复方苦参注射液联合XELOX化疗方案治疗晚期结直肠癌的临床疗效观察

Clinical observation of compound Kushen injection combined with XELOX chemotherapy regimen in the treatment of advanced colorectal cancer

目的 探讨复方苦参注射液(compound Kushen injection, CKI)联合XELOX化疗方案对晚期结直肠癌(colorectal cancer, CRC)的临床疗效和安全性。方法 选取2020年1月至2023年1月江汉大学附属医院武汉市第六医院晚期CRC患者84例,根据治疗方法分为对照组(40例)和试验组(44例)。对照组采用XELOX方案(奥沙利铂+卡培他滨)化疗,试验组在对照组基础上给予CKI,连续治疗6个月。比较两组患者近期疗效指标、肿瘤标志物水平、免疫功能水平及不良反应发生情况。结果 84例患者中,男54例,女30例,年龄36~87岁,平均(64.1±8.6)岁。治疗后试验组部分缓解(partial reponse, PR)比例(70.5%比42.5%)、客观缓解率(overall response rate, ORR, 70.5%比42.5%)、CD4+[(46.7±2.8)/μl比(44.3±3.9)/μl]和CD4+/CD8+[(1.3±0.1)比(1.2±0.1)]水平均高于对照组,稳定(stable disease, SD)比例低于对照组(18.2%比42.5%);试验组治疗后癌胚抗原水平低于治疗前[47.1(22.8,85.9)ng/ml比75.1(25.4,117.8)ng/ml],两组治疗后糖类抗原19-9[165.9(86.3,285.8)U/ml比250.1(98.4,434.6)U/ml,144.9(78.4,265.6)U/ml比190.0(85.8,258.6)U/ml]、CD3+[(45.3±3.4)/μl比(51.7±8.6)/μl,(45.2±3.4)/μl比(52.1±8.8)/μl]、CD4+[(46.7±2.8)/μl比(53.1±2.7)/μl,(44.3±3.9)/μl比(53.5±2.7)/μl]和CD4+/CD8+[(1.3±0.1)比(1.4±0.1),(1.2±0.1)比(1.5±0.1)]水平均低于治疗前,差异均有统计学意义(P<0.05);试验组治疗后CD4+和CD4+/CD8+水平高于对照组,差异均有统计学意义(P<0.05)。结论 CKI联用XELOX化疗方案能够提高晚期CRC患者的临床疗效,降低肿瘤标志物水平,改善免疫功能。

Objective To explore the clinical efficacy and safety of compound Kushen injection(CKI)combined with XELOX chemotherapy in the treatment of advanced colorectal cancer(CRC).Methods A total of 84 patients with advanced CRC in the Sixth Hospital of Wuhan,Affiliated Hospital of Jianghan University from January 2020 to January 2023 were selected,and were divided into control group(40 cases)and experimental group(44 cases)according to different treatment methods.The control group was treated with XELOX regimen(oxaliplatin+capecitabine)chemotherapy,and the experimental group was treated with CKI on the basis of the control group for six months.The short-term efficacy index,tumor marker level,immune function level and occurrence of adverse reactions were compared between the two groups.Results Among 84 patients,there were 54 males and 30 females,aged from 36 to 87 years,with an average age of(64.1±8.6)years.The levels of partial reponse(70.5%vs.42.5%),overall response rate(70.5%vs.42.5%),CD4+[(46.7±2.8)/μl vs.(44.3±3.9)/μl]and CD4+/CD8+[(1.3±0.1)vs.(1.2±0.1)]in experimental groups were higher after treatment than those in the control group,the level of stable disease(18.2%vs.42.5%)was lower than that in the control group.Carbohydrate antigen level in the experimental group after treatment was lower than that before treatment[47.1(22.8,85.9)ng/ml vs.75.1(25.4,117.8)ng/ml],carbohydrate antigen 19-9 of two groups after treatment[165.9(86.3,285.8)U/ml vs.250.1(98.4,434.6)U/ml,144.9(78.4,265.6)U/ml vs.190.0(85.8,258.6)U/ml]、CD3+[(45.31±3.42)/μl vs.(51.7±8.6)/μl,(45.2±3.4)/μl vs.(52.1±8.8)/μl]、CD4+[(46.7±2.8)/μl vs.(53.1±2.7)/μl,(44.3±3.9)/μl vs.(53.5±2.7)/μl],CD4+/CD8+[(1.3±0.1)vs.(1.4±0.1),(1.2±0.1)vs.(1.5±0.1)]were lower than those before treatment,and the differences were statistically significant(P<0.05).Conclusions CKI combined with XELOX chemotherapy can improve the clinical efficacy of patients with advanced CRC,reduce the level of tumor markers and improve immune function.