目的 探讨奥沙利铂、雷替曲塞联合复方苦参注射液(Compound Kushen Injection,CKI)对晚期结直肠癌(colorectal carcinoma,CRC)的临床疗效及安全性。方法 采用随机数字表将2019年3月至2021年2月期间于我院拟行RALOX方案(奥沙利铂+雷替曲塞)二线化疗的78例晚期CRC患者随机分为观察组(RALOX方案化疗+CKI治疗,n=39)与对照组(RALOX方案化疗,n=39),比较两组患者治疗4个疗程后的临床疗效、生存状况、血肿瘤标志物水平、免疫功能及安全性。结果 观察组的疾病控制率、二线化疗后6、12个月的无进展生存率、治疗后的血NK细胞比例、CD4+/CD8+比值、免疫球蛋白(immunoglobulin,Ig)A、IgG、IgM水平明显高于对照组,治疗后的血癌胚抗原、糖类抗原(carbohydrate antigen,CA)199、CA125水平明显低于同期对照组(P＜0.05)。安全性方面,两组患者的不良反应以Ⅰ～Ⅱ级的骨髓抑制、恶心呕吐最常见,两组的各不良反应的发生率比较无显著差异(P＞0.05)。结论 在奥沙利铂+雷替曲塞的二线化疗基础上,联用CKI能提高晚期CRC的肿瘤控制效果,降低血肿瘤标志物水平,改善免疫功能。

Objective To investigate the clinical efficacy and safety of oxaliplatin, raltitrexed and Compound Kushen Injection (CKI) in the treatment of advanced colorectal cancer (CRC). Methods Seventy-eight patients with advanced CRC who planned to undergo second line chemotherapy with RALOX regimen (oxaliplatin + raltitrexed) in our hospital from March 2019 to February 2021 were randomly divided into observation group (RALOX regimen chemotherapy + CKI treatment, n=39) and control group (RALOX regimen chemotherapy, n=39) according to the random number table. The clinical efficacy, survival status, blood tumor marker levels, immune function and safety after four treatment courses were compared between the two groups. Results The disease control rate, progression free survival rate at 6 and 12 months after second-line chemotherapy, blood NK cell ratio, CD4+/CD8+ ratio, immunoglobulin (Ig) A, IgG, and IgM levels after treatment in the observation group were significantly higher than those in the control group, and blood levels of carcinoembryonic antigen, carbohydrate antigen (CA) 199 and CA125 after treatment were significantly lower than those in the control group during the same period (P<0.05). In terms of safety, the most common adverse reactions in the two groups were bone marrow suppression and nausea and vomiting with grade I-II. There were no significant difference in the incidences of various adverse reactions between the observation group and the control group (P>0.05). Conclusions On the basis of the second-line chemotherapy of oxaliplatin+raltitrexed, combination with CKI could improve the tumor control effect of advanced CRC, reduce blood levels of tumor markers and improve immune function.

2020年度安徽省自然科学(2008085QH213)