1.Research on Access Evaluation System of New Medical Technology Based on HB-HTA
Jing WANG ; Xiaoli FU ; Shuai JIANG ; Yudong MIAO ; Zihan MU ; Yanyu TANG ; Suxian WANG ; Yaojun ZHAO
Chinese Hospital Management 2024;44(3):9-12
The access evaluation of new medical technology is an important part of the preclinical application of medical technology and plays a vital role in ensuring the quality and safety of medical services.However,in the con-crete practice of access evaluation,there are still some problems such as imperfect access theoretical framework,imperfect evaluation index system.With the strategic support of health policies,laws,and regulations,the theory and method of HB-HTA are used for reference,core elements such as assessment subject,assessment object,and assessment content are comprehensively considered,the index system is designed from the dimensions of tech-nical characteristics,safety,effectiveness,economy and applicability,and the access evaluation framework of im-ported medical new technologies is constructed.To offer a theoretical framework and evidence-based basis for medi-cal facility medical technology access management.
2.Problems and countermeasures of industry-university-research cooperation in Liaoning Province
Yudong WU ; Ji WU ; Wei WU ; Xin LI ; Yu YI ; Yanming LIU ; Shuyin LI ; Yuting KANG ; Wenrui LU ; Weiyun CHEN ; Fu REN ; Kebin XU
Journal of Shenyang Medical College 2024;26(5):542-546
Industry-university-research cooperation is not only the core of technological innovation,but also an important way to enhance industrial competitiveness and achieve high-quality development.Industry-university-research cooperation in Liaoning Province has achieved significant results in promoting technological innovation and economic development,but there are still some problems and challenges.The main problems include insufficient depth of industry-university-research cooperation,scattered innovation resources,lack of long-term stable cooperation mechanisms,as well as talent loss and lack of high-quality innovative talents.Through systematically sorting out the existing models of industry-university-research cooperation,it proposes a series of targeted and operable countermeasures and suggestions.These measures and suggestions provide solid theoretical support for the healthy development of industry-university-research cooperation in Liaoning Province.
3.Research on legal regulations of deep integration of industry-university-research in Liaoning
Yudong WU ; Ji WU ; Wei WU ; Xin LI ; Yu YI ; Yanming LIU ; Shuyin LI ; Kebin XU ; Wenrui LU ; Fu REN ; Yuting KANG
Journal of Shenyang Medical College 2024;26(6):644-649
Objective:To study the situation of legal regulations for the integration of industry-university-research in Liaoning,improve the concept of legal regulation,optimize the legal regulation methods,so as to promote the deep integration of industry-university-research in Liaoning.Method:Problem-oriented approach was used,and the problems of the current legal regulations for the integration of industry-university-research in Liaoning were reviewed.Result:It was found that legal regulations for the deep integration of industry-university-research in Liaoning were not yet perfect,which was manifested in insufficient coverage of policies and regulations,relatively lagging update of regulations,and insufficient highlighting of local characteristics.Conclusion:In response to the above issues,it is proposed to use measures such as collaborative regulation,incentive regulation and moderate regulation to establish and improve the legal system of the integration of industry-university-research in Liaoning province.
