精元康胶囊治疗脾肾亏虚型癌因性疲乏的临床研究

Clinical Study of Jingyuankang Capsules in the Treatment of Cancer-related Fatigue with Deficiency of Spleen and Kidney

目的观察精元康胶囊治疗脾肾亏虚型癌因性疲乏(Cancer-Related Fatigue,CRF)的疗效。方法选取符合纳入标准的患者100例,随机分为对照组和观察组。观察组口服精元康胶囊,对照组口服健脾益肾颗粒。30天为一个疗程,共观察2个疗程。治疗结束后评价两组治疗前后Piper评分量表、卡氏评分(Karnofsky Performance Status,KPS)、中医证候积分量表,抽取治疗前后外周血检查T细胞亚群、TNF-α、IL-6以及血常规、肝、肾功指标,评价精元康胶囊对治疗恶性肿瘤及癌因性疲乏患者的临床疗效及安全性。结果治疗后观察组在疲乏状况方面,疲乏总分、行为、认知维度评分明显低于对照组(P<0.01),感觉维度评分低于对照组(P<0.05),情感维度评分两组无明显差异(P>0.05)。治疗后观察组KPS较对照组显著性增加(P<0.01),观察组有效率(85%)明显高于对照组(53%)(P<0.01)。治疗后观察组证候总分明显低于对照组(P<0.05),观察组有效率明显高于对照组(P<0.01)。治疗后观察组CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)水平高于对照组(P<0.05),CD8^(+)水平低于对照组(P<0.05)。治疗后观察组TNF-α、IL-6水平低于对照组(P<0.05)。结论应用精元康胶囊治疗癌因性疲乏患者,可调节其免疫及炎症因子,提高机体的免疫功能,有效改善CRF症状,提高患者生活质量。

Objective To observe the clinical efficacy and therapeutic mechanism of Jingyuankang Capsules in the treatment of cancer-related fatigue(CRF)with deficiency of spleen and kidney.Methods From January 2019 to December 2019,100 patients with advanced malignant cancer complicated with CRF and meeting the inclusion criteria were included into the trial.The patients were randomly divided into control group and observation group,50 cases in each group.The observation group was given Jingyuankang Capsules orally,and the control group was given Jianpi Yishen Granules orally.Thirty days constituted one course of treatment,and the treatment covered 2 courses.Before and after treatment,we observed the changes in the Piper scale scores,Karnofsky Performance Status(KPS)scores,traditional Chinese medicine(TCM)syndrome scores,the levels of T cell subsets,tumor necrosis factor alpha(TNF-α),and interleukin 6(IL-6)in the peripheral blood samples,and parameters of the routine blood analysis,liver function and kidney function.After treatment,the clinical efficacy and safety in the two groups were evaluated.Results After treatment,fatigue overall scores,and scores of the dimension of behavior and cognition in the observation group were significantly lower than those in the control group(P<0.01),and sensory scores were also lower than those in the control group(P<0.05).There was no significant difference in emotional scores between the two groups(P>0.05).The KPS scores of the observation group were significantly increased as compared with those of the control group after treatment(P<0.01),and the effective rate of the observation group was 85%and that of the control group was 53%,the effective rate of the observation group being significantly higher than that of the control group(P<0.01).After treatment,the total scores of TCM syndrome in the observation group were significantly lower than that in the control group(P<0.05),and the effective rate of the observation group was 85%and that of the control group was 49%,the effective rate of the observation group was significantly higher than that of the control group(P<0.01).The levels of CD3+,CD4+and CD4+/CD8+in the observation group were higher and the level of CD8+was lower than those in the control group after treatment(P<0.05).After treatment,TNF-αand IL-6 levels in the observation group were lower than those of the control group(P<0.05).Conclusion Jingyuankang Capsules are effective in the treatment of CRF with deficiency of spleen and kidney by regulating immune and inflammatory factors,improving immune function,effectively relieving CRF symptoms and enhancing the quality of life of CRF patients.