1.Evaluation of ATP bioluminescence technology for cleaning and disinfection of flexible endoscopes: a meta-analysis
Can ZHAO ; Longsong LI ; Ke HAN ; Yawei BI ; Enqiang LINGHU ; Ningli CHAI
Chinese Journal of Digestive Endoscopy 2025;42(8):639-644
Objective:To systematically evaluate the efficacy of ATP bioluminescence technology versus traditional microbiology detection method in assessing flexible endoscope cleaning and disinfection.Methods:Eight Chinese and English databases, including PubMed, Embase, Web of Science, Cochrane Library, CNKI, Wanfang Database, VIP Chinese Medical Journal Database and China Biology Medicine disc, were searched from inception to October 1, 2023. Comparative studies on evaluating post-reprocessing endoscope quality using both methods were included. Positive sample numbers and positive rates were taken as the main effect indicators, and the fixed effect model was used to conduct a meta-analysis of the included literature.Results:A total of 14 Chinese and English articles were included, involving 4 569 samples (gastroscopes, colonoscopes, duodenoscopes and fiberbronchoscopes). The pooled analysis demonstrated low heterogeneity across studies ( I2=23%), with a combined odds ratio ( OR) of 1.57 (95% CI: 1.27-1.94). It indicated a statistically significant difference in positive detection rates between the two methods ( P<0.001). However, funnel plot analysis suggested potential publication bias. Conclusion:ATP bioluminescence correlates with microbiological methods for monitoring endoscope reprocessing. While ATP offers rapid assessment advantages, its consistently higher positive rates preclude replacement of conventional microbiological verification for terminal disinfection.
2.Evaluation of ATP bioluminescence technology for cleaning and disinfection of flexible endoscopes: a meta-analysis
Can ZHAO ; Longsong LI ; Ke HAN ; Yawei BI ; Enqiang LINGHU ; Ningli CHAI
Chinese Journal of Digestive Endoscopy 2025;42(8):639-644
Objective:To systematically evaluate the efficacy of ATP bioluminescence technology versus traditional microbiology detection method in assessing flexible endoscope cleaning and disinfection.Methods:Eight Chinese and English databases, including PubMed, Embase, Web of Science, Cochrane Library, CNKI, Wanfang Database, VIP Chinese Medical Journal Database and China Biology Medicine disc, were searched from inception to October 1, 2023. Comparative studies on evaluating post-reprocessing endoscope quality using both methods were included. Positive sample numbers and positive rates were taken as the main effect indicators, and the fixed effect model was used to conduct a meta-analysis of the included literature.Results:A total of 14 Chinese and English articles were included, involving 4 569 samples (gastroscopes, colonoscopes, duodenoscopes and fiberbronchoscopes). The pooled analysis demonstrated low heterogeneity across studies ( I2=23%), with a combined odds ratio ( OR) of 1.57 (95% CI: 1.27-1.94). It indicated a statistically significant difference in positive detection rates between the two methods ( P<0.001). However, funnel plot analysis suggested potential publication bias. Conclusion:ATP bioluminescence correlates with microbiological methods for monitoring endoscope reprocessing. While ATP offers rapid assessment advantages, its consistently higher positive rates preclude replacement of conventional microbiological verification for terminal disinfection.