4.Clinical study on patient-derived organoids as a predictive model for assessing treatment response in pancreatic cancer
Suya SHEN ; Jingjing LI ; Hao CHENG ; Wenyan GUAN ; Zhiwen LI ; Xiao FU ; Yingzhe HU ; Zhenghua CAI ; Yuqing HAN ; Yudong QIU
Chinese Journal of General Surgery 2023;38(9):655-661
Objective:To construct a biospecimen bank of patient derived organoids (PDOs) from pancreatic cancer tissues and to explore the feasibility of PDOs drug sensitivity assay technology to guide chemotherapy drug selection for pancreatic cancer.Methods:Pancreatic cancer tissue specimens obtained after surgical resection and puncture biopsy from Mar 2020 to Dec 2022 at Drum Tower Hospital, Nanjing University School of Medicine were collected. Pancreatic cancer PDOs were cultured in vitro and histologically identified; PDOs were treated with gemcitabine, Nab-paclitaxel, fluorouracil, Oxaliplatin, and Irinotecan and cell viability was measured to analyze the correlation between PDOs drug sensitivity and the actual clinical treatment response.Results:The PDOs can reproduce the pathological features of corresponding tumor tissues; the sensitivity of different PDOs to the same chemotherapeutic drug is significantly different; The sensitivity of PDOs was highly consistent with the actual treatment effect of the corresponding patients 75.76% (25/33); organoid organ-based susceptibility testing had predictive value for the treatment response of patients (AUC=0.733, 95% CI: 0.546-0.919, P<0.05). Conclusion:A biobank of pancreatic cancer PDOs was successfully constructed, and the drug susceptibility test results were significantly correlated with the actual medication response of patients, suggesting that the drug susceptibility test technology based on PDOs has the potential to guide individualized chemotherapy for pancreatic cancer.
5.Surgical efficacy and prognosis influencing factors of hilar cholangiocarcinoma based on multi-disciplinary diagnosis and treatment
Liang MAO ; Yifei YANG ; Alexer ABAYDULLA ; Tie ZHOU ; Xu FU ; Hao CHENG ; Jing ZHANG ; Youjun LIANG ; Yinyin FAN ; Wentao KONG ; Jian HE ; Aimei LI ; Min TANG ; Qun ZHOU ; Qibin HE ; Yi WANG ; Lei WANG ; Weiwei KONG ; Jie SHEN ; Baorui LIU ; Jun CHEN ; Jiong SHI ; Qi LI ; Zhao LIU ; Yudong QIU
Chinese Journal of Digestive Surgery 2023;22(7):873-883
Objective:To investigate the surgical efficacy and prognosis influencing factors of hilar cholangiocarcinoma based on multidisciplinary diagnosis and treatment.Methods:The retrospective cohort study was conducted. The clinicopathological data of 91 patients with hilar cholangiocarcinoma who underwent surgery in Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from April 2004 to April 2021 were collected. There were 59 males and 32 females, aged (61±10)years. Patients who were admitted from April 2004 to March 2014 underwent traditional surgical diagnosis and treatment, and patients who were admitted from April 2014 to April 2021 underwent multidisciplinary diagnosis and treatment. Observation indica-tors: (1) surgical situations; (2) postoperative situations; (3) postoperative pathological examina-tions; (4) postoperative prognosis analysis; (5) influencing factors of postoperative prognosis. Follow-up was conducted using telephone interview and outpatient examination. Patients were followed up once every 6 months after surgery to detect survival. The follow-up was up to April 2023. Measure-ment data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Comparison of ordinal data was conducted using the rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. The Kaplan-Meier method was used to draw survival curve and calculate survival rate. The Log-Rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the COX proportional hazard model. Results:(1) Surgical situations. Of the 91 patients, there were 65 cases receiving hemi- or expanded hemi-hepatectomy, 13 cases receiving tri-hepatectomy, 9 cases receiving partial hepatectomy, 4 cases receiving extrahepatic bile duct resection. There were 24 cases receiving combined vein resection and reconstruction, 8 cases receiving combined pancreaticoduodenectomy, 6 cases receiving com-bined hepatic artery resection and reconstruction, including 24 cases receiving extended radical surgery (tri-hepatectomy, hepatic artery resection and reconstruction, hepatopancreaticoduodenec-tomy). The operation time, volume of intraoperative