氢溴酸樟柳碱注射液治疗急性缺血性脑卒中随机对照临床试验  

Anisodine Hydrobromide Injection for the Treatment of Acute Ischemic Stroke:A Randomized Controlled Trial

作　　者：董志领[1] 韩丽丽[1] 段朋仓 梁静涛[2] 董瑞芳[1] 刘宁宁[1] 刘红梅[1] 胡晨 Dong Zhiling;Han Lili;Duan Pengcang;Liang Jingtao;Dong Ruifang;Liu Ningning;Liu Hongmei;Hu Chen(DivisionⅠ,Department of Neurology,Cangzhou Central Hospital,Cangzhou 061001,Hebei,China;Hospital of Chengdu University of Traditional Chinese Medicine)

机构地区：[1]沧州市中心医院神经内一科,河北沧州061001 [2]成都中医药大学附属医院

出　　处：《药物流行病学杂志》2021年第5期296-300,共5页Chinese Journal of Pharmacoepidemiology

基　　金：四川省科技支撑计划项目(编号:2016SZ0027)。

摘　　要：目的:观察氢溴酸樟柳碱注射液治疗急性缺血性脑卒中的有效性和安全性。方法:采用前瞻性随机对照临床试验方法,220例缺血性脑卒中患者随机分为对照组和试验组。其中对照组110例,脱落9例,最终纳入101例,给予规范基础治疗;试验组110例,脱落10例,最终纳入100例,在对照组治疗基础上,加用氢溴酸樟柳碱注射液2 mg, ivd, qd,连续用药14 d。分别在治疗前和治疗7 d、14 d、90 d进行随访,比较两组疗效指标(NIHSS评分、改良Rankin量表)和安全性指标(生命体征、不良事件和联合血管事件)。结果:治疗14 d后,两组患者的NIHSS评分均较治疗前明显降低(P<0.05),且试验组NIHSS评分明显低于对照组(P<0.05)。治疗90 d后,试验组mRS≤2分患者比例明显高于对照组(P<0.05)。两组患者随访期间生命体征无明显变化(P>0.05),两组不良事件发生率无明显差异(P>0.05),均未发生联合血管事件。结论:氢溴酸樟柳碱注射液治疗急性缺血性脑卒中有效、安全。Objective:To observe the efficacy and safety of anisodine hydrobromide injection in the treatment of acute ischemic stroke. Methods:A prospective randomized controlled clinical trial method was used. Two hundred and twenty patients with acute ischemic stroke were randomly divided into control group and experimental group. Among the 220 patients, 110 cases in the control group, 9 cases were dropped, and 101 cases were finally, they were treated regulating primary. 110 cases were in the experimental group, 10 cases were dropped, and 100 cases were finally, they were treated with anisodine hydrobromide injection 2 mg, ivd, qd on the basis of the control group. Both groups were treated for 14 days. Follow-up was conducted on before therapy, 7 d, 14 d and 90 d after treatment. Comparing the differences of curative effect [National Institute of Health Stoke Scale(NIHSS), Modified Rankin Scale(mRS)] and safety index(vital signs, adverse reactions and combined vascular event) between the two groups. Results:After 14 days of treatment, the NIHSS scores of the experimental group and the control group were significantly reduced(P<0.05), the NIHSS score in the experimental group was significantly lower than that of the control group(P<0.05). After 90 days of treatment, the proportion of patients with mRS≤2 in the experimental group was significantly higher than that in the control group(P<0.05). During the follow-up period, there was no significant difference in vital signs and adverse reactions between two groups and no combined vascular events occurred.Conclusion:The anisodine hydrobromide injection is effective and safe in the treatment of ischemic stroke.

关 键 词：氢溴酸樟柳碱注射液 急性缺血性脑卒中 有效性 安全性 

分 类 号：R971[医药卫生—药品]