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OBJECTIVE To provide reference for standardizing the labeling of medication information for pregnant women and lactating women in the instructions of antiarrhythmic drugs. METHODS The instructions of antiarrhythmic drugs were collected from the terms of “medication reference ”on official website of Yimaitong Technology Co. ，Ltd. The labeling of medication information of pregnant women and lactating women were sorted out ，counted and analyzed with reference to the Detailed Rules for Specifications of Instructions of Chemical Drugs and Therapeutic Biological Products issued by the State Food and Drug Administration. RESULTS A total of 111 instructions of antiarrhythmic drugs were collected in this study ，of which 102 instructions were marked with “medication for pregnant women ”（91.89％），of which the proportion of those with medication guidance and without medication guidance were 75.68％ and 16.22％ respectively. Eighty-eight drug instructions were marked with the item “medication for lactating women ”（79.28％），of which the proportion of those with medication guidance and without medication guidance were 70.27％ and 9.01％ respectively. Among different categories of antiarrhythmic drugs ，the best labeling of “medication for pregnant women ”was class Ⅰ antiarrhythmic drugs （100％），while class Ⅲ drugs（25.00％）were most missing ； class Ⅳ antiarrhythmic drugs （94.44％）were the best labeled for “medication for lactating women ”，while class Ⅰ（26.47％）were the most missing . There were differences in the labeling contents of “medication for pregnant women ”and“medication for lactating women ”in some drug instructions of the same variety from different manufacturers. Among the 99 drug instructions of domestic pharmaceutical enterprises ， 92 listed the items of “medication for pregnant women”and“medication for lactating women ”，and the proportions of them with medication guidance were 74.75％ and 69.70％ respectively；among the 12 drug instructions of foreign pharmaceutical enterprises ，10（83.33％）listed the items of “medication for pregnant women ”and“medication for lactating women ”，and the proportion with medication guidance was 83.33％ and 75.00％ respectively. CONCLUSIONS There are some problems in the labeling content of domestic antiarrhythmic drug instructions，such as the lack of information related to “medication for pregnant women ”and“medication for lactating women ”， the confusion of guidance expression ， the inconsistent content of drug instructions of the same variety from different manufacturers，the lag of modification and update ，and the poor standardization of drug instructions. Drug supervision and administration departments and drug manufacturers should pay attention to them and constantly strengthen the management and standardization of instructions.
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Abstract@#Inoculation of COVID-19 vaccines is an important approach to preventing SARS-CoV-2 infections and reducing the severe disease and mortality of COVID-19. The elderly, children and adolescents, pregnant women, lactating women, patients with chronic diseases and immunocompromised individuals are considered to be susceptible to and at a high risk of COVID-19. Early, safe and effective inoculation of COVID-19 vaccines is critical for the successful building of the population immune barrier against COVID-19. This review, based on data from clinical trials, summarizes the safety and efficacy and safety of COVID-19 vaccines among special populations, so as to provide insights into COVID-19 vaccination among special populations.
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Direct-acting antivirals (DAAs) can achieve a high cure rates in most patients with hepatitis C, including many previously refractory patients, making it possible to eliminate hepatitis C. The prevalence of hepatitis C in high-risk populations is significantly higher than that in general population. Therefore, the micro elimination strategy of elimination of hepatitis C according to the characteristics of different high-risk groups may be a more practical and feasible way. Currently, the screening of HCV in some high-risk or special populations has been applied in China, such as dialysis patients, pregnant women, and patients with hepatitis B or human immunodeficiency virus infection. However, there are still other high-risk groups of hepatitis C that can’t be identified by the routine screening system due to their scattered distribution, the first diagnosis in the non-infectious department, the lack of understanding of hepatitis C by the medical staff, or belonging to the marginalized group, which have become the blind spots and difficulties in the elimination of hepatitis C. This article discusses the challenges in diagnosis and treatment of these special populations, in order to provide reference for public health workers and clinicians, especially doctors in non-infectious or hepatology departments to better carry out the screening, diagnosis and treatment of hepatitis C in China.
