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The paper is to explore how to carry out post-market technical evaluation of dietary supplements in China by referring to the experiences at home and abroad. Experiences of major countries and regions in the post-market evaluation of similar products of dietary supplements and China’s experience in drugs were systematically reviewed. Combined with the actual situation of the health food industry in China， suggestions were put forward for the post-market technical evaluation of health foods in China. There are many useful experiences worth learning from， such as the mandatory reporting responsibility of enterprises in the United States， a special scientific committee which provides long-term technical support in the European Union， post-market monitoring by enterprises in Australia， the establishment of relevant monitoring systems in Taiwan， the relatively mature regulatory system， evaluation system and management system in the field of drugs and medical devices， and the establishment of adverse reaction monitoring bases in the field of cosmetics， the responsibility of post-mark adverse reaction monitoring of food for special medical purposes by medical institutions， and the post-market management in various fields giving priority to safety. In combination with the current situation of China’s health food industry， five specific suggestions， such as promoting the construction of laws and regulations， are put forward.
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We report the management and maternal and neonatal outcomes of four cases of delayed interval delivery after cervical cerclage in twin pregnancies, who hospitalized in Shanghai First Maternity and Infant Hospital from year 2017 to 2018. Four patients with dichorionic diamniotic twin pregnancies all presented with gradually weakened uterine contractions after spontaneous vaginal delivery of twin 1. After informed consent, the patients received cervical cerclage at 2 to 3 days after delivery when the maternal and fetal conditions were stable, to delay delivery of twin 2. The gestational weeks at delivery of twin 1 were 25 +4, 23 +1, 27 +1, and 23 weeks, which were noted for 30 +1, 32 +6, 31 +4, and 24 weeks for twin 2, respectively. Delayed delivery intervals were 32, 69, 31 and 7 d. Three of the four twin 2 survived, with Apgar score ≥ 8 at 1 minute and birth weight of 1 390, 2 290 and 1 620 g. During a 2-year follow-up, no developmental abnormalities were observed in the children, and no serious maternal complications were found, including severe infection, bleeding or cervical laceration.
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Objective:To explore the influence of mindfulness meditation intervention on the professional identity and turnover tendency of the second victim of nurses.Methods:The convenience sampling method was used to select the second victim of 46 nurses who experienced medical adverse events within six months from January to June 2019 in Zhongnan Hospital of Wuhan University, and then an 8 weeks of mindfulness meditation intervention was carried out for them. In the entire intervention process, a self-control study was conducted, the Second Victim Experience and Support Scale (SVSET) and the Nurse Occupational Identity Scale were used to assess nurses' turnover intentions, absence and professional identity before the intervention and at 2 hours, 4 weeks, and 8 weeks after the intervention.Results:By analyzing the data, the results showed that after the mindfulness meditation intervention, the second victim of the nurse before intervention, 2h, 4 weeks, and 8 weeks of intervention were 3.28±0.87, 3.20±0.83, 2.85±0.92, 2.71±0.87, the difference was statistically significant ( F time value was 6.609, P<0.05). Before and after the intervention of the sense of grasp in professional identity were 4.91±0.83, 5.47±0.81, 5.83±0.91, 5.94±0.80, the difference was statistically significant ( F time value was 20.973, P<0.01). Consensus before and after intervention were 4.61±0.78, 5.09±0.85, 5.54±1.12, 5.76±0.85, the difference was statistically significant ( F time value was 22.237, P<0.01). The meaningful sense before and after intervention were 4.38±1.03, 5.04±0.75, 5.44±0.86, 5.59±0.76, the difference was statistically significant ( F time value was 23.656, P<0.01). The self-efficacy before and after intervention were 4.71±0.82, 5.33±0.63, 5.83±0.84, 5.90±0.77, the difference was statistically significant ( F time value was 28.866, P<0.01). The self-determination before and after intervention were 4.43±0.97, 5.06±0.81, 5.59±0.91, 5.62±0.87, the difference was statistically significant ( F time value was 25.237, P<0.01). Before and after intervention, the influence of tissue was 4.17±0.96, 4.71±0.85, 4.96±0.99, 5.30±0.88, the difference was statistically significant ( F time value was 16.487, P<0.01). Before and after intervention, the patients' feelings were 4.59±0.96, 5.08±0.84, 5.70±0.83, 5.83±0.68, the difference was statistically significant ( F time value was 25.406, P<0.01). Conclusion:This article provides an effective method to help nurses' second victims out of their predicament which confirms that mindfulness meditation intervention can effectively reduce turnover tendency of nurses 'second victims and improve their professional identity.
