目的 探討拉帕替尼聯(lián)合曲妥珠單抗治療HER2陽(yáng)性乳腺癌患者的臨床效果。方法 選取2011年1月-2014年3月在寶雞市婦幼保健院接受治療的261例乳腺癌患者，隨機(jī)分為拉帕替尼組（82例）、曲妥珠單抗組（84例）和聯(lián)合組（95例），3組患者中途各有3、2和1例停止治療。拉帕替尼組口服拉帕替尼片，6片/次，1次/d；曲妥珠單抗組靜脈注射注射用曲妥珠單抗，1次/周，前9周4 mg/kg，后9周2 mg/kg維持；聯(lián)合組治療方法是上述兩組治療方法的聯(lián)用，3組均連續(xù)治療18周。治療后，觀察3組患者臨床療效，同時(shí)比較3組治療前后無(wú)進(jìn)展生存率（PFS）、總生存期（OS）、中樞神經(jīng)系統(tǒng)（CNS）轉(zhuǎn)移情況、總反應(yīng)率（ORR）、臨床受益反應(yīng)（CBR）以及不良反應(yīng)變化情況。結(jié)果 治療后，拉帕替尼組治愈率為21.52%，控制率為51.90%；曲妥珠單抗組治愈率為24.39%，控制率為57.32%；聯(lián)合組治愈率為45.74%，控制率為76.60%，3組治愈率比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05），控制率比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.01）。治療后，拉帕替尼組、曲妥珠單抗組和聯(lián)合組的PFS分別為41、43、55個(gè)月，聯(lián)合組PFS比拉帕替尼組和曲妥珠單抗組均顯著延長(zhǎng)，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后隨訪期間拉帕替尼組（72例）、曲妥珠單抗組（76例）和聯(lián)合組（83例）的PFS分別為24、26、36個(gè)月，聯(lián)合組的PFS比拉帕替尼組、曲妥珠單抗組的均顯著延長(zhǎng)，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，拉帕替尼組、曲妥珠單抗組和聯(lián)合組的CNS轉(zhuǎn)移率分別為32.91%、29.27%、19.15%，聯(lián)合組的CNS轉(zhuǎn)移率明顯低于拉帕替尼組和曲妥珠單抗組，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。拉帕替尼組、曲妥珠單抗組和聯(lián)合組的ORR分別為56.96%、59.76%、76.60%，聯(lián)合組ORR均高于拉帕替尼組、曲妥珠單抗組，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。拉帕替尼組、曲妥珠單抗組和聯(lián)合組的CBR分別為43.04%、47.56%、69.15%，聯(lián)合組的均高于拉帕替尼組、曲妥珠單抗組，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。聯(lián)合組的不良反應(yīng)發(fā)生率顯著低于拉帕替尼組和曲妥珠單抗組，差異比較具有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 拉帕替尼聯(lián)合曲妥珠單抗對(duì)HER2陽(yáng)性乳腺癌患者具有較好的臨床治療效果，具有一定的臨床推廣應(yīng)用價(jià)值。

Objective To observe the therapeutic effect of lapatinib combined with trastuzumab in treatment of HER2 positive breast cancer. Methods Patients (261 cases) with breast cancer in Baoji Maternal and Child Health Hospital from January 2011 to March 2014 were randomly divided into lapatinib group (82 cases), trastuzumab group (84 cases), and combination group (95 cases), and there were respectively 3, 2 and, 1 patients discontinuing treatment. Patients in the lapatinib group were po administered with Lapatinib Tablets, 6 tablets/time, once daily. Patients in the trastuzumab group were iv administered with Trastuzumab for injection, once a week, the dosage in the first 9 weeks was 4 mg/kg, and 2 mg/kg for the last 9 weeks. The treatment method in the combination group was the combination of the lapatinib and trastuzumab groups. Patients in three groups were treated for 18 weeks. After treatment, the clinical efficacy was evaluated, and PFS, OS, the transfer situation of CNS, ORR, CBR and adverse reactions in three groups before and after treatment were compared. Results After treatment, the cure and control rate in the lapatinib group respectively were 21.52% and 51.90%, which in the trastuzumab group were 24.39% and 57.32%, and were 45.74% and 76.60% in the combination group, the difference of cure rate among three groups was statistically significant (P<0.05), and the difference of control rate among three groups was statistically significant (P<0.01). After treatment, PFS in the lapatinib, trastuzumab, and combination groups respectively were 41, 43, and 55 months, PFS in the combination group was significantly longer than that in the other groups with significant difference (P<0.05). After treatment, CNS transfer rate in the lapatinib, trastuzumab, and combination group respectively were 32.91%, 29.27%, and 19.15%, and CNS transfer rate in the combination group was significantly lower than that in the other groups with significant difference (P<0.05). After treatment, ORR in the lapatinib, trastuzumab, and combination group respectively were 56.96%, 59.76%, and 76.60%, and ORR in the combination group was significantly higher than that in the other groups with significant difference (P<0.05). After treatment, CBR in the lapatinib, trastuzumab, and combination group respectively were 43.04%, 47.56%, and 69.15%, and CBR in the combination group was significantly higher than that in the other groups with significant difference (P<0.05). The incidence of adverse reactions in the combination group was significantly lower than the other groups with significant difference (P<0.05). Conclusion Lapatinib combined with trastuzumab has a significant clinical therapeutic effect in treatment of HER2 positive breast cancer, which has a certain clinical application value.