From Oregon Health & Science University, Portland, Oregon, and San Francisco Department of Public Health, San Francisco, California.
Ann Intern Med. 2017 Dec 19;167(12):867-875. doi: 10.7326/M17-2224. Epub 2017 Nov 28.
Naloxone is effective for reversing opioid overdose, but optimal strategies for out-of-hospital use are uncertain.
To synthesize evidence on 1) the effects of naloxone route of administration and dosing for suspected opioid overdose in out-of-hospital settings on mortality, reversal of overdose, and harms, and 2) the need for transport to a health care facility after reversal of overdose with naloxone.
Ovid MEDLINE (1946 through September 2017), PsycINFO, Cochrane Central Register of Controlled Trials, CINAHL, U.S. Food and Drug Administration (FDA) materials, and reference lists.
English-language cohort studies and randomized trials that compared different doses of naloxone, administration routes, or transport versus nontransport after reversal of overdose with naloxone. Main outcomes were mortality, reversal of overdose, recurrence of overdose, and harms.
Dual extraction and quality assessment of individual studies; consensus assessment of overall strength of evidence (SOE).
Of 13 eligible studies, 3 randomized controlled trials and 4 cohort studies compared different administration routes. At the same dose (2 mg), 1 trial found similar efficacy between higher-concentration intranasal naloxone (2 mg/mL) and intramuscular naloxone, and 1 trial found that lower-concentration intranasal naloxone (2 mg/5 mL) was less effective than intramuscular naloxone but was associated with decreased risk for agitation (low SOE). Evidence was insufficient to evaluate other comparisons of route of administration. Six uncontrolled studies reported low rates of death and serious adverse events (0% to 1.25%) in nontransported patients after successful naloxone treatment.
There were few studies, all had methodological limitations, and none evaluated FDA-approved autoinjectors or highly concentrated intranasal formulations.
Higher-concentration intranasal naloxone (2 mg/mL) seems to have efficacy similar to that of intramuscular naloxone for reversal of opioid overdose, with no difference in adverse events. Nontransport after reversal of overdose with naloxone seems to be associated with a low rate of serious harms, but no study evaluated risks of transport versus nontransport.
Agency for Healthcare Research and Quality. (PROSPERO: CRD42016053891).
纳洛酮可有效逆转阿片类药物过量，但院外使用的最佳策略尚不确定。
综合评估院外疑似阿片类药物过量使用纳洛酮的给药途径和剂量对死亡率、药物过量逆转和危害的影响，以及使用纳洛酮逆转药物过量后是否需要转运至医疗机构。
Ovid MEDLINE（1946 年至 2017 年 9 月）、PsycINFO、Cochrane 对照试验中心注册库、CINAHL、美国食品和药物管理局（FDA）资料以及参考文献列表。
比较不同剂量纳洛酮、给药途径或逆转药物过量后转运与非转运的英语队列研究和随机试验。主要结局为死亡率、药物过量逆转、药物过量复发和危害。
对个体研究进行双重提取和质量评估；对总体证据强度（SOE）进行共识评估。
在 13 项符合条件的研究中，3 项随机对照试验和 4 项队列研究比较了不同的给药途径。在相同剂量（2mg）下，1 项试验发现高浓度鼻内纳洛酮（2mg/ml）与肌内纳洛酮疗效相似，1 项试验发现低浓度鼻内纳洛酮（2mg/5ml）的疗效不如肌内纳洛酮，但与激越风险降低相关（低 SOE）。证据不足以评估其他给药途径的比较。6 项非对照研究报告了在成功使用纳洛酮治疗后，非转运患者的死亡率和严重不良事件发生率（0%至 1.25%）较低。
研究数量较少，所有研究均存在方法学局限性，且均未评估 FDA 批准的自动注射器或高浓度鼻内制剂。
高浓度鼻内纳洛酮（2mg/ml）似乎与肌内纳洛酮逆转阿片类药物过量具有相似的疗效，且不良事件无差异。纳洛酮逆转药物过量后不转运似乎与严重危害发生率较低相关，但无研究评估转运与非转运的风险。
美国医疗保健研究与质量局。（PROSPERO：CRD42016053891）
