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目的评价注射用国产盐酸瑞芬太尼的有效性和安全性。方法检索“万方数据库”“中国知网全文数据库(CNKI)”“维普资讯网”等数据库2010年1月至2015年5月发表的关于国产盐酸瑞芬太尼有效性和安全性的相关文献,提取有关麻醉效果、生命体征及不良反应等指标,对符合质量标准的随机对照试验进行Meta分析。结果最终纳入文献12篇,病例总数为1054例,其中观察组530例,对照组524例。与对照组比较,观察组清醒时间(OR=0.45,95%CI 0.27~0.76,Z=3.03,P=0.000)、呼吸恢复时间(OR=-0.70,95%CI-1.70~0.20,Z=1.31,P=0.010)、拔管时间(OR=0.53,95%CI 0.27~0.76,Z=3.03,P=0.002)均缩短,诱导后心率(OR=1.18,95%CI 0.43~1.93,Z=3.10,P=0.002)及术后不良反应发生率(OR=0.75,95%CI 0.62~0.90,Z=3.09,P=0.002)均降低,而麻醉时间、手术出血量、收缩压、舒张压比较,差异无统计学意义(P=0.190,0.746,0.140,0.400)。结论国产盐酸瑞芬太尼起效快、作用持续时间短、术后不良反应少,且有利于保持血压和心率稳定,安全可靠。
Objective To evaluate the efficacy and safety of domestic remifentanil hydrochloride for injection. Methods A retrospective analysis was conducted on the validity of domestic remifentanil hydrochloride published from January 2010 to May 2015 in databases such as “CNKI”, “CNKI” and “VIP Information Network” And safety related literature, extraction of indicators of anesthesia, vital signs and adverse reactions, met the quality standards of randomized controlled trials for meta-analysis. The results were finally included in the literature 12, the total number of cases was 1054 cases, of which 530 cases of observation group, control group 524 cases. Compared with the control group, the recovery time (OR = -0.70, 95% CI-1.70-0.20, Z = 1.31, OR = 0.45, 95% CI 0.27-0.76, Z = 3.03, P = 0.000) (OR = 1.18, 95% CI 0.43-1.93, Z = 3.10, P = 0.010) and extubation time (OR = 0.53,95% CI 0.27-0.76, Z = 3.03, P = 0.002) , P = 0.002), and the incidence of postoperative adverse reactions (OR = 0.75, 95% CI 0.62-0.90, Z = 3.09, P = 0.002) The difference was not statistically significant (P = 0.190,0.746,0.140,0.400). Conclusion Domestic remifentanil has rapid onset, short duration of action and few adverse reactions after operation, and is beneficial to maintain stable blood pressure and heart rate and is safe and reliable.