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Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.
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Reference Standards , China , IndustryABSTRACT
Objective:To analyze the clinical characteristics and risk factors of ischemic stroke in young adults.Methods:A retrospective analysis was conducted on 80 ischemic stroke patients (age ≤45 years) admitted to Beijing Tiantan Hospital from March 2019 to October 2019 as the young stroke group, and 117 ischemic stroke patients (age >45 years) hospitalized during the same period as the middle-aged and elderly stroke group. The blood test indexes of the two groups were compared, and the risk factors related to stroke, including smoking history, drinking history, hypertension, hyperlipidemia and diabetes history, were compared and analyzed. Two sets of independent sample t-test, Mann-Whitney U-test or χ2 test were used to compare the above indicators of patients in the two groups. Results:The activated partial prothrombin time, protein S, uric acid, homocysteine and D-dimer levels in middle-aged and elderly stroke group were (29.73±3.40) s, (105.58±27.23) %, (297.29±85.99) μmol/L, (17.58±14.45) μmol/L and (2.75±3.08) mg/L, respectively. Compared with the middle-aged and elderly stroke group, the young stroke group had higher activated partial thrombin time (31.51±6.75) s, protein S (115.20±26.97) %, uric acid (326.82±93.51) μmol/L, homocysteine (22.63±16.98) μmol/L and lower D dimer level of (1.19±2.88) mg/L compared with the elder group, the difference between the two groups was statistically significant ( t values were 2.17, 2.01, 2.20, 2.14 and 2.13, respectively, P values were 0.032, 0.046, 0.029, 0.039 and 0.034, respectively). The positive rate of lupus anticoagulant in young stroke group was 12.5% (4/32), which was higher than 1.8% (1/57) in middle-aged and elderly stroke group, and there was significant difference between the two groups (χ 2=4.46, P=0.035). The proportions of smoking and drinking in young stroke group were 63.8% (51/80) and 62.5% (50/80), respectively, which were higher than 49.6% (58/117) and 47.9% (56/117) in middle-aged and elderly stroke group, and there was significant difference between the two groups (χ 2 values were 3.86 and 4.09; P values were 0.04 and 0.04). The proportion of hypertension and diabetes in young stroke group was 48.8% (39/80) and 17.5%(14/80), respectively, which were lower than 63.2%(74/117) and 30.8%(36/117) in middle-aged and elderly stroke group, and there was significant difference between the two groups (χ 2 values were 4.08 and 4.56; P values were 0.043 and 0.033). According to the levels of uric acid and homocysteine, young stroke was divided into different subgroups and compared.The creatinine level of high uric acid group (≥416 μmol/L) was (90.08±28.46) mmol/L, which was higher than that of normal uric acid group (<416 μmol/L) of (63.37±22.2) mmol/L. There was significant difference between the two groups ( t value was 2.23, P value was 0.046). The levels of fibrinogen and creatinine in high homocysteine group (≥15 μmol/L) were (3.27±1.09) g/L and (72.13±28.69) mmol/L, respectively which were significantly higher than those in normal homocysteine group (<15 μmol/L) of (2.78±0.67) g/L and (58.92±12.08) mmol/L, There was significant difference between the two groups (the t values were 2.32 and 2.51; P values were 0.023 and 0.014). Conclusions:Compared with middle-aged and elderly stroke, young ischemic stroke has higher levels of prothrombin time, protein S, uric acid and homocysteine, lower levels of D dimer and higher positive rate of lupus anticoagulant. At the same time, the proportion of smoking and drinking was higher in young stroke group, but the proportion of hypertension and diabetes was relatively lower.
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The information-based management of medical device standards is of great significance for promoting the development of the medical device standardization. Here we analyzed the important role of the information-based management of medical device standards in the delicacy management of the whole process of establishing and modifying medical device standards, introduced its present situation and upgrade of information-based management system of medical device standards, and put forward work ideas and suggestions for it.
