1.A retrospective analysis of 1028 adverse events of medical device reports.
Chinese Journal of Medical Instrumentation 2013;37(6):447-450
OBJECTIVETo provide suggestion for MDAEs monitoring with analyzing the features of the 1028 reports of MDAEs.
METHODSWith retrospective case study, this paper analyzed 1 028 MDAE reports in Guiyang during 2012.
RESULTSThe intrauterine device (IUD) caused the higher proportion of adverse events with serious degree. Monitoring consciousness of grassroots users needs to be improved. The quality of the reports should be enhanced.
CONCLUSIONSMore attention should be paid to monitoring on IUD. The level of MDAEs monitoring should be improved through carrying out targeted training and publicity, establishing and improving MDAEs monitoring network.
Equipment Safety ; Intrauterine Devices ; adverse effects ; Product Surveillance, Postmarketing ; Retrospective Studies
2.The Effect of Lovastatin Combined with Calcitonin on Fracture Repair in Osteoporotic Rats
Guolong CAO ; Xiaopo LIU ; Yunbo FENG ; Faming TIAN
Tianjin Medical Journal 2014;(3):238-240
Objective To investigate the effects of lovastatin alone or combined with calcitonin on fracture repair in osteoporotic rats. Methods Forty 4-month-old female SD rats were randomized into 5 groups(8 rats in each group):normal fractured group (A), osteoporotic fractured group (B), lovastatin treatment group(C), calcitonin treatment group (D) and lovastatin combined with calcitonin treatment group. All rats except group A received bilateral ovariectomy. The midshaft femur fracture model was established in all rats 8 weeks after operation. The serum level of procollagen amino-terminal propeptide (PINP) was assessed by ELISA. X-ray and bone mineral density detection was used to observe the fracture healing process. The maximal loading of femoral fractures was analyzed by biomechanical method. Results (1) The serum level of PINP was significantly lower in group A than that of other groups. There was a significantly higher level of PINP in group C and group E than that of group B, and the level of PINP was significantly lower in group D than that of group C. (2) The X-ray showed more progressed fracture healing in group A and group E. The accordingly score indicated that there was a markedly higher score in groups A and group E compared to that of other three groups. (3) There was a highest bone mineral density in the full-length and in the middle of femur bone in group A, followed by group E, group D and group C. The lowest bone mineral density was found in group B. (4) The biomechanical test showed that the maximal loading in femur fracture side was significantly higher in group A than that of other four groups, in which it was higher in group E than that of group B. Conclusion The osteoporosis decreased bone mass and delayed fracture healing process in rat model. The treatment of lovastatin combined with calcitonin showed more positive effect on preventing bone loss and promoting fracture repair than lovastatin alone.
3.Effect of Strontium ranelate on stress-absence induced osteoporosis
Yunbo FENG ; Xiaopo LIU ; Guolong CAO ; Faming TIAN
Tianjin Medical Journal 2015;(10):1171-1174
Objective To investigate the preventive effect of Strontium ranelate on stress-absence induced osteoporo?sis in tail-suspended rat. Methods A total of 30 SD rats with average age of 6 month were randomly divided into 3 groups (n=10 in each group):Group A was normal control group while rats in group B and C were subjected to tail suspension test to establish stress absence models. Rats in group C were administered with Strontium ranelate [1 g/(kg·d)]. All rats were sacri?ficed 4 weeks later. Left femurs were harvested for bone mineral density (BMD) test and prepared for undecalcified tissue sec?tion and thereby bone histomorphometry assessment. Bone marrow from right femurs and tibias were cultured and induced to?wards osteogenic-differentiation. The expression levels of osteocalcin in the fourth-passage cultured bone marrow cells and in blood serum were detected separately. Results Rats in group B showed markedly decreased BMD comparing to those in group A and C(P<0.05). Trabecular volume (BV/TV), number (Tb.N) and thickness (Tb.Th) in group B were lower than those in group A and C;erosion percentage (Er.Pm) and osteoclast number (Oc.N) in group B and C were higher than those in group A;comparing to those in group B, bone formation rate (BFR/BV), labeled percentage (L.Pm), were higher in group C, coupled with decreased Er.Pm and Oc.N(P<0.05). mRNA expression levels of OCN in group B and C were higher than those of group A. But its level in plasma were lower in group B than those in group A and C(P<0.05). Conclusion Tail suspension could induce osteosporosis. Strontium ranelate prevent bone loss in stress-absence osteoporosis in rat induced by tail-suspension for 4 weeks, which might be partially through upregulating the expression of OCN, thereby promoting bone formation.