blood loss and intraoperative blood transfusion rate of 91 patients was (590±124)minutes, 800(range, 500?1 200)mL and 75.8%(69/91), respectively. Of the 91 patients, cases receiving extended radical surgery, the volume of intraoperative blood loss were 4, 650(range, 300?1 000)mL in the 31 patients who were admitted from April 2004 to March 2014, versus 20, 875 (range, 500?1 375)mL in the 60 patients who were admitted from April 2014 to April 2021, showing significant differences between them ( χ2=4.39, Z=0.31, P<0.05). (2) Post-operative situations. The postoperative duration of hospital stay and cases with postoperative infectious complications were (27±17)days and 50 in the 91 patients. Cases with abdominal infection, cases with infection of incision, cases with bacteremia and cases with pulmonary infection were 43, 7, 5, 8 in the 91 patients. One patient might have multiple infectious complications. Cases with bile leakage, cases with delayed gastric emptying, cases with chylous leakage, cases with liver failure, cases with pancreatic fistula, cases with intraperitoneal hemorrhage, cases with reoperation, cases dead during the postoperative 90 days were 30, 9, 9, 6, 5, 3, 6, 3 in the 91 patients. Cases with abdominal infection was 10 in the 31 patients who were admitted from April 2004 to March 2014, versus 33 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=4.24, P<0.05). Cases dead during the postoperative 90 days was 3 in the 31 patients who were admitted from April 2004 to March 2014, versus 0 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( P<0.05). (3) Post-operative pathological examinations. Of the 91 patients, cases with Bismuth type as type Ⅰ?Ⅱ, type Ⅲ, type Ⅳ, cases with T staging as Tis stage, T1 stage, T2a?2b stage, T3 stage, T4 stage, cases with N staging as N0 stage, N1 stage, N2 stage, cases with M staging as M0 stage, M1 stage, cases with TNM staging as 0 stage, Ⅰ stage, Ⅱ stage, Ⅲ stage, ⅣA stage, ⅣB stage, cases with R 0 radical resection, cases with R 1 or R 2 resection were 15, 46, 30, 1, 9, 25, 30, 26, 49, 36, 6, 85, 6, 1, 7, 13, 58, 6, 6, 63, 28. Cases with R 0 radical resection, cases with R 1 or R 2 resection were 15, 16 in the 31 patients who were admitted from April 2004 to March 2014, versus 48, 12 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=9.59, P<0.05). (4) Postoperative prognosis analysis. Of the 91 patients, 3 cases who died within 90 days after surgery were excluded, and the 5-year overall survival rate and median overall survival time of the rest of 88 cases were 44.7% and 55 months. The 5-year overall survival rate was 33.5% in the 28 patients who were admitted from April 2004 to March 2014, versus 50.4% in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=5.31, P<0.05). Results of further analysis showed that the corresponding 5-year overall survival rate of cases without lymph node metastasis was 43.8% in the 16 patients who were admitted from April 2004 to March 2014, versus 61.6% in the 31 patients who were admitted from April 2014 to April 2021. There was a significant difference in the 5-year overall survival rate between these patients without lymph node metastasis ( χ2=3.98, P<0.05). The corresponding 5-year overall survival rate of cases with lymph node metastasis was 18.5% in the 12 patients who were admitted from April 2004 to March 2014, versus 37.7% in the 29 patients who were admitted from April 2014 to April 2021. There was no significant difference in the 5-year overall survival rate between these patients with lymph node metastasis ( χ2=2.25, P>0.05). (5) Influencing factors of postoperative prognosis. Results of multivariate analysis showed that poorly differentiated tumor and R 1 or R 2 resection were inde-pendent risk factors influencing prognosis after surgical treatment of hilar cholangiocarcinoma ( hazard ratio=2.62, 2.71, 95% confidence interval as 1.30?5.29, 1.30?5.69, P<0.05). Conclusions:Compared with traditional surgical diagnosis and treatment, treatment of hilar cholangiocarcinoma based on multidisciplinary diagnosis and treatment can expand surgical indications, reduce proportion of dead patients within 90 days after surgery, improve proportation of radical resection and long-term survival rate. Poorly differentiated tumor and R 1 or R 2 resection are independent risk factors influencing prognosis after surgical treatment of hilar cholangiocarcinoma.
