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The Diabetes Prevention Program (DPP) is effective for the prevention of type 2 diabetes by weight loss with diet and physical activity. However, there is little evidence as to whether this program could be translated into real-world clinical practice in Latin American countries. The objective of this work was to evaluate the effectiveness of the DPP for the management of overweightness and obesity at 6 and 12 months in clinical practice in Mexico. This was a non-controlled intervention study implemented in five public clinics in northern Mexico. Two hundred and thirty-seven adults aged 45.7 &plusmn, 9.9 years with a Body Mass Index (BMI) of 34.4 &plusmn, 5.4 kg/m2 received group sessions with an adaptation of the DPP, in addition to nutrition counseling. One hundred and thirty-three (56%) participants concluded the 6 month phase. They showed a significant weight loss, ranging from 2.76 &plusmn, 4.76 to 7.92 &plusmn, 6.85 kg (p &le, 0.01) in the clinics. The intention-to-treat analysis showed a more conservative weight loss. Participant retention at the end of 12 months was low (40%). The implementation of the DPP in different public clinics in Mexico was effective in the management of obesity in the short term, but better strategies are required to improve participant retention in the long term.

Introduction: Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico. Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. These programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol. However, most Mexican primary care clinics and public hospitals apply traditional treatments for obesity management with limited results on weight loss. The purpose of the study is to evaluate the effectiveness of the Diabetes Prevention Program (DPP) “Group Lifestyle Balance” for weight loss among adults with overweight and obesity from baseline to 6 months and from baseline to 12 months in primary care clinics and public hospitals from Sonora, Mexico.Material and Methods: This is a translational, multi-center, non-controlled, 6 and 12-month follow-up clinical study with a pre-test and post-test design. Healthcare providers from two primary care clinics, two hospitals and one university clinic will be trained with the DPP protocol to implement on their patients with overweight and obesity. Body weight, body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in participants receiving the program at baseline, 6 and 12 months. Biochemical parameters will be measured at baseline and 12 months. The primary outcome is the change in body weight at 6 and 12 months.Discussion: This study will provide scientific evidence of the effectiveness of the DPP protocol as a model for obesity management in real world clinical practice among the adult Mexican population.

Objective: To analyze whether for an equal health problem there are gender differences in the drugs used in an adult population attended in the Health Care Centers of the Valencian Community (Spain). Methods: A cross-sectional analytical study was carried out between February-August 1997. The independent variables were: socio-economic parameters, frequency of visits, and self-perceived or diagnosed health problems, and the dependent one the number of drugs consumed. Results: Of the 812 patients considered, 801 consumed medication. Eighty percent of the health problems for which drugs were used involved 5 apparatuses and systems (mean: 3.3 health problems/patient). The 5 most consumed therapeutic groups accounted for 81% of the total (mean: 4.5 drugs/patient). Significant differences were recorded, with greater female consumption in the central nervous system and genitourinary tract therapeutic groups, and with greater male consumption in relation to the respiratory system and systemic anti-infectious therapy. Drug use increased with age, lowest educational level, lowest professional categories, and with the highest frequency of visits to the physician. Significant differences were also recorded in drug use by occupational status, marital status and family structure. The multivariate analysis showed the number of health problems and the frequency of visits accounted for 82.2% of the variability of the variable «number of drugs consumed». The variability accounted for by gender was explained by the variable health problems, the main factor underlying drug consumption among women and men. Conclusion: The main finding is probably that women do not use larger numbers of drugs than men if health problems and frequency of visits are controlled.

