Casadei Gardini Andrea, Tenti Elena, Masini Carla, Nanni Oriana, Scarpi Emanuela, Valgiusti Martina, Restuccia Silvia, Gallani Maria Laura, Palazzini Simonetta, Bianchini Erica, Menozzi Silvia, Maugeri Antonio, Amadori Dino, Minguzzi Martina, Frassineti Giovanni Luca
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori IRST IRCCS, Meldola, Italy.
Oncology Pharmacy Laboratory, IRST IRCCS, Meldola, Italy.
Oncotarget. 2016 Jun 28;7(26):40719-40724. doi: 10.18632/oncotarget.8942.
Antiblastic drugs have a high number of potential side-effects. Paradoxically, according to the National Network of Pharmacovigilance, the number of reported adverse reactions to these agents is proportionally lower than that registered for non antiblastic drugs. Critical phenomena such as treatment interruptions and significant dose reductions within the first two months of use may be indicators of adverse drug reactions. The aim of the present study was to increase our knowledge of pharmacovigilance to facilitate the actions taken to improve the risk-benefit profile of cancer drugs and, consequently, their safety. This retrospective observational survey was carried out on prescriptions from 1st January 2012 to 31st December 2012.Dose reductions of more than 10% during the first 90 days of therapy were considered as a surrogate indicator of an adverse reaction. Dose interruptions during the first 60 days of therapy were taken into consideration. Of the12,472 patients 1,248 underwent a dose reduction. The drugs that most often required a dose reduction were paclitaxel and oxaliplatin (17.4% and 17.3%, respectively), docetaxel (14.8%), carboplatin (15%), fluorouracil (10.7%) and, among oral medications, capecitabine (6.9%). Of the 1896 patients treated with the same drugs, 9.7% interrupted treatment. Patients required a lower dose reduction than that reported by other authors. Around 15% of cases underwent a 30% dose reduction within three months of starting therapy, indicating a possible adverse reaction. Constant monitoring of dose prescription and continuous training of medical and nursing staff are clearly needed to increase awareness of the importance of reporting adverse events.
抗有丝分裂药物有大量潜在的副作用。矛盾的是，根据国家药物警戒网络的数据，这些药物报告的不良反应数量按比例低于非抗有丝分裂药物。治疗中断和使用后头两个月内大幅减量等关键现象可能是药物不良反应的指标。本研究的目的是增加我们对药物警戒的了解，以促进采取行动改善癌症药物的风险效益比，从而提高其安全性。这项回顾性观察性调查针对2012年1月1日至2012年12月31日的处方进行。治疗前90天内剂量减少超过10%被视为不良反应的替代指标。治疗前60天内的剂量中断也被纳入考虑。在12472名患者中，有1248名患者进行了剂量减少。最常需要减量的药物是紫杉醇和奥沙利铂（分别为17.4%和17.3%）、多西他赛（14.8%）、卡铂（15%）、氟尿嘧啶（10.7%），在口服药物中，卡培他滨（6.9%）。在使用相同药物治疗的1896名患者中，9.7%中断了治疗。患者所需的剂量减少幅度低于其他作者报告的幅度。约15%的病例在开始治疗后三个月内剂量减少了30%，表明可能存在不良反应。显然需要持续监测剂量处方并对医护人员进行持续培训，以提高对报告不良事件重要性的认识。
