4476例大株红景天注射液的安全性评价

Safety evaluation of 4476 cases of sofren injection

目的:对大株红景天注射液上市后的安全性再评价。方法:采用非前瞻性集中监测方法,对2013年11月–2016年8月入住我院心内科使用大株红景天注射液的住院患者进行药品不良反应/药品不良事件(ADR/ADE)分析。结果:本研究共纳入4476例患者,37例患者用药后出现ADR/ADE,除外70～79岁年龄段,其他各年龄段女性ADR/ADE的发生率明显高于男性(χ~2=0.79,P=0.02);既往有过敏史者ADR/ADE发生率显著高于无过敏史者;使用0.9%氯化钠注射液作为溶媒者ADR/ADE发生率(0.80%)低于使用5%葡萄糖注射液者(1.39%);病例组患者的心率明显高于对照组(t=2.34,P=0.02),大株红景天注射液相关的ADR/ADE未累及造血、凝血、肝肾功能及离子水平。结论:大株红景天注射液的安全性较好,但在临床应用中还应警惕大株红景天注射液引起的心率加快,另外溶媒的选择与药品说明书存在矛盾,值得关注。

Objective： To reevaluate the post-marketing safety of sofren injection. Methods： Inpatients using sofren injection in the department of cardiovascular disease in our hospital were collected from November 2013 to August 2016. The adverse drug reactions/adverse drug events （ADR/ADE） of the sofren injection were analyzed by the non-prospective centralized monitoring method. Results： A total of 4476 patients were enrolled in the study. Among them, 37 patients had ADR/ADE induced by sofren injection. The incidence of ADR/ADE in women of all age groups except the 70 – 79 age group was signifcantly higher than that of men （χ^2 = 0.79, P = 0.02）. Patients with allergic history also had a signifcant higher incidence of ADR/ADE compared with those without allergies. The incidence of ADR/ADE were lower in patients using 0.9% sodium chloride injection （0.80%） as solvent than those using 5% glucose injection （1.39%） as solvent. The heart rate was signifcant higher in the case group than that in the control group （t = 2.34, P = 0.02）. Hematopoiesis, coagulation, liver and kidney function and ion disturbance were not involved in ADR/ADE associated with sofren injection. Conclusion： In clinic, sofren injection is comparatively safe. However, we need to be wary of the heart rate acceleration caused by sofren injection. In addition, our results showed that 0.9% sodium chloride injection was a suitalble solvent while 5% glucose injection was a recommended solvent in the instruction, which deserved more attentions.