格隆溴铵预防新斯的明诱导心率减慢:多中心、随机、双盲双模拟、平行对照临床试验  

Prevention of glycopyrrolate against bradycardia induced by neostigmine:a multicenter,randomized,double-blind,double-dummy,parallel-controlled clinical trial

作　　者：樊玉花 丁正年[2] 于泳浩[3] 于浩 马虹[5] 马宇 仓静 王亚平[7] 王海莺[8] 王俊[5] 田鲲 冯娅妮[5] 刘克玄[10] 成浩[11] 严敏[8] 李敏 李偲[10] 陈郡郡 陈丽钗[8] 吴君蓓 肖艳英[7] 杨孟昌[12] 张媛媛[3] 房崇亮 姚尚龙[9] 俞红丽 夏芹 秦秀男 徐广民[12] 傅舒昆[13] 嵇富海[11] 蔡姝[11] 廖欣鑫[10] 魏新川[12] 魏国华[2] 魏欣 邓小明 Fan Yuhua;Ding Zhengnian;Yu Yonghao;Yu Hao;Ma Hong;Ma Yu;Cang Jing;Wang Yaping;Wang Haiying;Wang Jun;Tian Kun;Feng Yani;Liu Kexuan;Cheng Hao;Yan Min;Li Min;Li Cai;Chen Junjun;Chen Lichai;Wu Junbei;Xiao Yanying;Yang Mengchang;Zhang Yuanyuan;Fang Chongliang;Yao Shanglong;Yu Hongli;Xia Qin;Qin Xiunan;Xu Guangmin;Fu Shukun;Ji Fuhai;Cai Shu;Liao Xinxin;Wei Xinchuan;Wei Guohua;Wei Xin;Deng Xiaoming(Faculty of Anesthesiology,Changhai Hospital Affiliated to Naval Military Medical University,Shanghai 200433,China;Department of Anesthesiology,Jiangsu Province People's Hospital,Nanjing 210029,China;Department of Anesthesiology,Tianjin Medical University General Hospital,Tianjin 300052,China;Department of Biostatistics,School of Public Health Nanjing Medical University,Nanjing 211166,China;Department of Anesthesiology,the First Hospital of China Medical University,Shenyang 110001,China;Department of Anesthesiology,Zhongshan Hospital Affiliated to Fudan University,Shanghai 200032,China;Department of Anesthesiology,the Second Xiangya Hospital Affiliated to Central South University,Changsha 410011,China;Department of Anesthesiology,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 313000,China;Department of Anesthesiology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Department of Anesthesiology,Nanfang Hospital Affiliated to Southern Medical University,Guangzhou 510515,China;Department of Anesthesiology,the First Affiliated Hospital of Suzhou University,Suzhou 215006,China;Department of Anesthesiology,Sichuan Province People's Hospital,Chengdu 610072,China;Department of Anesthesiology,Shanghai Tenth People's Hospital,Shanghai 200072,China)

机构地区：[1]海军军医大学附属长海医院麻醉学部,上海200433 [2]江苏省人民医院麻醉科,南京210029 [3]天津医科大学总医院麻醉科,300052 [4]南京医科大学公共卫生学院生物统计学系,211166 [5]中国医科大学附属第一医院麻醉科,沈阳110001 [6]复旦大学附属中山医院麻醉科,上海200032 [7]中南大学湘雅二医院麻醉科,长沙410011 [8]浙江大学医学院附属第二医院麻醉科,杭州313000 [9]华中科技大学同济医学院附属协和医院麻醉科,武汉430022 [10]南方医科大学南方医院麻醉科,广州510515 [11]苏州大学附属第一医院麻醉科,215006 [12]四川省人民医院麻醉科,成都610072 [13]上海市第十人民医院麻醉科,200072

出　　处：《国际麻醉学与复苏杂志》2019年第12期1094-1098,共5页International Journal of Anesthesiology and Resuscitation

摘　　要：目的以阳性药物为对照,评价格隆溴铵预防新斯的明诱导心率减慢的有效性和安全性。方法择期行全身麻醉非心脏手术的患者,中心化随机分组方法分为试验组(123例)和对照组(124例)。手术结束时,试验组给予格隆溴铵0.008 mg/kg+新斯的明0.04 mg/kg,对照组给予阿托品0.016 mg/kg+新斯的明0.04 mg/kg,推注时间1 min,用于拮抗肌肉松弛(肌松)药残留作用。比较给药后15 min内心率与基线心率差值的时间曲线下面积(area under the time ceurve,AUC)、每分钟心率的实测值、每分钟心率与基线比较的变化值,给药后阿托品补救治疗使用率和剂量,术后24 h内不良事件。结果试验组给药后15 min内心率较基线心率变化值的AUC小于对照组,差异有统计学意义(P<0.05);各时间点心率的实测值变化幅度小于对照组;试验组心率维持在基线水平的时间长于对照组,试验组心率变化的速度小于对照组(P<0.05)。两组患者阿托品补救治疗使用率和剂量差异均无统计学意义(P>0.05)。两组患者的不良反应发生率差异无统计学意义(P>0.05)。结论格隆溴铵与阿托品均可安全地用于预防非去极化肌松药拮抗剂新斯的明诱导的心率减慢,格隆溴铵更有利于患者的心率维持稳定。Objective To compare the efficacy and safety of glycopyrrolate versus atropine against bradycardia induced by neostigmine.Methods Patients scheduled for elective non-cardiac surgery were central randomly assigned to experimental group(n=123)and control group(n=124).Patients in experimental group were administered with glycopyrrolate at a dose of 0.008 mg/kg and neo stigmine 0.04 mg/kg in 1 minute,whereas patients in control group received atropine at a dose of 0.016 mg/kg and neostigmine 0.04 mg/kg in 1 min to antagonize the remained neuromuscular block effect at the end of operation,respectively.Heart rate was recorded for 15 min after administration of the antagonized mixture,the area under the time curve(AUC)of the difference between heart rate and baseline heart rate,heart rate per minute and the difference between heart rate and baseline heart rate were compared.The dose of atropine for rescue therapy after administration was also recorded.Also,the adverse events within 24 h after operation were followed and compared.Results The AUC of the difference between heart rate and baseline heart rate was smaller in experimental group than the AUC in control group(P<0.05).The difference between heart rate and baseline heart rate was lower in experimental group than the difference in control group(P<0.05).The time of heart rate around to the baseline was longer in experimental group than the time in control group(P<0.05).There was no statistical significance on using rates of atropine in rescue therapy and adverse reactions between the two groups(P>0.05).Conclusions The effects of glycopyrrolate and atropine on preventing bradycardia when given in a mixture with neostigmine for the reversal of non-depolarizing neuromuscular block were compared.Glycopyrrolate has better effect than atropine for maintaining heart rate stability.

关 键 词：格隆溴铵 阿托品 新斯的明 心率减慢 

分 类 号：R614[医药卫生—麻醉学]