China's Class 1 medical devices whose applications for filing were accepted in Anhui Province drug licensing system from January 2021 to December 2022 in some city of Anhui Province were used as the study object.The problems were analyzed in filing application,review and filing materials.It's suggested that the filer pay attention to the definition of medical devices,specifications for compiling filing materials,rigor of filing materials and whole-process quality management of medical device filing.References were provided for Class I medical device filer to standardize filing application materials and regulatory authorities to strengthen in-process and ex-post supervision of Class I medical device filing.[Chinese Medical Equipment Journal,2023,44(11):90-94]

Objective To determine the effect of local mild hypothermia on patients with acute cerebral infarction and ascertain its optimal therapeutic window. Methods According to the time receiving treatment, 114 patients with acute cerebral infarction were divided into group A (≤6 h), group B (6-24 h) and group C (≥ 24 h). Then, each group was subdivided into 2 groups at random: treatment group (A1, B1, C1) and control group (A2, B2, C2). Patients in the control group were subjected to such conventional therapy as anti-platelet aggregation. Patients in the treatment group were treated with local mild hypothermia (33-35 ℃ body-core temperature) for 48 h besides conventional therapy. Clinical outcomes were assessed by the National institutes of health stroke scale (NIHSS) on admission and 7, 14,30 d after treatment. Furthermore, we detected the serum level of nitrogen monoxidum (NO) and superoxide dismutasc (SOD) on admission, and 7 and 14 d after treatment. Results Compared with the control group, treatment group enjoyed significantly decreased scores of NIHSS 7, 14 and 30 d after treatment and significantly decreased level of NO 7 and 14 d after treatment (P＜0.05), but obviously increased SOD vitality 7 and 14 d after treatment (P＜0.05). No significant differences in terms of NIHSS scores, level of NO and SOD vitality were noted between group C1 and group C2 at each time point (P＞0.05). Group Al and group B1 had obviously lower scores of NIHSS than group C1 on the 7th, 14th and 30th d of treatment, and had significantly lower level of NO and obviously increased SOD vitality as compared with group C1 on the 7th and 14th d of treatment (P＜ 0.05), and group A1 enjoyed its advantage.Conclusion Early local mild hypothermia therapy can improve neurological function in patients with acute cerebral infarction. The mild hypothermia induced within 6 h may be optimal therapeutic window;mild hypothermia induced at 6-24 h is less effective and that above 24 h is non-effective.

OBJECTIVETo explore the feasibility of creating a 3D-CAD model of craniofacial prostheses through mirror technique to repair the unilateral craniofacial defects and restore craniofacial symmetry.

METHODSPatients with unilateral craniofacial defects underwent spiral CT scanning. CAD3-D image was reconstructed ad 3-D CAD model of craniofacial prosthesis was created with mirror technique, Boolean operation and rapid prototyping technique. Then the prosthesis made of bioactive artificial bone was made through plaster cavity block.

RESULTS15 cases were treated with no complications. Good symmetry was achieved after operation.

CONCLUSIONSDesigning the craniofacial prosthesis with mirror technique guarantees excellent functional and cosmetic results for repairing the unilateral craniofacial defects.

Adolescent ; Adult ; Child ; Computer-Aided Design ; Female ; Humans ; Imaging, Three-Dimensional ; Male ; Middle Aged ; Prosthesis Design ; methods ; Skull ; diagnostic imaging ; pathology ; surgery ; Tomography, Spiral Computed ; Young Adult

From the perspective of information technology,the paper designes and implementes the queuing & calling system in the complex environment of specialized hospitals according to actual circumstances and characteristics of out-patient and examination areas,and introduces the architecture,operating process,comparison of effects before and after the optimization,specific application of the system.After launched and used,the system can improve the order in various areas and enhance the satisfaction of both doctors and patients.

