1.Expression of mitogen-activated protein kinase in prostatic intraepithelial neoplasia
Yucheng LI ; Shumin ZHANG ; Tienan BAI ; Tengxiang MA
Journal of Clinical Urology 2001;16(6):273-274
Purpose:To study the expression of mitogen-activated protein kinases (MAPKs) and explore whether MAPKs play an important role in the tissue of prostatic intraepithelial neoplasia (PIN).Methods:In this study,samples of 12 cases with PIN and 16 cases with benign prostate hyperplasia (BPH) were examined using immunohistochemical staining with ERK1/2 antisera.Results:A variety of levels of immunohitochemical staining for MAPK have been detected in all of 12 cases with PIN.An increased expression of MAPK in cytoplasm has been noted in 6 of 12 cases with PIN.Compared with BPH,activaty of MAPK increased 1.48 fold in PIN (P<0.05.Conclusions:There is a higher levels of MAPK activaty in PIN than in BPH. MAPK might be a major pathway of transducing prostatic neoplasia signals, and has promotive effect on the progression of prostatic neoplasia.
2.Comparison of clinical outcomes of forearm radial flap and anterolateral thigh flap for repairing soft tissue defects after oral cancer resection
Jiang ZHU ; Wushuang XU ; Zihan MA ; Yucheng XIANG ; Wanying SHI ; Senbin WU ; Donghui SONG
Chinese Journal of Plastic Surgery 2024;40(9):992-1001
Objective:To compare the efficacy of radial forearm flap and anterolateral thigh flap in repairing soft tissue defects after oral cancer surgery and to explore their indications.Methods:A retrospective analysis was conducted on clinical data of patients with oral cancer treated at the Department of Stomatology, Affiliated Hospital of Nantong University, from May 2019 to February 2023. Patients were divided into two groups based on the repair method: the radial forearm flap group and the anterolateral thigh flap group. The groups were compared in the following aspects. (1) Surgical parameters including defect area after oral cancer resection, flap area, flap preparation time, operation time, and length of hospital stay. (2) Inflammatory markers (interleukin-6 and C-reactive protein levels) measured 1 day before surgery and 1 day after surgery. (3) Flap survival rate was calculated. (4) Complication rates was calculated in the flap donor area and infection rates in the oral recipient area within 6 months postoperatively. (5) Six months postoperatively, the patient’s oral function was assessed by a physician using the University of Washington quality of life scale (UW-QOL). The evaluation included assessments of oral opening, speech, and eating functions. Each parameter was scored on a scale of 0 to 10 (higher scores indicated better recovery). (6) Quality of life was assessed using the 36-item short form health survey scale(SF-36) at 2, 4 and 6 months postoperatively, with scores ranging from 0 to 100 (higher scores indicated better quality of life). (7) Patient satisfaction was assessed at 6 months postoperatively, with satisfaction levels categorized as satisfied, basically satisfied, and dissatisfied. The satisfaction rate was calculated as (satisfied + basically satisfied ) cases / total cases in each group × 100%. Statistical analysis was performed using SPSS 22.0. Measurement data were expressed as Mean±SD, and comparisons between groups were conducted using t-tests. Count data were expressed as cases and (or) percentages, and comparisons were made using chi-square test. P<0.05 was considered statistically significant. Results:The radial forearm flap group included 48 cases (32 males, 16 females), aged (49.3±5.0) years, with a body mass index (BMI) of (23.0±1.1) kg/m 2 and a disease course of (6.5±2.1) months. The group had 21 cases of tongue cancer, 12 of floor of mouth cancer, and 15 of buccal cancer, including 40 squamous cell carcinomas and 8 basal cell carcinomas. The anterolateral thigh flap group included 32 cases (20 males, 12 females), aged (50.1±5.0) years, with a BMI of (23.0±1.0) kg/m 2 and a disease course of (7.0±2.2) months. The group had 16 cases of tongue cancer, 7 cases of floor of mouth cancer, and 9 cases of buccal cancer, including 27 squamous cell carcinomas and 