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糖皮质激素用于婴幼儿急性病毒性细支气管炎

Glucocorticoids for acute viral bronchiolitis in infants and young children.

作者信息

Patel H, Platt R, Lozano J M, Wang E E L

机构信息

Pediatrics, McGill University Health Centre, Room A216, Montreal Children's Hospital, 2300 Tupper Street, Montreal, Quebec, Canada, H3H 1P3.

出版信息

Cochrane Database Syst Rev. 2004(3):CD004878. doi: 10.1002/14651858.CD004878.

Abstract

BACKGROUND

Systemic glucocorticoids have been widely prescribed for use in infants and young children with acute viral bronchiolitis but the actual benefit of this intervention requires clarification.

OBJECTIVES

To systematically review the evidence on the effectiveness of systemic glucocorticoids for the treatment of infants and young children with acute viral bronchiolitis.

SEARCH STRATEGY

Multiple strategies were incorporated to maximize identification of suitable studies. The following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2003); MEDLINE (January 1966 to September 2003); Current Contents (1998 to 2000); EMBASE (January 1990 to September 2003); and Sci Search. Handsearches through cited references and contacts with experts were also used.

SELECTION CRITERIA

Only randomised controlled trials (RCT) were eligible for inclusion. Studies were included if participants were diagnosed with acute viral bronchiolitis and treated with systemic (oral, intramuscular or intravenous) corticosteroids. Three reviewers independently selected potentially relevant articles. Four reviewers evaluated these studies, determined eligibility and assessed the methodological quality of each RCT.

DATA COLLECTION AND ANALYSIS

The primary outcome of interest was length of hospital stay (LOS). Secondary outcomes were: respiratory rate, haemoglobin oxygen saturation, and hospital admission and revisit rates. Data were extracted independently by the four reviewers and the results compiled and compared. Two reviewers reassessed studies to clarify points of discrepancy in the data extraction and database entry processes. Missing data were requested from the authors or calculated from other data presented in the study report.

MAIN RESULTS

There was complete agreement on the inclusion of 13 trials and the exclusion of five studies. Two main study recruitment groups were identified: a) infants and young children within the first 48 hours of hospitalisation (10 trials), and b) outpatient infants and young children who were randomised from the emergency department and who may nor may not have required hospital admission (three trials).A total of 1,198 children aged 0 to 30 months were treated with the equivalent of 0.5 to 10 mg/kg of systemic prednisone for two to seven days. Outcomes of interest were not measured in each RCT. In the pooled analysis of seven trials, there was a decrease in LOS in treated children of 0.38 days (95% confidence interval (CI) -0.81 to 0.05), indicating no significant difference between treatment groups. In the pooled analysis of eight trials, the day three clinical score measured: a standard mean difference (SMD) of -0.20 (95% CI -0.73 to 0.32), indicating no difference between treatment groups. Subgroup analyses for base LOS and clinical score outcomes were performed on infants who were a) less than 12 months of age, b) all respiratory syncytial virus (RSV) positive, c) treated with less than 6 mg/kg of prednisone equivalent throughout the illness and d) first-time wheezers. These were limited by the small number of studies in each subgroup. Hospital admission rates were examined in three trials and no difference was seen between treatment groups (odds ratio (OR) 1.05 (95% CI 0.23 to 4.87). Readmission rates were reported in six studies; with no significant differences between treatment groups. Hospital revisit rates were reported in three studies, with a significant difference between treatment groups reported in one study only. The respiratory rate and haemoglobin oxygen saturation were reported descriptively in six RCTs; no differences were found between groups. Co-interventions (oxygen, supportive fluids and bronchodilators) were used similarly between treatment groups in all RCTs.

REVIEWERS' CONCLUSIONS: No benefits were found in either LOS or clinical score in infants and young children treated with systemic glucocorticoids as compared to placebo. There were no differences in these outcomes between treatment groups; either in the pooled groups; either in the pooled analysis or in any of the sub analyses. Among the three studies evaluating hospital admission rates following the initial hospital visit there was no difference between treatment groups. There were no differences found in respiratory rate, haemoglobin oxygen saturation, hospital revisit or readmission rates. Subgroup analyses were significantly limited by the low number of studies in each comparison. Marked study heterogeneity and occasionally conflicting direction of benefit between trials suggests that these results should be interpreted with caution. Specific data on the harm of corticosteroid therapy in this patient population are lacking. Available evidence suggests that corticosteroid therapy is not of benefit in this patient group.