6.The first policy of serious illness benefits of voluntary blood donors in China: implementation and suggestions
Shangyun YING ; Qunhong LU ; Qiang FU ; Yudong DAI ; Qizhong LIU ; Wanli CHENG ; Yading TANG ; Yilun ZHAO
Chinese Journal of Blood Transfusion 2022;35(2):206-208
【Objective】 To analyze the implementation and problems in the process of the first policy of serious illness benefits for voluntary blood donors in China, therefore provide reference for other provinces and cities to formulate care policies for voluntary blood donors. 【Methods】 The number of blood donors who received serious illness benefits and the proportion to the total number of blood donors in that year were obtained by Excel, and their basic demographic information, illness and reasons for failing to receive benefits were analyzed. 【Results】 From 2015 to 2019, a total of 198 blood donors applied for serious illness benefits, and 159 received benefits (638 000 yuan), accounting for 0.017% of the total number of voluntary blood donors in Nanjing. The average age of the recipients was 52.66, with the proportion of males (63.5%) higher than that of females (36.5%). 52.8% (the highest proportion) got benefits of 5 000 yuan. 39 applicants failed to obtain serious illness benefits, among which 27 applicants failed during 2017 to 2018 due to unidentifiable funding source. But after Nanjing Blood Donation Regulations clarified the funding sources, the implementation of serious illness benefits policy was continued in 2018. 【Conclusion】 The implementation of serious illness benefits for voluntary blood donors presented the Nanjing municipal government's care for voluntary blood donors. The legalization of this policy is conducive to the continuity and stability of policy implementation. Relevant departments and blood centers should continue to strengthen the policy publicity and make sure the policy is implemented effectively.
7.Application value of pancreatoduodenectomy with preservation of the gastric tube
Xu FU ; Yifei YANG ; Min TANG ; Yudong QIU ; Liang MAO
Chinese Journal of Digestive Surgery 2021;20(12):1358-1363
Objective:To investigate the application value of pancreatoduodenectomy (PD) with preservation of the gastric tube.Methods:The retrospective and descriptive study was conducted. The clinicopathological date of 3 male patients who underwent PD with preservation of the gastric tube for the treatment of periampullary tumor in Nanjing Drum Tower Hospital affiliated to Nanjing University Medical School from May 2018 to November 2019 were collected. The 3 patients were aged from 66 to 77 years, with a median age of 76 years. All 3 patients with surgical history of radical resection of esophageal tumors and tubular gastric surgery underwent PD with preservation of the gastric tube. Observation indications: (1) preoperative three-dimensional (3D) reconstruction; (2) surgical and postoperative situations; (3) follow-up. Follow-up using outpatient exa-mination or telephone interview was conducted to detect survival of patients and tumor metastasis and recurrence up to April 2021. Measurement date with skewed distribution were expressed as M(range).Count date were expressed as absolute numbers. Results:(1) Preoperative 3D recons-truction: results of preoperative 3D reconstruction for the 3 patients showed none of patients with vascular variation. (2) Surgical and postoperative situations: 3 patients underwent PD with preserva-tion of the gastric tube successfully. The operation time and the volume of intraoperative blood loss were 402 minutes(range, 345?480 minutes) and 330 mL(range, 300?400 mL) for the 3 patients. Of 3 patients, 1 case had postoperative grade B pancreatic fistula and 1 case had chylous leakage, respectively, who were improved after conservative treatment. There was no perioperative death. The duration of postoperative hospital stay was 18 days(range, 15?20 days) for the 3 patients. Results of postoperative histopathological examination for the 3 patients showed that 1 case with pancreatic cancer as T2N0M0 stage, 1 case with ampulla carcinoma as T2N0M0 stage and 1 case with intraductal papillary mucinous neoplasms of the pancreas. (3) Follow-up: 3 patients were followed up for 12 to 18 months, with a median follow-up time of 16 months. Results of abdominal enhanced computed tomography examination at postoperative 14 month for the 3 patients showed that the right gastroepiploic artery and vein around the pancreas were unobstructed. Of 3 patients, 1 case with pancreatic cancer who did not receive chemotherapy died at postoperative 14 months due to tumor recurrence and metastasis. There was no recurrence and metastasis in the other two cases.Conclusion:PD with preservation of the gastric tube is safe and feasible, which can be used for patients with periampullary lesions who underwent radical resection of esophageal tumors and tubular gastric surgery in the past.
