Glycemic control and maternal and fetal outcomes in pregnant women with type 1 diabetes according to the type of basal insulin.

OBJECTIVE: To examine the potential role of the type of basal insulin on glycemic control and maternal and foetal outcomes in pregnant women with type 1 diabetes (T1DM). STUDY DESIGN: Retrospective cohort study of pregnancies attended at 18 Spanish tertiary hospitals. INCLUSION CRITERIA: T1DM, singleton pregnancies, delivery between 2002-2010, and use of the same basal and prandial insulin from before pregnancy until delivery. RESULTS: A total of 1534 pregnancies were included. The basal insulin most commonly used was Neutral Protamine Hagedorn (NPH) (51.7%), followed by glargine (23.2%) and continuous subcutaneous insulin infusion (CSII) (21.1%). CSII users had longer diabetes duration. Multiple logistic regression analysis showed that CSII was independently associated with lower doses of insulin, higher glycated haemoglobin (HbA1c) in all trimesters, and higher rates of miscarriage, preterm birth and neonatal hypoglycemia. Glargine was related to a higher risk of preterm birth and a small-for-gestational age infant (SGA). The odds ratios (OR) of the associations between insulin type and clinical outcomes (from 0.642 to 4.894) have a relevant magnitude. CONCLUSIONS: In this observational study of pregnant women with T1DM, the type of basal insulin was independently associated with metabolic variables and foetal outcomes.

Maternal glucose tolerance status influences the risk of macrosomia in male but not in female fetuses.

OBJECTIVE: To elucidate whether the risk of macrosomia, large for gestational age (LGA) and small for gestational age (SGA) is influenced by maternal body mass index and glucose tolerance differently in male and female fetuses. METHODS: A population study was conducted in 16 general hospitals from the Spanish National Health Service that included 9270 consecutive women with singleton pregnancies and without a former diagnosis of diabetes mellitus who delivered 4793 male and 4477 female newborns. Logistic regression analyses were performed to predict the effect of body mass index (BMI) category and glucose tolerance on macrosomia, large for gestational age newborns (LGA) and small for gestational age newborns (SGA) Separate analyses according to foetal sex were carried out for each outcome. The results were adjusted for maternal age, gestational age and pregnancy-induced hypertension. RESULTS: There were significant differences between males and females in the percentage of infants who had macrosomia, LGA or SGA. Maternal BMI category was positively associated with the risk of macrosomia and LGA in both male and female newborns. In addition, there was a negative association between maternal BMI and SGA that only reached significance in males. In contrast, gestational diabetes was only a predictor of macrosomia exclusively in male fetuses (OR 1.67, 95% CI 1.12 to 2.49) CONCLUSIONS: There is sexual dimorphism in the risk of abnormal birth weight attributed to maternal glucose tolerance status. A closer surveillance of foetal growth might be warranted in pregnant women with abnormal glucose tolerance carrying a male fetus.

[Salivary calculi in children]. / Litiasis salival en la infancia.

UNLABELLED: The main salivary glands are the submaxillary, sublingual and parotid glands. Infectious and tumoral conditions are prominent in the parotid gland whilst calculi are in submaxillary and sublingual glands. METHODS. Medical record review of 18 cases with a diagnosis of salivary calculi over a 13 year period. Data collected consisted in, clinical presentation, ultrasound (US), sialography (SG) and computarized tomography (CT), and treatment. RESULTS: 13 male and 5 female. Mean age was 7.2 years. All of them presented with pain and tenderness. Parotid gland was affected in 10 cases. An infectious cause for calculi was found in 7 while 3 presented calculi with no underlying infectious cause. Submaxillary gland was affected in 6 and sublingual in 2. No infectious condition was associated to submaxillary and sublingual calculi. Surgical treatment consisted in duct canalization for calculi removal and was performed in all patients after initial treatment with antibiotics. Neither complications nor relapse was found after surgical removal. CONCLUSIONS: Diagnosis of salivary calculi is made by clinical symptoms and imaging exams. Treatment is surgical and has to be performed after medical treatment for infection and inflamation.

[Palatal necrosis in children. Case report]. / Necrosis palatina en el lactante. A propósito de un caso.

Palate necrosis as a consequence of palate infection it's an exceptional condition about there's not too much references at literature. We present a case of a 6 months old child who present a palatal necrosis after a supurative medial otitis that involved hard and soft palate, with positive culture for Pseudomona aeruginosa causing a almost complete absence of the palate that simulate a bilateral palatal cleft.

