Observation On The Clinical Efficacy Of Modified Gusuibuwan Combined With Zoledronic Acid In The Treatment Of Prostate Cancer Bone Metastases

Objective: To observe the clinical efficacy of Modified Gusuibuwan combined with zoledronic acid in the treatment of prostate cancer bone metastases(kidney deficiency and blood stasis syndrome),the effect on biochemical indicators such as alkaline phosphatase,and the improvement of patients’ clinical symptoms and quality of life.To evaluate its efficacy and safety,and further enrich the clinical application of traditional Chinese medicine in patients with bone metastases.Methods:Patients who were diagnosed with prostate cancer bone metastases from October 1,2019 to September 30,2021 in the outpatient and inpatient departments of the Oncology Department of Chengdu University of Traditional Chinese Medicine/Sichuan Provincial Hospital of Traditional Chinese Medicine were selected,and the included 47 patients were randomly divided into.There were 23 cases in the combined traditional Chinese medicine group and 24 cases in the control group.The control group was given only zoledronic acid,and the combined Chinese medicine group was given Modified Gusuibuwan orally on the basis of the control group.4weeks as a course of treatment,and the treatment was continued for 6 courses.Bone metastases,new fractures,pain severity score,24-hour oxycodone dosage change,alkaline phosphatase level,TCM syndrome score,KPS score,quality of life score,etc.were recorded respectively in the two groups for observation.Blood routine,liver and kidney function,serum calcium,electrocardiogram and other safety indicators.SPSS25.0 statistical software was used for data processing to evaluate the curative effect and safety of Modified Gusuibuwan.Results:A total of 46 patients completed the study,including 23 in the combined Chinese medicine group and 23 in the control group.The age,bone metastases site,number of bone metastases,pain score,KPS score,TCM syndrome score,quality of life score,alkaline phosphatase,and baseline blood routine,liver and kidney function,serum calcium,and electrocardiogram of the two groups of patients were compared.The conditions were comparable(P>0.05).1.Main efficacy indicators: Including comparison of bone metastases,ORR and DCR between groups after treatment;the comparison between the two groups of new fractures during the treatment process.(1)Conditions of bone metastases:(1)After 24 weeks of treatment,the curative effect of bone metastases in the combined traditional Chinese medicine group was better than that in the control group,and the difference was statistically significant(P<0.05);(2)After 24 weeks of treatment,the comparison between the two groups,the ORR of the combined traditional Chinese medicine group was significantly better than that of the control group(P<0.05).(2)New fracture situation: During the treatment process,there was no significant difference in the new fracture rate between the combined traditional Chinese medicine group and the control group(P>0.05).2.Secondary efficacy indicators: The secondary efficacy indicators of this trial mainly include statistical comparison of pain score,24 h oxycodone dosage,alkaline phosphatase level,TCM syndrome score,KPS score,and quality of life score before and after treatment.(1)Pain severity score: compared between groups,in all observation time points after treatment,there was no significant difference in pain severity score between the patients in the combined traditional Chinese medicine group and the control group(P>0.05).(2)Dosage of oxycodone in 24 hours:(1)Intra-group comparison: The dosage of oxycodone in the combined traditional Chinese medicine group and the control group at all observation time points after treatment was lower than before treatment(P<0.05);(2)Comparison between groups: 24 weeks After treatment,the 24-hour oxycodone dosage in the combined traditional Chinese medicine group was significantly lower than that in the control group(P<0.05).(3)Serum alkaline phosphatase:(1)Alkaline phosphatase at 3 observation time points after treatment in the combined traditional Chinese medicine group was lower than the level before treatment(P<0.05);Alkaline phosphatase in the control group decreased significantly after 24 weeks of treatment,and the difference was statistically significant(P<0.05);(2)Comparison between groups: After 16 and 24 weeks of treatment,the level of alkaline phosphatase in the combined Chinese medicine group was significantly lower than that in the control group(P<0.05).(4)TCM syndrome scores:(1)Comparison within the group: The TCM syndrome scores of the combined TCM group were significantly improved at 3 observation time points after treatment(P<0.05);There was no significant change in TCM syndrome scores in the control group after treatment(P>0.05);(2)Comparison between groups:After treatment,the TCM syndrome scores of patients in the combined TCM group were significantly improved compared with those in the control group(P<0.05).(3)Effective rate of TCM syndromes: Compared between groups,the effective rate of TCM syndromes in the combined TCM group at each observation time point after receiving treatment was significantly higher than that in the control group(P<0.05).(5)KPS score:(1)Intra-group comparison: The KPS scores of the two groups at all observation time points after treatment were lower than those before treatment(P<0.05);During the same period,there was no significant difference in KPS score between the two groups(P>0.05).(6)Quality of life score:(1)The quality of life scores of the two groups of patients decreased after receiving treatment,and there was a statistical difference(P<0.05);(2)Comparison between groups: After 24 weeks of treatment,the quality of life score of the combined traditional Chinese medicine group was significantly lower than that of the control group(P<0.05).3.Drug side effects: 0 cases of fever,1 case of constipation,1 case of joint and muscle pain,2 cases of nausea and vomiting occurred in the combined Chinese medicine group during the treatment;soreness,nausea and vomiting in 5 cases;the incidence of drug toxicity in the combined traditional Chinese medicine group was significantly lower than that in the control group,but there was no significant difference(P>0.05).4.Safety evaluation: no serious adverse events occurred during the trial.Blood routine(WBC,WBC,HGB,PLT),liver and kidney function(ALT,AST,Scr,BUN),serum calcium(Ca),electrocardiogram and other indicators were not significantly different(P>0.05).Conclusion:Modified Gusuibuwan can enhance the efficacy of zoledronic acid,improve ORR,relieve pain,reduce the use of analgesics,improve alkaline phosphatase levels,TCM syndromes,and improve the quality of life of patients.Moreover,the addition and subtraction of Modified Gusuibuwan will not increase adverse reactions,and the safety is good.