替吉奥联合康艾注射液治疗晚期非小细胞肺癌的临床效果(1)
[摘要] 目的 比较替吉奥联合康艾注射液与多西他赛治疗晚期非小细胞肺癌(NSCLC)的临床效果和安全性。 方法 回顾性分析了河北港口集团有限公司港口医院2010年1月～2015年3月96例经一线和/或二线化疗失败的晚期NSCLC患者采用区组随机化法分为联合康艾注射液组(A组)和多西他赛组(B组)，每组48例。A组：替吉奥80 mg/(m2·d)，分2次口服，康艾注射液60 mL，静滴qd，d1-14，B组：多西他赛75 mg/m2，静滴d1，21 d为一个周期。 结果 两组的中位总生存(OS)分别为9.5个月和10.0个月，中位无进展生存(PFS)分别为2.8个月和4.2个月；两组的客观缓解率(ORR)分别为6.25%和8.33%，疾病控制率(DCR)分别为39.58%和43.75%。差异无统计学意义(P > 0.05)。A组在血液学毒性、恶心呕吐、乏力、感染性发热等方面的不良反应明显低于B组(P < 0.05)。 结论 替吉奥联合康艾注射液与多西他赛治疗晚期NSCLC的效果相当，但毒副作用较低，耐受性更好，适用于晚期NSCLC的临床治疗。
[关键词] 替吉奥；康艾注射液；多西他赛；晚期非小细胞肺癌
[中图分类号] R734.2 [文献标识码] A [文章编号] 1673-7210(2016)05(a)-0125-04
[Abstract] Objective To compare the efficacy and safety of S‐1 plus Kang'ai injection and docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC). Methods 96 patients with the failure of one or more regimens of systemic chemotherapy in Hebei Port Holdings Limited Port Hospital from January 2010 to March 2015 were retrospectively studied and divided into S-1 plus Kang'ai Injection group (group A) and Docetaxel group (group B) by block randomization， with 48 cases in each group. group A： received oral S-1 (80 mg/m2) in two divided doses daily and Kang'ai injection (60 mL/d) as an iv infusion， qd， on days 1–14； group B： received docetaxel (75 mg/m2) intravenously on day 1. Repeated every 21 days. Results The median OS of two groups were 9.5 months and 10.0 months， and the median PFS of two groups were 2.8 months and 4.2 months respectively. The ORR of two groups were 6.25% and 8.33%， and the DCR of two groups were 39.58% and 43.75% respectively. The difference was not statistically significant. The adverse reactions of group A in hematological toxicity， nausea， vomiting， fatigue and infectious fever were significantly lower than those of group B (P < 0.05). Conclusion Clinical effectiveness of S-1 plus Kang'ai injection and docetaxel in the treatment of advanced NSCLC is equal， but the toxicity is lower， and the tolerance is better， and it is suitable for the clinical treatment of advanced NSCLC.
[Key words] S-I； Kang'ai Injection； Docetaxel； Advanced non-small cell lung cancer
肺癌是世界最常见的恶性肿瘤之一，非小细胞肺癌(non-small cell lung cancer，NSCLC)占肺癌总数的85%，是最为常见的肺癌[1]。本项目旨在针对一线和/或二线化疗失败的晚期NSCLC患者，分析对比了替吉奥联合康艾注射液与单药多西他赛对其治疗的临床效果与安全性，以期探索这一中西医结合治疗的新模式与常规化疗相比较是否具有优越性。
1 资料与方法
1.1 一般资料
选取2010年1月～2015年3月河北港口集团有限公司港口医院肿瘤内科确诊的晚期NSCLC患者96例。入选病例病灶为可评估、可测量病灶；所有患者接受过标准的一线和/或二线化疗(未接受过紫杉类抗癌药物化疗)，病情进展，行为状态(KPS)评分≥70分，且与末次化疗间隔时间至少1个月；预计生存期大于3个月；无严重的脏器功能损害；其基线血常规、尿便常规、肝肾功能及心电图等检查均符合化疗适应证。将96例患者采用区组随机化方法分为2组，分别为替吉奥联合康艾注射液组(A组)和多西他赛组(B组)，每组各48例。患者一般资料比较差异无统计学意义(P > 0.05)，具有可比性。见表1。 (杨君 韩莹 王爱辉 郭晓辉)
[关键词] 替吉奥；康艾注射液；多西他赛；晚期非小细胞肺癌
[中图分类号] R734.2 [文献标识码] A [文章编号] 1673-7210(2016)05(a)-0125-04
[Abstract] Objective To compare the efficacy and safety of S‐1 plus Kang'ai injection and docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC). Methods 96 patients with the failure of one or more regimens of systemic chemotherapy in Hebei Port Holdings Limited Port Hospital from January 2010 to March 2015 were retrospectively studied and divided into S-1 plus Kang'ai Injection group (group A) and Docetaxel group (group B) by block randomization， with 48 cases in each group. group A： received oral S-1 (80 mg/m2) in two divided doses daily and Kang'ai injection (60 mL/d) as an iv infusion， qd， on days 1–14； group B： received docetaxel (75 mg/m2) intravenously on day 1. Repeated every 21 days. Results The median OS of two groups were 9.5 months and 10.0 months， and the median PFS of two groups were 2.8 months and 4.2 months respectively. The ORR of two groups were 6.25% and 8.33%， and the DCR of two groups were 39.58% and 43.75% respectively. The difference was not statistically significant. The adverse reactions of group A in hematological toxicity， nausea， vomiting， fatigue and infectious fever were significantly lower than those of group B (P < 0.05). Conclusion Clinical effectiveness of S-1 plus Kang'ai injection and docetaxel in the treatment of advanced NSCLC is equal， but the toxicity is lower， and the tolerance is better， and it is suitable for the clinical treatment of advanced NSCLC.
[Key words] S-I； Kang'ai Injection； Docetaxel； Advanced non-small cell lung cancer
肺癌是世界最常见的恶性肿瘤之一，非小细胞肺癌(non-small cell lung cancer，NSCLC)占肺癌总数的85%，是最为常见的肺癌[1]。本项目旨在针对一线和/或二线化疗失败的晚期NSCLC患者，分析对比了替吉奥联合康艾注射液与单药多西他赛对其治疗的临床效果与安全性，以期探索这一中西医结合治疗的新模式与常规化疗相比较是否具有优越性。
1 资料与方法
1.1 一般资料
选取2010年1月～2015年3月河北港口集团有限公司港口医院肿瘤内科确诊的晚期NSCLC患者96例。入选病例病灶为可评估、可测量病灶；所有患者接受过标准的一线和/或二线化疗(未接受过紫杉类抗癌药物化疗)，病情进展，行为状态(KPS)评分≥70分，且与末次化疗间隔时间至少1个月；预计生存期大于3个月；无严重的脏器功能损害；其基线血常规、尿便常规、肝肾功能及心电图等检查均符合化疗适应证。将96例患者采用区组随机化方法分为2组，分别为替吉奥联合康艾注射液组(A组)和多西他赛组(B组)，每组各48例。患者一般资料比较差异无统计学意义(P > 0.05)，具有可比性。见表1。 (杨君 韩莹 王爱辉 郭晓辉)