参芪扶正注射液治疗非小细胞肺癌化疗后相关疲乏120例

目的：评价参芪扶正注射液对非小细胞肺癌化疗后相关疲乏患者的疗效及安全性。方法:将240 例Ⅲ～IV期非小细胞肺癌气虚证患者随机分为治疗组和对照组，每组各120 例。对照组单用化疗，治疗组在对照组基础上联合参芪扶正注射液治疗。采用Piper疲乏修订量表对2组进行疲乏评估，同时比较2组的中医证候积分、卡氏评分（KPS）和不良反应。结果：治疗组脱落6 例，对照组脱落4 例。治疗后，治疗组Piper疲乏修订量表积分低于对照组，尤其是在情感、躯体及认知维度方面，差异有统计学意义（P<0.05）;治疗组在中医证候积分方面，其神疲乏力、自汗症状较对照组明显减轻（P<0.05）;且治疗组在提升KPS积分方面优于对照组（P<0.05）。治疗组中有20例发生不良反应，共出现25次不良事件;对照组中有36例发生不良反应，共出现48次不良事件，2组比较，差异有统计学意义（P<0.05）。结论：参芪扶正注射液有助于减轻非小细胞肺癌化疗后气虚证患者的疲乏症状，改善体力状况，且安全性良好。

Clinical effect of Shenqi Fuzheng injection in treatment of cancer-related fatigue after chemotherapy for non-small cell lung cancer: An analysis of 120 cases

Objective: To investigate the clinical effect and safety of Shenqi Fuzheng injection in the treatment of patients with cancer-related fatigue after chemotherapy for non-small cell lung cancer.Methods: A total of 240 patients with stage III-IV non-small cell lung cancer with Qi deficiency syndrome were randomly divided into treatment group and control group，with 120 patients in each group.The patients in the control group were given chemotherapy alone，and those in the treatment group were given Shenqi Fuzheng injection in addition to the treatment in the control group.Revised Piper Fatigue Scale was used to assess fatigue for both groups，and the two groups were compared in terms of traditional Chinese medicine (TCM) syndrome score，Karnofsky Performance Scale (KPS) score，and adverse reactions.Results: Six patients in the treatment group and 4 in the control group were lost to follow-up.After treatment，compared with the control group，the treatment group had a significantly lower score of Revised Piper Fatigue Scale，especially in the emotional，physical，and cognitive dimensions (P<0.05).As for TCM syndrome score，compared with the control group，the treatment group had significant alleviation of fatigue and spontaneous sweating symptoms (P<0.05).The treatment group had a significantly better improvement in KPS score compared with the control group (P<0.05).In the treatment group，20 patients experienced 25 episodes of adverse events，while in the control group，36 patients experienced 48 episodes of adverse events;there was a significant difference between the two groups (P<0.05).Conclusion: Shenqi Fuzheng injection helps to alleviate fatigue and improve performance status in patients with Qi deficiency syndrome after chemotherapy for non-small cell lung cancer，with a relatively good safety profile.