参芪扶正注射液治疗癌症相关疲劳的临床研究

Clinical study on Shenqi Fuzheng Injection in the Treatment of Cancer-Related Fatigue

目的评价参芪扶正注射液治疗癌症相关疲劳的临床疗效,为中医药治疗癌症相关疲劳,提高患者生活质量方面提供临床证据。方法选取2016年4月—2017年2月期间于北京中医药大学东直门医院血液肿瘤科入组晚期肺癌、胃癌患者66例,采用随机入组原则,对照组和治疗组各33例,脱落6例,其中1例拒绝治疗出组,5例患者治疗过程中因病情进展情况出组,最终60例进入统计学处理,治疗组31例,对照组29例。对照组接受常规基础治疗,治疗组在基础治疗上加用参芪扶正注射液治疗,两组均治疗1个疗程(14 d);采用简明Piper疲乏量表在每个访视时间点对患者的疲乏状况进行评价;在每个访视时间点,观察记录肺脾气虚证的症状、体征与舌脉积分变化。结果两组患者组治疗后Piper量表积分均较治疗前下降,差异有统计学意义(P<0.05);且治疗组治疗后Piper量表积分较对照组改善明显,差异有统计学意义(P<0.05)。治疗组治疗后相关领域Piper量表积分与治疗前比较,行为疲乏、躯体疲乏领域Piper量表积分降低明显,差异有统计学意义(P<0.05);而情感疲乏、认知疲乏领域Piper量表积分变化不明显,差异无统计学意义(P>0.05)。两组患者治疗后躯体疲乏领域Piper量表积分组间比较,治疗组改善较对照组明显,差异有统计学意义(P<0.05);行为疲乏、情感疲乏、认知疲乏领域Piper量表积分组间比较,差异无统计学意义(P>0.05)。两组患者治疗后中医证候疗效组间比较,治疗组优于对照组,差异有统计学意义(P<0.05)。两组患者治疗后中医单项证候积分体倦乏力症状积分组间比较,治疗组优于对照组,差异有统计学意义(P<0.05)。结论参芪扶正注射液能缓解晚期癌症患者疲乏症状,改善中医症状,提高患者生活质量。

Objective To evaluate the clinical efficacy of Shenqi Fuzheng injection in the treatment of cancer-related fatigue,and to provide clinical evidence of treating cancer-related fatigue and improving patients’quality of life with Traditional Chinese Medicine(TCM).Methods From April 2016 to February 2017,66 patients with advanced lung cancer and gastric cancer were enrolled in the Department of Hematology and Oncology of Dongzhimen Hospital.The principle of randomization was adopted.There were 33 cases in the control group and the treatment group,and 6 cases were dropped,including 1 case.Rejected treatment and left the group,5 patients were removed from the group due to disease progression during the treatment process,and finally 60 cases entered the statistical treatment,31 cases in the treatment group and 29 cases in the control group.The control group received conventional basic treatment,and the treatment group was treated with Shenqi Fuzheng injection in addition to the basic treatment.Both groups were treated for 1 course(14 d);the concise Piper fatigue scale was used to assess the patient’s health at each visit time point.The fatigue status is evaluated;at each visit time point,the symptoms,signs,and tongue pulse score changes of the lung-spleen-qi deficiency syndrome are observed and recorded.Results Piper scale scores of the two groups of patients after treatment decreased compared with before treatment,the difference was statistically significant(P<0.05);and the Piper scale scores of the treatment group after treatment were significantly improved compared with the control group,the difference was statistically significant(P<0.05).Piper scale scores in related areas after treatment in the treatment group were compared with those before treatment.The Piper scale scores in the areas of behavioral fatigue and physical fatigue were significantly reduced,and the difference was statistically significant(P<0.05),while the Piper scale in the areas of emotional fatigue and cognitive fatigue The integral change was not obvious,and the difference was not statistically significant(P>0.05).Comparing the Piper scale scores in the field of physical fatigue between the two groups of patients after treatment,the treatment group improved significantly compared with the control group,and the difference was statistically significant(P<0.05).The Piper scale score group in the fields of behavioral fatigue,emotional fatigue,and cognitive fatigue There was no statistically significant difference between them(P>0.05).Comparing the efficacy of TCM syndrome between the two groups of patients after treatment,the treatment group was better than the control group,and the difference was statistically significant(P<0.05).After the treatment of the two groups of patients,the TCM single syndrome score physical fatigue symptom score comparison between the groups,the treatment group was better than the control group,the difference was statistically significant(P<0.05).Conclusions Shenqi Fuzheng injection can relieve fatigue symptoms of patients with advanced cancer,improve TCM symptoms,and improve the quality of life of patients.