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Objective@#To understand the current situation of suicide attempts in middle school students and to explore its relation with adolescent parent attachment, to provide a basis for the prevention and control of middle school students suicidal behavior.@*Methods@#A total of 4 419 students from grades 7 to 12 in Ezhou City and Xiaogan City, Hubei Province were selected by stratified cluster random sampling. The Inventory of Parent and Peer Attachment, Rosenberg Self Esteem Scale, Kessler Psychological Distress Scale were used to conduct a questionnaire Survey, and evaluated the suicide attempts of middle school students.@*Results@#The detection rate of attempted suicide among middle school students was 6.8%. The detection rate of attempted suicide varies among different grades, family types, parental relation, parenting style, family income, self esteem level, and psychological distress( χ 2/ t =3.88, 10.12, 18.00, 52.54, 13.90 , 2.37, 8.99, P <0.05). The scores of paternal attachment and maternal attachment ( 14.64 ±13.45, 14.77±12.26) in the group with attempted suicide were lower than those without attempted suicide(22.05±16.08, 23.79±14.93)( t =-9.07, -12.11, P <0.05). Logistic regression analysis showed that both paternal attachment and maternal attachment were associated with lower rate of suicide attempts among middle school students(paternal attachment, OR=0.99, 95%CI = 0.98 -0.99; maternal attachment OR=0.97, 95%CI =0.96-0.98), with paternal attachment for girls only( OR=0.98, 95%CI= 0.97 -0.99)(P <0.05).@*Conclusion@#Adolescent parent attachment may be a protective factor for middle school students suicide attempts. Sex specific effects are observed in adolescent father attachment in girls. Parents should pay attention to cultivating a good attachment relationship with their children and promote the healthy growth of middle school students.
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Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.
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Humanos , Ensayos Clínicos como Asunto , Análisis Costo-Beneficio , Economía Farmacéutica , Guías como Asunto , Preparaciones Farmacéuticas , Economía , Vigilancia de Productos Comercializados , Economía , Estadística como AsuntoRESUMEN
This study aims to assess if adverse drug reactions (ADRs) to parenterally administered salvianolate are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a retrospective nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered salvianolate. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission, allergic history, dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the condition on admission had a significant effect, P values was < 0.000 1 on suspected cases of allergic reactions in the first subgroup analysis. For the second subgroup analysis, we found condition on solvents had a significant effects, P values was 0.005 1 on suspected cases of allergic reactions. We also found that using other four injections at the same time as parenterally administered salvianolate could be risky factors in suspected cases of allergic reactions. For the second subgroup analysis combining using three injections could increase risks. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered salvianolate.
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Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios de Casos y Controles , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Diagnóstico , Sistemas de Información en Hospital , Extractos Vegetales , Usos Terapéuticos , Estudios RetrospectivosRESUMEN
Tanreqing injection is suitable for early pneumonia, acute bronchitis, acute exacerbations of chronic, and upper respiratory tract infection which are classified with phlegm-heat obstructing lung syndrome of traditional Chinese medicine. To understand the clinical adaptation syndromes and medication characteristics of the post-market Tanreqing injection, the research team of the paper monitored the patients who are used with Tanreqing injection from September 2012 to October 2013 in four leader hospitals based on the method--prospective, multi-center, large sample, registration-type hospital centralized monitoring,and analyzes the general information, diagnostic information and medication characteristics of patients, in order to produce evidence for clinical practice and medication decisions and to establish the foundation of rational drug use.
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Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Adulto Joven , Medicamentos Herbarios Chinos , Usos Terapéuticos , Medicina Tradicional China , Estudios Prospectivos , Infecciones del Sistema RespiratorioRESUMEN
The paper is focused on the clinical applications of Tanreqing injection after listing, detecting and analyzing the related blood indicators of patients with allergic reactions based on prospective, multi-center, large sample, registration-type clinical safety monitoring nested case-control study (NCCS) to explore the possible mechanisms of allergic reaction of Tanreqing injection, 3 006 patients cases used with Tanreqing injection were monitored, including 3 cases of adverse reactions and 2 cases of allergic reactions. Each patient of allergic reactions, according to the ratio of 1:4 matches four cases of not adverse reactions as a control group of patients, while 5 healthy and 5 cases of volunteers into the healthy group. We examined the correlation detection of cases of allergic reactions among groups such as T-IgE, IgA, IgG, C3, C4, IFN-g, IL-2, IL-4, IL-6, IL-10. Allergic reactions of Tanreqing injection may be mediated by IgE as type I based on existing research data. This results and conclusions will promote the justifiability and safety of clinical applications.
