急性缺血性脑卒中患者应用羟乙基淀粉200/0.5氯化钠注射液情况调查与循证医学评价

目的:了解急性缺血性脑卒中患者羟乙基淀粉200/0.5氯化钠注射液(以下简称"羟乙基淀粉200/0.5")应用情况,并进行循证医学评价,为临床合理应用羟乙基淀粉200/0.5提供依据。方法:收集北京大学第三医院神经内科2010年6月—2010年10月应用羟乙基淀粉200/0.5的缺血性脑卒中住院患者的病例资料,对羟乙基淀粉200/0.5应用的适应证、用法与用量、用药时间、疗程、安全性等进行调查,并根据药品说明书、治疗指南和临床研究证据对其应用进行评价。结果:共纳入86个病例,羟乙基淀粉200/0.5用于分水岭脑梗死符合相关指南,占5.8%(5/86)。用于多发脑梗死存在2b级证据,占5.8%(5/86);用于大脑中动脉梗死存在1a级证据,占55.8%(48/86);用于颈内动脉梗死仅存在4级证据,占2.3%(2/86)。有30.2%(26/86)的用药适应证缺乏临床研究证据。羟乙基淀粉用药疗程平均为(13.66±5.81)d,75.6%(65/86)的患者用药疗程超过说明书建议的10 d。单次用药剂量均为500 mL,滴速均为160～200 mL·h-1,快于说明书中规定的滴速。结论:部分缺血性脑卒中患者羟乙基淀粉200/0.5的应用尚缺乏循证医学证据的支持,且在用法和疗程方面存在与说明书不符之处。

Application of Hydroxyethyl Starch 200/0.5 Injection for Acute Ischemic Stroke and Evidence-based Medical Evaluation

OBJECTIVE: To investigate the application of hydroxyethyl NaCl injection(hydroxyethyl starch 200/0.5 injection for short) for acute ischemic stroke,and to perform an evidence-based medical evaluation so as to provide reference for rational use of hydroxyethyl starch 200/0.5 injection.METHODS: We collected the medical records of the patients with acute ischemic stroke in the department of nephrology of our hospital who were treated with hydroxyethyl starch 200/0.5 from June 2010 to October 2010.The indication,usage and dosage,medication time,course of treatment and safety of hydroxyethyl starch 200/0.5 were investigated,and the use of hydroxyethyl starch 200/0.5 injection was evaluated in accordance with drug package insert,treatment guidelines and clinical research evidence.RESULTS: A total of 86 cases were included.The treatment was in line with the related guidelines in 5.8%(5/86) cases in which hydroxyethyl starch 200/0.5 was used for cerebral watershed infarction.Evidence of class 2b level was noted in 5.8%(5/86) cases in which hydroxyethyl starch 200/0.5 was used for multiple-cerebral infarction,evidence of class 1a level in 55.8%(48/86) cases in which hydroxyethyl starch 200/0.5 was used for middle cerebral artery occlusion,and evidence of class 4 level in 2.3%(2/86) cases in which hydroxyethyl starch 200/0.5 was used for carotid artery occlusion.30.2%(26/86) used hydroxyethyl starch 200/0.5 in the absence of clinical research evidence-based indications.Hydroxyethyl starch 200/0.5 was used for an average of(13.66±5.81) days,and 65(75.6%) used hydroxyethyl starch 200/0.5 for a duration longer than 10 days as labeled in package inserts.The single dose for all cases was 500 mL at an infusion rate of 160-200 mL·h-1 that was faster than the infusion rate as described by the package inserts.CONCLUSION: In some acute ischemic stroke cases,the hydroxyethyl starch 200/0.5 was used in the absence of clinical research evidence and the usage and course of treatment were not in line with those labeled in package inserts.