The basic concept and related background of multivariate statistical process control(MSPC)were intro-duced.The basic process of MSPC implementation and the common statistics and control charts were described.The important role of MSPC in the pharmaceutical production process was emphasized,especially in the field of tra-ditional Chinese medicine,providing reference for the selection of quality control methods in drug production process.The advantages and disadvantages of MSPC were summarized,and the development trend of MSPC in drug production and quality control was prospected.

Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5％were gram-positive and 70.5％were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3％,76.7％and 77.9％,respectively.Overall,94.0％of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8％of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2％in the isolates from children and 95.7％in the isolates from adults.The resistance rate to carbapenems was lower than 13.1％in most Enterobacterales species except for Klebsiella,21.7％-23.1％of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1％to 13.3％.The prevalence of meropenem-resistant strains decreased from 23.5％in 2019 to 18.0％in 2022 in Pseudomonas aeruginosa,and decreased from 79.0％in 2019 to 72.5％in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.

Objective:To investigate the feasibility,safety and effectiveness of robot-assisted laparo-scopic buccal mucosa graft ureteroplasty in the treatment of complex long proximal ureteral stricture.Methods:The clinical data of 20 patients with proximal ureteral stricture undergoing robot-assisted lapa-roscopic buccal mucosa graft ureteroplasty admitted to the Department of Urology,Peking University First Hospital and Beijing Jiangong Hospital from July 2022 to January 2023 were prospectively collected and analyzed.Intraoperative conditions,postoperative complications and follow-up data were also recorded and analyzed.Results:The operations under robot-assisted laparoscopy were performed successfully in all the 20 patients without conversion to traditional laparoscopic surgery or open surgery.The study in-cluded 14 males and 6 females with a mean age of(41±11)years(range:19 to 60 years)and a mean body mass index of(24.3±3.6)kg/m2(range:18.2 to 31.8 kg/m2).There were 9 cases on the left side and 11 cases on the right side.The strictures of all the patients were located in the proximal segment of the ureter(including the ureteropelvic junction).The mean preoperative serum creatinine was(92.2±23.3)μmol/L(range:49.2 to 138.9 μmol/L),and the mean length of ureteral stricture was(2.8±0.9)cm(range:1.0 to 4.0 cm).Ten patients had previously undergone unsuccessful reconstructive surgery.During the operation,12 patients received posteriorly augmented anastomosis with ventral onlay.The mean length of the buccal mucosa graft harvested during the operation was(3.1±0.6)cm(range:2.0 to 4.3 cm),and the median width was 1.5 cm(range:1.0 to 2.0 cm).The omentum flap was used to wrap the reconstructed ureteral segment in all the 20 cases.The median operative time was 154 min(range:113 to 300 min),and the median estimated blood loss was 45 mL(range:0 to 100 mL).The median postoperative hospital stay was 4 d(range:4 to 14 d).The mean postoperative follow-up time was(15.0±1.7)months(range:12.5 to 17.9 months),and the surgical success rate was 100.0％in this study.After surgery,11 patients reported mild discomfort at the oral donor site,2 patients deve-loped urinary tract infection,and no postoperative complications were reported in the other 7 patients.The mean serum creatinine was(90.9±23.9)μmol/L(range:60.0 to 153.0 μmol/L)six months after surgery.Conclusion:Robot-assisted laparoscopic buccal mucosa graft ureteroplasty for the treatment of complex long proximal ureteral stricture has satisfactory efficacy without severe complications,which has shown good feasibility,safety and effectiveness.However,large sample studies and long-term follow-up are still needed to evaluate its long-term efficacy.

