1. Application and Control of FMEA in the Risk Management of Instruments and Equipments of Drug Inspection Organizations
Chinese Pharmaceutical Journal 2018;53(1):72-75
OBJECTIVE: To investigate the application and control of failure mode and effect analysis (FMEA) in the risk management of food and drug inspection institutions. METHODS: A 25-people team was set up and the factors related to equipments in the management review report and external review were analyzed through brainstorming and expert consultation. Thirty-four large risk factors were idendified. RESULTS: The top five risk factors in respect to risk priority number(RPN) value were as follows equipment not undergoing period verification, lack of experience, communication risk between inspection department and equipment management department, daily use and maintenance not meeting the requirements, inadequate consciousness of equipment management. CONCLUSION: The application of FMEA can identify and deal with the failure mode in the process of equipment management and timely detect high risk projects in the equipment management to achieve better control of quality of laboratories.
2.Effect of different pacing sites on ventricular synchrony evaluated by gated blood pool SPECT
Xue, GONG ; Yan-gang, SU ; Wen-zhi, PAN ; Shu-guang, CHEN ; Hong-cheng, SHI ; Xian-hong, SHU ; Jun-bo, GE
Chinese Journal of Nuclear Medicine 2010;30(5):307-311
Objective To compare the effect of right ventricular outflow tract (RVOT) and right ventricular apex (RVA) pacing on ventricular systolic synchrony using gated blood pool SPECT (GBPS).Methods A total of 50 patients implanted with pacemaker due to high degree or complete atria-ventricular block were enrolled in the study. Twenty-three patients were RVOT paced ( Group A, n = 23) and 27 were RVA paced (Group B, n=27). Twenty-four patients with malignancy, normal echocardiographic findings and no history of cardiac diseases were scheduled for pre-chemotherapy evaluation of cardiac structure and function and were enrolled as control group ( Group C, n = 24). All patients underwent GBPS imaging and the values of phase angle (PS), mean phase of each wall, standard deviation (SD) of mean phase of each wall, lateral-septal motion delay of left ventricle ( LV Sep-Lat Delay), septal-right ventricular (RV) delay of LV ( LV Sep-RV Delay) and LV-RV Delay were acquired. The parameters of ventricular systolic synchrony among the three groups were compared using one-way ANOVA. Results The mean phase of LV lateral wall in Groups A and B were significantly higher than that in Group C: Group A (120.50 ±40.58) ms; Group B (103.23±28.34) ms; Group C (84.63 ±22.38) ms (F=7.72, P <0.05). There was no significant difference between Groups A and B ( t = 1.30, P > 0.05 ). The mean phase of RV in Group A was significantly larger than those in Groups B and C: Group A ( 137.05 ± 39.27) ms, Group B ( 100.85 ± 23.79) ms,Group C (59. 13 ±30.52) ms (F=35.55, P<0.05). PS, SD and LV Sep-Lat Delay in Groups A and B were significantly higher than those in Group C: (85.73 ± 12.00)°vs (89.85 ± 15.61 )°vs (58.95 ±9.87)°, (27.68±10.66) ms vs (26.15 ±13.02) ms vs (15.63 ±8.35) ms, (25.06±34.23) ms vs (2. 62 ± 60. 31 ) ms vs ( - 23.66 ± 31.39) ms, F = 41.54,8.55,6.81, all P < 0.01 ), however, there was no significant difference between Groups A and B ( t = 0. 68, 0.68, 1.30, all P > 0.05 ). LV Sep-RV Delay and LV-RV Delay were significantly different among the three groups ( LV Sep-RV Delay: Group A (57.60 ±56.77) ms, Group B (6.36 ±61.88) ms, Group C ( -41.89 ±35.78) ms; LV-RV Delay:Group A (47.36 ±42.59) ms, Group B ( 3.08 ± 38.81 ) ms Group C ( - 26.50 ± 20.99 ) ms, F = 20. 32,25.38, both P < 0.01 ). Conclusion Both RVA and RVOT pacing increase the segmental phases detected by GBPS, causing inter- and intra- ventricular asynchrony compared with patients without pacemakers.
3.Hypoglycemic and hypolipidemic effects of quercetin and its glycosides.
Shu-xia YAN ; Xian LI ; Chong-de SUN ; Kun-song CHEN
China Journal of Chinese Materia Medica 2015;40(23):4560-4567
Quercetin and its glycosides are important flavonols in traditional herbal drugs and plant-derived food, and they have diverse hiological activities such as antioxidant, anticarcinogenic, anti-inflammatory, hypoglycemic and hypolipidemic activities. Numerous studies have demonstrated that quercetin and its glycosides were effective in the prevention and treatment of non-infectious chronic disease such as diabetes, obesity, and hyperlipidemia. They can regulate glucose and lipid metaholism through different mechanisms. They can decrease blood glucose via protecting pancreatic/p cells or/and improving insulin sensitivity. Also, they have lipid-lowering effects, which may be the result of regulation of lipid catabolism or/and anabolism. Their distributions, as well as the hypoglycemic and hypolipidemic effects are reviewed in this paper. In addition, further bioactivities as well as their dose-activity relationship, structure-activity relationship, bioavailability, and future clinical application of quercetin and its glycosides are discussed and proposed.
