Luo Hua, Fan Shaohua, Liang Lu, He Youfu, Chen Jiangjie, Xu Chenghao, Zhu Jing, Zhang Liwei
Department of Orthopedics, Taizhou Hospital of Zhejiang Province, Zhejiang University, Taizhou, China.
Department of Operating Room, Taizhou Hospital of Zhejiang Province, Zhejiang University, Taizhou, China.
Front Pharmacol. 2025 Mar 6;16:1534802. doi: 10.3389/fphar.2025.1534802. eCollection 2025.
In gliomas, various oncogenic factors can lead to an imbalance between cell proliferation and apoptosis. Lomustine inhibits tumor cell growth by disrupting DNA replication and repair mechanisms. In contrast, temozolomide, an imidazole tetrazine compound, promotes cell apoptosis through DNA alkylation. The present study aimed to systematically analyze and compare the adverse drug reactions (ADRs) associated with lomustine and temozolomide, as reported in the World Health Organization (WHO) VigiAcess database.
Utilizing a retrospective descriptive analysis design, this study focused on two commercially available anti-glioma drugs. ADR reports pertaining to these medications were collected from the WHO-VigiAccess database. The data collection process involved gathering detailed information on various parameters, including age groups, gender, and geographical distribution of patients involved in the ADR reports. Additionally, the study examined the disease systems and symptoms reported alongside the adverse reactions, as recorded in the annual ADR summaries generated by the WHO. By calculating the proportion of adverse events reported for each drug, this investigation provided a comparative analysis of both the similarities and differences in the adverse reactions observed across the two anti-glioma drugs.
At the time of the search, a total of 22,854 adverse events (AEs) associated with the two anti-glioma drugs were documented in the VigiAccess database. Lomustine exhibits a higher reporting rate concerning blood and lymphatic system disorders, gastrointestinal disorders, and hepatobiliary disorders. In contrast, Temozolomide has a higher reporting rate for general disorders and administration site conditions, nervous system disorders, and skin and subcutaneous tissue disorders. The top five types of AEs for anti-glioma drugs are as follows: general disorders and administration site conditions (8,825 cases, 38.61%), blood and lymphatic system disorders (7,369 cases, 32.24%), gastrointestinal disorders (5,614 cases, 24.56%), nervous system disorders (5,047 cases, 22.08%), and investigations (4,855 cases, 21.24%).
The present comparative observational study indicates that these inhibitors are associated with both common and specific adverse reactions, as documented in ADR reports. Clinicians should formulate individualized treatment plans that consider the adverse reactions linked to various drugs and the specific conditions of each patient, thereby promoting the rational use of these costly medications.
在胶质瘤中，多种致癌因素可导致细胞增殖与凋亡之间的失衡。洛莫司汀通过破坏DNA复制和修复机制来抑制肿瘤细胞生长。相比之下，替莫唑胺是一种咪唑四嗪化合物，通过DNA烷基化促进细胞凋亡。本研究旨在系统分析和比较世界卫生组织（WHO）VigiAcess数据库中报告的与洛莫司汀和替莫唑胺相关的药物不良反应（ADR）。
本研究采用回顾性描述性分析设计，聚焦于两种市售抗胶质瘤药物。从WHO-VigiAccess数据库收集与这些药物相关的ADR报告。数据收集过程包括收集关于各种参数的详细信息，包括ADR报告中涉及患者的年龄组、性别和地理分布。此外，该研究还检查了WHO生成的年度ADR摘要中记录的与不良反应同时报告的疾病系统和症状。通过计算每种药物报告的不良事件比例，本调查对两种抗胶质瘤药物观察到的不良反应的异同进行了比较分析。
在检索时，VigiAccess数据库中共记录了与这两种抗胶质瘤药物相关的22854例不良事件（AE）。洛莫司汀在血液和淋巴系统疾病、胃肠道疾病以及肝胆疾病方面的报告率较高。相比之下，替莫唑胺在全身疾病和给药部位状况、神经系统疾病以及皮肤和皮下组织疾病方面的报告率较高。抗胶质瘤药物的前五种AE类型如下：全身疾病和给药部位状况（8825例，38.61%）、血液和淋巴系统疾病（7369例，32.24%）、胃肠道疾病（5614例，24.56%）、神经系统疾病（5047例，22.08%）以及检查（4855例，21.24%）。
本比较观察性研究表明，如ADR报告中所记录的，这些抑制剂与常见和特定的不良反应相关。临床医生应制定个体化治疗方案，考虑与各种药物相关的不良反应以及每位患者的具体情况，从而促进这些昂贵药物的合理使用。
