Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years / 中国医疗器械杂志

OBJECTIVE@#Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement.@*METHODS@#Classify and analyze the on-site audit findings from different type of medical device manufacturers.@*RESULTS@#The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high.@*CONCLUSIONS@#The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.

Pathological Changes in APP/PS-1 Transgenic Mouse Models of Alzheimer's Disease Treated with Ganoderma Lucidum Preparation / 中国医学科学院学报

Objective To explore the efficacy of ganoderma lucidum preparation(Ling Zhi) in treating APP/PS-1 transgenic mouse models of Alzheimer's disease(AD).Methods APP/PS-1 transgenic mice of 4 months were randomly divided into model group,ganoderma lucidum treatment groups,including high [2250 mg/(kg·d)] and middle [750 mg/(kg·d)] dose groups,i.e.LZ-H and LZ-M groups,and the positive control group(treated with donepezil hydrochloride [2 mg/(kg·d)]).In addition,C57BL/6J wild mice were selected as normal group.The animals were administered for 4 months.Histopathological examinations including hematoxylin-eosin(HE) staining,immunohistochemistry,special staining,and electron microscopy were applied,and then the pathological morphology and structures in different groups were compared. Results The senile plaques and neurofibrillar tangles in the cerebrum and cerebellum were dissolved or disappeared in LZ-H and LZ-M groups.Decrease of amyloid angiopathy was found in LZ-H and LZ-M groups.The immature neurons appeared more in hippocampus and dentate nucleus of LZ-H and LZ-M groups than those in AD model and donepezil hydrochloride groups(hippcampus:F=1.738,P=0.016;dentate nucleus:F=1.924,P=0.026),and these immature neurons differentiated to be neurons.More Purkinje cells loss occurred in AD model mice than that in LZ-H and LZ-M groups(F=9.46,P=0.007;F=9.46,P=0.010).The LZ-H and LZ-M groups had more new neuron stem cells grown up in cerebellum.Electromicroscopic examination showed the hippocampal neurons in LZ-H and LZ-M group were integrated,the nuclear membrane was intact,and the mitochondria in the cytoplasm,endoplasmic reticulum,Golgi bodies,microtubules,and synapses were also complete.The microglial cell showed no abnormality.No toxicity appeared in the pathological specimens of mice treated with ganoderma lucidum preparation.Conclusion The ganoderma lucidum preparation can dissolve and decline or dismiss the senile plaques and neurofibrillar tangles in the brain of AD mice and also reduce the amyloid angiopathy.

Composition Analysis of Remaining Metal Particles on Ferrochrome Kitchen Knife / 法医学杂志

OBJECTIVE@#To establish a feasible evaluation index and method to identify composition of remaining metal particles on ferrochrome kitchen knife.@*METHODS@#The small samples of remaining metal particles were rubbed from the knives using filter paper. The composition of remaining metal particles was detected by scanning electron microscopy and energy dispersive X-ray spectrometer (SEM-EDX) and GSR particle analysis function, using mathematical methods to calculate the ratio (relative amount) of Fe and Cr in remaining metal particles.@*RESULTS@#The ratio (relative amount) of Fe and Cr of remaining metal particles had significant differences among most ferrochrome kitchen knives (P < 0.05).@*CONCLUSION@#Using GSR particle analysis function to quantitatively detect the ratio (relative amount) of Fe and Cr of remaining metal particles on ferrochrome kitchen knife, which can establish the feasible evaluation method to estimate such injury tool.

Investigation of Hospital Pharmacists in 15 Provinces and Cities in the Background of Healthcare Reform in China / 中国药师

Objective:To explore the future development of pharmacists. Methods:The combination of on-site and mailed ques-tionnaire was adopted to investigate the present work situation of pharmacists in hospitals at different levels in 15 provinces and munici-palities of east China. Based on the statistical analysis of data, some problems in the present work of pharmacists were investigated. Results:The data showed that there was a wide gap of human resource among the hospitals at different levels, and the working condi-tion improvement for pharmacists should be performed. Continuing education and legislation were not standardized and unified yet, and the clinical pharmacy and the rational drug use needed further development. Conclusion:The relevant laws and regulations should be established and improved to guarantee the lawful right and interests of pharmacists. The pharmacist training system should be improved to raise the professional quality of pharmacists and promote the development of hospital pharmacy.

