Adrenal Cortex Hormones ; therapeutic use ; Antitubercular Agents ; therapeutic use ; Diagnosis, Differential ; Humans ; Sarcoidosis ; drug therapy ; epidemiology ; microbiology ; pathology ; Tuberculosis ; drug therapy ; epidemiology ; microbiology ; pathology

Through the analysis of the present problems of the quality of medical device standards in China, combined with the development trend of the last ten years of medical devices, the paper made proposals on the medical device standards quality evaluation system, so as to improve the medical device standards management level and the quality of medical device standard in our country.
China ; Equipment and Supplies ; standards

Objective To explore the association between ankylosing spondylitis(AS)with the poly- morphism in -308 site of tumor necrosis factor(TNF)-?promoter region. Methods The literature about AS and polymorphism in -308 site of TNF-?promoter region were searched and the meta analysis as performed. Results Eight studies enrolled 987 AS patients and 922 controls in total. The analysis showed that the fre- quencies of alleles and the genotypes had no statistical difference between AS group and the control group [OR=0.86(0.53, 1.38), P=0.53; OR=0.90(0.52, 1.55), P=0.69]. But the frequencies of alleles of western origin had statistical difference between AS group and the control group [OR=0.75(0.59, 0.96), P=0.02]; The TNF-?gene promoter polymorphism may play a role in the severity of sacroiliitis[OR=0.37(0.15. 0.90), P=0.03]. Conclusion The meta-analysis reveales that the alleles of -308 site of TNF-?promoter region may be associated with AS in western ethnical group and play a role in the severity of saeroiliitis.

OBJECTIVETo investigate the Churg-Strauss syndrome (CSS) associated lung involvement, concentrating on clinical characteristics, pathological findings of lung involvements, response to treatment, and prognosis.

METHODSWe retrospectively analyzed the characters of the clinical manifestations, thin-section CT and pathological findings of CSS. The study involved 16 patients. Clinical data were obtained by chart review. All patients underwent transbronchial lung biopsy (TBLB). Six of them underwent surgical lung biopsy as well.

RESULTSThe patients included 7 men and 9 women, aged from 14 to 61 years (median, 47.5 years). Extrathoracic organs involved included nervous system (7/16) and skin (5/16). Respiratory symptoms included cough (12/16), exertional dyspnea (11/16), hemoptysis (4/16), and chest pain (3/16). CT findings included bilateral ground-glass opacities (12/16), bilateral patchy opacities (12/16), and centrilobular nodules (6/16). The pathological findings of TBLB demonstrated increased eosinophils (3/16), vasculitis (3/16), and interstitial pneumonia (16/16). The pathological findings of surgical lung biopsy of 6 cases showed necrotizing vasculitis in 4 cases, capillaries in 5, eosinophilic pneumonia in 3, granulomas in 2, and airway abnormalities in 3. All patients improved in symptoms after therapy during the study period (range, 3 to 51 months; median, 15 months).

CONCLUSIONSAsthma may be present in CSS patient when there is bronchial involvement. Ground-glass opacities and consolidation seen on high-resolution CT reflect the presence of eosinophilic pneumonia, vasculitis, and pulmonary alveolar hemorrhage. TBLB has significant limitations for the diagnosis of CSS. Early diagnosis and therapy can result in satisfactory prognosis.

Adolescent ; Adult ; Asthma ; physiopathology ; Biopsy ; Churg-Strauss Syndrome ; diagnosis ; diagnostic imaging ; drug therapy ; pathology ; Cyclophosphamide ; Female ; Humans ; Immunosuppressive Agents ; therapeutic use ; Lung ; diagnostic imaging ; pathology ; physiopathology ; surgery ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Tomography, X-Ray Computed ; methods ; Treatment Outcome ; Young Adult

OBJECTIVETo investigate the features and duration of viral nucleic acid shedding in children with influenza A.

METHODSThe clinical data of 90 children with influenza A with positive influenza A virus nucleic acid in nasopharyngeal swab detected by PCR were collected, and these children were divided into simple influenza A group (n=10), influenza A-pneumonia group (n=61), influenza A-nervous system damage group (n=10), and influenza A-underlying disease group (n=9). A retrospective analysis was performed for clinical features, treatment process, duration of viral nucleic acid shedding, and prognosis.

