十全大补加味方脐敷联合耳穴压丸治疗癌因性疲乏临床疗效观察

Evaluation of the clinical efficacy of topical application of Shiquan Dabu Jiawei Formula at the navel and acupressure with magnetic ear beads for cancer-related fatigue

目的观察十全大补加味方脐敷联合耳穴压丸治疗癌因性疲乏(CRF)的临床疗效。方法将65例CRF患者随机分为治疗组33例、对照组32例,剔除脱落病例后治疗组30例、对照组30例。对照组予基础治疗,治疗组在基础治疗上加用脐敷联合耳穴压丸治疗。观察Piper疲乏修订量表(PFS-R)评分、疲乏程度分级情况、中医证候积分、中医证候疗效、外周血象,并进行安全性评估。结果治疗后治疗组感觉评分、情绪评分、认知评分、行为评分及总疲乏评分较本组治疗前均降低(P<0.01),对照组感觉评分、情绪评分、认知评分、行为评分及总疲乏评分与本组治疗前比较差异均无统计学意义(P>0.05)。治疗组感觉评分、情绪评分、认知评分、行为评分及总疲乏评分较对照组降低明显(P<0.01),治疗组优于对照组。治疗后治疗组疲乏程度较前有所改善(P<0.05),对照组无明显差异(P>0.05)。2组治疗前、后疲乏程度分级比较,差异均无统计学意义(P>0.05)。2组中医证候积分治疗后较本组治疗前均降低(P<0.01),治疗组较对照组降低明显(P<0.01),治疗组优于对照组。治疗组中医证候疗效优于对照组(P<0.01)。治疗组红细胞(RBC)计数、血红蛋白(Hb)浓度治疗后较本组治疗前均升高(P<0.05),白细胞(WBC)计数、血小板(PLT)计数、中性粒细胞(N)绝对值与本组治疗前比较差异均无统计学意义(P>0.05)。对照组WBC计数、RBC计数、Hb浓度、PLT计数、N绝对值治疗后与本组治疗前比较差异均无统计学意义(P>0.05)。2组WBC计数、RBC计数、Hb浓度、PLT计数、N绝对值治疗前后差值比较,差异均无统计学意义(P>0.05)。结论十全大补加味方脐敷联合耳穴压丸治疗CRF具有较好的疗效。

Objective To evaluate the clinical efficacy of topical application of Shiquan Dabu Jiawei Formula at the navel with auricular acupressure with magnetic ear beads in patients with cancer-related fatigue(CRF).Methods Sixty-five patients with CRF were randomly assigned to the treatment group(n=33)and control group(n=32).After dropouts were removed,there were 30 cases each in both treatment and control groups.The control group received basic treatment for CRF,while the treatment group received additional topical application of Shiquan Dabu Jiawei Formula at the navel with auricular acupressure with magnetic ear beads.Efficacy was assessed by using the Revised Piper Fatigue Scale(PFS-R),degree of fatigue,TCM syndrome scores and therapeutic efficacy,and full blood count.Safety was assessed by adverse events.Results Sensory,affect,cognition and behavior subscales of PFS-R,as well as total fatigue score in the treatment group were significantly decreased after treatment(P<0.01).There were no significant differences in the subscales and total fatigue score in the control group after treatment(P>0.05).After treatment,as compared with the control group,the sensory,affect,cognition and behavior subscales,as well as the total fatigue score in the treatment group were significantly lower(P<0.01).Degree of fatigue in the treatment group improved after treatment(P<0.05),while no significant change was detected in the control group(P>0.05).TCM syndrome scores in both groups decreased significantly after treatment(P<0.01),with lower scores in the treatment group than in the control group(P<0.01).TCM therapeutic efficacy was significantly better in the treatment group than in the control group(P<0.01).In the treatment group,red blood cell(RBC)count and hemoglobin(Hb)concentration increased after treatment(P<0.05),while no significant differences were observed for white blood cell(WBC)count,platelet(PLT)count,and the absolute value of neutrophils(N)(P>0.05).In the control group,no significant differences were observed in WBC count,RBC count,Hb concentration,PLT count and absolute value of N after treatment(P>0.05).No significant differences were observed for changes in WBC count,RBC count,Hb concentration,PLT count,and absolute value of N for both groups(P>0.05).Conclusions Topical application of Shiquan Dabu Jiawei Formula at the navel and acupressure with magnetic ear beads is effective in relieving CRF.