Animals
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Drugs, Chinese Herbal
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chemistry
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pharmacology
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Glycosides
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chemistry
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pharmacology
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Humans
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Hyperlipidemias
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drug therapy
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metabolism
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Hypoglycemia
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drug therapy
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metabolism
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Hypoglycemic Agents
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chemistry
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pharmacology
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Hypolipidemic Agents
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chemistry
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pharmacology
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Quercetin
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chemistry
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pharmacology
4.Progress in studies on Mycoplasma pneumoniae-produced community-acquired respiratory distress syndrome toxin.
Xue-jing LI ; Shu-xian LI ; Zhi-min CHEN
Chinese Journal of Pediatrics 2013;51(7):555-557
Amino Acid Sequence
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Animals
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Bacterial Proteins
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genetics
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metabolism
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Bacterial Toxins
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genetics
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metabolism
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Base Sequence
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Community-Acquired Infections
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microbiology
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Gene Expression Regulation, Bacterial
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Humans
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Lung
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microbiology
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pathology
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Mycoplasma pneumoniae
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Pneumonia, Mycoplasma
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microbiology
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Respiratory Distress Syndrome, Adult
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microbiology
6.Pterygium conjunctive reverse transplantation combined with amniotic membrane transplantation on recurrent pterygium
Ting, LI ; Shu-Xian, CHEN ; Xu-Guang, XIA ; Zheng, YIN ; Mu-Zhen, HUANG ; Ping-Ying, GUO
International Eye Science 2014;(9):1715-1716
To discuss the effective method of decreasing the postoperative recurrence rate of recurrent pterygium.
●METHODS:Totally 126 cases (126 eyes) with recurrent pterygium were randomly divided into A group (56 cases) and B group ( 70 cases ). Group A was treated by pterygium conjunctive reverse transplantation combined with amniotic membrane transplantation, group B was treated by amniotic membrane transplantation. The followed-up time after surgery was 6-24mo.
●RESULTS:ln group A, postoperative 5-7d (average 5. 62± 1. 38d), cornea epithelium was repaired. ln group B, postoperative 7- 10d ( average 7. 38 ± 1. 12d), the corneal wound was healed. There was statistical significant difference between two groups (t = 4. 307,P<0. 05). Three cases recurrence were noted in A therapeutic group (56 cases), the recurrent rate was 5. 4%; Twelve cases recurrence were noted in B compared group (70 cases), the recurrent rate was 17. 1%. There was statistical significant difference between two groups(P<0. 05).
●CONCLUSlON: lt is suggested that pterygium conjunctive reverse transplantation combined with amniotic membrane transplantation is effective in the treatment of recurrent pterygium.
7.Anti-platelet aggregation bioassay based quality control for XST capsules.
Bing HAN ; Xin MAO ; Shu-xian HAN ; Ying CHEN ; Yan-hua XIANG ; Yi-meng GE ; Fu-long LIAO ; Yun YOU
China Journal of Chinese Materia Medica 2015;40(23):4597-4602
A in vitro platelet aggregation bioassay was developed for the quality control of XST capsules. The in vitro anti-platelet aggregation effect in rats was observed to detect the bioactivity of XST capsules. Panax notoginseng saponins and Xuesaitong lyophilizedpowder for injection were taken as standard control substances to determine the potency. According to the results, XST capsules showeda significant inhibitory effect on thrombin-induced platelet aggregation in a dose-dependent manner. The in vitro anti-platelet activity oflyophilized powder for injection was stabler than that of Panax notoginseng saponins, and so suitable to serve as a standard control substance. The biological potency of XST capsules compared with standard control substance was detected by using parallel line assay. According to the results, the established bioassay method had a good repeatability (RSD 2.92%). The sample test results could pass thereliability test(linear deviation P > 0.05, parallel deviation P > 0.05). This bioassay method could be used as one of the complementary quality control methods for XST capsules.
Animals
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Capsules
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pharmacology
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Drugs, Chinese Herbal
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pharmacology
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Male
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Panax notoginseng
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chemistry
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Platelet Aggregation
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drug effects
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Platelet Aggregation Inhibitors
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pharmacology
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Rats
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Rats, Sprague-Dawley
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Saponins
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pharmacology
8.Effects of Se-riched soybean peptide on antioxidant function in rats of fatty liver caused by high-fat diet.
Feng-Jie WANG ; Xian-Bing CHEN ; Shu-Yu ZHANG ; Zhi-Xin TAN ; Guo-Min XIANG ; Jin-Hong LIU
Chinese Journal of Applied Physiology 2014;30(4):339-342
OBJECTIVETo explore the effect of Se-riched soybean peptide (SSP) on antioxidant function in rats of fatty liver caused by high-fat diet.
