| Objective: To evaluate the efficacy of Jieduqingre formula in treating [early to mid-stage lung cancer fever caused by heat toxicity] by observing changes in body temperature and improvements in TCM syndromes.This provides an objective clinical basis and experience for further in-depth and systematic research in the future.Methods: This study adopted a randomized controlled trial method and selected 50 patients who were treated at the outpatient the oncology department of Heze City Hospital of Traditional Chinese Medicine from December 2021 to December 2022.All patients met the [early to mid-stage lung cancer fever caused by heat toxicity],and were randomly assigned to the control group(25 cases)and the experimental group(25 cases).Both groups received the same basic treatment.The control group was given Naproxen tablets,while the experimental group was given the self-developed Jieduqingre formula,which contained the following herbs: Shijianchuang 20 g,arrowhead mushrooms 12 g,rattan root20 g,rabdosia rubescens 20 g,raw coix seed 25 g,Polygala tenuifolia 15 g,Acorus tatarinowii 20 g,orange peel 12 g,Zhebei 20 g,radish seed 15 g,zedoary rhizome 15 g,astragalus membranaceus 25 g,poria cocos 15 g,Herba rehmanniae 15 g,Rhizoma anemarrhenae 15 g,and roasted licorice 12 g,taken twice a day.The medication was administered for one week,followed by a 3-day follow-up period.SPSS 25.0 software was used for data analysis.Primary efficacy index: temperature change before and after treatment;secondary efficacy index: KPS score,TCM evidence score,number of relapses after discontinuation of medication.Safety indexes: blood routine,electrolytes,liver function,kidney function,electrocardiogram,checked once before treatment and once after completion of observation.Results: A total of 50 patients were enrolled in this study,with 3 dropouts,and finally24 patients in the control group and 23 patients in the experimental group completed the study.There was no difference in baseline treatment between the two groups.All of control group and experimental group could achieve the effect of fever reduction(P>0.05),and the difference was not statistically significant,which suggested that there was no significant difference in the efficacy of drug treatment for cancer fever between the two groups.Compared with the control group during the treatment period,the experimental group had a greater reduction in TCM syndrome score(P < 0.05)and was better at maintaining stable body temperature after a 2-week follow-up(P < 0.05).Safety evaluation:There was no significant difference in adverse reactions or incidence of adverse reactions between the control and experimental groups(P > 0.05),and there were no significant abnormalities in safety indicators.Conclusion: The self-developed Jieduqingre formula has shown good clinical efficacy in treating [early to mid-stage lung cancer fever cacaod by heat toxicity],and can effectively relieve the clinical symptoms of patients.The formula has a stable effect,a long duration of action,and is less likely to recur in a short period of time.Moreover,there were no significant abnormalities observed in the safety index,indicating that the formula is safe to use. |