ObjetivoConocer la calidad y la relevancia de las reacciones adversas a medicamentos (RAM) publicadas como Cartas al Director en las revistas médicas españolas.DiseñoEstudio descriptivo.ParticipantesCartas al director sobre RAM aparecidas durante 5 años (1994-98).EmplazamientoCuatro revistas españolas (Medicina Clínica, Revista Clínica Española, ATENCIÓN PRIMARIA y Anales de Medicina Interna).Mediciones principalesLas características de los pacientes, de los medicamentos, de las reacciones adversas, el algoritmo de causalidad, los criterios mínimos y la relevancia de la publicación.ResultadosDe 2.244 cartas, 204 (9,1%) se referían a RAM e incluían 235 casos. Los subgrupos terapéuticos más implicados fueron: anticoagulantes y antiplaquetarios, antibióticos y antineoplásicos. El 20,4% de los medicamentos era reciente. Las RAM más frecuentes afectaron al sistema nervioso (13,6%), el hígado (10,2%), la piel y anejos (9,8%), reacciones generales (9,8%) y aparato digestivo (8,1%). El 50,2% fueron moderadas y el 34%, graves/mortales. El valor medio (5,9±2,2) del algoritmo de causalidad fue similar entre revistas; las RAM fueron: 28 (11,9%) definidas, 182 (77%) posibles o probables y 26 (11,1%) improbables o condicionales; el 10,2% eran desconocidas. No se detectaron diferencias en la media (9,5±1,2) de criterios mínimos de publicación. La relevancia de la publicación fue de 3,2±1,6 puntos, superior en Medicina Clínica.ConclusionesLa publicación de RAM supone una parte importante de la sección de Cartas al Director en las revistas estudiadas. La relación de causalidad es aceptable y la calidad documental elevada, con pocas reacciones desconocidas y a medicamentos recientes. La relevancia ha sido escasa, aunque superior en Medicina Clínica.ObjectiveTo assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals.DesignObservational study.ParticipantsLE on adverse drug reactions published over 5 years (1994-98).SettingFour Spanish medical journals (Medicina Clínica, Revista Clínica Española, ATENCIÓN PRIMARIA, and Anales de Medicina Interna).Main measurementsPatient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance.ResultsOut of 2,244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9±2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5±1.2). Publication relevance was 3.2±1.6 points, and higher in Medicina Clínica.ConclusionsADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica.

Background The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, observational pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus hyperbaric bupivacaine for hip fracture surgery. Description Hundred twenty ASA status I-IV patients aged 65 and older undergoing hip fracture surgery were enrolled. The primary objective of our study was to compare hemodynamic effects based on systolic blood pressure (SBP) and dyastolic blood pressure (DBP) values, heart rate (HR) and hemoglobin (Hb) and respiratory effects based on partial oxygen saturation (SpO2%) values. The secondary objective was to assess potential adverse events with the use of levobupivacaine versus bupivacaine. Assessments were performed preoperatively, at 30 minutes into surgery, at the end of anesthesia and at 48 hours and 6 months after surgery. Among intraoperative events, the incidence of hypotension was statistically significantly higher (p

Fundamento El cumplimiento de un tratamiento es necesario para conseguir su efectividad. Se pretende conocer el cumplimiento del tratamiento hormonal sustitutivo (THS) en mujeres menopausicas. Metodo Estudio descriptivo observacional realizado en tres Areas de Salud de la Comunidad Valenciana. Periodo de seguimiento desde 1989 hasta 1999. Se incluyeron mujeres que acudieron a una unidad de menopausia y comenzaron con el THS. La informacion se obtuvo de la historia clinica y de una encuesta telefonica realizada a las pacientes. Se analizaron la edad de la mujer, la edad de inicio y el tipo de la menopausia, la edad de comienzo del THS, el nivel educativo, el motivo de prescripcion, el tiempo de utilizacion, el grado de informacion, los efectos secundarios y las causas de abandono. Se utilizo el metodo de Kaplan-Meier para conocer el cumplimiento y el riesgo proporcional de Cox para conocer las variables que influyen en el cumplimiento. Resultados Se incluyeron 363 mujeres. Existe un 75% de probabilidades de que las mujeres alcancen un tiempo de cumplimiento de 5 anos, la mediana se corresponde con un cumplimiento de 11 anos (intervalo de confianza [IC] del 95%, 9–13). Las mujeres que han padecido efectos secundarios (odds ratio ajustada [ORa], 2,60; IC del 95%, 1,84–3,68) presentan mayor tasa de abandono, mientras que este es menor en las que han tenido beneficios (ORa, 1,77; IC del 95%, 1,22–2,53), aquellas cuya menopausia ha sido quirurgica (ORa, 1,60; IC del 95%, 1,12–2,28) y las que tienen menos de 55 anos al comienzo del THS (ORa, 2,61; IC del 95%, 1,67–4,07). Conclusiones El cumplimiento del THS en mujeres menopausicas es alto y esta condicionado por el hecho de tener beneficios y/o efectos secundarios, por la edad al inicio del tratamiento y el tipo de menopausia.

