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无创正压通气预防肺癌患者肺切除术后并发症

Non-invasive positive pressure ventilation for prevention of complications after pulmonary resection in lung cancer patients.

作者信息

Torres Maria Fs, Porfírio Gustavo Jm, Carvalho Alan Pv, Riera Rachel

机构信息

Brazilian Cochrane Centre, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, SP, Brazil, 04038-000.

出版信息

Cochrane Database Syst Rev. 2019 Mar 6;3(3):CD010355. doi: 10.1002/14651858.CD010355.pub3.

Abstract

BACKGROUND

Pulmonary complications are often seen during the postoperative period following lung resection for patients with lung cancer. Some situations such as intubation, a long stay in the intensive care unit, the high cost of antibiotics and mortality may be avoided with the prevention of postoperative pulmonary complications. Non-invasive positive pressure ventilation (NIPPV) is widely used in hospitals, and is thought to reduce the number of pulmonary complications and mortality after this type of surgery. Therefore, a systematic review is needed to critically assess the benefits and harms of NIPPV for patients undergoing lung resection. This is an update of a Cochrane review first published in 2015.

OBJECTIVES

To assess the effectiveness and safety of NIPPV for preventing complications in patients following pulmonary resection for lung cancer.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and PEDro until 21 December 2018, to identify potentially eligible trials. We did not use any date or language restrictions in the electronic searches. We searched the reference lists of relevant papers and contacted experts in the field for information about additional published and unpublished studies. We also searched the Register of Controlled Trials (www.controlled-trials.com) and ClinicalTrials.gov (clinicaltrials.gov) to identify ongoing studies.

SELECTION CRITERIA

We considered randomised or quasi-randomised clinical trials that compared NIPPV in the immediate postoperative period after pulmonary resection with no intervention or conventional respiratory therapy.

DATA COLLECTION AND ANALYSIS

Two authors collected data and assessed trial risk of bias. Where possible, we pooled data from the individual studies using a fixed-effect model (quantitative synthesis), but where this was not possible we tabulated or presented the data in the main text (qualitative synthesis). Where substantial heterogeneity existed, we applied a random-effects model.

MAIN RESULTS

Of the 190 references retrieved from the searches, 7 randomised clinical trials (RCTs) (1 identified with the new search) and 1 quasi-randomised trial fulfilled the eligibility criteria for this review, including a total of 486 patients. Five studies described quantitative measures of pulmonary complications, with pooled data showing no difference between NIPPV compared with no intervention (RR 1.03; 95% CI 0.72 to 1.47). Three studies reported intubation rates and there was no significant difference between the intervention and control groups (RR 0.55; 95% CI 0.25 to 1.20). Five studies reported measures of mortality on completion of the intervention period. There was no statistical difference between the groups for this outcome (RR 0.60; 95% CI 0.24 to 1.53). Similar results were observed in the subgroup analysis considering ventilatory mode (bi-level versus continuous positive airway pressure (CPAP). No study evaluated the postoperative use of antibiotics. Two studies reported the length of intensive care unit stay and there was no significant difference between the intervention and control groups (MD -0.75; 95% CI -3.93 to 2.43). Four studies reported the length of hospital stay and there was no significant difference between the intervention and control groups (MD -0.12; 95% CI -6.15 to 5.90). None of the studies described any complications related to NIPPV. Of the seven included studies, four studies were considered as 'low risk of bias' in all domains, two studies were considered 'high risk of bias' for the allocation concealment domain, and one of these was also considered 'high risk of bias' for random sequence generation. One other study was considered 'high risk of bias' for including participants with more severe disease. The new study identified could not be included in the meta-analysis as its intervention differed from the other studies (use of pre and postoperative NIPPV in the same population).

AUTHORS' CONCLUSIONS: This review demonstrated that there was no additional benefit of using NIPPV in the postoperative period after pulmonary resection for all outcomes analysed (pulmonary complications, rate of intubation, mortality, postoperative consumption of antibiotics, length of intensive care unit stay, length of hospital stay and adverse effects related to NIPPV). However, the quality of evidence is 'very low', 'low' and 'moderate' since there were few studies, with small sample size and low frequency of outcomes. New well-designed and well-conducted randomised trials are needed to answer the questions of this review with greater certainty.

摘要

背景

肺癌患者肺切除术后常出现肺部并发症。预防术后肺部并发症可避免一些情况,如插管、在重症监护病房长时间停留、抗生素费用高昂以及死亡率等问题。无创正压通气(NIPPV)在医院中广泛使用,被认为可减少此类手术后的肺部并发症数量和死亡率。因此,需要进行系统评价以严格评估NIPPV对接受肺切除手术患者的益处和危害。这是对2015年首次发表的Cochrane系统评价的更新。

目的

评估NIPPV预防肺癌肺切除术后患者并发症的有效性和安全性。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、Embase、LILACS和PEDro,截至2018年12月21日,以识别潜在符合条件的试验。我们在电子检索中未使用任何日期或语言限制。我们检索了相关论文的参考文献列表,并联系该领域的专家以获取有关其他已发表和未发表研究的信息。我们还检索了对照试验注册库(www.controlled-trials.com)和ClinicalTrials.gov(clinicaltrials.gov)以识别正在进行的研究。

选择标准

我们纳入了比较肺切除术后即刻使用NIPPV与不干预或传统呼吸治疗的随机或半随机临床试验。

数据收集与分析

两位作者收集数据并评估试验的偏倚风险。在可能的情况下,我们使用固定效应模型(定量合成)汇总各个研究的数据,但在无法做到这一点时,我们将数据列表或在正文(定性合成)中呈现。当存在实质性异质性时,我们应用随机效应模型。

主要结果

在检索到的190篇参考文献中,7项随机临床试验(RCT)(1项通过新检索识别)和1项半随机试验符合本评价的纳入标准,共包括486例患者。五项研究描述了肺部并发症的定量测量,汇总数据显示NIPPV与不干预相比无差异(RR 1.03;95%CI 0.72至1.47)。三项研究报告了插管率,干预组和对照组之间无显著差异(RR 0.55;95%CI 0.25至1.20)。五项研究报告了干预期结束时的死亡率测量。该结局在两组之间无统计学差异(RR 0.60;95%CI 0.24至1.53)。在考虑通气模式(双水平与持续气道正压通气(CPAP))的亚组分析中观察到类似结果。没有研究评估术后抗生素的使用情况。两项研究报告了重症监护病房停留时间,干预组和对照组之间无显著差异(MD -0.75;95%CI -3.93至2.43)。四项研究报告了住院时间,干预组和对照组之间无显著差异(MD -0.12;95%CI -6.15至5.90)。没有研究描述与NIPPV相关的任何并发症。在纳入的七项研究中,四项研究在所有领域被认为“偏倚风险低”,两项研究在分配隐藏领域被认为“偏倚风险高”,其中一项在随机序列生成方面也被认为“偏倚风险高”。另一项研究因纳入病情更严重的参与者而被认为“偏倚风险高”。新识别的研究不能纳入荟萃分析,因为其干预与其他研究不同(在同一人群中术前和术后使用NIPPV)。

作者结论

本评价表明,对于所分析的所有结局(肺部并发症、插管率、死亡率、术后抗生素使用、重症监护病房停留时间、住院时间以及与NIPPV相关的不良反应),肺切除术后使用NIPPV没有额外益处。然而,证据质量为“非常低”、“低”和“中等”,因为研究较少,样本量小且结局发生率低。需要新的设计良好且实施得当的随机试验,以更确定地回答本评价中的问题。

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