[Drug utilization and recommended conditions for use in children]. / Utilización de medicamentos y condiciones de uso recomendadas en pediatría.

BACKGROUND: Studies carried out in other countries show that drugs are used in children outside the approved conditions, in a context in which investigation, information and authorization of medications in the pediatric population are scarce. OBJECTIVES: To evaluate the conditions of drug use recommended in children and variability in sources of drug information. METHODS: We performed a descriptive, retrospective study. Data on medication consumption in 1997 were obtained from a pediatric university hospital. Information on conditions of drug use in children was analyzed using a Spanish catalog of medications. This information was compared with that of a North American catalog for international reference. RESULTS: Most of the drugs used were of unrestricted (43; 47 %) or restricted (26; 28 %) pediatric use, but drugs that are not recommended (8; 9 %) or those with unspecified conditions of use in children were also used (15; 16 %). Approximately 12 % of the drugs were not identified in the North American catalog; of the remaining drugs, 60 % were of unrestricted pediatric use, 35 % of restricted use and 5 % were not recommended. CONCLUSIONS: A substantial proportion of drugs administered to hospitalized children are not recommended or their possible use in this population is not specified. It is worth encouraging research, having sources of information that help to make decisions, especially in conditions that have not been approved, and adapting regulatory attitudes, as far as possible, to the evidence and therapeutic needs.

Utilización de medicamentos y condiciones de uso recomendadas en pediatría / Drug utilization and recommended conditions for use in children

Antecedentes: Estudios realizados en otros países indican que en niños se utilizan fármacos en condiciones distintas a las aprobadas, en un contexto en que son escasas la investigación, información y autorización de medicamentos en población pediátrica. Objetivos: Evaluar las condiciones de uso recomendadas en pediatría para los fármacos utilizados en niños y la variabilidad de las fuentes de información sobre éstos. Métodos: Estudio descriptivo y retrospectivo. Se seleccionaron los datos de consumo de medicamentos en un hospital universitario pediátrico durante el año 1997. Se analizó la información sobre las condiciones de uso en pediatría de los fármacos utilizados a partir de un catálogo de medicamentos español. Esta información se comparó con la de un catálogo norteamericano de referencia internacional. Resultados: La mayor parte de los fármacos utilizados fueron de uso pediátrico no restringido (43 [47%]) o restringido (26 [28%]), pero también se utilizaron fármacos no recomendados (8 [9%]) o para los que no se especificaban condiciones de uso en niños (15 [16 %]). Alrededor del 12% de los fármacos no se identificaron en el catálogo norteamericano; de los restantes, el 60% de los fármacos fueron de uso pediátrico no restringido, el 35% de uso restringido y el 5% no recomendados. Conclusiones: En niños hospitalizados, una proporción relevante de los fármacos que se utilizan no se recomiendan o no se especifica su posible uso en población pediátrica. Sería conveniente incentivar la investigación, disponer de fuentes de información sobre terapéutica que ayuden a tomar decisiones, sobre todo en las condiciones no aprobadas, y que la actitud reguladora se ajuste en la medida de lo posible a las evidencias y necesidades terapéuticas (AU)

Gamma-detecting probe used intraoperatively to locate the sentinel lymph node in patients with malignant melanoma.

OBJECTIVE: To assess the usefulness of lymphoscintigraphy and intraoperative gamma probe in the detection of sentinel lymph nodes. DESIGN: Prospective open study. SETTING: University hospital, Spain. SUBJECTS: 40 patients with malignant melanoma (24 stage I/II, 16 stage III). INTERVENTION: The day before operation a lymphoscintigram with 99mTc-nanocolloid was taken and the first lymph node identified was considered to be the sentinel node. A hand-held gamma probe was used for intraoperative mapping. MAIN OUTCOME MEASURE: Identification of the sentinel node. RESULTS: Sentinel nodes were identified in 39/40 patients (98%). In 24 patients with stage I/II disease, 34 sentinel nodes were found (6 invaded and 28 clear of melanoma). A total number of 161 regional lymph nodes were harvested, none of them invaded by melanoma. In 16 patients with stage III disease, 22 sentinel nodes were located (14 invaded and 8 clear of melanoma). A total of 89 regional lymph nodes were excised in patients with invaded sentinel nodes (44 of which were invaded and 45 clear of disease). 41 lymph nodes were excised from patients with clear sentinel nodes, and all were also clear of melanoma. CONCLUSIONS: We conclude that this is a useful technique for the selection of patients with melanoma who may require lymphadenectomy.