RESULTSThe most common symptoms in these children were fever (89/90, 99%), cough (89/90, 99%), running nose (69/90, 77%), shortness of breath (26/90, 29%), and myalgia (23/90, 26%). The mean duration of viral nucleic acid shedding in 90 children was 9.4±2.9 days. The simple influenza A group had a significantly shorter duration of viral nucleic acid shedding than the influenza A-pneumonia, influenza A-nervous system damage, and influenza A-underlying disease groups (p<0.05), while there were no significant differences between the influenza A-pneumonia, influenza A-nervous system damage, and influenza A-underlying disease groups (p>0.05). The children who received antiviral therapy within 48 hours after disease onset had significantly shorter duration of viral nucleic acid shedding and time to body temperature recovery than those who received antiviral therapy more than 48 hours after disease onset (p<0.05). Of all the children with body temperature recovery, 83% still tested positive for viral nucleic acid.

CONCLUSIONSComplications, underlying diseases, and timing of antiviral therapy are influencing factors for the duration of influenza A virus nucleic acid shedding, and whether body temperature returns to normal cannot be used to decide whether to continue antiviral therapy.

Child ; Child, Preschool ; Female ; Fever ; etiology ; Humans ; Infant ; Influenza A virus ; isolation & purification ; Influenza, Human ; virology ; Male ; Nucleic Acids ; metabolism ; Retrospective Studies ; Time Factors ; Virus Shedding

China ; epidemiology ; Chronic Disease ; Humans ; Respiratory Tract Diseases ; epidemiology ; Rural Population ; Urban Population

Objective To verify and monitor the performance of accuracy, precision and comparability of 26 clinical biochemical analytes (29 methods) in the six centers involved in multi-centers reference intervals research, and to ensure the reliability of theirmeasurement results.Methods During the period of the systems evaluating, two levels of commercial quality control materials and fresh frozen human serum reference materials were applied to verify the performance of inter-laboratory precision and accuracy of analysis systems. During the period of samples testing, the commercial quality control materials were measured whenever samples were analysed, the fresh frozen serum reference materials were measured once a month.The coefficient of variations (CVs), bias and total errors were calculated to assess the precision, accuracy and comparability.Results Verification of precision and accuracy: ( 1 ) the ranges of CVs of 29 methods in the six laboratory laboratories were 0.4%-6.0%, the CVs of all 29 methods met the criterion . (2) The overall average bias of the analysis systems of 21 analytes (24 methods) ranged from -5.15%( ALT) to 4.46% ( Ur ) .Among 24 methods the overall average bias of TP, Glu-GOD, Ur, Cl, Ca exceeded the acceptable range.The quality assessment during the period of samples testing:(1) The overall average bias ranged from -1.95%(Ca) to 2.92%(Ur), median 1.26%, they all met the requirements of relevant standards.( 2 ) When commercial control materials were tested, the requirements of CVs were fulfilled for most methods in the six laboratories,and the CVs of TP, Alb, Cl, Ca exceeded the acceptable range.The overall average TE of all methods met the quality specification for the C-N controls material.For the C-P control material, only the overall average TE of TP (5.05%) exceeded thearceptable range while the other methods met the requirement in criterion.Conclusions The performance of precision and accuracy of the analysis systems used in the six laboratories passed the verification.During the period of sample testing, the performance of precision and accuracy of the most methods in the 6 laboratories met the requirements of quality specifications, and the overall performance was good.Because of the limitation of current technology the performance of some methods didn't fulfill the requirement of specifications, and need to be improved.

BACKGROUND: The immunosuppressant drugs (ISDs), tacrolimus and cyclosporine, are vital for solid organ transplant patients to prevent rejection. However, toxicity is a concern, and absorption is highly variable across patients; therefore, ISD levels need to be precisely monitored. In the Asia-Pacific (APAC) region, tacrolimus and cyclosporine concentrations are typically measured using immunoassays. The objective of this study was to assess the analytical performance of Roche Elecsystacrolimus and cyclosporinee electrochemiluminescence immunoassays (ECLIAs). METHODS: This evaluation was performed in seven centers across China, South Korea, and Malaysia. Imprecision (repeatability and reproducibility), assay accuracy, and lot-to-lot reagent variability were tested. The Elecsys ECLIAs were compared with commercially available immunoassays (Architect, Dimension, and Viva-E systems) using whole blood samples from patients with various transplant types (kidney, liver, heart, and bone marrow). RESULTS: Coefficients of variation for repeatability and reproducibility were ≤5.4% and ≤12.4%, respectively, for the tacrolimus ECLIA, and ≤5.1% and ≤7.3%, respectively, for the cyclosporine ECLIA. Method comparisons of the tacrolimus ECLIA with Architect, Dimension, and Viva-E systems yielded slope values of 1.01, 1.14, and 0.897, respectively. The cyclosporine ECLIA showed even closer agreements with the Architect, Dimension, and Viva-E systems (slope values of 1.04, 1.04, and 1.09, respectively). No major differences were observed among the different transplant types. CONCLUSIONS: The tacrolimus and cyclosporine ECLIAs demonstrated excellent precision and close agreement with other immunoassays tested. These results show that both assays are suitable for ISD monitoring in an APAC population across a range of different transplant types.
Absorption ; China ; Cyclosporine* ; Drug Monitoring ; Heart ; Humans ; Immunoassay* ; Korea ; Liver ; Malaysia ; Methods ; Tacrolimus* ; Transplants

