OBJECTIVE: To explore the differences in perioperative clinical and pathological characteristics of patients with different pathological types of prostate cancer undergoing radical prostatectomy, and to analyze the influencing factors that may affect the extraglandular invasion of ductal adenocarcinoma of the prostate. METHODS: Retrospective collection was made of the radical prostatectomy patients who were admitted to Peking University Third Hospital from December 2011 to April 2021. The patients were screened based on inclusion criteria to obtain basic clinical features and postoperative pathological results. According to the pathological results, the patients were divided into ductal adenocarcinoma group (mixed with ductal adenocarcinoma) and acinar adenocarcinoma group, and a 1 ∶1 propensity score matching was performed to compare the differences in clinical characteristics between the two groups. Univariate and multivariate analyses of the factors related to extraglandular invasion were performed in the matched ductal adenocarcinoma groups. RESULTS: A total of 764 patients with prostate cancer were enrolled in this study, of which 62 patients were confirmed to have ductal adenocarcinoma components by postoperative pathology. There was a statistically significant difference in the proportion of the patients with a history of diabetes in baseline characteristics between the two groups before propensity score matching (29.5% vs. 17.7%, P=0.027). A total of 61 patients with simple acinar adenocarcinoma were successfully matched with the patients with ductal adenocarcinoma, and there was no statistically significant difference in baseline characteristics between the two groups after matching (P>0.05). The comparison of perioperative clinical and pathological features showed that International Society of Urology Pathology (ISUP) grade (P=0.003), pT stage (P=0.004), extraglandular invasion rate (P=0.018) and vascular thrombus rate (P=0.019) in ductal adenocarcinoma group were significantly higher than those in simple acinous adenocarcinoma group. Univariate analysis of the influence factors of extraglandular invasion showed that prostate-specific antigen (PSA) level, prostate volume, ISUP grade, seminal vesicle invasion and perineural invasion might be the influencing factors of extraglandular invasion (P < 0.10). Binary Logistic regression analysis showed that perineural invasion was an independent factor of extraglandular invasion (OR=11.78, 95%CI: 1.97-70.56, P=0.007). CONCLUSION Prostatic ductal adenocarcinoma has a worse prognosis than simple acinar adenocarcinoma. Perineural invasion is the influencing factor of extraglandular invasion of ductal adenocarcinoma.
Humans ; Male ; Prostatic Neoplasms/surgery* ; Retrospective Studies ; Prostatectomy ; Neoplasm Invasiveness ; Middle Aged ; Aged ; Carcinoma, Ductal/surgery* ; Propensity Score ; Adenocarcinoma/surgery*

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Objective:To investigate the prognostic factors for all-cause mortality in patients with muscle-invasive bladder cancer(MIBC)with intermediate-to-high-risk primary prostate cancer.Methods:From January 2012 to October 2023,the clinical data of the patients with MIBC with intermediate-to-high-risk primary prostate cancer in Peking University Third Hospital were retrospectively analyzed.All the patients were monitored and the occurrence of all-cause death was documented as the outcome event in the prognostic study.Univariate and multivariate Cox proportional risk regression analysis models were implemented to search for independent influences on the prognosis of patients.For significant influencing factors(pathological T stage,M stage and perineural invasion of bladder cancer),survival curves were plotted before and after multifactorial Cox regression adjusting for confounding factors.Results:A total of 32 patients were included in this study.The mean age was(72.5±6.6)years;the median preoperative total prostate specific antigen(tPSA)was 6.68(2.47,6.84)μg/L;the mean preoperative creatinine was(95±36)μmol/L,and the median survival time was 65 months.The majority of the patients(87.5％)had high-grade bladder cancer,53.1％had lymphatic invasion,and 31.3％had perineural invasion.Prostate involvement was observed in 25.0％of the cases,and the positive rate of soft-tissue surgical margin was 37.5％.Multivariate Cox analysis revealed that preoperative creatinine level(HR=1.02,95％CI:1.01-1.04),pathological stage of bladder cancer T3(HR=11.58,95％CI:1.38-97.36)and T4(HR=19.53,95％CI:4.26-89.52)metastasis of bladder cancer(HR=9.44,95％CI:1.26-70.49)and perineural invasion of bladder cancer(HR=6.26,95％CI:1.39-28.27)were independent prognostic factors(P＜0.05).Survival curves with Log-rank test after adjusting for confounding factors demonstrated that bladder cancer pathology T3,T4,M1,and perineural invasion were unfavorable factors affecting the patients'survival prognosis(P＜0.05).Conclusion:Patients with MIBC with intermediate-to-high risk primary prostate cancer generally portends a poor prognosis.High preoperative serum creatinine,T3 or T4 pathological stage of bladder cancer,metastasis of bladder cancer and bladder cancer perineural invasion are poor prognostic factors for patients with MIBC with intermediate-to-high risk primary prostate cancer.