3.Impact of pancreatic and biliary stent on post-endoscopic papillectomy complications: A single-center retrospective study
Nan RU ; Ningli CHAI ; Bo ZHANG ; Longsong LI ; Yawei BI ; Enqiang LINGHU
Chinese Medical Journal 2024;137(17):2111-2118
Background::Endoscopic papillectomy (EP) is recommended as the first-line therapy for ampullary tumors, despite a relatively high incidence of complications. Pancreatic and/or biliary stents are placed at the endoscopist’s discretion to prevent post-EP complications. The present study aimed to evaluate the efficacy of different stents.Methods::A total of 117 patients who underwent EP and met the criteria between June 2006 and October 2022 were enrolled in the study. These patients were divided into a pancreatic stent group (PS group, n = 47), a biliary stent group (BS group, n = 38), and a two-stent group (PBS [PS and BS] group, n = 32). Relevant clinical data were collected and compared among the three groups. Multivariate logistic analyses were performed to explore risk factors for post-EP complications. Results::The incidence of all complications was 37.6% (44/117). Pancreatitis and hemorrhage were the two most common complications with incidence rates of 14.5% (17/117) and 17.9% (21/117). The incidence rates of post-EP pancreatitis were 10.6% (5/47), 23.7% (9/38), and 9.4% (3/32) in the PS group, BS group, and PBS group, respectively, with no significant differences. There were also no significant differences in other complications among the three groups. Age (odds ratio [OR]: 0.95; 95% confidence interval [CI]: 0.91-0.99; P = 0.022) was independently associated with post-EP pancreatitis while tumor size (OR: 1.66; 95% CI: 1.06-2.60; P = 0.028) was independently associated with post-EP hemorrhage. Conclusions::While pancreatic stenting is the first choice to prevent post-EP pancreatitis, biliary stenting could also be considered as a substitute for patients with difficulties in pancreatic cannulation. Two-stent (biliary and pancreatic stent) placement is unnecessary unless it is required due to other concerns.
4.Interpretation of Local Standard Specification for Pharmacy Intravenous Centralized Admixture in Beijing
Yawei DU ; Ning PANG ; Yu BI ; Rongsheng ZHAO
China Pharmacy 2021;32(1):12-16
OBJECTIVE:To interpret the key points in local standard Specification for Pharmacy Intravenous Centralized Admixture(DB11/T 1701-2019)(Beijing Local Standard for short )in Beijing ,and to provide guidance and reference for managers of medical institutions and staff of PIVAS to deeply understand the standard and further improve the quality of PIVAS in medical institutions. METHODS :The background and main content of Beijing Local Standard were interpreted in detail ,and then compared with Quality Specification of Pharmacy Intravenous Admixture (National Specification for short )promulgated by Chinese National Ministry of Public Health and Quality Specification of Pharmacy Intravenous Admixture Services of Guangdong Provincial (Trial)(Specification of Guangdong Province for short )promulgated by Guangdong Pharmaceutical Association. RESULTS & CONCLUSIONS:Beijing Local Standard had been promulgated and implemented by Beijing Municipal Administration for Market Regulation on April 1st,2020. The text of Beijing Local Standard is divided into 7 parts,mainly including the scope of application,normative references ,terms and definitions ,basic requirement ,environmental requirements (design,location, layout),equipment and facilities (ventilation system and console ,operation and maintenance ),and admixture requirements. Beijing Local Standard further refines the relevant contents on the basis of following the requirements of National Specification . Like Specification of Guangdong Province ,the applicability and operability of the standard are enhanced by combining their local characteristics and practice status. As the first local standard in this domain ,the local standard is expected to promote the improvement of the working quality of PIVAS in Beijing ,enable the PIVAS of proposed construction ,under construction and operation maintenance to meet uniform standards and reduce the failure of acceptance or reconstruction after completion.