5 basal cell carcinomas. There were no significant differences in gender, age, BMI, disease course, tumor location, or pathological type between the two groups ( P>0.05). The defect area after oral cancer resection was smaller in the radial forearm flap group[ (39.0±1.3) cm 2 ] compared to the anterolateral thigh flap group[ (40.3±2.2) cm 2] ( t=3.32, P=0.001). There were no significant differences in flap area, flap preparation time, or length of hospital stay between the two groups ( P>0.05). The operation time was shorter in the radial forearm flap group [(5.1±1.1) h] compared to the anterolateral thigh flap group [(6.8±2.8) h] ( t=0.26, P<0.001). There were no significant differences in interleukin-6 and C-reactive protein levels between the two groups 1 day before surgery and 1 day after surgery ( P>0.05). The flap survival rates were 97.9% (47/48) in the radial forearm flap group and 93.8% (30/32) in the anterolateral thigh flap group, with no significant difference( P>0.05). Postoperative donor site complications mainly included infection, pigmentation, itching, etc. The overall incidence of complications in the donor site of the radial forearm flap [33.3% (16/48)] was higher than that in the anterolateral thigh flap group [12.5% (4/32)], and the difference was statistically significant ( χ2=4.44, P=0.035). There was no significant difference in infection rates in the oral recipient area between the two groups ( P>0.05). Six months postoperatively, the average scores for oral opening, speech, and eating functions were above 7 in both groups, with no significant differences ( P>0.05). Quality of life scores improved over time in both groups, with average scores above 90 at 6 months postoperatively, and no significant differences at any time point ( P>0.05). The patient satisfaction rate was 91.7% (44/48) in the radial forearm flap group and 90.6% (29/32) in the anterolateral thigh flap group, with no significant difference ( P>0.05). Conclusion:Both radial forearm flap and anterolateral thigh flap can effectively repair soft tissue defects after oral cancer resection, significantly improving patients’oral function. The anterolateral thigh flap provides sufficient tissue volume and is suitable for patients with larger defect areas. The radial forearm flap is suitable for patients with a smaller defect area after oral cancer resection. Its surgical procedure is relatively less complex and offers an advantage in reducing surgery time. However, the donor site complications are higher with the radial forearm flap compared to the anterolateral thigh flap.
3.Comparison of clinical outcomes of forearm radial flap and anterolateral thigh flap for repairing soft tissue defects after oral cancer resection
Jiang ZHU ; Wushuang XU ; Zihan MA ; Yucheng XIANG ; Wanying SHI ; Senbin WU ; Donghui SONG
Chinese Journal of Plastic Surgery 2024;40(9):992-1001
Objective:To compare the efficacy of radial forearm flap and anterolateral thigh flap in repairing soft tissue defects after oral cancer surgery and to explore their indications.Methods:A retrospective analysis was conducted on clinical data of patients with oral cancer treated at the Department of Stomatology, Affiliated Hospital of Nantong University, from May 2019 to February 2023. Patients were divided into two groups based on the repair method: the radial forearm flap group and the anterolateral thigh flap group. The groups were compared in the following aspects. (1) Surgical parameters including defect area after oral cancer resection, flap area, flap preparation time, operation time, and length of hospital stay. (2) Inflammatory markers (interleukin-6 and C-reactive protein levels) measured 1 day before surgery and 1 day after surgery. (3) Flap survival rate was calculated. (4) Complication rates was calculated in the flap donor area and infection rates in the oral recipient area within 6 months postoperatively. (5) Six months postoperatively, the patient’s oral function was assessed by a physician using the University of Washington quality of life scale (UW-QOL). The evaluation included assessments of oral opening, speech, and eating functions. Each