痰热清联合参附注射液治疗老年晚期EGFR野生型非小细胞肺癌(脾虚痰湿证)疗效及安全性

Efficacy and safety of Tanreqing injection combined with Shenfu injection on treatment of advanced NSCLC with EGFR wild-type(Spleen deficiency and phlegm dampness syndrome) in elderly patients

目的:探讨痰热清联合参附注射液对多西他赛治疗老年Ⅳ期EGFR野生型非小细胞肺癌的疗效、生活质量及安全性的影响。方法:符合条件的64例患者分为对照组(多西他赛单药化疗方案)32例和治疗组(对照组基础上加用痰热清联合参附注射液方案)32例。21天为1个周期,治疗2周期后进行疗效、生活质量及安全性评价。结果:治疗组RR 25.0%,对照组18.8%,两组比较无统计学差异(P>0.05);治疗组DCR78.1%,对照组62.5%,两组比较具有统计学差异(P<0.05)。治疗组中医症候改善情况优于对照组。治疗组的生活感受、健康感受、活动能力、日常生活能力、家庭支持评分优于对照组,差异均有统计学意义(P<0.05)。两组毒副反应主要是骨髓抑制(中性粒细胞减少、血小板减少、贫血为主要表现)、胃肠道反应(恶心/呕吐、便秘为主要表现)及失眠。与对照组相比,治疗组的Ⅲ/Ⅳ度血液学毒性降低,差异具有统计学意义(P<0.05);主要胃肠道反应、心肝肾功能异常、皮疹差异均无统计学意义。结论:痰热清联合参附注射液能提高晚期老年非小细胞肺癌的DCR,改善中医症候,提高患者生活质量及减轻血液学毒性,安全性高,值得临床推广应用。

Objective：To investigate the efficacy,quality of life and safety of Tanreqing injection combined with Shenfu injection on treatment of advanced stage non-small cell lung cancer（NSCLC） with EGFR wild-type in elderly patients.Methods：All 64 patients were divided into control group （docetaxel single drug chemotherapy regimen） 32 cases and treatment group （Tanreqing injection combined Shenfu injection based on control group） 32 cases.It＇s 21 days for 1 cycle.They were evaluated after 2 cycles＇s treatment about efficacy,quality of life and safety.Results：After treatment,the RR of treatment group and control group was 25% and 18.8%（P〉0.05）.The DCR of treatment group and control group was 78.1% and 62.5%（P〈0.05）.The improvement of TCM symptoms in the treatment group was superior to the control group.The scores of life experience,health feeling,activity ability,daily life ability and family support score of the treatment group were better than those of the control group,and the difference was statistically significant（P〈0.05）.The main side effects of the two groups were myelosuppression（neutral cell depletion,thrombocytopenia,anemia as the main manifestation）,gastrointestinal reactions（nausea/vomiting,constipation as the main manifestation） and insomnia.Compared with the control group,the treatment group had a lower hematologic toxicity of grade III/IV,and the difference was statistically significant （P〈0.05）.There were no significant differences in primary gastrointestinal reactions,heart,liver and kidney dysfunction,rash between the two groups.Conclusion：Tanreqing injection combined with Shenfu injection can improve the elderly patients with advanced non-small cell lung cancer DCR,improve TCM symptoms,improve the quality of life of patients and reduce hematologic toxicity.It is safe and worthy to be popularized in clinical application.