Maleki Alimohammad, Ghadiyani Mojtaba, Salamzadeh Jamshid, Salari Sina, Banihashem Seyedshahab, Tavakoli-Ardakani Maria
Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Medical Oncology, Hematology and Bone Marrow Transplantation, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2020 Summer;19(3):451-464. doi: 10.22037/ijpr.2020.113955.14584.
We evaluated and compared the efficacy and safety of mirtazapine (MTZ) with olanzapine (OLP) for preventing chemotherapy-induced nausea and vomiting (CINV) following anthracycline plus cyclophosphamide (AC) regimen. Eligible participants were chemotherapy-naive early-stage breast cancer patients who were scheduled to undergo adjuvant AC. The patients were randomized to take oral MTZ or OLP in combination with aprepitant (A), dexamethasone (D), and granisetron (G), (ADG). The endpoints included rates of complete response (CR), complete control (CC), total control (TC), and adverse events during the acute, delayed, and overall phases in the two cycles of chemotherapy. The influence of CINV on the quality of life (QoL) was evaluated on day 6 of chemotherapy. Of 82 patients, 60 were randomized. In the first cycle, CR rates in cycle 1 were 83.3% and 76.6% during the acute period, 80% and 86.6% during the delayed period, and 66.6% and 63.3% during the overall period, for the ADG-M and ADG-O, respectively. High efficacy of both groups was maintained over 2 cycles. More patients in the ADG-M group noted minimal or no impact of CINV on daily life in cycle 2 (89.7% 67.9%; 0.044). Incidence of somnolence and fatigue was more frequent with the olanzapine group. In this study, there was no substantial difference between mirtazapine and olanzapine in preventing CINV. Further large randomized trials are essential to demonstrate the anti-emetic effect of mirtazapine in chemotherapy.
我们评估并比较了米氮平（MTZ）与奥氮平（OLP）在预防蒽环类药物联合环磷酰胺（AC）方案化疗引起的恶心和呕吐（CINV）方面的疗效和安全性。符合条件的参与者为初治的早期乳腺癌患者，计划接受辅助AC化疗。患者被随机分为口服MTZ或OLP联合阿瑞匹坦（A）、地塞米松（D）和格拉司琼（G）（ADG）。终点指标包括两个化疗周期中急性、延迟和总体阶段的完全缓解（CR）率、完全控制（CC）率、总控制（TC）率以及不良事件。在化疗第6天评估CINV对生活质量（QoL）的影响。82例患者中，60例被随机分组。在第一个周期中，ADG-M组和ADG-O组在急性期的CR率分别为83.3%和76.6%，延迟期分别为80%和86.6%，总体期分别为66.6%和63.3%。两组在两个周期中均保持了较高疗效。ADG-M组更多患者在第2周期中指出CINV对日常生活的影响极小或无影响（89.7%对67.9%；P = 0.044）。奥氮平组嗜睡和疲劳的发生率更高。在本研究中，米氮平和奥氮平在预防CINV方面无实质性差异。进一步的大型随机试验对于证明米氮平在化疗中的止吐作用至关重要。
