重组人白细胞介素-2治疗实体瘤及胸腹水Ⅲ期临床研究  

PHASE Ⅲ CLINICAL STUDY OF INTERLEUKIN2 IN TREATMENT OF SOLID TUMORS AND MALIGNANT EFFUSIONS

作　　者：孙燕 张弘纲 彭民 颜敏 张和平 

出　　处：《中国新药杂志》1998年第3期171-174,共4页Chinese Journal of New Drugs

摘　　要：目的：通过多中心前瞻性Ⅲ期临床试验进一步观察重组人白细胞介素２（ｒｈＩＬ２）的疗效和不良反应。方法：分为静脉注射、介入治疗、腔内注射和加用ＬＡＫ细胞等。结果：可统计近期疗效３１５例。治疗后完全缓解２３例，部分缓解１１９例，好转２７例，稳定１１８例，进展２８例，总有效率为４５．１％。单用ｒｈＩＬ２治疗胸腹腔积液９０例，ｒｈＩＬ２加ＬＡＫ治疗１０例，ｒｈＩＬ２加化疗治疗９例，有效率分别为７６．７％，９０．０％，１００．０％。单用治疗实体瘤９９例，加ＬＡＫ细胞治疗４９例，ｒｈＩＬ２加化疗５８例，有效率分别为１４．１％，１４．３％和５８．６％。大部分病人治后生活质量、免疫功能有一定程度提高。不良反应主要表现为流感样症状如寒战、发热和不同程度的消化道反应等。结论：注射用ｒｈＩＬ２的疗效和不良反应与Ⅱ期临床研究相近，在临床上是安全、有效的。OBJECTIVE:To observe the efficacy and ADRs of interleukin2.METHODS:A multicenter prospective study was conducted on 350 patients and interleukin2(IL2)was given by infusion,intervention,intracavitary injection or together with lymphokineactivated killer(LAK)cell.RESULTS:There are 315 evaluable cases.Among them 23 patients reached CR,119 reached PR,27 MR,118 SD,and 28 PD after treatment with a total response rate of 45.1%.The response rate in 90 effusion patients treated with IL2 alone;in 10 cases treated with IL2 plus LAK cell and in 9 cases treated with IL2 plus chemotherapy were 76.7%,90.0% and 100% respectively.The response rate in 99 patients with solid tumors who received IL2 alone was 14.1%;that in 49 patients received IL2 plus LAK cell was 14.3%;and that in 48 patients received IL2 plus chemotherapy was 58.6%.The ADRs were mainly flulike reaction and fever as well as gastrointestinal effects. CONCLUSION:IL2 is safe and effective in clinical use and the efficacy and ADRs obtained in this study are similar to that in the phase Ⅱ study.

关 键 词：癌性胸水 胸水 腹腔积液 黑色素瘤 肾癌 RHIL-2 

分 类 号：R730.51[医药卫生—肿瘤]