复方骨肽致药物不良反应文献分析

目的系统分析复方骨肽致不良反应（ADR）的发生规律,为临床合理用药提供参考。方法计算机检索2000-2013年中国期刊全文数据库、中文科技期刊全文数据库、万方数字化期刊全文库及手工在百度、谷歌等检索相关资料及各论文参考文献目录有关复方骨肽所致ADR的个案报道,按年龄、性别、给药用法用量、ADR发生时间、临床表现等进行统计分析。结果共检索到15篇文献,25例病例。ADR发生的性别差异无统计学意义（P〉0.05）。40-69岁发生率为76%,明显高于其他年龄段（P〈0.05）。复方骨肽致ADR发生率与药物浓度及溶媒种类均无关（P均〉0.05）。ADR多发生在30 min之内,占67%。临床表现均为变态反应,其中过敏性休克4例（16%）,类过敏休克反应13例（52%）,皮肤变态反应8例（32%）。结论复方骨肽所致ADR与性别、用药浓度、溶媒均无显著性差异,多发生在首次用药30 min之内,临床以各种变态反应为主,建议须警惕严重ADR的发生,如过敏性休克等。

Analysis of compound ossotide injection induced adverse drug reactions

Objective To analyze the characterisitics of the adverse drug reactions（ADR） associated with compound ossotide injection and provide reference for clinical medication.Methods ADR of compound ossotide injection reported in China journal full text database,Chinese scientific journals full text database,Wanfang and in Baidu,Google and other search related information and the reference lists of relevant papers by the manual form 2000 to 2013were collected and analyzed by age,sex,drug dosage,ADR time of occurrence,clinical manifestations and so on.Results The literature retrieved 14 of 25 cases were collected.ADR of compound ossotide injection with sex,drugs solvent species were unrelated（P 0.05）,and the rate of ADR in 40 ~ 69 years old occurrence rate of 76 %,higher than any other age group（P 0.05）,and ADR always occurred within 30 minutes after injection.Clinical manifestations were all allergic reactions,there were 4 cases（16%） allergic shock,13 cases（52%） anaphylactic shock reaction,and8 cases（32%） skin allergic reaction.Conclusion Clinicians,pharmacists and nurses should be aware of compound ossotide injection induced ADR rules and characteristics,strengthen the monitoring of its application,in order to reduce the incidence of ADR.