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| 长春瑞宾(盖诺)治疗消化道癌多中心、随机对照Ⅲ期临床研究 | |
| 引用本文： | 洪专,潘良熹,郑秀立,冯继锋,魏荣富,谭清和,吴云,刘福平,邱少敏,茆俊卿.长春瑞宾(盖诺)治疗消化道癌多中心、随机对照Ⅲ期临床研究[J].实用临床医药杂志,2006,10(9):57-60. |
| 作者姓名： | 洪专 潘良熹 郑秀立 冯继锋 魏荣富 谭清和 吴云 刘福平 邱少敏 茆俊卿 |
| 作者单位： | 1. 江苏省肿瘤医院,肿瘤内科,江苏,南京,210009 2. 江苏省高淳县人民医院,肿瘤内科,江苏,高淳,211300 3. 江苏省南通市肿瘤医院,肿瘤内科,江苏,南通,226361 4. 江苏省淮安市楚州医院,肿瘤内科,江苏,淮安,223200 5. 江苏省句容市人民医院,肿瘤内科,江苏,句容,212400 6. 江苏省南京市肿瘤医院,肿瘤内科,江苏,南京,210003 7. 江苏省扬州市中医院,肿瘤内科,江苏,扬州,225002 |
| 基金项目： | 中国临床肿瘤学科学基金资助(CSCO2002) |
| 摘 要： | 目的采用多中心、随机对照的原则,研究长春瑞宾(盖诺)治疗晚期消化道肿瘤的作用及地位、临床疗效和安全性。方法来源于7家医院肿瘤科51例晚期消化道肿瘤,随机分成2组,盖诺组在FP方案(5-FU、DDP)基础上加盖诺25 mg/m2第1天、第5天静脉推注;对照组在FP方案基础上加VP-16 0.1第1~5天静滴。结果盖诺组总有效率RR 54.2%(13/24),CR率4.2%,PD率16.7%;对照组总有效率RR 40.7%(11/27),无CR,PD率29.6%。2组无统计学意义(P>0.05)。近期综合疗效盖诺组好转率高于对照组,进展率低于对照组,亦有显著意义(P<0.05)。结论长春瑞宾治疗晚期消化道肿瘤总有效率较高,近期综合疗效较好,长春瑞宾在消化道肿瘤上的作用及地位值得进一步研究。 |
| 关 键 词： | 消化道肿瘤 长春瑞宾 化学疗法 随机对照 |
| 文章编号： | 1672-2353(2006)05-0057-04 |
| 修稿时间： | 2005年12月6日 |
RANDOMIZED STUDY OF VINORELBINE IN ADVANCED DIGESTIVE TRACT CANCER: INITIAL RESULTS OF A PHASE Ⅲ MULTICENTER TRIAL |
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| HONG Zhuan,PAN Liang-xi,ZHENG Xiu-li,FENG Ji-feng,WEI Rong-fu,TAN Qing-he,WU Yun,LIU Fu-ping,QIU Shao-min,MAO Jun-qin.RANDOMIZED STUDY OF VINORELBINE IN ADVANCED DIGESTIVE TRACT CANCER: INITIAL RESULTS OF A PHASE Ⅲ MULTICENTER TRIAL[J].Journal of Clinical Medicine in Practice,2006,10(9):57-60. | |
| Authors: | HONG Zhuan PAN Liang-xi ZHENG Xiu-li FENG Ji-feng WEI Rong-fu TAN Qing-he WU Yun LIU Fu-ping QIU Shao-min MAO Jun-qin |
| Abstract: | Objective Evaluation of randomized study of domestic-made vinorelbine in advanced digestive tract cancer.A phase Ⅲ multicenter trial initial report.Methods 51 cases of stage Ⅲ～Ⅳ advanced digestive tract cancer were randomized in two groups: vinorelbine group and control group.Results Vinorelbine group: 54.2%(13/24) of response rate was achieved with 1 CR and 12 PR in all 24 cases.Control group: 40.7%(11/27) of response rate was achieved with 11 PR but no CR in all 27 cases(P>0.05). Main toxicity was neutropenia with occurrence rate of 87.5%(21/24)in vinorelbine group and 74.1%(20/27) in control group(P>0.05).Vinorelbine group is better than control group in comprehensive response rate(P<0.05).Conclusion Vinorelbine is an effective single drug in advanced digestive tract cancer.The adverse reactions are not severe,and further clinical study should be carried out. |
| Keywords: | advanced digestive tract cancer vinorelbine chemotherapy random/control trial |
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