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The physiologically based pharmacokinetic (PBPK) model, as a physiological mechanism-based model, can simulate the absorption, distribution, metabolism and excretion of drugs in the body. In recent years, it has been widely used in drug-drug interaction study, special population extrapolation, clinical trial dose selection, individualized medication and impact of different factors on the pharmacokinetic course. This review briefly describes the history and current development of PBPK model, introduces the work flow of PBPK model, and reviews its application in drug clinical study in recent years. We hope this review could provide a reference for researchers who are interested in this field.
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Objective To understand the prevalence of Toxoplasma gondii infection among special populations in Nanjing City, so as to provide the reference for formulating the interventions for the prevention and control of T. gondii infections in this population. Methods The HIV/AIDS patients, tumor patients, pregnant women, and people with livestock and poultry breeding or processing works were selected as the study subjects from September to November 2015. The venous blood samples were collected from each participant for detecting IgG and IgM antibodies against T. gondii by ELISA. Results The overall prevalence of T. gondii infection was 10.2% in the study subjects in Nanjing City. The T. gondii infection rates were 12.2%, 11.3%, 4.0%, and 13.0% among the HIV/AIDS patients, tumor patients, pregnant women, and people with livestock and poultry breeding or processing works, respectively, and there was no statistically significant difference among the four groups (χ2 = 5.668, P = 0.130). The prevalence of T. gondii infection was higher in men than in women (15.3% vs. 5.8%; χ2 = 10.213, P = 0.001), and there were significant differences in the prevalence of T. gondii infection in terms of gender (χ2 = 9.501, P = 0.023), education levels (χ2 = 9.850, P = 0.043) or occupations (χ2 = 8.983, P = 0.062). Conclusions The infection rate of T. gondii among the special population in Nanjing City is high. Therefore, the health education intervention should be strengthened in the follow-up work for the special population.
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Objective To understand the prevalence of Toxoplasma gondii infection among special populations in Nanjing City, so as to provide the reference for formulating the interventions for the prevention and control of T. gondii infections in this population. Methods The HIV/AIDS patients, tumor patients, pregnant women, and people with livestock and poultry breeding or processing works were selected as the study subjects from September to November 2015. The venous blood samples were collected from each participant for detecting IgG and IgM antibodies against T. gondii by ELISA. Results The overall prevalence of T. gondii infection was 10.2% in the study subjects in Nanjing City. The T. gondii infection rates were 12.2%, 11.3%, 4.0%, and 13.0% among the HIV/AIDS patients, tumor patients, pregnant women, and people with livestock and poultry breeding or processing works, respectively, and there was no statistically significant difference among the four groups (χ2 = 5.668, P = 0.130). The prevalence of T. gondii infection was higher in men than in women (15.3% vs. 5.8%; χ2 = 10.213, P = 0.001), and there were significant differences in the prevalence of T. gondii infection in terms of gender (χ2 = 9.501, P = 0.023), education levels (χ2 = 9.850, P = 0.043) or occupations (χ2 = 8.983, P = 0.062). Conclusions The infection rate of T. gondii among the special population in Nanjing City is high. Therefore, the health education intervention should be strengthened in the follow-up work for the special population.