【Objective】 To explore the feasibility of using autoregressive moving average model (ARIMA) to predict the dosage of suspended red blood cells in children, and to provide a basis for the development of clinical blood reserve plans in children's hospitals. 【Methods】 ARIMA model was constructed using the total blood consumption of clinical suspended red blood cells from March 2016 to May 2022 at the Children's Hospital of Chongqing Medical University as the data source by SPSS26.0 software. The optimal model was used to predict the clinical suspended red blood cell consumption from June to October 2022, and the predictive effect of the model was tested. 【Results】 ARIMA(0, 1, 1) (0, 1, 1)12 was the optimal model for predicting the consumption of suspended red blood cells in pediatrics. The autocorrelation function and partial autocorrelation function of the residual sequence basically fell within the 95% confidence interval. At the same time, Ljung-Box Q statistical results showed that there was no correlation between the residual (P>0.05), indicating that the residual was white noise, which met the randomicity hypothesis. The average relative error between the predicted values of the model and the actual clinical red blood cell usage from June to October 2022 was 5%, indicating high prediction accuracy. 【Conclusion】 The blood usage of children has obvious seasonal and periodic patterns, and the optimal model ARIMA (0, 1, 1) (0, 1, 1)12 can better fit the trend of changes in pediatric suspended red blood cell usage, thus providing a basis for the development of clinical blood reserve plans in children's hospitals.

【Objective】 To investigate the common etiology, characteristics and treatment of iatrogenic ureteral stricture. 【Methods】 The clinical data of 226 patients with ureteral stricture repaired during May 2019 and Mar. 2022 were retrospectively analyzed, including 68 cases of iatrogenic ureteral stricture. According to the etiology, the patients were divided into urinary group and non-urinary group. 【Results】 There were 42 females and 26 males, aged 25 to 67 (average 49.0±10.4) years. Upper ureteral stricture was detected in 24 (35.3%) cases, who received oral mucosal repair of the ureter. Middle ureteral stricture was detected in 12 (17.6%) cases, who underwent ileal ureterography. Lower ureteral stricture was observed in 24 (35.3%) cases, who were treated with vesical wall flap ureteroplasty. Full-length stricture was observed in 8 (11.8%) cases,who were treated with ileal ureterography. There were significant differences in age, gender, stenosis side, stenosis location and length, surgical methods and types between patients in the urinary group and non-urinary group (P<0.05). During the follow-up of 8 to 20 (average 12.3±5.6) months, the symptoms and renal function of all patients improved, and no recurrence occurred. 【Conclusion】 Invasive endourological surgery is the most common cause of iatrogenic ureteral stenosis. Different treatment strategies should be adopted according to patients’ condition, time of diagnosis and location and length of ureteral injury.

Objective:To investigate the clinicopathologic features and differential diagnosis of ureteral fibroepithelial polyps.Methods:The clinicopathologic features and prognosis of ureteral fibroepithelial polyps with complete data retrieved from the pathology database of the Institute of Urology, Peking University from January 2013 to December 2021 were collected and analyzed. All HE staining sections were reviewed by a senior urologic pathologist. Immunohistochemical analysis was done in some cases for differential diagnosis. The clinical, imaging and outcome data were collected, and discussed together with relevant literature.Results:There were 45 patients with complete clinicopathologic data, including 34 males and 11 females (male: female=3.1∶1.0), with a median age of 36 (range 13-80) years. Preoperative diagnosis included polyp in 23 cases, tumor in 19 cases and calculi in 3 cases. The main clinical symptoms were hematuria (13 cases), low back and abdominal pain (9 cases) and no symptoms (9 cases). There were 29 cases of multiple polyps, 16 cases of single polyp; 32 cases were on the left side, 13 cases were on the right side; 29 cases of upper polyps, 9 cases of middle polyps, and 6 cases of lower polyps. Twenty-seven patients had no related urologic history, 10 patients had history of urolithiasis, and the rest had history of stents, strictures or tumors. Local ureteral resection and anastomosis were the most common treatment (20 cases), followed by ureteroscopic polypectomy (12 cases). The patients were followed up from the pathological diagnosis to the cut-off time: 4 cases were lost to follow-up, and the remaining 34 cases were followed up for 3 to 85 (mean 60 months). One case had polyp recurrence after 3 months, and the other case had polyp recurrence after 2 years. Fibroepithelial polyps had a variety of gross manifestations, ranging from elongated polyps or small papillary and polypoid to large papillary masses. Microscopically, they were divided into type 1, type 2 and type 3, and the type 3 was the most common type (28 cases). In this study, there were 41 cases of simple fibroepithelial polyp, 2 cases of malignant transformation of polyps into urothelial carcinoma, one case of polyps with urothelial carcinoma, and one case of polyp with surface urothelial carcinoma in situ; the stroma showed myofibroblastic proliferation.Conclusions:The clinical manifestations and morphologic characteristics of ureteral fibroepithelial polyps are diverse. The three microscopic types are easily confused with many benign and malignant ureteral diseases, such as inflammatory polyps, adenocystitis, papilloma, etc. Awareness of the key differentiation points and judicious use of immunohistochemistry will be helpful for the diagnosis and differential diagnosis.