parameter was scored on a scale of 0 to 10 (higher scores indicated better recovery). (6) Quality of life was assessed using the 36-item short form health survey scale(SF-36) at 2, 4 and 6 months postoperatively, with scores ranging from 0 to 100 (higher scores indicated better quality of life). (7) Patient satisfaction was assessed at 6 months postoperatively, with satisfaction levels categorized as satisfied, basically satisfied, and dissatisfied. The satisfaction rate was calculated as (satisfied + basically satisfied ) cases / total cases in each group × 100%. Statistical analysis was performed using SPSS 22.0. Measurement data were expressed as Mean±SD, and comparisons between groups were conducted using t-tests. Count data were expressed as cases and (or) percentages, and comparisons were made using chi-square test. P<0.05 was considered statistically significant. Results:The radial forearm flap group included 48 cases (32 males, 16 females), aged (49.3±5.0) years, with a body mass index (BMI) of (23.0±1.1) kg/m 2 and a disease course of (6.5±2.1) months. The group had 21 cases of tongue cancer, 12 of floor of mouth cancer, and 15 of buccal cancer, including 40 squamous cell carcinomas and 8 basal cell carcinomas. The anterolateral thigh flap group included 32 cases (20 males, 12 females), aged (50.1±5.0) years, with a BMI of (23.0±1.0) kg/m 2 and a disease course of (7.0±2.2) months. The group had 16 cases of tongue cancer, 7 cases of floor of mouth cancer, and 9 cases of buccal cancer, including 27 squamous cell carcinomas and 5 basal cell carcinomas. There were no significant differences in gender, age, BMI, disease course, tumor location, or pathological type between the two groups ( P>0.05). The defect area after oral cancer resection was smaller in the radial forearm flap group[ (39.0±1.3) cm 2 ] compared to the anterolateral thigh flap group[ (40.3±2.2) cm 2] ( t=3.32, P=0.001). There were no significant differences in flap area, flap preparation time, or length of hospital stay between the two groups ( P>0.05). The operation time was shorter in the radial forearm flap group [(5.1±1.1) h] compared to the anterolateral thigh flap group [(6.8±2.8) h] ( t=0.26, P<0.001). There were no significant differences in interleukin-6 and C-reactive protein levels between the two groups 1 day before surgery and 1 day after surgery ( P>0.05). The flap survival rates were 97.9% (47/48) in the radial forearm flap group and 93.8% (30/32) in the anterolateral thigh flap group, with no significant difference( P>0.05). Postoperative donor site complications mainly included infection, pigmentation, itching, etc. The overall incidence of complications in the donor site of the radial forearm flap [33.3% (16/48)] was higher than that in the anterolateral thigh flap group [12.5% (4/32)], and the difference was statistically significant ( χ2=4.44, P=0.035). There was no significant difference in infection rates in the oral recipient area between the two groups ( P>0.05). Six months postoperatively, the average scores for oral opening, speech, and eating functions were above 7 in both groups, with no significant differences ( P>0.05). Quality of life scores improved over time in both groups, with average scores above 90 at 6 months postoperatively, and no significant differences at any time point ( P>0.05). The patient satisfaction rate was 91.7% (44/48) in the radial forearm flap group and 90.6% (29/32) in the anterolateral thigh flap group, with no significant difference ( P>0.05). Conclusion:Both radial forearm flap and anterolateral thigh flap can effectively repair soft tissue defects after oral cancer resection, significantly improving patients’oral function. The anterolateral thigh flap provides sufficient tissue volume and is suitable for patients with larger defect areas. The radial forearm flap is suitable for patients with a smaller defect area after oral cancer resection. Its surgical procedure is relatively less complex and offers an advantage in reducing surgery time. However, the donor site complications are higher with the radial forearm flap compared to the anterolateral thigh flap.
