目的 探討曲妥珠單抗聯(lián)合IP方案（伊立替康＋順鉑）治療人類表皮因子受體-2（HER-2）陽性晚期胃癌的療效和安全性。方法 選取襄陽市中心醫(yī)院在2014年1月-2015年1月收治的72例HER-2陽性晚期胃癌患者進行研究，隨機分為對照組和治療組，每組各36例。對照組給予IP方案化療，即在治療的第1、8天靜脈滴注鹽酸伊立替康注射液60 mg/m²；并在治療的第1～3天靜脈滴注注射用順鉑30 mg/m²。治療組在對照組的基礎(chǔ)上于治療的第1天靜脈滴注注射用曲妥珠單抗8 mg/kg，并于隨后的每個治療周期的第1天靜脈滴注注射用曲妥珠單抗6 mg/kg。兩組患者均連續(xù)治療2個周期，每個周期為21 d。依據(jù)改良版實體腫瘤療效評價標(biāo)準(zhǔn)（mRECIST）評價其臨床療效，依據(jù)不良反應(yīng)標(biāo)準(zhǔn)（CTC第3版）評價治療期間出現(xiàn)的不良反應(yīng)。觀察并記錄兩組患者的疾病無進展生存期（PFS）、中位總生存時間（mOS）、1年生存率。結(jié)果 治療后，對照組的客觀有效率（ORR）和疾病控制率（DCR）分別為36.1%、66.7%，治療組的ORR、DCR分別為58.3%、88.9%，兩組ORR、DCR比較差異均有統(tǒng)計學(xué)意義（P<0.05）。兩組患者骨髓抑制、神經(jīng)毒性、肝功能異常、惡心嘔吐、腹瀉發(fā)生率組間比較差異不顯著。對照組的PFS、mOS分別為6.1、10.9個月，治療組的PFS、mOS分別為8.5、13.2個月，兩組PFS、mOS組間比較差異有統(tǒng)計學(xué)意義（P<0.05）。對照組的1年生存率為43.6%，治療組1年生存率為44.8%，組間比較差異無統(tǒng)計學(xué)意義。結(jié)論 曲妥珠單抗聯(lián)合IP方案治療HER2陽性晚期胃癌的療效確切，近期療效、遠期療效和安全性較高，值得臨床推廣應(yīng)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.