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目的探索恩度联合同步放化疗治疗局部晚期非小细胞肺癌(NSCLC)的临床疗效、毒副反应及耐受性。方法经过病理组织学或细胞学检查确诊的局部晚期(ⅢA、ⅢB)非小细胞肺癌患者46例,随机分成同步放化疗联合恩度治疗组(试验组23例)和同步放化疗组(对照组23例)。采用调强放疗技术对肿瘤区域以及累及淋巴结区域进行放疗,总剂量DT 60~76Gy/30~38次,共6~8周。同步化疗长春瑞滨20 mg/m2第1、8 d,顺铂30 mg/m2第1~3天,21~28 d为1个周期,共3~4个周期。重组人血管内皮抑素15 mg/d,第1~14天连续给药,与化疗同步进行。按照RECIST标准评价近期疗效,参照Karnofsky评分(KPS)变化评价生活质量(QoL),按照NCI CTC 3.0版标准评价毒性反应。结果试验组和对照组总有效率(CR+PR)分别为78.3%(18/23)和69.6%(16/23)(P>0.05),QoL改善稳定率为86.9%(20/23)和82.6%(19/23)(P>0.05)。1年的生存率分别为74.1%(17/23)和65.5%(15/23),1年无进展生存率为56.7%(13/23)和52.3%(12/23),1年的局部控制率为78.3%(18/23)和65.4%(15/23)(P>0.05)。主要毒副反应是骨髓抑制和消化道反应,试验组中4例患者出现暂时性的心电图改变,经过对症处理后均能够恢复正常。结论恩度联合同步放化疗组具有良好的近期疗效,能够改善或稳定生活质量,毒性较低,安全性和耐受性比较好,其1年生存率、1年无进展生存率以及1年局控率较单纯同步放化疗均有所提高,但是差异无统计学意义。
Objective To explore the clinical efficacy, side effects and tolerability of Endue combined with concurrent chemoradiotherapy in the treatment of locally advanced non-small cell lung cancer (NSCLC). Methods Forty-six patients with locally advanced (ⅢA, ⅢB) non-small cell lung cancer diagnosed by histopathology or cytology were randomly divided into concurrent chemoradiotherapy and enamel treatment group (23 cases) and concurrent chemoradiotherapy group (control group 23 cases). The use of intensity modulated radiotherapy for tumor area and involved lymph node area radiation, the total dose of DT 60 ~ 76Gy / 30 ~ 38 times, a total of 6 to 8 weeks. Chemotherapy vinorelbine 20 mg / m2 on the first 1,8 d, cisplatin 30 mg / m2 on the first 3 days, 21 ~ 28 d for a period of 3 to 4 cycles. Recombinant human endostatin 15 mg / d, the first to 14 days of continuous administration, in parallel with chemotherapy. The short-term efficacy was evaluated according to the RECIST criteria, QoL was evaluated according to Karnofsky score (KPS), and toxicity was evaluated according to NCI CTC version 3.0. Results The total effective rate (CR + PR) in the experimental and control groups were 78.3% (18/23) and 69.6% (16/23), respectively. The improvement rate of QoL was 86.9% (20/23) 82.6% (19/23) (P> 0.05). The 1-year survival rates were 74.1% (17/23) and 65.5% (15/23), respectively. The 1-year progression-free survival rates were 56.7% (13/23) and 52.3% (12/23) Control rates were 78.3% (18/23) and 65.4% (15/23) (P> 0.05). The main toxicities were myelosuppression and digestive tract reaction. Four patients in the experimental group had transient ECG changes and returned to normal after symptomatic treatment. Conclusions Endo combined with concurrent chemoradiotherapy has good short-term curative effect, which can improve or stabilize the quality of life, lower toxicity, better safety and tolerability, and its 1-year survival rate, 1-year progression-free survival rate and 1-year bureau Control rate than simple concurrent chemoradiotherapy have increased, but the difference was not statistically significant.