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Adolescente , Adulto , Femenino , Humanos , Masculino , Adulto Joven , Estudios de Casos y Controles , Medicamentos Herbarios Chinos , Hipersensibilidad , Diagnóstico , Metabolismo , Interleucina-10 , Metabolismo , Interleucina-2 , Metabolismo , Interleucina-4 , Metabolismo , Interleucina-6 , Metabolismo , Estudios ProspectivosRESUMEN
There are few articles or reports collecting evidence about parenterally administered salvianolate from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about parenterally administered salvianolate. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data) and literature analysis. All the four aspects build an evidence body for Kudiezi Solution in order to inform its safety use in clinical practice and further study.
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Humanos , Sistemas de Información en Hospital , Extractos VegetalesRESUMEN
There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.
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Mercadotecnía , Medicina Tradicional China , Economía , Fitoterapia , Economía , Sistema de Registros , Administración de la Seguridad , MétodosRESUMEN
Spontaneous reporting system (SRS) is currently a basic method to monitor and find adverse drug reactions (ADR) signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively prevent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported promptly, ADR information in the national ADR monitoring center's SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern. This study uses BCPNN and PRR to detect early warning signals. S739 ADR case reports were identified. There were 106 types, 1 310 events, and 24 serious ADR cases ( 3.25% of 739 case reports) There wre no deaths. The ten most frequent ADRs were: rash, dizziness, itch, headache, chills and breath, nausea, palpitation, anaphylactic reaction and hot. The drugs early warning signs were dizziness, headache, nausea, itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.
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Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Adulto Joven , Sistemas de Registro de Reacción Adversa a Medicamentos , China , Epidemiología , Bases de Datos Factuales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Epidemiología , Infusiones Parenterales , Farmacovigilancia , Extractos VegetalesRESUMEN
Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.
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Humanos , Consenso , Hipersensibilidad a las Drogas , Alergia e Inmunología , Monitoreo de Drogas , Métodos , Estándares de Referencia , Medicamentos Herbarios Chinos , Testimonio de Experto , Técnicas Inmunológicas , Métodos , Estándares de Referencia , Vigilancia de Productos Comercializados , Métodos , Estándares de Referencia , Células TH1 , Alergia e Inmunología , Células Th2 , Alergia e InmunologíaRESUMEN
Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.
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Humanos , China , Análisis Costo-Beneficio , Monitoreo de Drogas , Economía , Estándares de Referencia , Medicamentos Herbarios Chinos , Economía , Estándares de Referencia , Economía Farmacéutica , Vigilancia de Productos Comercializados , Economía , Estándares de ReferenciaRESUMEN
It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.
