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机构地区:[1]扬州大学医学院附属医院/扬州市妇幼保健院药剂科,江苏扬州225002 [2]扬州大学医学院附属医院/扬州市妇幼保健院中医内科,江苏扬州225002
出 处:《中国药房》2016年第26期3636-3640,共5页China Pharmacy
基 金:扬州市科技指导性计划(临床药学)资助项目(No.YZCZSYJJ410)
摘 要:目的:为患儿合理使用热毒宁注射液提供参考。方法:收集我院儿科2014年11月-2015年10月使用热毒宁注射液患儿的临床信息,以ADR为结局指标,进行队列内病例对照研究,采用二分类单因素及多因素Logistic回归和Cox回归拟合1∶3匹配Logistic回归分析患儿使用热毒宁注射液致ADR的影响因素。结果:9 187例使用热毒宁注射液的患儿,平均年龄(4.21±2.63)岁,共发生ADR 23例,发生率为0.25%。其中,皮疹21例(合并瘙痒9例);有2例严重的ADR(包括四肢抽动、面色青紫、末梢凉、高热、腿痛1例,手足冷、高热1例),23例ADR经处理转归良好。基于我院的药物剂量与低浓度低滴速用法,回归分析显示:年龄、性别、药物剂量、溶剂量、浓度、滴速、患儿来源、联合用药、连续输注组数、输注顺序和连续用药天数等因素比较,差异均无统计学意义(P〉0.05);使用热毒宁注射液ADR发生率,1~〈3岁患儿组为0.11%,3~16岁患儿组为0.31%,两组比较差异无统计学意义(P〉0.05)。结论:热毒宁注射液ADR发生的原因可能有药物本身因素、错误的使用方法等。合理的药物用量、低浓度、低滴速、使用精密过滤装置输液器以及换药即换输液器是减少或避免ADR发生的防护措施。OBJECTIVE:To observe the characteristics and influential factors of aderverse drug reactionl(ADR)induced by Reduning injection. METHODS:The clinical information of pediatric patients receiving Reduning injection were collected from pediatric department of our hospital during Nov. 2014-Oct. 2015. Using ADR as outcome indicators,case control in the queue design was conducted. The influential factors of ADR induced by Reduning injection were analyzed by using binary univariate and multivariate Logistic regression analysis,Cox regression fitted 1∶3 matching Logistic regression analysis. RESULTS:Of 9 187 cases,the average age of children was(4.21±2.63)year-old;there were 23 ADR cases,with the incidence of 0.25%. There were 21 cases of rash(9 cases of combined pruritus)and 2 severe ADR cases(including 1 case of twitching limbs,blue complexion,peripheral cold,high fever,leg pain and 1 case of limbs cold and high fever);23 cases of ADR symptoms finally disappeared after treated. Based on drug dose and usage of low concentrations and low drip rate in our hospital,regression analysis showed that age,sex,drug dose,solvent amount,concentration,drip rate,source of children,drug combination,the group number of daily continuous intravenous infusion,infusion order,the days of continuous medication and other factors were not statistically significant(P〉0.05);the incidence of ADR induced by Reduning injection was 0.11% in the group of 1-3 years old children and was 0.31% in the group of 3-16 years old children. There was no statistical significance between 2 groups(P〉0.05). CONCLUSIONS:The reasons for ADR induced by Reduning injection might be the drug itself,the wrong methods,etc. Reasonable drug dosage,low concentration,low drip rate,using sophisticated filters infusion device and changing infusion device while dressing can reduce the occurrence of ADR.
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