ObjetivoDada la posibilidad de efectos adversos, interacciones con medicamentos e intoxicaciones por contaminantes entre consumidores de hierbas medicinales (HM), nuestro objetivo es describir el consumo de HM en usuarios de los centros de salud en tratamiento con medicamentos.DiseñoEstudio observacional, transversal.EmplazamientoTrece centros de salud de la Comunidad Valenciana.Pacientes u otros participantesUsuarios, de sexo indistinto, mayores de 14 años, seleccionados para un estudio de utilización de medicamentos para encontrar diferencias entre sexos. Mediciones y resultados principales. Las variables de estudio, edad, sexo, nivel educativo, consumo de medicamentos y uso de HM se recogieron desde la historia clínica, tarjeta de largo tratamiento y encuesta estructurada ad hoc. De los 812 usuarios, 801 consumen medicamentos. Toman HM, 159 (19,6%; IC del 95%, 16,9–22,3); edad media, 55,8 años (DE, 16,5); mujeres, 58,5% (IC del 95%, 50,8–66,1). Consumen HM, 226 (media, 1,42; IC del 95%, 1,32–1,52); los varones consumen más HM (p < 0,05). No existen diferencias de consumo de HM por edad, nivel educativo o número de medicamentos consumidos. Un 42,8% (IC del 95%, 35,1–50,2) de los que consumen HM acudieron a la consulta más de 10 veces en el último año. El 96,9% (IC del 95%, 93,7–98,4) de las HM se consumen por automedicación. Se consumen: «por gusto», 36,7% (IC del 95%, 30,4–43,0); problemas de estómago, 19,5% (IC del 95%, 14,3–24,6); nervios/depresión, 12,8% (IC del 95%, 8,5–17,2); trastornos intestinales, 10,6% (IC del 95%, 6,6–14,6); insomnio, 5,8% (IC del 95%, 3,1–9,6). Un 49,1% (IC del 95%, 42,6–52,6) es HM manufacturadas.ConclusionesUno de cada 5 pacientes en tratamiento con medicamentos consume HM por automedicación. La administración sanitaria y los médicos deberían informar de los riesgos para la salud y las contraindicaciones de estos productos.ObjectiveGiven the possibility of adverse side-effects, interactions with medicines and poisoning by contaminants among herbal medicine consumers (HM), we aimed to describe the consumption of HM by health centre users being treated with medicines.DesignCross-sectional, observational study.SettingThirteen health centres in the Community of Valencia.Patients and others participantsUsers of either sex, over 14, chosen for a study of use of medicines to find differences between the sexes.Measurements and main resultsThe study variables, age, gender, education, consumption of medicines and use of HM, were gathered from the clinical records, the long-treatment card and an ad hoc structured survey. 801 out of 812 users took medicines. 159 took HM (19.6%; 95% CI, 16.9–22.3); average age 55.8 (SD, 16.5); women 58.5% (95% CI, 50.8–66.1). They took 226 HM (mean of 1.42; 95% CI, 1.32–1.52). Men consumed more HM (p < 0.05). There were no differences in consumption of HM for age, educational background or number of medicines taken. 42.8% (95% CI, 35.1–50.2) of those who took HM attended for consultation over 10 times in the previous year. 96.9% (95% CI, 93.7–98.4) of HM were taken by self-medication. They were consumed: «because I like them» by 36.7% (95% CI, 30.4–43.0); stomach problems, 19.5% (95% CI, 14.3–24.6); nerves/depression, 12.8% (95% CI, 8.5–17.2); intestinal disorders, 10.6% (95% CI, 6.6–14.6); insomnia 5.8% (95% CI, 3.1–9.6). 49.1% (95% CI, 42.6–52.6) were manufactured HM.ConclusionsOne of every five patients being treated with medicines is also taking HM by self-medication. The health authorities and doctors should advise of the risks to health and of the counter-indications of these products.

