ABSTRACT
Las regulaciones éticas de las investigaciones clínicas serán modificadas y enriquecidas en la medida en que las necesidades de salud del ser humano continúen insatisfechas y requieran de las investigaciones clínicas para ser resueltas. Teniendo en cuenta lo anterior, en el presente artículo se describen los aspectos éticos que deben cumplirse en los ensayos clínicos, así como la responsabilidad de la universidad médica en la formación del capital humano dedicado a la medicina, como protagonista fundamental de la realización y conducción de las investigaciones clínicas. Se destaca, además, que esta temática, al ir de la mano del desarrollo del hombre y la sociedad, ha tenido un largo y controvertido camino hasta la actualidad.
The ethical regulations of the clinical investigations will be modified and enriched while health necessities of the human being continue unsatisfied and require of the clinical investigations to be solved. Keeping this in mind, the ethical aspects that should be completed in the clinical assays are described in the present work, as well as the responsibility of the medical university in the training of the human capital studying medicine, as fundamental main character of the realization and conduction of the clinical investigations. Also, as this topic goes on according to man and society development, it has had a long and controversial road up to the present times.
Subject(s)
Clinical Protocols , EthicsABSTRACT
En Cuba, los investigadores clínicos como profesionales de las ciencias médicas, ejecutan las investigaciones científicas relacionadas con los procesos salud-enfermedad. De ahí que resulta necesario determinar la verdadera dimensión que alcanza la formación científico - investigativa de dichos profesionales. A tales efectos, se realizó el presente estudio en el cual se exponen algunas ideas en torno a un proceso imprescindible en los momentos actuales de desarrollo de la investigación clínica, donde la sistematización formativa constituye el elemento fundamental de la formación de estos profesionales.
In Cuba, the clinical researchers as professionals of the medical sciences, carry out the scientific investigations related to the health-disease processes. So that, it is necessary to determine the true dimension that reaches the scientist - investigative training of these professionals. To fulfil this objective, the present study was carried out in which some ideas are exposed regarding an indispensable process in the current moments of the clinical investigation development, where the formative systematization constitutes the fundamental element in training these professionals.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Research Personnel/education , Staff Development , Professional TrainingABSTRACT
Desde sus inicios, en Cuba se le ha otorgado gran importancia a los ensayos clínicos. El gobierno ha dedicado innumerables recursos para el desarrollo de la industria biofarmacéutica y la obtención de nuevos productos farmacológicos empleados para tratar disímiles enfermedades. Debido a la relevancia científica y la ética que poseen estos ensayos clínicos, resulta necesario que sean conducidos por profesionales con una calificación científica apropiada. Ante tal situación, ha sido necesario formar a dichos profesionales desde los puntos de vista científico e investigativo. Por ello, en este artículo se exponen elementos relacionados con los antecedentes históricos de esa formación y su dinámica como un primer acercamiento al tema tratado.
Since their beginnings, great importance has been granted to the clinical trials in Cuba. The government has dedicated countless resources for the development of biopharmaceutical industry and the elaboration of new pharmacological products for treating different illnesses. Due to the scientific relevance and the ethics of these clinical trials, it is necessary that are conducted by professionals with an appropriate scientific qualification. In such a situation, it has been necessary to train these professionals from the scientific and investigative points of view. That is why, elements related with the historical background of that training and its dynamics are exposed in this work, as a first approach to the treated topic.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Young Adult , Research Personnel/education , Staff Development/history , Scientific Domains , Professional Training , Physicians , Clinical Trial , CubaABSTRACT
For medical device clinical evaluation activities, reference to international and domestic medical device regulations and guidance documents, this paper briefly introduces the implementation steps of clinical evaluation of medical devices, and focus on the evaluation report should be included in the content, provides reference for relevant personnel of medical devices registration and certification on medical device clinical evaluation practice.
