摘要
目的:观察丙泊酚中/长链脂肪乳注射液[利泊芬(Propofol-Lipuro)]在全凭静脉麻醉中的有效性和安全性。方法:采用前瞻性、区组随机、盲法、多中心、阳性药平行对照临床试验。选取207例择期手术患者,美国麻醉医师学会(American So-ciety of Anesthesiologists,ASA)分级Ι～Ⅱ级,年龄18～65岁。将207例患者随机分为两组,试验组(n=104):丙泊酚中/长链脂肪乳注射液组,对照组(n=103):丙泊酚长链脂肪乳注射液组。所有患者均采用丙泊酚/瑞芬太尼靶控输注全凭静脉麻醉方式行全身麻醉,丙泊酚3μg/mL,血浆靶控输注至患者睫毛反射消失后,开始瑞芬太尼靶控输注。观察患者麻醉期间的临床效应和不良事件发生情况。结果:试验组和对照组患者睫毛反射消失所需时间和丙泊酚药量比较,差异无统计学意义。两组患者全麻过程中的丙泊酚、瑞芬太尼总用量差异无统计学意义。试验组不良事件的发生率为30.77%,对照组不良事件的发生率为48.54%,试验组显著低于对照组(P<0.05)。在所有发生的不良事件中,注射部位疼痛发生率最高,其在试验组的发生率为25.00%,对照组的发生率为44.66%,试验组显著低于对照组,差异有统计学意义(P<0.05)。结论:丙泊酚中/长链脂肪乳注射液利泊芬与丙泊酚长链脂肪乳注射液得普利麻相比,用于全凭静脉麻醉的诱导与维持同样安全有效,但能显著降低患者注射痛的发生率。
Objective：To investigate the effect and safety of propofol in a medium- and long-chain triglyceride （MCT/LCT） emulsion （Propofol-Lipuro） in the course of total intravenous anesthesia （TIVA）. Methods：As a randomized, blind, positively controlled, multi-center and prospectively clinical study, the study involved 2 groups： trial group （propofol medium- and long- chain triglyceride emulsion group, n = 104） and control group （propofol long-chain triglyceride emulsion group, n = 103）. Ge- neral anesthesia was performed according to the unified method of total intravenous anesthesia with target-controlled infusion （TCI） of propofol and remifentanil. Before starting the remifentanil, the target plasma concentration （Cp） of propofol was set at 3 μg/mL until the loss of patient＇s eyelash reflex. Then TCI of both drugs was used throughout induction and maintenance of anesthesia. Clinical effect of anesthesia and adverse events （AE） during the study were evaluated. Results： There were no significant difference between the two groups in time to loss of eyelash reflex and dosage of propofol needed, and the total do- sage of propofol and remifentanil during anesthesia as well. AE incidence was 30. 77% in trial group and 48.54% in control group. The former was significantly lower than the latter （P〈0.05）. Of all the AEs, pain at injection site had the highest in- cidence in both groups, and its occurrence was 25.00% in trial group and 44.66% in control group. The former was signifi- cantly lower than the latter （P〈0.05）. Conclusions： As compared with LCT emulsion Diprivan, MCT-LCT emulsion Propo- fol-Lipuro is equally safe and efficacious for induction and maintenance using TIVA. In addition, Propofol-Lipuro can reduce the incidence of injection pain.
出处
《中国临床医学》
2012年第6期679-681,共3页
Chinese Journal of Clinical Medicine
关键词
静脉麻醉
丙泊酚
靶控输注
注射痛
Intravenous anesthesia Propofol
Target-controlled infusion
Pain at injection site
