1.Application of root cause analysis in falling of hospitalized elderly patients
Chinese Journal of Practical Nursing 2015;31(13):977-979
Objective To analyze the falling events using root cause analysis (RCA) in hospitalized elderly patients in order to supply theoretic reference for precaution of falling events.Methods RCA method was used to analyze the root cause against 62 cases of nursing adverse events of hospitalized elderly patients' falling.Results Hospitalized elderly patients' falling is related to various factors such as body,disease,medicine,psychology,environment and so on.The root cause lied in the elderly' physical function decline,risk factors of external environment,unfulfilled health education,and lack of the care and support system for the elderly,among which cerebral infarction belonging to the disease factors accounted for 22.58% (14/62),which was the highest;next was senile dementia [20.97% (13/62)].The rates of agents against psychiatric disorders belonging to the medicine factors and no braking of bed pulley and no use of blister light belonging to environmental factors were the lowest,all were 3.23% (2/62).Conclusions The falling reason of elderly inpatients can be found out by RCA in order to attain the purpose of improving procedure and prevention in advance.
2.Effects of Folic Acid Combined Methylcobalamin in the Treatment of the Patients that Are Uremia Ac-companied by Hyperhomocysteinemia
Shuming CHEN ; Shaobo DING ; Dongwen ZHENG ; Liqing ZHOU ; Hongying HUANG ; Weiguo YE ; Yulong HUANG ; Ling GUAN
China Pharmacy 2001;0(09):-
OBJECTIVE:To study the plasma total homocysteine(tHcy)level in the uremia patients and to study the therapeutic effects of folic acid combined with methylcobalamin in the intervention treatment of uremia patients with homo-cysteinemia.METHODS:Levels of plasma tHcy of60uremia patients(treatment group)and40normal subjects(control group)were determined both before treatment and8weeks after intervention treatment with folic acid combined with methylcobal-amin.RESULTS:The plasma level of tHcy in uremia patients were significantly higher than that in the normal subjects(P
3.Analysis of W1~W2 in wave intensity in carotid artery and left ventricular ejection time
Husheng XIAO ; Fang XU ; Haoqiang YIN ; Xin PENG ; Zhizhang XU ; Aihong ZHANG ; Yajuan REN ; Liangmei ZHOU ; Qi WANG ; Dongwen GAO
Chinese Journal of Ultrasonography 2009;18(4):311-313
Objective To make certain about the phase of time from the culminated point of instantaneous accelerating wave intensity (W1) to that of instantaneous decelerating wave intensity (W2) wave intensity(WI) technique. Methods The ejection time of the curve of Doppler rate of flow in aortic opens and W1~W2 of common carotid arteries of both sides were detected in 66 healthy adults by Prosound α10 color Doppler ultrasound and the data were contrasted and analyzed. Results There were no statistical significances in the standardized value difference of ejection time of aorta and of time from starting point of W1 to culminated point of W2 in common carotid arteries of both sides (P>0.05). And there were all statistical significances in the standardized value difference of ejection time of aorta and of time in other groups (P<0. 001). Conclusions The ejection time is the time from starting point of W1 to culminated point of W2. The beginning of cardiac ejection should be the starting point of W1 curve,and the culminated point of W2 is the terminal time of ejection.
4.Differential proteome of human synovial fibroblasts from rheumatoid arthritis patients
Ganping BO ; Lina ZHOU ; Weifeng HE ; Gaoxing LUO ; Xiwei CHEN ; Guangxing CHEN ; Xiaohong HU ; Dongwen SHI ; Yongfei FANG ; Jun WU
Journal of Third Military Medical University 1984;0(02):-
ObjectiveTo understand the possible role of some proteins expressed by human synovial fibroblasts(SFs)in the pathogenesis of rheumatoid arthritis.MethodsThe expression difference of synovial fibroblast proteins between rheumatoid arthritis(RA)patients and healthy controls was analyzed by 2-DE.The differential expression spots were identified by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry(MALDI-TOF-MS),followed by bioinformatics analysis,some of which were validated by Western blot.ResultsUsing 12% SDS-PAGE following pH 4-7 IPG strips in IEF,averagely 837 and 852 protein spots were detected in RA patients and normal subjects,respectively.Gel image analysis revealed that there were 49 differential protein spots.By peptide mass fingerprinting strategy,we identified 40 protein spots derived from gels of SFs in RA patients among differential spots and 23 valid proteins were obtained.Western blot analysis showed that expressions of Enolase ?,Annexin I,Cathepsin D,SOD2,Peroxiredoxin 2 were significantly higher in SFs from RA patients than those from normal subjects,which was consistent with proteome analysis.ConclusionThe differential proteins might be involved in inflammation of synovitis in RA.
