食管癌、贲门癌患者术中植入5-氟尿嘧啶缓释剂安全性随机对照研究

A RANDOMIZED CONTROLLED STUDY OF SAFETY ABOUT IMPLANTING SUSTAINED RELEASE 5 -FLUOROURACIL DURING OPERATION IN PATIENTS WITH ESOPHAGEAL CANCER OR GASTRIC CARDIAC CARCINOMA

目的探讨术中植入5-氟尿嘧啶缓释剂行局部化疗在中晚期食管癌、贲门癌综合治疗的安全性。方法将90例食管癌、贲门癌患者随机分为试验组和对照组,其中试验组45例行食管/贲门癌根治术并在术中植入缓释性5-氟尿嘧啶;对照组45例单纯根治手术。在术前第1天和术后第7天分别检测2组患者血常规、肝肾功能,记录胸腔引流液体量和拔除胸腔引流管时间,术后2周内观察比较2组患者术后并发症和化疗不良反应的发生情况,进行统计学比较。结果术后2组患者血细胞数值及肝肾功能比较差异无统计学意义。试验组术后胸腔引流液量明显多于对照组(P<0.05),且拔除胸腔闭式引流管时间长于对照组(P<0.05),但不影响患者的病情恢复。试验组术后切口感染发生率为8.8%高于对照组的2.2%(P<0.05),其余术后并发症发生率差异无统计学意义(P>0.05)。结论术中植入临床推荐用药剂量的5-氟尿嘧啶缓释剂治疗食管/贲门癌是比较安全的。

Objective To evaluate the efficiency and safety of implanting sustained release 5 - fluorouracil during local chemotherapy with operation in combined therapy of esophageal cancer and gastric cardiac carcinoma. Methods All of the trial patients were randomly divided into two groups, control group and experimental groups,45 patients in each group. Sustained release 5 -fluorouracil were implanted during the radical operation in experimental groups, while 45 patients as control group received radical operation only. The liver and kindney funciions, blood cell count levels were measured on the 1 st day of pre - operation and the 7th day of post - operation respectively in all patients. The volume of thoracic drainage fluid and time of pulling out thoracic closed drainage tube were recorded. The postoperative complications and toxic side effects of chemotherapy in postoperative 2 weeks were observed and stastistieally analyzed. Results There were no significant differences in liver and kindney functions and blood cell count between the control group and the experimental group. The time of pulling out thoracic close drainage tube in experimental group was longer than in control group （ P 〈 O. 05 ） and the volume of postoperative thoracic drainage fluid in experimental group was more than in control group, which did not delay rehabilitation. The incidence rate of infection of incisional wound in experimental group was 8.8% and 2.2% in control group （ P 〈 O. 05 ）. The incidence rate of the postoperative complications had no significant difference. One patient had mild nausea symptom and 2 patient had mild diarrhoea symptom in experimental group while 1 patient had mild nausea symptom and 1 patient had mild diarrhoea symptom in control group in 2 weeks after operation. Other patients did not show any toxicity of chemotherapy in both groups. Conclusion Implanting sustained release 5 - fluorouracil in recommended clinical dose during operation is safe for esophageal cancer and gastric cardiac adenocarcinom.