| Objective: To investigate the possible mechanism of Shenbai Fuzheng Granules in reducing cancer-related Fatigue(CRF)symptoms and provide theoretical foundation for further clinical application,we need to observe the clinical efficacy and changes of inflammatory factors(IL-1 、 IL-6 、 TNF-α 、 CRP)of Shenbai Fuzheng Granules in patients with cancer-related Fatigue(CRF)of qi and blood deficiency with randomized controlled design.Methods: Adopting the random digital table method,36 patients out of the 72 qualified patients assigned into trial group,with those left being assigned into control group.The control group was treated with routine symptomatic support during intravenous chemotherapy,and the trial group received the treatment using Shenbai Fuzheng Granules on the basis of the control group.A total of 2 cycles were observed with 21 days as one observation cycle.We record Piper Fatigue revised scale(PFS-R)questionnaire 、 TCM syndrome questionnaire,KPS score,levels of peripheral WBC,RBC,HB,ALT and ALB.Besides,levels of the serum inflammatory factors,such as IL-1,IL-6 and TNF-α and CRP,were recorded.Last,we also recorded the incidence of adverse reactions for safety evaluation.SPSS was adopted for statistical data analysis and R software was used for plotting.Results: Totally 70 participants were kept with one case fell off from each group.The final number of effective cases was 35 in each group.(1)PFS-R score:(1)between-group comparisons: the trial group had lower scores on behavior,emotion,feeling and cognition and the total score of fatigue(P < 0.05);However,we could not found any significant difference no matter in the single dimension or the total score between the given two groups(P >0.05).(2)within-group comparison: compared with those scores before treatment,the dimensions of PFS-R fatigue and the total score of fatigue in the two groups were significantly decreased(P < 0.05).(2)TCM syndrome score and curative effect:(1)betweengroup comparison: after receiving the relevant treatment,participants from the trial group gained lower total score of Qi and blood deficiency syndrome in contrast to those from the control group significantly(P<0.05).Besides,significant differences were identified in scores of the spiritual fatigue,shortness to breath and weakness in speaking,pale complexion,insomnia and forgetfulness,dizzy feeling in the skull and dim of eyesight,palpitation,light color in lips and nails and spontaneous perspiration between the two groups.However,we could not identify the score difference on hands-feet numbness between the two groups as significant(P > 0.05);The effective rate of Qi and blood deficiency syndrome in the trial group outnumbered that in the control group(P < 0.01).(2)Withingroup comparison: Each group’s Qi and blood deficiency syndrome score decreased significantly after treatment(P < 0.05);The scores of TCM symptoms in the trial group were significantly lower than those before treatment(P >0.05)(3)KPS score:(1)Between-group comparison: with regard to the score obtained after treatment,the trial group exceeded the control group(P < 0.05);(2)Within-group comparison: the KPS score in each group rose significantly after treatment(P < 0.05).(4)WBC,Hb,PLT,RBC and ALB indexes:(1)Betweengroup comparisons: after treatment,Hb and ALB in the trial group ranked significantly over than those in the control group(P < 0.05).However,the indexes of WBC,PLT and RBC saw no difference(P > 0.05);(2)Within-group comparison: On the one hand,for the control group,we found no significant drop except for the Hb and ALB levels(P < 0.05).On the other hand,for the trial group,we could not find any significant difference in all indexes(P > 0.05).(5)Serum inflammatory factors:(1)Between-group comparisons: after treatment,the proportion of serum inflammatory factors like IL-1,IL-6,TNF-α and CRP in the trial group were significantly below than those in the control group(P< 0.01);(2)Within-group comparisons: the contents of those four inflammatory factors in each group all dropped after treatment(P< 0.05).(6)Safety evaluation: no significant difference was found in the occurrence rate of marrow suppression as well as the liver and kidney function injury between the two groups neither before nor after treatment(P > 0.05).No adverse reactions related to Shenbai Fuzheng Granules were observed during the treatment.Conclusions: Shenbai Fuzheng Granules can improve the fatigue symptoms of CRF patients with Qi and blood deficiency,and its possible mechanism is to modulate the level of serum inflammatory factors.Shenbai Fuzheng Granules can also improve the TCM syndrome,nutrition and functional status of patients without apparent adverse reactions,which is promising for prevalence in clinical practice. |
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