4.Comparison of knee joint function following total knee arthroplasty with fixed platform versus rotating platform high-flexion prostheses
Jun LIU ; Jiangang CAO ; Mengqiang TIAN ; Lei WANG ; Yunbo SUN
Chinese Journal of Tissue Engineering Research 2008;12(39):7781-7784
BACKGROUND:Early knee ioint prosthesis is used to relieve severe pain of patients.With continuous modification,the knee joint prosthesis with high flexion has developed.OBJECTIVE:To compare the clinical outcome between fixed platform high—flexion prosthesis and rotating platform high-flexion prosthesis following total knee arthroplasty.DESIGN:Non-randomized concurrent control trial of patients.PARTICIPANTS:Thirty-four patients(50 knees)with severe osteoarthritis underwent total knee replacement in Department of Bone and Joint,Tianjin Union Medicine Center from January to December 2006.METHODS:Of 34 patients,16(25 knees)underwent fixed platform high-flexion prosthesis replacement(LPS flexion,Zimmer,USA),and 18(25 knees)underwent rotating platform high-flexion prosthesis replacement(PFC sigma RPF prosthesis.Johnson & Johnson,USA).MAIN OUTCOME MEASURES:Knee joint function was evaluated using Hospital for Special Surgery Knee Score (HSS)before and 2 weeks,1,3 and 6 months after surgery.In addition,range of flexion of the knee was observed at 6 months postoperatively.RESULTS:Thirty-four cases completed the treatment and were followed up for 6 months.HSS scores of patients undergoing rotating platform high-flexion prosthesis replacement were higher than fixed platform high·flexion prosthesis replacement group at 2 weeks postoperatively(P<0.05),while no differences were found in HSS scores at 1,3 and 6 months after surgery(P>0.05).In addition,there were no significant differences in the range of flexion of the knee at 6 months postoperatively[(130.4±15.2)°,(129.9±13.8)°,P>0.05].CONCLUSION:Fixed platform and rotating platform high-flexion prosthesis replacement exhibit similar early effects on severe osteoarthritis.
5.Comparison of the Effects of Strontium Ranelate and PTH (1-34)on Bone Quality of Ovariectomized Rats
Yunbo FENG ; Xiaopo LIU ; Guolong CAO ; Pei ZHANG ; Faming TIAN
China Pharmacy 2016;27(19):2638-2640
OBJECTIVE:To compare the effects of strontium ranelate and PTH(1-34)on bone quality of ovariectomized rats. METHODS:80 SD rats were randomly divided into sham operation group(group A,n=10)and dual ovariectomy(group B,n=70). 3 months after operation,group B were randomly divided into 7 groups,with 10 rats in each group. B0 group were given nor-mal saline [0.9 g/(kg·d)] subcutaneously;B1-B3 groups were given low-dose,medium-dose and high-dose of strontium ranelate [0.45,0.9,1.35 g/(kg·d)] intragastrically;B4-B6 groups were given low-dose,medium-dose and high-dose of PTH(1-34)[30, 60,90 μg/(kg·d),treated for 5 days,rested for 2 days] subcutaneously. Group A was same to group B0 in therapy regimen. All rats were sacrificed 8 weeks later. The contents of P1NP and CTX-1 in serum of rats were determined by ELISA assay;bone densi-ty of 4th lumbar vertebrae was detected by bone densitometer;BV/TV,Tb.Th,Tb.N and Tb.Sp were detected by CT;maximal load and elastic modulus of 5th lumbar vertebrae were measured by compression test. RESULTS:Compared with group A,the se-rum levels of P1NP and CTX-1 in B0-B6 groups increased significantly,while bone density of 4th lumbar vertebrae,maximal load and elastic modulus of 5th lumbar vertebrae decreased significantly in B0-B3 groups(P<0.05);BV/TV level of 4th lumbar verte-brae decreased significantly,while Tb.Sp level increased significantly in B0 group(P<0.05). Compared with B0 group,bone den-sity of 4th lumbar vertebrae,maximal load and elastic modulus of 5th lumbar vertebrae increased significantly in B1-B3 groups (P<0.05);P1NP content,BV/TV,Tb.N level,bone density of 4th lumbar vertebrae,maximal load and elastic modulus of 5th lumbar vertebrae increased significantly in B4-B6 groups,and were higher than in B1-B3 groups(P<0.05). Tb.Sp level of B1-B6 groups decreased significantly and were lower than those of B1-B3 groups(P<0.05). There was no statistical significance in Tb.Th level among 8 groups and CTX-1 content among B0-B6 groups (P>0.05). CONCLUSIONS:PTH(1-34) is better than strontium ranelate in inhibiting bone loss,improving vertebral bone micro-structure and biomechanical properties of ovariectomized rats.
