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奥氮平、地塞米松和帕洛诺司琼预防化疗引起的恶心和呕吐的II期试验:一项印第安纳肿瘤学组研究

A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study.

作者信息

Navari Rudolph M, Einhorn Lawrence H, Loehrer Patrick J, Passik Steven D, Vinson Jake, McClean John, Chowhan Naveed, Hanna Nasser H, Johnson Cynthia S

机构信息

Notre Dame Cancer Institute, University of Notre Dame, 224 Raclin-Carmichael Hall, Notre Dame, IN 46556, USA.

Indiana University School of Medicine South Bend, South Bend, IN, USA.

出版信息

Support Care Cancer. 2007 Nov;15(11):1285. doi: 10.1007/s00520-007-0248-5. Epub 2007 Mar 21.

DOI:10.1007/s00520-007-0248-5
PMID:17375339
Abstract

OBJECTIVE

The purpose of this study is to determine the control of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) with the combined use of palonosetron and olanzapine, and dexamethasone with the dexamethasone given on day 1 only.

MATERIALS AND METHODS

Forty chemotherapy-naive patients received on the day of chemotherapy, day 1, an anti-emetic regimen consisting of dexamethasone, palonosetron, and olanzapine. Patients continued olanzapine for days 2-4 after chemotherapy administration. Patients recorded daily episodes of emesis, daily symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of rescue therapy.

RESULTS

For the first cycle of chemotherapy, the complete response (no emesis, no rescue) for the acute period (24 h post-chemotherapy) was 100%, the delayed period (days 2-5 post-chemotherapy) 75%, and the overall period (0 120 h post-chemotherapy) 75% in 8 patients receiving HEC and was 97, 75, and 72% in 32 patients receiving MEC. Patients with no nausea for the acute period was 100%, the delayed period 50%, and the overall period 50% in 8 patients receiving HEC and was 100, 78, and 78% in 32 patients receiving MEC.

DISCUSSION

The complete response and control of nausea in subsequent cycles of chemotherapy were not significantly different from cycle one.

CONCLUSION

Olanzapine combined with a single dose of dexamethasone and a single dose of palonosetron was very effective in controlling acute and delayed CINV in patients receiving both HEC and MEC.

摘要

目的

本研究旨在确定接受中度致吐性化疗(MEC)和高度致吐性化疗(HEC)的患者联合使用帕洛诺司琼和奥氮平以及仅在第1天给予地塞米松时对急性和延迟性化疗引起的恶心和呕吐(CINV)的控制情况。

材料与方法

40例初治化疗患者在化疗当天(第1天)接受由地塞米松、帕洛诺司琼和奥氮平组成的止吐方案。化疗给药后第2 - 4天患者继续服用奥氮平。患者记录每日呕吐发作次数、使用MD安德森症状量表记录每日症状以及急救治疗的使用情况。

结果

在接受HEC的8例患者中,化疗第一个周期急性期(化疗后24小时)的完全缓解率(无呕吐、无急救)为100%,延迟期(化疗后第2 - 5天)为75%,总期(化疗后0 - 120小时)为75%;在接受MEC的32例患者中,上述指标分别为97%、75%和72%。接受HEC的8例患者急性期无恶心的比例为100%,延迟期为50%,总期为50%;接受MEC的32例患者中,上述指标分别为100%、78%和78%。

讨论

后续化疗周期中恶心的完全缓解率和控制情况与第一个周期无显著差异。

结论

奥氮平联合单剂量地塞米松和单剂量帕洛诺司琼在控制接受HEC和MEC的患者的急性和延迟性CINV方面非常有效。

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