Instruções em bulas destinadas ao uso de medicamentos para dispepsia e constipação durante a lactação / Instructions in package inserts intended for the use of medicines for dyspepsia and constipation during lactation / Instrucciones en prospectos destinados al uso de medicamentos para la dispepsia y el estreñimiento durante la lactancia

Introdução: A segurança e eficácia do uso de medicamentos durante a lactação são preocupações para mães e profissionais de saúde. Esta pesquisa analisa as orientações das bulas de medicamentos comumente prescritos para dispepsia e constipação, que visa fornecer informações essenciais para orientar as decisões terapêuticas durante esse período crucial da maternidade. Objetivos: Analisar as informações das bulas sobre contraindicações de medicamentos para dispepsia e constipação durante a amamentação, verificando se estão de acordo com as evidências científicas. Métodos: Medicamentos para dispepsia e constipação foram selecionados de acordo com a classificação da Anatomical Therapeutic Chemical (ATC) e o registro ativo no Brasil. A presença de contraindicações para o uso de medicamentos nas bulas do profissional de saúde e do paciente foi comparada com as informações contidas no manual técnico do Ministério da Saúde, Medicamentos e Leite Materno, LactMed, UptoDate, Micromedex, Documento Científico da Sociedade Brasileira de Pediatria e Reprotox. Resultados: Nenhuma informação sobre o uso durante a amamentação foi encontrada em 20,0 e 24,3% das bulas para dispepsia e constipação, respectivamente. A concordância entre as bulas dos medicamentos para dispepsia e as fontes consultadas foi baixa (27,2% das bulas contraindicavam o medicamento na lactação, enquanto nas fontes o percentual de contraindicação variou de 0 a 8,3%). Com relação a medicamentos para constipação, 26,3% das bulas os contraindicavam, enquanto nas fontes o percentual variou de 0 a 4,8%. Conclusões: O estudo mostrou que pelo menos duas em cada dez bulas para dispepsia e constipação não fornecem informações adequadas sobre o uso desses medicamentos em lactentes, e também que houve baixa concordância entre o texto das bulas e as fontes de referência quanto à compatibilidade do medicamento com a amamentação.

Introduction: The safety and effectiveness of medication use during lactation are concerns for mothers and healthcare professionals. This research analyzes the instructions on the leaflets of medications commonly prescribed for dyspepsia and constipation, which aims to provide essential information to guide therapeutic decisions during this crucial period of motherhood. Objectives: To analyze the information in package inserts about contraindications of drugs for dyspepsia and constipation during breastfeeding, verifying whether these are consistent with scientific evidence. Methods: Drugs for dyspepsia and constipation were selected according to the Anatomical Therapeutic Chemical (ATC) classification and active registry in Brazil. The presence of contraindications for the use of medications in the health professional's and patient's package inserts was compared with the information in the technical manual of the Ministry of Health, Medications and Mothers' Milk, LactMed, UptoDate, Micromedex, Documento Científico da Sociedade Brasileira de Pediatria and Reprotox. Results: No information about use during breastfeeding was found in 20.0 and 24.3% of leaflets for dyspepsia and constipation, respectively. The agreement between the leaflets of medications for dyspepsia and the sources consulted was low (27.2% of the leaflets contraindicated the medication during lactation, while in the sources the percentage of contraindication varied from 0 to 8.3%). In relation to medicines for constipation, 26.3% of the leaflets contraindicated them, while in the sources the percentage ranged from 0 to 4.8%. Conclusions: The study pointed out that at least two out of every ten package inserts for dyspepsia and constipation do not provide adequate information on the use of these drugs in infants, and also shows low concordance between the text of the package inserts and the reference sources regarding compatibility of the drug with breastfeeding.