4.Effect of parthenolide on apoptosis of chondrocyte under mechanical stretch stress by inhibiting Piezo1 expression and its mechanism
Xuan MA ; Kaixiang YANG ; Hai DENG ; Yucheng HUANG
Journal of Jilin University(Medicine Edition) 2024;50(6):1621-1631
Objective:To discuss the effect of parthenolide(PTL)on the apoptosis of the chondrocytes under mechanical stretch stress by regulating the expression of piezo type mechanosensitive ion channel component 1(Piezo1),and to clarify the related mechanism.Methods:The chondrocytes were divided into 0%,5%,10%,15%,and 20%stretch groups according to the stretch variable.Additionally,the chondrocytes were divided into control group,20%stretch group,20%stretch+5 μmol·L-1 PTL group,20%stretch+10 μmol·L-1 PTL group,and 20%stretch+20 μmol·L-1 PTL group.The Piezo1 short hairpin RNA(shRNA)interference lentivirus(sh-Piezo1)or shRNA-NC lentivirus were used to infect the chondrocytes,and the chondrocytes were divided into sh-Piezo1 group and sh-NC group,and also set up blank control group.The chondrocytes were also devided into 20%stretch group,20%stretch+PTL group,20%stretch+sh-Piezo1 group,and 20%stretch+sh-Piezo1+PTL group.Hoechst 33258 fluorescence staining was used to observe the morphology of the nuclear in various groups;flow cytometry was used to detect the apoptotic rates of the cells in various groups;spectrophotometry was used to detect the cysteinyl aspartate specific proteinase(Caspase)-3 activities in the cells in various groups;CCK-8 method was used to detect the proliferation rates of the cells in various groups;Fluo-4/AM fluorescent probe method was used to detect the calicium ion(Ca2+)levels in the cells in various groups;real-time fluorescence quantitative PCR(RT-qPCR)method was used to detect the expression levels of Piezo1 mRNA in the cells in various groups;Western blotting method was used to detect the expression levels of Piezo1 protein in the cells in various groups.Results:The Hoechst 33258 fluorescence staining resuts showed that as the increasing of stretch,the number of the chondrocytes with fragmented and densely stained nuclei in 0%,5%,10%,15%,and 20%stretch groups were gradually increased.The flow cytometry results showed that compared with 0%stretch group,the apoptotic rates of the chondrocytes in 5%,10%,15%,and 20%stretch groups were significantly increased(P<0.01);compared with control group,the apoptotic rate of the chondrocytes in 20%stretch group was significantly increased(P<0.05);compared with 20%stretch group,the apoptotic rates of the chondrocytes in 20%stretch+5 μmol·L-1 PTL group,20%stretch+10 μmol·L-1 PTL group,and 20%stretch+20 μmol·L-1 PTL group were significantly decreased(P<0.05);compared with 20%stretch group,the apoptotic rates of chondrocytes in 20%stretch+PTL group and 20%stretch+sh-Piezo1 group were significantly decreased(P<0.05).The spectrophotometry results showed that compared with 0%stretch group,the Caspase-3 activities in the chondrocytes in 5%,10%,15%,and 20%stretch groups were significantly increased(P<0.01);compared with control group,the Caspase-3 activity in the chondrocytes in 20%stretch group was significantly increased(P<0.05);compared with 20%stretch group,the Caspase-3 activities in the chondrocytes in 20%stretch+5 μmol·L-1 PTL group,20%stretch+10 μmol·L-1 PTL group,and 20%stretch+20 μmol·L-1 PTL group were significantly decreased(P<0.05).Compared with 20%stretch group,the Caspase-3 activities in the chondrocytes in 20%stretch+PTL group and 20%stretch+sh-Piezo1 group were significantly decreased(P<0.05).The CCK-8 method results showed that compared with 0 μmol·L-1 PTL group,the proliferation rates of the chondrocytes in 40.00,80.00,and 160.00 μmol·L-1 PTL groups were significantly decreased(P<0.05),indicating that 20.00 μmol·L-1 PTL was the maximum non-toxic concentration.The Fluo-4/AM fluorescent probe method results showed that compared with control group,the Ca2+level in the chondrocytes in 20%stretch group was significantly increased(P<0.05);compared with 20%stretch group,the Ca2+levels in the chondrocytes in 20%stretch+5 μmol·L-1 PTL group,20%stretch+10 μmol·L-1 PTL group,and 20%stretch+20 μmol·L-1 PTL group were significantly decreased(P<0.05);compared with 20%stretch group,the Ca2+levels in the chondrocytes in 20%stretch+PTL group and 20%stretch+sh-Piezo1 group were significantly decreased(P<0.05).The RT-qPCR results showed that compared with blank control group and sh-NC group,the expression level of Piezo1 mRNA in the chondrocytes in sh-Piezo1 group was significantly decreased(P<0.05).The Western blotting results showed that compared with control group,the expression levels of Piezo1 protein in the chondrocytes in 20%stretch group was significantly increased(P<0.05);compared with 20%stretch group,the expression levels of Piezo1 protein in the chondrocytes in 20%stretch+5 μmol·L-1 PTL group,20%stretch+10 μmol·L-1 PTL group,and 20%stretch+20 μmol·L-1 PTL group were significantly decreased(P<0.05);compared with blank control group and sh-NC group,the expression level of Piezo1 protein in the chondrocytes in sh-Piezo1 group was significantly decreased(P<0.05).Conclusion:PTL can inhibit the apoptosis of the chondrocyte induced by high-intensity cyclic mechanical stretch stress,and its mechanism may be related to inhibiting the Piezo1-mediated Ca2+influx-induced apoptosis.