Objective:To improve the differential awareness of lead porsoning.Methods:A case with stomachache, anemia, myasthenia, and abnormal urine color was described. The diagnosis and treatment were analyzed and discussed.Results:A middle-aged female was admitted with a 9-month medical history, compalnied with rash, stomachache. She also had evidence of hemolytic anemia,nervous system and kidneys imvolvement, and Lab test showed a significantly elevated blood lead level. It was considered to be in line with multiple organ system damage caused by lead poisoning.Conclusion:Lead poisoning can mimic the clinical presentations of rheumatic diseases, resulting in multiple system ivolvement. When the patient's clinical manifestation cannot be fully explained, some special situations should be considered, such as toxic testing.

OBJECTIVETo investigate the relationship of susceptibility loci in chromosomes 1q21-25 and 6p21-25 and schizophrenia subtypes in Chinese population.

METHODSA genomic scan and parametric and non-parametric analyses were performed on 242 individuals from 36 schizophrenia pedigrees, including 19 paranoid schizophrenia and 17 undifferentiated schizophrenia pedigrees, from Henan province of China using 5 microsatellite markers in the chromosome region 1q21-25 and 8 microsatellite markers in the chromosome region 6p21-25, which were the candidates of previous studies. All affected subjects were diagnosed and typed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revised (DSM-IV-TR; American Psychiatric Association, 2000). All subjects signed informed consent.

RESULTSIn chromosome 1, parametric analysis under the dominant inheritance mode of all 36 pedigrees showed that the maximum multi-point heterogeneity Log of odds score method (HLOD) score was 1.33 (α = 0.38). The non-parametric analysis and the single point and multi-point nonparametric linkage (NPL) scores suggested linkage at D1S484, D1S2878, and D1S196. In the 19 paranoid schizophrenias pedigrees, linkage was not observed for any of the 5 markers. In the 17 undifferentiated schizophrenia pedigrees, the multi-point NPL score was 1.60 (P= 0.0367) at D1S484. The single point NPL score was 1.95(P= 0.0145) and the multi-point NPL score was 2.39 (P= 0.0041) at D1S2878. Additionally, the multi-point NPL score was 1.74 (P= 0.0255) at D1S196. These same three loci showed suggestive linkage during the integrative analysis of all 36 pedigrees. In chromosome 6, parametric linkage analysis under the dominant and recessive inheritance and the non-parametric linkage analysis of all 36 pedigrees and the 17 undifferentiated schizophrenia pedigrees, linkage was not observed for any of the 8 markers. In the 19 paranoid schizophrenias pedigrees, parametric analysis showed that under recessive inheritance mode the maximum single-point HLOD score was 1.26 (α = 0.40) and the multi-point HLOD was 1.12 (α = 0.38) at D6S289 in the chromosome 6p23. In nonparametric analysis, the single-point NPL score was 1.52 (P= 0.0402) and the multi-point NPL score was 1.92 (P= 0.0206) at D6S289.

CONCLUSIONSusceptibility genes correlated with undifferentiated schizophrenia pedigrees from D1S484, D1S2878, D1S196 loci, and those correlated with paranoid schizophrenia pedigrees from D6S289 locus are likely present in chromosome regions 1q23.3 and 1q24.2, and chromosome region 6p23, respectively.

Adult ; Chromosomes, Human ; Genetic Linkage ; Genetic Loci ; Genetic Predisposition to Disease ; Humans ; Microsatellite Repeats ; genetics ; Middle Aged ; Schizophrenia ; genetics ; Young Adult

OBJECTIVETo investigate the status of the clinical agency of detection, management, and health insurance for hypertensive patients in urban and rural communities of five provinces in China in 2010, in order to provide fundamental data for implementation and evaluation of community health management of hypertensive patients in basic public health service.

METHODSFrom Jiangsu, Shandong, Hebei, Sichuan and Gansu provinces, cities and districts (counties) were selected according to economic development level and 10 survey sites were finally determined. In each survey site, 3-4 communities or townships were selected by cluster sampling methods in 2010. A total of 8326 eligible hypertensive patients (4363 in urban and 3963 in rural) were included. The urban-rural difference of clinical agency and health insurance was compared for hypertensive patients.

