艾迪注射液联合雷替曲塞治疗晚期结肠癌的临床研究

Clinical study on Aidi Injection combined with raltitrexed in treatment of advanced colorectal cancer

目的探讨艾迪注射液联合雷替曲塞治疗晚期结肠癌的有效性与安全性。方法选取中国医科大学附属盛京医院2016年3月—2017年3月收治的晚期结肠癌患者121例,随机分成对照组(60例)和治疗组(61例)。对照组患者静脉滴注注射用雷替曲塞,3 mg/m2加入250 m L生理盐水,1次/3周;治疗组在对照组的基础上静脉滴注艾迪注射液,50 m L加入5%葡萄糖注射液400 m L,1次/d。两组患者均治疗9周。评价两组患者临床疗效,同时比较治疗前后两组患者KPS评分、VAS评分、肿瘤标志物水平和不良反应情况。结果治疗后,对照组客观缓解率和疾病控制率分别为43.33%、75.00%,均分别显著低于治疗组的63.93%、93.44%,两组比较差异均具有统计学意义(P<0.05)。治疗后,两组患者KPS评分明显升高,VAS评分明显降低,同组比较差异具有统计学意义(P<0.05);且治疗组患者KPS和VAS评分改善情况明显优于对照组患者(P<0.05)。治疗后,两组患者癌胚抗原(CEA)和CA199水平均明显下降(P<0.05);且治疗组患者CEA和CA199水平比对照组降低的更明显(P<0.05)。治疗组患者不良反应发生率为21.31%,显著低于对照组患者的50.00%,两组比较差异具有统计学意义(P<0.05)。结论艾迪注射液联合雷替曲塞治疗晚期结肠癌疗效较好,安全性较高,具有一定的临床推广应用价值。

Objective To explore the clinical effect and safety of Aidi injection combined with raltitrexed in treatment of advanced colorectal cancer. Methods Patients （121 cases） with advanced colorectal cancer in Shengjing Hospital of China Medical University from March 2016 to March 2017 were randomly divided into control （60 cases） and treatment （61 cases） groups. Patients in the control group were iv administered with Raltitrexed for injection, 3 mg/m2 added into normal saline 250 mL, once every three weeks. Patients in the treatment group were iv administered with Aidi Injection on the basis of the control group, 50 mL added into 5% glucose injection 400 mL, once daily. Patients in two groups were treated for 9 weeks. After treatment, the clinical efficacy was evaluated, and the KPS and VAS scores, tumor marker level and adverse reactions in two groups before and after treatment were compared. Results After treatment, objective remission rate and disease control rate in the control group were 43.33% and 75.00%, which were significantly lower than 63.93% and 93.44% in the treatment group, respectively, and there were differences between two groups （P 〈 0.05）. After treatment, the KPS score in two groups was significantly increased, VAS score was significantly decreased, and the difference was statistically significant in the same group （P 〈 0.05）. And the KPS and VAS scores in the treatment group were obviously better than those in the control group （P 〈 0.05）. After treatment, the CEA and CA199 levels in two groups were significantly decreased （P 〈 0.05）. And the CEA and CA199 levels in the treatment group were obviously lower than that in the control group （P 〈 0.05）. During the treatment, the incidence of adverse reactions in the control group was 50.00%, which were significantly higher than 21.31% in the control group, with significant difference between two groups （P 〈 0.05）. Conclusion Aidi Injection combined with raltitrexed has perfect curative effect and high safety in treatment of advanced colorectal cancer, which has a certain clinical application value.