益气养血补髓膏治疗肺癌虚证患者癌因性疲乏的疗效观察

Clinical Efficacy Observation on Yiqi Yangxue Busui Soft Extract for the Treatment of Cancer-related Fatigue in Lung Cancer Patients with Deficiency Syndrome

【目的】观察益气养血补髓膏治疗肺癌虚证患者癌因性疲乏的疗效。【方法】将60例肺癌虚证癌因性疲乏患者随机分为膏方组和对照组,每组各30例。对照组给予常规处理(包括干预期间指导患者合理作息、适当运动、心理辅导等),治疗组在对照组基础上给予口服益气养血补髓膏治疗,疗程为21 d。观察2组患者治疗前后中医证候评分、Piper疲乏量表评分、欧洲癌症治疗研究组织(EORTC)生命质量测定量表(QLQ-C30)评分、血液分析指标的变化情况,评价2组患者的中医证候疗效及安全性。【结果】(1)治疗过程中,膏方组脱落2例,对照组脱落1例,最终膏方组28例、对照组29例患者完成全部疗程的治疗。(2)治疗21 d后,膏方组中医证候疗效的有效率为67.86%(19/28),对照组为37.93%(11/29),组间比较,膏方组的中医证候疗效明显优于对照组(P<0.05)。(3)治疗后,2组患者的气虚评分、血虚评分和中医证候总评分均较治疗前明显降低(P<0.05),且膏方组的气虚评分、血虚评分和中医证候总评分均明显低于对照组(P<0.05或P<0.01)。(4)治疗后,2组患者Piper疲乏量表的行为、情绪、感觉、认知等各维度评分及总分均较治疗前明显降低(P<0.01),且膏方组的各维度评分及总分均明显低于对照组(P<0.05或P<0.01)。(5)治疗后,2组患者QLQ-C30量表的躯体、角色、情绪、认知功能评分均较治疗前降低(P<0.05),生活质量评分均较治疗前明显提高(P<0.05);组间比较,膏方组的躯体、情绪、认知功能评分明显低于对照组,生活质量评分明显高于对照组,差异均有统计学意义(P<0.05)。(6)治疗后,2组患者的血红蛋白(HGB)、红细胞(RBC)均较治疗前明显提高(P<0.05),且膏方组的HGB、RBC明显高于对照组,差异均有统计学意义(P<0.05);而白细胞(WBC)、血小板(PLT)、中性粒细胞(NEU)、淋巴细胞(LYM)及中性粒细胞/淋巴细胞(NLR)等血液分析指标治疗前后及组间比较,差异均无统计学意义(P>0.05)。(7)研究过程中,未发现与益气养血补髓膏相关的不良反应,患者的生命体征、心电图、肝肾功能、空腹血糖和尿常规等均无异常变化。【结论】益气养血补髓膏对肺癌虚证患者的癌因性疲乏有一定的疗效,且安全性良好。

Objective To observe the efficacy of Yiqi Yangxue Busui Soft Extract,a Chinese patent medicine for reinforcing qi,nourishing blood and tonifying marrow,for the treatment of cancer-related fatigue(CRF)in lung cancer patients with deficiency syndrome.Methods Sixty lung cancer CRF patients with deficiency syndrome were randomly divided into soft extract group and control group,30 cases in each group.The control group was given conventional treatment including guidance for daily life,appropriate exercise,psychological counseling,etc.,and the treatment group was given oral use of Yiqi Yangxue Busui Soft Extract on the basis of treatment for the control group,the course of treatment lasting 21 days.The changes of TCM syndrome scores,Piper fatigue scale scores,scores of quality of life questionnaire(QLQ-C30)issued by European Organization for Research in Cancer Treatment(EORTC)and blood analysis standard in the two groups were observed before and after treatment.After treatment,the efficacy for TCM syndromes and clinical safety in the two groups were evaluated.Results(1)During the treatment,2 patients in the soft extract group and one patient in the control group fell off.Finally,28 patients in the soft extract group and 29 patients in the control group completed the whole course of treatment.(2)After 21 days of treatment,the effective rate for improving TCM syndromes in the soft extract group was 67.86%(19/28),and that in the control group was 37.93%(11/29).The intergroup comparison showed that the efficacy for TCM syndromes in the soft extract group was significantly superior to that in the control group(P<0.05).(3)After treatment,the scores of qi deficiency and blood deficiency as well as the total scores of TCM syndromes in the two groups were significantly decreased compared to those before treatment(P<0.05),and the scores of qi deficiency and blood deficiency as well as the total scores of TCM syndromes in the soft extract group were significantly lower than those in the control group(P<0.05 or P<0.01).(4)After treatment,the scores of behavior,emotion,sensation,and cognition dimensions of Piper fatigue scale as well as the total scores in the two groups were significantly lower than those before treatment(P<0.01),and the scores of each dimension and the total scores of Piper fatigue scale in the soft extract group were significantly lower than those in the control group(P<0.05 or P<0.01).(5)After treatment,the scores of body,role,emotion and cognitive function dimensions of QLQ-C30 in the two groups were decreased compared to those before treatment(P<0.05),and the scores of quality of life were significantly increased compared to those before treatment(P<0.05).The intergroup comparison showed that the scores of body,emotion and cognitive function dimensions in the soft extract group were significantly lower than those in the control group,and the scores of QLQ-C30 in the soft extract group were significantly higher than those in the control group,the differences being statistically significant(P<0.05).(6)After treatment,the hemoglobin(HGB)and red blood cell(RBC)in the two groups were significantly increased compared with those before treatment(P<0.05),and the HGB and RBC in the soft extract group were significantly higher than those in the control group,the differences all being statistically significant(P<0.05).There were no significant differences in the blood analysis indexes of white blood cells(WBC),platelets(PLT),neutrophils(NEU),lymphocytes(LYM)and neutrophils to lymphocytes ratio(NLR)in the two groups before and after treatment as well as between the two groups after treatment(P>0.05).(7)During the trial,no adverse reactions related to Yiqi Yangxue Busui Soft Extract were found,there were no abnormal changes in patients’vital signs,electrocardiogram,liver and kidney functions,fasting blood glucose and urine routine,either.Conclusion Yiqi Yangxue Busui Soft Extract has certain effect on cancer-related fatigue in lung cancer patients with deficiency syndrome,and the soft extract has high safety.