Ecteinascidin-743 (ET-743) for chemotherapy-naive patients with advanced soft tissue sarcomas: multicenter phase II and pharmacokinetic study.

PURPOSE: To evaluate the response rate, toxicity profile, and pharmacokinetics of ecteinascidin-743 (ET-743) as first-line therapy in patients with unresectable advanced soft tissue sarcoma (STS). PATIENTS AND METHODS: Thirty-six patients with STS were enrolled onto the study between September 1999 and August 2000. Patients were treated with 1.5 mg/m2 of ET-743 given as a 24-hour continuous intravenous (IV) infusion every 21 days. Pharmacokinetic sampling was performed in 23 patients. RESULTS: One complete and five partial responses were achieved in 35 assessable patients for an overall response rate of 17.1% (95% CI, 6.6% to 33.6%). In addition, one patient had a minor response, leading to an overall clinical benefit of 20%. Neutropenia and transaminitis were the main grade 3 to 4 toxicities, which occurred in 33% and 36% of the patients. The estimated 1-year progression-free and overall survival rates were 21% (95% CI, 11% to 41%) and 72% (95% CI, 59% to 88%), respectively. Total body clearance (L/h) was not significantly correlated with body-surface area (r = -0.28; P = .21). Mild hepatic impairment or the extent of prior cytotoxic therapy does not seem to contribute significantly to the high interpatient variability (49%) in the clearance of this drug. Severity of treatment-related toxicity was not correlated with pharmacokinetic variables. CONCLUSION: ET-743 demonstrates clinical activity as first-line therapy against STS with acceptable toxicity. Additional studies to establish empirical dosing guidelines may be necessary to improve the safety of the drug in patients with varying degrees of hepatic dysfunction and definitively establish the role of ET-743 for patients with these malignancies.

Body mass index has a greater impact on pregnancy outcomes than gestational hyperglycaemia.

AIMS/HYPOTHESIS: We evaluated diabetes-related pregnancy outcomes in a cohort of Spanish women in relation to their glucose tolerance status, prepregnancy BMI and other predictive variables. METHODS: The present paper is part of a prospective study to evaluate the impact of American Diabetes Association (2000) criteria in the Spanish population. A total of 9,270 pregnant women were studied and categorised as follows according to prepregnancy BMI quartiles and glucose tolerance status: (1) negative screenees; (2) false-positive screenees; (3) gestational diabetes mellitus (GDM) according to American Diabetes Association criteria only; and (4) GDM according to National Diabetes Data Group criteria (NDDG). We evaluated fetal macrosomia, Caesarean section and seven secondary outcomes as diabetes-related pregnancy outcomes. The population-attributable and population-prevented fractions of predictor variables were calculated after binary logistic regression analysis with multiple predictors. RESULTS: Both prepregnancy BMI and abnormal glucose tolerance categories were independent predictors of pregnancy outcomes. The upper quartile of BMI accounted for 23% of macrosomia, 9.4% of Caesarean section, 50% of pregnancy-induced hypertension and 17.6% of large-for-gestational-age newborns. In contrast, NDDG GDM accounted for 3.8% of macrosomia, 9.1% of pregnancy-induced hypertension and 3.4% of preterm births. CONCLUSIONS/INTERPRETATION: In terms of population impact, prepregnancy maternal BMI exhibits a much stronger influence than abnormal blood glucose tolerance on macrosomia, Caesarean section, pregnancy-induced hypertension and large-for-gestational-age newborns.

Potential impact of American Diabetes Association (2000) criteria for diagnosis of gestational diabetes mellitus in Spain.

AIMS/HYPOTHESIS: This study was carried out to determine the impact of American Diabetes Association (ADA) 2000 criteria for the diagnosis of gestational diabetes mellitus (GDM) in the Spanish population. METHODS: Pregnant women were assigned to one of four categories: negative screenees, false-positive screenees, ADA-only-GDM (untreated) and GDM according to National Diabetes Data Group (NDDG) criteria (treated). Fetal macrosomia and Caesarean section were defined as primary outcomes, with seven additional secondary outcomes. RESULTS: Of 9,270 pregnant women screened for GDM, 819 (8.8%) met NDDG criteria. If the threshold for defining GDM had been lowered to ADA criteria, an additional 2.8% of women would have been defined as having the condition (relative increase of 31.8%). Maternal characteristics of women with ADA-only-GDM were between those of false-positive screenees and women with NDDG-GDM. The risk of diabetes-associated complications was slightly elevated in the individuals who would have been classified as abnormal only after the adoption of ADA criteria. In addition, the ADA-only-GDM contribution to morbidity was lower than that of other variables, especially BMI. CONCLUSIONS/INTERPRETATION: Use of the ADA criteria to identify GDM would result in a 31.8% increase in prevalence compared with NDDG criteria. However, as the contribution of these additionally diagnosed cases to adverse GDM outcomes is not substantial, a change in diagnostic criteria is not warranted in our setting.

Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy.

PURPOSE: To assess the efficacy of the marine-derived alkaloid ecteinascidin 743 (ET-743) in patients with soft tissue sarcomas that progressed despite prior conventional chemotherapy and to characterize the pharmacokinetic profiles of ET-743 in this patient population. PATIENTS AND METHODS: Thirty-six previously treated soft tissue sarcoma patients from three institutions received ET-743 as a 24-hour continuous intravenous (IV) infusion at a dose of 1,500 microg/m(2) every 3 weeks. Pharmacokinetic studies were also performed. Patients were restaged every two cycles for response by objective criteria. RESULTS: Objective responses were observed in three patients, with one complete response and two partial responses, for an overall response rate of 8% (95% CI, 2% to 23%). Responses were durable for up to 20 months. Two minor responses (43% and 47% tumor reduction) were observed, for an overall clinical benefit rate of 14%. The predominant toxicities were neutropenia and self-limited transaminitis of grade 3 to 4 severity in 34% and 26% of patients, respectively. The estimated 1-year time to progression and overall survival rates were 9% (95% CI, 3% to 27%) and 53% (95% CI, 39% to 73%), respectively. The maximum observed plasma concentration and total plasma clearance of ET-743 (mean +/- standard deviation), 1.04 +/- 0.48 ng/mL and 35.6 +/- 16.2 L/h/m(2), respectively, were consistent with previously reported values from phase I studies of the drug given as a 24-hour IV infusion. CONCLUSION: ET-743 is a promising new option for the management of several histologic subtypes of sarcoma. Durable objective responses were obtained in a subset of sarcoma patients with disease progression despite prior chemotherapy. Additionally, the relatively high survival rate noted in this series of previously treated patients further justifies development of this agent.

[Fetal skin allografts on newborn excisional wounds]. / Injertos de piel fetal sobre superficies cruentas en el recién nacido.

There is clinical and experimental evidence that skin allografts improve secondary intention wound healing, however the grafts do not take. Because of the special characteristics of the healing process in the fetal period, fetal skin allografts could be presumed to be a good alternative to adult skin allografts, and even to autografts in particular cases. In order to explore the behavior of fetal skin grafts on newborn animals, skin has been grafted to laboratory rabbits of two different ages: 26 fetal skin allografts to fetuses and newborns and 21 neonatal skin allografts to newborns. Macroscopic and microscopic features of the grafted area have been compared at the 7th, 14th and 21st postoperative days. The newborn response to a fetal skin graft was somewhat different from that to a newborn skin allograft, the first showing an earlier increase in graft bed vascularization, less edema and less foreign body reaction.

Upper lip fistulas: three new cases.

OBJECTIVE: We present three new cases of congenital upper lip fistula. Two of them were located in the philtrum midline, one of which was associated to a double maxillary frenulum, a medial lip cleft, and a medial cleft of the primitive palate. The other was located in the left side of the vermilion. All three patients had clear fluid discharge through the fistulous orifice without pain. Two of them had a history of recurrent swelling of the philtrum area. CONCLUSIONS: A simple surgical excision is the treatment of choice in these cases, in which the anatomy is preserved; this fact is more consistent with a completed but aberrant development than with focal dysgenesis.

[Mammaplasty in adolescent girls]. / Mastoplastia en la adolescente.

The aim of this work is to analyze the experience in our pediatric center on the surgical management of mammary malformation in teenagers. We have reviewed or mammaplasty cases until 1999 (n = 24). We have divided them in two groups: augmentation (A) and reduction (R) mammaplasty. The analyzed parameters were: ethiology, associated pathology, surgical approach, aesthetic results and complications. Group A (n = 14; 17 implants). The surgical indication was moderate-severe mammary hypoplasia with psychological repercussion. Associated pathology: thoracic malformation (n = 13) and psychiatric pathology (n = 2). The surgical approach was submammary in 6 cases, videoassisted transaxillary in 4 and iterative on thoracic scar in 3. All the implants were located at the subglandular space. No major complications were found and the cosmetic results were good, with only one reoperation because of asymmetry. Group R (n = 10). Surgery was indicated because of bilateral puberal mammary hipertrophy in all cases. Associated pathology: obesity (n = 3), psychiatric and behaviour disorders (n = 3), scoliosis (n = 2), and one case of isosexual precocious puberty. In all cases but one the Strömbeck mammaplasty was performed. We used the Lejour technique in this single case. The cosmetic results were good, except for 2 cases of hypertrophic scar. The only complication was a wound infection that healed well.