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Objective To investigate the prevalence of Toxoplasma gondii infection and related knowledge and behavior among special population in Changzhou City,so as to provide the evidence for formulating effective measures of toxoplasmosis prevention. Methods The pregnant women and patients with neoplasia in Changzhou hospitals,and livestock and poultry breeding or processing workers were selected as the subjects of the study. Venous blood samples were collected from each partici-pant for detecting IgG and IgM antibodies against T. gondii by ELISA. A questionnaire investigation on knowledge and behavior about T. gondii infection was conducted. Results Among the total 300 respondents investigated from March to May,2015,the prevalence of T. gondii infection was 16.3％(49/300). Totally 52 respondents knew the knowledge about the prevention and con-trol of T. gondii infection with an awareness rate of 17.3％(52/300). The proportion of participants who frequently contacted with cats/dogs(25.0％,13/52)in the group who knew the knowledge about the prevention and control of T. gondii infection was lower than that of participants(50.8％,126/248)in the group who did not know the knowledge about the prevention and control of T. gondii infection,and the difference was statistically significant(X2=11.51,P<0.05). The proportion of participants sepa-rating chopping boards for raw and cooked food(61.5％,32/52)in the group who knew the knowledge about the prevention and control of T. gondii infection was statistically higher than that of the participants(9.3％,23/248)in the group who did not know the knowledge about the prevention and control of T. gondii infection,and the difference was statistically significant (X2=78.43,P<0.001). There was a negative correlation between the awareness rate of the knowledge about the prevention and con-trol of T. gondii infection and the infection rate of T. gondii. The infection rate of T. gondii(5.8％,3/52)in the group who knew the knowledge about the prevention and control of T. gondii infection was lower than that(18.5％,46/248)of the group who did not know the knowledge about the prevention and control of T. gondii infection,and the difference was statistically significant (X2=5.14,P<0.05). Conclusions The awareness rate of the knowledge about the prevention and control of T. gondii infec-tion among special population in Changzhou City is low. The health education on the knowledge of the prevention and control of toxoplasmosis should be strengthened,in order to improve the awareness of personal hygiene and change the unhealthy lifestyles and dietary habits.
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The efficacy and safety of application of traditional Chinese medicines (TCMs) during the pregnancy is a hotspot among scholars. However, the traditional pregnancy contraindication content has certain historical limitations, and cannot meet the needs of the current pregnant women for rational drug use. We need to refine and interpret it with modern medical science. In this paper, we summarized the ancient and modern knowledge about pregnancy contradiction and tried to establish a grading safety system, based on the actual clinical practices and thte medication grading concept of western medicines. Specifically speaking, in this paper, we compared the connotations of forbidden/contradiction and cautious use, and focused on the safe herbs that included in the prescriptions for dietary therapy. Meanwhile, in this paper, we summarized the core content of the famous theories of ″You Gu Wu Yun (pregnancy disease)″ and ″Shuai Qi Da Ban Er Zhi (therapy during pregnancy)″, and studied the dangerous and unknown risk of TCMs during pregnancy. At last, a five-grade safety system of TCMs applied on the pregnant women was established, including forbidden, contraindicated, cautious, uncertain and available medicines. We classified medicines with the embryotoxicity (e.g. teratogenic, mutagenic, ageneisa), the traditional toxicity (e.g. abortion), the fierce herbal property (e.g. removing blood stasis, promoting Qi circulation) and reliable edible medicinal herbs. We also place an ″uncertain″ category based on objective reality. Meanwhile, 33 sample TCMs were preliminarily determined. This paper proposed the preference and ideas for the rational herbal use in pregnancy.
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Physiologically based pharmacokinetic (PBPK) modeling and simulation can be used to predict the pharmacokinetic behavior of drugs in humans using preclinical data. It can also explore the effects of various physiologic parameters such as age, ethnicity, or disease status on human pharmacokinetics, as well as guide dose and dose regiment selection and aid drug-drug interaction risk assessment. PBPK modeling has developed rapidly in the last decade within both the field of academia and the pharmaceutical industry, and has become an integral tool in drug discovery and development. In this mini-review, the concept and methodology of PBPK modeling are briefly introduced. Several case studies were discussed on how PBPK modeling and simulation can be utilized through various stages of drug discovery and development. These case studies are from our own work and the literature for better understanding of the absorption, distribution, metabolism and excretion (ADME) of a drug candidate, and the applications to increase efficiency, reduce the need for animal studies, and perhaps to replace clinical trials. The regulatory acceptance and industrial practices around PBPK modeling and simulation is also discussed.
