慈仁胶囊治疗Ⅲ_b、Ⅳ期非小细胞肺癌近期疗效观察

Observasion of immediate effectiveness of Ciren capsulein treating advanced NSCLC

目的:观察慈仁胶囊治疗Ⅲb、Ⅳ期非小细胞肺癌的近期疗效。方法:60例符合标准的Ⅲb、Ⅳ期非小细胞肺癌患者随机分为治疗组和对照组,分别服慈仁胶囊和接受NP方案[即NVB(诺维本)+DDP(顺铂)]化疗4周期。测定两组治疗前和治疗后实体瘤疗效、症状积分、免疫状况、生存质量和不良反应等指标。结果:治疗组的瘤体缓解总有效率(CR+PR)为0,对照组为26.7%,有显著性差异(P<0.05);治疗组病灶稳定率为(CR+PR+SD)为86.7%,对照组的病灶稳定率为80%,无显著性差异(P>0.05)。治疗组和对照组均可改善症状,但前者明显优于后者(P<0.01)。治疗后治疗组CD3+、CD4+和NK细胞升高,对照组的CD3+和CD4+降低。治疗后两组的体质量和体力状况评分变化均无显著性差异(P>0.05),生活质量评分均升高,但治疗组优于对照组,有显著性差异(P<0.05)。治疗组没有发生不良反应,对照组白细胞减少发生率为53.3%,恶心呕吐发生率为66.7%,肝功能损害发生率为20%,偶见脱发、神经系统损害等不良反应。结论:慈仁胶囊治疗Ⅲb、Ⅳ期非小细胞肺癌,可稳定瘤体,有效改善肺癌症状和提高生活质量,提高机体细胞免疫力,无明显不良反应。

Objective： To evaluate the effectiveness and safety of Ciren capsule in the treatment of advanced NSCLC. Methods： A total of 60 eligible patients with advanced NSCLC were randomly assigned to treatment group and control group. 30 patients in treatment group took Ciren capsule for 4 cycles. 30 patients in control group accepted NP regimens for 4～6 cycles. The effectiveness and safety of both treatment were estimated. Results： The response rates （CR＋PR）were 0 and 26.7% in the treatment group and control group, significant difference was detected among them（ P 〈0.05）. The stable rates （CR＋ PR ＋ SD） were 86.7% and 80% in the treatment group and control group, no significant difference was detected among them（ P 〉0.05）. Both the chemotherapy and Ciren capsule relieved symptom and improved the quality of life, but the former was significantly better than the latter. In the treatment group, the count of CD3^＋ , CD4^＋ and NK cell was higher than that of pre treatment. In the control group, the count of CD3^＋ ,CD4^＋ lowered after chemotherapy （ P 〈0.05）. No toxicities were observed in Ciren capsule. In the control group, leukocytopenia incidence is 53.3%, vomiting incidence 66.7%, hepatic function lesion incidence 20% ,still alopecia and neurologic toxicities occurred. Conclusion： Ciren capsule in the treatment of advanced NSCLC contribute to stabilizing the neoplasia, relief of symptom, improvement of the quality of life and enhancement of the immunity. Also it proved to be safe.