Vonderheid E C, Thompson R, Smiles K A, Lattanand A
Arch Dermatol. 1987 Jun;123(6):757-63.
A two-part clinical trial was conducted to determine the therapeutic efficacy of recombinant interferon alfa-2b in plaque-phase mycosis fungoides. In an initial randomized double-blind study, each of six patients had two representative plaques injected intralesionally with 1 X 10(6) U of recombinant interferon alfa-2b per site and two control plaques injected with placebo three times weekly for four consecutive weeks. Complete clinical regression of disease was observed at ten of 12 recombinant interferon alfa-2b sites compared with one of 12 placebo-treated sites four weeks after treatment with injections was stopped. Subsequently, in an open-labeled study, five of these patients were treated intramuscularly with 5 X 10(6) U of recombinant interferon alfa-2b three times weekly for four weeks and two patients were treated with a second, more extended course of therapy lasting 12 to 16 weeks. Three of the five patients treated systemically showed some improvement overall, but the responses were judged not to be clinically significant. The differential response observed from intralesional and intramuscular injections may be related to differences in concentration of recombinant interferon alfa-2b achieved in lesional skin by the two methods of administration.
进行了一项分为两部分的临床试验，以确定重组干扰素α-2b在斑块期蕈样肉芽肿中的治疗效果。在最初的随机双盲研究中，6名患者每人有两个代表性斑块，每个斑块内注射1×10⁶U重组干扰素α-2b，每周3次，连续4周，另外两个对照斑块注射安慰剂。在停止注射治疗4周后，12个重组干扰素α-2b注射部位中有10个观察到疾病完全临床消退，而12个安慰剂治疗部位中只有1个。随后，在一项开放标签研究中，其中5名患者每周3次肌肉注射5×10⁶U重组干扰素α-2b，持续4周，2名患者接受第二个更长疗程的治疗，持续12至16周。全身治疗的5名患者中有3名总体上有一些改善，但这些反应被判定在临床上不显著。从皮损内注射和肌肉注射观察到的差异反应可能与两种给药方法在皮损内皮肤中达到的重组干扰素α-2b浓度差异有关。
