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昂丹司琼和甲氧氯普胺联合皮质类固醇在接受非顺铂化疗的恶性淋巴瘤患者中的止吐疗效。

Antiemetic efficacy of ondansetron and metoclopramide, both combined with corticosteroid, in malignant lymphoma patients receiving non-cisplatin chemotherapy.

作者信息

Jørgensen M, Victor M A

机构信息

Department of Internal Medicine, Copenhagen County Hospital Herlev, Denmark.

出版信息

Acta Oncol. 1996;35(2):159-63. doi: 10.3109/02841869609098496.

Abstract

The aim of the present study was to compare the antiemetic efficacy of ondansetron (OND) with metoclopramide (MCP), both combined with corticosteroid (CS) in patients with malignant lymphoma. A total of 109 patients with malignant lymphoma receiving their first series of non-cisplatin chemotherapy (CT) (CHOP or MOPP) were divided into prospective, randomized, open and parallel groups and analyzed at two hematological centres at university hospitals in Copenhagen, Denmark. The patients were randomized to receive one of the two following regimens; 1) OND 8 mg/methylprednisolone 80 mg i.v. before CT and OND 8 mg p.o. after 8 h and at bedtime. OND 8 mg tid days 2-3, and 8 mg tid prn days 4-5 and prednisolone 75-100 mg qds days 2-5 and 2) MCP 30 mg/metylprednisolone 80 mg i.v. before CT and MCP 20 mg p.r. after 4 and 8 h respectively. MCP 20 mg p.r. prn days 1-5 and prednisolone 75-100 mg qds days 2-5. In the acute phase OND/CS was superior to MCP/CS in the control of nausea and emesis, resulting in no emesis in 92% of the OND/CS treated group vs. 50% treated with MCP/CS (p < 0.001), and no nausea in 79% (OND/CS) vs. 42% (MCP/CS) (p < 0.001). The ultimate aim - neither nausea nor emesis - was reached in 77% (OND/CS) vs. 35% (MCP/CS) day 1 (p < 0.001). OND/CS is significantly better than MCP/CS in the control of delayed nausea, 81% (OND/CS) vs. 58% (MCP/CS) (p < 0.026). Both the OND/CS and MCP/CS regimens are highly effective in the control of delayed emesis, 94% (OND/CS) vs. 85% (MCP/CS) (p < 0.26). Adverse events were mild and experienced in 31% of the patients. In the OND/CS group 13% had constipation vs. 8% in the MCP/CS group. Nine percent treated with OND/CS had headaches compared to none treated with MCP/CS (p < 0.08). One extrapyramidal reaction was recorded in the MCP/CS group. In malignant lymphoma patients receiving moderately emetogenic CT, the combination of OND and CS was very effective and significantly better than low dose MCP and CS in the control of acute emesis, acute nausea and delayed nausea.

摘要

本研究旨在比较昂丹司琼(OND)与甲氧氯普胺(MCP)联合皮质类固醇(CS)对恶性淋巴瘤患者的止吐疗效。总共109例接受首个非顺铂化疗(CT)疗程(CHOP或MOPP)的恶性淋巴瘤患者被分为前瞻性、随机、开放和平行组,并在丹麦哥本哈根大学医院的两个血液学中心进行分析。患者被随机分配接受以下两种方案之一:1)CT前静脉注射OND 8 mg/甲泼尼龙80 mg,8小时后及睡前口服OND 8 mg。第2 - 3天每日三次口服OND 8 mg,第4 - 5天按需每日三次口服8 mg,第2 - 5天每日四次口服泼尼松龙75 - 100 mg;2)CT前静脉注射MCP 30 mg/甲泼尼龙80 mg,4小时和8小时后分别直肠给予MCP 20 mg。第1 - 5天按需直肠给予MCP 20 mg,第2 - 5天每日四次口服泼尼松龙75 - 100 mg。在急性期,OND/CS在控制恶心和呕吐方面优于MCP/CS,OND/CS治疗组92%无呕吐,而MCP/CS治疗组为50%(p < 0.001);OND/CS组79%无恶心,MCP/CS组为42%(p < 0.001)。第1天达到最终目标(无恶心也无呕吐)的患者,OND/CS组为77%,MCP/CS组为35%(p < 0.001)。OND/CS在控制延迟性恶心方面显著优于MCP/CS,分别为81%(OND/CS)和58%(MCP/CS)(p < 0.026)。OND/CS和MCP/CS方案在控制延迟性呕吐方面均非常有效,分别为94%(OND/CS)和85%(MCP/CS)(p < 0.26)。不良事件较轻,31%的患者出现此类情况。OND/CS组13%有便秘,MCP/CS组为8%。OND/CS治疗的患者中有9%出现头痛,而MCP/CS治疗的患者中无头痛发生(p < 0.08)。MCP/CS组记录到1例锥体外系反应。在接受中度致吐性CT的恶性淋巴瘤患者中,OND与CS联合在控制急性呕吐、急性恶心和延迟性恶心方面非常有效,且显著优于低剂量MCP与CS联合。

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