目的 研究參芪扶正注射液聯(lián)合伊立替康和西妥昔單抗治療晚期直腸癌的臨床療效和安全性。方法 選取2013年1月-2015年5月武漢市第八醫(yī)院收治的晚期直腸癌患者80例,隨機分為對照組和治療組,每組各40例。對照組患者在每個化療周期的第1、8、15天靜脈滴注鹽酸伊立替康注射液,90 mg/m²,滴注時間30~90 min,同時靜脈滴注西妥昔單抗注射液,首次劑量是400 mg/m²,滴注時間大于2 h,然后每周250 mg/m²,滴注時間大于1 h。治療組在對照組化療基礎(chǔ)上靜脈滴注參芪扶正注射液,250 mL/次,1次/d,化療前3 d開始使用,連續(xù)使用14 d。每4周為1個化療周期。連續(xù)治療2個化療周期后評定療效。觀察兩組的臨床療效,同時比較兩組治療前后CD⁴⁺CD²⁵⁺調(diào)節(jié)性T細胞、腫瘤壞死因子α(TNF-α)、白介素12(IL-12)及生活質(zhì)量評分的變化。結(jié)果 治療后,對照組和治療組的總有效率分別為37.5%、60.0%,兩組比較差異具有統(tǒng)計學(xué)意義(P < 0.05)。治療后,對照組CD⁴⁺CD²⁵⁺細胞、IL-12、TNF-α降低,治療組CD⁴⁺CD²⁵⁺細胞顯著降低,IL-12、TNF-α升高,同組治療前后差異具有統(tǒng)計學(xué)意義(P < 0.05);且治療后,治療組這些觀察指標的改善程度優(yōu)于對照組,兩組比較差異具有統(tǒng)計學(xué)意義(P < 0.05)。治療后,兩組心理評分、軀體評分、認知評分、社會評分、角色評分均顯著升高,同組治療前后差異具有統(tǒng)計學(xué)意義(P < 0.05);治療后,治療組心理評分、軀體評分、認知評分、社會評分均顯著高于對照組,兩組比較差異具有統(tǒng)計學(xué)意義(P < 0.05)。結(jié)論 參芪扶正注射液聯(lián)合伊立替康和西妥昔單抗治療晚期直腸癌具有較好的臨床療效,可調(diào)節(jié)患者的免疫功能,提高患者的生活質(zhì)量,具有一定的臨床推廣應(yīng)用價值。

Objective To study the clinical effect and safety of Shenqi Fuzheng Injection combined with irinotecan and cetuximab in treatment of advanced colorectal cancer. Methods Patients (80 cases) with advanced colorectal cancer in Eighth Hospital of Wuhan City from January 2013 to May 2015 were randomly divided into control and treatment groups, and each group had 40 cases. The patients in the control group were iv administered with Irinotecan Hydrochloride Injection on the first, eighth, and fifteenth day of each chemotherapy cycle, 90 mg/m², and drop injection time was 30-90 min. They were iv administered with Cetuximab Solution for infusion with the first dosage of 400 mg/m², and the injection time was more than 2 h. And then the dosage was adjusted to 250 mg/m² per week, and the injection time was more than 1 h. The patients in the treatment group were iv administered with Shenqi Fuzheng Injection on the basis of control group 3 d before chemotherapy, 250 mL/time, once daily, and for 14 d. Every four weeks was as one chemotherapy cycle, and two groups were treated for two cycles. After treatment, the efficacy was evaluated, and the changes of CD4⁺CD25⁺ regulatory T cells, TNF-α, IL-12, and scores of quality life in two groups before and after treatment were compared. Results After treatment, the efficacies in the control and treatment groups were 37.5% and 60.0%, respectively, and there were differences between two groups (P < 0.05). After treatment, CD⁴⁺CD²⁵⁺ cell, IL-12, and TNF-α in the control group reduced, CD⁴⁺CD²⁵⁺ cell significantly reduced in the treatment group, while TNF-α and IL-12 were increased, and the difference was statistically significant in the same group (P < 0.05). The improved degree of those observation indicators in the treatment group was better than those in the control group, with significant difference between two groups (P < 0.05). After treatment, psychological scores, physical scores, cognitive scores, social scores and role scores in two groups were significantly higher, and the difference was statistically significant in the same group (P < 0.05). Psychological scores, physical scores, cognitive scores, and social scores in treatment group were significantly higher than those in the control group, with significant difference between two groups (P < 0.05). Conclusion Shenqi Fuzheng Injection combined with irinotecan and cetuximab has good clinical curative effect in treatment of advanced colorectal cancer, and can adjust the immune function of patients, also can improve the life quality of patients, which has certain clinical application value.