α-硫辛酸注射液不良反应的发生率及相关因素分析  

Analysis of incidence rate and of related factors on the adverse drug reaction caused by Alpha Lipoic Acid Injection

作　　者：汤智慧[1] 熊娜[1,2] 郭代红[1] 黄清杰[1,3] 王波[1] 

机构地区：[1]解放军总医院药品保障中心,北京100853 [2]解放军第二六一医院药剂科,北京100094 [3]甘肃省中医院药学部,甘肃兰州730050

出　　处：《中国医药导报》2013年第12期156-157,160,共3页China Medical Herald

摘　　要：目的通过分析α-硫辛酸在临床使用过程中引起不良反应情况以及相关因素,以期规避不良反应发生,促进临床安全用药。方法对2010年11月～2011年11月解放军总医院108例使用α-硫辛酸(商品例:奥力宝)的糖尿病合并糖尿病神经病变的患者进行回顾性分析,根据不良反应发生情况分为两组,并对两组患者的临床数据进行单因素χ2检验或Fisher精确概率分析和多因素Logistic回归分析。结果不良反应组17例,对照组(无不良反应发生组)91例。不良反应发生率为15.75%。不良反应临床表现主要有:输注部位疼痛10例、静脉炎3例、头痛(头晕)2例、手臂酸胀1例、针刺样疼痛1例。两组临床数据经Logistic回归分析提示,α-硫辛酸注射液不良反应发生与患者年龄、性别、体重指数、糖尿病病程无相关性。结论α-硫辛酸注射液临床治疗糖尿病神经病变是安全有效的,在严格按照说明书推荐的溶媒、浓度、滴速、滴注时长、遮光规范使用的过程中,其ADR的发生与其临床使用过程中不良反应的发生与年龄、性别、糖尿病病程和体重指数无关。为规避不良反应发生,建议临床严格按照说明书使用。Objective To analyze the incidence and related factors of the adverse drug reactions （ADRs） in the clinical use of Alpha Lipoic Acid, avoid adverse reactions occurr amd promote clinical safety. Methods 108 inpatients diagnosed as diabetic peripheral neuropathy and treated with Alpha Lipoic Acid from November 2010 to November 2011 were retrospectively analyzed. By the incidence of ADR, 108 inpatients were divided into two groups. The clinical data were compared by X2 test or Fisher＇s exact test and Logistic regression analysis was performed to reveal the risk factors of ADR. Results 17 （15.74%） patient suffered from ADR to alpha lipoic acid. ADR events included 10 patients of pain in infusion parts, 1 patient of headache, 2 patients of dizziness, 3 patients of phlebitis, 1 patient of prick pain in his left upper limbs and left foot were recorded. With Logistic regression analysis, age, sex, body mass index, the duration of diabete were irrelevant to incidence of ADR to Alpha Lipoic Acid. Conclusion Alpha Lipoic Acid Injection is safe and effective in treatment of diabetic neuropathy. The occurrence of adverse reactions in clinical use has nothing to do with age, sex, duration of diabetes, and body mass index. This article has recommended medical workers to use Alpha Lipoic Acid strictly according to the the solvent, concentration, drip rate mentioned in instructions.

关 键 词：a-硫辛酸注射液 不良反应 相关因素 

分 类 号：R593.1[医药卫生—内科学]