论文部分内容阅读
目的:通过前瞻性多中心Ⅱ期临床试验,观察重组人白细胞介素-2(125Ser-rhIL-2)对晚期实体肿瘤及恶性胸腹腔积液患者的疗效及不良反应。方法:180例入组患者可评价疗效者174例,癌性胸腹腔积液和实体瘤患者分别为126例和48例,肾透明细胞癌和恶性黑色素瘤等实体瘤采用皮下注射(200～300万IU,每周3次,疗程4～6周),胸腔内注射(200～300万IU,每周1～2次,疗程2周),恶性胸腔积液采用腹腔内注射(300～400万IU,每周1～2次,疗程2周)。结果:恶性胸腹腔积液和晚期实体瘤的总有效率分别为59.5%和25.0%,治疗后大部分患者生存质量和免疫功能有一定提高。主要的不良反应为低热、寒颤、乏力、局部皮肤红肿及消化道反应。未发现低血压及毛细血管渗漏综合征。结论:125Ser-rhIL-2对恶性黑色素瘤、肾透明细胞癌及恶性胸腹腔积液有效,不良反应较轻。
Objective: To observe the curative effect and adverse reactions of recombinant human interleukin-2 (125Ser-rhIL-2) in patients with advanced solid tumors and malignant pleural effusion by prospective multicenter phase Ⅱ clinical trial. Methods: One hundred and eighty patients were enrolled in this study. The curative effect was evaluated in 174 patients. 126 patients with malignant pleural effusion and solid tumors and 48 patients with solid tumors were treated with subcutaneous injection (200 ~ 300 Million IU, 3 times a week, treatment of 4 to 6 weeks), intrathoracic injection (200 ~ 3 million IU, 1 or 2 times a week, treatment for 2 weeks), malignant pleural effusion by intraperitoneal injection (300 ~ 4 million IU, 1 ~ 2 times a week, treatment for 2 weeks). Results: The total effective rates of malignant pleural effusion and ascites fluid were 59.5% and 25.0% respectively. After treatment, the quality of life and immune function of most patients were improved. The main adverse reactions were fever, chills, weakness, local skin irritation and digestive tract reactions. No hypotension and capillary leak syndrome found. Conclusion: 125Ser-rhIL-2 is effective in malignant melanoma, clear cell renal cell carcinoma and malignant pleural and peritoneal effusion with less adverse reactions.