目的 分析2004—2019年河南省雷公藤制劑不良反應(yīng)/事件（ADR/ADE），分析雷公藤制劑不良反應(yīng)/事件的發(fā)生特點(diǎn)，為雷公藤制劑的臨床合理應(yīng)用提供參考依據(jù)。方法 收集河南省內(nèi)2004年1月—2019年5月有關(guān)雷公藤制劑不良反應(yīng)報(bào)告203例。回顧性分析此203例患者ADR/ADE的時(shí)間、性別、年齡、既往史分布、用藥原因及合并用藥情況、劑型、累及系統(tǒng)及臨床表現(xiàn)、結(jié)局。結(jié)果 203例發(fā)生ADR/ADE的患者中，以2017年比例最高（13.30%），其次為2018年（10.34%）；季度分布上1～3月發(fā)生率最低，年度/季節(jié)分布差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。男、女構(gòu)成比分別為56.39%、46.31%，以45～64歲年齡層發(fā)生率最高（47.29%），但性別與年齡分布差異無統(tǒng)計(jì)學(xué)意義。203例患者中，4例既往有過敏史、8例有吸煙史、3例有腎病病史、2例為妊娠期女性、4例飲酒史。片劑劑型比例最高（90.15%）。ADR/ADE發(fā)生時(shí)間以用藥后2～6 h比例最高，其次為用藥后6 h～1 d。藥物使用時(shí)長<1周、1～3周、＞3周的構(gòu)成比分別為71.43%、17.24%、11.33%。類風(fēng)濕性關(guān)節(jié)炎、風(fēng)濕性關(guān)節(jié)炎的比例（25.12%、24.14%）最高，其中91.13%為單藥治療，8.87%為聯(lián)合用藥。胃腸損害比例（54.68%）最高，其次為皮膚及其附件損害（10.84%），用藥部位損害、免疫功能紊亂和感染、內(nèi)分泌紊亂罕見，構(gòu)成比分別為0.49%；在臨床表現(xiàn)上，以惡心、嘔吐出現(xiàn)頻次最高。203例患者中181份報(bào)告類型為一般，22例為嚴(yán)重；其中結(jié)局為痊愈、好轉(zhuǎn)患者構(gòu)成比分別為58.13%、39.41%，僅1例未好轉(zhuǎn)，構(gòu)成比為0.49%；未見ADR/ADE所致的死亡事件。結(jié)論 醫(yī)務(wù)人員應(yīng)重視雷公藤制劑的不良反應(yīng)觀察，了解雷公藤制劑所致的ADR/ADE的臨床規(guī)律及特點(diǎn)，嚴(yán)格遵循說明書適應(yīng)癥及劑量操作，最大限度降低雷公藤制劑ADR/ADE相關(guān)風(fēng)險(xiǎn)。

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.

R969.3