1.Implementation of performance metrics in clinical trial data management.
Ya-zhong DENG ; Hong-wei WANG ; Hai-jun FU
Acta Pharmaceutica Sinica 2015;50(11):1488-1492
There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China
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Clinical Trials as Topic
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standards
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Data Collection
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standards
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Information Storage and Retrieval
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standards
2.Internal fixation for unstable scapular fracture.
Wei-Zhong WANG ; Hai-Ming ZHANG ; Lei HAN
China Journal of Orthopaedics and Traumatology 2012;25(8):687-689
OBJECTIVETo investigate surgical methods and effects of unstable scapular fracture.
METHODSFrom October 2008 to August 2011, 14 patients with unstable scapular fracture were treated. There were 12 males and 2 females with an average age of 38.7 years (ranging, 21 to 55 years).The time from injury to hospitalization was 1 hour to 10 days (mean 3 days). Among patients,3 patients had scapular body fracture,4 patients had scapular neck and body fracture,4 patients had scapular neck and acromion fracture,2 patients had glenoid cavity and coracoid fracture, 1 patient with scapular spine and coracoid fracture. All patients were treated by operation, Hardegger classification system was applied to evaluate the function.
RESULTSAll patients were followed up for 2 to 36 months (mean 12.4 months). The healing time ranged from 6 to 8 weeks. No infection and internal fixation failure occurred. The effect result of Hardegger scoring system was excellent in 9 cases, good in 3 cases, fair in 2 cases.
CONCLUSIONSurgical treatment for unstable scapular fracture can reconstruct stability of shoulder joint, promote early rehabilitation of joint function, and maximally restore shoulder function.
Adult ; Female ; Fracture Fixation, Internal ; methods ; Fractures, Bone ; diagnostic imaging ; physiopathology ; surgery ; Humans ; Male ; Middle Aged ; Radiography ; Recovery of Function ; Scapula ; injuries ; physiopathology ; surgery ; Young Adult
3.Prophylaxis and therapy of early complications for relatives partial live small bowel transplantation
Hai SHI ; Wei-Zhong WANG ; Guang-Long DONG ;
Chinese Journal of Organ Transplantation 2005;0(11):-
Objective To investigate prophylaxis and therapy of early complications following relatives' partial live small bowel transplantation.Methods Four relatives' partial live small bowel transplantations were carried out.Among the 4 patients,there were 3 cases of short intestine syn- drome and one case of non-function of small bowel caused by the absence of nerve ganglion of small in- testine.More than 4 antigens of HLA were completely matched between donators and receptors.In- testines of donators were got from terminal ileum with the length of (150?10) cm.After operations, tacrolimus (FK506),mycophenolate mofetil (MMF),and methylprednisolone were used to prevent rejections.Measures such as use of anticoagulation,improving microcirculation and albumin infusion, aimed at regulating the function of blood coagulation and preventing bleeding and formation of thrombus at anastomotic stoma;famotidine and omeprazole were used to prevent irritable ulcer;use of the third generation of cephalosporins antibiotics,ganciclovir and fluconazol could prevent bacteria,vi- rus and eumycete infections;disinfection and care of easily-infected organs were emphasized;receptors were encouraged to get out of their beds to move frequently;glutamine and enteral nutrition were used early to promote recovery of intestinal function.Results Three days after operation,one patient's lung was infected with baumanii,and the infection had been under control after being treated with the third generation cephalosporins antibiotics;five days after operation,haematoma was detected on an- other patient and was cleared through the second operations growth of eumycete was found in 2 pa- tients' excretion and secretion from enteron,and their situations were improved with fluconazol;acute rejections of the 4 patients were detected 20 days after operation and reversed by the increased use of FK506 combined with methylprednisolone.Among the 4 patients,2 of them have survived for a long time,and the first patient has survived for 6 years and 8 months till now and the other one for 3 years and 2 months;furthermore,other 2 patients respectively died of infections 5 months and 35 days after the operations.Conclusion Because of special constitution of intestine,early complications of rela- tives' partial live small intestine transplantation are frequent and complicated.Therefore,prophylaxis and therapy of early complications are crucial to the success of the transplantation.
