参芪解毒汤加味联合TP方案治疗肺脾气虚型晚期非小细胞肺癌

Modified Shenqi Jiedu Decoction combined with TP Regimen in Treatment of Advanced Non-small Cell Lung Cancer with Lung and Spleen Deficiency

目的:观察参芪解毒汤辅助化疗对肺脾气虚型晚期非小细胞肺癌患者的临床疗效、免疫功能、生活质量及无进展生存期(progression-free survival,PFS)的影响。方法:80例肺脾气虚型晚期非小细胞肺癌患者按照随机数字表法分为试验组(紫杉醇+顺铂+参芪解毒汤,40例)及对照组(紫杉醇+顺铂,40例)。比较两组患者的近期疗效、免疫功能、血清基质金属蛋白酶-9(matrix metalloproteinase-9,MMP-9)和巨噬细胞抑制因子-1(macrophage inhibitory factor-1,MIC-1)、生活质量、PFS及不良反应情况。结果:(1)近期疗效:试验组缓解率为67.50%,高于对照组的42.5%,差异有统计学意义(P<0.05)。试验组和对照组的疾病控制率分别为95.00%、85.00%,两组疾病控制率比较,差异无统计学意义(P>0.05)。(2)免疫功能:治疗后,对照组CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+)显著降低(P<0.05);试验组CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+)均高于同期对照组,差异有统计学意义(P<0.05)。(3)血清MIC-1和MMP-9:治疗后,两组MIC-1和MMP-9水平均显著降低(P<0.05);且试验组血清MIC-1、MMP-9水平均显著低于同期对照组,差异均有统计学意义(P<0.05)。(4)生活质量:治疗后,两组患者卡氏(KPS)评分均高于本组治疗前(P<0.05);试验组治疗后KPS评分为(76.10±3.11)分,显著高于同期对照组的(73.90±2.52)分,差异均有统计学意义(均P<0.05)。(5)PFS:两组患者随访6~24个月,共死亡10例,进展21例,试验组PFS优于对照组(χ^(2)=6.085,P<0.05)。(6)不良反应:两组患者不良反应集中在胃肠道、神经毒性、骨髓抑制、心血管系统方面,差异无统计学意义(P>0.05)。结论:参芪解毒汤治疗肺脾气虚型晚期非小细胞肺癌疗效显著,可显著提高患者免疫功能,降低MIC-1、MMP-9水平,提高患者生活质量。

Objective:To observe the effect of Shenqi Jiedu Decoction on the clinical efficacy,immune function,quality of life and progression-free survival(PFS)of patients with advanced non-small cell lung cancer with deficiency of lung and spleen.Methods:80 patients with lung-spleen deficiency type advanced non-small cell lung cancer were randomly divided into experimental group(paclitaxel+cisplatin+Shenqi Jiedu Decoction,40 cases)and control group(paclitaxel+cisplatin,40 cases).The short-term efficacy,immune function,serum matrix metalloproteinase-9(MMP-9)and-1(macrophageinhibitoryfactor1-1)(MIC-1),changes in quality of life,PFS and adverse reactions were compared between the two groups.Results(1)Short-term curative effect:The remission rate in the experimental group was 67.50%,which was higher than that in the control group(42.5%),with statistical significance(P<0.05).The disease control rates of the experimental group and the control group were 95.00%and 85.00%respectively,and there was no statistical difference between the two groups(P>0.05).(2)Immune function:After treatment,CD4^(+),CD8^(+)and CD4^(+)/CD8^(+)in the control group decreased significantly(P<0.05);CD4^(+),CD8^(+)and CD4^(+)/CD8^(+)in the experimental group were higher than those in the control group at the same period,and the difference was statistically significant(P<0.05).(3)Serum MIC-1 and MMP-9:After treatment,the levels of MIC-1 and MMP-9 in both groups decreased significantly(P<0.05);The levels of serum MIC-1 and MMP-9 in the experimental group were significantly lower than those in the control group at the same period,and the differences were statistically significant(P<0.05).(4)Quality of life:After treatment,the KPS scores of both groups were significantly higher than those before treatment(P<0.05);After treatment,the KPS score of the experimental group was(76.10±3.11),which was significantly higher than that of the control group(73.90±2.52),and the differences were statistically significant(all P<0.05).(5)PFS:The patients in the two groups were followed up for 6-24 months,with 10 cases dead and 21 cases progressing.PFS in the experimental group was significantly better than that in the control group(Log Rankχ^(2)=6.085,P<0.05).(6)Adverse reactions:The adverse reactions of the two groups focused on gastrointestinal tract,neurotoxicity,bone marrow suppression and cardiovascular system,with no statistical significance(P<0.05).Conclusion:Shenqi Jiedu Decoction is effective in treatment of advanced non-small cell lung cancer with deficiency of Lung and Spleen,which can significantly improve the immune function,reduce the levels of MIC-1 and MMP-9 and improve the quality of life of patients.