目的 探讨康莱特联合替吉奥治疗老年中晚期结直肠癌的临床疗效和安全性。方法 选择2011年1月－2014年4月沈阳市第四人民医院收治的老年中晚期结直肠癌患者88例, 随机分为对照组和治疗组, 每组44例。对照组采用替吉奥胶囊单药化疗。治疗组在对照组基础上加用康莱特注射液, 第一天开始静脉注射200 mL/d, 连用21 d, 停药21 d。6周为1个疗程, 两组患者均完成2个疗程的治疗。评价两组患者的临床疗效、毒性反应、生活质量以及免疫功能。结果 治疗后, 对照组总有效率为18.18%, 临床获益率为56.82%;治疗组总有效率为29.55%, 临床获益率为79.55%, 两组总有效率、临床获益率比较差异有统计学意义(P<0.05)。治疗组消化道反应、口腔黏膜炎和血液学毒性等不良反应发生率均低于对照组, 两组比较差异有统计学意义(P<0.05)。对照组和治疗组生活质量有效率分别为34.09%、56.82%, 两组比较差异有统计学意义(P<0.05)。治疗后, 治疗组CD³⁺、CD⁴⁺、CD⁴⁺/CD⁸⁺、NK较治疗前均有不同程度增高, CD⁸⁺水平低于治疗前, 同组治疗前后差异有统计学意义(P<0.05)。治疗后, 治疗组CD³⁺、CD⁴⁺、NK、CD⁴⁺/CD⁸⁺细胞高于对照组, CD⁸⁺细胞水平低于对照组, 两组比较差异有统计学意义(P<0.05)。结论 康莱特联合替吉奥治疗老年中晚期结直肠癌具有较好的临床疗效, 可改善患者生存质量和免疫功能, 降低化疗的不良反应, 值得临床推广应用。

Objective To investigate the efficacy and safety of Kanglaite combined with Tegafur, Gimeracil and Oteracil Potassium in treatment of elderly patients with advanced colorectal cancer. Methods Elderly patients (88 cases) with advanced colorectal cancer who came to the Fourth People's Hospital of Shenyang from January 2011 to April 2014 were randomly divided into the control and treatment groups, and each group had 44 cases. The patients in control group were given Tegafur, Gimeracil and Oteracil Potassium Capsule single-agent therapy. The patients in the treatment group were iv administered with Kanglaite Injection at the basis of control group, beginning on the first day of 200 mL/d for 21 d, and withdrawal 21 d. Six weeks were as one course of treatment, and two groups were treated for two courses. The clinical efficacy, toxic effects, life quality and immune function in two groups were evaluated. Results After treatment, the total effective rate of control group was 18.18%, and the clinical benefit rate was 56.82%, while the total effective rate of treatment group was 29.55%, and the clinical benefit rate was 79.55%, and there were differences between the two groups (P < 0.05). The incidences of gastrointestinal reaction, inflammation of the oral mucosa and hematology toxicity in the treatment group were lower than those in the control group, and there were differences between the two groups (P < 0.05). The life quality effectiveness in control and treatment group were 34.09% and 56.82%, respectively, and there were differences between the two groups (P < 0.05). After treatment, numbers of CD³⁺, CD⁴⁺, CD⁴⁺/CD⁸⁺ and NK cell in the treatment group were increased, and the level of CD⁸⁺ cell was lower, and the difference was statistically significant in the same group before and after treatment (P < 0.05). After treatment, CD³⁺, CD⁴⁺, NK, and CD⁴⁺/CD⁸⁺ cell in the treatment group were more than those in the control group, while the level of CD8 cells was lower than that in the control group, and there were differences between the two groups (P < 0.05). Conclusion Kanglaite combined with Tegafur, Gimeracil and Oteracil Potassium has the good clinical effect in treatment of elderly patients with advanced colorectal cancer, and can improve the quality of life and immune function, while can reduce the adverse reaction of chemotherapy, which is worth clinical promotion.