5.Analysis of medication safety self-assessment results of 67 hospitals in China
Xiaoling LI ; Simiao ZHAO ; Yawei WANG ; Qingxia ZHANG ; Suying YAN ; Yuzhen LI ; Dan MEI ; Xiao CHEN ; Lingli ZHANG ; Mingkang ZHONG ; Ling JIANG ; Xin HUANG ; Hui YANG ; Pinfang HUANG ; Rongsheng TONG ; Weihong SUN ; Shiting LIU ; Taotao LIU ; Weiyi FENG ; Jun ZHANG ; Bi ZE ; Xiujuan FU ; Yufeng DING ; Manling MA ; Yuqin WANG
Adverse Drug Reactions Journal 2019;21(1):20-29
Objective To preliminarily understand the current status of medication safety management of medical institutions in China. Methods Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs (INRUD) and Chinese Pharmacological Society Professional Committee of Drug-induced Diseases jointly established a research group. Basing on the voluntary principle,members (medical institutions)of the group did medication safety self-assessment using the questionnaires of "2011 ISMP Medication Safety Self Assessment? for Hospitals (Chinese version)", which included 10 key elements,20 core indicators,and 270 assessment projects. The questionnaires were handed out on August 17,2018 and needed to be completed and submitted within 2 months. Results As of October 19,2018,67 hospitals of 16 provincial administrative regions in total had submitted their questionnaires,including 61 (91. 0%)3A hospitals and 6 (9%)2A hospitals. The average value of total scores of medication safety self-assessment in the 67 hospitals was 58. 9% (7. 6% -90. 0%). None of the 67 hospitals evaluated the key element Ⅵ(medication device acquisition,use,and monitoring). The scores of the other 9 key elements from high to low were 67. 6%,66. 2%,65. 1%,64. 8%,64. 1%,58. 2%, 54. 5%,54. 4%,and 52. 5% respectively for element Ⅶ (environmental factors,workflow and staffing patterns),element Ⅳ(drug labeling,packaging and nomenclature),element Ⅸ (patient education), element Ⅲ(communication of drug orders and other drug information),element Ⅷ (staff competency and education),element Ⅴ(drug standardization,storage and distribution),element Ⅹ (quality processes and risk management),element Ⅰ (patient information),and element Ⅱ (drug information). Conclusion The data of medication safety from 67 hospitals of 16 provincial administrative regions were obtained through the first national self-assessment questionnaire survey in medical institutions,which initially reflected the current status of medication safety in medical institutions in China.
6.Analysis of medication safety self-assessment results of 67 hospitals in China
Xiaoling LI ; Simiao ZHAO ; Yawei WANG ; Qingxia ZHANG ; Suying YAN ; Yuzhen LI ; Dan MEI ; Xiao CHEN ; Lingli ZHANG ; Mingkang ZHONG ; Ling JIANG ; Xin HUANG ; Hui YANG ; Pinfang HUANG ; Rongsheng TONG ; Weihong SUN ; Shiting LIU ; Taotao LIU ; Weiyi FENG ; Jun ZHANG ; Bi ZE ; Xiujuan FU ; Yufeng DING ; Manling MA ; Yuqin WANG
Adverse Drug Reactions Journal 2019;21(1):20-29
Objective To preliminarily understand the current status of medication safety management of medical institutions in China. Methods Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs (INRUD) and Chinese Pharmacological Society Professional Committee of Drug-induced Diseases jointly established a research group. Basing on the voluntary principle,members (medical institutions)of the group did medication safety self-assessment using the questionnaires of "2011 ISMP Medication Safety Self Assessment? for Hospitals (Chinese version)", which included 10 key elements,20 core indicators,and 270 assessment projects. The questionnaires were handed out on August 17,2018 and needed to be completed and submitted within 2 months. Results As of October 19,2018,67 hospitals of 16 provincial administrative regions in total had submitted their questionnaires,including 61 (91. 0%)3A hospitals and 6 (9%)2A hospitals. The average value of total scores of medication safety self-assessment in the 67 hospitals was 58. 9% (7. 6% -90. 0%). None of the 67 hospitals evaluated the key element Ⅵ(medication device acquisition,use,and monitoring). The scores of the other 9 key elements from high to low were 67. 6%,66. 2%,65. 1%,64. 8%,64. 1%,58. 2%, 54. 5%,54. 4%,and 52. 5% respectively for element Ⅶ (environmental factors,workflow and staffing patterns),element Ⅳ(drug labeling,packaging and nomenclature),element Ⅸ (patient education), element Ⅲ(communication of drug orders and other drug information),element Ⅷ (staff competency and education),element Ⅴ(drug standardization,storage and distribution),element Ⅹ (quality processes and risk management),element Ⅰ (patient information),and element Ⅱ (drug information). Conclusion The data of medication safety from 67 hospitals of 16 provincial administrative regions were obtained through the first national self-assessment questionnaire survey in medical institutions,which initially reflected the current status of medication safety in medical institutions in China.