1. We carried out experiments in anesthetized rats to study the hemodynamic effects of intravenous injections of epinine. 2. Epinine (1-320 micrograms/kg) produced a biphasic effect on mean arterial blood pressure (n = 30). At doses lower than 40 micrograms/kg, arterial blood pressure decreased (by as much as 21.5 +/- 3.4%), though at higher doses it increased dose dependently (by as much as 73.2 +/- 14.5%). Epinine also produced bradicardia in a dose-dependent manner (by as much as 26.4 +/- 4.9%). Sulpiride (100 micrograms/kg) suppressed the hypotensive effect of epinine but did not change the hypertensive effect. In the presence of prazosin (1,000 micrograms/kg), arterial blood pressure remained significantly decreased at all doses of epinine. Neither sulpiride nor prazosin changed the bradycardic effect of epinine. 3. Prazosin produced a significant decrease in renal vascular resistance. Epinine (5 micrograms/kg) after prazosin reverted the effects of prazosin in renal vascular resistance, without any significant modification in the renal blood flows. However, 20 micrograms/kg epinine increased the renal vascular resistances and, moreover, produced a significant decrease in the blood flows of both kidneys. Neither prazosin nor epinine produced modifications in the intestinal vascular bed. 4. Although epinine possesses significant dopamine and alpha-adrenergic activities that are involved in the biphasic effect of the agent on mean arterial blood pressure in anesthetized rats, in the presence of prazosin, it is not possible to manifest dopaminergic activity involved in the increase in renal or mesenteric blood flow; this may be due to the low tone of the vascular wall induced by the alpha-adrenergic antagonist, though an alpha 2-activity cannot be discarded.

UNLABELLED In an attempt to assess the relative toxicity of amoxycillin and amoxycillin-clavulanic acid, we compared the adverse drug reactions reports collected using the spontaneous reporting system of a Regional Drug Surveillance Centre of Spain for both drugs between November 1986 and December 1992. During the 7-year period 1986-92, the 247 reports of amoxycillin-clavulanic acid represent twice the number of reports of amoxycillin alone, and the number of reports related with sales received concerning the association were higher than those concerning amoxycillin alone. The adverse effects classified as severe were quantitatively and qualitatively similar for both drugs and gastrointestinal and skin are the most common system-organ affected by both drugs. With amoxycillin-clavulanic acid there is a higher proportion of stomatological reactions reported and a later onset of adverse drug reactions related with oropharyngeal lesions, and the reaction of the resistance mechanism when compared with the other organs and systems affected. The duration of the adverse drug reactions to amoxycillin-clavulanic acid is longer than for amoxycillin alone. IN CONCLUSION (i) the adverse drug reactions profile of both drugs is different; (ii) the higher reporting rate for amoxycillin-clavulanic acid may be due to more recent marketing; and (iii) amoxycillin-clavulanic acid produces proportionately more gastrointestinal and fewer skin adverse reactions than amoxycillin alone.

OBJECTIVE: To describe two cases of stomatitis related to fluoxetine given for the treatment of depression that were detected in the hospital emergency department. DATA SYNTHESIS: Two women developed stomatitis after the intake of fluoxetine for the treatment of depression. One of the patients had six recurrent episodes of stomatitis without suspecting an association with fluoxetine. No other drugs were administered during these episodes. The second patient was treated concurrently with fluoxetine and bentazepam. In both patients the lesion improved upon discontinuation of fluoxetine, even though the second patient continued to take a different benzodiazepine. DISCUSSION: Stomatitis related to fluoxetine has not been previously reported in clinical trials or in the literature. According to the causal algorithm used by the Spanish Drug Surveillance Schemes, the first case constituted a defined adverse reaction and the second was probable. CONCLUSIONS: Our observations suggest that fluoxetine may be considered as a probable cause of stomatitis. The reporting of isolated cases of adverse drug reactions (ADRs) makes it possible to define the toxicity profile of recently marketed drugs such as selective serotonin-reuptake inhibitors, including fluoxetine. Emphasis is placed on the potential role played by emergency departments in detecting ADRs.

