目的 研究康萊特注射液腹腔熱灌注聯(lián)合替吉奧和紫杉醇對進(jìn)展期胃癌的不良反應(yīng)及安全性。方法 選擇2016年1月-2018年1月陜西省腫瘤醫(yī)院治療的60例進(jìn)展期胃癌患者作為研究對象，用抽簽法隨機(jī)將患者分為對照組和觀察組，每組各30例。對照組患者在第1~14 d口服替吉奧膠囊，80 mg/（m²·d）；并在第1天和第8天靜脈滴注紫杉醇注射液135 mg/m²。觀察組在對照組的基礎(chǔ)上，在化療第1天時開展腹腔熱灌注治療，把2 500 mL的0.9%氯化鈉注射液注入一次性的藥袋中，加熱后按照20 mL/min的速度灌注入患者的腹腔內(nèi)，然后把200 mL康萊特注射液加入500 mL的0.9%氯化鈉注射液，迅速且恒溫地滴入患者的腹腔中，灌注時間為1 h。每周治療1次，共連續(xù)4周。觀察兩組患者的不良反應(yīng)發(fā)生情況、生存率、復(fù)發(fā)率及平均生存時間，同時比較白細(xì)胞介素-10（IL-10）和白細(xì)胞介素-2（IL-2）水平。結(jié)果 治療后，兩組的血清IL-2水平明顯降低，IL-10水平明顯升高（P<0.05），且觀察組IL-2水平顯著低于對照組，IL-10水平高于對照組（P<0.05）。觀察組生存率及平均生存時間顯著高于對照組（P<0.05），復(fù)發(fā)率顯著低于對照組（P<0.05）。結(jié)論 康萊特注射液腹腔熱灌注聯(lián)合替吉奧和紫杉醇能降低進(jìn)展期胃癌患者的復(fù)發(fā)率，提高生存率，明顯增強(qiáng)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

陜西省科學(xué)技術(shù)研究發(fā)展計(jì)劃項(xiàng)目（2014K11-01-02-12）