Pharmacovigilance of patients with multiple myeloma being treated with bortezomib and/or thalidomide

In order to evaluate the main adverse effects of drug protocols using bortezomib and/or thalidomide for the treatment of multiple myeloma, we conducted a prospective study. Data were collected through interviews, clinical observation, and from hospital records. A total of 59 patients were included. There was a predominance of females, 36 (61%) vs 23 (39%) males, and of whites, 49 (83.1%) vs 10 (16.9%) blacks. Age ranged from 40 to 94 years, with a median of 65 years (SD=11.6). Regarding staging at diagnosis, 27 (45.7%) patients were in stage III-A, with 12 (20.3%) patients having serum creatinine ≥2 mg/dL. The main adverse effects in the bortezomib treatment group (n=40) were: neutropenia (42.5%), diarrhea (47.5%), and peripheral neuropathy in 60% of cases, with no difference between the iv (n=26) and sc (n=14) administration routes (P=0.343). In the group treated with thalidomide (n=19), 31.6% had neutropenia, 47.4% constipation, and 68.4% peripheral neuropathy. Neutropenia was associated with the use of alkylating agents (P=0.038). Of the 3 patients who received bortezomib in combination with thalidomide, only 1 presented peripheral neuropathy (33.3%). Peripheral neuropathy was the main adverse effect of the protocols that used bortezomib or thalidomide, with a higher risk of neutropenia in those using alkylating agents. Improving the identification of adverse effects is critical in multiple myeloma patient care, as the patient shows improvements during treatment, and requires a rational and safe use of medicines.

为评估硼替佐米（bortezomib）和/或沙利度胺（thalidomide）用药方案治疗多发性骨髓瘤（multiple myeloma）的主要不良反应，本研究开展了一项前瞻性研究。研究数据通过访谈、临床观察及医院病历采集获得。本研究共纳入59例患者，其中女性占比更高：36例（61%），男性23例（39%）；种族以白人为主：49例（83.1%），黑人10例（16.9%）。患者年龄跨度为40至94岁，中位年龄65岁（标准差SD=11.6）。关于确诊时的临床分期，27例（45.7%）患者处于Ⅲ-A期，其中12例（20.3%）患者血清肌酐≥2mg/dL。硼替佐米治疗组（n=40）的主要不良反应包括：中性粒细胞减少症（42.5%）、腹泻（47.5%），60%的病例出现周围神经病变；静脉给药（iv，n=26）与皮下给药（sc，n=14）两种给药途径间无统计学差异（P=0.343）。沙利度胺治疗组（n=19）中，31.6%的患者出现中性粒细胞减少症，47.4%出现便秘，68.4%出现周围神经病变。中性粒细胞减少症与烷化剂（alkylating agents）的使用存在显著相关性（P=0.038）。在3例联合使用硼替佐米与沙利度胺的患者中，仅1例出现周围神经病变（33.3%）。综上，采用硼替佐米或沙利度胺的治疗方案的主要不良反应为周围神经病变，使用烷化剂的患者发生中性粒细胞减少症的风险更高。在多发性骨髓瘤患者的诊疗照护中，优化不良反应识别工作至关重要——患者在治疗期间病情会得到改善，同时需合理、安全地使用治疗药物。