4.Experimental Study on Prevention of Post-surgical Abdominal Adhesions by Medical Chitin Degraded Membrane
Xin SHEN ; Meng-bin LI ; Wei-zhong WANG ; Hai SHI
Chinese Journal of Rehabilitation Theory and Practice 2006;12(7):581-582
ObjectiveTo investigate the effects of medical chitin degraded membrane on post-surgical abdominal adhesions.MethodsForty adult rabbits were made to form abdominal adhesions and divided randomly into four groups including group A1 and its control group A2, group B1 and its control groups B2 with 10 animals in each group. Medical chitin degraded membrane was applied in the group A and group B to the surfaces of the positions where would be adhered. All animals were cut the belly open again on the 7th, 14th postoperative day; the adhesions about incision and appendix were graded according to the severity, and took on bioscopy.ResultsThe abdominal adhesions model was successful. The severity of adhesions and inflammatory reaction of the group A1 and group B1 was significantly milder than that of the group A2 and group B2 in every different periods ( P<0.05).ConclusionThe medical chitin degraded membrane used intraoperatively might have some efficacy in preventing post-surgical abdominal adhesions.
5.Prophylaxis and Treatment of Early Complications after Live Small Bowel Transplantation: 4 Cases Report
Hai SHI ; Wei-zhong WANG ; Wen-xian GUAN
Chinese Journal of Rehabilitation Theory and Practice 2006;12(7):624-626
ObjectiveTo summarize the means of prevention and treatment for early complications (in the first month) of partial live small bowel transplantation.MethodsThrombus of anastomosis blood vessel, bleeding, infection, rejection, dysfunction of transplantated bowel were the main complications in the first month after operation, which should be paied more attention to. ResultsFour patients suffered acute rejection, respiratory tract infection, dysfunction of transplantated bowel in first month after operation. After accurately treating, all the complications were cured. The function of transplantated bowels were well. ConclusionPreventing and treating early complications accurately after partial live small bowel transplantation is important.
6.Molecular biological on rifampim-depending M.Tuberculosis straims isolated from patients
Min ZHONG ; Bo-Hai WEN ; Rong CHEN ; Wei CHEN ; Yiwei WANG ; An-Rong WANG ; Ming ZHONG ;
Chinese Journal of Laboratory Medicine 2001;0(01):-
Objective To study the molecular biology of rifampin-depending M. Tuberculosis. Methods The seguence (a 319-bp DNA fragment) of rpoB gene were analyzed by automated DNA sequencing machine. (2) The fingerprints of genomic DNA were obtained by random amplified polymorphic DNA (RAPD) fingerprinting. (3)The protein electrophoresis of bacterium by SDS-polyacrylamide gel (SDS-PAG).(4) The cases of pulmonary tuberculosis by rifampin-depending strains were retrospectively analyzed. Results (1) rpoB gene sequenced: The point mutationrate of rifampin-depending strainswas 96.7%(29/30) and that of rifampin-residtant strains 81.1%(30/37), P
7.A case of hemolytic anemia induced by dipterex.
Chong-hai LIU ; Xing-wei CHEN ; Gang LI ; Chun WU ; Bin ZHONG ; Yu-shu WEI
Chinese Journal of Pediatrics 2003;41(10):765-765
Anemia, Hemolytic
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etiology
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Child
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Female
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Humans
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Insecticides
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poisoning
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Trichlorfon
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poisoning
8.ISOLATION OF FOREIGN NEURONS IN CORNU ANTERIUS MEDULLAE SPINALIS AFTER ARTIFICAL SOMATIC-AUTONOMIC NERVE ANASTOMOSIS OF RATS AND STUDY OF EXPRESSION CHANGES OF AGRIN
Bo HAI ; Zhaohui CHEN ; Yu LIU ; Wei LI ; Wei ZHONG ; Chuanguo XIAO
Acta Anatomica Sinica 2002;0(05):-
Objective To study the changes of agrin expression in spinal cord motor neurons after somatic-autonomic ventral root(VR) anastomosis and somatic-somatic VR anastomosis,and the factors related to the synapse formation of foreign nerve regeneration. Methods Artifical somatic-automomic reflex pathway and somatic nerve self-anastomosis were established in rats.Retrograde tracing was carried out to label the motor neurons,and the neurons were isolated by flow cytometry.Real-time PCR was used to investigate the agrin mRNA expression of the neurons.Anterograde tracing and immunofluorescence technique were employed to label the new synapses of pelvic ganglia(PG). Results After 4 months of surgery,the somatic nerve can regenerate into PG successfully and form new synapses observed under laser scanning confocal microscope.The neurons involved in foreign nerve regeneration can be isolated successfully by retrograde tracing and flow cytometry.The expression of agrin in L_4-L_6 VRs anastomosis group was lower than that of the control group of L_4-L_4 VR self-anastomosis(P
9.Determination of 27 elements in Maca nationality's medicine by microwave digestion ICP-MS.