5.Preliminary study of spectral CT imaging in the differential diagnosis of metastatic lymphadenopathy due to various tumors
Jingang LIU ; Ya LIU ; Lixin LI ; Xingsheng ZHAO ; Maoyi ZHOU ; Weiguang SHAO ; Kuitao YUE ; Dongwen ZHANG ; Wenqiang LI ; Qiyu NIAN ; Shuai ZHANG ; Huizhi CAO
Chinese Journal of Radiology 2011;45(8):731-735
Objective To investigate the feasibility of differentiating lymph node metastases of four types of primary tumors (lymphoma, lung adenocarcinoma, lung squamous cell carcinoma and cholangiocarcinoma) using gemstone spectral imaging (GSI) . Methods Three cases with lymphoma (28 lymph node), five cases with lung adenocarcinoma(30 lymph node), four cases with lung squamous cell carcinoma(24 lymph node) and two cases with cholangiocarcinoma( 10 lymph node) were evaluated by germstona spectra imaging CT scans. Imaging protocol included unenhanced conventional CT scan (120 kVp) ,enhanced GSI (80/140 kVp) on arterial phase and conventional CT scan (120 kVp) on portal phase. CT attenuation values of lymph nodes in the monochromatic images at 11 sets of keV levels (40-140 keV, 10 keV step) and the iodine and water contents of these lymph nodes were measured. All results were analyzed with ANOVA and t test. Results The optimal monochromatic level was 70 keV for the optimal contrast-noise ratio (CNR) of metastatic lymphadenopathy. The CT attenuation values of metastatic lymphadenopathy were (81.36 ±9. 81 ), (58.33 ± 21.55 ), (56. 47 ± 10.62) and (73. 57 ±4. 43 ) HU,respectively, at 70 keV( F = 17.29, P <0. 01 ). There were significant differences in CT attenuation values between lymphoma and lung adenocarcinoma, between lymphoma and lung squamous cell carcinoma and between lung squamous cell carcinoma and cholangiocarcinoma (P < 0. 05 ). The differences in CT attenuation values were significant between cholangiocarcinoma and lung squamous cell carcinoma, between cholangiocarcinoma and lymphoma ( P < 0. 05 ). There was no difference in CT attenuation values at all 11 sets of keV levels between lung squamous cell carcinoma and lung adenocarcinoma ( P > 0. 05 ). The iodine contents of lymphoma, lung adenocarcinoma, lung squamous cell carcinoma and cholangiocarcinoma were ( 1. 93 ± 0. 04 ), ( 1.16 ± 0. 15 ), ( 1.25 ± 0. 21 ) and ( 1.44 ± 0. 04 ) g/L, respectively. The water contents of lymphoma, lung adenocarcinoma, lung squamous cell carcinoma and cholangiocarcinoma were (1029.40 ± 20. 85), (1024.98 ± 11.19), (1022.12 ± 12. 94) and (1030.87 ± 10.10) g/L,respectively. Except between lung squamous cell carcinoma and lung adenocarcinoma, the differences in the iodine contents of metastatic lymphadenopathy were significant among tumors ( P < 0. 05 ). There was no difference in the water contents of metastatic lymphadenopathy among tumors ( P > 0. 05 ). Conclusions Although CT spectral imaging fails to differentiate metastatic lymphadenopathy of lung adenocarcinoma and lung squamous cell carcinoma, it is also a promising method of distinguishing metastatic lymphadenopathy of malignant tumors by CT attenuation values in monochromatic images and iodine contents in material density images. The optimal monochromatic level was determined to be at 70 keV for providing the optimal CNR of metastatic lymphadenopathy.