An analysis is made of the effect of alternateday dosing of atorvastatin and standard once-daily dosing, based on mean low-density lipoprotein (LDL) reduction from baseline in type 2 diabetics. Forty-four type 2 diabetics were enrolled in the study. In compliance with American Diabetes Association (ADA) and National Cholesterol Education Program Expert Panel (NCEP-III) guidelines, LDL-C

To describe patterns observed in the treatment of acute otitis media (AOM) in several locations of five countries.Cross-sectional, descriptive study. Random sample of 12,264 paediatric outpatients seen by paediatricians or general practitioners (GPs). Data on patient demographics, diagnoses and treatment were collected. Diagnoses were coded by ICD-9 and drugs by ATC classification. Patients diagnosed with AOM (ICD-9 codes: 381 and 382) were selected for analysis.Cases of AOM (873) accounted for 7.1% of the sample. There is a clear variation in the percentage of children diagnosed with AOM and treated with antibiotics in the different locations, antibiotic prescriptions being higher in Barcelona (93% of children), and lowest in Smolensk (56.4 % of children were treated without antibiotics). The antibiotics used varied widely: ampicillin use is almost limited to Smolensk (26.7%) and Bratislava (13.8%), whereas amoxicillin plus clavulanic acid is the choice in Toulouse (33.8%), Valencia (30.2%) and Barcelona (28.9%), and cephalosporins are more frequently prescribed in Tenerife (51.7%). Finally, macrolides are used in Barcelona (18.3%), Valencia (17.5%) and Tenerife (13.6%), but not prescribed in Toulouse or Sofia. Prescriptions of anti-inflammatory drugs were only relevant in Valencia (31.7%), Tenerife (27.2%) and Toulouse (17.4%) and of otological preparations in Sofia, where almost each child received ear drops (91.9%). Nasal preparations are commonly used only in Sofia (41.9%), Bratislava (65.5%) and Smolensk (68.6%).Despite the general agreement of most guidelines, wide differences in the treatment of uncomplicated AOM in children are observed. Non-antibiotic therapy for AOM and the use of first-choice antibiotics should be more actively encouraged in the primary care centres. Studies to measure prevailing rates of antibiotic resistance in these populations are needed.

Scarce information about comparative diagnostic and therapeutic patterns in paediatric outpatients of different countries is found in the literature.To describe the similarities and differences observed in diagnosis and therapeutic patterns of paediatric patients of seven locations in different countries.Cross-sectional, prospective, international comparative, descriptive study.A randomly selected sample of 12,264 paediatric outpatients seen in consultation rooms of urban and rural areas and attended by paediatricians or general practitioners of the participating locations. Data on patient demographic information, diagnosis and pharmacological treatment were collected using pre-designed forms. Diagnoses were coded using the ICD-9 and drugs according to the ATC classification.Among the ten most common diagnoses, upper respiratory tract infections are in the first position in all locations; asthma prevalence is highest in Tenerife (8.4%). Tonsillitis, otitis, bronchitis and dermatological affections are the most common diagnoses in all locations. Pneumonia is only reported in Sofia (3.8%) and Smolensk (2.3%). The average number of drugs prescribed per child varied from 1.3 in Barcelona to 2.9 in Smolensk. There are no great differences in the profile of pharmacological groups prescribed, but a considerable range of variations in antibiotic therapy is observed: prescription of cephalosporins is low in Smolensk (0.7%) and higher in the other locations, from 16.5% (Bratislava) to 28% (Tenerife). Macrolides prescriptions range from 12.6% (Toulouse) to 24.7% (Smolensk), except in Sofia where they drop to 5.6%. Trimethoprim and its combinations are used in Smolensk (23.3%), Sofia (11.8%) and Bratislava (8.7%). Check-up consultations are not recorded in Smolensk and Bratislava, whereas in Toulouse these visits account for 16.2% of all consultations and in the other locations the percentage varies from 6.1% (Tenerife) to 1.9% (Sofia). Homeopathic treatments are registered only in Toulouse.Except in asthma prevalence, there are no great differences in diagnostic maps among locations. Significant variations in the number of drugs prescribed per child and antibiotic therapies are observed. Areas for improvement have been identified.

