康艾注射液联合吉西他滨治疗非小细胞肺癌的临床研究

Clinical study on Kang'ai Injection combined with gemcitabine in treatment of non-small cell lung cancer

目的探讨康艾注射液联合注射用盐酸吉西他滨治疗非小细胞肺癌的临床疗效。方法选取西安交通大学医学院第一附属医院2013年1月—2015年1月就诊的非小细胞肺癌患者100例,将患者随机分为对照组和治疗组,每组各50例。对照组给予注射用盐酸吉西他滨1 200 mg/m^2,加入100 m L生理盐水中,第1、8天静脉滴注。治疗组在对照组基础上静脉滴注康艾注射液50 m L/m^2,加入250 m L生理盐水中,连续使用14 d。两组均连续治疗21 d。观察两组的临床疗效,同时比较治疗前后两组患者的免疫功能指标、蛋白表达和毒副反应。结果治疗后,对照组、治疗组的客观有效率分别为48.0%、66.0%,两组比较差异有统计学意义(P<0.05)。两组疾病控制率比较差异无显著性。治疗后,两组CD^(4+)、CD^(4+)/CD^(8+)明显上升,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组CD^(3+)、CD^(4+)、CD^(4+)/CD^(8+)明显上升CD^(8+)明显下降,其改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组Ki67蛋白、bcl-2蛋白表达水平明显降低,bax蛋白表达水平明显升高,两组比较差异有统计学意义(P<0.05)。治疗后,治疗组血小板减少、白细胞下降、红细胞减少发生率明显低于对照组,两组比较差异有统计学意义(P<0.05)。但两组ALT异常升高、恶心呕吐的发生率比较差异无统计学意义。结论康艾注射液联合注射用盐酸吉西他滨治疗非小细胞肺癌具有较好的临床疗效,能够增强患者免疫功能,改善蛋白表达,降低毒副反应,具有一定的临床推广应用价值。

Objective To investigate the effects of Kang＇ai Injection combined with Gemcitabine Hydrochloride for injection in treatment of non-small cell lung cancer. Methods Patients（100 cases） with non-small cell lung cancer in the First Affiliated Hospital of Xi＇an Jiao Tong University Medical College from January 2013 to January 2015 were randomly divided into the control and treatment groups, and each group had 50 cases. Patients in the control group were iv administered with Gemcitabine Hydrochloride for injection of 1 200 mg/m^2, added into normal saline 100 m L, given on days 1 and 8. The patients in treatment group were iv administered with Kang＇ai Injection on the basis of control group, 50 m L/m^2 Kang＇ai Injection added into normal saline 250 m L, and treated for 14 d. The patients in two groups were treated for 21 d. After treatment, the clinical efficacies were evaluated, and immune function indexes, protein expression, and side effect in two groups were compared before and after treatment. Results After treatment, objective response rate（ORR） in the control group and treatment group were 48.0% and 66.0%, respectively, and there were differences between two groups（P〈0.05）. But there were no differences on disease control rates（DCR） between two groups. After treatment, CD^4＋ and CD^4＋/CD^8＋ in two groups were significantly increased, and the difference was statistically significant in the same group（P〈0.05）. After treatment, CD^（3＋）、CD^4＋ and CD^4＋/CD^8＋ in the treatment group were significantly increased, CD^8＋ was significantly decreased, the observational indexes were significantly better than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, protein expression of Ki67 and bcl-2 in two groups was significantly decreased, protein expression of bax was significantly increased, and the difference was statistically significant in the same group（P〈0.05）. After treatment, the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the incidence rates of thrombocytopenia, leucopenia, and oligocythemia in the treatment group were significantly lower than those in the control group, and there were differences between two groups（P〈0.05）. But there were no differences on incidence of ALT abnormalities and nausea and vomiting between two groups. Conclusion Kang＇ai Injection combined with Gemcitabine Hydrochloride for injection has clinical curative in treatment of non-small cell lung cancer, can significantly improve the immune function, and improve protein expression, reduce the adverse reactions of chemotherapy, which has a certain clinical application value.