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目的 探究克唑替尼联合紫杉醇和顺铂治疗间变淋巴瘤激酶(ALK)阳性非小细胞肺癌(NSCLC)的临床疗效。方法 选取2012年1月-2014年3月在榆林市第一医院接受治疗的ALK阳性NSCLC患者67例,随机分为对照组(33例)和治疗组(34例)。对照组静脉滴注紫杉醇注射液175 mg/m2,1次/d;并于停药30 min后静脉滴注顺铂注射液75 mg/m2,1次/d。治疗组在对照组基础上口服克唑替尼胶囊,1粒/次,2粒/d。两组均治疗2个月,并随访24个月。观察两组的临床疗效,比较两组的血清肿瘤标志物、不良反应和生存率。结果 治疗后,对照组和治疗组的有效率分别为27.27%、61.76%,两组比较差异有统计学意义(P<0.05)。治疗后,两组癌胚抗原(CEA)、糖类抗原(CA125)和细胞角蛋白19片段(CYFRA21-1)水平均显著降低,同组治疗前后比较差异有统计学意义(P<0.05、0.01);且治疗组这些观察指标的下降程度明显优于对照组,两组比较差异具有统计学意义(P<0.05)。随访后,对照组和治疗组的死亡率分别为24.24%、14.71%,中位无进展生存期(PFS)分别为13、17个月,两组比较差异有统计学意义(P<0.05)。结论 克唑替尼联合紫杉醇和顺铂治疗ALK阳性NSCLC具有较好的临床疗效,可降低血清肿瘤标志物水平,延长中位PFS,提高患者的生存率,具有一定的临床推广应用价值。
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[Abstract]
Objective To investigate the clinical effect of crizotinib combined with paclitaxel and cisplatin in treatment of anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC). Methods Patients (67 cases) with NSCLC in the First Hospital of Yulin from January 2012 to March 2015 were randomly divided into control group (33 cases) and treatment group (34 cases). Patients in the control group were iv administered with Paclitaxel Injection 175 mg/m2, once daily. And Patients in the control group were also iv administered with Cisplatin Injection 75 mg/m2, once daily. Patients in the treatment group were po administered with Crizotinib Capsules on the basis of the control group, 1 grain/time, twice daily. Patients in two groups were treated for 2 months, and followed up for 24 months. After treatment, the clinical efficacies were evaluated, and serum tumor marker, adverse reaction, and survival rate in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 27.27% and 61.76%, respectively, and there was difference between two groups (P<0.05). After treatment, the levels of CEA, CA125, and CYFRA21-1 in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05, 0.01). And the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups (P<0.05). After follow-up, the mortality rate in the control and treatment groups were 24.24% and 14.71%, respectively, the median PFS in the control and treatment groups were 13 and 17 months, respectively, and there was difference between two groups (P<0.05). Conclusion Crizotinib combined with paclitaxel and cisplatin has clinical curative effect in treatment of ALK positive NSCLC, can decrease serum tumor marker, extend median PFS, and improve survival rate, which has a certain clinical application value.
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