Maral J, Steinberg M, Weil M, Chleq C, Khayat D, Banzet P, Jacquillat C
Presse Med. 1987 Jun 6;16(21):1031-4.
Twenty-two patients with metastatic malignant melanoma received either 36 X 10(6) U (15 patients) or 18 X 10(6) U (7 patients) of human recombinant interferon alpha-2-A daily for 3 months by the intramuscular route, with progressive increase of dosage. This was followed in responders by a maintenance treatment consisting of 3 intramuscular injections per week in the same doses as those received at the end of the induction treatment. Out of 18 patients assessable for effectiveness, 1 had complete remission (7 months +) and 3 had partial response (52,61 and 82 days respectively), an overall improvement rate of 22%. The main side-effects observed were: pseudoinfluenza syndrome (100%), fatigue (100%), somnolence (95%), anorexia (90%) and haematological disorders. Dosage reduction was necessary in 13 of the 15 patients receiving 36 MU. This study shows that human recombinant interferon alpha-2-A has antitumoral activity in metastatic malignant melanoma. Other studies, notably with therapeutic combinations, are needed to determine the optimal dosage regimen of the drug and to increase its effectiveness.
22例转移性恶性黑色素瘤患者通过肌肉注射途径，每日接受36×10⁶U（15例患者）或18×10⁶U（7例患者）的人重组干扰素α-2-A治疗，为期3个月，剂量逐渐增加。对有反应者随后进行维持治疗，每周肌肉注射3次，剂量与诱导治疗结束时相同。在18例可评估疗效的患者中，1例完全缓解（7个月以上），3例部分缓解（分别为52、61和82天），总改善率为22%。观察到的主要副作用有：假性流感综合征（100%）、疲劳（100%）、嗜睡（95%）、厌食（90%）和血液系统疾病。接受36MU的15例患者中有13例需要减少剂量。本研究表明，人重组干扰素α-2-A在转移性恶性黑色素瘤中具有抗肿瘤活性。需要进行其他研究，尤其是联合治疗研究，以确定该药物的最佳剂量方案并提高其疗效。
