1.Efficacy and safety study of Chinese botulinum toxin A 100U in patients with overactive bladder: a prospective, multicenter, double-blind and randomized controlled trial
Limin LIAO ; Huiling CONG ; Zhihui XU ; Enhui LI ; Zhiliang WENG ; Haihong JIANG ; Ben LIU ; Xiao HUANG ; Shujie XIA ; Wei WEN ; Juan WU ; Guowei SHI ; Yang WANG ; Peijun LI ; Yang YU ; Zujun FANG ; Jie ZHENG ; Ye TIAN ; Haodong SHANG ; Hanzhong LI ; Zhongming HUANG ; Liqun ZHOU ; Yunxiang XIAO ; Yaoguang ZHANG ; Jianlong WANG ; Xiaodong ZHANG ; Peng ZHANG ; Dongwen WANG ; Xuhui ZHANG ; Keji XIE ; Bin WANG ; Lulin MA ; Xiaojun TIAN ; Lijun CHEN ; Jinkai DONG
Chinese Journal of Urology 2021;42(6):414-422
Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.
2.Effects of diabetes on the expression and function of bradykinin 1 and 2 receptors after cerebral ischemia/reperfusion in rats
Hongfei SANG ; Zhongming QIU ; Ling LIU ; Lili XU ; Jun ZHANG ; Hao ZHANG ; Yi XIE ; Renliang ZHANG
Journal of Medical Postgraduates 2015;(5):458-464
Objective There is little research focusing on the expression and function of bradykinin 1 receptor ( B1R ) and bradykinin 2 receptor ( B2R) after cerebral ischemia/reperfusion on the basis of diabetes .The aim of this study was to compare the ex-pression difference and function change of B 1R and B2R in non-dia-betic and diabetic rats . Methods The cerebral ischemia/reperfu-sion model was established on 41 non-diabetic and type 2 diabetic rats, the weight and the biochemical index were measured on these two types of rats .8 non-diabetic rats and 8 diabetic rats were respec-
tively assigned to two groups according to random number tables:control group and I/R 24 h group, 4 in each group.Real-time PCR was performed to observe the expressions of two receptors at 24 h after reperfusion .Then, 33 non-diabetic rats and 33 diabetic rats were randomly divided into 4 groups respectively, including sham group (n=6), saline group (n=9), B1R antagonist group (n=9) and B2R antagonist group (n=9).At 24 hours after cerebral I/R, neurological deficiency was evaluated by neurological severity scores ( NSS);infarct volume was observed by TTC staining;cell apoptosis was determined by TUNEL staining;neuron degeneration was de-tected by Fluoro-Jade C staining. Results Glucoses of diabetics at 3, 7, 14 d after model establishment [(23.45 ±5.01), (23.71 ±4.87), (22.72 ±4.11) mmol/L] were obviously elevated compared with non-diabetics [(5.77 ±0.75), (6.05 ±0.69), (7.15 ±1.09) mmol/L];blood cholesterin [(4.59 ±3.43) mmol/L] and insulin [(67.26 ±12.02) pmol/L] at 14 d after model establishment were evidently incresaed in comparison to those in non-diabetics [(1.58 ±0.37) mmol/L, (25.34 ±4.88) pmol/L] (P<0.05), while no significant difference was found in the blood triglyceride of diabetics between them (P>0.05).Compared with non-diabetics, diabetics suffered from more apparent up-regulation of B1R mRNA (P<0.01) but relatively less B2R mRNA (P<0.05) at 24 h after I/R.NSS score, infarction volume, damaged and apoptotic cells in B2R antagonis-treated non-diabetic rats at 24 h after I/R conspicuously decreased compared with saline-treated non-daibetic rats.Those indicators in B1R antagonis-treated diabeics were strikingly lessened compared with saline-treated daibetics . Conclusion I/R induced distinct up-regulation of B2R mRNA in non-diabetics and inhibiton of B 2R effectively ameliorated the infarct volume and cell injury after I/R in non-diabetics; I/R induced more notable up-regulation of B1R mRNA in diabetics and B1R antagonist exerted neuroprotective effects instead of B 2R antagonist af-ter I/R in diabetics.