7. A phase Ⅲ multi-center clinical trial on safety and efficacy of a domestic plasma derived factor Ⅸ for the treatment of patients with hemophilia B
Wei LIU ; Rongfeng FU ; Yawei ZHOU ; Yun CHEN ; Jie YIN ; Ziqiang YU ; Linhua YANG ; Meifang WANG ; Hui BI ; Zeping ZHOU ; Xinsheng ZHANG ; Jielai XIA ; Renchi YANG
Chinese Journal of Hematology 2018;39(5):404-407
Objective:
To evaluate the efficacy and safety of a domestic human plasma derived coagulation Factor Ⅸ concentrate (pd-FⅨ) in patients with hemophilia B.
Methods:
The study was a multicenter, open-label and single-arm study. The efficacy of pd-F Ⅸ was evaluated by objective performance criteria. The doses of pd-FⅨ were calculated according to the bleeding symptom and disease severity. The infusion efficiency of pd-FⅨ and improvement of bleeding symptoms were measured at 30 minutes and (24±4) h after the first infusion, respectively. Adverse events were recorded. Viral infection and FⅨ inhibitor were detected 90 d after the first infusion.
Results:
All 36 subjects with hemophilia B were enrolled in the study. The median age of these patients was 31 years old and the median injection doses were 4 (1-17) times. The hemostatic effect of 27/36 (75.00%) and 9/36 (25.00%) acute bleeding events were rated as "excellent" and "better" , respectively. The recovery rate was 111.92% (65.55%-194.28%) at 30 minutes after infusion of FⅨ. There was no adverse event related to FⅨ. No reactivation of HBV, HCV or HIV and FⅨ inhibitor was detected at 90-104 d after the first FⅨ infusion.
Conclusion:
This domestically made human plasma derived FⅨ concentrate is safe and effective in the treatment of acute bleeding in patients with hemophilia B.
Clinical trial registration
China food and Durg Administration, 2016L08027.
8.Clinical survey of recurrent acute pancreatitis
Di ZHANG ; Yaping LIU ; Hao ZHANG ; Yawei BI ; Dan WANG ; Honglei GUO ; Xiangpeng ZENG ; Teng WANG ; Lei XIN ; Lianghao HU ; Maojin XU ; Zhaoshen LI
Chinese Journal of Pancreatology 2017;17(2):88-92
Objective To analyze the clinical features of recurrent acute pancreatitis (RAP).Methods The clinical data of patients diagnosed as RAP were collected in Changhai Hospital, the Second Military Medical University between January 2016 to July 2016, and chronic pancreatitis(CP) patients and RAP patients to matching, as control group.A prospective cohort study about the clinical features of RAP and CP was set.The survival analysis model was established by Kaplan-Meier′s method, to calculate the cumulative rate of RAP which progressed into CP.Results The morbidity of male patients was 69.0% in the RAP group(n=100) and 60% in the CP group(n=100).The average first onset age of RAP and CP was 38 and 21 years old, respectively;and the teenagers accounted for 12% and 38.6%.The incidence of diabetes was 49.5% and 9%;and the incidence of fatty diarrhea was 46.6% and 19% of the two groups.The cumulative incidence of CP was 2% within 1 year, 4.6% in 3 years, and 12.4% in 5 years.Conclusions Men has higher morbidity in both RAP group and CP group.RAP patients′ first onset age was older than that of CP.Teenagers had a low incidence in RAP group.The risk of diabetes and fatty diarrhea was lower in RAP group than CP group.A certain proportion of RAP patients can progress to CP.

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