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头颈部肿瘤治疗中多西他赛类固醇预处理的安全剂量降低

Safe dose reduction of steroid pre-medication for docetaxel in head and neck neoplasm treatment.

作者信息

Chen Nan-Xiang, Zhao Fei-Fan, Yan Fang, Zhang Xin-Xin

机构信息

a Department of Otorhinolaryngology/Head and Neck Surgery , Chinese People's Liberation Army General Hospital , Beijing , PR China.

出版信息

Acta Otolaryngol. 2016;136(2):177-80. doi: 10.3109/00016489.2015.1096957. Epub 2015 Oct 15.

Abstract

CONCLUSION

The results suggest that the rate of severe hypersensitivity reactions did not increase when the dexamethasone pre-medication dose was reduced to 11 mg prior to docetaxel infusion.

OBJECTIVES

Dexamethasone is commonly used to prevent the adverse effects of docetaxel in head and neck neoplasm treatment. The recommended dexamethasone dose is 8 mg orally twice daily for 3 days for each injection of docetaxel. This pre-medication reduces the incidence of adverse effects to 1-2% of treated patients. However, many adverse events have been observed with long-term steroid use. In an attempt to balance the benefits and harms of steroid prophylaxis without affecting the safety of docetaxel, this study tried to reduce the duration and dose of dexamethasone.

METHODS

In this study, a total of 336 patients underwent docetaxel-containing protocols (TP or TPF regimens) to treat head and neck neoplasms. Docetaxel was given in doses of 70 mg/m(2) once every 3 weeks. Dexamethasone (0.75 mg/tablet) pre-medication was given in different doses (45, 24, 18, and 11 mg); the minimum dose included 6 mg orally in the morning and 5 mg intravenously immediately before docetaxel infusion.

RESULTS

Severe hypersensitivity reactions were experienced by none of 30 patients who received 45 mg (7.5 mg orally twice for 3 days) dexamethasone pre-medication in 125 cycles, none of 20 patients who received 24 mg (6 mg orally twice for 2 days) dexamethasone in 77 cycles, and none of 20 patients who received 18 mg (4.5 mg orally twice for 2 days) dexamethasone in 79 cycles. Three of 266 patients who received 11 mg dexamethasone in 1054 applications developed a severe hypersensitivity reaction with bronchospasm and hypotension, two of the 266 patients developed a severe rash, and four developed severe oedema.

摘要

结论

结果表明,在多西他赛输注前将地塞米松预处理剂量降至11毫克时,严重过敏反应的发生率并未增加。

目的

地塞米松常用于预防多西他赛在头颈部肿瘤治疗中的不良反应。多西他赛每次注射时,推荐的地塞米松剂量为每日口服8毫克,分两次服用,共3天。这种预处理可将不良反应的发生率降低至治疗患者的1%-2%。然而,长期使用类固醇会观察到许多不良事件。为了在不影响多西他赛安全性的情况下平衡类固醇预防的利弊,本研究试图减少地塞米松的使用时间和剂量。

方法

在本研究中,共有336例患者接受含多西他赛的方案(TP或TPF方案)治疗头颈部肿瘤。多西他赛剂量为70毫克/平方米,每3周给药一次。地塞米松(0.75毫克/片)预处理采用不同剂量(45、24、18和11毫克);最小剂量包括早上口服6毫克,在多西他赛输注前立即静脉注射5毫克。

结果

在125个周期中,接受45毫克(每日口服7.5毫克,分两次服用,共3天)地塞米松预处理的30例患者中无一发生严重过敏反应;在77个周期中,接受24毫克(每日口服6毫克,分两次服用,共2天)地塞米松的20例患者中无一发生严重过敏反应;在79个周期中,接受18毫克(每日口服4.5毫克,分两次服用,共2天)地塞米松的20例患者中无一发生严重过敏反应。在1054次应用中接受11毫克地塞米松的266例患者中有3例发生了伴有支气管痉挛和低血压的严重过敏反应,266例患者中有2例出现严重皮疹,4例出现严重水肿。

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