OBJECTIVE:To optimize the formulation of Mirabegron sustained-release tablets. METHODS:Using polyethylene oxide(PEO)and hydroxypropylmethyl cellulose(HPMC K4M)as the sustained release matrix,Mirabegron sustained-release tab-lets were prepared by powder direct compression technology. Using 1,3,5,7 h accumulative release rate as indexes,the amounts of PEO,HPMC K4M and OPADRY? were optimized by composite design-response surface method,and then validated. Accumula-tive release rates of sustained-release tablet and original tablet (MyrbetriqTM) were compared in different pH mediums (water,pH 1.0 simulated gastric fluid,pH 4.5 acetate buffer solution,pH 6.8 phosphate buffer solution) at different rotation rates (100,50 r/min),and similiar factor f2 was calculated to fit drug release model of sustained-release tablet. RESULTS:In the optimized firmu-lation each Mirabegron sustained-release tablet contained mirabegron 25 mg,PEO 108.02 mg,HPMC K4M 21.69 mg,OPADRY? 2.27%. Relative error of accumulative release rates at 1,3,5,7 h to predicted value were 4.78%,3.48%,0.69% and -1.41%, respectively. f2 of release curves of sustained-release tablet and original tablet were higher than 65 in different pH medium at differ-ent rotation rates. The drug release of sustained-release tablet was fitted to zero-order release equation. CONCLUSIONS:Mirabe-gron sustained-release tablet by optimized technology is similar to original tablet in drug release behavior.

Objective:To compare the left ventricular (LV) reverse remodeling after transcatheter aortic valve replacement (TAVR) between patients with bicuspid aortic valve (BAV) stenosis and tricuspid aortic valve (TAV) stenosis.Methods:The data of patients who underwent TAVR procedure from March 2013 to December 2018 in the Second Affiliated Hospital of Zhejiang University were retrospectively reviewed. The patients were divided into BAV group and TAV group according to cardiac computed tomography. Echocardiographic parameters, including aortic valve peak velocity (Vmax), mean gradient (PGmean), effective orifice area(EOA), interventricular septum diastolic thickness (IVSd), left ventricular posterior wall diastolic thickness (LVPWd), left ventricular end diastolic diameter( LVEDd), LV mass index (LVMI), ΔLVMI%, left ventricular ejection fraction( LVEF) of the two groups at baseline, 1 week, 1 month and 1 year post TAVR procedure were obtained and compared.Results:①Compared with preoperative measurements, both groups showed decreases in Vmax, PGmean and increase in EOA at 1 week, 1 month, 1 year follow-ups(all P<0.05). No significant differences were found in Vmax, PGmean, EOA, moderate/sever perivalvular leakage(PVL), moderate/sever prosthetic-patient mismatch(PPM) between BAV group and TAV group at 1 year. ②Both groups showed decreases in IVSd, LVPWd, LVEDd at 1 month, 1 year post TAVR compared with those before the procedure (all P<0.05), as well as increases in LVEF at 1 week, 1 month, 1 year (all P<0.05). Downward trends of LVMI were detected in both groups within 1 year follow-up( P<0.05). ③Compared to TAV group, BAV group showed smaller baseline LVMI( P<0.05), while there were no significant differences in ΔLVMI% post TAVR for all follow-up times of the two groups(all P>0.05). Repeated measures analysis of variance also showed no significant differences in downward trend of LVMI between the two groups after TAVR within 1 year( P>0.05). Conclusions:Left ventricular reverse remodeling can be detected in both BAV and TAV patients after TAVR, which starts from 1 week and can be lasted for 1 year post procedure. Patients with bicuspid morphology might experience similar reverse LV remodeling post TAVR versus patients with tricuspid morphology.

OBJECTIVETo explore the efficacy of video-assisted anal fistula treatment (VAAFT) in treatment of complex anal fistula.

METHODSClinical data of 87 patients with complex anal fistula undergoing operation at Department of General Surgery, the Second Affiliated Hospital of Suzhou University from September 2015 to December 2016 were collected to conduct a cohort study. The operative procedure depended on economic conditions and patient preference. Patients were divided into VAAFT group (42 cases) and traditional fistula resection plus seton (FRS) group (45 cases). The procedure of FRS was to completely remove the fistula along external wall, the inner opening and surrounding scar tissues, then, the inner opening was closed with absorbable suture. For deeper and more complex fistula, the above procedure should be combined with seton. Based on the concept of endoscopic minimally invasive surgery, VAAFT could deal with the fistula and inner opening under direct vision. The brief steps were as follows: insertion of the anal fistula scope through external opening into the fistula; continuous injection of glycine-mannitol solution to expand and clean the foul fistula; electrocoagulation of all lesions; clearance of burnt tissues from the lumen with endoscopic brush and forceps; injection of medical fibrin glue through the inner opening; closing the inner opening by suture. Intraoperative and postoperative indices were compared between two groups.

RESULTSVAAFT group included 33 males and 9 females with mean age of (37.4±13.5) years, mean BMI of (24.3±3.2) kg/m, and mean disease course of (4.8±3.9) months. Of 42 cases, 5 had preoperative diabetes mellitus, 31 were high fistula and 11 were low fistula. FRS group included 32 males and 13 females with mean age of (42.1±15.6) years, mean BMI of (24.8±3.7) kg/m, and mean disease course of (5.7±3.6) months. Of 45 cases, 4 had preoperative diabetes mellitus, 37 were high fistula and 8 were low fistula. There were no significant differences in baseline data between two groups(all P>0.05). Compared with FRS group, VAAFT group had significantly shorter operative time [(44.6±10.5) minutes vs. (57.4±12.3) minutes, t=5.203, P=0.000], lower incidence of postoperative bleeding (14.3% vs. 33.3%,χ²=4.304, P=0.038), less pain (Visual Analogue Scale,VAS) (2.9±1.8 vs. 7.3±1.2, t=13.500, P=0.000), faster pain relief [(1.0±0.8) days vs. (4.5±1.2) days, t=15.890, P=0.000] and shorter hospital stay [(4.1±3.5) days vs.(7.5±2.3) days, t=5.389, P=0.000]. However, there were no significant differences between two groups in urinary retention rate, first postoperative fecal time and postoperative infection rate(all P>0.05). All patients were followed up for more than 6 months, FRS group had significantly higher incidence of anal incontinence than VAAFT group (20.0% vs. 2.4%, Fisher P=0.015). However, no significant difference in recurrence rate was found between VAAFT and FRS group(7.1% vs. 15.6%, Fisher P=0.317).

CONCLUSIONSCompared to traditional FRS treatment, VAAFT possesses some advantages in less injury, less pain, faster recovery, and lower postoperative anal incontinence rate. Thus, VAAFT is a superior operative choice in treatment of patients with complex anal fistula.

Adult ; Cohort Studies ; Fecal Incontinence ; Female ; Humans ; Male ; Middle Aged ; Rectal Fistula ; surgery ; Treatment Outcome ; Video-Assisted Surgery ; Young Adult