6.Expression and construction of “bait plasmid” containing human Foxp3 gene in yeast two-hybrid system
Lina ZHOU ; Jun WU ; Gaoxing LUO ; Weifeng HE ; Xiwei CHEN ; Ganping BAI ; Dongwen SHI ; Qinghong WANG ; Shunzong YUAN ; Xiaorong ZHANG ; Xiaohong HU
Journal of Third Military Medical University 2003;0(08):-
Objective To construct a bait vector containing human Foxp3 gene in yeast two-hybrid system in order to screen the cDNA library of T lymphocyte. Methods RT-PCR was used to amplify the Foxp3 gene fragment from the peripheral blood mononuclear cells (PBMC) with the primers designed in accordance with the sequence in GenBank. The product was inserted into pMD18-T vector. After verified with restriction endonuclease digestion of EcoRⅠ and SalⅠ, the vector was inserted into the “bait plasmid” pGBKT7 (named as pGBKT7-Foxp3). After confirmation with restricted endonuclease digestion and sequence analysis, the plasmid was transformed into the yeast cell AH109, and its toxicity and transcriptional activation was tested by both the phenotype assay and the color assay. Results The amplified product of 1 203 bp was inserted into PMD18-T vector and proven correctly by double restriction enzyme digestion. Sequence analysis revealed that the fragment was correctly inserted into pGBKT7 with a right reading frame and its expression in yeast was verified. Conclusion The bait plasmid pGBKT7-Foxp3 constructed expresses correctly, and can not activate the transcription of reporter gene alone in yeast two-hybrid system
7.Heart sound denoising by dynamic noise estimation.
Chundong XU ; Jing ZHOU ; Dongwen YING ; Pengli XIN
Journal of Biomedical Engineering 2020;37(5):775-785
Denoising methods based on wavelet analysis and empirical mode decomposition cannot essentially track and eliminate noise, which usually cause distortion of heart sounds. Based on this problem, a heart sound denoising method based on improved minimum control recursive average and optimally modified log-spectral amplitude is proposed in this paper. The proposed method uses a short-time window to smoothly and dynamically track and estimate the minimum noise value. The noise estimation results are used to obtain the optimal spectrum gain function, and to minimize the noise by minimizing the difference between the clean heart sound and the estimated clean heart sound. In addition, combined with the subjective analysis of spectrum and the objective analysis of contribution to normal and abnormal heart sound classification system, we propose a more rigorous evaluation mechanism. The experimental results show that the proposed method effectively improves the time-frequency features, and obtains higher scores in the normal and abnormal heart sound classification systems. The proposed method can help medical workers to improve the accuracy of their diagnosis, and also has great reference value for the construction and application of computer-aided diagnosis system.
Algorithms
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Heart Sounds
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Humans
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Signal Processing, Computer-Assisted
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Signal-To-Noise Ratio
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Wavelet Analysis
8.The efficacy and safety of BCG in the prevention of postoperative recurrence of intermediate and high-risk non-muscle invasive bladder cancer: a randomized, controlled, multi-center clinical trial (mid-term report)
Hao YU ; Tianxin LIN ; Xiang LI ; Hailong HU ; Nan LIU ; Jian ZHANG ; Xudong YAO ; Zhaoyang WU ; Xiangbo KONG ; Liqun ZHOU ; Jiacun CHEN ; Wei LI ; Jinjian YANG ; Dongwen WANG ; Xiaodong ZHANG ; Youhan CAO ; Shaozhong WEI ; Ye TIAN ; Huiqing ZHANG ; Benkang SHI ; Zhanpo YANG ; Qingwen LI ; Jinkai SHAO ; Tie ZHONG ; Xiaolin WANG ; Hongxing HUANG ; Liming LI ; Jianhua TIAN ; Zhimin WANG ; Jin YANG ; Lin QI ; Jian HUANG
Chinese Journal of Urology 2019;40(7):485-491
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.
9.The 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: a randomized, controlled, multi-center clinical trial with 2 years’ follow-up
Hao YU ; Kaiwen LI ; Hailong HU ; Xiang LI ; Nan LIU ; Jian ZHANG ; Xudong YAO ; Xiaodong ZHANG ; Wei LI ; Liqun ZHOU ; Xiangbo KONG ; Jinjian YANG ; Youhan CAO ; Junli WEI ; Jiacun CHEN ; Zhaoyang WU ; Dongwen WANG ; Xuhui ZHANG ; Jinkai SHAO ; Qingwen LI ; Huiqing ZHANG ; Xiaolin WANG ; Shaozhong WEI ; Ye TIAN ; Tie ZHONG ; Hongshun MA ; Kun LI ; Benkang SHI ; Jin YANG ; Yuhua QIAO ; Hongxing HUANG ; Liming LI ; Zhimin WANG ; Jianhua TIAN ; Tianxin LIN ; Jian HUANG
Chinese Journal of Urology 2020;41(10):724-730
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.
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.