Almeida Olga Laura Sena, Ferriolli Eduardo, Taveira Roberta Cristina Cintra, Rosenburg Meire Gallo, Campanari Daniela Dalpubel, da Cruz Alves Natália Maira, Pfrimer Karina, Rapatoni Liane, Peria Fernanda Maris, Lima Nereida K C
Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, SP, Brazil.
Department of Medical Imaging, Hematology and Clinical Oncology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, SP, Brazil.
Cancers (Basel). 2023 Jul 12;15(14):3588. doi: 10.3390/cancers15143588.
This study compared mirtazapine with megestrol in the management of cancer-related anorexia-cachexia syndrome in patients with advanced cancer. A randomized, double-blind, controlled clinical trial involving patients with advanced cancer and anorexia-cachexia syndrome was performed. Participants received mirtazapine 30 mg/day or megestrol 320 mg/day for eight weeks. The primary endpoint was the effect of mirtazapine on weight gain and the secondary endpoints were its effect on appetite, muscle strength, physical performance, body composition, adverse events, and medication adherence. Linear regression model with mixed effects was applied and a significance level of 5% was adopted. Fifty-two patients were randomized. Mean age was 65.8 ± 8.4 years. There was weight gain in 52% of the participants in the megestrol group and in 38% in the mirtazapine group after four weeks ( = 0.040). Appetite improved in 92% of the participants in the megestrol group and in 56% in the mirtazapine group after eight weeks ( = 0.007). In the sub-analysis by sex, women showed improvement in appetite ( < 0.001) and weight gain ( < 0.005) in the mirtazapine group, which was not observed in men. Mirtazapine appears to be inferior to megestrol in weight and appetite improvement. However, there may be a difference in the therapeutic response between sexes.
本研究比较了米氮平与甲地孕酮对晚期癌症患者癌症相关性厌食-恶病质综合征的治疗效果。开展了一项针对晚期癌症和厌食-恶病质综合征患者的随机、双盲、对照临床试验。参与者接受为期八周的每日30毫克米氮平或每日320毫克甲地孕酮治疗。主要终点是米氮平对体重增加的影响，次要终点包括其对食欲、肌肉力量、身体机能、身体成分、不良事件及药物依从性的影响。应用了混合效应线性回归模型，并采用5%的显著性水平。52名患者被随机分组。平均年龄为65.8±8.4岁。四周后，甲地孕酮组52%的参与者体重增加，米氮平组为38%（P=0.040）。八周后，甲地孕酮组92%的参与者食欲改善，米氮平组为56%（P=0.007）。在按性别进行的亚分析中，米氮平组女性的食欲（P<0.001）和体重增加（P<0.005）有所改善，男性未观察到这种情况。在体重和食欲改善方面，米氮平似乎不如甲地孕酮。然而，两性之间的治疗反应可能存在差异。
