1.Application of modified percutaneous closure in the treatment of ventricular septal rupture after acute myocardial infarction
Zirui SUN ; Yu HAN ; Yuhao LIU ; Jicheng JIANG ; Yan HAN ; Lele BEN ; Jing ZHANG ; Chuanyu GAO
Chinese Journal of Cardiology 2024;52(12):1412-1416
Objective:To investigate the effect of modified percutaneous closure in the treatment of ventricular septal rupture.Methods:This study is a retrospective cohort study. Forty-four patients with ventricular septal rupture who underwent percutaneous closure at the Fuwai Central China Cardiovascular Hospital from December 2017 to October 2023 were included. According to the closure method, patients were divided into the modified group (11 cases) and the traditional group (33 cases). Surgical success was defined as successful placement of the occluder. The operation time, X-ray intake, sheath bending rate, incidence of ventricular fibrillation and pericardial tamponade, and postoperative residual shunt were compared between the two groups.Results:The age of the patients was (75.0±5.7) years, with 20 (45%) males. There were 3 cases of operation failure in the traditional group, while all patients in the modified group were successfully occluded. The procedure time in the modified group was shorter than that in the traditional group (40 (35, 45) min vs. 60 (50, 65)min, P<0.001); X-ray dose intake was lower ((442.43±73.26)mGy vs. (784.45±247.78)mGy, P<0.001). There was no occurrence of sheath bending in the modified group, while the incidence of sheath bending in the traditional surgery group was 46% (15/33), and the difference was statistically significant ( P=0.017). Intraoperative ventricular fibrillation and pericardial tamponade occurred in 7 cases (21%) and 2 cases (6%) in the traditional group respectively, while none occurred in the modified group, but the differences between the groups were not statistically significant (both P>0.05). There was no significant difference in residual shunt between the two groups (3.6 (2.5, 4.3) mm vs. 4.0 (3.5, 4.5) mm, P=0.506). Conclusion:The procedure of modified ventricular septal rupture closure is more simplified, with a lower incidence ofventricular fibrillation and pericardial tamponade.
2.Bidirectional relationship between type 2 diabetes mellitus and coronary artery disease: Prospective cohort study and genetic analyses
Wenqiang ZHANG ; Li ZHANG ; Chenghan XIAO ; Xueyao WU ; Huijie CUI ; Chao YANG ; Peijing YAN ; Mingshuang TANG ; Yutong WANG ; Lin CHEN ; Yunjie LIU ; Yanqiu ZOU ; Ling ZHANG ; Chunxia YANG ; Yuqin YAO ; Jiayuan LI ; Zhenmi LIU ; Xia JIANG ; Ben ZHANG
Chinese Medical Journal 2024;137(5):577-587
Background::While type 2 diabetes mellitus (T2DM) is considered a putative causal risk factor for coronary artery disease (CAD), the intrinsic link underlying T2DM and CAD is not fully understood. We aimed to highlight the importance of integrated care targeting both diseases by investigating the phenotypic and genetic relationships between T2DM and CAD.Methods::We evaluated phenotypic associations using data from the United Kingdom Biobank ( N = 472,050). We investigated genetic relationships by leveraging genomic data conducted in European ancestry for T2DM, with and without adjustment for body mass index (BMI) (T2DM: Ncase/ Ncontrol = 74,124/824,006; T2DM adjusted for BMI [T2DM adjBMI]: Ncase/ Ncontrol = 50,409/523,897) and for CAD ( Ncase/ Ncontrol = 181,522/984,168). We performed additional analyses using genomic data conducted in multiancestry individuals for T2DM ( Ncase/ Ncontrol = 180,834/1,159,055). Results::Observational analysis suggested a bidirectional relationship between T2DM and CAD (T2DM→CAD: hazard ratio [HR] = 2.12, 95% confidence interval [CI]: 2.01–2.24; CAD→T2DM: HR = 1.72, 95% CI: 1.63–1.81). A positive overall