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Humanos , China , Epidemiología , Monitoreo de Drogas , Estándares de Referencia , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Epidemiología , Medicamentos Herbarios Chinos , Estándares de Referencia , Sistemas de Información en Hospital , Vigilancia de Productos Comercializados , Métodos , Estándares de ReferenciaRESUMEN
<p><b>OBJECTIVE</b>Based on real world research the circumstances of the clinical use of usual drugs combined with salvianolate injection are surveyed.</p><p><b>METHOD</b>Descriptive statistics on the use of salvianolate injection in 18 general hospitals in China.</p><p><b>RESULT</b>In 1 605 patients with coronary heart disease (CHD), salvianolate injection was most frequently (51%) combined with clopidogrel and isosorbide dinitrate. In addition this combination showed a higher clinical effectiveness as compared with other drug combinations.</p><p><b>CONCLUSION</b>In the real world, salvianolate injection combined with usual treatment was found to be more effective than other treatment combinations. In addition practice conformed to the clinical treatment of coronary heart disease (CHD) guidelines for drug use. However, liver and kidney function, routine blood tests and the blood's coagulation function require ongoing monitoring.</p>
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Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Coronaria , Quimioterapia , Mortalidad , Quimioterapia Combinada , Medicamentos Herbarios Chinos , Sistemas de Información en Hospital , Dinitrato de Isosorbide , Usos Terapéuticos , Extractos Vegetales , Ensayos Clínicos Pragmáticos como Asunto , Puntaje de Propensión , Ticlopidina , Usos Terapéuticos , Resultado del TratamientoRESUMEN
<p><b>OBJECTIVE</b>To investigate the curative effect of Kudiezi Injection in the treatment of cerebral infarction.</p><p><b>METHOD</b>Hospital information system (HIS) data from 18 national, general hospitals were used to compare patients with and without the use of parenterally administered Kudiezi injection in treating cerebral infarction. To balance confounding factors between the two groups propensity score method was used; effectiveness evaluation of parenterally administered Kudiezi in treatment of cerebral infarction was carried out using Logistic regression method.</p><p><b>RESULT</b>There was a statistically significant difference (P < 0.05) between positive curative outcomes in those receiving conventional therapy plus Kudiezi injection compared to those using other parenterally received medications on cerebral infarction.</p><p><b>CONCLUSION</b>According to the current data conventional therapy combined with parenterally administered Kudiezi has a better outcome to cure cerebral infarction than other parenterally administered medications. This data provides a reference for clinical medication. However, the exact conclusions still need further verification.</p>
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Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Infarto Cerebral , Quimioterapia , Medicamentos Herbarios Chinos , Sistemas de Información en Hospital , Infusiones Parenterales , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Pragmáticos como AsuntoRESUMEN
<p><b>OBJECTIVE</b>Parenterally administered Kudiezi (KDZ) is used in real world clinical situations to treat coronary heart disease and cerebral infarction. This paper analyzes its clinical use with other drug combinations. Clinicians' experiences of using such treatments are also referred to.</p><p><b>METHOD</b>Hospital information system (HIS) data from 18 hospitals, comprising records of 6 032 patients with Coronary heart disease and 3 468 patients with cerebral infarction were analyzed.</p><p><b>RESULT</b>Comparison and analysis between varying courses of KDZ plus different drug combinations was carried out. The mean single dose of KDZ, death rate and improvement rates along with drug combinations were ascertained with various illustrations given.</p><p><b>CONCLUSION</b>Although data showed some clinical correlations between factors analyzed, strong causal relationships are yet to be found. Hence, there is a need for further exploration and analysis.</p>
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Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Infarto Cerebral , Quimioterapia , Mortalidad , Enfermedad de la Arteria Coronaria , Quimioterapia , Mortalidad , Quimioterapia Combinada , Medicamentos Herbarios Chinos , Sistemas de Información en Hospital , Infusiones Parenterales , Ensayos Clínicos Pragmáticos como Asunto , Estudios RetrospectivosRESUMEN
<p><b>OBJECTIVE</b>To understand the affect on liver function of using salvianolate injection above the recommended dose.</p><p><b>METHOD</b>Nationwide, research of hospital information system (HIS) data from 18 general hospitals comprising 14 191 patients was carried out. Two groups of patients were studied and their blood tests monitored before and after injections. One group received the recommended dose of 200 mg, the other exceeded it. To take into account group differences the propensity score method and logstic regression was used alongside liver function.</p><p><b>RESULT</b>When salvianolate injection was administered above the recommended dose patients were more likely to have abnormal AST and ALT levels. However, the difference between the groups was not statistically significant.</p><p><b>CONCLUSION</b>According to our data the affect of exceeding the recommended dose of salvianolate injection on liver function is not significant. However, monitoring of liver function should be carried out in clinic.</p>