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Objective To understand the prevalence of Toxoplasma gondii infection and related factors among special popu?lation in Changzhou City,so as to provide the evidence for formulating toxoplasmosis prevention measures. Methods The ve?nous blood was collected from participants in Changzhou City for detecting IgG and IgM antibodies against T. gondii by ELISA;and an epidemiological questionnaire investigation was also conducted. Results Among the total 400 respondents detected,the prevalence of T. gondii infection was 15.0%and the positive rates of IgG and IgM were 15.0%and 0.8%,respectively. The T. gondii infection rates of pregnant women,HIV/AIDS patients,patients with neoplasia,and livestock and poultry breeding and processing workers were 11.0%,11.0%,24.0%and 14.0%,respectively. As the age increased,the infection rate of T. gondii showed an upward trend,with the highest infection rate(21.6%)among the group of respondents aged above 50 years. The in?fection rates of groups with different education levels were statistically different(χ2=11.443,P<0.05),and there was a trend that the infection rate decreased with the increase of education level. The prevalence of T. gondii infection in pregnant women was not significantly associated with the number of pregnancies and gestational age. The infection rate of T. gondii in the live?stock and poultry breeding and processing workers increased with the length of their working years. Conclusions The preva?lence of T. gondii infection among the special population in Changzhou City is high. Therefore,it is necessary to enhance the health education on the knowledge and information of prevention and control of toxoplasmosis,and to improve the awareness of personal protection,the hygiene practices and diet habits. In addition,more attention should be paid to T. gondii monitoring in the special population.
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Objective:To explore the role of clinical pharmacists in the development of individualized drug treatment regimens for the osteosarcoma children with irregular body weight .Methods:Clinical pharmacists involved in the calculation of body weight surface area increased to that of adult for one case of osteosarcoma child during the chemotherapy , comparatively analyzed the suitable calcula-tion formula of surface area for the children in our country and helped clinicians make accurate dose of chemotherapy drugs .Mean-while, according to the pathological and physiological characteristics of the child , clinical pharmacist also provided advice on adjuvant drug use such as antiemetic regimen etc .Results:Physicians adopted the suggestions of clinical pharmacists and the chemotherapy was successfully completed .Overdose adverse reactions were avoided without the use of foreign general calculation formula of body surface area for the overweight child , and inadequate dose was also avoided for the conservative treatment , which could lower the risk of re-duced potential anticancer efficacy .Conclusion:Clinical pharmacists can help doctors perform safer and more effective drug treatment program and reduce adverse drug reactions in the treatment of special patients through participation in the development of individualized medication for cancer children to obtain maximum profit .
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Quinolones are widely used due to the wide antimicrobial spectrum and strong activity .The common adverse reactions of quinolones include gastrointestinal disturbances ,central nervous system reaction ,skin reaction ,etc .These adverse reactions are mild in severity and self-healing .Since some agents were withdrawn from the market due to severe adverse effects ,we should pay more attention to quinolones .Both internal and abroad literatures were reviewed ,the adverse effects , the high risk factors of the adverse effects and the application in special population were summarized to provide reference for ra-tional clinical drug use .
