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[目的]评价手术联合胸腔内留置重组人p53腺病毒(r Ad-p53)治疗非小细胞肺癌的围手术期的安全性。[方法]2013年2月1日至2014月6月30日共连续招募180例患者,最终非小细胞肺癌有效病例151例按随机数字进行完全随机化分组,分为手术联合r Ad-p53(试验组)75例和单纯手术治疗(对照组)76例,记录手术操作时间、术中出血量、术后胸腔引流量、胸引管留置时间,并观察围手术期并发症和不良反应。[结果]试验组和对照组在手术时间、术中出血量、术后3d内引流量、术后引流总量、胸引管留置时间、手术并发症等方面无统计学差异(P>0.05)。两组间在肝肾功能异常、血常规异常、心律失常的发生率以及发热程度等方面差异也无统计学意义(P>0.05)。[结论]外科手术联合胸腔内留置r Ad-p53是非小细胞肺癌的一种安全治疗方案。
[Objective] To evaluate the perioperative safety of combined surgery with thoracic and recombinant human p53 adenovirus (r Ad-p53) in the treatment of non-small cell lung cancer. [Methods] A total of 180 patients were enrolled continuously from February 1, 2013 to June 30, 2013. The final 151 patients with non-small cell lung cancer were randomly divided into randomized groups and were divided into operation combined with r Ad-p53 (N = 75) and surgery alone (n = 76). The operation time, intraoperative blood loss, postoperative thoracic drainage and indwelling thoracic catheter were recorded. Perioperative complications and adverse reactions were observed. [Results] There was no significant difference between the experimental group and the control group in operation time, intraoperative blood loss, drainage within 3 days after operation, total drainage after operation, indwelling time of thoracic tubes and complications of operation (P> 0.05) . There was no significant difference between the two groups in liver and kidney dysfunction, blood abnormalities, the incidence of arrhythmia and fever degree (P> 0.05). [Conclusion] Surgical operation combined with pleural indwelling r-p53 is a safe treatment for non-small cell lung cancer.