genetic correlation between T2DM and CAD was observed ( rg = 0.39, P = 1.43 × 10 -75), which was largely independent of BMI (T2DM adjBMI–CAD: rg = 0.31, P = 1.20 × 10 –36). This was corroborated by six local signals, among which 9p21.3 showed the strongest genetic correlation. Cross-trait meta-analysis replicated 101 previously reported loci and discovered six novel pleiotropic loci. Mendelian randomization analysis supported a bidirectional causal relationship (T2DM→CAD: odds ratio [OR] = 1.13, 95% CI: 1.11-1.16; CAD→T2DM: OR = 1.12, 95% CI: 1.07-1.18), which was confirmed in multiancestry individuals (T2DM→CAD: OR = 1.13, 95% CI: 1.10-1.16; CAD→T2DM: OR = 1.08, 95% CI: 1.04-1.13). This bidirectional relationship was significantly mediated by systolic blood pressure and intake of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, with mediation proportions of 54.1% (95% CI: 24.9-83.4%) and 90.4% (95% CI: 29.3-151.5%), respectively. Conclusion::Our observational and genetic analyses demonstrated an intrinsic bidirectional relationship between T2DM and CAD and clarified the biological mechanisms underlying this relationship.
3.Causal association between depression and stress urinary incontinence:A two-sample bidirectional Mendelian randomization study
Cheng-Xiao JIANG ; Wei-Qi YIN ; Jing-Jing XU ; Ying-Jiao SHI ; Li WANG ; Zhi-Bo ZHENG ; Rui SU ; Qin-Bo HU ; Jun-Hai QIAN ; Shu-Ben SUN
National Journal of Andrology 2024;30(3):217-223
Objective:To investigate the causal correlation between depression and stress urinary incontinence(SUI)using Mendelian randomization(MR)analysis.Methods:We searched the FinnGen Consortium database for genome-wide association studies(GWAS)on depression and obtained 23 424 case samples and 192 220 control samples,with the GWAS data on SUI provided by the UK Biobank,including 4 340 case samples and 458 670 control samples.We investigated the correlation between depression and SUI based on the depression data collected from the Psychiatric Genomics Consortium(PGC).We employed inverse-variance weighting as the main method for the MR study,and performed sensitivity analysis to verify the accuracy and stability of the findings.Results:Analysis of the data from the UK Biobank and FinnGen Consortium showed that depression was significantly correlated with an increased risk of SUI(P=0.005),but not SUI with the risk of depression(P=0.927).And analysis of the PGC data verified the correlation of depression with the increased risk of SUI(P=0.043).Conclusion:Depression is associated with an increased risk of SUI,while SUI does not increase the risk of depression.
4.Gene Analysis for the Sebaceous Carcinoma of Scalp by Whole Exome Sequencing
Ben-rong ZHENG ; Yi-na WANG ; Bo-xiong JIANG ; Ya-le LIANG ; Sheng-jun CAI ; Na-na ZHANG
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(4):712-717
ObjectiveTo reveal the differences of the related pathogenicity gene mutations between sebaceous adenocarcinoma (SC) of scalp and sebaceous adenoma (SA) of scalp on whole exome level. MethodsWhole exome sequencing was performed on a SC sample and a SA sample by Illumina Hiseq 2500 platform. Suspicious single nucleotide variation sites were selected for mutation conservation and functional analysis. SciClone was used to track subclone evolution and clonal map information was obtained for each tumor sample. The high-frequency significant gene mutations in the tumor sample were screened by MutSigCV software, and compared with the known driver genes. ResultsTwo driver genes TFDP1 and ACVR1B harboring mutations in scalp SC compared to SA were found. ConclusionsThe finding of mutation in driver genes TFDP1 and ACVR1B should be confirmed in a large cohort, which might reveal the mechanism of scalp SC development and find a therapeutic target for SC.