5.A comparative study on safety and immunogenicity of an inactivated hepatitis A vaccine in HBsAg carriers and healthy children.
Jiangting CHEN ; Yinhai REN ; Wenting WU ; Shoudong MA ; Shengping LI ; Jianhong WANG ; Wenxue KANG ; Lianjun HAN ; Shuanjing GAO ; Yucheng ZHANG ; Chongbai LIU
Chinese Journal of Experimental and Clinical Virology 2002;16(4):380-381
OBJECTIVETo evaluate safety and immunogenicity of inactivated hepatitis A vaccine in HBsAg carriers and healthy children.
METHODSOne hundred and twenty-one healthy children and ten HBsAg carriers, aged 1-10 years HAV susceptible were enrolled in the study. The inactivated hepatitis A vaccine was produced by Tangshan Biogenetic Company. The dosage of the vaccine was 1000 U/Dosage and 500 U/Dosage. The vaccination schedule was six month apart for two injections. The serum anti-HAV level was detected with EIA at one month after first injection and at one and six month after the booster injection, respectively.
RESULTSThe anti-HAV appeared in all the children. One month after the booster injection, the serum anti-HAV level in children vaccinated 500 U/Dosage was 4684.9 mIU and 4535.6 mIU, respectively and in the children vaccinated 1000 U/Dosage, 5399.8 mIU and 7347.1 mIU, respectively. The anti-HAV level was not statistically different between the two groups of children. There was no adverse reaction after the vaccination. The anti-HAV level was still high one year after first injection.
CONCLUSIONSThe data indicated that the safety and immunogenicity of the domestic inactivated hepatitis A vaccine were excellent in both groups of children.
Child ; Child, Preschool ; Hepatitis A Antibodies ; blood ; Hepatitis A Vaccines ; immunology ; Hepatitis B Surface Antigens ; blood ; Humans ; Immunization ; Infant ; Vaccines, Inactivated ; immunology
6.Impact of subtropical climate on frequency of ambulance use for trauma patients in a coastal area of China.
Yuqiang CHEN ; Yucheng LAI ; Jiajie KE ; Yuefeng CHEN ; Yuling XU ; Yuqin MA ; Jiayin YUAN ; Tian LIANG ; Pengzhan MAI ; Changmin LIN ; Yang XIE ; Keng HUANG
Chinese Journal of Traumatology 2015;18(3):141-146
PURPOSETo explore the impact of subtropical maritime monsoon climate on the frequency of ambulance use for trauma patients in a coastal region in China.
METHODStatistical analysis of data on ambulance use from the 120 Emergency Command Center in Shantou City, Guangdong Province, from January to December 2012 as well as daily meteorological data from a Shantou observatory was performed to determine how climatic factors (seasons, time, and weather) affect the frequency of ambulance use for trauma patients.
RESULTSThe daily ambulance use for trauma patients differed between spring and summer or autumn (p<0.05), between sunny and rainy days (p<0.05), and between cloudy and lightly or moderately rainy days (p<0.05).We found a linear correlation between daily maximum temperature and daily ambulance use for trauma patients (R² =0.103, p<0.05). In addition, there was significant difference in ambulance use between good and bad weather (p<0.05).
CONCLUSIONFrequency of ambulance use for trauma patients is affected by the subtropical maritime monsoon climate in the coastal region. Better weather contributes to increased daily frequency of ambulance use, which is the highest in autumn and lowest in spring.
