Grupo Hospitalar Conceição, Ave. Francisco Trein, 596, Porto Alegre, Rio Grande do Sul, Brazil.
Int J Clin Pharm. 2013 Aug;35(4):513-9. doi: 10.1007/s11096-013-9780-1. Epub 2013 Jun 5.
Introduction of the monoclonal antibody rituximab to chemotherapy regimens has substantially improved disease-free and overall survival in patients with non-Hodgkin lymphomas (NHL). The short-term safety of this drug has been widely reported, but there are few data on long-term safety, which suggests that these patients require prolonged follow-up.
To review the literature on follow-up models, with a focus on the safety of rituximab therapy for diffuse large B-cell lymphoma and follicular lymphoma.
The Cochrane Library, Embassy, Lilacs, Medline, and Scirus databases were searched for systematic reviews and randomized controlled trials. Furthermore, textbooks and journals on pharmaceutical care and institutional websites were searched for patient management recommendations. The outcomes were follow-up models and grade 3, 4, and 5 adverse reactions.
Five systematic reviews and eight clinical trials or updates describing patient follow-up or reporting adverse reactions were identified. Only one systematic review and seven clinical trials reported follow-up routines for patients receiving rituximab, including information on staging, frequency of reassessment, and laboratory tests, as well as pre-infusion care and management of acute or delayed adverse reactions. Five systematic reviews and four clinical trials reported data on statistically significant adverse reactions (fever, leukopenia, infection). Four guidelines or institutional protocols for treatment and follow-up were identified, as well as seven studies describing experiences in the implementation of pharmaceutical care for oncology patients, but none were specifically focused on follow-up of patients receiving rituximab for NHL.
Although some systematic reviews and clinical trials contain guidance on follow-up of patients receiving rituximab for NHL, there are no validated strategies for systematic follow-up of these patients with a focus on safety. As there are few data on long-term safety profile of these novel treatments, monitoring strategies should be developed and implemented to ensure safe and optimized use of drugs recently added to the therapeutic arsenal of clinical oncology.
单克隆抗体利妥昔单抗引入化疗方案后，显著改善了非霍奇金淋巴瘤（NHL）患者的无病生存和总生存。该药物的短期安全性已被广泛报道，但长期安全性数据较少，这表明这些患者需要长期随访。
综述文献中关于随访模式的研究，重点关注利妥昔单抗治疗弥漫性大 B 细胞淋巴瘤和滤泡性淋巴瘤的安全性。
检索 Cochrane 图书馆、Embase、Lilacs、Medline 和 Scirus 数据库中的系统评价和随机对照试验，此外还检索了关于药物治疗和机构网站的教科书和期刊，以获取患者管理建议。研究结果为随访模式和 3、4、5 级不良反应。
共确定了 5 篇系统评价和 8 篇临床试验或更新报告，描述了患者的随访或报告不良反应情况。只有 1 篇系统评价和 7 篇临床试验报告了接受利妥昔单抗治疗的患者的随访常规，包括分期、重新评估频率和实验室检查，以及预输注护理和急性或迟发性不良反应的管理。5 篇系统评价和 4 篇临床试验报告了有统计学意义的不良反应（发热、白细胞减少、感染）的数据。确定了 4 项治疗和随访指南或机构方案，以及 7 项描述肿瘤患者药物治疗实施经验的研究，但均未专门关注 NHL 患者接受利妥昔单抗治疗的随访。
尽管一些系统评价和临床试验包含了 NHL 患者接受利妥昔单抗治疗后的随访指导，但针对这些患者的安全性，没有经过验证的系统随访策略。由于这些新型治疗方法的长期安全性数据较少，应制定和实施监测策略，以确保最近加入临床肿瘤学治疗武器库的药物安全和优化使用。