6.Medial patellofemoral ligament reconstruction with semitendinosus tendon autograft for the treatment of patellar dislocation with arthroscopic-assisted
Jiangang CAO ; Jun LIU ; Zhenhui SUN ; Lei WANG ; Mengqiang TIAN ; Yu ZHANG ; Yunbo SUN ; Dongliang ZHANG
Chinese Journal of Postgraduates of Medicine 2011;34(5):9-11
Objective To evaluate the clinical effects of medial patellofemoral ligament reconstruction using the semitendinosus tendon autograft for the treatment of the patellar dislocation.Methods From January 2007 to January 2010,16 cases of patellar dislocation were included in this group.Lysholm score was averaged preoperatively.Arthroscopic-assisted in the semitendinosus tendon autograft reconstruction of the medial patellofemoral ligament,the central graft were fixed on the inner edge of the patellar in the upper 1/3 and the mid-point location,the end were fixed on the channel of femoral epicondyle and adductor tubercle.Results All the patients that lined progressive knee rehabilitation after operation,returned to normal walking for 3 months,6 months could be sports.Followed up for 7-54( 26.36 ± 20.48 ) months,all of patients incision were healed as grade Ⅰ,knee function were normal.Postoperative Lysholm score (93.21 ± 4.68) scores compared with preoperative ( 76.53 ± 8.35 ) scores was significant difference (P < 0.05 ).Conclusions Using the semitendinosus tendon autograft for the treatment of the patellar dislocation method is simple and can effectively restore normal patellar trajectory.At the same time,which is an effective surgical method to treat recurrentdislocation of the patellar.
8.BRICS report of 2016-2017: the distribution and antimicrobial resistance profile of clinical isolates from blood culture in China
Yunbo CHEN ; Jinru JI ; Chaoqun YING ; Peipei WANG ; Qing YANG ; Haishen KONG ; Yongyun LIU ; Ying HUANG ; Yuanyuan DAI ; Liping ZHANG ; Hui DING ; Liang GUO ; Baohua ZHANG ; Lisha ZHU ; Haifeng MAO ; Zhixiang LIAO ; Yanhong LI ; Lu WANG ; Shuyan HU ; Zhenghai YANG ; Beiqing GU ; Haixin DONG ; Fei DU ; Lin ZHENG ; Bo QUAN ; Wencheng ZHU ; Jianzhong WANG ; Lan MA ; Rong XU ; Li SUN ; Aiyun LI ; Junmin CAO ; Jinhua LIANG ; Hongyun XU ; Kunpeng LIANG ; Dengyan QIAO ; Xiaoyan QI ; Xiusan XIA ; Lanjuan LI ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2020;13(1):42-54
Objective:To investigate the distribution and antimicrobial resistance profile of clinical bacteria isolated from blood culture in China.Methods:The clinical bacterial strains isolated from blood culture from member hospitals of Blood Bacterial Resistant Investigation Collaborative System (BRICS) were collected during January 2016 to December 2017. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by US Clinical and Laboratory Standards Institute (CLSI) 2019. WHONET 5.6 was used to analyze data.Results:During the study period, 8 154 bacterial strains were collected from 33 hospitals, of which 2 325 (28.5%) were Gram-positive bacteria and 5 829 (71.5%) were Gram-negative bacteria. The top 10 bacterial species were Escherichia coli (34.7%), Klebsiella pneumoniae (15.8%), Staphylococcus aureus (11.3%), coagulase-negative Staphylococci (7.4%), Acinetobacter baumannii (4.6%), Pseudomonas aeruginosa (3.9%), Enterococcus faecium (3.8%), Streptococci (2.9%), Enterobacter cloacae (2.7%) and Enterococcus faecalis (2.5%). Methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococcus (MRCNS) accounted for 34.2%(315/922) and 77.7%(470/605), respectively. No vancomycin-resistant Staphylococcus was detected. The resistance rate of Enterococcus faecium to vancomycin was 0.6%(2/312), and no vancomycin-resistant Enterococcus faecium was detected. The ESBLs-producing rates in Escherichia coli, Klebsiella pneumoniae and Proteus were 55.7%(1 576/2 831), 29.9%(386/1 289) and 38.5%(15/39), respectively. The incidences of carbapenem-resistance in Escherichia coli, Klebsiella pneumoniae were 1.2%(33/2 831), 17.5%(226/1 289), respectively. The resistance rates of Acinetobacter baumannii to polymyxin and tigecycline were 14.8%(55/372) and 5.9%(22/372) respectively, and those of Pseudomonas aeruginosa to polymyxin and carbapenem were 1.3%(4/315) and 18.7%(59/315), respectively. Conclusion:The surveillance results from 2016 to 2017 showed that the main pathogens of blood stream infection in China were gram-negative bacteria, while Escherichia coli was the most common pathogen; the MRSA incidence was lower than other surveillance data in the same period in China; carbapenem-resistant Escherichia coli was at a low level during this surveillance, while carbapenem-resistant Klebsiella pneumoniae is on the rise.