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Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Alanina Transaminasa , Metabolismo , Aspartato Aminotransferasas , Metabolismo , Estudios de Casos y Controles , Relación Dosis-Respuesta a Droga , Medicamentos Herbarios Chinos , Sistemas de Información en Hospital , Infusiones Parenterales , Hígado , Extractos Vegetales , Ensayos Clínicos Pragmáticos como Asunto , Puntaje de PropensiónRESUMEN
<p><b>OBJECTIVE</b>To explore the toxic effect on mouse administrated Kudiezi injection multy times a day, and on rats repeat administrated for many days.</p><p><b>METHOD</b>Mouse tail intravenous injection of Kudiezi, 0.04 mL x g(-1), 3 times a day, rats tail intravenous injection of Kudiezi, 20, 10, 4 mL x kg(-1), once a day, for 6 weeks.</p><p><b>RESULT</b>There is no abnormal to the mouses administrated many times a day. The rats administrated large doses of drug for many days have certain effects on hematology, blood biochemistry. Some animals appear liver, kidney lesions mild, injection local appear haemorrhage, edema and inflammatory reaction.</p><p><b>CONCLUSION</b>The mouse which was intravenous injection in the dose of 180 times Kudiezi injection as much as people used, revealed no toxicity reaction. Repeated large-dose administration, rats caused by lesions of the main target organs may be for kidney, liver. But the recovery result on liver, kidney toxicity was reversible, no delayed toxicity. At the same time, large doses of long-term administration of local have a certain irritation. Tips the medication should be under the guidance of doctors, and pay attention to replace the injection site. This research will provide safety basis for the clinical use of Kudiezi injection.</p>
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Animales , Femenino , Humanos , Masculino , Ratones , Ratas , Relación Dosis-Respuesta a Droga , Quimioterapia , Medicamentos Herbarios Chinos , Modelos Animales , Ratas WistarRESUMEN
By retrieving the relevant database, aim was to achieve the security reported of Kudiezi injection (Yueanxin). To analysis the gender, age, underlying disease, medication dosage, solvent, adverse event/adverse reaction time of occurrence, clinical presentation of patients, It was found the adverse event/adverse reaction usually occur in older people, involving the organs and systems include skin and its appendages, digestive system, nervous system, circulatory system, respiratory system, systemic reaction, part of the adverse event/adverse reaction's cause were not according to the instructions. It was found on the adverse event/adverse reaction of the judgment on the lack of objective evidence, to produce certain effect for objective evaluation of security of Kudiezi injection (Yueanxin).
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Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ensayos Clínicos como Asunto , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Epidemiología , Medicamentos Herbarios ChinosRESUMEN
<p><b>OBJECTIVE</b>To describe the reality of clinical use for Kudiezi injection based on analyzing hospital information system from 18 hospitals in China.</p><p><b>METHOD</b>Descriptive statistic methods were used in the analysis of 24 225 cases.</p><p><b>RESULT</b>Patients using Kuediezi injection were mainly between 46 years old to 65 years old and there was a gender balance. Kuediezi injection was used most in neurology department and department of cardiology to treat coronary heart diseases and cerebral infarction. Patients who had Chinese medicine diagnosis were most about "Xiongbi"with syndrome qi-yin deficiency, and also more patients with syndrome qi-yin stagnation were treated by Kudiezi injection. The dosage of using Kudiezi was between 10 to 40 mL and treating course was between 1 to 3 days, with 0.9% sodium chloride.</p><p><b>CONCLUSION</b>Although most of the patients received a right treatment of Kudiezi injection in clinical practice, there is still using Kudiezi injection for some diseases not on its drug instruction. We must remind those doctors who should be careful of using Kudiezi injection treating other diseases not on the instruction. This is just a retrospective and descriptive study, so prospective studies need to be developed in future to validate the results from this study.</p>
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Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Adulto Joven , Ensayos Clínicos como Asunto , Quimioterapia , Medicamentos Herbarios Chinos , Sistemas de Información en Hospital , Evaluación de Resultado en la Atención de SaludRESUMEN
In recent years, pharmacoeconomic studies have drawn increasing attention from experts in clinical medicine, pharmacy, health economics and health management. Their findings play an important role in drug pricing, drafting of the List of Essential Medicines and rational selection of clinical drugs. The essay summarizes the literatures published in recent years concerning pharmacoeconomics of traditional Chinese medicines on stroke, in order to make clear the current development of the latest studies on traditional Chinese medicines on treating stroke and rehabilitation methods and provide basis for further studies on pharmacoeconomics of traditional Chinese medicines on stroke and reference for rational clinical drug use.