Clinical and pathological features of acute optic neuritis in Chinese patients / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The incentives and the factors that affect the onset and outcome of optic neuritis (ON) are not very clear. The aim of this study is to define and get a comprehensive understanding of the clinical profile of ON, and to identify the factors that were related to the prognosis of the patients.</p><p><b>METHODS</b>Medical records of patients with diagnosis of ON at Huashan Hospital, Fudan University between March 2008 and June 2011 were reviewed. Clinical features, ophthalmologic and neurologic assessments, neuroimaging studies, laboratory examinations, visual recovery, and final outcome of the patients were evaluated by the authors.</p><p><b>RESULTS</b>Records of 50 patients (32 females and 18 males), aged 15 - 56 years, were reviewed, in which 22% patients had a previous onset of ON. Maximal visual deficit was severe in 72.5% (< 20/200). Abnormal rates of hormone levels and rheumatoid indicators were found in 54.2% and 25.0%. ANA test returned positive in 40%, oligoclonal banding (OCB) was identified in 31.3%, and Serum neuromyelitis optica (NMO)-IgG studies were abnormal in 25% of the patients. Neuroimaging abnormalities associated with ON were documented in six patients. Three of the 50 patients have been diagnosed with multiple sclerosis, and two with NMO. Visual acuity was 20/20 or better in 26.1% and 20/100 or worse in 39.1% affected eyes at the last visit. Poor visual acuity at onset is the main factor that would affect the final outcome of vision (P < 0.05).</p><p><b>CONCLUSIONS</b>Vision defects of this group of patients were severe. Females had a higher incidence of ON than males. Hormone levels, rheumatoid indicators and immune parameters may be related to the onset of ON. The severe reduction of visual acuity at onset may be related to the poor outcome of vision in ON patients.</p>

Drug synergistic antifertility effect of combined administration of low-dose gossypol with steroid hormones in rats / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Our previous studies suggested that low-dose gossypol combined with steroid hormones has a reversible antifertility role in adult male rats, and the course of treatment was shorter than that of either gossypol or steroid hormones alone. This result suggested that low-dose gossypol and steroid hormones have a drug synergistic effect on antifertility. The aim of the study was to find the target organs of the antifertility synergistic effect of the combined regimen.</p><p><b>METHODS</b>Thirty-two adult male rats were divided into four groups randomly: group GH, rats were fed orally with gossypol acetic acid (GA, 12.5 mg×kg(-1)×d(-1)) and desogestrel (DSG, 0.125 mg×kg(-1)×d(-1))/ethinylestradiol (EE, 0.025 mg×kg(-1)×d(-1))/testosterone undecanoate (TU, 100 mg×kg(-1)×d(-1)); group G, a single dose of GA (12.5 mg×kg(-1)×d(-1)) was given; group H, the same dosage of DSG/EE/TU as in group GH were administered; group C, rats were treated with vehicle (1% methyl cellulose) as control. Testes and epididymis were removed at 8 weeks post-treatment for evaluating their weight, volumes, volume fraction, and total volume of testicular tissue structures and the seminiferous tubule diameter using stereological assay. Sperm cell numbers and the motility of epididymal sperm were quantitated by flow cytometry and morphological methods.</p><p><b>RESULTS</b>Compared with group C, spermatogenesis was normal in group G and suppressed in groups H and GH. Similar changes of testicular tissue structures and sperm number were found in groups H and GH. The decreases of epididymal sperm number and motility in group GH were greater than that of the low-dose gossypol or steroid hormones alone group.</p><p><b>CONCLUSIONS</b>The suppression of spermatogenesis was induced by steroid hormones in the combined regimen, and the epididymis was the target organ of low-dose gossypol. Combined use of low-dose gossypol and steroid hormones played a comprehensive antifertility role in their synergistic effect on reducing the number and motility of epididymal sperm.</p>

