国产丙泊酚注射液用于临床麻醉的有效性和安全性探讨  

Efficacy and safety of domestic propofol in general anesthesia

作　　者：黄明[1,2] 陈艳红[1] 孙莹杰[1] 周锦[1] 张铁铮[1] 

机构地区：[1]沈阳军区总医院麻醉科,沈阳110016 [2]铁岭市妇婴医院麻醉科,辽宁铁岭112000

出　　处：《实用药物与临床》2013年第4期296-298,共3页Practical Pharmacy and Clinical Remedies

摘　　要：目的评价国产丙泊酚注射液用于临床麻醉的有效性和安全性。方法 80例全麻下行择期手术的患者随机双盲分为2组:试验组(国产丙泊酚组)和对照组(竟安组)各40例。靶控输注丙泊酚,设定血浆靶浓度3μg/mL,至受试者意识消失,然后静脉注射维库溴铵、芬太尼2 min后进行气管插管。靶控输注丙泊酚靶浓度3μg/mL、瑞芬太尼效应室靶浓度4～8 ng/mL和肌松药维持麻醉。麻醉诱导后每5分钟记录血压、心率、BIS。同时记录意识消失时间、意识消失后血浆丙泊酚靶浓度为3μg/mL时的BIS值、辅助用药的种类和剂量、麻醉维持期是否知晓及不良反应。结果试验期间两组最高心率、最低心率、最低血压的差异均无统计学意义(P>0.05)。两组各时点BIS值、意识消失后血浆3μg/mL时BIS均值比较差异无统计学意义(P>0.05)。两组意识消失时间比较差异无统计学意义(P>0.05)。两组术中知晓率均为0。试验组辅用阿托品或麻黄碱的人数少于对照组(P<0.05),但使用总剂量两组间差异无统计学意义(P>0.05)。注射痛、兴奋多语等不良反应发生率两组间比较差异无统计学意义(P>0.05)。结论国产丙泊酚注射液在麻醉深度、意识消失时间、麻醉知晓率及不良反应等方面与进口丙泊酚注射液(竟安)相当,用于临床麻醉安全有效。Objective To discuss the clinical efficacy and safety of domestic propofol in general anesthesia. Methods 80 patients with general anesthesia for elective surgical procedures were randomized into two groups：treatment group （domestic propofol group）and the control group （import propofol group）, which both conducted with TCI started by plasma concentration of propofol with 3 μg/mL. After unconsciousness, tracheal intubation was facilitated with intravenous vecuronium and fentanyl. Anesthesia was maintained by infusing of propofol with target concentration 3 μg/mL, remifentanil with target concentration 4 - 8 ng/mL and vecuronium. The heart rate, blood pressure, BIS were recorded every 5 min after induction of anesthesia. The time of consciousness disappearing, BIS value of plasma propofol target concentration 3μg/mL for unconsciousness,the kind and dosage of adjuvants, the rate of consciousness and adverse reaction were recorded. Results The highest heart rate, the lowest blood pressure and heart rate of the two groups has no significant difference（ P 〉 0.05 ）. Between the two groups ,there was no significant difference in BIS value and the time of consciousness disappearing（ P 〉 0. 05 ）. The rate of intraoperative awareness of the two groups are zero. The number of using ephedrine and atropine in treatment group was less than that in control group （ P 〈 0.05 ）, but the total dose has no significant difference between the two groups （ P 〉 0. 05 ）. There was no significant difference in the rate of adverse reactions （ P 〉 0. 05 ）. Conclusion Domestic propofol for clinical general anesthesia is safe and effecfive.

关 键 词：丙泊酚 麻醉 安全性 

分 类 号：R614[医药卫生—麻醉学]