Subject(s)
Humans , Clinical Trials as Topic , Device Approval , Equipment and SuppliesABSTRACT
Objective To investigate the epidemic pattern,diagnosis and treatment of schistosomiasis after the 16-years intervention program on its transmissionin Jiaxing region of Zhejiang province.Methods Clinical data of schistosomiasis patients during the last 10 years and pathological specimens with deposited schistosomal eggs during the last 8 years were retrospectively analyzed.Results The total numbers of schistosomiasis patients admitted to hospital increased from 194 in 2001 to 960 in 2010,and from 78 to 266 with complications.Number of the ones with accompanied diseases increased from 116 to 694.All the numbers of the above said three groups showed an yearly increase.The hardest hit age of the patients was between 60 and 74.The number of specimens with deposited schistosomal eggs increased from 192 in 2003 to 298 in 2010.While the ratio of specimens with deposited schistosomal eggs to the total number of pathological specimens became slightly decreasing,the average age of patients increased,Eggs were mainly deposited on appendix,colon,rectum,stomach,liver,gallbladder and small intestine.Conclusion Schistosomiasis still hit the Jiaxing region,with the average age of patients increased.
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Objective To observe the clinical effects of topiramate together with low-dose ACTH and prednisone、vitamine B6、gamma globulin on infantile spasms. Methods 134 infantile spasms patients were selected and randomly divided into control group and treatment group, each group 67 patients. The control group was treated with sodium valproate. The treatment group received low-dose ACTH and prednisone、topiramate、vitamine B6 、gamma globulin. The two groups all completed a therapeutic period of 3 months. Results The effect of the treatment group compared with the control group has significantly statistical difference (P ＜ 0.05) ;the result of the treatment group'electroencephalogran compared with that of the control group also has significants difference (P ＜ 0.05). Conclusion The therapeutic effect of low-dose ACTH and prednisone、 topiramate、 vitamine B6、 gamma globulin together on infantile spasms was much better than just taking sodium valproate only.
ABSTRACT
Debido al avance progresivo de la investigación clínica, nuevas exigencias y requerimientos se hacen necesarios, tales como: apertura de comités de ética, creación o adaptación de legislaciones, mayor entrenamiento de investigadores, entre otros. El objetivo del presente artículo es hacer una crónica de lo sucedido con Reglamento Peruano de Ensayos Clínicos y analizar si la regulación peruana incluye una efectiva participación de la comunidad en los comités de ética.
Due to the progressive advance of clinical investigation, new demands and requirements are made necessary, such as: the formation of ethics committees, the creation or adaptation of legislation, and increased training for researchers, among others. The objective of this article is to report on what occurred with the Peruvian Regulation of Clinical Tests and to analyze if the Peruvian regulation includes an effective participation of the community in ethics committees.
Devido ao avanço progressivo da pesquisa clínica, novas exigências e requerimentos se fazem necessários, tais como: criação de comitês de ética, criação ou adaptação de legislações, maior treinamento de pesquisadores, entre outros. O objetivo do presente artigo é fazer uma crônica do sucedido com o Regulamento Peruano de Ensaios Clínicos e analisar se a regulação peruana inclui uma efetiva participação da comunidade nos comitês de ética.
Subject(s)
Humans , Biomedical Research , Clinical Trials as Topic , Ethics Committees , Bioethics , PeruABSTRACT
A ruptura ou fistulização de vasos linfáticos para o interior do sistema excretor urinário dá origem à quilúria, que tem na bancroftose a sua principal etiologia. Pode ser, raramente, também causada por neoplasia, malformação linfática, traumatismo abdominal, assim como outras doenças infecciosas como a tuberculose. Os autores propõem as diretrizes gerais para a condução do portador de "urina leitosa" em áreas endêmicas e não endêmicas de filariose bancroftiana. Ressaltam a importância dos exames de triagem e de outros mais sofisticados para uma investigação etiológica a partir da realização de anamnese e de exame físico criteriosos. Enfatizam a necessidade de que a doença deve ser conduzida através de uma abordagem mais abrangente, que compreenda, além da médica, a assistência social e a nutricional. Na grande maioria dos casos, o controle da quilúria está basicamente fundamentado na educação e na adequação do paciente a uma dieta hipolipídica/hiperprotéica e rica em líquidos.
