目的 研究康莱特注射液腹腔热灌注联合替吉奥和紫杉醇对进展期胃癌的不良反应及安全性。方法 选择2016年1月-2018年1月陕西省肿瘤医院治疗的60例进展期胃癌患者作为研究对象，用抽签法随机将患者分为对照组和观察组，每组各30例。对照组患者在第1~14 d口服替吉奥胶囊，80 mg/（m²·d）；并在第1天和第8天静脉滴注紫杉醇注射液135 mg/m²。观察组在对照组的基础上，在化疗第1天时开展腹腔热灌注治疗，把2 500 mL的0.9%氯化钠注射液注入一次性的药袋中，加热后按照20 mL/min的速度灌注入患者的腹腔内，然后把200 mL康莱特注射液加入500 mL的0.9%氯化钠注射液，迅速且恒温地滴入患者的腹腔中，灌注时间为1 h。每周治疗1次，共连续4周。观察两组患者的不良反应发生情况、生存率、复发率及平均生存时间，同时比较白细胞介素-10（IL-10）和白细胞介素-2（IL-2）水平。结果 治疗后，两组的血清IL-2水平明显降低，IL-10水平明显升高（P<0.05），且观察组IL-2水平显著低于对照组，IL-10水平高于对照组（P<0.05）。观察组生存率及平均生存时间显著高于对照组（P<0.05），复发率显著低于对照组（P<0.05）。结论 康莱特注射液腹腔热灌注联合替吉奥和紫杉醇能降低进展期胃癌患者的复发率，提高生存率，明显增强免疫力，安全可靠。

Objective To study the adverse reactions and safety of Kanglaite intraperitoneal thermal perfusion combined with tegafur, gimeracil and oteracil potassium, and paclitaxel in advanced gastric cancer. Methods A total of 60 patients with advanced gastric cancer treated in Shaanxi Provincial Cancer Hospital from January 2016 to January 2018 were selected as study subjects, and randomly divided into control group and observation group by lottery, with 30 patients in each group. Patients in the control group were po administered with given Tegafur, Gimeracil and Oteracil Potassium Capsules for 80 mg/(m²·d) on the 1st to 14th day, and iv administered with Paclitaxel Injection for 135 mg/m² on day 1 and 8. On the basis of the control group, patients in the observation group was given intraperitoneal hyperthermic perfusion therapy on the first day of chemotherapy. 2 500 mL of 0.9% sodium chloride injection was injected into the disposable medicine bag. After heating, the patient's abdominal cavity was perfused at the speed of 20 mL/min. Then, 200 mL Kanglaite Injection were added into 500 mL Sodium chloride injection, was infused into the abdominal cavity of the patient rapidly and stably for 1 h. Once a week for 4 weeks. After treatment, the occurrence of adverse reactions, survival rate, recurrence rate, and average survival time of patients in two groups were observed, and the levels of IL-10 and IL-2 were also compared. Results After treatment, serum levels of IL-2 was significantly decreased, but IL-10 were significantly increased (P<0.05), and the levels of IL-2 in the observation group was significantly lower than that of the control group, IL-10 level was significantly higher than that of the control group (P<0.05). The survival rate and average survival time of the observation group were significantly higher than those of the control group (P<0.05), and the recurrence rate was significantly lower than that of the control group (P<0.05). Conclusion Kanglaite Injection intraperitoneal thermal perfusion combined with tegafur, gimeracil and oteracil potassium, and paclitaxel can reduce the recurrence rate of advanced gastric cancer patients, improve the survival rate, significantly enhance the immunity, safe and reliable.

R979.1

陕西省科学技术研究发展计划项目（2014K11-01-02-12）