硫酸长春地辛Ⅲ期临床试验总结  

Phase Ⅲ Clinical Study of Vindesine

作　　者：徐瑞华[1] 管忠震[1] 

机构地区：[1]中山医科大学肿瘤医院内科

出　　处：《癌症》1998年第3期197-200,共4页Chinese Journal of Cancer

摘　　要：目的：评价国产硫酸长春地辛（ＶＤＳ）治疗多种恶性肿瘤的疗效及其不良反应。方法：从１９９６年１月至１９９７年７月选择了不同肿瘤共６１０例，应用不同的含ＶＤＳ的联合化疗方案，每例至少化疗２程，按ＷＨＯ疗效及毒性标准进行评价。结果：能评价疗效的有５２３例，总的有效率为５４．３％，其中非小细胞肺癌为４４．２％、小细胞肺癌为６２．１％、非何杰金氏淋巴瘤为８８．７％、乳腺癌为６２．５％、食管癌为５６．４％、胃肠道癌为４１．７％。全组均可评价不良反应，主要的不良反应为血白细胞下降、恶心呕吐，脱发，及外周神经毒性，多为Ⅰ～Ⅱ级。结论：该药联合化疗对多种肿瘤有客观疗效，不良反应能耐受。Purpose: The purpose of this Phase Ⅲ clinical trial was to evaluate the efficacy and the toxicity of Vindesine. Method: 610 cases of various maglinancies were treated with vindesine-containing combinantion regimens from Jan 1996 to July 1997. Each patient was given at least 2 cycles of VDS-containing combination chemotherapy. The response and the toxicity of chemotherapy were assessed according to the WHO criteria. Result: The overall response rate in 523 evaluable patients was 54.3%, and the RR in some kinds of tumor were: NSCLC 44.2%, SCLC 62.1%, NHL 88.7%, Breast Cancer 62.5%, Esophageal Carcinoma 56.4%, Stamach and colorectal concer 41.7%. The main side effects were Grade I-II Leucopenia, vomiting, alopecia and peripheral neurotoxicity. Conclusion: This trial confirmed that Vindesine was an effective drug in the treatment of various maglignancies, and this drug was well tolerated.

关 键 词：硫酸长春地辛 疗效 副作用 肿瘤 药物疗法 

分 类 号：R730.53[医药卫生—肿瘤] R979.1[医药卫生—临床医学]