METHODSForty Wistar rats were divided into 4 groups randomly and fed with standard diet and water (NC), high-fat diet and water (HC), high-fat diet and SSP (0.1 g/d) (SeH), standard diet and SSP (0.1 g/d) (SeN) respectively. After 10 weeks, the rats were killed to investigate the pimelosis level in liver tissues by Sudan III staining and the expression of hepatic GRP78 by immunohistochemical analysis. We also analyzed the changes of liver function, blood lipid, the glutathione peroxidase (GSH-Px), superoxide dismutase (SOD) activity and malondialdehyde (MDA) content in livers and serum.
RESULTSThe pimelosis level, total cholesterol (TC), triglyceride (TG), MDA contents and the expression of GRP78 in HC group were significantly higher than those in NC, SeN, SeH groups. The activities of GSH-Px and SOD in liver and serum were markedly up-regulated in SeH (P < 0.01). There was no significant difference between NC and SeN groups.
CONCLUSIONSSP can improve liver cell injury and the antioxidant functions in rats with fatty liver effectively and decrease the expression of GRP78 in liver.
Animals ; Antioxidants ; metabolism ; Diet, High-Fat ; adverse effects ; Disease Models, Animal ; Fatty Liver ; chemically induced ; metabolism ; Heat-Shock Proteins ; metabolism ; Liver ; drug effects ; metabolism ; Male ; Rats ; Rats, Wistar ; Selenium ; pharmacology ; Soybean Proteins ; pharmacology ; Soybeans ; chemistry
9.Treatment of Steroid-induced Osteonecrosis of Femoral Head by Porous Tantalum Rod and Gugutou Huaisiyu Capsule.
Xu-yi TAN ; Fei-fei GAO ; Shu-tu GAO ; You-wen LIU ; Xian-tao CHEN ; Li-yun LIU
Chinese Journal of Integrated Traditional and Western Medicine 2016;36(1):40-43
OBJECTIVETo observe the curative effect of porous tantalum rod and Gugutou Huaisiyu Capsule (GHC) for steroid-induced osteonecrosis of femoral head (SONFH).
METHODSA total 60 hips of 50 SONFH patients were randomly assigned to the treatment group and the control group according to grouping time, 25 in each group (30 hips). Patients in the control group were implanted with porous tantalum rod, while those in the treatment group additionally took GHC (5 pills each time, three time per day for 2 successive months; and then twice per day for 4 successive months). Then all patients were followed-up to observe Harris hip score. The curative effect and the femoral head survival time were assessed.
RESULTSA total of 49 patients (59 hips) were followed-up. The Harris hip score of the two groups at the final follow-up was significantly improved after treatment, with statistical difference when compared with before treatment (P < 0.01). Besides, it was higher in the treatment group than in the control group. The curative effect and the survival time were superior in the treatment group, with statistical difference when compared with the control group (P < 0.05).
CONCLUSIONSPorous tantalum rod combined GHC got better effect in treating SONFH. It could significantly improve the function of affected hips and prolong the survival time of femoral head.
Capsules ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; therapeutic use ; Femur Head Necrosis ; drug therapy ; Humans ; Prostheses and Implants ; Steroids ; adverse effects ; Tantalum
10.Determination of optimal left ventricular pacing site for cardiac resynchronization therapy by tissue Doppler imaging
Hao-ying, SHI ; Fang, WANG ; Wei, JIN ; Jian, LIU ; Xian-hong, SHU ; Hao-zhu, CHEN ; Shao-wen, LIU
Journal of Shanghai Jiaotong University(Medical Science) 2009;29(6):641-645
Objective To investigate whether the left ventricular delayed contraction site determined by tissue Doppler imaging might be an optimal left ventricular lead position for improved outcomes of cardiac resynchronization therapy (CRT) in patients with non-ischemic cardiomyopathy. Methods Thirty-three patients subjected to CRT were selected, and all were performed conventional ultrasound cardiography and tissue Doppler examinations before operation. The left ventricular delayed contraction site was determined according to the interval between the onset of QRS and the peak systolic velocity. Retrograde coronary venography was performed during operation, and the left ventricular lead site was selected according to the left ventricular delayed contraction site determined by tissue Doppler examination before operation. The coronary sinus lead site was determined under the guidance of X ray of dorsaventral, lateral, right anterior oblique and left anterior oblique positions. Patients were divided into group A(n=20, the left ventricular lead site was in line with the delayed contraction site) and group B (n=13, the left ventricular lead site was not in line with the delayed contraction site). Results There was no significant difference in age, NYHA grading, left ventricular end-systolic volume(LVESV), left ventricular ejection fraction(LVEF), pulmonary arterial systolic pressure, QRS width and Ts-SD between the two groups before operation(P> 0.05). Six months after CRT, there was no significant difference in NYHA grading, LVESV and mitral regurgitation(MR) grading between the two groups(P>0.05), while the increase in LVEF and decrease in LVESV of group A were more significant than those of group B (P<0.01). Conclusion In patients with non-ischemic cardiomyopathy, CRT significantly improves left ventricular performance, and the more favourable outcomes are achieved in those pace at the delayed contraction site. Tissue Doppler imaging may help to guide the implant of left ventricular lead.