Objective:To explore the clinical value of modified upper urinary tract video urodynamics in evaluating the surgical effect and guiding the follow-up treatment after ureteral reconstruction.Methods:From December 2018 to November 2020, sixty-nine patients underwent upper urinary tract reconstruction and received modified video urodynamics at the time of nephrostomy removal 3 months after the surgery in the RECUTTER database (29 cases in Peking University First Hospital, 22 cases in Emergency General Hospital, and 18 cases in Beijing Jiangong Hospital). There were 39 males and 30 females, with an average age of (40.4±12.7)years. The stricture was located in left in 34 patients, right side in 27 patients, and bilateral sides in 8 patients. The upper, middle, and lower thirds of the ureter were affected in 26, 10, and 33 cases, respectively. The preoperative creatinine was (92.3±26.9)μmol/L, and the estimated glomerular filtration rate (eGFR) was (85.1±23.2)ml/(min·1.73m 2). The upper urinary tract reconstruction included ileal replacement of ureter in 25 cases (36.2%), pyeloplasty in 8 cases (11.6%), ureteroneocystostomy in 9 cases (13.0%), boari flap in 6 cases (8.7%), lingual mucosal graft ureteroplasty in 9 cases (13.0%), appendiceal onlay ureteroplasty in 3 cases (4.3%), ureteroureterostomy in 3 cases (4.3%), and balloon dilation in 6 cases (8.7%). Based on the pressure and imaging, the results could be divided into three types, type Ⅰ, the pressure difference remained stable near baseline, and the renal pelvis pressure was below 22 cmH 2O(1 cmH 2O=0.098 kPa), and the reconstructed ureter is well visualized during the whole perfusion process; type Ⅱ, the pressure difference increases with the perfusion, but it can decrease to a normal level with the ureteral peristalsis; type Ⅲ, the pressure difference exceeds 15 cmH 2O, and the ureteral peristalsis is weak or disappears at the same time. The management strategies and treatment effects of different subtypes were analyzed. Successful treatment was defined as no further treatment required, the absence of hydronephrosis-related symptoms, and the improved or stabilized degree of hydronephrosis. Results:All 69 patients successfully completed upper urinary tract video urodynamics. The pressure difference was higher than 15 cmH 2O in 8 patients, and the median pressure difference was 37(19-54)cmH 2O. The renal pelvis pressure exceeded 22 cmH 2O in 10 patients, and the median pressure was 63.5 (24-155) cmH 2O. Video urodynamic results of upper urinary tract were classified as type Ⅰ in 60 cases, type Ⅱ in 5 cases, and type Ⅲ in 4 cases. Patients in type Ⅰ do not require other treatment after nephrostomy tube removal. Patients in type Ⅱ should avoid holding urine after the removal of nephrostomy and D-J tubes. All patients in type Ⅲ received further treatment, of which 2 patients replaced D-J tube regularly, 1 patient underwent long-term metal ureteral stent replacement, and 1 patient underwent ureteroscopic balloon dilation. The median follow-up time was 24 (18-42) months. All patients in type Ⅰ met the criteria for surgical success, The pre-and postoperative creatinine in type Ⅰ patients were (88.71±23.09)μmol/L and (88.75±23.64)μmol/L ( P=0.984), and eGFR were (88.06±22.66)ml/(min· 1.73m 2)and (87.97±23.01)ml/(min·1.73m 2), respectively( P=0.969). For type Ⅱ patients, ultrasound showed that the degree of hydronephrosis improved in 3 cases and remained stable in 2 cases. The pre-and postoperative creatinine were (105.97±7.75)μmol/L and (97.63±7.56)μmol/L ( P=0.216), and eGFR were (69.08±14.74)ml/(min·1.73m 2)and (75.95±14.02)ml/(min·1.73m 2)( P=0.243), respectively. For type Ⅲ patients, ultrasound showed that the degree of hydronephrosis remained stable. The pre-and postoperative creatinine were (105.14±44.34)μmol/L and (101.49±57.02)μmol/L ( P=0.684), and eGFR were (65.32±19.85)ml/(min·1.73m 2) and (73.42±27.88) ml/(min·1.73m 2), respectively( P=0.316). Conclusions:The pressure and imaging results of modified upper urinary tract video urodynamics can assist in evaluating the surgical effect of ureteral reconstruction, and the classification has certain guiding significance for further treatment.

