目的 探討欖香烯注射液聯(lián)合TAC方案（多西他賽、環(huán)磷酰胺聯(lián)合多柔比星）治療中晚期乳腺癌的臨床療效。方法 選取2015年1月-2017年12月在天津醫(yī)科大學(xué)腫瘤醫(yī)院治療的105例中晚期乳腺癌患者，根據(jù)患者住院病歷號(hào)末尾奇偶數(shù)分為對(duì)照組（49例）和治療組（56例）。對(duì)照組患者接受TAC化療方案：靜脈滴注多西他賽注射液，75 mg/m²，靜脈注射注射用環(huán)磷酰胺，500 mg/m²加生理鹽水20~30 mL；靜脈注射注射用鹽酸吡柔比星，60 mg/m²加入5%葡萄糖注射液10 mL溶解。治療組患者在對(duì)照組治療的基礎(chǔ)上靜脈滴注欖香烯注射液，0.4~0.6 g/次，1次/d。每個(gè)化療周期為21 d，兩組患者持續(xù)6個(gè)化療周期。觀察兩組臨床療效，比較兩組的免疫功能、毒性反應(yīng)、生存質(zhì)量和預(yù)后。結(jié)果 治療后，治療組總有效率（44.64%）明顯高于對(duì)照組（26.53%）（P<0.05）。治療后，兩組軀體功能（PF）、認(rèn)知功能（CF）、總健康狀況（QL）評(píng)分較治療前升高（P<0.05）；且治療后治療組PF、CF、QL評(píng)分明顯高于對(duì)照組（P<0.05）。治療后，治療組CD3⁺、CD4⁺較治療前升高，CD8⁺較治療前降低（P<0.05）；對(duì)照組CD8⁺較治療前降低（P<0.05）；治療后，治療組CD3⁺、CD4⁺明顯低于對(duì)照組（P<0.05）。治療后，治療組免疫球蛋白G（IgG）、免疫球蛋白M（IgM）水平較治療前升高（P<0.05）；且治療組IgG、IgM水平明顯高于對(duì)照組（P<0.05）。治療后，兩組毒性反應(yīng)比較無(wú)顯著性差異。治療組中位無(wú)進(jìn)展生存時(shí)間（14個(gè)月）明顯長(zhǎng)于對(duì)照組（10個(gè)月），治療組總生存時(shí)間（22個(gè)月）明顯長(zhǎng)于對(duì)照組（17個(gè)月），差異比較有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 欖香烯注射液聯(lián)合TAC方案治療中晚期乳腺癌有較好的臨床效果，能提高患者免疫功能，改善患者生存質(zhì)量及預(yù)后。

Objective To investigate the effect of Elemene Injection combined with TAC chemotherapy regimen (docetaxel, cyclophosphamide combined with pirarubicin) in treatment of advanced breast cancer. Methods Patients (105 cases) with advanced breast cancer in Tianjin Medical University Cancer Institute & Hospital from January 2015 to December 2017 were randomly divided into the control group (49 cases) and the treatment group (56 cases). Patients in the control group were given TAC chemotherapy regimen:patients were iv administered with Docetaxel Injection, 75 mg/m², and patients were iv administered with Cyclophosphamide for injection, 500 mg/m² added into normal saline 20-30 mL, and patients were also iv administered with Pirarubicin Hydrochloride for injection, 60 mg/m² added into 5% glucose solution 10 mL. Patients in the treatment group were iv administered with Elemene Injection on the basis of the control group, 0.4-0.6 g/time, once daily. Each chemotherapy cycle had 21 d, and patients in two groups were treated for 6 cycles. After treatment, the clinical efficacies were evaluated, and immune function, toxic reaction, quality of life, and prognosis in two groups were compared. Results After treatment, the total effective rate of the treatment group (44.64%) was significantly higher than that of the control group (26.53%) (P<0.05). After treatment, the scores of physical function (PF), cognitive function (CF), and total health status (QL) in two groups were higher than those before treatment (P<0.05). And the scores of PF, CF, and QL in the treatment group were significantly higher than those in the control group after treatment (P<0.05). After treatment, the CD3⁺ and CD4⁺ in the treatment group were higher than before treatment, but the CD8⁺ in the treatment group was lower than before treatment (P<0.05). The CD8⁺ in the control group was lower than before treatment (P<0.05). After treatment, the CD3⁺ and CD4⁺ in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, the levels of immunoglobulin G (IgG) and immunoglobulin M (IgM) in the treatment group were higher than those before treatment (P<0.05), and the levels of IgG and IgM in the treatment group were significantly higher than those in the control group (P<0.05). After treatment, there was no significant difference in toxicity between two groups. The median progression free survival time (14 months) of the treatment group was significantly longer than that of the control group (10 months), and the total survival time (22 months) of the treatment group was significantly longer than that of the control group (17 months), and the difference was statistically significant (P<0.05). Conclusion Elemene Injection combined with TAC chemotherapy regimen has clinical curative effect in treatment of advanced breast cancer, can improve the immune function, quality of life and prognosis of patients.

R979.1

國(guó)家自然科學(xué)基金資助項(xiàng)目（81703454）