3.Comparison of Clinical Efficacy and Safety of Amiodarone and Propafenone in the Treatment of Chronic Atri-al Fibrillation Cardioversion
Zhanxiong XIE ; Cuixia LIANG ; Qingwen WANG ; Guihong CHEN ; Chaofeng LIAO ; Zhongming WEN
China Pharmacy 2015;(21):2916-2918
OBJECTIVE:To compare the clinical efficacy and safety of amiodarone and propafenone in the treatment of chron-ic atrial fibrillation cardioversion. METHODS:60 patients with chronic atrial fibrillation cardioversion were randomly divided into propafenone group and amiodarone group. All patients were given conventional treatment,including treating primary disease,con-trolling symptoms,orally giving aspirin,intravenous infusion of GIK,monitoring heart rate,QT interval,P-R interval,QRS time,serum potassium and serum magnesium,etc. On this basis,propafenone group was orally given propafenone 450 mg for con-tinuous 3 months,3 times a day,and then the dose was decreased to 300 mg to maintain the sinus rhythm;amiodarone group was orally given amiodarone 200 mg for continuous 7 d a month,twice a day,and then the dose was decreased to 200 mg or 100 mg to maintain the sinus rhythm. The clinic data in 2 groups was observed,including clinical efficacy,simple drug cardioversion,elec-trical cardioversion,electrical cardioversion power,hospitalization time and incidence of adverse reactions,and the recurrence rate in 48 months was followed up. RESULTS:There were no significant differences in the clinical efficacy,simple drug cardiover-sion,electrical cardioversion,electrical cardioversion power,hospitalization time,incidence of adverse reactions and recurrence rate between 2 groups(P>0.05). CONCLUSIONS:Based on the conventinal treatment,amiodarone and propafenone have similar clinical efficacy and safety in the treatment of chronic atrial fibrillation cardioversion,and both of them can be used as the conven-tional drugs for treating chronic atrial fibrillation cardioversion.
4.Correlation analysis of early prognosis of progressive neurological deterioration and cerebral watershed infarction:a clinical study
Yi XIE ; Xiaohao ZHANG ; Zhongming QIU ; Jun ZHANG ; Lian YANG ; Xia XIE ; Nan MA ; Xinfeng LIU
Chinese Journal of Cerebrovascular Diseases 2014;(10):505-510
Objective To investigate the effect of progressive neurological deterioration ( PND) of cerebral watershed infarction on early prognosis. Methods The consecutive patients with cerebral watershed infarction admitted in the Department of Neurology,Jinling Hospital,Nanjing University School of Medicine and their cerebral watershed infarctions confirmed by the imaging examination from March 2009 to March 2014 were enrolled. The clinical features, laboratory indicators and imaging features of internal watershed infarction,cortical-type watershed infarction,and mixed watershed infarction were identified and analyzed. The National Institutes of Health Stroke Scale was used to score neurological deficit. The modified Rankin scale ( mRS) was used to score the prognosis of patients. Single factor analysis was used to compare the differences between the groups. At the same time,the correlation between PND and poor prognosis of cerebral watershed infarction at day 90 was analyzed by multivariable Logistic regression analysis. Results A total of 89 patients with cerebral watershed infarction were enrolled,including 43 cortical-type watershed infarctions,36 internal watershed infarctions, and 10 mixed watershed infarctions. Single factor analysis indicated that the incidences of PND of internal watershed infarction and mixed watershed infarction were significantly higher than the cortical-type watershed infarction (36. 1% [n=13],50. 0% [n=5], and 16. 3% [n=7],respectively;P=0. 018). At day 90,28 patients had poor prognosis,and mRS was (3.4±1. 0) scores at day 90. There was significant difference in the types of infarction between the patients with poor prognosis and patients with good prognosis (P<0. 05). In patients with poor prognosis, most of them were internal watershed infarctions,accounting for 50. 0% (14/28),while in patients with good prognosis,most of them were cortical-type watershed infarctions(57. 4% [35/61]). The incidence of PND in patients with poor prognosis was significantly higher than that in patients with good prognosis (57.1% [16/28] vs. 14. 8% [9/61];P<0. 05). The result of multivariate Logistic regression analysis showed that after adjustment for confounding factor, PND was independently associated with the poor prognosis of cerebral watershed infarction at day 90 (OR 6. 969,95%CI 2. 451-19. 869;P<0. 01). Conclusion Compared with the cortical-type watershed infarction, the patients with internal watershed infarction is more prone to have PND, and PND is independently correlate with the poor prognosis at day 90.
5.Whole esophagus deep burns with a metal foreign body in the stomach: a case report.
Yan YANG ; Nengkan XIAO ; Hanqiu XIE ; Zhongming TANG
Journal of Southern Medical University 2014;34(4):582-583
Whole esophagus deep burn is an extremely rare upper gastrointestinal tract disease. We report a case of severe burns of involving extensive body skin, eyes, throat, and esophagus. Endoscopic examination revealed acute necrotizing esophagitis and detected a metal foreign body in the stomach. The patient underwent burn wound debridement with analgesia, anti-shock rehydration, anti-infection, and symptomatic treatments, which failed to improve the conditions. The patient died of respiratory and circulatory failure secondary to serious sepsis.
