Objective To investigate the clinical efficacy of methylene blue in the treatment of refractory hypotension caused by vascular paralysis during the course of vasodilatory shock. Methods The related articles were searched by retrieving the terms using methylene blue, vascular paralysis, hemodynamics, hypotension, vasodilatory shock in CNKI, China Biomedical Literature database, Wanfang database, PubMed, Springer Link, and BIOSIS Previews database. The retrieval time was from January 1994 to June 2017. The randomized clinical trials (RCTs) which using methylene blue as the experimental group, normal saline or catecholamine as the control in the treatment of refractory hypotension caused by vascular paralysis during the course of vasodilatory shock were collected. The primary end points were mean arterial pressure (MAP) immediately or 1 hour after the methylene blue administration, and the mortality at the longest follow-up available; the secondary end point was serum lactic acid (Lac) 1 hour after the methylene blue administration. Literature screening, data extraction and quality evaluation were carried out by two researchers. Meta analysis was performed using RevMan 5.3 software. The sensitivity analysis was performed in two trials with low risk of bias. The funnel plot for MAP was performed in five relative trials to analyze the research and publication bias. Results Totally 269 relative articles were collected, according to the inclusion and exclusion criteria, finally 6 RCTs with 214 patients were enrolled, 108 in methylene blue group, and 106 in control group. Four of the studies were considered to have mild to moderate risk of bias, two studies of high risk of bias. The Meta-analysis demonstrated that compared with the control group, methylene blue could significantly improve MAP [mean difference (MD) = 4.87, 95% confidence interval (95%CI) = 2.61 to 7.13, P < 0.000 1], reduce the serum Lac levels (MD = -1.06, 95%CI = -1.98 to -0.14, P = 0.02), and the mortality was decreased without statistical difference [odds ratio (OR) = 0.58, 95%CI = 0.25 to 1.31, P = 0.19]. Sensitivity analysis was performed in two trials with low risk of bias, which demonstrated methylene blue could exactly increase MAP (MD = 8.93, 95%CI = 1.55 to 16.32, P = 0.02). Funnel plot for MAP was performed in five relative trials which found no obvious publication bias. Conclusions Methylene blue could significantly increase MAP in the patients with refractory hypotension caused by vascular paralysis during the course of vasodilatory shock, decrease the Lac levels, and does not increase the risk of death. Therefore, methylene blue should be a potential and safe vasoconstrictor.%目的 探讨亚甲蓝对血管扩张性休克时血管麻痹所致顽固性低血压的临床疗效.方法 以亚甲蓝、美蓝、血管麻痹、血流动力学、低血压、扩张性休克等为检索词,检索中国知网、中国生物医学文献数据库、万方医学数据库;以methylene blue、vasoplegic、hemodynamics、hypotension、vasodilatory shock等为检索词,检索美国国立医学图书馆PubMed数据库、德国施普林格全文数据库(Springer Link)、美国生物科学信息预测数据库(BIOSIS Previews).检索时限为1994年1月至2017年6月.检索以亚甲蓝为试验组、以生理盐水或常规儿茶酚胺类血管收缩剂为对照组治疗血管扩张性休克时血管麻痹致顽固性低血压的随机对照临床试验(RCT);主要观察指标为亚甲蓝给药1 h后或完成给药即刻的平均动脉压(MAP),以及随访期间病死率;次要观察指标为亚甲蓝给药1 h后的血清乳酸(Lac)水平.由2名研究者分别进行文献筛选、数据提取和质量评价.应用RevMan 5.3软件进行Meta分析;以质量等级较高的2项研究的MAP为指标进行敏感性分析;以5项测量了MAP的研究为对象绘制漏斗图,分析纳入研究发表偏倚.结果 共检索出相关文献269篇,根据纳入和排除标准,最终纳入6项RCT研究、共计214例患者,亚甲蓝组108例、对照组106例;其中4项研究被认为存在轻到中度偏倚风险,2项研究偏倚风险较高.Meta分析结果显示:与对照组相比,亚甲蓝能够显著提高患者MAP 〔均数差(MD)=4.87,95%可信区间(95%CI)=2.61~7.13,P<0.0001〕,降低血清Lac水平(MD=-1.06,95%CI=-1.98~-0.14,P=0.02),随访期间病死率有所降低,但差异无统计学意义〔优势比(OR)=0.58,95%CI=0.25~1.31,P=0.19〕.以质量等级较高的2项研究的MAP为指标进行敏感性分析,进一步证实亚甲蓝可明显提高MAP(MD=8.93,95%CI=1.55~16.32,P=0.02).以5项测量了MAP的研究为对象进行漏斗图检验,结果显示各研究未发现明显的发表偏倚.结论 亚甲蓝可明显升高血管扩张性休克时血管麻痹致顽固性低血压患者的MAP,降低血清Lac水平,且不增加死亡风险,是一种潜在的、安全的血管收缩剂.
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