Introducción: La seguridad y eficacia del uso de medicamentos durante la lactancia son preocupaciones para las madres y los profesionales de la salud. Esta investigación analiza las instrucciones contenidas en los prospectos de medicamentos comúnmente recetados para la dispepsia y el estreñimiento, con el objetivo de proporcionar información esencial para guiar las decisiones terapéuticas durante este período crucial de la maternidad. Objetivos: Analizar la información contenida en los prospectos sobre las contraindicaciones de los medicamentos para la dispepsia y el estreñimiento durante la lactancia, verificando si estas son consistentes con la evidencia científica. Métodos: Se seleccionaron medicamentos para la dispepsia y el estreñimiento de acuerdo con la clasificación ATC y el registro activo en Brasil. Se comparó la presencia de contraindicaciones para el uso de medicamentos en los prospectos del profesional de la salud y del paciente con la información del manual técnico del Ministerio de Salud, Medicamentos y Leche Materna, LactMed, UptoDate, Micromedex, Documento Científico da Sociedade Brasileira de Pediatria y Reprotox. Resultados: No se encontró información sobre su uso durante la lactancia en el 20% y el 24,3% de los prospectos para dispepsia y estreñimiento, respectivamente. La concordancia entre los prospectos de los medicamentos para la dispepsia y las fuentes consultadas fue baja (el 27,2% de los prospectos contraindicaba el medicamento durante la lactancia, mientras que en las fuentes el porcentaje de contraindicación variaba del 0% al 8,3%). Con relación a los medicamentos para el estreñimiento, el 26,3% de los prospectos los contraindicaba, mientras que en las fuentes el porcentaje osciló entre el 0% y el 4,8%. Conclusiones: El estudio señaló que al menos dos de cada diez prospectos para dispepsia y estreñimiento no brindan información adecuada sobre el uso de estos medicamentos en lactantes, y también muestra la baja concordancia entre el texto de los prospectos y la referencia. fuentes sobre la compatibilidad del fármaco con la lactancia.

Tratamento da doença de Crohn durante a gravidez / Treatment of Crohn's disease during pregnancy

A doença de Crohn é uma doença inflamatória intestinal, que pode acometer todo o tubo digestivo, principalmente o íleo, o cólon e a região perianal. Praticamente não há diferença de incidência entre os sexos, sendo mais comum entre judeus e brancos, e com maior incidência na faixa etária de 14 a 24 anos, acometendo mulheres em idade fértil. O uso de medicamentos durante o período de concepção e gravidez é causa de grande preocupação para médicos e pacientes. Com objetivo de analisar o tratamento da doença de Crohn durante a gravidez, foi elaborada uma revisão da literatura recente. Em geral, a maioria dos medicamentos utilizados no tratamento das doenças inflamatórias intestinais não está associada a efeitos adversos significativos, e manter a saúde da mãe continua a ser uma prioridade no manejo destas pacientes. O tratamento inclui as seguintes classes de medicamentos: aminossalicilatos, antibióticos, corticosteroides, imunomoduladores e drogas anti-TNF-alfa. O metotrexato e a talidomida são comprovadamente teratogênicos, sendo ambos contraindicados durante a gravidez e o aleitamento. Portanto, a maioria dos medicamentos utilizados para o tratamento da doença de Crohn é compatível com a gravidez. Manter a doença em remissão é o principal fator determinante de um bom prognóstico para a gestação.

Crohn's disease is an inflammatory bowel disease, which may affect the entire gastrointestinal tract, especially the ileum, colon and perianal region. There is virtually no difference in the incidence between the genders, with it being more common among Jews and white people, with a higher incidence in the age group from 14 to 24 years, affecting women of childbearing age. The use of drugs during the period of conception and pregnancy is a cause of great concern to physicians and patients. In order to analyze the treatment of Crohn's disease during pregnancy, a review of recent literature was performed. In general, most drugs used in the treatment of inflammatory bowel disease is not associated with significant adverse effects, and to keep the mother's health remains a priority in the management of these patients. The treatment includes the following drug classes: aminosalicylates, antibiotics, corticosteroids, immunomodulators, and anti-TNF-α drugs. Methotrexate and thalidomide proved to be teratogenic, with both being contraindicated during pregnancy (and breastfeeding). Therefore, most of the medications used to treat Crohn's disease are compatible with pregnancy. To keep the disease in remission is the main determinant of a good prognosis for pregnancy.

