鸦胆子油乳注射液联合CapeOx方案治疗早发型结肠癌的临床研究

目的 探讨鸦胆子油乳注射液联合CapeOx方案治疗早发型结肠癌的临床疗效。方法 选取2017年6月—2021年5月徐州医科大学附属连云港医院收治的96例早发型结肠癌患者,按随机数字表法将所有患者分为对照组和治疗组,每组各48例。对照组患者给予CapeOx方案化疗,化疗第1～14天餐后30 min口服卡培他滨片,1 g/m²,2次/d;第1天静脉滴注注射用奥沙利铂,130 mg/m²加入5%葡萄糖注射液250 mL中后给药,1次/d,每次滴注2 h。治疗组在对照组治疗基础上化疗第1～14天静脉滴注鸦胆子油乳注射液,30 mL/次加入0.9%氯化钠注射液250 mL中后给药,1次/d。两组均以21 d为1个周期,且均连续治疗2个周期。观察两组的临床疗效,比较治疗前后两组血清肿瘤标志物[癌胚抗原（CEA）、糖类抗原（CA）199、CA72-4、CA50]和血管内皮生长因子（VEGF）水平、大肠癌患者生命质量测定量表（FACT-C）评分。统计两组不良反应情况。结果 治疗后,治疗组客观缓解率（ORR）是47.92%,较对照组的35.42%有所提高,但差异无统计学意义;治疗组疾病控制率（DCR）是87.50%显著高于对照组的70.83%（P＜0.05）。治疗后,两组FACT-C中生理状况评分、情感状况评分、附加关注领域评分及量表总评分均显著增加（P＜0.05）;且均以治疗组患者增加更显著（P＜0.05）;功能状况和社会/家庭状况领域评分组内治疗前后及组间同期比较差异均无统计学意义。治疗后,两组血清CEA、CA199、CA72-4、CA50和VEGF水平均显著下降（P＜0.05）;均以治疗组降低更显著（P＜0.05）。治疗过程中,治疗组白细胞减少、肝肾损害、血小板减少的发生率分别为18.75%、10.42%、14.58%,显著低于对照组的37.50%、27.08%、33.33%（P＜0.05）。结论 鸦胆子油乳注射液联合CapeOx方案治疗早发型结肠癌具有一定的增效减毒作用,能有效提高患者近期疗效、下调血清肿瘤标志物水平及抑制肿瘤血管生成,并提高化疗耐受性,改善患者生命质量,值得临床推广应用。

Clinical study of Yadanzi Oil Emulsion Injection combined with CapeOx regimen in treatment of early-onset colon cancer

Objective To explore the clinical efficacy of Yadanzi Oil Emulsion Injection combined with CapeOx regimen in treatment of early-onset colon cancer. Methods A total of 96 patients with early-onset colon cancer admitted to Lianyungang Hospital Affiliated to Xuzhou Medical University from June 2017 to May 2021 were selected and divided into control group and treatment group according to random number table method, with 48 cases in each group. Patients in the control group were given CapeOx chemotherapy, and on the 1st to 14th day of chemotherapy, they were po administered with Capecitabine Tablets 30 min after meal, 1 g/m², twice daily. At the same time, they were iv administered with Oxaliplatin for Injection on the first day of chemotherapy, 130 mg/m² was added into 5% Glucose Injection 250 mL, once daily, each time for 2 h. Patients in the treatment group were iv administered with Yadanzi Oil Emulsion Injection on the 1st to 14th day of chemotherapy on the basis of the control group, 30 mL/time was added into 0.9% sodium chloride injection 250 mL, once daily. Both groups were treated for 21 d for 1 cycle, and both groups were treated for 2 consecutive cycles. The clinical efficacy of the two groups was observed, and the serum tumor markers (CEA, CA 199, CA72-4, CA50), vascular endothelial growth factor (VEGF) levels, quality of Life scale (FACT-C) scores of patients with colorectal cancer were compared before and after treatment. The adverse reactions of the two groups were analyzed. Results After treatment, the objective response rate (ORR) of the treatment group was 47.92%, which was higher than that of the control group (35.42%), but the difference was not statistically significant. The disease control rate (DCR) in the treatment group was 87.50% significantly higher than that in the control group (70.83%) (P < 0.05). After treatment, the physiological status score, emotional status score, additional areas of concern score and total scale score of FACT-C in both groups were significantly increased (P < 0.05). The increase was more significant in treatment group (P < 0.05). There were no significant differences in functional status and social/family status before and after treatment. After treatment, serum CEA, CA199, CA72-4, CA50 and VEGF levels in both groups were significantly decreased (P < 0.05). The decrease was more significant in the treatment group (P < 0.05). During the treatment, the incidence of leukopenia, liver and kidney damage and thrombocytopenia in the treatment group were 18.75%, 10.42% and 14.58%, respectively, which were significantly lower than those in the control group (37.50%, 27.08% and 33.33%, P < 0.05). Conclusion Yadanzi Oil Emulsion Injection combined with CapeOx regimen has a certain synergistic and toxic effect in treatment of early-onset colon cancer, and can effectively improve the short-term curative effect of patients, down-regulate the level of serum tumor markers, inhibit tumor angiogenesis, improve chemotherapy tolerance and life quality of patients, which is worthy of clinical application.