目的 通過研究熱毒寧注射液不良反應(yīng)（ADR）與其可能影響因素之間的關(guān)聯(lián)性，總結(jié)熱毒寧注射液ADR發(fā)生特點(diǎn)，為減少熱毒寧注射液ADR特別是嚴(yán)重ADR的發(fā)生提供有益信息。方法 對(duì)2017年1月—2022年12月河南省不良反應(yīng)監(jiān)測(cè)中心收集的熱毒寧注射液相關(guān)ADR進(jìn)行回顧性分析，采用描述性統(tǒng)計(jì)方法分析ADR風(fēng)險(xiǎn)增加的可能影響因素，包括年齡、性別和原患疾病等。使用Apriori算法評(píng)價(jià)ADR與影響因素之間的關(guān)聯(lián)。結(jié)果 共納入有效ADR報(bào)告1 028例。近2/3的ADR發(fā)生于14歲及14歲以下患者中。主要累及器官為皮膚及其附件損害（55.54%），其次有全身性損害（15.18%）、胃腸系統(tǒng)損害（11.77%）和神經(jīng)系統(tǒng)損害（5.25%）。關(guān)聯(lián)規(guī)則分析中，根據(jù)支持度和置信度的值挖掘了多個(gè)強(qiáng)關(guān)聯(lián)規(guī)則。其中，規(guī)則“是否伴隨用藥＝是and年齡段＝2～6歲”與“ADR分類＝皮膚及其附件損害”的置信度最高其支持度、置信度和提升度分別為6.42%、81.82%和1.47。結(jié)論 熱毒寧注射液的不良反應(yīng)主要發(fā)生在14歲以下人群；2～6歲且伴隨用藥的兒童尤其需要密切監(jiān)測(cè)皮膚及附件損害類ADR。

Objective To investigate adverse drug reactions (ADRs)induced by Reduning Injection by analyzing the associations between these ADRs and potential risk factors, and therefore provide useful information for reducing the incidence of ADRs induced by Reduning Injection, especially serious ADRs. Methods A retrospective analysis was performed on ADRs induced by Reduning Injection reported to the Center for ADR Monitoring of Henan during the period January 2017— December 2021. Descriptive statistic was used to analyze possible risk factors associated with increased risk of ADRs, including gender, age, pre-existing diseases, et al. Then the Apriori algorithm was used to evaluate the associations between ADRs and these risk factors. Results A total of 1 028 effective ADR reports were included in the study. Almost two-third (64.90%) of the ADRs occurred in patients under 14 years old (inclusive). Skin and appendages disorders (55.54%) were the most commonly involved organ systems, followed by body as a whole-general disorders (15.18%), gastrointestinal disorders (11.77%) and nervous system disorders (5.25%). Several strong association rules were mined based on support value and confidence value in associations rule analysis. The rule between concomitant medication = yes and age group = 2 — 6 and ADR category = skin and appendages disorders had the highest confidence, with a 6.42% support, 81.82% confidence and 1.47 lift values. Conclusion The ADRs induced by Reduning Injection occur mainly in the population under 14 years old, children aged 2 to 6 years with concomitant drugs are especially required to be closely monitored for ADRs of skin and appendages disorders.

R978.7

河南省醫(yī)學(xué)科技攻關(guān)計(jì)劃聯(lián)合共建項(xiàng)目（LHGJ20200944）；河南省市場(chǎng)監(jiān)督管理局科技計(jì)劃項(xiàng)目（2022sj59）