8.Comparative study of simultaneous three scopes surgery and staged two scopes surgery in the treatment of choledocholithiasis with cholecystolithiasis
Miao WU ; Tie ZHOU ; Yi WANG ; Liang MAO ; Xu FU ; Yudong QIU
International Journal of Surgery 2021;48(4):254-259
Objective:To compare the clinical efficacy of the Simultaneous three scopes combined surgery [laparoscopic cholecystectomy(LC)+ choledochoscopy exploration + choledochectomy and removal of the common bile duct + primary suture of the common bile duct + endoscopic guided nasobiliary duct placement] and staged two scopes surgery[endoscopic retrograde cholangiopancreatography (ERCP) combined with LC] in the treatment of choledocholithiasis and cholecystolithiasis.Methods:From January 2018 to June 2020, we retrospectively analyzed the clinical data of 83 patients with choledocholithiasis and choledocholithiasis, who underwent minimally invasive treatment in our center. According to the different surgical procedures, the patients were divided into three-mirror group ( n=42) and two-mirror group ( n=41). All patients in the three-mirror group underwent three-scopy combined surgery. The patients in two-mirror group received endoscopic retrograde cholangiopancreatography (ERCP) combined with laparoscopic cholecystectomy (LC). In this study we compared the relevant clinical indicators of the two groups, in terms of the operation time, intraoperative blood loss, one-time stone clearance rate, postoperative exhaust time, postoperative defecation time, total hospitalization cost, incidence of postoperative acute pancreatitis, postoperative stone recurrence rate, incidence of postoperative cholangitis, and incidence of postoperative biliary fistula, total hospitalization time, postoperative bile duct stricture rate. Use SPSS 26.0 software to statistically analyze various indexes such as intraoperative, postoperative, follow-up, etc. Normally distributed measurement data were described by the mean±standard deviation ( Mean± SD), the comparison between groups was by t test, and measurement data with skewed distribution were destribed as M( P25, P75), Pairwise comparisons were analyzed using nonparametric test. The comparison of count data between groups was by the chi-square test. Results:No death was observed in both two groups. The operation time, intraoperative blood loss, one-time stone clearance rate, postoperative exhaust time, and postoperative defecation time of the three-mirror groupwere (167.98±47.37) min, 50(50, 100) mL, 100%(42/42), (2.10±0.76) days, 3(3, 4) days, the two-mirror group were (143.80±34.47) min, 50(50, 50) mL, 85.4%(35/41), (1.53±0.99) days and 2(1, 3) days. Compared with the two groups, the three-mirror group was higher than the two-mirror group, and the difference was statistically significant ( P<0.05). The total hospitalization expenses, postoperative acute pancreatitis incidence, and postoperative calculus recurrence rate in the three-mirror group were (3.46±0.77) ten thousand yuan, 0(0/42), 2.38%(1/42), the two-mirror group were (4.22±1.50) ten thousand yuan, 9.8%(4/41), 19.5%(8/41). Compared with the two groups, the three-mirror group was lower than the two-mirror group, and the difference was statistically significant ( P<0.05). No postoperative cholangitis or biliary fistula occurred in the two groups. There was no statistically significant difference in the total hospital stay and incidence of postoperative bile duct stenosis between the two groups ( P>0.05). Conclusions:For choledocholithiasis combined with cholecystolithiasis patients, simultaneous three-scopes combined surgery and elective LC after ERCP are safe and effective, and each has its own advantages. It should be selected reasonably according to the patient′s condition and combined with the technical advantages of the treatment team.
