参芪固本方破壁饮片与传统汤剂联合鹤蟾片治疗ⅢB、Ⅳ期非小细胞肺癌的疗效及安全性研究

Comparison of the Efficacy and Safety of Shenqi Guben Recipe Ultrafine Granular Powder and Traditional Decoction Combined with He Chan Tablets for the Treatment of Patients with StageⅢB/Ⅳ Non-small Cell Lung Cancer

目的观察参芪固本方传统汤剂或参芪固本方破壁饮片联合鹤蟾片治疗ⅢB、Ⅳ期非小细胞肺癌的疗效及安全性。方法将受试患者分为试验组(参芪固本方破壁饮片联合鹤蟾片组)和对照组(参芪固本方传统汤剂联合鹤蟾片组),疗程共90天,评测分析患者体力状况评分(Performance Status,PS)、中医症状积分、肝肾功能、骨髓抑制发生率,并随访观察生存期。结果试验组与对照组在治疗期V2(30天±3天)、V3(90天±3天)中医症状积分、体力状况、相关肿瘤标志物等方面差异均没有统计学意义(P>0.05)。治疗前后自身对照比较,传统汤剂组与破壁饮片组均能改善痰湿证积分,破壁饮片组略优,而传统汤剂组能更好地改善阴虚证积分。两组中位生存时间比较,差异没有统计学意义(P>0.05)。在安全性方面,两组均未见明显的肝肾功能损害,均未见骨髓抑制的发生。结论参芪固本方破壁饮片或参芪固本方传统汤剂联合鹤蟾片在晚期肺癌的治疗中具有一定的疗效,且疗效及副作用方面两组均无差异,破壁饮片可作为传统汤剂的替代用药。

Objective To study the efficacy and safety of Shenqi Guben Recipe traditional decoction or Shenqi Guben Recipe ultrafine granular powder combined with He Chan Tablets for the treatment of patients with stageⅢB/Ⅳnon-small cell lung cancer(NSCLC).Methods The patients were divided into the experimental group(Shenqi Guben Recipe ultrafine granular powder combined with He Chan Tablets)and the control group(Shenqi Guben Recipe traditional decoction combined with He Chan Tablets).The course of treatment for both groups lasted for 90 days.The performance status,traditional Chinese medicine(TCM)symptom scores,liver and kidney function,and the incidence of bone marrow suppression of the two groups were observed,and the survival period was examined by follow-up.Results In the treatment period V2(30±3 days)and V3(90±3 days),there was no significant difference in TCM symptom scores,PS and tumor-related markers in both the experimental group and the control group(P>0.05).The pre-and post-treatment self-contrast results showed that both of the experimental group and the control group were effective on improving the score of phlegm-dampness syndrome,and the effect of the experimental group was slightly stronger.The control group had stronger effect on improving the score of yin deficiency syndrome.There was no significant difference in survival analysis between the two groups(P>0.05).In terms of the safety,no obvious bone marrow suppression or liver and kidney function damage was found in the two groups.Conclusion Both Shenqi Guben Recipe traditional decoction or Shenqi Guben Recipe ultrafine granular powder combined with He Chan Tablets exert certain effect for the treatment of advanced NSCLC patients,their therapeutic effect is similar with the same safety,and the ultrafine granular powder of Shenqi Guben Recipe can be used as its alternative dosage form.