Objective:To investigate the diagnostic value of Japan NBI Expert Team (JNET) classification with blue-laser imaging magnifying endoscopy (BLI-ME) for colorectal neoplastic lesions.Methods:Data of 40 colorectal neoplastic lesions in 34 patients that received BLI-ME from September 2016 to December 2018 in Peking University International Hospital were reviewed and endoscopic images from those lesions were selected. Four senior endoscopists analyzed and classified these images according to the JNET criteria and determined the possible pathologic type. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of JNET classification under BLI-ME system were calculated with final pathologic results as the golden standard.Results:Of all the 40 lesions, there were 3 non-cancerous lesions, 20 adenoma, 10 high grade intraepithelial neoplasia/submucosal-superficial lesions and 7 submucosal-deep lesions. The accuracy of 4 endoscopists was 75.00%-87.50%, and 65.38%-95.89% for different JNET types. For each JNET type, the sensitivity was 60.71%-91.67%, specificity was 84.17%-97.73%, PPV was 63.46%-95.89%, and NPV was 88.51%-99.31%. For the 4 endoscopists, the assurance rate of surface pattern was 73.08%-100.00%, 80.77%-100.00% for deciding vascular pattern, and 67.31%-100.00% for deciding final JNET type. The Kappa value between any two endoscopists was 0.630-0.887, and the interclass correlation coefficient for all results was 0.880. Conclusion:JNET classification shows significant diagnostic value under BLI-ME system for colorectal neoplastic lesions.

Objective: To evaluate the efficacy and safety of Institution Urology of Peking University modified technique for transperitoneal laparoscopic pyeloplasty combined with deflectable tip rigid ureteroscope(the Sun's ureteroscope) in ureteropelvic junction obstruction(UPJO) complicated with renal calculi. Methods: From January 2018 to September 2018, eight patients, including five males and three females, were diagnosed as UPJO with coexistent ipsilateral renal calculi in Peking University First Hospital and Changzheng Hospital of Second Military Medical University. The age ranged from 14 to 50 years(mean 28 years). Four patients had flank pain and one patient had flank pain with hematuria, while the other three patients came without clinical symptom.The BMI ranged from 16.8 to 26.2 kg/m²(mean 22.0 kg/m²). The lesion located on the left side in 4 cases and on the right side in 4 cases. One patient suffered with multiple pelvis stones. Four patients suffered with multiple lower calyceal stones, and 3 patients had solitary lower calyceal stone. The stone size ranged from 2 mm to 10 mm (mean 6.4 mm). 3 cases had slight hydronephrosis and 5 cases had moderate hydronephrosis. Two patients combined with crossing vessels. All patients underwent modified transperotoneal laparoscopic dismembered pyeloplasty with pyelolithotomy. In cases with left lesion, an incision was made for the veress needle 5mm inferior to the costal margin in the left midclavicular line to establish pneumoperitoneum . A 12-mm camera port was placed 30 mm inferior to the umbilicus and 10 mm lateral to the border of left rectus muscle. Then, a 5 mm operative trocars was inserted at 30mm superior to the umbilicus 10 mm lateral to the border of left rectus muscle. Another 12 mm operative trocar was inserted at the opposite McBurney point. The last 5 mm operative trocar was placed at the veress needle point. After visualizing the pelvis and the proximal ureter at the lower pole of the kidney, a 1.0 cm transverse incision on the lower pole of the pelvis above the obstruction site was made. The Sun’s ureteroscope was introduced into the renal pelvis through the 1.0 cm transverse incision via the 12-mm trocar below the umbilicus. Stones in the renal pelvis and calyces were extracted with basket catheters and removed via the port. After the pyelo-nephroscopy, a modified transperitoneal laparoscopic pyeloplasty was made. A F6 double-J stent was inserted into the ureter during the surgery. Result: All surgeries were finished successfully without conversion. The surgical duration ranged from 111 to 185 min(mean 135 min). The estimated blood ranged from 10 to 50 ml(mean 38.8 ml). The hospital stay ranged from 3 to 7 days(mean 4 days). The intraoperative stone free rate was 100%(8/8). No perioperative complications occured. With the follow-up from 6 to 14.4 months(mean 8.9 months), there was no evidence of obstruction in all patients, as confirmed by symptoms or radiological improvement of hydronephrosis, and two patients found recurrence of renal calculi. Conclusions Our modified technique for transperitoneal laparoscopic pyeloplasty combined with deflectable tip rigid ureteroscope(the Sun′s ureteroscope) is a safe, effective method to manage ureteropelvic junction obstruction with renal calculi.