The rupture or fistulization of lymph vessels into the urinary system, known as chyluria (milky urine), is caused mainly by bancroftian filariasis. On rare occasions chyluria may also be caused by neoplasia, lymphatic malformation, abdominal trauma, as well as other infectious diseases such as tuberculosis. The authors proposed general guidelines to manage patients suffering from milky urine in Bancroftian filariasis endemic and non-endemic areas. They emphasized the importance of a careful diagnostic process accomplished using screening procedures, evaluating a detailed history of illness and performing a careful physical examination, targeting on the most suitable diagnostic tools for each case. In addition, they emphasized the need to manage the patient from a broader perspective, which goes beyond the medical aspect, involving also social and nutritional contexts. In the great majority of cases, controlling chyluria is fundamentally based on patient education and adjustment to a low lipid, high protein diet in addition to increased fluid intake.
Subject(s)
Animals , Humans , Chyle , Urinary Fistula , Diagnosis, Differential , Diet , Urine , Urinary Fistula/diagnosis , Urinary Fistula/etiology , Urinary Fistula/therapy , Wuchereria bancroftiABSTRACT
Objective:To explore TCM syndrome variation regularity on acute stage of ischemia stroke.Methods:To collect clinical dynamic state information of ischemia stroke from 72h to 14days by using prospective clinical research method and investigate TCM syndrome variation regularity in acute stage of ischemia stroke.Results:Wind,fire and phlegm syndromes were the most frequent syndromes in acute stage of ischemia stroke.They appeared varied regularity.There were forty-four combination patterns about six basic syndromes.The wind syndrome and fire-phlegm syndrome were increasing in acute stage of ischemia stroke.The wind-phlegm syndrome was decreasing in the first three days,the wind-fire syndrome peaked on the third day,the phlegm was decreasing on the fifth day.The wind-fire-phlegm was the most frequent and undulate syndrome on the fifth day.The wind-phlegm-stagnation syndrome was increasing for the first three days.Conclusion:There were fastly morbility,changeable and complicated syndrome change in acute stage of ischemia stroke.It was very necessity and urgency for complementing diagnostic criteria of stroke differentiation.
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Objective To discuss diagnostic classification and emergency treatment protocols for complex pelvic fractures. Methods The first aid management of 23 cases of major pelvic fractures were analyzed retrospectively. Results 22 of the patients survived, but one died of hemorrhagic shock.Conclusions Correct classification of severe pelvic fractures is of guidance value to the first aid management. Cooperation among multiple departments, comprehensive application of various surgical methods, early stabilization of hemodynamics, rapid repair of injured organs, stabilization of pelvic ring with external fixator are effective techniques to enhance the survival rate of patients with severe pelvic fractures.
ABSTRACT
BACKGROUND: Seborrheic dermatitis is a very common chronic inflammatory disease. Previous studies suggested that, Pityrosporum, lipophilic fungi, may play an important role in the pathogenesis of the disease. OBJECTIVE: The purpose of this study was to investigate the disease clinically and mycologically for better understanding of the pathogenesis. METHODS: Two hundred and one new patient.s with seborrheic dermatitis of the scalp and 67 norrnal subjects were obs!,rved clinically by the dermatologist and studied stat,istically by questionnaires. A mycologic study of Pityrosporum was also performed by direct smear. RESULTS: Among a total of 201 patients wit,h seborrheic dermatitis, 72.6% had pityriasis sicca, 10.5% had pityr iasis steartoides and 16.9% had inflammatory seborrheic dermatitis. On clinical grading by the Kligman.. scale, grade III(slightly scaling) was the most common in the patients and 52.6% of the norma. subjects were below grade II (no scaling). Spores of Pityrosporum were observed in 76.7% of the patients and 91.5% of the normal subjects. The incidence of Pityrosporum was lower particularly in t,he patients with inflammatory seborrheic dermatitis t,han in other pa~tients groups. CONCLUSION: According to the results of the study, it, is difficult to conclude that Pityrosporum is a main causative ager t of seborrheic dermatitis. In addition, it is thought t.hat further studies of the role of Pityrosporum in seborrheic dermatitis are needed.
