| Objective:To observe the clinical efficacy and safety of Fu Jin Hua Ji Paste in the prevention and treatment of myelosuppression after chemotherapy in NSCLC,and further evaluate its effectiveness,in order to provide a new preparation for the prevention and treatment of myelosuppression after chemotherapy in NSCLC with traditional Chinese medicine,and also provide a scientific basis for further research and dosage form improvement of Fu jin Hua ji Paste.Methods: This study included 62 patients who were randomly divided into a control group of 31 cases and a treatment group of 31 cases.The control group was treated with standard chemotherapy regimen,while the treatment group was treated with oral Fu Jin Hua Ji Paste on the basis of the control group.They were treated with 21 days as a cycle and 3cycles.The WBC,HGB,PLT,NEU,myelosuppression grade,clinical symptoms of TCM,KPS scores,gastrointestinal toxicity,Symptomatic administration of toxic reactions in the blood system,adverse reactions and etc.Using SPSS26.0 to analyze the data,it was found that P<0.05 was statistically significant.Results:After removal and elimination,59 cases of data were finally included in this study,including 30 cases in the treatment group and 29 cases in the control group.After comparison,the baseline data of two groups before treatment were not statistically significant(P>0.05),and the two groups were comparable.The results after treatment are described as follows:1.Hematology in both groups(1)WBC and NEU in both groups had no statistical significance at each visit point during the first chemotherapy cycle(P>0.05),but had statistical significance at each visit point during the second and third chemotherapy cycles(P<0.05);(2)PLT in both groups had no statistical significance at each visit point during the first and second chemotherapy cycles(P>0.05),but had statistical significance at each visit point during the third chemotherapy cycle(P<0.05);(3)There was no statistically significant difference in HGB between the two groups at each period and visit point(P>0.05).2.Hematological system toxicity reaction graduation(1)The WBC toxicity scores of the two groups were not statistically significant at each visit point of the first cycle and at d15 and d21 of the second cycle(P >0.05),but were statistically significant at d10 of the second cycle and each visit point of third cycle(P<0.05);(2)The NEU toxicity scores in both groups were not statistically significant at each visit point in the first and second cycles(P>0.05),but were statistically significant at each visit point in the third cycle(P<0.05);(3)There was no statistically significant difference in PLT and HGB toxicity scores between the two groups at each cycle and visit point(P >0.05);(4)Incidence of myelosuppression:There was statistically significant difference in the occurrence of toxic reactions above 0 degree in the blood system between the two groups(P<0.05).3.TCM syndrome:(1)TCM syndrome scores after treatment:(1)Intragroup comparison:in the treatment group P<0.01,with statistical significance;In the control group P<0.01,with statistical significance.(2)Comparison between groups:P<0.05,combined with the mean value of total scores after treatment(control group>treatment group),indicating that the treatment group is superior to the control group.(2)Therapeutic effect of TCM syndrome after treatment:Intragroup comparison P<0.05,Combined with the total effective rate(treatment group > control group),it indicates that the treatment group is superior to the control group.(3)Comparison of primary and secondary symptoms of TCM:there was no difference between groups before treatment(P>0.05),which was comparable.After treatment,the symptoms of the treatment group were improved(P < 0.05),and fatigue,sweating,shortness of breath,dry mouth,hot hands and feet,cough,sputum and afternoon hot flash were better than those of the control group(P < 0.05).4.KPS scoreAfter treatment,the KPS score in the treatment group was significantly higher than that in the control group(P<0.05),5.Gastrointestinal toxicityThere was no significant incidence of gastrointestinal toxicity between the two groups(P > 0.05).6.Symptomatic administration of toxic reactions in the blood systemrhG-CSF:The number of people using rhG-CSF in the treatment group was significantly lower than that in the control group(P<0.05);rhG-CSF:There was no statistically significant difference between the two groups of users(P>0.05);EPO:Both groups of patients were not used during the trial.7.Completion of chemotherapyAfter comparative analysis,there was no statistically significant difference in the completion of chemotherapy between the two groups(P>0.05).8.Safety evaluationThe treatment group had no differences in urine and fecal routine tests,coagulation series,liver and renal functions,and electrocardiogram before and after treatment(P>0.05),and there were no adverse reactions such as allergies,palpitations,and edema,indicating that Fujin Huaji Ointment is safe and reliable in preventing and treating bone marrow suppression after chemotherapy for non small cell lung cancer.Conclusion:(1)Fu Jin Hua Ji Paste Can Reduce the Incidence of myelosuppression after chemotherapy in NSCLC;(2)Fu Jin Hua Ji Paste can improve the peripheral blood of NSCLC after chemotherapy,especially for WBC,NEU,and PLT;(3)Fu Jin Hua Ji Paste can significantly alleviate the degree of myelosuppression after chemotherapy in NSCLC,especially for WBC and NEU;(4)Fu Jin Hua Ji Paste can reduce the number of times rhG-CSF used in patients with myelosuppression after chemotherapy for non small cell lung cancer;(5)Fu Jin Hua Ji Paste can significantly improve the clinical symptoms of TCM in patients with myelosuppression after chemotherapy for NSCLC,Fatigue,sweating,shortness of breath,dry mouth,hot hands and feet,cough,phlegm,hot flashes in the afternoon are more obvious;(6)Fu Jin Hua Ji Paste can significantly improve the quality of life of patients with myelosuppression after chemotherapy for NSCLC;(7)Fu Jin Hua Ji Paste is safe and reliable in preventing and treating myelosuppression after chemotherapy for NSCLC,and can be widely used. |
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