Effectiveness of Ganoderma lucidum preparation in treating simian acquired immune deficiency syndrome / 中国医学科学院学报

<p><b>OBJECTIVE</b>To explore the effectiveness of the traditional Chinese herbal medicine Lingzhi (Ganoderma lucidum) preparation in treating simian acquired immune deficiency syndrome (SAIDS).</p><p><b>METHODS</b>Five female adult Chinese rhesus monkeys were inoculated rectally with SIVmac239, and were all diagnosed as SAIDS by laboratory and clinical examinations 17 months later. Of these 5 monkeys, 3 (#393, #374, and #381; treatment group) were orally administered with Ganoderma lucidum (2 spores powder capsules plus 2 spores oil capsules on a daily basis), and the remaining other two monkeys (#348 and #361) served as control and did not receive treatment.</p><p><b>RESULTS</b>Animal #393 (treatment group), #361 (control group) and #348 (control group) died of SAIDS (opportunity infection) 3.5 months, 6 months, and 11 months later, respectively. Two animals (#374 and #381) survived. The necropsy revealed depletion and/or exhaustion of their lymphoid tissue. In the monkey #374, the peripheral CD4(+) T lymphocyte increased by 30% in the 6(th) month compared with the baseline level and then fluctuated. The plasma viral load gradually fell and reached about 1 log(10) in the treatment group, but remained stable in the control group. As shown by pathological examinations, the lymph node and spleen of monkeys #374 (treatment group) and #381 (treatment group) showed rehabilitation and reconstruction in the lymphatic tissue, thymus, nerve tissue of gyrus hippocampi, pituitary gland, pineal body, thyroid gland, adrenal gland, and ovary. In the control group, however, animals experienced depletion of lymph nodes, atrophy of spleen, disappearance of thymus, and other disorders in endocrine organs.</p><p><b>CONCLUSION</b>Ganoderma lucidum preparation may have certain protective effect on the immune system, nervous system, and endocrine system of monkeys with SAIDS.</p>

An optimized method for extracting corosolic acid from loquat leaves / 南方医科大学学报

<p><b>OBJECTIVE</b>To extract corosolic acid from loquat leaves for medical use.</p><p><b>METHODS</b>Loquat leaves were boiled in water to remove the water-soluble substances followed by 3 cycles of extraction with 25% aqueous methanol for 30 min and then by 95% aqueous methanol for 1 h at 80 degrees celsius;. After cooling at room temperature and filtration, the extract was treated with activated carbon to remove chlorophyll, and the liquid was filtered and concentrated to allow precipitation. The sediment was washed to obtain the total crude triterpene acid, which was further dissolved with methanol and purified by high-performance liquid chromatography (HPLC). The fractions including corosolic acid were collected, concentrated with vacuum distillation, and dried to obtain corosolic acid product, which was analyzed with HPLC.</p><p><b>RESULTS</b>HPLC analysis of the extracts showed that the percentages of corosolic acid were 4.66%, 2.42%, and 24.18% in crude corosolic acid extracted with methanol, boiling water, and 95% aqueous methanol, respectively. After purification with HPLC, the purity of corosolic acid in the product exceeded over 80%.</p><p><b>CONCLUSION</b>The optimal extraction method, which is convenient and cost-effective, is established for extracting corosolic acid from loquat leaves for medical use.</p>

Normative data and clinical practice of sinusoidal harmonic acceleration test / 中华耳鼻咽喉头颈外科杂志

