Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
First Clinical Medical College of Beijing University of Chinese Medicine, Beijing, 100029, China.
Chin J Integr Med. 2019 Dec;25(12):926-935. doi: 10.1007/s11655-019-3037-3. Epub 2019 Aug 5.
To investigate the effectiveness and safety of Xingnaojing Injection (XNJ, ) compared with naloxone for the treatment of acute alcohol intoxication (AAI), and provide the latest evidence through evidence-based approach.
Seven electro-databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure Databases, Chinese Biomedical Literature Database, Chinese Science and Technology Periodical Database (VIP) and Wanfang Database were searched from the inception to January 2018. Randomized controlled trials (RCTs) comparing XNJ with naloxone for patients with AAI and reporting at least one of the below outcomes were included: patients' conscious recovery time, stay length in emergency department, disappearance time of the ataxia symptom, the severity of the symptoms, the blood alcohol content as well as the adverse events. Methodological quality of included trials was assessed using the risk of bias tool which recommended by the Cochrane Collaboration. Meta-analysis was conducted by Review Manager 5.3 software.
Totally 141 trials with 13,901 patients were included in this review, all of them were assessed as unclear or high risk of bias. Results showed that on the basis of routine therapy, standard dose XNJ (10-20 mL) may have similar results with naloxone on the recovery time of consciousness (MD 12 min, 95% CI 7.2-17.4 min) and disappearance time of symptoms (MD 6 min, 95% CI-13.8-25.8 min) for patients with AAI. Larger dose of XNJ Injection (21-40 mL) may speed up the time (almost 1 h earlier). Combination of XNJ and naloxone seemed superior to the naloxone alone for all the relevant outcomes. The average difference of time in consciousness recovery was 2 h and the number of AAI patients whose consciousness recovery within 1 h was above 50% the combination group than in the control group (RR 1.42, 95% CI 1.29 to 1.56). No severe adverse events or adverse reactions of XNJ were reported in the included trials.
Low quality of evidence showed XNJ may have equal effect as naloxone and may achieve better effect as add-on intervention with naloxone for patients with AAI. We failed to evaluate the safety of XNJ Injection due to the insufficient evidence in this review. Registration number. in PROSPERO (No. CRD42018087804).
通过循证方法，研究醒脑静注射液（XNJ）与纳洛酮治疗急性酒精中毒（AAI）的疗效和安全性，为临床提供最新证据。
检索 PubMed、EMBASE、Cochrane 中央对照试验注册库、中国知网数据库、中国生物医学文献数据库、中国科技期刊数据库（VIP）和万方数据库 7 个电子数据库，检索时限为建库至 2018 年 1 月。纳入比较醒脑静注射液与纳洛酮治疗 AAI 患者，且至少报告以下 1 个结局的随机对照试验（RCT）：患者意识恢复时间、急诊留观时间、共济失调症状消失时间、症状严重程度、血酒精含量和不良反应。采用 Cochrane 协作网推荐的偏倚风险评估工具对纳入研究的方法学质量进行评估。使用 Review Manager 5.3 软件进行荟萃分析。
本研究共纳入 141 项试验，共 13901 例患者，所有研究均被评为不确定偏倚或高偏倚风险。结果显示，在常规治疗基础上，标准剂量醒脑静注射液（10-20 ml）与纳洛酮治疗 AAI 患者的意识恢复时间（MD 12 min，95% CI 7.2-17.4 min）和症状消失时间（MD 6 min，95% CI-13.8-25.8 min）相似。较大剂量醒脑静注射液（21-40 ml）可能会加快这一时间（提前近 1 h）。醒脑静注射液联合纳洛酮似乎优于单独使用纳洛酮治疗所有相关结局。意识恢复时间的平均差异为 2 h，联合组在 1 h 内意识恢复的 AAI 患者比例高于对照组（RR 1.42，95% CI 1.29-1.56）。纳入研究未报告醒脑静注射液的严重不良事件或不良反应。
低质量证据表明，醒脑静注射液与纳洛酮疗效相当，与纳洛酮联合应用可能效果更好。由于本研究证据不足，未能评估醒脑静注射液的安全性。注册号：in PROSPERO（No. CRD42018087804）。