5.Correlation between Serum Osteoprotegerin/Soluble Receptor Activator of Nuclear Factor-κβ Ligand Levels and the Left Ventricular Diastolic Dysfunction in Type 2 Diabetes
Ben-rong ZHENG ; Xi-xiang TANG ; Bo-xiong JIANG ; Mei LI ; Yi-na WANG
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(6):991-998
ObjectiveTo study the possible correlation between serum osteoprotegerin (OPG)/soluble receptor activator of the nuclear factor κB ligand (sRANKL) levels and the left ventricular diastolic dysfunction (LADD) in patients with type 2 diabetes mellitus (T2DM). MethodsTotally 68 T2DM patients and 37 healthy controls were selected. Serum OPG and sRANKL were determined by solid-phase enzyme-linked immunosorbent assay (ELISA). The left ventricular diastolic function of T2DM patients was measured by transthoracic echocardiography, where E/A < 1 were regarded as LVDD. T2DM patients were further divided into two subgroups according to E/A ratio (E/A≥1.0 and E/A<1). Spearman correlation analysis, logistic regression and ROC curves were used to assess the possible correlation between serum OPG/sRANKL and LADD in T2DM patients. ResultsCompared with the healthy controls, serum OPG level in T2DM patients was higher with statistically significant difference (P <0.01), while serum sRANKL level was lower without statistically significant difference (P =0.32). T2DM patients with E/A<1 had significantly higher OPG level and lower sRANKL level than those with E/A≥1(P <0.01) in subgroup analysis. Spearman correlation analysis showed serum OPG level was negatively correlated with E/A ratio, while sRANKL was positively related with E/A ratio. In single factor logistic regression analyses, serum OPG [OR (95% CI)=1.068 (1.031, 1.106), P<0.001] and sRANKL [OR (95% CI)=0.976 (0.959, 0.992), P=0.003] were significant correlation with LVDD in T2DM patients. ROC curve analysis showed that the sensitivity and specificity of combined OPG and sRANKL in diagnosing T2DM patients LADD were 78.13% and 88.3%, respectively (area under the curve: 0.857; 95% CI=(0.768, 0.946); P<0.001). ConclusionsThe elevated OPG and decreased sRANKL levels may be associated with LADD in T2DM patients.
6.Establishment and validation of a risk prediction model for early-stage complications after liver transplantation
Xing DAI ; Ben GAO ; Xinxin ZHANG ; Yanyan SUN ; Wentao JIANG ; Jiang LI
Journal of Clinical Hepatology 2022;38(2):402-408
Objective To investigate the risk factors for early-stage complications among liver transplant recipients, and to establish and validate a risk prediction model for early-stage complications after transplantation. Methods A retrospective analysis was performed for the clinical data of 234 patients who underwent orthotopic liver transplantation in Department of Liver Transplantation, Tianjin First Central Hospital, from January 2016 to December 2018. According to the presence or absence of Clavien-Dindo grade ≥Ⅲ complications after liver transplantation, the patients were divided into complication group with 97 patients and non-complication group with 137 patients. The two groups were compared in terms of the indices including age, sex, body mass index (BMI), blood type, psoas muscle thickness/height (PMTH), Controlling Nutritional Status (CONUT) score, Model for End-Stage Liver Disease (MELD) score, total serum bilirubin, serum creatinine, international normalized ratio of prothrombin time, blood urea nitrogen, hemoglobin, white blood cell count, platelet count, amount of intraoperative red blood cell transfusion, amount of frozen plasma transfusion, blood loss, anhepatic phase, time of operation, donor age, donor BMI, cold ischemia time of donor liver, and warm ischemia time of donor liver. The independent samples t -test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. Univariate analysis and the binary logistic regression analysis were used to investigate the risk factors for early-stage complications after liver transplantation, and a risk prediction model for complications after liver transplantation was established based on the method for establishing a scoring system using the logistic model provided by Framingham