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目的观察雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期胃癌的临床疗效及安全性。方法将80例晚期胃癌患者随机分成对照组40例和试验组40例。对照组予以顺铂20 mg·m~(-2),静脉滴注,第1~5天+5-氟尿嘧啶500mg·m~(-2),静脉滴注4 h,第1~5天;试验组予以雷替曲塞3 mg·m~(-2),静脉滴注15 min,第1天+奥沙利铂130 mg·m~(-2),静脉滴注3 h,第1天。2组患者一个疗程均为28 d,共治疗2个疗程。比较2组患者的近期疗效、中位生存时间和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为45.00%(18/40例)和42.50%(17/40例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的中位生存时间分别为(12.68±5.26)和(8.81±5.78)个月,差异有统计学意义(P<0.05)。2组患者的药物不良反应主要有骨髓抑制、腹泻、口腔黏膜炎和神经毒性。试验组和对照组的药物不良反应发生率分别为57.50%和62.50%,差异无统计学意义(P>0.05)。结论雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期胃癌的临床疗效和安全性与顺铂注射剂联合5-氟尿嘧啶注射剂相当,但前者可显著延长患者的中位生存时间。
Objective To observe the clinical efficacy and safety of raltitrexed injection combined with oxaliplatin injection in the treatment of advanced gastric cancer. Methods Eighty patients with advanced gastric cancer were randomly divided into control group (40 cases) and experimental group (40 cases). The control group was treated with cisplatin 20 mg · m -2, intravenously dripped for 1 to 5 days and 5-fluorouracil 500 mg · m -2, iv for 1 to 5 days. The patients were treated with raltitrexed 3 mg · m ~ (-2), intravenously for 15 min on day 1 + oxaliplatin 130 mg · m -2, intravenously for 3 h on the first day. Two groups of patients with a course of 28 days, a total of 2 courses of treatment. The short-term efficacy, median survival time and adverse drug reactions in two groups were compared. Results After treatment, the total effective rate was 45.00% (18/40 cases) and 42.50% (17/40 cases) in experimental group and control group, respectively, with no significant difference (P> 0.05). After treatment, the median survival time was (12.68 ± 5.26) and (8.81 ± 5.78) months in experimental and control groups, respectively, with significant difference (P <0.05). Adverse drug reactions in the two groups were primarily bone marrow suppression, diarrhea, oral mucositis and neurotoxicity. The incidence of adverse drug reactions in the experimental group and the control group were 57.50% and 62.50%, respectively, with no significant difference (P> 0.05). Conclusion The efficacy and safety of raltetracetam injection combined with oxaliplatin injection in the treatment of advanced gastric cancer is comparable to cisplatin injection plus 5-fluorouracil injection, but the former can significantly prolong the median survival time.