Ambulances ; China ; Climate ; Humans ; Retrospective Studies ; Wounds and Injuries ; therapy
7.Relationship between expression of miR-203 and FGF-2 in children with hemangiomas and its significance
Xiaojun HE ; Yucheng MA ; Sui HUANG
International Journal of Pediatrics 2020;47(5):353-357
Objective:To analyze the expression levels of microRNA-203(miR-203)and fibroblast growth factor-2(FGF-2)in hemangiomas of infancy(HOI)and to explore their clinical significance.Methods:A total of 55 patients with HOI admitted to our hospital from March 2016 to August 2017 were selected as HOI group and divided into proliferative phase(31 cases)and regressive phase(24 cases), normal tissue specimens were taken as control group(34 cases). Real time fluorescence quantitative PCR(qRT-PCR)was used to detect the expression levels of miR-203 and FGF-2 mRNA in HOI tissues.Immunohistochemistry was used to detect the expression of FGF-2 protein in HOI tissues.Clinical indicators of HOI patients included angiogenin(ANG), vascular endothelial growth factor(VEGF), basic fibroblast growth factor(bFGF), glucocorticoid receptor alpha(GRα), glucocorticoid receptor beta(GRβ). Pearson method was used to compare and analyze the correlation between various indicators in children with HOI group.Logistic multivariate regression analysis was used to analyze the related influencing factors of HOI.Results:Compared with the control group(1.01±0.15), the expression level of miR-203 in HOI group(0.73±0.24)decreased significantly( P<0.05), and the proliferative phase(0.72±0.21)was significantly higher than the regression phase(0.59±0.19)( P<0.05); the expression levels of FGF-2 mRNA and protein in HOI group(2.38±0.74)were significantly higher than those in control group(1.02±0.14)( P<0.05), and the regression phase(2.37±0.79)was significantly higher than the proliferative stage(2.03±0.68)( P<0.05); Pearson analysis showed that miR-203 was negatively correlated with FGF-2, ANG, VEGF and bFGF( P<0.05), while FGF-2 was positively correlated with them( P<0.05); Logistic analysis showed that the expression levels of miR-203 and FGF-2 were both influencing factors of HOI. Conclusion:MiR-203 is low expressed in HOI, while FGF-2 is highly expressed.There is a significant difference in the expression changes of the two in HOI stages and it is important for clinical diagnosis of HOI and treatment.
8.Single-stage total corpus callosotomy combined with different resective operations in children with Lennox-Gastaut syndrome
Kangping MA ; Bojing TAN ; Linhua YI ; Guangbiao QIN ; Yucheng YANG ; Yunlin LI
Chinese Journal of Neuromedicine 2017;16(12):1290-1293
Objective To study the outcomes of Lennox-Gastaut syndrome (LGS) with single-stage total corpus callosotomy combined with different resective surgeries. Methods Nine LGS patients, admitted to our hospital from May 2010 to May 2014, were chosen in our study. Their clinical data were retrospectively analyzed. According to the results of anatomy, electrophysiology and clinical comprehensive evaluation, all the 9 children received single-stage total corpus callosotomy combined with different resective operations. The differences of epileptic seizures of these children before and after surgery were compared. Results The 9 LGS children were followed up for 2 years;5 achieved Engel grade I, 3 achieved Engel grade II, and one achieved Engel grade III. The surgical effective rate was 88.9% (8/9). The frequencies of drop seizures, convulsive seizures, tonic seizures and tonic-clonic seizures were decreased of different degrees, with drop seizures enjoying the best control. Three patients had transient silence, remarkable relief one week after surgery and total recovery half year after surgery. Conclusion Early single-stage total corpus callosotomy combined with different resective operations can help to control seizures in children with intractable LGS.
