ABSTRACT
Objective:To investigate the 2 years’ efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation.Methods:From July 2015 to June 2020, 18-75 years old patients with moderate to high-risk non muscle invasive bladder cancer (NMIBC) confirmed by pathological examination were involved. The ECOG score was 0-2. Exclusion criteria included ①immune deficiency or impairment (such as AIDS), using immunosuppressive drugs or radiotherapy, suspected allergic to BCG or epirubicin or excipients of the two drugs, fever or acute infectious diseases including active tuberculosis or receiving anti tuberculosis treatment, with severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; ②combined with other urogenital system tumors or other organ tumors; ③combined with muscle invasive bladder urothelial carcinoma (≥T 2); ④undergoing chemotherapy, radiotherapy or immunotherapy within 4 weeks (immediate instillation after surgery not included); ⑤ pregnant or lactating women; ⑥ comfirmed or suspected bladder perforation; ⑦gross hematuria; ⑧cystitis with severe bladder irritation that may affect the evaluation; ⑨participat in other clinical trials within 3 months; ⑩alcohol or drug addiction; ?any risk factors that may increasing the risk of patients. Epirubicin 50 mg was irrigated immediately after the operation(TURBT or laser resection). The patients were randomly divided into BCG15 group, BCG19 group and epirubicin group by the ratio of 2∶2∶1, and the patients were maintained intravescical instillation for 1 year. The recurrence and adverse events of the three groups were compared. Univariate and multivariate analysis was performed to predict the risk factors of BCG irrigated therapy failure. Result:By June 15, 2020, the median follow-up duration was 22.1 months(12.1, 32.3), and there was no statistical difference between the groups ( P=0.9024). There were 274 patients enrolled in BCG19 group, 277 patients enrolled in BCG15 group and 130 patients enrolled in the epirubicin group. The drop-off rate was 16.6%(113 cases)and made no difference between groups( P=0.6222). There were no significant difference in age, gender, BMI, or ECOG score( P>0.05). During the follow-up, 116 cases was detected recurrence or progression. The recurrence rate of the three groups was 14.2% and 14.8% in BCG19 group and BCG15 group, and 27.7% in the epirubicin group. There was no difference in recurrence rate between BCG19 and BCG15 group( P=0.9464). The recurrence rate of BCG19 group was lower than that of the epirubicin group ( P=0.0017). The recurrence rate of BCG15 group was lower than that of the epirubicin group ( P=0.0020). There was no difference in the cumulative recurrence free survival rate between BCG19 and BCG15 group (95% CI0.57-1.46, P=0.7173). The cumulative recurrence free survival rate of BCG 19 group was better than that of the epirubicin group( HR=0.439, 95% CI0.26-0.74, P=0.0006), and the cumulative recurrence free survival rate of BCG15 group was better than that of the epirubicin group ( HR=0.448, 95% CI0.29-0.80, P=0.0021). The total incidence of adverse events in 19 BCG19, BCG15 and epirubicin group were 74.5%, 72.6% and 69.8% respectively. There was no difference in the incidence of adverse events between BCG19 and BCG15 group( P=0.6153). The incidence of adverse events in epirubicin group was lower than that of BCG19( P=0.0051) and BCG15( P=0.0167) groups.There was no significant difference in the incidence of serious adverse events (SAE) among the three groups ( P=0.5064). Log rank test univariate analysis and Cox risk regression model multivariate analysis showed that the history of bladder cancer recurrence( HR=6.397, 95% CI1.95-20.94, P=0.0001)was independent risk factor for BCG irrigation failure. Conclusions:The 2 years’ efficacy of intravesical instillation of domestic BCG is better than than of epirubicin with good tolerance and safety. There is no difference between BCG19 and BCG15 group. BCG doesn’t increase SAE compared with epirubicin. Recurrence status was an independent prognostic factor regarding recurrence-free survival.
ABSTRACT
Objective To investigate the efficacy and safety of intravesical instillation of BCG vaccine in the prevention of early recurrence of middle and high risk non-muscle invasive bladder cancer.Methods From July 2015,patients with non-muscle invasive bladder cancer aged 18-75 years with informed consent were screened and underwent transurethral resection of bladder tumor (TURBT).Immediately intravesical instillation of epirubicin 50 mg was given postoperatively.After pathology was comfirmed,patients was enrolled in group 1 (BCG15) or group 2 (BCG 19) or the control group (epirubicin 18) randomly with SAS 9.3 software.Data of follow-up and Adverse event was collected and analyzed.Results By May 31,2019,531 patients were enrolled in the study.The drop-off rate was 20.1％.167 patients (143 males and 24 females)in group 1,172 patients (141 males and 31 females)in group2 and 84(75 males and 9 females) in the control group with follow-up data were analyzed.There were no significant differences in age,gender,BMI,ECOG score,risk stratification between the three groups (P =0.8641,P =0.2906,P =0.9384,P =0.6126).The median follow-up time makes no statistical difference between the groups (P =0.9251),12.0 (6.0,22.5) months,13.0 (6.0,22.3) months,and 13.0 (7.0,22.3) months.The median recurrence time of the three groups was 4.0 (3.0,6.0) months,4.5 (3.0,9.8) months,4.5 (3.0,8.8) months.There was no statistical difference between the three groups (P =0.2852).Risk stratification in the patients got no significant difference between the three groups (P ＞ 0.05).The 1-year recurrence-free survival rates were 80.0％ in the group 1 and 88.3％ in the group 2 and 73.7％ in the control group.The group 2 was superior to the group 1 and the control group (P =0.0281,P =0.0031).There