RESULTSIn urban areas, 43.74% (1867/4268) hypertensive patients were first diagnosed at hospitals of district level or above, 25.07% (1070/4268) at community health service centers (CHSC), and 20.20% (862/4268) at community health service stations (CHSS), respectively; 30.72% (1274/4147) and 31.11% (1290/4147) patients chose CHSC and CHSS for their follow-up visiting, respectively; 60.23% (3073/5102) antihypertensive medication was obtained from pharmacies. In rural areas, 54.58% (2133/3908) hypertensive patients were first diagnosed at village clinics, 22.36% (874/3908) at township hospitals, and 18.86% (737/3908) at hospitals of county level or above; 70.49% (2695/3823) patients chose village clinics for their follow-up visiting; 46.23% (2116/4577) antihypertensive medication was obtained from village clinics, and 36.29% (1661/4577) from pharmacies. The main reasons for choosing clinical agency for both urban and rural patients were convenience (45.79%, 6276/13 706) and low cost (11.78%, 1614/13 706). The proportions of reimbursements for hospitalization expenses and total medical expenses for hypertensive patients in urban in the past year were 66.67% and 34.78%, respectively, which were much higher than those in rural (35.71% and 9.50%) (Z value was -12.13 and -17.56, P < 0.01).

CONCLUSIONCommunity-based hypertension detection and routine blood pressure measurement during clinical visiting should be further strengthened to improve early diagnosis of hypertension. The development of community-based clinical agency should be able to provide convenient and low cost health service for hypertensive patients to improve treatment, follow-up and control of hypertension.

Adult ; Aged ; China ; Cities ; Community Health Services ; Female ; Humans ; Hypertension ; diagnosis ; therapy ; Insurance, Health ; Male ; Middle Aged ; Public Health ; Rural Health Services ; Urban Health Services

OBJECTIVETo investigate the current situation of drug cost, hospitalization cost and direct medical expense in community health management of hypertensive patients, in order to lay foundation for evaluating whether the community health management in basic public health service has cost-effect in Health Economics.

METHODSA total of 8326 hypertensive patients from 10 survey pilots in 5 provinces were selected by cluster sampling methods, including 3967 patients who took part in community health management for over 1 year as management group and 4359 cases who have never taken part in community health management as control group. The essential information of research objects were collected by questionnaire; and the medical cost information in the last year (from November 2009 to November 2010) were collected retrospectively. The different annual medical treatment cost, hospitalization cost and direct medical expense in the two groups were compared and analyzed.

RESULTSThe average annual drug cost in hypertension was (621.50 ± 1337.78) yuan per patient; while the cost was (616.13 ± 1248.40) yuan in management group and (626.44 ± 1414.30) yuan in control group respectively. The average annual drug cost of hypertensive patients who took medicine therapy was (702.05 ± 1401.79) yuan per person, while the cost in the management group ((688.50 ± 1300.70) yuan) was much lower than it in control group ((714.64 ± 1489.60) yuan). The annual average drug cost in urban was (731.88 ± 1403.31) yuan per person, which was higher than it in rural as (407.44 ± 1171.44) yuan per person. The average hospitalized rate was 12.2% (1014/8326), and the average annual cost among the hospitalized patients was (9264.47 ± 18 088.49) yuan per person; while the cost was (7583.70 ± 13 267.00) yuan in management group, which was lower than it in control group as (11 028.00 ± 21 919.00) yuan. The average annual hospitalized cost in hypertension was (1064.87 ± 6804.83) yuan per person; while the cost was (936.73 ± 5284.90) yuan in management group, which was lower than it in control group as (1181.50 ± 7937.90) yuan. The average annual direct medical expense in hypertension was (2275.08 ± 8225.66) yuan per person; while the expense was (2165.10 ± 6564.60) yuan in management group and (2375.20 ± 9487.60) yuan in control group. The average annual direct medical expense in urban ((2801.06 ± 9428.54) yuan per person) was higher than it in rural ((1254.70 ± 4990.27) yuan per person).