Objective and design: To study both the desensitisation induced by short-term exposure to histamine and the mechanism responsible in the isolated rat uterus.¶Material: Precontracted isolated uterus (37 mM KCl) from oestrogenised Wistar rats were used.¶Treatment: Repetitive responses to histamine (10–6, 10–5, 10–4, 10–3 M), dimaprit and clonidine (10–4 M) were tested at 15, 30, 45 and 105 min., with their modifications by (5 mg/ kg, 24 h before sacrifice) reserpine, 10–7 M propranolol, 10–8 M atropine, and 10–6 M indomethacin. Dose-response curves for adrenaline were carried out as standard protocol.¶Methods: In vitro techniques (de Jalon's solution, 31°C, carbogen, isotonic registration, resting tension 1 g). Levels of cAMP were studied in response to histamine, adrenaline and isoproterenol by radioassay.¶Results: Repeated histamine produced a rapid loss of inhibitory uterine response depending on the number of exposures and increase in concentration. The tachyphylaxis phenomenon is not modified by the different pretreatments used. Dimaprit, but not clonidine or adrenaline, produced tachyphylaxis. The second exposition to 10–3 M histamine produced a 38.8% reduction in cAMP production.¶Conclusion: Histamine appears to induce homologous and probably cAMP-dependent desensitisation of H2-receptors.

OBJECTIVE: To report four cases of cinnarizine-induced weight gain. DATA SOURCES: Case reports from a local obesity center and review articles. DATA EXTRACTION: Data were abstracted from spontaneous comments made by patients to one of the authors, who was a doctor at the clinic, and reviewed by the remaining authors. DATA SYNTHESIS: We reviewed the cases of four women, aged 50–57 years without endocrine or metabolic pathologies, that showed weight gain associated with the intake of cinnarizine for one to two years. No other drugs usually were administered during the period in which the women gained weight, although in two cases cinnarizine was associated with dihydroergocristine in the same medicine (Clinadil). The mean weight increase was 6.25 kg (range 4–10). The increases do not appear to be related to whether the patients' initial weight was ideal or excessive. The weight gain was always associated with increased appetite and food intake. One patient discontinued cinnarizine treatment and her weight returned to its previous level. CONCLUSIONS: Cinnarizine is a piperazine derivative used in the treatment of vertigo and in the prophylaxis of migraine. In contrast to related drugs, data about cinnarizine are scarce because randomized trials of cinnarizine have been inconclusive. Our observations indicate that cinnarizine may cause weight gain, as observed with other drugs in the same class.

Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982–1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal reactions. Conclusions: Adverse drug reaction are not common in pediatric patients, and most are mild. However, due to limitations of clinical trials in children, pharmacoepidemiological studies may be the only source of information on the benefit-risk profile of drugs received by these patients, and as such require special attention.

1A total of 512 consecutive paediatric hospital admissions of children 2 years old or less were evaluated to assess the extent and pattern of admission caused by suspected adverse drug reactions (ADRs). The proportion of suspected ADRs related to hospital admissions was 4.3%. 2The organ-systems most commonly implicated were the central nervous system (40.5%), digestive system (16.7%), and skin and appendages (14.3%). Together, they accounted for 71.5% of admissions attributed to ADRs. The most common clinical manifestations inducing admission were convulsions (4 cases), dizziness (4), vomiting (3), and tremor, fever, itching and apnoea (2 cases each). 3The four classes of drugs most frequently suspected in admissions due to ADRs were respiratory drugs (35%), anti-infective agents (25%), drugs active on the central nervous system (15%) and drugs used in dermatology (10%). The most common drugs related to ADRs were a combination of chlorpheniramine, diphenhydramine, phenylephrine, guaiphenesin and salicylic acid (4 cases), followed by fenoterol, adrenaline, paracetamol, DTP vaccine and antipolio vaccine (2 cases each). 4There were no significant differences between children older and younger than 1 year (odds ratio 0.89; 95% CI 0.37–2.17) or between the sexes as regards hospital admittance due to suspected ADRs (odds ratio 1.94; 95% CI 0.72–5.42). 5The results of this kind of study may be influenced by patterns of drug utilization. Nevertheless, the lack of specific studies of drug effects in young children makes it desirable to carry out pharmacoepidemiological studies in this age group.

