| 操艺,张亚飞,李娜,等.抗肿瘤药品不良反应及其影响因素[J].安徽医药,2026,30(4):843-848. |
| 抗肿瘤药品不良反应及其影响因素 |
| The adverse reactions of antitumor drugs and their relationship with risk factors |
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| DOI：10.3969/j.issn.1009-6469.2026.04.041 |
| 中文关键词: 抗肿瘤药 药品不良反应 用药安全 合理用药 多因素分析 |
| 英文关键词: Antineoplastic agents Adverse drug reactions Medication safety Rational use of drugs Multivariate analysis |
| 基金项目:安徽医科大学校科研基金项目( 2022xkj178) |
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| 中文摘要: |
| 目的分析安徽医科大学第二附属医院抗肿瘤药品不良反应( ADR)的发生规律及其影响因素，为临床安全使用抗肿瘤药物提供参考。方法收集安徽医科大学第二附属医院 2020年 1月至 2023年 9月上报国家药品不良反应监测中心的 ADR报告，按照病人性别、年龄、药物剂型、给药途径、抗肿瘤药品分类、 ADR类型、 ADR严重程度和 ADR病人的结局进行分析。结果研究期间共收集抗肿瘤药物引起的 ADR病人 595例，剔除抗肿瘤药物与非抗肿瘤药物合用引起的 ADR病人 44例，最后纳入 ADR病人 551例进行分析，其中男性 334例(60.6%)；年龄分组 60岁及以上组较多共 234例(42.5%)；使用的剂型主要是注射液 342例( 62.0%)；给药途径主要是静脉滴注 347例( 63.0%)；抗肿瘤药物的类型主要是细胞毒性药物 385例( 69.9%)；引起的 ADR类型主要是血液系统 224例( 40.7%)； ADR严重程度中，一般为 346例( 62.8%)； ADR的结局以好转 423例( 76.8%)最多。不同性别组比较发现，年龄、剂型、给药途径、抗肿瘤药物分类和不良反应结局均差异有统计学意义。多因素回归分析发现抗肿瘤药物引起 ADR严重程度与年龄和抗肿瘤药物分类有关；抗肿瘤药物 ADR结局与年龄 <20岁组呈负关联，与年龄 20~<40岁组以及粉针剂、注射液、胶囊和片剂组呈正关联关系。结论肿瘤病人因长期使用抗肿瘤药所致 ADR数量较多且较严重，临床治疗时应加强对抗肿瘤药物 ADR的主动监测，合理用药，以减少其发生，从而减轻病人的痛苦和经济负担，保障用药安全。 |
| 英文摘要: |
| Objective To analyze the occurrence law and risk factors for adverse reactions (ADRs) of antineoplastic drugs in a tertia-ry hospital, so as to provide a reference for the safe use of antineoplastic drugs in clinical practice.Methods The ADR reports submit-ted to the National Adverse Drug Reaction Monitoring Center from The Second Affiliated Hospital of Anhui Medical University fromJanuary 2020 to September 2023 were collected, and statistical descriptions and statistical analysis were carried out according to gen-der, age, drug dosage form, route of administration, classification of anti-tumor drugs, ADR type, ADR severity and the outcome of ADR patients. Results During the study, a total of 595 patients were collected who experienced adverse reactions caused by anti-tumor drugs. After excluding 44 patients with ADRs resulting from the combined use of antineoplastic and non-antineoplastic drugs, we ulti-mately included 551 patients with ADRs for analysis. Of these patients, 334 (60.6%) were male. In terms of age distribution, the groupaged 60 years and above constituted the largest proportion, with a total of 234 (42.5%) cases. Regarding the dosage forms, injectionswere predominantly utilized, accounting for 342 (62.0%) cases. The principal route of administration was intravenous drip, with 347(63.0%) cases. The most prevalent type of antineoplastic drugs was cytotoxic drugs, totaling 385 (69.9%) cases. The primary type ofADRs was related to the blood system, with 224 (40.7%) cases. As for the severity of ADRs, 346 (62.8%) cases were classified as gener-al. The most common outcome of ADRs was improvement, with 423 (76.8%) cases. Comparisons between different gender groups re-vealed that age, dosage form, route of administration, classification of antineoplastic drugs, and adverse reaction outcomes were all sta-tistically significant. Multiple regression analysis results showed that the severity of ADRs caused by anti-tumor drugs was correlated with age and the classification of anti-tumor drugs, which had statistical significance. Additionally, the outcome of ADRs of antineoplas-tic drugs was negatively correlated with the age group <20 years old, and positively correlated with the age group of 20-<40 years old, as well as the use of powder injections, injections, capsules, and tablets, which was also statistically significant.Conclusion ADRs in cancer patients caused by long-term use of antitumor drugs is relatively high and severe. In clinical practice, active monitoring of ADRs caused by anti-tumor drugs should be strengthened, and rational drug use should be adopted to reduce their occurrence, thereby reduc-ing patients' pain and economic burden and ensuring medication safety. |
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