| Background:Non-muscle invasive bladder cancer is the most common type of bladder cancer,accounting for about 75%of the initial bladder tumors.The initial symptoms of patients are mostly intermittent painless gross hematuria.Transurethral resection of bladder tumor is not only an important diagnostic method for NMIBC,but also the main treatment method.However,surgery alone cannot solve the problem of high postoperative recurrence rate and disease progression.It has been found that intravesical infusion can effectively reduce the recurrence of NMIBC after TURBT,and has become the standard treatment for low-risk to high-risk NMIBC after TURBT.Although postoperative intravesical instillation can effectively kill tumor cells and greatly reduce the possibility of bladder tumor recurrence and progression,high-risk NMIBC patients still face the problems of high recurrence rate,high probability of progression,and unresponsiveness to BCG treatment.During the perfusion process,patients often have adverse reactions such as hematuria and urinary tract irritation that cannot be tolerated,leading to interruption or even termination of perfusion.Therefore,it is necessary to continue to find new treatment modalities to address the high rate of postoperative recurrence and progression and the adverse effects associated with perfusion.Fuzheng Xiaozheng Decoction is a basic formula for the treatment of bladder cancer,created by Professor Liu Youfang,the founder of the Department of Urology,Guang’anmen Hospital,Chinese Academy of Chinese Medical Sciences,based on the theory of traditional Chinese medicine and the disease characteristics of patients with bladder cancer.It has decades of clinical accumulation.After repeated clinical practice,we believe that the disease always belongs to the deficiency of the essence,the deficiency of the righteousness,the dampness,heat,and the accumulation of blood stasis to form a cancer virus as its pathogenic characteristics.A number of previous clinical trials have shown that Fuzheng Xiaozheng Decoction can reduce the recurrence rate of NMIBC and improve the quality of life of patients.In the previous basic research,it was found that Fuzheng Xiaozheng Decoction can inhibit the proliferation of bladder tumor T24 cells in vitro and increase Apoptosis of tumor cells.So whether Fuzheng Xiaozheng Decoction can have clinical effect on high-risk NMIBC patients is not well understood.Based on the above,this study will further focus on exploring the intervention effect of Fuzheng Xiaozheng Decoction on high-risk NMIBC patients.Objective:To evaluate the effect of Fuzheng Xiaozheng Decoction combined with intravesical irrigation on the recurrence rate and chemotherapy completion rate of patients with high-risk non-muscle invasive bladder cancer(NMIBC)objectively.To observe the effect of Fuzheng Xiaozheng Decoction on quality of life and TCM symptoms.To explore the efficacy and safety of Fuzheng Xiaozheng Decoction in the treatment of high-risk NMIBC patients to provide more treatment options.Methods:Through a prospective and cohort study,patients eligible for inclusion and exclusion were divided into an treatment group and a control group.The treatment group was treated with Fuzheng Xiaozheng decoction combined with intravesical irrigation and the control group was treated with intravesical irrigation.The basic information,EORTC QLQC30 score,and Traditional Chinese Medicine(TCM)symptom score of the patients at the time of enrollment were recorded,and follow-up was conducted at 6 and 12 months after treatment,respectively.The treatment effects were compared including recurrence rate,chemotherapy completion rate,and EORTC QLQ-C30 score,TCM symptom score and incidence of adverse reactions between intergroup and intragroup.Results:In this study,48 patients were included,and 1 patient in the treatment group was excluded.Finally,47 patients were included,with 23 patients in the treatment group and 24 patients in the control group.There were no statistical differences in gender,age,height,weight,respiration,heart rate,blood pressure,BMI,etc(P>0.05).The two groups were comparable at baseline.There was no statistical difference between the two groups in the completion rate of Intravesical Instillation Therapy.(P>0.05).Regarding the recurrence rate of patients,there were 2 recurrences in the treatment group and 4 recurrences in the control group,and the number of recurrences between the two groups did not statistical difference at 6 months after operation(P>0.05).There were 3 cases of recurrence in the group accounting for 13.04%,and 11 cases of recurrence in the control group accounting for 45.83%.The recurrence rate between the two groups was statistical different(P<0.05).Regarding the quality of life score,there was no statistical difference between the two groups at baseline(P>0.05),and the overall health status of the two groups was significantly different at the 6month and 12-month follow-up(P<0.05).The overall score of the patients reached a median of 7 points at the last 12-month follow-up,and the control group reached 4 points.Significant improvements in physical function were observed at 6 and 12 months of follow-up(P<0.05).In the functional area,significant improvement in emotional function was observed at 12 months(P<0.05),but there was no statistical difference in role,cognition,and social function(P>0.05).In the symptoms area,the treatment group was significantly different from the control group in terms of fatigue and loss of appetite after 6 months of treatment(P<0.05).There was little change in the scores,and the difference between the two groups was statistically significant(P<0.05).The appetite loss score in the control group increased to 1(2),the score in the observation group remained unchanged,and the difference between the two groups was statistically significant(P<0.05).The comparison was not statistically significant(P>0.05).After 12 months of treatment,the fatigue score in the treatment group continued to drop to 1(0),while the average score in the control group remained at 1.67,with a statistically significant difference between the two groups(P<0.05).The appetite score of the control group decreased to 1(0.5),and the score of the observation group was 1(0).There was no statistical difference(P>0.05).Regarding adverse reactions and safety,1 case of BCGrelated high fever occurred in the treatment group,1 case of hematuria due to poor wound healing in the control group,1 case of bacterial cystitis,and 2 cases of bladder calculi.There were urethral strictures related to perfusion.A total of 3 patients in the treatment group developed chemical cystitis,and 10 patients in the control group developed chemical cystitis.There was a statistically significant difference in the incidence of chemical cystitis between the two groups(P<0.05).It has good security because of no patients with liver and kidney function damage in both groups and only one patient having mild leukopenia from enrollment to completion of follow-up.Conclusion:Fuzheng Xiaozheng Decoction combined with intravesical instillation can significantly reduce the recurrence rate within 1 year of diagnosed high-risk NMIBC patients.Fuzheng Xiaozheng Decoction can enhance the patient’s overall health,improve the patient’s phy sical and emotional condition,relieve symptoms of fatigue and loss of appetite,and improve the patient’s quality of life.Fuzheng Xiaozheng Decoction can improve the patient’s fatigue,dysuria to relieve symptoms and adjust the patient’s living condition.Fuzheng Xiaozheng Decoction can also significantly reduce the incidence of chemical cystitis,and has good security in the long-term medication process. |
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