目的 探讨曲妥珠单抗联合IP方案（伊立替康＋顺铂）治疗人类表皮因子受体-2（HER-2）阳性晚期胃癌的疗效和安全性。方法 选取襄阳市中心医院在2014年1月-2015年1月收治的72例HER-2阳性晚期胃癌患者进行研究，随机分为对照组和治疗组，每组各36例。对照组给予IP方案化疗，即在治疗的第1、8天静脉滴注盐酸伊立替康注射液60 mg/m²；并在治疗的第1～3天静脉滴注注射用顺铂30 mg/m²。治疗组在对照组的基础上于治疗的第1天静脉滴注注射用曲妥珠单抗8 mg/kg，并于随后的每个治疗周期的第1天静脉滴注注射用曲妥珠单抗6 mg/kg。两组患者均连续治疗2个周期，每个周期为21 d。依据改良版实体肿瘤疗效评价标准（mRECIST）评价其临床疗效，依据不良反应标准（CTC第3版）评价治疗期间出现的不良反应。观察并记录两组患者的疾病无进展生存期（PFS）、中位总生存时间（mOS）、1年生存率。结果 治疗后，对照组的客观有效率（ORR）和疾病控制率（DCR）分别为36.1%、66.7%，治疗组的ORR、DCR分别为58.3%、88.9%，两组ORR、DCR比较差异均有统计学意义（P<0.05）。两组患者骨髓抑制、神经毒性、肝功能异常、恶心呕吐、腹泻发生率组间比较差异不显著。对照组的PFS、mOS分别为6.1、10.9个月，治疗组的PFS、mOS分别为8.5、13.2个月，两组PFS、mOS组间比较差异有统计学意义（P<0.05）。对照组的1年生存率为43.6%，治疗组1年生存率为44.8%，组间比较差异无统计学意义。结论 曲妥珠单抗联合IP方案治疗HER2阳性晚期胃癌的疗效确切，近期疗效、远期疗效和安全性较高，值得临床推广应用。

Objective To study the effect and safety of trastuzumab combined with IP chemotherapy scheme (irinotecan+cisplatin) in the treatment of human epidermal growth factor receptor 2 (HER-2) positive advanced gastric cancer. Methods Patients (72 cases) with HER-2 positive advanced gastric cancer in Xiangyang Central Hospital from January 2013 to January 2014 were randomly divided into control group and treatment groups,, and each group had 36 cases. The patients in the control group were treated with IP chemotherapy scheme, and were iv administered with Irinotecan Hydrochloride Injection of 60 mg/m², given on days 1 and 8. And they were also iv administered with Cisplatin for injection of 30 mg/m² on days 1 to 3. The patients in treatment group were iv administered with Trastuzumab Injection 8 mg/kg on the basis of the control group in the first day, and the dosages were changed to 6 mg/kg in the next treatment time. The patients in two groups were treated for two courses, and a course had 21 d. After treatment, the clinical efficacies were evaluated according to the modified version of entity tumor response evaluation criteria mRCIST, and adverse drug reactions were observed according to the standard of adverse reaction (CTC Third Edition). Disease progression free survival (PFS), the median overall survival time (MOS), and 1 year survival rate of two groups were observed and recorded. Results After treatment, the objective efficiency (ORR) and disease control rate (DCR) of the control and treatment groups were 36.1%, 66.7% and 58.3%, 88.9% respectively, and there were differences between two groups (P<0.05). There was no difference in all kinds of adverse reaction incidence, such as bone marrow inhibition, neurotoxicity, abnormal liver function, nausea and vomiting, and diarrhea in two groups. PFS and MOS of the control group were 6.1 and 10.9 months, those of the treatment group were 8.5 and 13.2 months, and the difference was statistically significant between two groups (P<0.05). While 1 year survival rate of the control group and treatment group were 43.6% and 44.8%, but the difference was not statistically significant. Conclusion Trastuzumab combined with IP chemotherapy scheme in treatment of HER-2 positive advanced gastric cancer is effective, can improve the clinical benefit rate without disease progression free survival time and median overall survival time, and does not increase the incidence of adverse reactions, which has a certain clinical application value.