<p><b>OBJECTIVE</b>To establish the normative data of sinusoidal harmonic acceleration test (SHAT) and evaluate the value of clinical application.</p><p><b>METHODS</b>One hundred and twenty normal persons, 21 Meniere's disease patients, 2 bilateral vestibular peripheral lesion patients, 15 unilateral vestibular peripheral lesion patients and 10 central lesion patients were tested with SHAT.</p><p><b>RESULTS</b>The calibration time was longer in the older persons. The phase decreased with the frequency, and the gain increased with the frequency, but the reliability of the re-test of the phase was better in the lower frequency. The results of the 7 Meniere's disease patients without symptoms were normal, 14 patients post-attack revealed abnormal, 11 had phase abnormal, 3 had gain decrease, 10 revealed asymmetry and spontaneous nystagmus simultaneously, 8 patients had two parameters abnormal. The unilateral vestibular peripheral lesion patients showed 73% (11/15) phase abnormal, 67% (10/15) gain decrease and 40% (6/15) asymmetry, while 5/6 asymmetry patients had spontaneous nystagmus. The gain of the bilateral vestibular peripheral lesion patients showed severe decrease. The abnormal rate in central lesion patients were 70% (7/10) in phase, 20% (2/10) in gain and 40% (4/10) in asymmetry, but the patients with asymmetry had no spontaneous nystagmus.</p><p><b>CONCLUSIONS</b>The normal range of the phase, gain and asymmetry of SHAT is in narrow bandwidth. The phase is the most important abnormal sign.</p>

Epidemiologic study of chronic kidney disease among Uygur adults in rural area of Moyu county in Xinjiang / 中华肾脏病杂志

Objective To explore the method to carry out epidemiological investigation of chronic kidney disease (CKD) in rural area surrounding the Tarim Basin, and to elucidate the prevalence and risk factors associated with CKD among the Uygur adults in Moyu county. Methods A total of 1650 residents (age >18 years) from 15 villages in 3 rural town of Moyu county were randomly selected by using a stratified, multistage sampling. All the residents were interviewed and received physical examination and tested for random spot urine of albumin to creatinine ratio (ACR). Estimated glomerular filtration rate (eGFR) was calculated by modified factors of CKD were examined. Results Valid data of 1552 subjects were enrolled in the study. After the adjustment of age and gender component, the prevalence of albuminuria and reduced eGFR was 4.5% (95% CI 4.4-4.6) and 1.4% (95% CI 1.4-1.5) respectively. Approximately 5.4% subjects had at least one indicator of kidney damage. Age and hypertension were independently associated with CKD. Conclusions Experience and method of epidemiology investigation of CKD in the rural areas of Uygur are obtained through this study. The prevalence of CKD is 5.4% and the awareness is 12.5% in the Uygur adults of Moyu county. Independent risk factors associated with CKD are hypertension and age.

Stereological measurement of rat's seminiferous tubule / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The morphological measurements of seminiferous tubules are important in the studies of testis tissues. The purpose of this study was to evaluate the feasibility of using a stereological method to measure the geometric parameters of seminiferous tubule and to optimize the method.</p><p><b>METHODS</b>A stereological image processing program was developed with Delphi for the stereological measurement. Fields of view were obtained from 15 healthy Wistar rats' testis tissues (n = 247). The diameter, area and volume of seminiferous tubule were estimated with the image processing program by two individual observers. The area results were compared with those obtained by the standard morphometric method of planimetry.</p><p><b>RESULTS</b>Diameter measurements showed the diameters of different seminiferous tubules were almost the same and the mean value of about 50 tubules could be a good representation of the whole structure. Area measurements indicated there was no significant difference between stereology and planimetry (P > 0.05). But the stereological method required about 45% less time. Volume measurement showed the inter-observer variability was small (P > 0.05) and the reproducibility of the stereological method was good.</p><p><b>CONCLUSION</b>The stereological technique was practical and efficient in the quantitative measurement of the rat's seminiferous tubule.</p>

Comparison of intravenous and intrarectal SIVmac239 infections in rhesus monkeys of Chinese origin / 中国医学科学院学报