摘要

背景

全身用糖皮质激素已被广泛用于婴幼儿急性病毒性细支气管炎的治疗,但这种干预措施的实际益处尚需明确。

目的

系统评价全身用糖皮质激素治疗婴幼儿急性病毒性细支气管炎有效性的证据。

检索策略

采用多种检索策略以尽可能全面地识别合适的研究。检索了以下数据库:Cochrane系统评价数据库(CENTRAL)(2003年第3期Cochrane图书馆);医学索引数据库(MEDLINE)(1966年1月至2003年9月);现刊目次数据库(1998年至2000年);荷兰医学文摘数据库(EMBASE)(1990年1月至2003年9月);以及科学引文索引数据库(Sci Search)。还通过查阅参考文献和与专家联系进行手工检索。

入选标准

仅纳入随机对照试验(RCT)。如果研究对象被诊断为急性病毒性细支气管炎并接受全身(口服、肌内或静脉)糖皮质激素治疗,则纳入该研究。三名评价员独立筛选可能相关的文章。四名评价员评估这些研究,确定其是否符合纳入标准并评估每个RCT的方法学质量。

数据收集与分析

主要关注的结局是住院时间(LOS)。次要结局包括:呼吸频率、血红蛋白氧饱和度、住院率和复诊率。数据由四名评价员独立提取,结果汇总并进行比较。两名评价员重新评估研究,以澄清数据提取和数据库录入过程中的差异点。向作者索取缺失的数据,或根据研究报告中提供的其他数据进行计算。

主要结果

对于纳入13项试验和排除5项研究完全达成一致。确定了两个主要的研究招募组:a)住院48小时内的婴幼儿(10项试验),b)从急诊科随机分组的门诊婴幼儿,这些婴幼儿可能需要也可能不需要住院(3项试验)。共有1198名0至30个月的儿童接受了相当于0.5至10mg/kg全身泼尼松的治疗,疗程为2至7天。并非每个RCT都测量了关注的结局。在7项试验的汇总分析中,治疗组儿童的住院时间减少了0.38天(95%置信区间(CI)-0.81至0.05),表明治疗组之间无显著差异。在8项试验的汇总分析中,第三天的临床评分测量结果为:标准均数差(SMD)为-0.20(95%CI -0.73至0.32),表明治疗组之间无差异。对以下婴儿进行了住院时间基线和临床评分结局的亚组分析:a)年龄小于12个月,b)呼吸道合胞病毒(RSV)均为阳性,c)整个病程中接受泼尼松等效剂量小于6mg/kg治疗,d)首次喘息患儿。这些亚组分析因每个亚组中的研究数量较少而受到限制。在3项试验中检查了住院率,治疗组之间未见差异(比值比(OR)1.05(95%CI 0.23至4.87))。6项研究报告了再入院率;治疗组之间无显著差异。3项研究报告了复诊率,仅1项研究报告治疗组之间存在显著差异。6项RCT以描述性方式报告了呼吸频率和血红蛋白氧饱和度;各治疗组之间未发现差异。在所有RCT中,治疗组之间对联合干预措施(氧气、支持性液体和支气管扩张剂)的使用情况相似。

评价员结论

与安慰剂相比,全身用糖皮质激素治疗的婴幼儿在住院时间或临床评分方面均未发现益处。治疗组之间在这些结局方面无差异;无论是在汇总组中,还是在汇总分析或任何亚组分析中。在评估首次住院后住院率的3项研究中,治疗组之间无差异。在呼吸频率、血红蛋白氧饱和度、复诊率或再入院率方面未发现差异。亚组分析因每个比较中的研究数量较少而受到显著限制。显著的研究异质性以及试验之间偶尔相互矛盾的益处方向表明,这些结果应谨慎解释。缺乏关于该患者群体中糖皮质激素治疗危害的具体数据。现有证据表明,糖皮质激素治疗对该患者群体无益。

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