Objective:To analyze the clinical effects of intraoperative transesophageal echocardio-graphy(TEE)in different surgical methods for nephrectomy combined with Mayo Ⅲ-Ⅳ inferior vena cave(IVC)tumor thrombectomy.Methods:In the study,28 patients who did surgery of nephrectomy and Mayo Ⅲ-Ⅳ IVC thrombectomys in Peking University Third Hospital from 2022 January to 2024 February were included.Of the 28 patients,16 patients did robotic surgery,2 patients did laparoscopic surgery,and 10 patients did open surgery.All patients'clinical data were collected.Results:Intra-operative TEE was used in 9 robotic surgeries,of which 7 cases showed image changes compared with preoperative image results.Intraoperative TEE indicated that tumor thrombus entered the right atrium in 2 cases,showed that tumor thrombus grade rose from Mayo Ⅲ to Mayo Ⅳ in 2 cases,and indicated that tumor thrombus adhered to IC wall in 3 cases.All of these surgical plans were timely adjusted.Intra-operative TEE was used in 6 cases of open surgery,and 4 cases of them showed Mayo grade changes com-pared with preoperative image results.Intraoperative TEE indicated that tumor thrombus adhered to the IVC wall in 3 cases,and tumor thrombus adhered to the IVC wall with thrombus in one case.The surgi-cal plans were adjusted,and the tumor thrombus was left or segmentally removed.Laparoscopic surgery did not use intraoperative TEE.The effects of intraoperative TEE included:the combination of explora-tion and TEE monitoring was used in open surgery,and tumor thrombus removal process was fully moni-tored by intraoperative TEE in the robotic surgery.Intraoperative TEE real-time monitored circulatory sta-tus and cardiac function changes.Conclusion:In different surgical methods for nephrectomy com-bined with Mayo Ⅲ-Ⅳ tumor thrombectomy,intraoperative TEE can re-determine the tumor thrombus grade and degree of tumor thrombus adhered to IVC,track the tumor thrombus removal process in real-time,and monitor circulatory status and cardiac function changes.Intraoperative TEE plays an important role in different surgical methods,but its clinical application is still insufficient.Intraoperative TEE is recommended to such type of surgeries.

Objective To analyze the changes of postoperative pulmonary function in lung transplant recipients. Methods Clinical data of 81 recipients undergoing bilateral lung transplantation and combined heart-lung transplantation were collected, and postoperative status of the recipients was analyzed. Pulmonary ventilation and diffusion function indexes at 1 month, 3 months, every 3 months (3-18 months after lung transplantation) and every 6 months (18-36 months after lung transplantation) were analyzed in the recipients. The characteristics of the optimal pulmonary function in the recipients were assessed. Results Postoperative mechanical ventilation time was 4 (2, 9) d, and the length of postoperative ICU stay was 10 (7, 20) d. Among 81 recipients, 27 recipients developed primary graft dysfunction (PGD) after lung transplantation, with an incidence rate of 33%. Postoperative forced vital capacity (FVC) to predicted value ratio (FVC%pred), forced expiratory volume in one second (FEV₁) to predicted value ratio (FEV₁%pred), FEV₁/FVC to predicted value ratio (FEV₁/FVC%pred) and corrected diffusion lung capacity for CO to predicted value ratio (D_LCOc%pred) were changed over time (all P<0.001). FVC%pred and FEV₁%pred were gradually increased within postoperative 9 months, and D_LCOc%pred was gradually elevated within postoperative 3 months (all P<0.05). Thirty-six recipients had FVC%pred≥80%, FEV₁%pred≥80% in 41 cases, FEV₁/FVC%pred≥92% in 76 cases, FVC%pred≤40% in 1 case and FEV₁%pred≤40% in 1 case, respectively. Sixteen recipients had D_LCOc%pred≥80%, corrected diffusion lung capacity for CO/alveolar volume to predicted value ratio (D_LCOc/V_A%pred) ≥80% in 63 cases, D_LCOc%pred≤40% in 4 cases and D_LCOc/V_A%pred≤40% in 1 case, respectively. Postoperative FVC%pred, FEV₁/FVC%pred and D_LCOc%pred in recipients with a primary disease of obstructive pulmonary disease were significantly higher than those in their counterparts with restrictive pulmonary disease (all P<0.05). Postoperative D_LCOc%pred in recipients with PGD was significantly lower than that in those without PGD (P<0.05). Conclusions Pulmonary ventilation function in lung transplant recipients reaches the optimal state and maintains a steady state at postoperative 9 months, and pulmonary diffusion function reaches a steady state at postoperative 3 months. Primary diseases and the incidence of PGD may affect postoperative pulmonary function.