<p><b>OBJECTIVE</b>To investigate the biological and clinical features of Chinese rhesus monkeys after intravenous (IV) and intrarectal (IR) challenge with SIVmac239 in rhesus monkeys of Chinese origin, and compare the differences between the routes of infection.</p><p><b>METHODS</b>Rhesus monkeys of Chinese origin were inoculated with SIVmac239 either by IV (n = 19) or IR (n = 6) routes. Simian immunodeficiency virus (SIV)-specific antibody titer, CD4 + T cell counting, plasma SIV load, lymph node pathology, and clinical manifestations were compared between these two groups 232 or 168 days after challenging.</p><p><b>RESULTS</b>All SIVmac239-inoculated animals became seropositive for SIV-specific antibodies. SIV-specific IgM was detected in IV groups as from day 10 but was not detected in IR for all the time points. Although SIV-specific IgG was detected as from day 30 in both groups, the IgG titers were ten-fold higher in IV group than in IR group after day 168. CD4 + T-cell counting decreased progressively in IV group but remained stable in IR group over time. Plasma SIV RNA loads peaked in all animals between day 10 and day 14 (10(7) copies/ml), then declined to "setpoint" (10(3) - 10(6) copies/ml) about 2 months later. Most inoculated animals manifested lymphadenopathy. Two animals in IV group and one in IR group died of simian AIDS between day 150 and day 210, as evidenced by the autopsies showing the depletion of lymph tissues, Pneumocystis carinii pneumonia and other opportunity infections. Conclusion IV or IR inoculation of SIVmac239 in Chinese rhesus monkeys will result in chronic SIV infection with a similar clinical feature of natural HIV infection, which provides an excellent experimental animal model for AIDS.</p>

Autoantibodies and autoimmunity in simian immunodeficiency virus-infected monkeys / 中国医学科学院学报

<p><b>OBJECTIVE</b>To study the relationship between simian acquired immunodeficiency syndromn (SAIDS) and autoimmunity in simian immunodeficiency virus (SIV)-infected monkeys.</p><p><b>METHODS</b>Indirect immunofluorescence assays were performed to detect plasma or serum autoantibodies in SIV-infected monkeys. The heart, liver, spleen, lung, kidney, and lymph node of BALB/c mice, a strain of endothelial cell ECV304, and granulocytes were used as target antigens. These results were compared with HE stained slides of SIV-infected monkeys.</p><p><b>RESULTS</b>The levels of various autoantibodies, including anti-lymphocyte autoantibodies, anti-endothelial cell autoantibodies, and anti-granulocyte antibodies, increased after SIV infection in monkeys. Moreover, pathological examinations showed injuries in the lymphoid tissue and vascular pathological changes in cerebral cortex, submucosa of gastrointestinal tract, interstitial capillaries of myocardium, nephron of the kidney, and sinusoid cell of liver.</p><p><b>CONCLUSION</b>The increased autoantibodies and the pathological changes of tissues and organs confirm the existence of autoimmunity in SIV-infected monkeys.</p>

Expression of type II collagen gene and structural change in bone tissues of rats with experimental fluorosis / 中华预防医学杂志

<p><b>OBJECTIVE</b>To investigate the effects of excessive intake of fluoride on the expression of type II collagen gene and types and morphological change of collagen fiber in the bone tissues of rats.</p><p><b>METHODS</b>A rat model with fluorosis was established by adding 221 mg/L of sodium fluoride (NaF) to drinking water for the rats for 15 days, 30 days and two months, respectively. Type II collagen alpha1 (II) cDNA probe was prepared, and cDNA-mRNA in-situ hybridization was employed to detect change in expression of type II collagen mRNA in the bone tissues of rats with excessive intake of fluoride (221 mg/L NaF). Picrosirius-polarization method was used to observe types of collagen and morphology of collagen fiber in the bone tissues.</p><p><b>RESULTS</b>Chondroblasts were found in the femur and other bone tissues of the rats after exposure to fluoride. cDNA-mRNA in-situ hybridization showed that expression of type II collagen gene could be observed in the cytoplasm of chondrocytic lacuna and chondrified bone tissues. mRNA in collagen of chondrocytes of the rib cartilage reached the peak level 15 days after exposure to fluoride, and decreased gradually one month and two months after exposure. Polychromatic type II collagen, breakage of collagen fiber, disorder array and reduced content of type II collagen could be found in the bone tissues with picrosirius-polarization method.</p><p><b>CONCLUSIONS</b>Excessive intake of fluoride could lead to changes in types and structure of collagen (cross-linkage) of bone tissues, which caused expression of type II collagen gene in the chondrified bone tissues and enhanced its expression in the rib cartilage tissues.</p>