂消失率方面差異無統(tǒng)計(jì)學(xué)意義(OR:0.83,95%CI:[0.17,4.07],P=0.82);3.不良反應(yīng)發(fā)生率:潑尼松龍與ACTH在不良反應(yīng)發(fā)生率方面差異無統(tǒng)計(jì)學(xué)意義(OR:1.22,95%CI:[0.97,1.54],P=0.09)。小劑量潑尼松龍與大劑量潑尼松龍比較部分,共納入1個(gè)RCT研究,合計(jì)63例患兒。meta分析結(jié)果顯示:1.小劑量潑尼松龍與大劑量潑尼松龍治療IS痙攣發(fā)作緩解率方面差異有統(tǒng)計(jì)學(xué)意義(OR:0.31,95%CI:[0.11,0.91],P=0.03);2.小劑量潑尼松龍與大劑量潑尼松龍治療IS EEG高峰節(jié)律紊亂消失率方面差異無統(tǒng)計(jì)學(xué)意義(OR:0.35,95%CI:[0.09,1.29],P=0.11);3.小劑量潑尼松龍與大劑量潑尼松龍治療IS痙攣無復(fù)發(fā)患兒所占比例差異有統(tǒng)計(jì)學(xué)意義(OR:0.19,95%CI:[0.05,0.76],P=0.02)。4.不良反應(yīng):大小劑量潑尼松龍不良反應(yīng)無明顯差異。結(jié)論:meta分析結(jié)果提示:1.潑尼松龍與ACTH在治療IS痙攣發(fā)作緩解率、EEG高峰節(jié)律紊亂消失率方面療效相近,不良反應(yīng)兩組發(fā)生率相當(dāng)。2.大劑量潑尼松龍?jiān)谥委烮S痙攣發(fā)作緩解率、痙攣無復(fù)發(fā)患兒所占比例方面療效優(yōu)于小劑量潑尼松龍,EEG高峰節(jié)律紊亂消失率方面小劑量潑尼松龍與大劑量潑尼松龍療效相近。不良反應(yīng)兩組發(fā)生率相當(dāng)。目前有限的證據(jù)支持:潑尼松龍能夠替代ACTH治療IS,且以大劑量潑尼松龍效果更佳,其最佳治療方案為起始劑量4mg/(kg.d)口服2周,并于接下來2周內(nèi)逐漸減停。納入的臨床研究較少,仍需要更多相關(guān)的大樣本臨床研究對(duì)結(jié)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.
【學(xué)位授予單位】:西南醫(yī)科大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類號(hào)】:R742.1

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