参附注射液联合 GP 方案治疗气虚型晚期 NSCLC 的临床疗效观察

目的：观察参附注射液联合吉西他滨加顺铂方案（GP 方案）治疗气虚型晚期非小细胞肺癌（NSCLC）患者的临床疗效。方法：将192例中医辨证为气虚型的晚期 NSCLC 患者，随机分为治疗组（96例）和对照组（96例）。治疗组选用参附注射液联合 GP 方案治疗，对照组仅采用 GP 方案治疗。比较两组的生活质量、毒副反应、近期疗效、生存期。结果：化疗结束后，治疗组体力状态评分（PS 评分）低于对照组，差异具有统计学意义（P ＜0．05）。两组中医症候总有效率分别为81．25％、15．62％，治疗组明显优于对照组（P ＜0．05）。与对照组相比，治疗组的血液学毒性及非血液学毒性均降低，差异具有统计学意义（P ＜0．05）。治疗组与对照组的有效率分别为20．45％、11．24％，两组比较差异无统计学意义；疾病控制率（DCR）分别为57．95％、41．57％，差异有统计学意义（P ＜0．05）。治疗组中位 PFS 和 OS 分别为4．6个月、7．9个月，对照组中位 PFS和 OS 为4．1个月、7．0个月，两组相比差异均无统计学意义（P ＞0．05）。结论：参附注射液联合 GP 方案治疗气虚型晚期 NSCLC 患者，能改善患者的生活质量，改善中医症状，减轻化疗引起的毒副反应，提高疾病控制率，但不能提高 GP 方案治疗晚期 NSCLC 患者的远期疗效。

A clinical study of Shenfu injection combined with GP regimen in the treatment of vital energy deficiency type patients with advanced non -small cell lung cancer

Objective:To observe the clinical efficacy of Shenfu injection combined with gemcitabine plus cisplatin (GP regimen)in the treatment of vital energy deficiency type patients with advanced non -small cell lung cancer. Methods:Total of 192 cases of vital energy deficiency type patients with advanced non -small cell lung cancer were randomly divided into study group (96 cases)and control group (96 cases).The study group received Shenfu injec-tion combined with GP regimen,the control group using only GP regimen in the treatment.The quality of life,adverse effect,short -term effect and survival time were compared between the two groups.Results:After treatment,the physi-cal status score (PS score)of study group was lower than that of the control group(P <0.05).The total effective rate of TCMsymptoms in two groups was 81.25%,15.62%,and the treatment group was significantly better than that of the control group (P <0.05).Compared to the control group,the hematological toxicity and non -hematological tox-icity of study group were decreased,with significant difference (P <0.05).The effective rate of the study group and control group were 20.45% and 11.24% respectively,the study group higher than the control group,but there was no significant difference (P >0.05).Disease control rate (DCR)were 57.95% and 41.57% respectively,with signifi-cant difference (P <0.05).The median PFS and OS of the study group were 4.6 months and 7.9 months,and the control group were 4.1 months and 7.0 months.There was no significant difference between the two groups (P >0.05).Conclusion:Shenfu injection combined with GP regimen in the treatment of vital energy deficiency type pa-tients with advanced non -small cell lung cancer,can improve the quality of life,improve symptoms of TCM,reduce the adverse effect and improve disease control rate,but can not improve the survival time.