Objective: To investigate the operating key steps and the initial experience of IUPU (Institute of Urology, Peking University) modified extraperitoneal laparoscopic VIP (Vattikuti institute prostatectomy) technique and the initial follow-up outcomes. Methods: 46 patients of prostate cancer underwent the modified extraperitoneal laparoscopic VIP and were reviewed from November 2017 to September 2018. Patients aged 54 to 77 years, with mean age of 65.5 years old. Their preoperative PSA was 0.15 to 69.76 ng/ml with an average of 13.4 ng/ml. All patients were diagnosed by prostate biopsy and Gleason score was 6 to 10 with an average of 7.5. MRI was used to assess their clinical stage before operation. All the modified laparoscopic VIP were done through the extraperitoneal approach by a single surgeon and the follow-up by telephone for the PSA level and continence recovery (urine pad test). The major differences between modified laparoscopic VIP and the routine steps of radical prostatectomy are as follows: use of extraperitoneal approach and traditional laparoscopic operation; after the setup of the extraperitoneal cavity, the bladder neck is separated, isolated and cut down first; the management of DVC: Cut down the super-facial and deep layers of DVC just along the capsule of the prostate apex and it’s unnecessary to suture it. Perioperative data of these patients were collected retrospectively, including operation time, intraoperative blood loss, length of hospital stay, postoperative pathology, and continence outcome after surgery. Result: All 46 patients underwent the IUPU modified extraperitoneal laparoscopic VIP successfully without converting to open surgery. The operation time was 69-143 min with an average of 95.7 min and the estimated blood loss was 20-200 ml with an average of 81.5 ml. It was 3-17 days for the average time to remove the retropubic drainage tube postoperatively, with an average of 4.3 days. The postoperative hospital stay was 3-17 days with an average of 5.3 days. The Foley catheter was removed 14 days postoperatively. Five patients suffered from urine leakage and were managed successfully with conservative treatment. For the postoperative pathological stage, 1 patient was pT_2a, 12 patients were pT_2c, 12 patients were pT_3a and 21 patients were pT_3b. The postoperative Gleason score was 6-9 with an average of 7.7. The postoperative follow-up time was 1-11 months with an average of 6.3 months. The PSA was 0.001-0.966 ng/ml with an average of 0.181 ng/ml 1 month postoperatively and the continence rate was 54%(25/46) and 89%(34/38) 1 month and 3 months after operation respectively. Conclusions The IUPU modified extraperitoneal laparoscopic VIP might be a safe and feasible for the radical prostatectomy. It’s simplified for the operative steps, unnecessary to isolate and suture DVC and doesn’t increase the blood loss. It’s almost left intact for the surrounding tissues of the prostate apex and satisfactory for the early urinary continence. The oncological outcomes are needed to followup further.