Gemcitabine治疗晚期非小细胞肺癌的临床研究

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目的:评价Gemcitabine(中文译名:健择)单药及其与顺氯铵铂联合化疗方案治疗II、IV期非小细胞肺癌(NSCLC)的临床疗效及其不良反应。材料与方法:1健择单药研究:从1997年9月至1998年5月入选II、IV期NSCLC病人21例,以前未接受过任何化疗、放疗。II期病人11例,IV期病人10例。健择1000mg/m2,第1,8,15天各注一次,每28天为一疗程。2健择与顺氯铵铂联合化疗研究:从1997年10月至1998年7月入选II、IV期NSCLC病人48例,以前未接受过任何化疗、放疗。II期病人19例,IV期病人29例。健择1000mg/m2,第1,8,15天各注一次;顺氯铵铂100mg/m2,第一天用,每28天为一疗程。结果:1健择单药研究:可评价疗效的有19例,6例获部分缓解(PR),其中2例(105%)经4周以上复查证实。总有效率315%[95%CI,94%~4515%]。全组均可评价不良反应,少数病人发生轻微胃肠道反应、白细胞下降、血红蛋白下降和血小板下降,只有48%(各1例)患者发生II度的恶心呕吐及白细胞下降,有1例患者发生II度感染。全组中位生存期613月。2? OBJECTIVE: To evaluate the clinical efficacy and adverse reactions of Gemcitabine (Gemzard) and its combination with cisplatin in the treatment of stage II and IV non-small cell lung cancer (NSCLC). Materials and Methods: 1Study of Ginseng monotherapy: From September 1997 to May 1998, 21 patients with stage II and IV NSCLC were enrolled in the study. They had not received any chemotherapy or radiotherapy before. There were 11 patients with stage II disease and 10 patients with stage IV disease. Gemza 1000mg/m2, each one on the first, eighth and fifteen days, each 28 days is a course of treatment. (2) Combination chemotherapy with cisplatin and cisplatin: From October 1997 to July 1998, 48 patients with stage II and IV NSCLC were enrolled in the study. No chemotherapy or radiotherapy had been received before. There were 19 patients in stage II and 29 in stage IV. GemZe 1000mg/m2, once each on the 1st, 8th and 15th days; cisplatin platinum 100mg/m2, on the first day, every 28 days as a course of treatment. RESULTS: 1Study of Gemzard monotherapy: 19 cases were evaluated for efficacy, 6 cases were partially relieved (PR), and 2 cases (105%) were confirmed after more than 4 weeks of review. The total effective rate is 315% [95% CI, 94%~4515%]. Adverse reactions were evaluated in all groups. A small number of patients experienced mild gastrointestinal reactions, leukopenia, hemoglobin drop, and platelet drop. Only 4.8% of patients (one patient) developed grade II nausea and vomiting and leukopenia, and there was one case. The patient developed a grade II infection. The median survival time was 6 months and 13 months. 2?
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