We investigated the spontaneous uterine activity of isolated corpus uteri myometrial strips from 30 patients with nonpathologic myometrium, 26 patients with uterine myoma, 23 patients with uterine adenomyosis, and three patients with uterine malignancy. We also investigated the influence of these conditions on the response of the uterus to histamine. The results show the same qualitative cyclic changes of the spontaneous motility of isolated myometrial strips throughout the menstrual cycle in all the abnormalities studied. These changes are characterized by a low amplitude and high frequency of spontaneous contractions in the proliferative phase and lower frequency with higher amplitude of contractions in the secretory phase. The isolated strips from patients with myomas present the highest spontaneous activity in reproductive age and preclimacteric women, but not in menopausal women. Histamine produced concentration-related contractions that are not significantly different in all the myometrial strips studied.

The effects of guanfacine have been studied on guinea-pig isolated atria and diethylstilboestrol-treated rat isolated uterus to determine whether it possesses histamine-like activity. Guanfacine produced a concentration-dependent negative chronotropic effect which was not modified by ranitidine (0.1 μM). In rat isolated uterus contracted by KCl, clonidine (5–5000 μM) produced concentration-dependent relaxation which was blocked by ranitidine (0.1 μM), but guanfacine only produced relaxation at high concentrations (100–1000 μM), and this was not affected by ranitidine (0.1 μM). It is concluded that guanfacine, unlike clonidine, does not produce effects due to activation of H2-receptors in either guinea-pig atria or rat uterus.

ObjetivoAnalizar la relación entre el sexo del paciente y la calidad del medicamento controlando por las variables predictoras más relevantes.DiseñoEstudio observacional transversal.EmplazamientoTrece centros de salud de la Comunidad Valenciana.ParticipantesUsuarios adultos, seleccionados por muestreo consecutivo.Mediciones principalesEncuesta semiestructurada que recoge variables sociodemográficas, de utilización de medicamentos por problemas de salud, frecuentación de los servicios y origen de la prescripción. La calidad del medicamento se midió con el valor intrínseco (VI).ResultadosDe los 812 pacientes, 412 son mujeres. Los varones consumen más medicamentos con VI elevado (VIE) y las mujeres más de VI inaceptable. Las mujeres mayores de 45 años consumen más medicamentos de VI no elevado (VINE). El análisis multivariante pone de manifiesto: a) la prevalencia en las mujeres de uso de medicamentos de VINE es una vez y media mayor que en los varones, diferencias no significativas, y b) en el grupo de edad de 45-64 años el sexo femenino se comporta como modificador de efecto aumentando la prevalencia en el consumo de medicamentos de VINE en dos veces y media respecto a los varones ajustado por frecuentación, problemas de salud y origen de la prescripciónConclusionesSe contribuye a clarificar la influencia del sexo en la calidad del medicamento al señalar la mayor probabilidad de consumir medicamentos de peor calidad por el hecho de ser mujer y tener entre 45 y 64 años. Además, se demuestra el papel del origen de la prescripción y los problemas de salud en la explicación de este consumo diferencial.ObjectiveTo analyse the relationship between patient’s sex and quality of medicine taken by monitoring the most pertinent predictive variables.DesignObservational cross-sectional studySettingThirteen Health Centres in the Community of Valencia.ParticipantsAdult users, selected by consecutive sampling.Main measurementsA semi-structured questionnaire collected the following variables: social and personal details, use of medicines for health problems, frequency of use of services, and place where prescription was issued. The quality of the medication was measured by its intrinsic value (IV).Results412 of the 812 patients were women. Men took more medication with a high IV, and women more with an unacceptable IV. Women over 45 took more medication with a not-high IV. Multivariate analysis showed: a) women took one and a half times more medicines with a not-high IV than men, with differences not significant, and b) in the 45-64 age-group, being a woman operated as a modifier of effect, increasing prevalence of consumption of not-high IV to two and a half times more than men. This was adjusted for frequency of attendance, health problems and where the prescription was issued.ConclusionsThe study helped clarify the influence of gender on the quality of medicine, by pointing to the greater likelihood of women between 45 and 64 taking lower-quality medication. In addition, it showed the effect of where the prescription was issued and of health problems on explaining this difference in consumption.