【罂粟摘要】瑞玛唑仑在高危患者结肠镜检查中的安全性和有效性：一项随机试验
瑞玛唑仑在高危患者结肠镜检查中的安全性和有效性：一项随机试验
翻译：吴学艳 编辑：佟睿 审校：曹莹
贵州医科大学高鸿教授课题组
结肠镜操作时的镇静增加了ASA III/IV患者的风险；瑞玛唑仑(一种超短效苯二氮卓类药物)在门诊结肠镜检查时镇静作用的有效性和安全性已被证实。
采用双盲、随机、多中心、平行对照试验，对79例ASA III~IV级行结肠镜检查患者在操作时进行镇静，比较瑞玛唑仑与安慰剂组和另一开放标记的咪达唑仑组镇静效果。此项试验是瑞玛唑仑在操作时镇静方案中的第III期临床试验，主要指标是观察瑞玛唑仑的安全性。
在美国3家医院随机选择79名接受结肠镜检查的患者中，有77人接受镇静下行结肠镜检查(分别为：31人接受瑞玛唑仑治疗，16人接受安慰剂治疗，30人接受咪达唑仑治疗)。 治疗出现不良事件（TEAEs）的发生率和频率在三个治疗组中具有相似性，且与ASA分级无关；咪达唑仑组报告了一例患者因TEAE而终止试验和一例严重的TEAE患者。瑞玛唑仑组、安慰剂组和咪达唑仑组分别达到治疗有效性和安全性的87.1%、0%和13.3%(瑞玛唑仑组与安慰剂组及咪达唑仑组相比，p＜0.00001)。
瑞玛唑仑用于高危ASA分级患者行结肠镜检查的术中镇静是安全有效的，其安全性与低危ASA分级患者相当。
Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial
Abstract
Background: Procedural sedation of ASA III/IV patients has increased risk. Remimazolam (an ultra-short-acting benzodiazepine) has proven safe and efficient for outpatient colonoscopy sedation.
Methods: A double-blind, randomized, multi-center, parallel group trial was performed, comparing remimazolam to placebo with an additional open-label arm for midazolam in procedural sedation of 79 ASA III/IV patients undergoing colonoscopy. This was the third of 3 Phase III trials for remimazolam in the procedural sedation program. The primary end point was the safety of remimazolam.
Results: Of 79 patients randomized at 3 US sites, 77 underwent sedation and colonoscopy (31 received remimazolam, 16 placebo and 30 midazolam). Incidence and frequency of treatment emergent adverse events (TEAEs) were comparable in all three treatment arms, and independent of ASA status. One TEAE leading to discontinuation and one serious TEAE were reported; both in the open label midazolam arm. The efficacy endpoint was achieved for remimazolam, placebo, and midazolam in 87.1%, 0%, and 13.3% of patients (p<0.00001 for remimazolam versus placebo and versus midazolam, respectively).
Conclusions: Remimazolam is safe and efficient in procedural sedation of high risk ASA patients undergoing colonoscopy, showing a safety profile comparable to that in low risk ASA. In peripartum cardiomyopathy (PPCM), electrocardiography (ECG) and its relationship to echocardiography have not yet been investigated in large multi-centre and multi-ethnic studies. We aimed to identify ECG abnormalities associated with PPCM, including regional and ethnic differences, and their correlation with echocardiographic features.