9. General considerations of model-based meta-analysis
Lujin LI ; Junjie DING ; Dongyang LIU ; Xipei WANG ; Chenhui DENG ; Shangmin JI ; Wenjun CHEN ; Guangli MA ; Kun WANG ; Yucheng SHENG ; Ling XU ; Qi PEI ; Yuancheng CHEN ; Rui CHEN ; Jun SHI ; Gailing LI ; Yaning WANG ; Yuzhu WANG ; Haitang XIE ; Tianyan ZHOU ; Yi FANG ; Jing ZHANG ; Zheng JIAO ; Bei HU ; Qingshan ZHENG
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(11):1250-1267
With the increasing cost of drug development and clinical trials, it is of great value to make full use of all kinds of data to improve the efficiency of drug development and to provide valid information for medication guidelines. Model-based meta-analysis (MBMA) combines mathematical models with meta-analysis to integrate information from multiple sources (preclinical and clinical data, etc.) and multiple dimensions (targets/mechanisms, pharmacokinetics/pharmacodynamics, diseases/indications, populations, regimens, biomarkers/efficacy/safety, etc.), which not only provides decision-making for all key points of drug development, but also provides effective information for rational drug use and cost-effectiveness analysis. The classical meta-analysis requires high homogeneity of the data, while MBMA can combine and analyze the heterogeneous data of different doses, different time courses, and different populations through modeling, so as to quantify the dose-effect relationship, time-effect relationship, and the relevant impact factors, and thus the efficacy or safety features at the level of dose, time and covariable that have not been involved in previous studies. Although the modeling and simulation methods of MBMA are similar to population pharmacokinetics/pharmacodynamics (Pop PK/PD), compared with Pop PK/PD, the advantage of MBMA is that it can make full use of literature data, which not only improves the strength of evidence, but also can answer the questions that have not been proved or can not be answered by a single study. At present, MBMA has become one of the important methods in the strategy of model-informed drug development (MIDD). This paper will focus on the application value, data analysis plan, data acquisition and processing, data analysis and reporting of MBMA, in order to provide reference for the application of MBMA in drug development and clinical practice.
10.Risk factors of recurrence after transperineal anastomotic urethroplasty of post-traumatic urethral stricture patients and construction of a nomogram: a retrospective study
Ya LI ; Banghua LIAO ; Liang ZHOU ; Yucheng MA ; Kunjie WANG
Chinese Journal of Urology 2023;44(8):571-576
Objective:To explore the risk factors for urethral stricture after transperineal anastomotic urethroplasty (TAU) by retrospectively analyzing patient data and to develop a nomogram to predict the risk of recurrence before the surgery.Methods:Clinical data of patients who underwent TAU because of post-traumatic urethral stricture from January 2016 to December 2017 in West China Hospital, Sichuan University were reviewd. A total of 78 patients were included in the retrospective analysis, with 13 of them having recurrence. The patients in the recurrence group had a median age of 49.8 and 76.9% (10/13) of them had membranous urethral stricture. The proximal urethra end was located above the superior margin of the pubic ramus (higher stricture site) in 53.8%(7/13)of patients in the recurrence group and the length of the stricture measured in the operation was (2.19±0.22) cm. In the non-recurrence group, the median age was (44.8±13.6) years old, 58.5% (38/65) of them had membranous urethral stricture, 21.5% (14/65) had higher stricture site, and the length of the stricture was (2.03±0.11) cm. Both univariate and multivariate logistics analyses were performed to evaluate the risk factors of recurrence of urethral stricture 5 years after surgery. The nomogram was built based on the multivariate logistics analysis. The Concordance Index (C-index), Receiver Operating Characteristic(ROC) curve and Calibration curve were used to evaluate the nomogram.Results:Univariate logistics analysis showed that higher stricture site, history of urethral dilation, smoking, diabetes and total serum protein may be associated with recurrence after surgery. Multivariate logistics analysis further confirmed that higher stricture site ( OR=34.64, 95% CI 3.71-754.53), history of urethral dilation( OR=13.15, 95% CI 1.27-210.00), smoking ( OR=13.75, 95% CI 2.15-166.05) and diabetes ( OR=64.98, 95% CI 3.80-1957.60) were independent risk factors for recurrent urethral stricture while higher total serum protein before surgery was related to lower recurrence risk ( OR=0.78, 95% CI 0.62-0.93). A nomogram was built based on the results. The C-index of the nomogram was 0.923(95% CI 0.908-0.938), the area under curve (AUC) was 0.923 (95% CI 0.855-0.991), and the Brier Score was 0.079. Conclusion:Higher stricture site, history of urethral dilation before surgery, smoking, diabetes and lower total serum protein before surgery are associated with higher recurrence TAU of post-traumatic urethral stricture patients. With the nomogram developed, prediction of the risk of recurrence could be achieved prior surgery.