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Equipment and Supplies , Reference Standards , Information Management , Reference Standards , Reference StandardsABSTRACT
<p><b>OBJECTIVE</b>To compare the effect differences between auricular intradermal needling combined with erjian (HX) bloodletting and oral administration of western medicine, and to explore the efficacy of neuroendocrine level in patients with perimenopausal insomnia.</p><p><b>METHODS</b>Ninety patients were randomized into an observation group and a control group, 45 cases in each one. In the observation group, auricular intradermal needling combined with erjian (HX) bloodletting were adopted alternately in the two ears. The auricular points were shen (CO), xin (CO), gan (CO), shenmen (TF), jiaogan (AH), neifenmi (CO) and erjian (HX). The treatment was required once 3 days on the auricular points of one side alternatively. Oral administration of estazolam (1mg each day) was applied in the control group for 2 courses, 4 weeks as 1 course, once a day. The scores of Pittsburgh sleep quality index (PSQI), the levels of serum estrogen (E), 5-hydroxy tryptamine (5-HT) and norepinephrine (NE) were valuated in the two groups before and after treatment.</p><p><b>RESULTS</b>After treatment, the total scores of PSQI reduced in the two groups (both <0.05), and the improvements of sleeping quality, sleeping time, sleeping difficulty, daytime dysfunction and the total PSQI score in the observation group were superior to those in the control group (all <0.05). There was no significant difference in serum E before and after treatment in the two groups，and between the two groups after treatment (all >0.05). After treatment, 5-HT contents increased and NE levels decreased in the two groups (all <0.05), with better results in the observation group (both <0.05). The total effective rate was 95.6% (43/45) in the observation group, which was higher than 82.2% (37/45) in the control group (<0.05).</p><p><b>CONCLUSION</b>Auricular intradermal needling combined with erjian (HX) bloodletting can improve the sleep quality of patients with perimenopausal insomnia, and adjust the neurotransmitter level, which achieves better effect than western medication.</p>
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Medical device standards provide effective technique foundation for supervision to ensure medical device safety for the people. With the optimization and upgrading of the medical device industry, the medical devices standard system including law and regulation system, organization management system, and technical management system has been advanced and developed. According to the requirements of the development of medical device industry and its standards, we put forward four working ideas, in order to improve the scientificity and applicability of medical device standards.
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Equipment Safety , Equipment and Supplies , Reference Standards , Industry , Reference StandardsABSTRACT
Objective To investigate the clinical characteristics,treatment and prognosis of senile epilepsy. Methods The clinical characteristics of 180 elderly patients with epilepsy were retrospectively studied. Results The common causes of senile epilepsy were cerebrovascular disease (8 cases,4.4％),brain tumor(24 cases,13.3％),brain trauma and operation (18 cases,10.0％),brain atrophy (6 cases,3.3 ％ ),The most type of seizures were focal seizures (106 cases,58.9 ％) or focal seizures preceding a generalized (62 cases,34.4％). Electroencephalogram (EEG) usually showed focal slow wave activity or rhythm.Most of seizures were responsive well to single antiepilepsy drug. Conclusions The causes of elderly epilepsy are cerebrovascular disease,brain tumor,brain trauma, brain operation, brain atrophy. Senile epilepsy is more likely to have symptomatic and focal seizures,and can be controlled by anti-epilepsy drugs.
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Objective To explore the clinical and electroencephalographic characteristics of frontal lobe ep- ilepsy(FLE).Methods The clinical and electroencephalographic data of 80 patients with FLE were analyzed.Re- suits The seizure types of frontal lobe epilepsy were simple focal seizure-complex focal seizure and secondary gen- eral tonic.clonic seizure.Seizures were often exhibited in relatively short duration,hyper motor,tonic or postural.Fre- quent nocturnal attacks and slight postictal mental confusion was increased.Interictal EEG manifested sharps or spikes or slow wave in the frontal area.Ictal EEG showed paroxysm rhythms.Conclusion FLE is a distinct epilepsy syndrome.
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Objective To define laboratory technology for expression and purification of nucleocapsid proteins of human coronaviruses SARS-CoV,HCoV-229E,HCoV-OC43,HCoV-NL63 and HCoV-HKU1,animal coronaviruses bovine coronavirus,murine hepatitis virus,feline infectious peritonitis virus,and infectious bronchitis virus.MethodsThe pET-30a-based recombinant plasmids containing full length nucleocapsid(N) protein of coronaviruses were transformed into E.coil BL21(DE3) competent cells and were induced to express N proteins by IPTG.The expression products were purified by ion exchange chromatography and Ni2+ affinity chromatography,and were verified by SDS-PAGE and Western blot.Results Nine coronavirus nucleocapsid proteins with correct Mr were solubly expressed and highly purified with purity over 90%.Conclusion Successfully expressed nine recombinant nucleocapsid proteins with high purity in E.Coli,which provides materials to study the function of these coronavirus N proteins.
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ObjectiveTo assess the efficacy and the immunological memory of plasma-derived hepatitis B vac- cine 11 years after the initial inoculation. Methods A randomized, double-blind and placebo-controlled trial design was used. Results The immunogenicity and protection rate of the vaccine were good 1 1 years after vaccination, how- ever, from 9 to 11 years after vaccination, the perscn year HBV infection rate showed no noticeable difference be- tween the vaccine group and placebo-controls. Furthermore, the immunological memory remained 11 years after in- oculation, but was significantly lower than that observed in the past 10 years. Conclusion Vaccine protection wanes over the years. More information is needed to define the appropriate time for vaccine booster doses.