Objective:To predict the transmembrane structure of transmembrane protein 26 (TMEM26), observe its expression in human retina and mouse retina, and investigate the relationship between it and primary open-angle glaucoma (POAG).Methods:The transmembrane structure of TMEM26 in human and mouse was obtained by inputting its amino acid sequences into the transmembrane protein structure prediction software, MemBrain.The expression and location of TMEM26 in human and mouse retinas were observed through frozen retinal sections stained with anti-TMEM26 antibody, which came from a human donor and five SPF-grade C57BL/6 mice.The possible function of TMEM26 gene and its influence on eyes were inferred on the basis of the specific expression of TMEM26 in retina.The single nucleotide polymorphism mutation of TMEM26 gene was searched in literature related to ocular diseases.The use and care of animals complied with the Regulations on the Management of Experimental Animals.This research protocol was approved by an Ethics Committee of Sichuan Provincial People's Hospital (No.2019-36). Results:Both human and mouse TMEM26 were eight transmembrane proteins with similar eight hydrophobic transmembrane domains, four hydrophilic cytoplasmic domains and five hydrophilic extracellular membrane domains.Small differences in the number of amino acid residues in the domains of TMEM26 were found.In both human and mouse retina, TMEM26 gene was only specifically expressed in the outer plexiform layer (OPL)and inner plexiform layer (IPL). TMEM26 was weakly associated with POAG in a published data. Conclusions:TMEM26 is a multi-pass transmembrane protein, mainly expressed in IPL and OPL of the retina. TMEM26 gene is weakly related to POAG.

Objective:To investigate the correlation between preoperative platelet parameters and clinicopathological features of renal cell carcinoma.Methods:The data of 452 patients with renal cell carcinoma treated in the Peking University Third Hospital from January 2015 to December 2016 were retrospectively analyzed, including 308 males and 144 females, and the mean age was 56.5(15-86) years. There were 178 cases, 72 cases, and 42 cases combined with hypertension, diabetes, and coronary heart disease, respectively. Preoperative platelet parameters were the mean PLT of 218.56(72-568)×10 9/L, MPV of 9.65(6.2-20.5)fl, PDW of 14.44(7.9-23.1) fl, and PCT of 20.72%(8%-49%). The data of 253 patients with simple renal cysts were selected as the controls, including 140 males and 113 females, and the mean age was 58(9-84) years. There were 178 cases, 72 cases, and 42 cases combined with hypertension, diabetes, and coronary heart disease, respectively. Preoperative platelet parameters were the mean PLT of 207.08(84-362)×10 9/L, MPV of 9.50(6.9-13.9)fl, PDW of 14.59(8.9-21.6)fl, and PCT of 19.49%(9%-36%). Propensity score matching method was used to balance the baseline differences between the two groups, and the differences of platelet parameters between the two groups were compared. The correlation between different clinicopathological characteristics of renal cell carcinoma and platelet parameters was analyzed. Multivariate logistic regression model was used to explore the risk factors of renal cell carcinoma with lymph node or distant metastasis. Results:After matching the baseline data, PLT( t=1.993, P=0.047) and PCT( t=2.396, P= 0.017) in renal cell carcinoma group were significantly higher than those in controls. Among 452 cases in renal cell carcinoma, there were 395 cases (87.4%) with clear cell renal cell carcinoma and 57 cases (12.6%) with non-clear cell renal cell carcinoma. For pathological stage, there were 325 cases (71.9%) of T 1-T 2 stage and 127 cases (28.1%) of T 3-T 4 stage. In addition, there were 444 cases (98.2%) of N 0 stage, 8 cases (1.8%) of N 1 stage, 428 cases (93.6%) of M 0 stage, and 24 cases (6.4%) of M 1 stage. There were 320 cases of nuclear grade Ⅰ-Ⅱ, 99 cases of nuclear grade Ⅲ-Ⅳ, and 33 cases without nuclear grade. Preoperative high PLT was significantly correlated with T 3-T 4( t=3.409, P=0.001), M 1( t=2.772, P=0.011) and nuclear grade Ⅲ-Ⅳ( t=2.859, P=0.005). Low MPV was significantly correlated with M 1( t=2.981, P=0.003). Low PDW was correlated with T 3-T 4( t=2.567, P=0.011). High PCT was significantly correlated with T 3-T 4( t=2.722, P=0.007) and nuclear grade Ⅲ-Ⅳ( t=3.011, P=0.003). Multivariate logistic regression analysis showed that PLT( OR=1.007, 95% CI 1.002-1.012, P=0.009), clear cell renal cell carcinoma( OR=4.467, 95% CI 1.574-12.679, P=0.005)and nuclear grade Ⅲ-Ⅳ( OR= 5.554, 95% CI 2.399-12.856, P<0.001)were independent risk factors for lymph node or distant metastasis of RCC. Conclusions:PLT and PCT are higher in patients with renal cell carcinoma compared to simple renal cysts. High PLT, PCT, and low MPV, PDW are correlated with the poor clinicopathological characteristics of renal cell carcinoma. Preoperative PLT can be used as an independent risk factor for lymph node or distant metastasis of renal cell carcinoma.