9.BRICS report of 2018-2019: the distribution and antimicrobial resistance profile of clinical isolates from blood culture in China
Yunbo CHEN ; Jinru JI ; Chaoqun YING ; Peipei WANG ; Zhiying LIU ; Qing YANG ; Haishen KONG ; Hui DING ; Yongyun LIU ; Haifeng MAO ; Ying HUANG ; Zhenghai YANG ; Yuanyuan DAI ; Guolin LIAO ; Lisha ZHU ; Liping ZHANG ; Yanhong LI ; Hongyun XU ; Junmin CAO ; Baohua ZHANG ; Liang GUO ; Haixin DONG ; Shuyan HU ; Sijin MAN ; Lu WANG ; Zhixiang LIAO ; Rong XU ; Dan LIU ; Yan JIN ; Yizheng ZHOU ; Yiqun LIAO ; Fenghong CHEN ; Beiqing GU ; Jiliang WANG ; Jinhua LIANG ; Lin ZHENG ; Aiyun LI ; Jilu SHEN ; Yinqiao DONG ; Lixia ZHANG ; Hongxia HU ; Bo QUAN ; Wencheng ZHU ; Kunpeng LIANG ; Qiang LIU ; Shifu WANG ; Xiaoping YAN ; Jiangbang KANG ; Xiusan XIA ; Lan MA ; Li SUN ; Liang LUAN ; Jianzhong WANG ; Zhuo LI ; Dengyan QIAO ; Lin ZHANG ; Lanjuan LI ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2021;14(1):32-45
Objective:To investigate the distribution and antimicrobial resistance profile of clinical bacteria isolated from blood culture in China.Methods:The clinical bacterial strains isolated from blood culture from member hospitals of Blood Bacterial Resistant Investigation Collaborative System (BRICS) were collected during January 2018 to December 2019. Antibiotic susceptibility tests were conducted with agar dilution or broth dilution methods recommended by US Clinical and Laboratory Standards Institute (CLSI). WHONET 5.6 was used to analyze data.Results:During the study period, 14 778 bacterial strains were collected from 50 hospitals, of which 4 117 (27.9%) were Gram-positive bacteria and 10 661(72.1%) were Gram-negative bacteria. The top 10 bacterial species were Escherichia coli (37.2%), Klebsiella pneumoniae (17.0%), Staphylococcus aureus (9.7%), coagulase-negative Staphylococci (8.7%), Pseudomonas aeruginosa (3.7%), Enterococcus faecium (3.4%), Acinetobacter baumannii(3.4%), Enterobacter cloacae (2.9%), Streptococci(2.8%) and Enterococcus faecalis (2.3%). The the prevalence of methicillin-resistant S. aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococcus were 27.4% (394/1 438) and 70.4% (905/1 285), respectively. No glycopeptide-resistant Staphylococcus was detected. More than 95% of S. aureus were sensitive to amikacin, rifampicin and SMZco. The resistance rate of E. faecium to vancomycin was 0.4% (2/504), and no vancomycin-resistant E. faecalis was detected. The ESBLs-producing rates in no carbapenem-resistance E. coli, carbapenem sensitive K. pneumoniae and Proteus were 50.4% (2 731/5 415), 24.6% (493/2001) and 35.2% (31/88), respectively. The prevalence of carbapenem-resistance in E. coli and K. pneumoniae were 1.5% (85/5 500), 20.6% (518/2 519), respectively. 8.3% (27/325) of carbapenem-resistance K. pneumoniae was resistant to ceftazidime/avibactam combination. The resistance rates of A. baumannii to polymyxin and tigecycline were 2.8% (14/501) and 3.4% (17/501) respectively, and that of P. aeruginosa to carbapenem were 18.9% (103/546). Conclusions:The surveillance results from 2018 to 2019 showed that the main pathogens of bloodstream infection in China were gram-negative bacteria, while E. coli was the most common pathogen, and ESBLs-producing strains were in majority; the MRSA incidence is getting lower in China; carbapenem-resistant E. coli keeps at a low level, while carbapenem-resistant K. pneumoniae is on the rise obviously.