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Stomach
6.Whole esophagus deep burns with a metal foreign body in the stomach:a case report
Yan YANG ; Nengkan XIAO ; Hanqiu XIE ; Zhongming TANG
Journal of Southern Medical University 2014;(4):582-583
Whole esophagus deep burn is an extremely rare upper gastrointestinal tract disease. We report a case of severe burns of involving extensive body skin, eyes, throat, and esophagus. Endoscopic examination revealed acute necrotizing esophagitis and detected a metal foreign body in the stomach. The patient underwent burn wound debridement with analgesia, anti-shock rehydration, anti-infection, and symptomatic treatments, which failed to improve the conditions. The patient died of respiratory and circulatory failure secondary to serious sepsis.
7.Whole esophagus deep burns with a metal foreign body in the stomach:a case report
Yan YANG ; Nengkan XIAO ; Hanqiu XIE ; Zhongming TANG
Journal of Southern Medical University 2014;(4):582-583
Whole esophagus deep burn is an extremely rare upper gastrointestinal tract disease. We report a case of severe burns of involving extensive body skin, eyes, throat, and esophagus. Endoscopic examination revealed acute necrotizing esophagitis and detected a metal foreign body in the stomach. The patient underwent burn wound debridement with analgesia, anti-shock rehydration, anti-infection, and symptomatic treatments, which failed to improve the conditions. The patient died of respiratory and circulatory failure secondary to serious sepsis.
8.Incidence of Metallo-beta-lactamase-producing Pseudomonas aeruginosa and their Antibiotic Resistance
Xiaojun XIE ; Shaoyuan WU ; Chong WANG ; Zhongming ZENG
Chinese Journal of Nosocomiology 2009;0(14):-
OBJECTIVE To study incidence of metallo-beta-lactamase(MBL)-producing Pseudomonas aeruginosa and their drug sensitivity.METHODS A total of 323 isolates of P.aeruginosa from Nanshan District of Shenzhen between Jun 2007 and Jun 2008 were subjected to susceptibility testing against various antibiotics and identified by ATB-Expression.Imipenem and meropenem resistant isolates were selected for the detection of MBL production by disc synergia test.Enhancement of inhibition zone around imipenem and meropenem discs impregnated with EDTA was found to confirme MBL production.RESULTS Totally 323 P.aeruginosa were isolated and MBL-producing accounted for 46(14.3%),drug resistance rate to imipenem and meropenem was respectively 45.4% and 26.3%.Colistin was the most sensitive to P.aeruginosa(96.9%).CONCLUSIONS Our findings show it needs to detect MBL producers,judiciously use carbapenems to prevent their spread.
9.A new surgery treatment for thumb reconstruction by one-stage plasty free second toe transfer
Jingliang ZHANG ; Zhenrong XIE ; Junbo XIAO ; Yanwen LEI ; Jun SONG ; Mingfei HE ; Zhongming HUANG ; Hang LI ; Huanwei CHEN ; Qiaohong GUO ; Huancai TANG ; Chao LIU ; Keli LIU
Chinese Journal of Microsurgery 2008;31(5):335-337,403
Objective To investigate a more pedect method for a nice outward appearance of a reconstructed thumb.Methods A free one-stage plasty second toe transfer for thumb reconstruction by interchanging the whole skin-nail flap from the great toe with another one from the second toe.Results There were 12 cases in this group,following-up 6-9 months in 8 cases,7 cases was excellent and 1 cases was good.The reconstructed thumb got a nice looking and more normal function while no blight to the great toe occurred.Conclusion It is an effective new procedure in ameliorating outward appearance of the reconstructed thumb by transferring the free moulded second toe.
10.The effect of fibronectin and arginine-glycine-aspartic-serine tetrepeptide on chemotherapy sensitivity of liver carcinoma cell lines
Zhongming WU ; Weilin WANG ; Jing JIN ; Haiyang XIE ; Lin ZHOU ; Shusen ZHENG
Chinese Journal of General Surgery 2008;23(7):537-539
Objecfive To study the effect of fibronectin(FN)and arginine-glycine-aspartateserine tetrapeptide (RGDS)on chemotherapy sensitivity of hepatocellular carcinoma(HCC)cell lines.Methods A HCC cell lines 7721 was divided into BSA group(BO),FN group(FO),RGDS group(RO)and FN+RGDS group(FR).Mitomycin-C(MMC)was added into each group with different concentrations for 2 h,12 h and 24 h.MTT assay was used to detect the survival rate of the tumor cell at different time,and fluorescent staining method and flow cytometry was used to detect the tumor cell's apoptosis.Results The survival rate and apoptosis rate was significantly different between each group with the treatment of MMC for 12 h or 24 h,and no statistical difference was found after incubation for 2 h.Conclusions With time FN down-regulates MMC induced apoptosis of the HCC cells.making HCC cells 1ess sensitive to chemotherapy,while RGDS enhances the sensitivity of HCC cells to chemotherapy.

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