摘要
目的探讨抗肿瘤中成药药品不良反应(ADR)及相关危险因素。方法回顾性分析中国人民解放军总医院2019年3月至2020年3月收治的106例抗肿瘤中成药治疗患者临床资料,按自制不良反应调查问卷收集患者发生的ADR及类型,根据是否发生ADR分为不良反应组(47例)和无不良反应组(59例)。分析抗肿瘤中成药ADR的临床特点,采用多因素Logistic回归模型分析抗肿瘤中成药ADR发生的危险因素。结果使用康莱特注射液患者18例,康莱特软胶囊20例,金龙胶囊15例,肝复乐片8例,华蟾素片11例,威麦宁胶囊14例,消癌平注射液8例,消癌平滴丸12例。有47例患者发生ADR,其中过敏反应(皮肤红疹、皮肤瘙痒)15例(31.91%),消化系统反应(恶心、呕吐、腹泻)12例(25.53%),神经系统反应(眩晕、头痛、失眠)10例(21.28%),呼吸系统反应(咳嗽、咽痛)6例(12.77%),血液系统反应(血小板减少)4例(8.51%)。单因素分析结果显示,两组患者的年龄、用药时间、联合用药、合并基础疾病、配伍不当与相互作用差异均有统计学意义(χ^(2)=11.723,4.916,10.647,6.947,4.456,P<0.05)。多因素非条件Logistic回归分析结果显示,年龄≥70岁、用药时间≥30 d,以及存在联合用药、合并基础疾病、配伍不当与相互作用均是抗肿瘤中成药发生ADR的独立危险因素(OR>1,P<0.05)。结论在使用抗肿瘤中成药时,应关注ADR危险因素,保证患者合理用药,延缓疾病进展。
ObjectiveTo investigate the adverse drug reactions(ADR)and their related risk factors of Chinese patent anti-tumor drugs.MethodsThe clinical data of 106 patients treated with Chinese patent anti-tumor drugs admitted to the General Hospital of Chinese PLA from March 2019 to March 2020 were retrospectively analyzed.Based on the results of self-made ADR questionnaire,the ADR and their types of patients were collected,and the patients were divided into the ADR group(47 cases)and the non-ADR group(59 cases)according to whether they had ADR.The clinical characteristics of ADR induced by Chinese patent anti-tumor drugs were analyzed,and the risk factors of the ADR induced by Chinese patent anti-tumor drugs were analyzed by the multivariate Logistic regression model.Results treated with Kanglaite Soft Capsules,15 cases treated with Jinlong Capsules,eight cases treated with Ganfule Tablets,11 cases treated with Huachansu Tablets,14 cases treated with Weimaining Capsules,eight cases treated with Xiaoaiping Injection,and 12cases treated with Xiaoaiping Dropping Pills.A total of 47 cases had ADR,including 15 cases(31.91%)of allergic reactions(skin rash and skin pruritus),12 cases(25.53%)of digestive system reactions(nausea,vomiting and diarrhea),10 cases(21.28%)of nervous system reactions(dizziness,headache and insomnia),six cases(12.77%)of respiratory system reactions(cough and sore throat)and four cases(8.51%)of blood system reactions(thrombocytopenia).The results of univariate analysis showed that the age,duration of medication,combination of medication,complicated with underlying diseases,incompatibility and drug interaction between the two groups were significantly different(χ^(2)=11.723,4.916,10.647,6.947,4.456,P<0.05).The results of multivariate unconditional Logistic regression analysis showed that the age≥70 years,duration of medication≥30 d,combination of medication,complicated with underlying diseases,incompatibility and drug interaction were independent risk factors for the ADR induced by Chinese patent anti
作者
霍静宜
王娜娜
李雪梅
张艳华
韩垚
HUO Jingyi;WANG Nana;LI Xuemei;ZHANG Yanhua;HAN Yao(Peking University Cancer Hospital,Beijing,China 100143;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing,China 100143)
出处
《中国药业》
CAS
2023年第5期120-122,共3页
China Pharmaceuticals
基金
北京中医药科技发展资金项目[QN2016-16]。
关键词
抗肿瘤中成药
药品不良反应
危险因素
合理用药
Chinese patent anti-tumor drugs
adverse drug reaction
risk factor
rational drug use