Factores predictivos de conversión a cirugía abierta de la colecistectomía laparoscópica. Análisis de una serie prospectiva de 502 pacientes / Factors predictive of conversion to open surgery in laparoscopic cholecystectomy. Analysis of a prospective series of 502 patients

Introducción. La colecistectomía laparoscópica es el tratamiento de elección de la colelitiasis sintomática. Pero existe un porcentaje de casos en los que es necesaria la conversión a cirugía convencional. El conocimiento de los posibles factores predictivos de conversión permitirá identificar con mayor precisión los pacientes con mayor riesgo de conversión. Pacientes y método. Se ha realizado el análisis estadístico de los posibles factores predictivos de conversión de una serie prospectiva de 502 pacientes a los que se les realizó una colecistectomía laparoscópica electiva. Los parámetros evaluados como posibles factores predictivos han sido aquellos que pueden ser valorados de forma preoperatoria: edad, sexo, factores de riesgo médico, existencia de cirugía previa, diagnóstico clínico, grosor de la pared vesicular visualizado por ecografía, realización de colangiografía retrógrada endoscópica (CPRE) previa y experiencia del cirujano que practicó la intervención. Se ha realizado un análisis univariado mediante el cálculo de la *2 y un estudio multivariado mediante un análisis de regresión logística múltiple. Resultados. El índice de conversión de la serie ha sido del 7,4 por ciento (37 pacientes). El estudio univariado identificó la existencia de enfermedades asociadas, el diagnóstico clínico, la laparotomía supraumbilical previa, el grosor de la pared superior a 2 mm visualizado por ecografía y la realización de una CPRE previa como factores de riesgo incrementado de conversión de la vía laparoscópica. En cambio, en el análisis multivariado la realización de una CPRE previa perdió su valor predictivo, probablemente debido a que su realización en la mayoría de casos venía determinada por el diagnóstico clínico (sospecha de coledocolitiasis). La existencia de una cardiopatía o una neumopatía no se acompañó de diferencias significativas respecto a los pacientes sin enfermedad médica asociada y en ningún caso la conversión se debió a la imposibilidad de mantener el neumoperitoneo debido a su enfermedad de base. Conclusión. Los resultados orientan a considerar el diagnóstico clínico como el parámetro más determinante para valorar la posibilidad de conversión, presentando mayor riesgo aquellos pacientes con colecistitis aguda o con historia de episodios previos de colecistitis frente a otras formas de presentación. Este dato se ve apoyado por la observación, en diferentes series, de que la causa más frecuente de conversión es la dificultad en la identificación correcta de las estructuras del hilio biliar. Mediante este modelo podemos predecir la posibilidad de conversión de un paciente en función de los factores de riesgo que presente (AU)

[Association between human papillomavirus infection, premalignant lesions of anal cancer, and the human immunodeficiency virus: prospective study on subjects with condylomata acuminata]. / Asociación entre la infección por el virus del papiloma humano, las lesiones premalignas del cáncer anal y el virus de la inmunodeficiencia humana: estudio prospectivo en individuos con condilomas acuminados.

BACKGROUND: Human immunodeficiency virus (HIV) increases the risk for anal premalignant lesions associated to human papillomavirus infection (HPV). The aim of this study was to compare the prevalence of HPV and squamous intraepithelial lesions (SIL) in patients with anal warts, with and without anti-HIV antibodies. PATIENTS AND METHODS: HPV was identified using in situ hybridization and SIL was classified in high and low grade. RESULTS: HPV infection was more frequent in anti-HIV positive patients although the difference was not statistically significant. All patients with a high grade SIL were anti-HIV positive (p < 0.05). CONCLUSION: HIV infection was associated with a high rate of high-grade SIL.

Effect of spleen size on splenectomy outcome. A comparison of open and laparoscopic surgery.