Gui-fang YU ; Hai-jie ZHONG ; Jun-hua HU ; Jing WANG ; Wen-zhe HUANG ; Zhen-zhong WANG ; Wei XIAO
China Journal of Chinese Materia Medica 2015;40(23):4545-4551
An analysis method has been established to test 27 elements (Li, Be, B, Mg, Al, Sc, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Ga, As, Sr, Mo, Cd, Sn, Sb, Ba, La, Hg, Pb, Bi) in Maca nationality's medicine with microwave digestion-ICP-MS. Sample solutions were analyzed by ICP-MS after microwave digestion, and the contents of elements were calculated according to their calibration curves, and internal standard method was adopted to reduce matrix effect and other interference effects. The experimental results showed that the linear relations of all the elements were very good; the correlation coefficient (r) was 0.9994-1.0000 (Hg was 0.9982) ; the limits of detection were 0.003-2.662 microg x L(-1); the relative standard deviations for all elements of reproducibility were lower than 5% (except the individual elements); the recovery rate were 78.5%-123.7% with RSD lower than 5% ( except the individual elements). The analytical results of standard material showed acceptable agreement with the certified values. This method was applicable to determinate the contents of multi-elements in Maca which had a high sensitivity, good specificity and good repeatability, and provide basis for the quality control of Maca.
Lepidium
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chemistry
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Mass Spectrometry
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methods
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Microwaves
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Reproducibility of Results
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Trace Elements
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chemistry
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isolation & purification
10.Clinical effect of circumcision stapler in the treatment of phimosis and redundant prepuce.
Zhong-chao HUO ; Gang LIU ; Wei WANG ; Da-guang HE ; Hai YU ; Wen-ju FAN ; Zheng ZHONG
National Journal of Andrology 2015;21(4):330-333
OBJECTIVETo observe the clinical effect and safety of circumcision stapler in the treatment of phimosis and redundant prepuce.
METHODSWe treated 120 patients with redundant prepuce or phimosis using circumcision stapler and another 60 by conventional dorsal-incision circumcision. We observed intraoperative blood loss, operation time, postoperative pain, wound healing time, cosmetic appearance of the penis, and postoperative complications and compared them between the two groups of patients.
RESULTSStapler circumcision showed obvious advantages over the conventional method in intraoperative blood loss ([2. 3 ± 1. 3] vs [15.6 ± 2.9] ml), operation time ([7.1 ± 1.4] vs [22.6 ± 4.6] min), wound healing time ([12.0 ± 2.9] as [16.3 ± 3. 1] d), postoperative pain score (1. 9 ± 1. 3 vs 5. 2 ± 1. 7), incision edema, and cosmetic appearance of the penis (all P <0. 05). Besides, stapler circumcision exempted the patients from stitch-removal pain. However, the incidence rate of postoperative local ecchymosis was significantly higher in the circumcision stapler group than in the conventional circumcision group (20. 8% vs 8. 3% , P <0. 05).
CONCLUSIONCircumcision stapler, with its advantages of easier manipulation, shorter operation time, better cosmetic penile appearance, less pain, and fewer complications, is superior to conventional circumcision in the treatment of phimosis and redundant prepuce.
Blood Loss, Surgical ; Circumcision, Male ; instrumentation ; methods ; Ecchymosis ; etiology ; Humans ; Male ; Pain, Postoperative ; Penis ; abnormalities ; Phimosis ; therapy ; Postoperative Complications ; Postoperative Period ; Surgical Staplers ; adverse effects ; Wound Healing