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共１５例恶性肿瘤病人接受了白介素－２（ＩＬ－２）的Ⅰ期临床试验，ＩＬ－２每周静脉滴注一次或每天静脉滴注一次连用４天，共治疗４周。５组病人分别接受ＩＬ－２的５个剂量级别治疗：第一组３０万单位；第２组６０万单位；第三组１２０万单位；第四组１２０万单位分４天用；第五组２１０万单位。毒性反应与剂量有关，主要包括发热、寒战、低血压、疲乏、恶心和呕吐。低血压为剂量限制性毒性。当ＩＬ－２剂量升至６０万单位时开始出现低血压，剂量再增高时低血压加重。最大耐受剂量（ＭＴＤ）为２１０万单位。本试验帮助了解ＩＬ－２的毒性反应及耐受性，将有助于ＩＬ－２Ⅱ期临床试验的设计与开展。
A total of 15 patients with malignant tumors received phase I clinical trial of interleukin-2 (IL-2), once weekly intravenous infusion of IL-2 or daily intravenous infusion for 4 days for 4 weeks. Five groups received five doses of IL-2: 300,000 units in the first group, 600,000 units in the second group, 1.2 million units in the third group, and 1.2 million units in the fourth group for four days. The fifth group 2.1 million units. Toxicity and dose-related, including fever, chills, hypotension, fatigue, nausea and vomiting. Hypotension is dose-limiting toxicity. Hypotension began to occur when the IL-2 dose increased to 600,000 units and hypotension was increased when the dose was increased. The maximum tolerated dose (MTD) was 2.1 million units. This experiment helps to understand the toxicity and tolerance of IL-2, will help IL-2 Ⅱ clinical trial design and development.