Research Center. Internal validation of the model was performed by C-index, receiver operating characteristic (ROC) curve, calibration curve, and the Hosmer-Lemeshow test, and the decision curve was used to evaluate the clinical applicability of the model. The Kaplan-Meier method was used to compare the incidence rate of early-stage complications after liver transplantation between the patients with different risk scores. Results Compared with the non-complication group, the complication group had significantly higher MELD score, proportion of patients with low PMTH, total serum bilirubin, serum creatinine, blood urea nitrogen, CONUT score, amount of intraoperative red blood cell transfusion, and amount of frozen plasma transfusion, as well as a significantly lower level of hemoglobin (all P < 0.1). The multivariate binary logistic regression analysis showed that MELD score (odds ratio [ OR ]=1.104, 95% confidence interval [ CI ]: 1.057-1.154, P < 0.05), PMTH ( OR =2.858, 95% CI : 1.451-5.626, P < 0.05), and CONUT score ( OR =1.481, 95% CI : 1.287-1.703, P < 0.05) were independent risk factors for grade ≥Ⅲ complications in the early stage after liver transplantation. MELD score, PMTH, and CONUT score were included in a predictive model, and this model had the highest score of 24 points, a C-index of 0.828, an area under the ROC curve of 0.812( P < 0.001), a sensitivity of 0.792, and a specificity of 0.751, suggesting that this predictive model had good discriminatory ability. The calibration curve of this model was close to the reference curve, and the Hosmer-Lemeshow test obtained a chi-square value of 8.528( P =0.382), suggesting that this predictive model had a high degree of fitting. The decision curve showed that most patients were able to benefit from the predictive model and achieved a high net benefit rate, suggesting that this predictive model had good clinical applicability. The score of 11 was selected as the cut-off value according to the optimal Youden index of 0.507, and the patients were divided into low-risk (< 8 points) group with 55 patients, moderate-risk (8-10 points) group with 63 patients, high-risk (11-14 points) group with 67 patients, and extremely high-risk (≥15 points) group with 49 patients. These four groups had a 90-day cumulative incidence rate of early-stage postoperative complications of 3.6%, 28.6%, 59.7%, and 75.5%, respectively, and the incidence rate of complications increased with the increase in risk score ( P < 0.001). Conclusion MELD score, PMTH, and CONUT score are independent risk factors for early-stage complications among liver transplant recipients, and the risk prediction model established based on these factors has a high predictive value in high-risk patients.
7.First report of invasive Pomacea snails in Shandong Province
Long-jiang WANG ; Yan XU ; Hui SUN ; Ben-guang ZHANG ; Xiang-li KONG ; Hai-tao HAN ; Jin LI ; Yue-jin LI ; Li-min YANG ; Yun-hai GUO ; Yong-bin WANG
Chinese Journal of Schistosomiasis Control 2022;34(4):407-411
Objective To characterize the species of invasive Pomacea snails that were discovered for the first time in Shandong Province. Methods Pomacea snails samples were collected in the field of Jining City, Shandong Province on October 2021 for morphological identification. Pomacea snails were randomly sampled and genomic DNA was extracted from foot muscle tissues of Pomacea snails for multiplex PCR amplification. The PCR amplification product was sequenced. Then, the sequence was aligned and a phylogenetic tree was created using the software MegAlign 7.1.0. In addition, Angiostongylus cantonensis infection was detected in Pomacea snails with the lung microscopy. Results A total of 104 living Pomacea snails were collected, and all were characterized as Pomacea spp. based on morphological features. Of 12 randomly selected adult Pomacea snails, multiplex PCR assay and sequencing identified eleven snails as P. canaliculata and one as P. maculata. No A. cantonensis infection was detected in 104 Pomacea snails. Conclusion This is the first report of invasive Pomacea snails in Shandong Province, where P. canaliculata and P. maculata are found.
