| PurposesTo investigate the clinical efficacy and safety of intravesical instillation of Huachansu injection in the treatment of bladder cancer hematuria.Method1.The study was designed as a prospective,self-controlled study.2.Case source:From August 2016 to September 20]7,we enrolled 60 patients with bladder cancer hematuria in the Henan Province Hospital of TCM.3.Therapeutic method:40 ml+0.9%NS100 ml of continuous injection of Huachansu injection for 7 days,7 days for 1 course.4.Efficacy evaluation:observe the changes of urine red blood cell level,urine color change,TCM syndrome,blood HGB and physical ECOG score in patients with bladder cancer hematuria.5.Safety Assessment:Observation of treatment-related adverse events throughout the treatment period:assessed using CTCAE v4.0.Result1.General information:Among the 60 cases,49 were male and 11 were female;the youngest was 27 years old,the oldest was 87 years old,and the average age was(64.05±12.37)years old;60 patients had pathology,and 45 of them did not give a clear histological grade.According to the classification and grading standards contained in the 2018 Guidelines for the Diagnosis and Treatment of Bladder Cancer,histological type:59 cases of urothelial papillary tumor and 1 case of adenocarcinoma;Histological grading:6 cases at low level,9 cases at high level,and 45 cases with unclear classification;According to the International Anti-Cancer Alliance 2009 7th Edition TNM(Tumor Node Metastasis)staging method,there were 43 cases of non-muscle invasive bladder cancer(NMIBC)and 17 cases of myometrial invasive bladder cancer(MIBC).Metastatic tumor status:1 case of prostate metastasis,1 case of urethral metastasis,58 cases without metastasis.There were 25 cases of initial hematuria,35 cases of recurrent hematuria(recurrent urethral bladder tumor resection),among them,24 patients had a course of 1-2 years,and 10 patients had a course of 3-5 years.2.Changes in uroscopic examination of red blood cells level:1)60 patients with bladder cancer hematuria,the Uroscopic examination of red blood cells level decreased significantly(after treatment,the uroscopic examination of red blood cells decreased by>25%).On the 7th day of treatment(D7),there were 88.33%(53 cases).and the 7th day after the end of the treatment(D14).with 97.67%(58 cases),and 98.33%(59 cases)on the 14th day after the end of treatment(D21).2)60 patients with bladder cancer hematuria after treatment showed a significant decrease in the mean value of urinary microscopy.Before treatment(DO)uroscopic examination of red blood cells average value of 1123.68±184.71,the seventh day of treatment(D7)mean 184.48±386.09,medication On the 7th day after the end(D14),the mean value was 119.66±463.38,and the mean value on the 14th day after the end of the drug(D21)was 59.55±194.69.The mean value of uroscopic examination of red blood cells detected by DO and D3,D7,D14 and D21.There was a statistically significant difference(p<0.001).3)After intravesical instillation of Huachansu injection for bladder cancer hematuria,uroscopic examination of red blood cells levels is not affected by "tumor staging","age","gender"and"initial/recurrence"factors.3.Urine color change:After 60 patients were treated with intravesical instillation of Huachansu injection,78%(47/60)of the patients had a lighter urine color.4.TCM symptom changes:After treatment,the patient's local syndrome urinary short red,urethral burning,urinary pain,urgency,urinary frequency scores were reduced,and statistically different(P<0.05),TCM syndromes were effectively improved.5.Blood HGB changes:After treatment,the number of cases of mild anemia(HGB:90g/L-105g/L)decreased from 6 cases before treatment to 2 cases,there was no statistically significant difference in blood HGB mean before and after treatment(P=0.507).6.Physical EC'OG score changes:The number of cases with an ECOG score of 0 increased after treatment,and the cases with ECOG scores of 1 and 2 showed a decreasing trend,there was statistically significant edge between before and after treatment(P=0.059).7.Safety evaluation:None of the 60 patients had drug-related adverse reactions and adverse events during the trial period.All patients had no abnormal changes in blood routine,liver and kidney function,blood coagulation function and electrocardiogram after treatment.Conclusion1.Intravesical instillation of Huachansu injection can effectively control hematuria of bladder cancer,The effect of hemostasis is not affected by factors such as"stage of bladder cancer","age","gender"and“initial/recurrence",which may be related to the direct contact of Huachansu injection with local hemostasis.2.The"cold"Huachansu injection for intravesical instillation of "heat syndrome"for bladder cancer hematuria patients,TCM symptoms have been effectively improved,indicating the effectiveness of local syndrome differentiation treatment ideas,clinical can be further promoted.3.Huachansu injection was used for intravesical instillation in 60 patients without drug-related adverse reactions and adverse events during the trial period.Huaqisu injection has better safety in bladder perfusion,it is a better choice for patients with poor constitution and low tolerance. |
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