BACKGROUND: Laparoscopic splenectomy (LS) is gaining acceptance as an alternative to open splenectomy (OS). However, splenomegaly presents an obstacle to LS, and massive splenomegaly has been considered a contraindication. Analyses comparing the procedure with the open approach are lacking. The purpose of this study was to analyze the effect of spleen size on operative and immediate clinical outcome in a series of 105 LS compared with a series of 81 cases surgically treated by an open approach. METHODS: Between January 1990 and November 1998, 186 patients underwent a splenectomy for a wide range of splenic disorders. Of these patients, 105 were treated by laparoscopy (group I, LS; data prospectively recorded) and 81 were treated by an open approach (group II, OS analyzed retrospectively). Patients also were classified into three groups according to spleen weight: group A, <400 g; group B, 400-1000 g; and group C, >1000 g. Age, gender, operative time, perioperative transfusion, spleen weight, conversion rate, mode of spleen retrieval (bag or accessory incision), postoperative analgesia, length of stay, and morbidity were recorded in both main groups. RESULTS: Operative time was significantly longer for LS than for OS. However, LS morbidity, mortality, and postoperative stay were all lower at similar spleen weights. Spleens weighing more than 3,200 g required conversion to open surgery in all cases. When LS outcome for hematologic malignant diagnosis was compared with LS outcome for a benign diagnosis, malignancy did not increase conversion rate, morbidity, and transfusion, even though malignant spleens were larger and accessory incisions were required more frequently. Postoperative hospital stay was significantly longer in malignant than in benign diagnosis (5 +/- 2.4 days vs. 4 +/- 2.3 days; p < 0. 05). CONCLUSIONS: In patients with enlarged spleens, LS is feasible and followed by lower morbidity, transfusion rate, and shorter hospital stay than when the open approach is used. For the treatment of this subset of patients, who usually present with more severe hematologic diseases related to greater morbidity, LS presents potential advantages.

Residual splenic function after laparoscopic splenectomy: a clinical concern.

OBJECTIVE: To document the existence of residual splenic function after laparoscopic splenectomy in a series of 48 patients. DESIGN: A noncomparative descriptive case series. SETTING: A tertiary care center. PATIENTS: A series of 9 patients without clinical improvement after laparoscopic splenectomy of 48 consecutive patients undergoing laparoscopic splenectomy for several hematologic disorders after a mean follow-up of 16 months (range, 1-40 months). INTERVENTIONS: A computed tomographic scan and technetium Tc 99m sodium pertechnetate heat-damaged red blood cell scintigraphy were performed for patients with partial (platelet count <100x10(9)/L) or total (platelet count <50x10(9)/L) failure of improvement. MAIN OUTCOME MEASURE: Evidence of residual splenic tissue by image diagnosis. RESULTS: The condition of 9 of the 48 patients failed to improve after laparoscopic splenectomy. Six patients experienced a total failure of improvement and 3 experienced a partial failure of improvement (1 patient had human immunodeficiency virus-related thrombocytopenia and 8 had idiopathic thrombocytopenic purpura). Three patients had residual splenic function, which was revealed by scintigraphy. The results of a computed tomographic scan showed an accessory spleen in one patient and splenic implants in splenic fossa in another patient. CONCLUSION: Laparoscopic splenectomy has a promising role in the management of hematologic diseases requiring splenectomy, but it requires exquisite care to avoid parenchymal rupture and cell spillage and to avoid leaving accessory spleens, which can lead to the failure of surgical treatment.

[Xanthogranulomatous cholecystitis simulating gallbladder neoplasm: therapeutic implications]. / Colecistitis xantogranulomatosa simulando una neoplasia de vesícula: implicaciones terapéuticas.

Xanthogranulomatous cholecystitis (XGC) is an infrequent type of chronic cholecystitis whose histologic features, in some cases, show a macroscopic appearance which may lead to suspicion of a gallbladder neoplasm with the consequent contraindication of the laparoscopic approach. The incidence of XGC was reviewed in a prospective series of 514 cholecystectomies performed in the authors' department from January 1991 to January 1996. Fourteen cases (2.7%) of XGC were identified with a male/female ratio of 1/1.8 and a mean age of 71 +/- 9 years. The most frequent form of presentation observed was hepatic cholic (43%). Echography showed cholelithiasis in 13 patients (93%). In 3 cases (21%), clinical and echographic suspicion of neoplasm was established, two being in the gallbladder, thus contraindicating the laparoscopic approach. A third patient underwent surgery for suspicion of a colon neoplasm. Xanthogranulomatous cholecystitis presents a macroscopic appearance which may be interpreted as a gallbladder neoplasm in up to 25% of the cases thus leading to treatment with laparoscopy.