Objective To evaluate the effects of diphenylhydantoin sodiumpolybutylcyanoacrylate nanoparticles (DPH-PBCA-NPs) and DPH-PBCA-NPs modified with Tween-80on rat models of epilepsy, and investigate the advantage of nanoparticle as the drug delivery system.Methods The rat models of acute epilepsy induced by lithium pilocarpine were established and randomly divided into 5 groups: group Ⅰ (performing injection of DPH-PBCA-NPs modified with Tween-80), group Ⅱ (performing injection of DPH-PBCA-NPs), group Ⅲ (performing injection of diphenylhydantoin sodium), group Ⅳ (performing injection of PBCA-NPs) and group Ⅴ (performing injection of physiological saline). The changes of electroencephalogram (EEG) manifestations of these rats were observed by using video-EEG monitoring; and their behavioral changes were noted too.Results The lithium pilocarpine induced rat models of acute epilepsy were successfully established and their status epilepticus were confirmed by EEG and their behaviors. The effective rate of DPH-PBCA-NPs modified with Tween-80 and DPH-PBCA-NPs was 91.67% and 54.55%, respectively;the effective rate of rats in group Ⅲ was 50%, and the effective rate of rats in group Ⅳ and Ⅴ was 0%;DPH-PBCA-NPs modified with Tween-80 enjoyed a better effect than DPH-PBCA-NPs and DPH (P＜0.05). Conclusion DPH-PBCA-NPs and DPH-PBCA-NPs modified with Tween-80 can be used to improve the behaviors of rats with acute epilepsy and modify the results of EEG of these rats.Nanoparticles as drug delivery system can help the drugs having their effects much quickly and effectively.

OBJECTIVETo study the clinical effificacy of electroacupuncture (EA) on treating knee osteoarthritis (KOA) of Shen ()-Sui () insuffificiency (SSI) syndrome type.

METHODSA total of 245 patients (279 knees) of KOA-SSI were randomly assigned to two groups by lottery: 141 knees in the treatment group and 138 knees in the control group. The treatment group was managed with EA at the dominant points of Neixiyan (Ex-LE4) and Waixiyan (Ex-LE5) as well as the conjugate points of Xuanzhong (GB39) and Taixi (KI3) for 30 min, once a day, with 15 days as one course; 2 courses were applied with a 5-day interval in between. The control group was treated with intra-articular injection of 2 mL hyaluronic acid into the affected joint every 7 days for 5 times in total. The clinical effects on the patients in different stages were observed, and their symptom scores of knee and contents of cytokines, including interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), prostaglandin E(2alpha) (PGE(2alpha)) and matrix metalloproteinases-3 (MMP-3), in the knee joint fluid were measured before and after treatment.

RESULTSThe study was completed in 235 patients (263 knees); four patients (7 knees) in the treatment group and six patients (9 knees) in the control group dropped out. Comparison of therapeutic effects (excellent and effective rates) between the two groups showed insignificant differences (P>0.05). Symptom scores of knee and contents of cytokines in the knee flfluid after treatment were lowered signifificantly in the patients of stage I-III in both groups (P<0.05 or P<0.01). However, the lowering of the total symptom score of knee in the patients of stage III in the treatment group was more signifificant (P<0.05).

CONCLUSIONSEA could effectively alleviate the clinical symptoms in KOA patients of stage III, showing an effect superior to that of hyaluronic acid. EA also shows action in suppressing the secretion of IL-1, IL-6, TNF-alpha, PGE(2alpha) and MMP-3 in the knee flfluid.

Aged ; Cytokines ; metabolism ; Electroacupuncture ; adverse effects ; methods ; Female ; Humans ; Male ; Matrix Metalloproteinase 3 ; metabolism ; Middle Aged ; Osteoarthritis, Knee ; diagnostic imaging ; enzymology ; therapy ; Radiography ; Syndrome ; Synovial Fluid ; enzymology ; Treatment Outcome