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Los antimicrobianos constituyen un grupo de medicamentos ampliamente utilizado en el mundo. Son muy eficaces en el tratamiento y control de las enfermedades infecciosas; pero como todos los fármacos pueden al mismo tiempo provocar efectos secundarios, sobre todo cuando se utilizan en poblaciones especiales, como lo es la población pediátrica. Es por tal motivo que se desarrolló esta revisión de la literatura con el objetivo de profundizar en el conocimiento de estos medicamentos y las características para su uso en esta población, lo que permita lograr una terapéutica eficaz y al mismo tiempo segura
Antimicrobials constitute a group of drugs that are widely used worldwide. They are very effective in both the treatment and control of infectious diseases but, as all drugs, they can also have secondary effects, mainly when they are used in a special population such as the paediatric one. This is the reason why this literature review was made. The review is aimed at going deeper into the knowledge of these drugs and their characteristics for their use in this population to achieve an effective and safe therapy
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Humans , Male , Female , Child, Preschool , Child , Adolescent , Anti-Infective AgentsABSTRACT
O estudo teve como objetivo realizar uma revisão da literatura publicada na última década sobre orientação profissional (OP) de pessoas com deficiências. As publicações, selecionadas, em bases de dados eletrônicas, somaram 55 referências entre, artigos (n = 41), teses e dissertações (n = 6), capítulos de livros (n = 2) e livros (n = 6), foram divididas em nacionais e estrangeiras e os dados comparados. A análise dos dados focalizou o tipo de suporte da produção, a natureza dos trabalhos, a faixa etária da população-alvo, o modelo teórico e metodológico e as características do processo de OP. Os resultados apontaram o predomínio de artigos em periódicos das áreas de Psicologia e Educação, referentes a pesquisas de levantamento sobre jovens adultos atendidos individualmente em OP, com abordagem comportamental ou psicanalítica e com pouca ênfase no processo. São apontadas algumas lacunas e indicados alguns limites da pesquisa.
The study aimed to conduct a review of the literature published in the last decade on vocational guidance of persons with disabilities. Publications, selected from electronic databases, totaled 55 references including articles (n = 41), theses and dissertations (n = 6), book chapters (n = 2) and books (n = 6) and were organized into national and international data and compared. Data analysis focused on the kind of production support, the nature of the work, the age of the target population, the theoretical model and methodology and the characteristics of the process of vocational guidance. The results showed a predominance of papers in the areas of Psychology and Education relating to survey research on young adults attended individually in vocational guidance, based on the behavioral or the psychoanalytic approach, with little emphasis on the process. Some gaps and limitations of the research were pointed out.
El estudio tuvo el objeto de realizar una revisión de la bibliografía publicada en la última década sobre orientación profesional (OP) de personas con deficiencias. Las publicaciones seleccionadas de bases electrónicas de datos sumaron 55 referencias entre artículos (n = 41), tesis y disertaciones (n = 6), capítulos de libros (n = 2) y libros (n = 6). Se dividieron en nacionales y extranjeras y se compararon los datos. El análisis de los datos se centró en el tipo de soporte de la producción, la naturaleza de los trabajos, la franja etaria de la población blanco, el modelo teórico y metodológico y las características del proceso de OP. Los resultados indicaron el predominio de artículos en periódicos de las áreas de Psicología y Educación referentes a investigaciones de encuestas sobre jóvenes adultos atendidos individualmente en OP, con enfoque de comportamiento o psicoanalítico y con poco énfasis en el proceso. Se observan algunas lagunas y se señalan algunos límites de la investigación.
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Career Choice , Education of Intellectually Disabled , Persons With Hearing Impairments , Visually Impaired Persons , Vocational GuidanceABSTRACT
OBJECTIVE: To investigate the tagging condition in medication of special population in package inserts in order to give reference for rational drug use of special population. METHODS: 389 pieces of common Chinese and western medicine package inserts of our inpatient and out-patient dispensaries were randomly collected and analyzed statistically in terms of the content of package inserts for special population, including pregnant and lactant women, children and the aged. RESULTS: A part of medication items of special population in package inserts had deficiency. According to the classification of dosage form, the tagging rate of injection exceeded other dosage forms reached to more than 90%, except of medication items for children. The tagging rate of oral formulation arrived at more than 90% only in terms of contraindications and cautions. According to the classification of manufacturer, the tagging rate of domestic drugs was kept at the low level while that of imported drugs exceeded 90%. CONCLUSIONS: Package inserts need to be improved with the effort of drug supervision management department, drug production department and population of using drugs to guarantee the safety of drug use in special population.