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Objective:To explore the effect of mild cognitive impairment on the subjective well-being of the elderly and the mediating role of self-efficacy in it. To provide an effective basis for health management and clinical intervention in the elderly with mild cognitive impairment.Methods:A total of 164 patients with mild cognitive impairment from December 2018 to June 2019 were surveyed by the General Self-efficacy Scale, the Montreal Cognitive Assessment Scale, and the Memorial University of Newfoundland Scale of Happiness Scale.Results:The overall score of self-efficacy was 21.41±3.98, and subjective well-being was 26.44±7.35. There was a positive correlation among cognitive function, self-efficacy and subjective well-being, except that there was no significant correlation between self-efficacy and cognitive function( r values were 0.263-0.687, P<0.01). Self-efficacy played a part in mediating between cognitive function and subjective well-being in patients with mild cognitive impairment, accounting for 37.8% of the total effect. Conclusions:Mild cognitive impairment can also have a negative impact on the subjective well-being of the elderly. Among them, self-efficacy plays a particularly important role in mediating. Interventions about self-efficacy on the elderly with mild cognitive impairment may have more significant effects.
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Objective@#To develop a new practical ampule cutter with simple operation.@*Methods@#According to the actual clinical situation, the structure of the ampoule cutting device were designed, which was mainly divided into three parts: the handle, the ampoule cutting tube and the ampoule cutting device.@*Results@#The device can effectively cut the bottleneck of ampoule bottle and avoid the injury of sharp instrument and drug contamination caused by traditional breaking the bottleneck of ampoule bottle.@*Conclusion@#This kind of ampoule cutter can break the bottleneck of ampoule effectively, avoid the cross infection of medical staff, improve the work efficiency of medical staff and the effective utilization rate of medicine.
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Objective To develop a new practical ampule cutter with simple operation. Methods According to the actual clinical situation, the structure of the ampoule cutting device were designed, which was mainly divided into three parts: the handle, the ampoule cutting tube and the ampoule cutting device. Results The device can effectively cut the bottleneck of ampoule bottle and avoid the injury of sharp instrument and drug contamination caused by traditional breaking the bottleneck of ampoule bottle. Conclusion This kind of ampoule cutter can break the bottleneck of ampoule effectively, avoid the cross infection of medical staff, improve the work efficiency of medical staff and the effective utilization rate of medicine.
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Objective To translate the Iconographical Falls Efficacy Scale (Icon-FES)and verify its reliability and validity in community-dwelling older people. Methods After obtaining authorization, the Icon-FES was initially developed according to the guidelines for cross-cultural adaptation. Adopting a convenient sampling method, from December 2017 to March 2018, 450 older adults from 2 communities in Wuhan City were selected to fillgeneral information questionnaire, iconographical falls efficacy scale(Icon-FES)and falls efficacy scale-international(FES-I). Results The Cronbach α coefficient of Icon-FES was 0.972( the shorten Icon-FES was 0.902);split-half reliability was 0.947; retest reliability coefficient was 0.951. Based on the rotation factor component matrix and scree plot, 2 common factors were selected and the cumulative variance contribution rate was 67.33％.The Spearman rank correlation coefficient between Icon-FES and FES-I was 0.663. Conclusion Icon-FES has good reliability and validity in measuring the fear of falls in the community, especially for the elderly with low cultural level and strong activity in China. The shorten Icon-FES is also one of the quick and simple tools.
