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一项前瞻性、随机双盲试验,比较单独使用甲氧氯普胺与甲氧氯普胺加地塞米松预防高剂量顺铂引起的呕吐。

A prospective, randomized double-blind trial comparing metoclopramide alone with metoclopramide plus dexamethasone in preventing emesis induced by high-dose cisplatin.

作者信息

Parikh P M, Charak B S, Banavali S D, Koppikar S B, Giri N, Nadkarni P, Saikia T K, Gopal R, Advani S H

机构信息

Department of Medical Oncology, Tata Memorial Hospital, Parel, Bombay, India.

出版信息

Cancer. 1988 Nov 15;62(10):2263-6. doi: 10.1002/1097-0142(19881115)62:10<2263::aid-cncr2820621032>3.0.co;2-t.

Abstract

We observed 50 patients receiving high-dose cisplatin-based chemotherapy in a prospective, randomized double-blind trial. One group received metoclopramide (MCP) alone (total dose, 6 mg/kg), whereas the other group was given dexamethasone (DMS) (total dose, 60 mg) in addition to MCP. The patient characteristics of the two groups were comparable, confirming satisfactory randomization. Multivariate regression analysis failed to show any statistical significance in the antiemetic response between the two treatment groups. However, female patients receiving Adriamycin (Adria Laboratories, Columbus, OH) concurrently and obese persons exhibited more vomiting. The overall antiemetic response rate was 66%. Because the side effects were minimal, a higher dose of MCP is expected to improve emetic control without increasing toxicity. The use of a 36-hour assessment period in our study gave more meaningful data. An exponential increase in the dose of MCP is probably required, with respect to weight, to obtain the same antiemetic efficacy.

摘要

我们在一项前瞻性随机双盲试验中观察了50例接受大剂量顺铂化疗的患者。一组仅接受甲氧氯普胺(MCP)(总剂量6mg/kg),而另一组除MCP外还给予地塞米松(DMS)(总剂量60mg)。两组患者的特征具有可比性,证实随机分组情况良好。多变量回归分析未显示出两种治疗组在止吐反应方面有任何统计学意义。然而,同时接受阿霉素(阿德里亚实验室,俄亥俄州哥伦布市)治疗的女性患者和肥胖者呕吐更为频繁。总体止吐有效率为66%。由于副作用极小,预计增加MCP剂量有望在不增加毒性的情况下改善呕吐控制。我们研究中使用36小时的评估期得出了更有意义的数据。可能需要根据体重指数增加MCP剂量,以获得相同的止吐效果。

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