Objective:To investigate the efficacy and safety of laparoscopic partial nephrectomy in the treatment of renal tumors with renal score of 10.Methods:From February 2016 to March 2021, 23 patients who underwent laparoscopic partial nephrectomy in Peking University Third Hospital with renal tumors of R. E.N.A.L. score of 10 was studied retrospectively, including 16 cases of male and 7 cases of female, with 11 cases on the right side and 12 cases on the left side. The patients’ age was (55.0±16.4) years, and BMI was (25.4±3.6) kg/m 2. The maximum diameter of the tumor was (3.5±1.4)cm. Laparoscopic partial nephrectomy was performed after complete examination. The observation indexes included operation time, blocking time, complications, postoperative hospital stay and the trifecta (negative surgical margin, blocking time ≤25 minutes, and no perioperative complications). Results:All operations were successfully completed, only 4 cases were converted to open surgery. The median operation time was 153 min(99-346 min). The median blocking time was 27 min(14-60min). The median postoperative hospital stay was 6 d(4-11 d). Postoperative complications occurred in 7 cases(fever in 5 cases, intestinal obstruction in 1 case, postoperative blood transfusion and leg intermuscular venous thrombosis in 1 case). 9 cases (39.1%) achieved the trifecta. 19 cases who completed by laparoscopy, their operation time was 151 min(99-303 min), blocking time was 28 min(18-60 min), postoperative hospital stay was 6 d(4-11 d), fever occurred in 4 cases, and 6 cases achieved the trifecta (31.6%). The follow-up time was 3-62 months, with a median of 32 months, and there was no recurrence or metastasis.Conclusions:Laparoscopic partial nephrectomy is safe and effective in the treatment of renal tumors with renal score of 10.Although the tumor is highly complex, it also achieves the purpose of preserving nephron to the greatest extent. If technical conditions permit, laparoscopic partial nephrectomy could be considered for the treatment of highly complex renal tumors.

Objective:To explore the application of real-time transrectal ultrasound (TRUS) during seminal vesiculoscopy in infertile men with azoospermia or oligoasthenospermia.Methods:We retrospectively analyzed the clinical data of 25 cases of azoospermia or oligoasthenospermia due to ejaculate ducts obstruction who were treated with real-time transrectal ultrasound-guided seminal vesiculoscopy between September 2011 and December 2015. Patients’ age was(29.4±4.5) years. All patients accepted semen analysis, serum sex hormone, MRI, TRUS and then diagnosed as obstructive azoospermia, and 13 cases had intractable obstructive azoospermia or oligoasthenospermia after the failure of simple seminal vesiculoscopy(the path to the ejaculatory duct and seminal vesicle couldn’t be found). All patients were treated with seminal vesiculoscopy under real-time guidance with TRUS. We assessed the success rate of surgery, surgical time and complications.Results:The scope was successfully inserted into the seminal vesicle in 21 of the 25 cases (success rate, 84%). The median operative time was 75(31, 148) min. None of the patients developed severe complications. Among 4 failure cases (4/25, 16%), 1 was due to abnormal congenital development. In 2 cases, a clear outlet of the dual ejaculatory duct could not be found after it was inserted into the prostatic utricle. One case was considered as a Müllerian tubular cyst, and the seminal vesicle scope was used to assess the cystic side wall. The 21 patients were followed up for 3 to 6 months, semen volume 2.0(0-5.2)ml, total sperm 28(0-832) ×10 6/ejaculate, sperm density 5.6(0-110.3)×10 6/ml, mobility rate of sperm 5.4%(0-63.6%), and the differences were significant as compared to that before the surgery [semen volume 0.4(0-2.8)ml, total sperm 0(0-342)×10 6/ejaculate, sperm density 0(0-90.7)×10 6/ml, mobility rate of sperm 0(0-24.1%), all P<0.05]. Among the 17 patients who underwent follow-up of 5 to 9 years, 3 patients was conceived naturally and 9 patients’ postoperative sperm quality has improved and pregnancy in vitro fertilization by extracting sperm from semen. Conclusions:Intraoperative real-time transrectal ultrasound guidance can improved the success rate of seminal vesiculoscopy and promoted operative safety.

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.