Efficacy of tepronone and folic acid in the treatment of chronic atrophic gastritis evaluated by the marking targeting biopsy / 中华消化杂志

Objective To explore the efficacy of tepronone and folic acid in the treatment of chronic atrophic gastritis (CAG) evaluated by the marking targeting biopsy (MTB).Methods A total of 224 H.pylori negative CAG patients were selected and divided into group A (n 96,tepronone 50 mg/time,folic acid 10 mg/time,three times/day),group B (n=23,tepronone 50 mg/time,three times/day),group C (n=74,unspecific treatment) and group D (n=31,no treatment).The treatment course lasted for one year.The clinical symptoms improvement of each group was observed before and after treatment.The pathological improvement of gastric mucosa by MTB was inspected before and after treatment.The chi square test was performed for the comparison between groups.Results The total efficacy rates of group A,B,C and D were 43.8％ (42/96),39.1％ (9/23),33.8％(25/74) and 32.3％ (10/31) respectively,there was no significant difference between groups (x2 =2.328,P =0.507).For the significant efficacy rate of gastric mucosa pathological improvement,group A was compared with group D,group A was compared with group C and group B was comparedwith group D,the differences were significant (x2 =14.520,14.628 and 8.995,all P＜0.01).In the total efficacy rate of gastric mucosa pathological improvement,group A (49.8％,131/263) was compared with group D (24.2％,16/66),group A was compared with group C (35.9％,66/184)and group B (44.7％,21/47) was compared with group D,the differences were significant (x2 =13.953,8.535 and 5.207,all P＜0.05).Conclusion Teprenone alone or teprenone and folic acid combination can obviously improve pathological changes of CAG patients.

Protection of gastric mucosa against aspirin-induced damage by teprenone / 中华消化杂志

Objective To investigate the protection effects of teprenone in aspirin-induced gastric mucosa injury.Methods From 2008 to 2010,a total of 296 patients who took aspirin for the first time at the Department of Cardiovascular,First Hospital Affiliated to Zhejiang Chinese Medicine University were randomly divided into two groups.There were 166 cases in aspirin group,which took aspirin 100mg daily; 130 cases in aspirin and teprenone group,the aspirin dose equivalent with aspirin group and took teprenone 50mg/time,3 times/day orally.Gastrointestinal symptoms and gastric mucosa injury of patients in these two group were inspected at 3 month,6 month and 1 year.Results A total of 143 cases were recruited in aspirin group and 118 cases in aspirin and teprenone group.After taking medicine for 3 months,the occurrence rate of gastrointestinal symptoms in aspirin group was 1.40 ％.Compared with aspirin and teprenone group,the difference was statistical significant (0,x2 =1.663,P＝ 0.197).Follow up after taking medicine for 6 months,the occurrence rate of gastrointestinal symptoms in aspirin group was 4.96％.Compared with aspirin and teprenone group,the difference was statistical significant (0,x2 ＝6.021,P＝0.014).Follow up after taking medicine for 1 year,the occurrence rate of gastrointestinal symptoms in aspirin group was 20.15 ％.Compared with aspirin and teprenone group,the difference was statistical significant (1.69％,x2 =20.984,P=0.001).Compared with aspirin group,the symptom and endoscopy score of aspirin and teprenone group decreased significantly at follow-up for 6 months and 1 year (P＜0.05; P＜0.01 ).Compared with at 6 month,the symptom and endoscopy score of aspirin group at 1 year increased significantly (P＜0.05 ; P＜0.01).Conclusion Teprenone has certain protection effects in aspirin-induced gastric mucosa injury.Long-term use of conventional doses of aspirin may cause vary degrees of gastric mucosal injury,and the gastric mucosal injury get more severe as the time of taking medicine increases.