CONCLUSIONThe community health or standardized management of hypertensive patients can reduce the average annual drug cost and hospitalization cost (around 26 yuan and 245 yuan separately); and thereby save the annual direct medical expense per capita in hypertension (around 210 yuan). In the reform and development of national medical health system, we should enhance and promote the standardized community health management of hypertensive patients.

Aged ; Community Health Services ; economics ; Cost-Benefit Analysis ; Drug Costs ; Female ; Health Care Costs ; statistics & numerical data ; Humans ; Hypertension ; drug therapy ; economics ; Male ; Middle Aged ; Public Health ; economics

BACKGROUNDAtopic dermatitis (AD) is an inflammatory skin disease characterized by chronic recurrent dermatitis with profound itching. Most patients have personal and/or family history of atopic diseases. Several criteria have been proposed for the diagnosis of AD. Although the clinical features of childhood AD have been widely studied, there has been less large-scale study on adult/adolescent AD. The aim of this study was to investigate the clinical features of adult/adolescent patients with chronic symmetrical eczema/AD and to propose Chinese diagnostic criteria for adult/adolescent AD.

METHODSA hospital-based study was performed. Forty-two dermatological centers participated in this study. Adult and adolescent patients (12 years and over) with chronic symmetrical eczema or AD were included in this study. Questionnaires were completed by both patients and investigators. The valid questionnaires were analyzed using EpiData 3.1 and SPSS 17.0 software.

RESULTSA total of 2662 valid questionnaires were collected (1369 male and 1293 female). Of all 2662 patients, 2062 (77.5%) patients had the disease after 12 years old, while only 600 (22.5%) patients had the disease before 12 years old, suggesting late-onset eczema/AD is common. Two thousand one hundred and thirty-nine (80.4%) patients had the disease for more than 6 months. One thousand one hundred and forty-four (43.0%) patients had a personal and/or family history of atopic diseases. One thousand five hundred and forty-eight (58.2%) patients had an elevated total serum IgE and/or eosinophilia and/or positive allergen-specific IgE. Based on these clinical and laboratory features, we proposed Chinese criteria for adult/adolescent AD. Of all 2662 patients, 60.3% were satisfied with our criteria, while only 48.2% satisfied with Hanifin Rajka criteria and 32.7% satisfied with Williams criteria, suggesting a good sensitivity of our criteria in adult/adolescent AD patients.

CONCLUSIONLate-onset of eczema or AD is common. The clinical manifestations of AD are heterogeneous. We have proposed Chinese diagnostic criteria for adolescent and adult AD, which are simple and sensitive for diagnosis of adult/adolescent AD.

Adolescent ; Adult ; Dermatitis, Atopic ; diagnosis ; immunology ; Eczema ; diagnosis ; Female ; Humans ; Immunoglobulin E ; blood ; Male ; Middle Aged ; Retrospective Studies ; Surveys and Questionnaires

Prolactinoma is an estrogen-related tumor and leukemia-related protein 16 (LRP16) is correlated with the progression of estrogen-related tumors, but the regulatory mechanism between LRP16 and prolactinoma remain unclear. This study demonstrates a variation in LRP16 with estrogen receptor α (ERα) in prolactinoma models and the up and downregulation effects of LRP16 on prolactin secretion of pituitary adenomas cells (GH3 cells). In our study, 50 male SD rats (30-day-old) were randomly divided into five groups of 10 rats each. After 120 days of treatment, the rats were sacrificed, and the expression of LRP16 and ERα were examined by Western blot and immunohistochemistry to explore the changes in ERα, LRP16, and prolactin. After siRNA transfection of the respective genes, the GH3 cells were cultured, and their secretory function as well as the expression of ERα mRNA and prolactin were analyzed by enzyme-linked immunosorbent assay and real-time-polymerase chain reaction analysis. The results show that secretion of prolactin by GH3 cells can be affected by up and downregulating LRP16 expression, which may provide a novel medical therapy in clinical trials.