盐酸阿芬太尼注射液在全身麻醉中有效性和安全性研究:一项多中心、双盲、对照研究  

Efficacy and safety of alfentanil hydrochloride injection in general anesthesia:a multicenter,double-blind,controlled study

作　　者：陈明华[1] 薛富善 冯艺[3] 罗爱林[4] 郭曲练[5] 王亚平[6] 艾登斌[7] 刘功俭 段开明[1] 欧阳文[1] 汪赛赢[1] CHEN Ming-hua;XUE Fu-shan;FENG Yi;LUO Ai-lin;GUO Qu-lian;WANG Ya-ping;AI Deng-bin;LIU Gong-jian;Duan Kai-ming;OUYANG Wen;WANG Sai-ying(Dept of Anesthesiology,The Third Xiangya Hospital,Central South University,Changsha 410013;Dept of Anesthesiology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050;Dept of Anesthesiology,Peking University People’s Hospital,Beijing 100044;Dept of Anesthesiology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030;Department of Anesthesiology,Xiangya Hospital,Central South University,Changsha 410008;Dept of Anesthesiology,The Second Xiangya Hospital,Central South University,Changsha 410011;Dept of Anesthesiology,Qingdao Municipal Hospital,Qingdao,Shandong 266011;Dept of Anesthesiology,Affiliated Hospital of Xuzhou Medical University,Xuzhou 266001)

机构地区：[1]中南大学湘雅三医院麻醉科,湖南长沙410013 [2]首都医科大学北京友谊医院麻醉科,北京100050 [3]北京大学人民医院麻醉科,北京100044 [4]华中科技大学同济医学院附属同济医院麻醉科,湖北武汉430030 [5]中南大学湘雅医院麻醉科,湖南长沙410008 [6]中南大学湘雅二医院麻醉科,湖南长沙410011 [7]青岛市市立医院麻醉科,山东青岛266011 [8]徐州医科大学附属医院麻醉科,江苏徐州266011

出　　处：《中国药理学通报》2022年第10期1504-1510,共7页Chinese Pharmacological Bulletin

基　　金：湖南省自然科学基金面上项目(No 2021JJ31022)。

摘　　要：目的探讨阿芬太尼应用于全身麻醉中的有效性和安全性。方法本研究采用多中心的随机双盲对照研究,共筛选受试者352名,分层随机分配至芬太尼组(A组,n=176)和阿芬太尼组(B组,n=176)。麻醉诱导:静脉给予咪达唑仑0.03 mg·kg^(-1)+芬太尼25μg·kg^(-1)(A组)或阿芬太尼4μg·kg^(-1)(B组)+丙泊酚2 mg·kg^(-1)+罗库溴铵0.8 mg·kg^(-1)。术中麻醉维持以七氟烷+芬太尼(A组)或阿芬太尼(B组)+罗库溴铵。比较两组患者麻醉诱导和维持期间生命体征的变化,苏醒时间和拔管时间,以及麻醉相关并发症和相关补救药物的使用情况。结果在麻醉诱导和维持期,阿芬太尼与芬太尼可以同样有效地抑制气管插管以及手术刺激引起的机体应激反应。阿芬太尼对气管插管及手术刺激引起的应激反应抑制效应明显优于芬太尼(P<0.05)。但是两组患者在术中低血压、高血压发生率的比较及麻醉苏醒和拔管时间差异无显著性。结论阿芬太尼与芬太尼可以同样有效地抑制手术刺激引起的机体应激反应,但阿芬太尼在麻醉诱导和维持期血压、心率稳定性方面更具优势。Aim To investigate the effectiveness and safety of alfentanil in general anesthesia.Methods In this study,a multicenter randomized double-blind controlled study was conducted.A total of 352 subjects were selected and randomly assigned to fentanyl group(group A,n=176)and alfentanil group(group B,n=176).Anesthesia induction:intravenous midazolam 0.03 mg·kg^(-1)+fentanyl 25μg·kg^(-1)(group A)or alfentanil 4μg·kg^(-1)(group B)+propofol 2 mg·kg^(-1)+rocuronium 0.8 mg·kg^(-1).Sevoflurane+fentanyl(group A)or alfentanil(group B)+rocuronium were used for anesthesia.The vital signs of patients recovery time and extubation time,anesthesia-related complications and the use of related remedial drugs during anesthesia induction and maintenance were compared between the two groups.Results During the induction and maintenance period of anesthesia,alfentanil and fentanyl could equally effectively inhibit the stress response induced by endotracheal intubation and surgical stimulation.Alfentanil also showed more effective inhibition on stress response induced by endotracheal intubation and surgical stimulation than that of fentanyl(P<0.05).However,there was no significant difference in the incidence of intraoperative hypotension and hypertension and the time of anesthesia recovery and extubation between the two groups.Conclusions Both alfentanil and fentanyl can effectively inhibit the stress response induced by surgical stimulation and could be safely used in general anesthesia in surgery.Alfentanil has more advantages in maintaining the stability of blood pressure and heart rate during anesthesia induction and maintenance.

关 键 词：阿芬太尼 芬太尼 全身麻醉 气管插管 心率 血压 

分 类 号：R472.9[医药卫生—护理学] R544[医药卫生—临床医学] R614.2R969.4