10.BRICS report of 2021: The distribution and antimicrobial resistance profile of clinical bacterial isolates from blood stream infections in China
Yunbo CHEN ; Jinru JI ; Zhiying LIU ; Chaoqun YING ; Qing YANG ; Haishen KONG ; Jiliang WANG ; Hui DING ; Haifeng MAO ; Yizheng ZHOU ; Yan JIN ; Yongyun LIU ; Yan GENG ; Yuanyuan DAI ; Hong LU ; Peng ZHANG ; Ying HUANG ; Donghong HUANG ; Xinhua QIANG ; Jilu SHEN ; Hongyun XU ; Fenghong CHEN ; Guolin LIAO ; Dan LIU ; Haixin DONG ; Jiangqin SONG ; Lu WANG ; Junmin CAO ; Lixia ZHANG ; Yanhong LI ; Dijing SONG ; Zhuo LI ; Youdong YIN ; Donghua LIU ; Liang GUO ; Qiang LIU ; Baohua ZHANG ; Rong XU ; Yinqiao DONG ; Shuyan HU ; Kunpeng LIANG ; Bo QUAN ; Lin ZHENG ; Ling MENG ; Liang LUAN ; Jinhua LIANG ; Weiping LIU ; Xuefei HU ; Pengpeng TIAN ; Xiaoping YAN ; Aiyun LI ; Jian LI ; Xiusan XIA ; Xiaoyan QI ; Dengyan QIAO ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2023;16(1):33-47
Objective:To report the results of national surveillance on the distribution and antimicrobial resistance profile of clinical bacterial isolates from bloodstream infections in China in 2021.Methods:The clinical bacterial strains isolated from blood culture from member hospitals of Blood Bacterial Resistant Investigation Collaborative System (BRICS) were collected during January 2021 to December 2021. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical Laboratory Standards Institute (CLSI). WHONET 5.6 was used to analyze data.Results:During the study period, 11 013 bacterial strains were collected from 51 hospitals, of which 2 782 (25.3%) were Gram-positive bacteria and 8 231 (74.7%) were Gram-negative bacteria. The top 10 bacterial species were Escherichia coli (37.6%), Klebsiella pneumoniae (18.9%), Staphylococcus aureus (9.8%), coagulase-negative Staphylococci (6.3%), Pseudomonas aeruginosa (3.6%), Enterococcus faecium (3.6%), Acinetobacter baumannii (2.8%), Enterococcus faecalis (2.7%), Enterobacter cloacae (2.5%) and Klebsiella spp (2.1%). The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococcus aureus were 25.3% and 76.8%, respectively. No glycopeptide- and daptomycin-resistant Staphylococci was detected; more than 95.0% of Staphylococcus aureus were sensitive to ceftobiprole. No vancomycin-resistant Enterococci strains were detected. The rates of extended spectrum B-lactamase (ESBL)-producing isolated in Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis were 49.6%, 25.5% and 39.0%, respectively. The prevalence rates of carbapenem-resistance in Escherichia coli and Klebsiella pneumoniae were 2.2% and 15.8%, respectively; 7.9% of carbapenem-resistant Klebsiella pneumoniae was resistant to ceftazidime/avibactam combination. Ceftobiprole demonstrated excellent activity against non-ESBL-producing Escherichia coli and Klebsiella pneumoniae. Aztreonam/avibactam was highly active against carbapenem-resistant Escherichia coli and Klebsiella pneumoniae. The prevalence rate of carbapenem-resistance in Acinetobacter baumannii was 60.0%, while polymyxin and tigecycline showed good activity against Acinetobacter baumannii (5.5% and 4.5%). The prevalence of carbapenem-resistance in Pseudomonas aeruginosa was 18.9%. Conclusions:The BRICS surveillance results in 2021 shows that the main pathogens of blood stream infection in China are gram-negative bacteria, in which Escherichia coli is the most common. The MRSA incidence shows a further decreasing trend in China and the overall prevalence of vancomycin-resistant Enterococci is low. The prevalence of Carbapenem-resistant Klebsiella pneumoniae is still on a high level, but the trend is downwards.