Subject(s)
Humans , Dermatitis, Seborrheic , Fungi , Incidence , Malassezia , Pityriasis , Scalp , Spores , Surveys and QuestionnairesABSTRACT
BACKGROUND: Seborrheic dermatitis is a very common chronic inflammatory disease. Previous studies suggested that, Pityrosporum, lipophilic fungi, may play an important role in the pathogenesis of the disease. OBJECTIVE: The purpose of this study was to investigate the disease clinically and mycologically for better understanding of the pathogenesis. METHODS: Two hundred and one new patient.s with seborrheic dermatitis of the scalp and 67 norrnal subjects were obs!,rved clinically by the dermatologist and studied stat,istically by questionnaires. A mycologic study of Pityrosporum was also performed by direct smear. RESULTS: Among a total of 201 patients wit,h seborrheic dermatitis, 72.6% had pityriasis sicca, 10.5% had pityr iasis steartoides and 16.9% had inflammatory seborrheic dermatitis. On clinical grading by the Kligman.. scale, grade III(slightly scaling) was the most common in the patients and 52.6% of the norma. subjects were below grade II (no scaling). Spores of Pityrosporum were observed in 76.7% of the patients and 91.5% of the normal subjects. The incidence of Pityrosporum was lower particularly in t,he patients with inflammatory seborrheic dermatitis t,han in other pa~tients groups. CONCLUSION: According to the results of the study, it, is difficult to conclude that Pityrosporum is a main causative ager t of seborrheic dermatitis. In addition, it is thought t.hat further studies of the role of Pityrosporum in seborrheic dermatitis are needed.
Subject(s)
Humans , Dermatitis, Seborrheic , Fungi , Incidence , Malassezia , Pityriasis , Scalp , Spores , Surveys and QuestionnairesABSTRACT
Serum levels of T3, T4, TSH, 24-h RAIU and Thyroid antibodies were examined in 13 cases of chronic lymphocytic thyroiditis who were diagnosed at the pediatric department of Yonsei University hospital during the period from 1978 to 1980. The results were as follows: 1. The age distribution was dispersed between 8 and 15 years of age and all the cases were female. 2. Common symptoms were Goiter, Poor Weight gain, fatigness, cold intolerance, lethargy, constipation and cold sweating. But in 5 cases(38%), there were no subjective symptoms. 3. The patients were classifed by their thyroid function state, as 1 case of hyperthroid group, 10 cases of euthyroid group, and 2 cases of hypothyroid group. 4. In the Euthyroid patients, Serum T3 concentration was 115-230ng/100ml)mean 167.4ng/100ml), T4 concentration 4.8-18.6microgram/100ml(mean 7.3 microgram/100ml) T3/T4 ratio 0.020-0.028(mean 0.024) and TSH was 37-60microU/ml(mean 49.5microU/ml). In the hyperthyroid patient, serum T3 concentration was 310ng/100ml. T4 concentration 14.9microgram/100ml, T3/T4 ratio 0.020 and TSH was 1.35microU/ml. 5. In 24-h RAIU, Euthyroid patients were in 2 cases of decreased state(15%), 2 cases of normal range (15~45%), and 6 cases of increased state(45%). All Hypothyroid patients were in normal range and hyperthyroid patient was in increased state. 6. Thyroglobulin antibody was positive in all the patients except 2 cases and microsomal antibody was positive in all the cases. 7.1 year of follow up study was performed in 4 cases of euthyroid patients, 1 case of hyperthroid patient, and 2 cases of hypothroid patients. There was no euthyroid patient who became hypothyroid state in the follow up study.