Department of Collection and Analysis of Adverse Drug Events, National Center Chalbi Belkahia of Pharmacovigilance; Research Unit UR17ES12, Faculty of Medicine, University of Tunis El Manar, Tunis, Tunisia.
Research Unit UR17ES12, Faculty of Medicine, University of Tunis El Manar, Tunis, Tunisia.
Indian J Pharmacol. 2022 May-Jun;54(3):208-215. doi: 10.4103/ijp.ijp_175_21.
Chemotherapy drugs can be responsible of several side effects such as hand-foot syndrome (HFS). This syndrome is also called "palmar-plantar erythrodysesthesia" and "acral erythema." Without proper management, it can deteriorate the quality of life of a patient, leading to temporary or definitive stop of chemotherapy.
To identify the epidemiological and clinical characteristics of patients, the risk factors for occurrence and worsening of this syndrome, and the drugs most likely to be responsible of HFS.
Our study was retrospective, including 42 patients with HFS secondary to a chemotherapy drug. These cases were notified to the National Center of Pharmacovigilance over 7 years. The severity of HFS has been classified according to the NCI-CTCAE v4.0 classification.
Our population was composed of 40 women and 2 men. The mean age was 51 years. Docetaxel was the main drug associated with this adverse effect. Hands were involved in all cases and were sometimes associated with other skin surfaces apart from feet. Erythema of the hands and/or feet was present in all patients; it was associated with edema in more than half of the cases. The distribution of different grades according to the NCI-CTCAE classification among the patients was almost equal: 28% Grade 1, 36% Grade 2, and 36% Grade 3. HFS occurred mainly after the first course of chemotherapy with a mean period of 3-4 days. The regression of HFS occurred more rapidly for Grade 1 and Grade 2 compared with Grade 3, especially when assisted by symptomatic treatment. The recurrence rate of HFS for those patients with decreased doses, spacing of cures, and/or symptomatic and prophylaxis treatment was 25%.
An early detection of HFS, associated with preventive measures, enables patients to continue the chemotherapy.
化疗药物可能会引起多种副作用,例如手足综合征(HFS)。这种综合征也称为“手掌-足底红斑感觉迟钝”和“肢端红斑”。如果不进行适当的管理,它会降低患者的生活质量,导致化疗暂时或永久停止。
确定患者的流行病学和临床特征、发生和加重这种综合征的危险因素,以及最有可能导致 HFS 的药物。
我们的研究是回顾性的,包括 42 例因化疗药物引起的 HFS 患者。这些病例在 7 年内被报告给国家药物警戒中心。HFS 的严重程度根据 NCI-CTCAE v4.0 分级进行分类。
我们的研究人群由 40 名女性和 2 名男性组成。平均年龄为 51 岁。多西他赛是与这种不良反应相关的主要药物。所有病例均累及手部,有时还伴有脚部以外的其他皮肤表面。所有患者均存在手部和/或脚部红斑;超过一半的病例伴有水肿。根据 NCI-CTCAE 分级,患者的分布几乎相等:28%为 1 级,36%为 2 级,36%为 3 级。HFS 主要发生在第一疗程化疗后,平均时间为 3-4 天。1 级和 2 级 HFS 的消退速度快于 3 级,尤其是在接受对症治疗时。对于那些减少剂量、延长疗程间隔、以及/或进行对症和预防治疗的患者,HFS 的复发率为 25%。
早期发现 HFS,并采取预防措施,可使患者继续接受化疗。