中国黑色素瘤患者对大剂量干扰素辅助治疗的耐受性观察*

目的:观察中国人对4 周大剂量干扰素IFN α-2b（甘乐能）方案辅助治疗恶性黑色素瘤的耐受性。方法:回顾性分析2007年9 月至2009年5 月在本院诊治的29例高危恶性黑色素瘤（AJCC分期为Ⅱb～Ⅲc 期）患者，采用大剂量干扰素IFN α-2b 4周治疗方案，每天剂量为（2 200～3 375U 单位），每周连续静脉输注5 天，休息2 天，共用4 周，观察不良反应以及早期进展情况。不良反应评定采用美国国家癌症研究所常用毒性评定标准NCI 2.0 版本。结果:全部29例患者接受大剂量干扰素治疗，患者平均接受干扰素的治疗强度为17.63U 单位/（m2·d）。 全部患者均接受毒性反应评价，2 例患者未完成4 周干扰素治疗，其中1 例因术后伤口愈合不良仅进行了1 周治疗，而另1 例因重度疲劳无法完成第4 周治疗；其余27例患者均完成4 周大剂量干扰素治疗。不良反应主要以一过性骨髓抑制为主，69%（20/29）曾经出现3～4 度中性粒细胞下降者，常规处理后迅速恢复，另有62%（18/29）患者出现1～2 度肝转氨酶升高，无肝毒性相关性死亡。26例患者接受随访超过3 个月，5 例在干扰素治疗开始3 个月内进展者，分别为局部复发1 例，区域淋巴结转移2 例，患肢皮下过路转移1 例，远处转移1 例。结论:中国人能耐受大剂量干扰素IFN α-2b 辅助治疗，但大剂量干扰素似乎不能有效抑制亚临床病灶。 

The Tolerability of Chinese Melanoma Patients to High-dose Interferon Adjuvant Therapy

Objective: To observe the tolerability of Chinese melanoma patients to four-week high-dose interferon alfa-2b(INTRON A(R)，Schering-Plough)therapy. Methods:A total of 29 patients with high risk melanomaAmerican Joint Committee on Cancer Staging(AJCC)ⅡB-ⅢC]who received adjuvant interferon therapy in our hospital between September 2007 and May 2009 were retrospectively reviewed.Patients received 4 hours of intravenous infusion of interferon alfa-2b fdose range，22.00 million international unit(MIU)to 33.75 MIU]Ⅳ 5 days/week for 4 weeks.The adverse events were evaluated with National Cancer Institute Common Toxicity Criteria(NCI 2.0 version). Results: The average daily dose was 17.63 MIU/(m~2·d).The therapy was ended in two patients because of poor wound healing or intolerability to severe fatigue.The most common adverse events were myelosuppression.Grade 3/4 neutropenia was observed in 69% (20/29)patients and was rapidly reversed after conventional support interventions.Grade 1/2 abnormal hepatic function occurred in 18 cases(62%).Twenty-six patients were followed up for 3 to 22 months.Five patients developed early progression:one with local recurrence，two with regional lymph node metastasis one with in-transit metastasis in the affected limb,and one with distant metastasis. Conclusion: High-dose interferon alfa-2b regimen can be well tolerated by Chinese patients but cannot effectively inhibit subclinical lesions.