| Objective: To evaluate the efficacy and safety of Jingyuankang Capsule in the treatment of cancer-related fatigue in patients with Middle and Advanced non-small cell lung cancer of Spleen and Kidney Deficiency Type,in order to provide a safe and effective treatment for cancer-related fatigue with traditional Chinese medicine.Methods: To identify patients with Middle and Advanced non-small cell lung cancer(NSCLC)of Spleen and Kidney Deficiency Type who are to be treated with "paclitaxel + cisplatin" regimen as the research object,the patients were divided into two groups according to random number table,32 cases in each group.The control group was treated with standard regimen of paclitaxel plus cisplatin,while the treatment group was treated with Jingyuankang Capsule on the basis of the control group.The changes of fatigue score,clinical symptoms,quality of life,immune function,blood routine and adverse reactions of two groups of patients before and after treatment were observed by Piper’s revised fatigue scale-Chinese version,quantification table of clinical syndromes of traditional Chinese medicine,Karl’s score table and WHO criteria for acute and subacute toxicity of anticancer drugs.Statistical analysis,objective evaluation of Jingyuankang Capsule in the prevention and treatment of cancer-related fatigue in patients with Middle and Advanced non-small cell lung cancer of Spleen and Kidney Deficiency Type clinical efficacy and safety.Result: 1.Fatigue: After treatment,the scores of behavior,emotion,perception,cognition and fatigue in the treatment group were significantly lower than those in the control group(P < 0.01).The scores of behavior,emotion,perception,cognition and fatigue in the treatment group were significantly lower than those before treatment(P < 0.01).The scores of emotion,cognition and fatigue in the control group were lower than those before treatment(P < 0.01),and there was no significant change in the scores of behavior and perception(P > 0.05).It showed that both groups could alleviate the symptoms of CRF fatigue in NSCLC patients,but Jingyuankang Capsule combined with chemotherapy had a better effect in improving the symptoms of CRF fatigue in Middle and Advanced NSCLC of Spleen and Kidney Deficiency Type patients.2.Comparing the improvement of TCM clinical syndromes: After treatment,the total score of TCM syndromes in the treatment group was lower than that in the control group(P < 0.05),with statistical difference.The scores of TCM syndromes in both groups were significantly lower than before(P < 0.01).The total effective rate of TCM clinical syndromes of the two groups was 68.75% in the treatment group and 53.13% in the control group.There was no significant difference between the treatment group and the control group(P > 0.05).It shows that Jingyuankang Capsule combined with chemotherapy can improve the symptoms of cancer-related fatigue in patients with Middle and Advanced NSCLC of Spleen and Kidney Deficiency Type.3.Quality of life score comparison: After treatment,the quality of life score of the treatment group was higher than that of the control group(P < 0.05).The score of treatment group was significantly higher than that before treatment(P < 0.01).The score of control group had no significant change compared with that before treatment(P > 0.05).The quality of life in the treatment group was significantly higher than that in the control group(P < 0.01).It is suggested that Jingyuankang Capsule combined with chemotherapy can improve the quality of life and physical condition of patients with Middle and Advanced NSCLC of Spleen and Kidney Deficiency Type.4.Immune function comparison: There were significant differences between the two groups after treatment.For the treatment group,there were significant differences in CD4 + cells,CD8 + cells,CD4 +/CD8 + cells after treatment compared with before treatment(P < 0.01);for the control group,there were differences in CD4 + cells,CD8 + cells,CD4 +/CD8 + cells after treatment compared with before treatment(P < 0.05).After treatment,there were significant differences in CD4 + cells and CD4 + / CD8 + between the treatment group and the control group(P < 0.01).Meanwhile,there was no significant difference in CD8 + cells between the two groups(P > 0.05).It shows that JingyuankangCapsule combined with chemotherapy has more advantages in improving immune function.5.Safety comparison: 1)Compared with the blood routine results,the leucocytes in the treatment group increased after treatment(P < 0.05);the leucocytes in the control group decreased after treatment(P < 0.01);the leucocytes in the treatment group were significantly higher than those in the control group after treatment(P < 0.01).As for platelets,platelets in the treatment group were significantly higher than those in the control group(P < 0.01).As for platelets,platelets in the treatment group were significantly higher than those in the control group(P < 0.01),while those in the control group were significantly lower than those before treatment(P < 0.05);There was no significant difference between the treatment group and the pre-treatment group(P > 0.05).As far as red blood cells and hemoglobin were concerned,there was no significant difference between the two groups before and after treatment(P > 0.05),and there was no significant difference between the two groups(P > 0.05).It shows that the treatment group has a certain protective effect on hematopoietic system compared with the control group.2)Comparison of liver and kidney function: There was no significant change in alanine aminotransferase,glutamic oxaloacetic aminotransferase,serum creatinine and blood urea nitrogen in the treatment group after treatment(P > 0.05).After treatment,glutamic oxaloacetic transaminase in the control group was higher than that before treatment(P < 0.05).The other safety indicators of glutamic-pyruvic transaminase,serum creatinine and blood urea nitrogen were changed after treatment,but there was no statistical difference(P > 0.05).In terms of liver function damage,the treatment group was lower than the control group;in terms of indicators reflecting renal function,there was no significant change in both groups.3)Adverse reactions: After treatment,there were differences in bone marrow toxicity between the two groups(P < 0.05);there were no significant differences in hepatotoxicity and nephrotoxicity between the two groups(P > 0.05).Conclusion: Jingyuankang Capsule is helpful to improve the fatigue of Middle and Advanced NSCLC of Spleen and Kidney Deficiency Type patients with cancer-related fatigue,alleviate clinical symptoms,protect immune function and improve the quality of life without obvious adverse reactions. |
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