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Objective@#To simplify the Mental Quality Inventory for Nurses (MQIN), and evaluate its reliability and validity.@*Methods@#The second sampling to include the 1 067 nurses from 5 third-class hospitals were investigated to screen items using dispersion tendency, independent-samples t test, coefficient correlation, factor analysis, Cronbach α coefficient and expert consultation. The reliability was evaluated by Cronbach α coefficient, the correlation coefficient of each dimension with scale to evaluate its content validity, the exploratory factor analysis to evaluate its structural validity.@*Results@#The simplified scale (MQIN-72) includes 72 items belonging to 5 dimensions, and accounted for 55.378% of the accumulated variances. The Cronbach′ s α coefficient was 0.856, the content validity index was between 0.599 and 0.903,@*Conclusions@#The simplified MQIN scale with excellent reliability and validity, this scale can be used as one of simple screening indexes for nurse′ s selection, cultivation and engagement.
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[Objective] To explore the relationship between brittle diabetes and yin fire, so as to more comprehensively understand fragile diabetes from TCM, broaden the clinical diagnosis and treatment, and improve the clinical curative effect. [Methods] The theory of yin-fire theory was summarized, and the relationship between brittle diabetes and yin-fire was expounded from the aspects of academic origin, pathological basis, clinical manifestation and so on, proposed treatment principles and prescriptions.[Result] The yin fire theory originated from Nei Jing. Yin and yang do not rise, wet muddy bets, endogenous fire, the fire is too weak. Fever is the reason for the formation of diabetes, Yin fire is an important reason for fluctuations in blood sugar; brittle diabetes expelling Bu Zhong Yi Qi, lifting fine, Xie Yin fire, from Dongyuan Qingshu Yiqi Decoction to the treatment of fragile diabetes sugar made a good effect. [Conclusion] The theory of yin fire has important practical significance for diabetes, especially brittle diabetes. It is a new idea and method to treat brittle diabetes by the thought and method.
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Objective To evaluate the clinical efficacy of small endoscopic sphincterotomy combined large-bal-loon dilation in treatment of common bile duct stones 1.0~2.5 cm in diameter. Methods 426 patients with large common bile duct (CBD) stones 1.0~2.5 cm in size were reviewed in our hospital between June 2010 and June 2014. They were randomized underwent small endoscopic sphincterotomy combined large-balloon dilation (SESPLBD) (n=218) or endoscopic sphincterotomy (EST) ( n= 208) for lithotripsy. The therapeutic outcome and complications were reviewed and compared. Results SESPLBD had higher complete duct clearance in one session (95.41 % vs. 93.75%), but there was no statistical significant difference. Bleeding was much less occurred in SESPLBD than in EST (2.29 % vs. 7.69 %, P= 0.025), especially when the stones were bigger than 1.5 cm in diameter. Mechanical lithotripsy was performed less in SESPLBD (13.76%vs 25.96 %, P=0.002), especially when the stones were 1.5 ~2.0 cm in diameter. There was no statistical significant difference in the incidence rate of post-ERCP pancreatitis (9.17 % vs. 6.73 %,P = 0.452), hyperamylasemia (19.72 % vs. 18.27 %,P = 0.796), perforation and death. Conclusions SESPLBD could be a safe method for large bile duct stones 1.0~2.5 cm in size. Compared with routine EST, it had less bleeding rate and mechanical lithotripsy requirement without increasing the incidence rate of post-ERCP pancreatitis or hyperamylasemia.
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Glutamate decarboxylase (GAD) can catalyze the decarboxylation of glutamate into γ-aminobutyrate (GABA) and is the only enzyme of GABA biosynthesis. Improving GAD activity and thermostability will be helpful for the highly efficient biosynthesis of GABA. According to the Ramachandran plot information of GAD 1407 three-dimensional structure from Lactobacillus brevis CGMCC No. 1306, we identified the unstable site K413 as the mutation target, constructed the mutant GAD by site-directed mutagenesis and measured the thermostability and activity of the wide type and mutant GAD. Mutant K413A led to a remarkably slower inactivation rate, and its half-life at 50 °C reached 105 min which was 2.1-fold higher than the wild type GAD1407. Moreover, mutant K413I exhibited 1.6-fold higher activity in comparison with the wide type GAD1407, although it had little improvement in thermostability of GAD. Ramachandran plot can be considered as a potential approach to increase GAD thermostability and activity.