8.Meta-analysis of the efficacy of conjunctival autograft and limbal conjunctival autograft for pterygium
Ben-Hao SONG ; Yi-Ru JIN ; Zi-Pei JIANG
International Eye Science 2022;22(8):1323-1332
AIM: To compare the analysis of conjunctival autograft(CAG)or limbal conjunctival autograft(LCAG)for treating pterygium.METHODS: Systematic search of the National Library of America Medical Literature Search System(PubMed), the Excerpta Medica Database(EMBASE), the Cochrane Library and the US Clinical Trial Registry which all literatures established of the database from September 2021. The rate of recurrence, corneal epithelial healing time, the change in Schirmer Ⅰ test(SⅠt)and the change in tear break-up time(BUT)were analyzed. Statistical analysis was performed using Review Manager 5.3, count data were expressed as relative ratio(RR),measurement data were expressed as standardized mean difference(SMD)with 95%CI.RESULTS: There were 15 studies included with a total number of 1 883 surgical eyes,among them, there were 897 eyes experienced LCAG while 986 eyes underwent CAG. For the rate of recurrence, LCAG group was lower than CAG group(RR=0.33, 95%CI: 0.15-0.71, P=0.004). For corneal epithelial healing time, LCAG group seemed to behave better than CAG group(SMD=-0.87, 95%CI: -1.64 to -0.11, P = 0.02). No statistical significance was found for SⅠt(SMD = 0.03, 95% CI, -0.33-0.40, P=0.86)and as for BUT, LACG group showed longer times against CAG group(SMD=0.40, 95%CI: 0.09-0.70, P=0.01).CONCLUSIONS: Pterygium resection combined with LCAG was with lower recurrence rate, faster corneal epithelial healing and more stable tear film rather than CAG.
9.A propensity score matching study on safety and efficacy of laparoscopic cholecystectomy for T2a and lower stages of gallbladder carcinoma
Ben LIU ; Qingyang YAO ; Yuting XIAO ; Jinshu WU ; Bo JIANG ; Shun CHEN ; Wei CHENG ; Xianhai MAO ; Xinmin YIN ; Pin LYU
Chinese Journal of Hepatobiliary Surgery 2022;28(7):520-524
Objective:To study the safety and efficacy of laparoscopic cholecystectomy (LC) in treatment of T2a and lower stages of gallbladder carcinoma.Methods:A retrospective study was performed on patients who were diagnosed with gallbladder cancer and underwent surgical treatment from January 2016 to January 2021 at Hunan Provincial People's Hospital. These patients were divided into the simple treatment group and the radical treatment group based on the surgical methods used. The simple treatment group consisted of 64 patients who underwent LC for accidental gallbladder cancers. The radical treatment group consisted of 30 patients who underwent laparoscopic radical cholecystectomy (LRC). The baseline characteristic of the two groups of patients were matched in a 1∶1 ratio using propensity score matching. After matching, there were 26 patients in each of the 2 groups. There were 7 males and 19 females in the simple group, with mean ± s. d. age of (60.6±9.6) years. There were 8 males and 18 females, with mean ± s. d. age (60.9±9.1) years in the radical treatment group. Blood loss, operation time, postoperative hospital stay, biliary leakage, acute pulmonary embolism, and incisional infection were compared between the two groups.Results:In the simple group, the operative time was (78.7±62.9) min, intraoperative blood loss was (10.7±11.6) ml and postoperative hospital stay was (4.4±2.6) d. These results were significantly better than those in the radical group with operative time (298.7±101.3) min, intraoperative blood loss (161.9±96.7) ml and postoperative hospital stay (9.9±4.0) d (all P<0.05). There were no significant difference in the postoperative complications and disease free survival rates between the two groups (both P>0.05). Conclusion:LC was safe and effective for treatment of T2a and lower stages of gallbladder cancer, and it could achieve a similar disease-free survival rate as LRC.
10.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.

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