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Study objective: To identify the efficacy and safety of haloperidol prophylaxis in adult patients with a high risk for delirium.

探索氟哌啶醇對預(yù)防具有高術(shù)后譫妄風(fēng)險(xiǎn)的成人的有效性和安全性

Design: A meta-analysis with trial sequential analysis of randomized controlled trials.

隨機(jī)對照序貫實(shí)驗(yàn)的meta分析

Intervention: A comprehensive search was performed in PubMed, the ISI Web of Knowledge, the Cochrane Library, and Embase databases from inception through to March 2019.Citation screening, data abstraction and quality assessment were performed in duplicate. Meta-analysis with trial sequential analysis (TSA) were used to assess the primary and secondary outcomes. In addition, we used the Grading of Recommendations Assessment Development and Evaluation (GRADE) to evaluate the certainty of the body of evidence.

在PubMed,ISI,Cochrane圖書館,Embase數(shù)據(jù)庫進(jìn)行了一個(gè)從研究開始至2019年3月的全面搜索。重復(fù)進(jìn)行引文篩選，數(shù)據(jù)提取和質(zhì)量評價(jià)。采用試驗(yàn)序貫分析(TSA)的meta分析來評價(jià)主要和次要結(jié)果。此外，我們還使用GRADE系統(tǒng)來評價(jià)證據(jù)主體。

Main results: We appraised 8 RCTs involving 3034 patients that that were in compliance with inclusion and exclusion criterion. Pooled analyses indicated patients receiving haloperidol prophylaxis and placebo or normal saline did not significantly differ in incidence of delirium (relative risk [RR] = 0.90, 95% confidence interval [CI] = 0.70 to 1.15), with TSA inconclusive. Notably, compared with the control group, use of haloperidol significantly decreased the duration of delirium (Mean difference [MD] ?0.94; 95% CI ?1.82 to ?0.06 days),with a marked heterogeneity. Additionally, haloperidol prophylaxis does not significantly affect duration of mechanical ventilation, length of intensive care unit (ICU) stay, length of hospital stay and mortality. In terms of safety profiles, haloperidol was not associated with increased risk for QTc prolongation, extrapyramidal symptoms, or adverse events. GRADE indicated the level of evidence was very low for a benefit from haloperidol prophylaxis.

我們評估了8項(xiàng)隨機(jī)對照試驗(yàn)，納入3034例符合標(biāo)準(zhǔn)的患者。綜合分析表明三組分別接受氟哌啶醇預(yù)防，安慰劑，生理鹽水的患者術(shù)后譫妄發(fā)生率沒有顯著差異([RR]：0.90；95%[CI]：0.70-1.15)，序貫實(shí)驗(yàn)分析不確定。值得注意的是，與對照組相比，使用氟哌啶醇顯著降低術(shù)后譫妄的持續(xù)時(shí)間（[MD]：?0.94；95%[CI]:?1.82-?0.06),但具有明顯的異質(zhì)性。

Conclusions: The results of our meta-analysis suggested the use of prophylactic haloperidol compared with placebo had no beneficial impacts on incidence of delirium, duration of mechanical ventilation, length of intensive care unit (ICU) stay, length of hospital stay and mortality in adult patients. It appeared to have a positive effect on duration of delirium, while with a significant heterogeneity. These findings do not support the routine usage of haloperidol for delirium prevention.

meta分析結(jié)果提示，預(yù)防性使用氟哌啶醇對成年患者的術(shù)后譫妄發(fā)生率、機(jī)械通氣時(shí)間、ICU住院時(shí)間、住院時(shí)間和死亡率均無積極影響。積極的一面是對術(shù)后譫妄持續(xù)時(shí)間的影響，同時(shí)具有顯著的異質(zhì)性。以上結(jié)果并不支持常規(guī)使用氟哌啶醇預(yù)防術(shù)后譫妄。

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