The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
China ; Consumer Product Safety ; Equipment and Supplies ; Safety Management

Objective To discuss the risk factors for incontinence-associated dermatitis (IAD) in elderly patients to provide the basis for the scientific research and formulation of effective precautions. Methods Totally 170 elderly patients were collected age, gender and other 10 data. The study allocated patients into case group and control group based on the end whether get incontinent dermatitis. Univarate and multivariate Logistic regression analysis were conducted to compare the 11 indicators mentioned above between the two groups to find out the risk factors. Results The types of incontinence, diarrhea, damp frequency, diabetes, and antimicrobials species were significantly different between the two groups (χ2=4.317-17.404, P<0.05). The multivariate logistic regression analysis showed that fecal incontinence, diarrhea and diabetes were risk factors (P < 0.05). Conclusions Clinical nurses should increase especially for incontinence frequency > 3 times per day and/or stool is thin and watery then patients, diarrhea and hemorrhoids patients, diabetes prevalence > 10 years or the level of blood glucose control with poor patients attention,and take effective intervention measures, focusing on prevention and cure together.

Objective To summarize the clinical and pathological features of glycogen storage disease (GSD) type Ⅱ. Methods The clinical and pathological data of the 20 GSD type Ⅱ patients were reviewed. Results One patient with infantile-onset mainly presented hypotonia, muscle weakness, feeding difficulties, pulmonary infection and cardiomyopathy insufficiency and increase of serum creatine kinase (778 IU/L) and echographic evidence of hypertrophic cardiomyopathy were detected. Electromyography studies indicated a definite myopathy. Nineteen cases were late-onset, presenting a slowly progressive proximal myopathy with truncal involvement or with symptoms dominated by respiratory insufficiency. Not all muscles were equally affected. Increase of serum creatine kinase (208-2600 IU/L) was detected in 14 patients and normal level in 1 patient. Electromyography studies indicated a definite myopathy in 9 patients,with abnormal irritability in 1 patient and susceptible in 4 patients and myotonic discharge in 1 patient and no abnormalities in 2 patients. Echographic evidence of thickening of the interventricular septum and pulmonary hypertension were detected in 2 patients respectively. The common light microscopic feature of all case was a vacuolar myopathy with high glycogen content and acid phosphatase activity in the vacuoles. Conclusions GSD type Ⅱ often presents slowly progressive myopathy which often affect the toro and respiratory muscles.In most patients the serum creatine kinase level is elevated slightly. Muscle biopsy is of use to make the definite diagnosis of this disease.

Objective To investigate the value of the cerebrospinal fluid ( CSF ) cytology in diagnosis of intracranial germinomas by reviewing the outcomes of CSF cytology of 8 patients with intracranial germinomas. Methods Eight patients with positive CSF cytology at our clinic from January 2006 to June 2009 were reviewed. Conventional cytology and immunocytochemistry of CSF were performed. The relevant literature on the subject was reviewed. Results The patients, including 7 male and 1 female, developed endocrinological or neurological symptoms at the age of 13 to 25, and the typical neurological presentation included vertigo, headache, mental and behavior disorders, double vision and weakness of legs. The CSF cell count ranged from 0 to 300 leukocytes per cubic and elevated in 7 cases, typically lymphocytic inflammation. CSF level of human chorionic gonadotropin was 3.2-1087.0 mIU/ml, higher than the individual serum level. On CSF cytology studies, typical tumor cells of germinima were found, which had positive particles in cytoplasm on periodic acid Schiff stain. All presents had lymphocyte inflammation ( small lymphocyte predominant ). On immunocytochemical studies of CSF, the tumor cells were positive on placental alkaline phosphatase and Ki-67 stains. Conclusions CSF cytology is clinically useful for diagnosis of primary intracranial germinoma. Further clinical and cytological studies will be necessary for a better understanding of the biology of these tumors.

Objective To investigate the clinical value of anatomic M-mode echocardiography (AMM)for pristine diagnosis of myocardial ischemia in patients with coronary heart diseases (CAD).Methods 44 inner patients who were suspected as CAD were detected.Ordinary ultrasound was performed first.The ventricular segmental wall thickness and amplitude were measured by AMM.Then,we got the ventricular wall thickening fractions.All subjects should take the coronary angiography after the ultrasound examination in 1 -3 days.Patients with the vascular stenosis rate≥50% were defined as the CAD group,patients with the completely normal angiographic results were included in the normal control group according to the results of angiography.The parametric differences between the patients and the normal control subjects were compared.Results In the normal control subjects,the ventricular segmental wall amplitude >5mm accounted for 78.67%,the ventricular wall thickening fractions >30% accounted for 99.13%.But in CAD group,the ventricular segmental wall amplitude <4mm accounted for 61.14%,<5mm accounted for 93.47%,the abnormal ventricular wall thickening fractions <30% accounted for 88.43%.The sensitivity, specificity,accuracy of AMM were 77.47%,90.00%,77.39% respectively.Conclusion The ventricular wall thickening fractions of AMMhas quite significant correlation with morbid blood vessel in patients with CAD,they are effective reference indicators to evaluate the left ventricular wall motion quantitatively.

Objective To prepare self-assembled thiolated chitosan derivatives gold nanoparticles (CS-GNRs) and carry out the feature tests.Methods CS-GNRs was prepared by chitosan derivatives and GNRs through strong metal sulfur chemical bond between thiols and gold on GNRs surface.Morphology features was tested by transmission electron microscope,dynamic light scattering was adopted to observe the size of nanoparticles.Ultraviolet-visible spectrophotometer was used to detect the optical properties and the property change.Meanwhile,the surface-enhanced Raman scattering (SERS) activity of CS-GNRs was investigated by using crystal violet (CV) as a probe molecular.Results CS-GNRs were in good shape,uniform particle size and good dispersion.The SERS of CV was enhanced,and the enhancement factor of CV adsorbed on CS-GNRs was up to 2×103.Conclusions The nanoparticles have potential application in molecular detection and Raman spectra detection.

Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

Objective To investigate the epidemiological characteristics of a family clustering of COVID-19. Methods Field epidemiological survey was conducted. Result Case 1 of the long-term residents from Hubei province was the source of infection of this family clustering. There were 6 cases (from case 2 to case 7) infected in the whole incubation period. The incubation period was more than 14 days for 3 of the second-generation cases. Routes of transmission include respiratory droplets (from case 1 transmitted to case 6, from case 1 to her family members) and closecontact (from case 1 to other cases in her family). All the age groups were generally susceptible, while elderly were easier to progress to critically ill. Besides respiratory symptoms, there were also gastrointestinal symptoms, of which diarrhea was the most common one. Conclusion Family clustering had been an important part for COVID-19 cases.