9.Risk factor analysis for pancreatic fistula after pancreaticoduodenectomy for Vater′s ampullary carcinoma
Yifei YANG ; Liang MAO ; Xu FU ; Zhenghua CAI ; Yudong QIU
Chinese Journal of Pancreatology 2021;21(5):346-352
Objective:To identify the risk factors of clinically relevant pancreatic fistula (CR-POPF) after pancreaticoduodenectomy (PD) for Vater′s ampullary carcinoma.Methods:The clinical data of 93 Vater's ampullary carcinoma patients who had undergone PD in Nanjing Drum Tower Hospital from January 2018 to December 2020 was retrospectively analyzed. According to the occurrence of CR-POPF, all patients were divided into the CR-POPF group and no CR-POPF group. Univariate analysis and multivariate analysis by logistic regression model were performed for perioperative risk factors of CR-POPF to identify the independent risk factors for CR-POPF after PD for Vater's ampullary carcinoma.Results:44 patients developed CR-POPF and the rate of CR-POPF was 47.3%(44/93). The most frequently detected microorganisms from abdominal drain fluid after operation were Klebsiella pneumoniae (25.8%), Enterococcus faecalis (19.4%), Enterobacter cloacae (11.8%) and Enterococcus faecium (10.7%). The results of univariate analysis showed that operation time, C-reactive protein (CRP) on postoperative day (POD)1, Klebsiella pneumoniae, Enterococcus faecalis and Enterococcus faecium in the abdominal drainage were statistically different between the two groups (all P value <0.05). Multivariate analysis revealed that CRP on POD1 ( OR 1.029, 95% CI 1.003-1.055, P=0.026), Klebsiella pneumoniae( OR 8.671, 95% CI 2.366-31.772, P=0.001), Enterococcus faecalis( OR 10.497, 95% CI 2.306-41.776, P=0.002) and Enterococcus faecium ( OR 22.580, 95% CI 2.303-221.403, P=0.007) in the abdominal drainage were independent risk factors for the development of CR-POPF after PD for Vater′s ampullary carcinoma. Conclusions:CRP on POD1, Klebsiella pneumoniae, Enterococcus faecalis and Enterococcus faecium in the drain samples were independent risk factors for the development of CR-POPF after PD for Vater′s ampullary carcinoma.
10.Investigation on feelings of blood donors during blood donation in Nanjing
Li QIU ; Mingze WANG ; Xubing CAI ; Xiaoming TU ; Yilun ZHAO ; Qiang FU ; Yudong DAI ; Zhenping LIN
Chinese Journal of Blood Transfusion 2021;34(4):385-388
【Objective】 To investigate the feelings of blood donors during blood donation and its influencing factors, thus providing references for high quality blood donation service for blood banks. 【Methods】 A self-developed questionnaire concerning voluntary blood donation was randomly issued by the research group and recruited investigators among blood donors in 6 street blood donation sites of Nanjing Red Cross Blood Center at weekends during December 1~23, 2018. The basic information of blood donors, the difference of feelings during blood donation and the influencing factors were analyzed by descriptive analysis, chi-square test and binary Logistic regression analysis, respectively. 【Results】 A total of 405 questionnaires were issued, and all 405 copies were valid, with the response rate at 100% (405/405). Among the valid questionnaires, 46.67% (189/405) were first-time blood donors, 27.65% (112/405) had donated for 2~3 times, and 25.68% (104/405) donated more than 4 times. 53.59%(97/181), 23.7%(43/181) and 22.65%(41/181) of the above three groups of blood donors worried about the needles, and 55.48%(81/146), 22.60%(33/146) and 21.92%(32/146) worried about the blood outflow, 52.69% (88/167), 28.14% (47/167), and 19.16% (32/167 )worried about the pain during blood collection (P<0.05). The anxiety of unqualified blood test was similar to that of poor service (P>0.05). There were differences in blood donation experience among the three groups (P<0.05), and gender (P<0.05) was its influencing factor showed by binary Logistic regression analysis. 【Conclusion】 The majority of blood donors, who have donated at the street sites of Nanjing, are worried during blood donation collection. Therefore, the blood centers should provide high-quality services and humanized nursing interventions as well as strengthen the citizens′ awareness of blood donation.

Result Analysis
Print
Save
E-mail