2004—2019年河南省雷公藤制剂不良反应分析

Analysis on adverse reactions caused by preparations containing Tripterygium wilfordii in Henan Province from 2004 to 2019

目的分析2004—2019年河南省雷公藤制剂不良反应/事件(ADR/ADE),分析雷公藤制剂不良反应/事件的发生特点,为雷公藤制剂的临床合理应用提供参考依据。方法收集河南省内2004年1月—2019年5月有关雷公藤制剂不良反应报告203例。回顾性分析此203例患者ADR/ADE的时间、性别、年龄、既往史分布、用药原因及合并用药情况、剂型、累及系统及临床表现、结局。结果 203例发生ADR/ADE的患者中,以2017年比例最高(13.30%),其次为2018年(10.34%);季度分布上1~3月发生率最低,年度/季节分布差异有统计学意义(P<0.05)。男、女构成比分别为56.39%、46.31%,以45~64岁年龄层发生率最高(47.29%),但性别与年龄分布差异无统计学意义。203例患者中,4例既往有过敏史、8例有吸烟史、3例有肾病病史、2例为妊娠期女性、4例饮酒史。片剂剂型比例最高(90.15%)。ADR/ADE发生时间以用药后2~6 h比例最高,其次为用药后6 h^1 d。药物使用时长<1周、1~3周、>3周的构成比分别为71.43%、17.24%、11.33%。类风湿性关节炎、风湿性关节炎的比例(25.12%、24.14%)最高,其中91.13%为单药治疗,8.87%为联合用药。胃肠损害比例(54.68%)最高,其次为皮肤及其附件损害(10.84%),用药部位损害、免疫功能紊乱和感染、内分泌紊乱罕见,构成比分别为0.49%;在临床表现上,以恶心、呕吐出现频次最高。203例患者中181份报告类型为一般,22例为严重;其中结局为痊愈、好转患者构成比分别为58.13%、39.41%,仅1例未好转,构成比为0.49%;未见ADR/ADE所致的死亡事件。结论医务人员应重视雷公藤制剂的不良反应观察,了解雷公藤制剂所致的ADR/ADE的临床规律及特点,严格遵循说明书适应症及剂量操作,最大限度降低雷公藤制剂ADR/ADE相关风险。

Objective To analyze the occurrence characteristics of adverse reactions or events(ADR/ADE)caused by preparations containing Tripterygium wilfordii in Henan Province from 2004 to 2019,so as to provide the basis for clinical rational use of such preparations.Methods 203 Cases of reports about ADR caused by preparations containing Tripterygium wilfordii in Henan Province from January 2004 to May 2019 were collected.The occurrence time of ADR/ADE,gender,age,past history,causes of drug use,drug combination,dosage form,involved systems,clinical manifestations,and outcomes were retrospectively analyzed.Results For the 203 patients with ADR/ADE,the proportion was the highest in 2017(13.30%),followed by 2018(10.34%).The incidence was the lowest between January and March,and there were significant differences in annual/seasonal distribution(P<0.05).The proportions of males and females were 56.39%and 46.31%,respectively.The incidence of was the highest in 45—64 years old group(47.29%).However,there was no significant difference in terms of gender or age.Of the 203 patients,4 cases had allergic history while 8 cases with smoking history,3 with history of nephropathy,2 with pregnant women,and 4 with drinking history.The proportion of patients taking tablets was the highest(90.15%).The proportion of ADR/ADE occurring in 2—6 h after administration was the highest,followed by 6 h—1 d after administration.The constituent ratio of drug use time with shorter than 1 week,1—3 weeks,and longer than 3 weeks were 71.43%,17.24%,and 11.33%.The proportions of patients with rheumatoid arthritis and rheumatic arthritis were the highest(25.12%and 24.14%).91.13%of them underwent monotherapy and 8.87%underwent treatment with drug combination.The proportion of patients with gastrointestinal damage was the highest(54.68%),followed by skin and its accessory damage(10.84%).Damage at medication site,immune dysfunction and infection,endocrine disorders were rare,accounting for 0.49%.For clinical manifestations,the occurrence frequency of nausea and vomiting was the highest.181 Cases of the 203 reports were general type,and 22 cases were severe.The proportions of cured and improved patients were 58.13%and 39.41%,respectively,and only 1 case was not improved,accounting for 0.49%.No deaths due to ADR/ADE occurred.Conclusion Medical staff should pay attention to observation on ADR caused by preparations containing Tripterygium wilfordii,and it is necessary to strengthen understanding of the clinical characteristics of the ADR/ADE and strictly follow the instructions to minimize the risks of ADR/ADE.