Efecto citoprotector y antisecretor del aceite de Copaifera officinalis en lesiones gástricas inducidas en ratas / Copaifera officinalis oil cytoprotector and antisecretory effects in induced gastric lesions in rats

Objetivos: Demostrar el efecto gastroprotector del aceite de Copaifera officinalis usando indometacina y ligadura de píloro en ratas. Diseño: Estudio preclínico. Lugar: Facultades de Medicina, de Farmacia y Bioquímica. Universidad Nacional Mayor de SanMarcos, Lima, Perú. Material biológico: Ratas y aceite de copaiba. Intervenciones: Se colectó el aceite de copaiba en Ucayali, Pucallpa. La citoproteccción fue evaluada con indometacina, considerando un grupo control normal, indometacina, grupos deaceite de copaiba y omeprazol. Las lesiones de la mucosa gástrica fueron calificadas como las compatibles con necrosis local (tejido no viable), hiperemia, enrojecimiento presente y hemorragia, empleando la escala de puntaje observacional; y la úlcera,según la escala de Macallister modificado. El ensayo de antisecreción fue realizado por el modelo de ligadura del píloro, en el que 24 ratas albinas fueron divididas al azar en 3 grupos; un control, otro de aceite de copaiba 40mg/kg y un tercero de omeprazol10 mg/kg. Después de 4 horas de ligazón, fueron sacrificados, extrayéndose los estómagos; con mucho cuidado se midió el volumen y se determinó el pH de la secreción gástrica, por potenciometría. Se realizó evaluación histopatológica segúnDevi. Principales medidas de resultados: Lesiones ulcerosas. Resultados: Losresultados indicaron 100 por ciento de efecto citoprotector con el aceite de copaiba y de 97,8 por ciento para el omeprazol (p menor que 0,0001), ratificado con los hallazgos histopatológicos; la disminución del volumen de secreción fue 79,4 por ciento para omeprazol y 42,8 por ciento para el aceite de copaiba (p menor que 0,001), con incremento del pH. Conclusiones: En condicionesexperimentales, el aceite de copaiba fue efectivo como agente gastroprotector enratas con inducción de úlcera gástrica.

Objetives: To determine the gastroprotector effect of Copaifera officinalis oil using indomethacin and pyloric ligature in rats. Design: Preclinical study. Setting: Faculties of Medicine, Pharmacy and Biochemistry, National University of San Marcos, Lima, Peru. Biological material: Rats and copaiba oil. Interventions: Copaiba oil was collected in Ucayali, Pucallpa. Cytoprotection was tested withindomethacin considering a normal control group, and indomethacin, copaibaand omeprazole groups. Using visual analogue scale mucosa gastric injuries were referred as those compatible with local necrosis (unviable tissue), hyperemia, flushing, and hemorrhage, and ulcers according to the modified MacallisterÆs scale. The anti-secretion trial used the pyloric ligature model. Twenty-four albino rats were randomized in three groups: control, copaiba oil 40 mg/kg and omeprazole 10 mg/kg, respectively. After 4 hours of linkage, they were sacrificed. Stomachs were removed, their volume measured carefully and gastric secretion pH determined by potentiometry. DevisÆs histopathological evaluation was used. Main outcome measures: Ulcerous injuries. Results: There was 100 per centcytoprotection with copaiba oil and 97,8 per cent with omeprazole (p minor that 0,0001), ratified by histological findings. Decrease in secretion volume was 79,4 per cent for omeprazole and 42,8 per cent for copaiba oil (p minor thet 0,0001) with pH increment. Conclusions: In experimental conditions copaiba oil was effective as gastroprotective agent in gastric ulcers-induced rats.