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Glutamate Decarboxylase , Metabolism , Half-Life , Industrial Microbiology , Levilactobacillus brevis , Mutagenesis, Site-Directed , Mutation , TemperatureABSTRACT
Objective The sirolimus-eluting stent (SES) has dramatically reduced the rate ofrestenosis in comparison to that with the bare-metal stent (BMS).This study aimed to evaluate the short-term efficacy and safety of Firebird stent implantation for patients with coronary heart disease (CHD). Methods From Apri12006 through July 2007, 155 patients (mean age 58.93～10.27 years) with CHD were implanted with Firebird stent or Cypher select stent at Daxing Hospital. Patients were followed up for one year. All-cause mortality, major adverse cardiac events (MACE, including cardiac death, myocardial infarction, recurrence of angina pectoris, heart failure, revascularization, and adverse arrhythmia) and stent thrombosis were compared between the 2 groups. Results Of the 155 consecutive patients, 147 patients were revascularized completely. Of these patients, 48 (with 59 lesions) were treated with Firebird stent, 59 patients (with 75 lesions) with Cypher select stent. The demographic characteristics were similar in the 2 groups. All the angiographic and procedural results were not significantly different between the 2 groups. All-cause mortality, myocardial infarction, recurrence of angina pectoris, MACE and stent thrombosis were almost identical between the 2 groups before discharge, at 6 months and at one year .Conclusion The short-term efficacy and safety of Firebird stent are similar to that of the cypher select stent for the treatment of patients with CHD.
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Objective To study the clinical features and operative methods for patients with hepatic tuberculosis.Methods The clinical features、diagnosis、operative methods and the location of tuberculosis focus in the liver were analysed in 8 patients.Results Difinite preoperative diagnosis could be reached in none of the 8 patients.Surgical procedure included focus remove (5 cases) and deroof plus drainage (3 cases).The diagnosis of hepatic tuberculosis was proved by pathological examination.Conclusions Surgical resection plus anti-tuberculosis drugs are the mainstay for the treatment of patients with hepatic tuberculosis.
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Objective To study the clinical features and treatment on hepatocellular carcinoma(HCC) with obstructive jaundice as primary symptom. Method We collected 39 cases of patients of HCC with obstructive jaundice as primary symptom in our hospital,the clinical features and treatments were studyed.Results The incidence of such patients was 6.3% in all HCC patients and all patients were operaed;the positive diagnostic rate of B ultrasonud and T was 88.2% and 80% respectively ,it was 48.7% in cases with intraportal thrombi.Conclutions Preperative correct diagnosis depends on image test,hepatectomy with biliary duct drainage is the mainstay for treatment .
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Objective To evaluate the clinical and pathological features and treatment of primary hepatocellular carcinoma invading on to the bile duct.[WT5”HZ]Methods [WT5”BZ]39 cases of hepatocellular carcinoma of icteric type were collected in our hospital.[WT5”HZ]Results [WT5”BZ]The incidence was 6% in all hepatocellular carcinoma patients.Preoperative correct diagnosis was achieved in only 33% of the 39 cases.The positive diagnostic rate of B ultrasound and CT was 88% and 80%respectively,and 49% of cases suffered from intraportal thrombi concomitantly.[WT5”HZ]Conclusion [WT5”BZ]Preoperative correct diagnosis depends on image test,hepatectomy with biliary duct drainage is the mainstay for treatment.
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Objective To study the clinical features and operative methods for patients with hepatic tuberculosis.Methods The clinical features、diagnosis、operative methods and the location of tuberculosis focus in the liver were analysed in 8 patients. Results Difinite preoperative diagnosis could be reached in none of the 8 patients. Surgical procedure included focus remove (5 cases) and deroof plus drainage (3 cases). The diagnosis of hepatic tuberculosis was proved by pathological examination. [WT5”HZ]Conclusions Surgical resection plus anti tuberculosis drugs are the mainstay for the treatment of patients with hepatic tuberculosis.