was no significant difference between group 1 and control group (P =0.2951).There was no significant difference in the cumulative recurrence-free survival between the experimental group 1 and the experimental group 2,(95％ CI 0.80-2.43,P =0.2433).The cumulative recurrence-free survival in the group 1 and the group 2 was better than the control group (95 ％ CI 0.31-0.92,P =0.0266;95 ％ CI 0.20-0.65,P =0.0008).All the cases underwent instillation were analyzed for adverse events.The incidence of overall AE(adverse events) in group 1 was 68.5％ (152/222),the incidence of grade Ⅰ-Ⅱ AE was 53.2％ (118/222),the incidence of grade Ⅲ-Ⅳ AE was 15.3％ (32/222).The incidence of overall AE in the group 2 was 71.8％ (160/223),the incidence of grade Ⅰ-Ⅱ AE was 60.1％ (134/223),and the incidence of grade Ⅲ-Ⅳ AE was 11.7％ (26/223).The overall AE rate in the control group was 53.2％ (59/111),of which the incidence of grade Ⅰ-Ⅱ AE was 42.4％ (47/111),and the incidence of grade Ⅲ-Ⅳ AE was 10.8％ (12/111).There was no difference in the incidence of overall AE between the group 1 and the group 2 (P =0.4497).The incidence of AE in the two experimental groups was higher than that in the control group (P =0.0062,P =0.0008).There was no difference in the incidence of grade Ⅲ-Ⅳ AE between the three groups (P =0.3902).Conclusions BCG(19 instillation schedule) has a better effect on preventing recurrence after 1 year of bladder surgery,which is superior to epirubicin group.The long-term efficacy of BCG in preventing recurrence and the efficacy of different schedules need to be further followed up.The lower urinary tract symptoms,which are mainly urinary frequency,are one of the causes of case fallout and should be fouced in future.Compared with epirubicin,BCG perfusion does not increase the incidence of grade Ⅲ-Ⅳ adverse reactions,and is safe to use.
ABSTRACT
To explore the association between sarcopenia (SAR) and long-term prognosis of patients with chronic heart failure (CHF) aged 70 years and over,182 CHF patients from January l,2012 to December 31,2014 were included in the present study.The patients were divided into the SAR group and the non-SAR group.The median follow-up period was 36 (3,57) months.The endpoint was any heart failure-related event (HFRE).There were significant differences in age,body mass index,hemoglobin,B-type natriuretic peptide,hypersensitive troponin T (hs-TnT),left ventricular ejection fraction (LVEF) and cardiac function class between the two groups (all P＜0.05).The Kaplan-Meier analysis showed that the survival time of the non-SAR patients was much longer than that of the SAR patients (P＜0.05).The multivariate Cox regression analysis indicated that SAR was an independent risk factor for HFRE suggesting a role of sarcopenia on long-term prognosis of patients with chronic heart failure.
ABSTRACT
Objective To observe the effect ofGuanxin-Shutongcapsule in the treatment of arterial elasticity on patients with hypertension.Methods The hypertension patients who met the inclusion criteria were divided into treatment group (50 cases) and control group (52 cases). The control group was treated with antihypertensive drugs to control blood pressure within the normal range. The treatment group was treated withGuanxin-Shutongcapsule on the basis of the control group. All were given 8 weeks treatment. The main artery elastic parameters were meansured by the carotid-femoral pulse wave velocity (C-FPWV) and cervical-dorsal arterial pulse wave velocity (C-DPWV). The immune turbidimetric method was employed to enhance for the determination of high sensitive C reactive protein (hs-CRP); and radioimmunoassay was used to assess the serum IL-6, TNF-a, triglyceride (TG) and total cholesterol (TC). The blood pressure was monitored during the treatment.Results After the treatment, the level of hs-CRP (2.83 ± 1.35 mg/Lvs. 3.65 ± 1.38 mg/L,t=6.357), TNF-α (0.16 ± 0.08 mg/Lvs. 0.28 ± 0.07 mg/L,t=18.213), C-FPWV (13.85 ± 1.86 m/svs. 15.34 ± 1.78 m/s,t=6.524), C-DPWV (11.98 ± 1.45 m/svs. 12.87 ± 1.48 m/s,t=7.152) in treatment group was significantly lower than those in the control group (P<0.01).ConclusionGuanxin-Shutong capsule by inhibiting systemic inflammation, reducing and reversing atherosclerosis, and improving the arterial elasticity and blood pressure.
ABSTRACT
Objective To evaluate the feasibility and clinical significance of radical nephrectomy with en bloc resection of involved adjacent organs.Methods Totally,24 cases of renal cancer invading adjacent structures underwent radical nephrectomy with en bloc resection of involved adjacent organs.Among the 24 cases,left radical nephrectomy with en bloc resection of splenic flexure and descending colon was performed in 7,partial resection of corpus and cauda pancreatis and spleen in 5,solitary splenectomy in 3;right radical nephrectomy with en bloc resection of hepatic flexure of the colon in 4,partial hepatectomy of right lobe and end-piece in 4,duodenectomy of pars descendens in 1.Of these cases,partial resection of the psoas muscle was performed in 5,and partial resection of mesocolon in 7.Postoperatively,9 cases received immunotherapy.Results There was no intraoperative mortality or severe posuoperative complication.Follow-up of 3-240 months was available in 21 cases.The follow-up showed that 1-,3-,5-and 8-year survival rates were 90.5%(19/21),42.9%(9/21),33.3%(7/21) and 19.0%(4/21),respectively.Conclusions Radical nephrectomy remains the treatment of choice in organ-confined stage of renal carcinoma.With careful selection,radical nephrectomy with en bloc resection of adjacent structures is technically feasible.It can obtain the radical excisional effect.Based on our experience,the operation is relatively safe.Complete surgical extirpation can lead to prolonged disease-free survival.It may also offer beneficial foundation for the subsequent systematic therapy.