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Objective In order to observe the efficacy of low-dose in the third injection of hepatitis B vaccine. Methods 126 children aged 5～9 years were enrolled in a double-blind, place-controlled and randomized field trial. They were randomly divided into 10μg and 20μg dose group, and were redivided into 2μg, 5μg, 10μg, 20μg or non-in jected subgroups when the third booster injections were given. Results During the 9 years follow-up, the differences of the anti-HBs levels(GMT) among the groups were not significant at every time (P ＞ 0. 05). The GMTs at the ninth year(T108) were 7. 0, 6. 4, 9.9, 6.1, 9.7, 5. 4 and 7.4, respectively (P＞ 0. 05). The HBV infection rates among the groups had no significant difference (P ＞ 0. 05). The protective rates in the groups were all higher than 75％ at T108. Conclusion According to the data, it can be concluded that the third injection with low-dose has no influence on the vaccine efficacy(either short-term or long-term efficacy).
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A serocpidemiologic study was conducted to approach the relation between HBV infection and PLC. In PLC patients, the positivity rates of HBsAg and anti-HBc are higher than that in the tumor and donors groups, but that of anti-HBs is lower. No significant difference between the HBV infections rates for PLA patients and donors was found. HBV infections pattern of patients with liver cirrhosis is very close to that of those with PLC.The outcome prompts that there is a relation between HBV infection and PLC, but it is not only one.
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HBV infection markers were oberved in the feaces of 25 newly-infected persons and 11 asymptomatic carriers, In all the 36 subjects, HBsAg was detected, with a detectable rate of 72.2%; according to the number of feaces samples, the positive rate of HBsAg was 35.2%(57/162). Of the samples of those who had HBsAg detected, the positive rate of HBeAg was 24.7%(23/93), and HBV-DNA was positive in 2 of 51 HBsAg positive samples. With immunoelectromicroscope round particles of larger clustering HBsAg were found in most of feaces samples; bacause of the use of ultracentrifugal method and monoclonal anti-HBs, their shape and size were the same as those found in HBsAg positive serum.
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74 primary hepatocellular carcinoma patients (PHC) and 75 controls are tested for HLA and investigated heritability. The results showed the frequency of Bw39 antigen was significantly higher in PHC patients than that in the controls. (Fisher P0.05); but the frequeney of Bw60 antigen, was lower (Fisher P0.05 ). The result of heritability proved the role ofgenetic factor in PHC development.
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With decision tree model, both net utility and cost-benefit were analysed to comprehensively assess hepatitis B vaccination strategy in China. The result showed that neonates shoulUbe taken as the most favourable vaccinated population, infants aged 0～3 years the next, and immediate vaccination scheme was recommended. Although vaccination would result in negative benefit in the population aged 7 and over, certain net utility was also gained, Therefore we suggest that the subjects to be vaccinated be extended in due course.
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A total of 5874 residents in Xian urban and rural districts were examin-ed for the survey of viral hepatitis in October, 1979-February, 1980. Therate of infection from the asymptomatic carriers of HBsAg was found to be5. 0% in total, being higher in the rural district than in the urban andhigher in male than in female. The rate in the carriers of 15-30 yearswas the highest of all and had a tendency to decrease in the carriers ofover 40. However, the positive rate in the carriers of 0-3 years was the low-est of all. It has been showed that the transmission of HBsAg from motherto infant might not be the main mode of spread in the districts. There wasa higher rate in the peasants and college students. All this indicated thatyoung people played a more important role in spreading the disease. As for the sources of infection, the asymptomatic carriers of HBsAgwere not only larger in amounts but more in the positive rate. The HBsAgtiter of carriers by RPHA was markedly higher than the titer of patients.With regard to the rates of HBeAg, it seems that carriers are the same withpatients. Furthermore, the carrier's household had a higher prevalence ratethan the control groups. As has been mentioned above, we considerab thatthe role of carriers as source of infection should no longer be suspected.
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A baseline seroepidemiologic study of HBV infection was conducted in 1384 people in Xi'an, The results show that in kindergarten children the prevalence rates of anti-Hbs and seropositivity (at least one of HBV markers detectable) are significantly lower than those in school children and adults. In children above 8 years of age both rates mentioned above are very close to those of adults. To conclude these, we put forward the following points for the decision making of hepatitis B vaccination in our country: (1) Hepatitis B vaccine should be given as soon as possible to all infants or newborns. (2) In children under 3 years of age, a no screening vaccination program should be extended. As to what the vaccination program for children above 3 years of age should be and whether a hepetitis B vaccination should be done or not in school children, further studies are to be carried out. The study also provides bases for the feasibility of using one or two HBV serologic markers in large scale population screening before vaccination.