参一胶囊联合局部放疗治疗晚期非小细胞肺癌48例的临床研究与相关影响因素分析

The clinical observation of Shenyi capsule in treating Qi-deficient patients with advanced non-small cell lung cancer and analysis of influencing factor

目的：观察参一胶囊联合局部姑息放疗对原发性非小细胞肺癌患者的远期疗效及不良反应。方法：48例均经病理组织学确诊为非小细胞肺癌，因年老体弱或合并有内科疾病不能耐受全身化疗的患者，口服参一胶囊20mg／日，1日2次，连服12周，同时给予局部原发灶及转移灶局部姑息放疗，12周后进行全面评价。结果：所有48例均可评价疗效：CR4例，PR16例，总有效率（RR）为41．6％，SD16例，疾病控制率（DCR）为75．0％，PD12例，其中性别、病理类型、吸烟史、年龄等因素都与RR相关。有效患者的中位缓解时间为12个月（95％CI为5．6—16．6个月），中位生存期为12．5个月（95％CI为8．6～14．2个月），中位肿瘤进展时间为8．4个月（95％CI为4．1～10．2个月），1年生存率为42．6％。生活质量明显改善。常见的反应有口干、大便干燥、便秘，偶尔血压升高，一般不影响治疗。结论：参一胶囊治疗疗效明确，不良反应较轻，耐受性较好，可以明显改善患者生存质量，作为晚期非小细胞肺癌的辅助治疗药物值得推广。

Objective： To observe the efficacy and drug - related toxicities of Shenyi capsule in Qi - deficient patients with advanced non -small cell lung cancer. Methods：Analyzed 48 patients with non -small cell lung cancer （ Ⅲ or Ⅳ）who were confirmed by pathology. All of them were orally administrated with Shenyi capsule 20mg/day, bid, po. Results： All the 48 patients could be evaluated. 4 cases CR;16 cases PR; RR was 41.6% ;16 cases SD; DCR was 75.0% ,12 cases PD.. In which, sex, pathology, history of smoking and age were related to RR respectively. The RR of Shenyi capsule were significantly higher in patients female,non - smoker and adenocarcinoma than in patients male,smoker and non ad The middle relievable time was 12.0 months （5.6 -16 6months）. The middle survival time was 12.5 months （8.6- 14.2 months）. The middle time of progression was 8.4 months （4. 1 - 10.2months）. the 1 -year survival rate was 42.6% respectively. The most common drug related adverse events were rash, diarrhea, nausea and vomit, most of which were endurable. Conclusions： Treating advanced stage adenocarcinoma with Shenyi capsule seems to be safe and effective, female,non - smoker and adenocarcinoma are related to higher effectively.