丙泊酚不良反应的多中心和大样本调查

The Incidence of Adverse Effects of Propofol: A Prospective,Large Sample and Multi-center Epidemiological Study

目的 对10680例患者使用丙泊酚注射液（静安注射液）全麻诱导期间不良反应的发生率进行了前瞻性、多中心调查。方法 全麻下择期手术的病人，术前未用药。以0．2mL／s的速度静脉注射丙泊酚，从开始注药至患者神智消失前，每间隔5～10S评测患者注射侧肢体有无疼痛反应及疼痛程度，同时观察记录兴奋、躁动的情况。结果 对10680例患者进行疼痛评分，其中无注射痛者6398例，轻度注射痛者3871例，中度注射痛者341例，重度注射痛者70例，疼痛发生率为40．09％；男性与女性疼痛的出现率分别为39．07％和40．59％（P=0．124）；上肢和下肢注射痛发生率分别为57．6％和59．3％（P=0．468）。观察了7815例患者躁动情况，未出现躁动者7099例；出现者为716例，出现率为9．2％。对7192例患者观察了多语情况，出现多语者168例，出现率为2．3％。结论 注射痛是丙泊酚在麻醉诱导时最常见的不良反应，虽然中、重度疼痛的发生率较低，但仍应该采取预防措施。

Objective To investigate the incidence of adverse effects of propofol in large samples and multi-center epidemiological study. Methods The patients without premedication were induced with propofol at 0.2 mL/s with peripheral venous injection. The pain evaluation was performed every 5-10 s and restlessness and talkative were investigated until the patients losing consciousness. Results 10 680 questionnaires that recorded pain scale were received. The incidence of mild injection pain was 36.25 %, moderate pain was 3.19%, and severity pain was 0.66%. The total incidence of injection pain was 40.09%. The incidences of pain were not significantly different between male and female（P= 0. 124）, or between venous injection from upper limb and lower limb（P= 0. 468）. 7 815 questionnaires that surveyed restlessness and 7 192 questionnaires that surveyed talkative were received. The number of patients＇ occurrence restlessness and talkative were 716 and 168, respectively. The incidence of restlessness and talkative was 9.2% and 2.3%, respectively. Conclusion Injection pain is the most common adverse. The incidence of injection pain of propofol 1% fresenius injection was 40.09 %. Some measures should be taken to prevent the injection pain.