[Morphologic study of the intestine in an experimental model of amnioinfusion in fetal rabbits with gastroschisis]. / Estudio morfológico del intestino en un modelo experimental de amnioinfusión en feto de conejo con gastrosquisis.

An experimental model of serial amnioinfusion has been developed in fetal rabbits with gastroschisis, using an intraamniotic catheter connected to a subcutaneous port. Fetuses of 4 groups were compared 7 days after surgery: group A: gastroschisis and daily amnioinfusion through an implanted catheter; group C: gastroschisis and blind amniotic catheter; group G: gastroschisis without catheter; group O: nonoperated fetuses. Survival rate, fetal body weight, lung weight, intestinal weight and length were determined. Computer aided morphometric analysis was performed, in which intestinal diameter, thickness and villi length were measured. Amniotic fluid samples were recovered along the experimental period. Intestinal length was significantly shorter and had a significantly thicker wall than nonoperated fetuses; we found no other morphometric differences between gastroschisis treated with amnioinfusion (group A) and the other gastroschisis groups (C and G). Amnioinfusion did not affect fetal survival rate; the amniotic catheter alone did not cause pulmonary hypoplasia due to significant amniotic leak. The physiological decrease in amniotic volume towards the end of gestation has not been modified by this regime of amnioinfusion.

[Creation of a model for myelomeningocele in rabbit embryos]. / Creación de un modelo de mielomeningocele en el feto de conejo.

UNLABELLED: Spinal dysraphism causes paraplegia, fecal incontinence, neurogenic bladder, sexual dysfunction, hydrocephalus and skeletal abnormalities in newborns. Its ethiology and pathogenesis are still not known, and probably multifactorial. AIM: To determine whether spinal cord exposition to the amniotic space causes a functional (impairment) and anatomic lesion similar to that of human myelomeningocele. MATERIAL AND METHODS: Forty-eight fetal rabbits underwent to create spina bifida on the 23rd gestational day (term is 31 days). The procedure consisted of lumbosacral skin excision and posterior laminectomy. The fetuses are allowed to continue their gestation. On the 30th gestational by the operated fetuses were harvested, together with a group of nonoperated littermates for control. A clinical and neurologic evaluation was done, as well a study of somato-sensorial evoked potentials in the upper and lower limb and histologic study of the affected vertebral and cordial segment. RESULTS: The 26 surviving animals had deformity and lack of movement of the lower limbs. Evoked potentials showed absent response to stimuli in the lower limbs of animals with spina bifida, whereas upper limbs and control animals did respond. Histologically the spinal cord of the operated rabbits was uncovered and flattened. CONCLUSION: This model of myelomeningocele in fetal rabbit reproduces a variety of features similar to human spinal dysraphism, and hence can be used to study the pathophysiology of spina bifida.

[Bilateral cleft lip and palate: experience from a center with a multidisciplinary approach]. / Fisura labiopalatina bilateral: experiencia de un centro con abordaje multidisciplinar.

The aim of this work is to analyse the global experience of a center where a pluridisciplinar approach of the child affected with a cleft lip and palate is regularly done. Since january 1980 until january 2000, a total of 36 children (8 F, 28 M) with bilateral cleft lip and palate were treated. Only 5 children were born at this hospital. The others (n = 31) were referred soon after birth (24/31) or later for treat sequels. A multidisciplinary team evaluated every case. The parameters analysed were: surgical protocol, aesthetic and speech outcome, hearing disturbance, complications and the number of secondary lip surgeries. Surgical approach consisted on a soft palate closure before 3 months follow by a bilateral cheiloplasty (6 months) and a hard palate closure before 4 years of age, in the majority of cases (24/36). The esthetical result was evaluated in 25 children and was acceptable in the great majority (22/25). 16 children were submitted to tympanic draining in order to treat their secretory otitis. Speech outcome was analysed in 27 children and was good in 23. With a follow-up of 8.4 years, 15 children (8 treated soon on this center and 7 that came for their sequels) were treated for complications. There was a media of 4.5 surgeries per children.

Intestinal damage in gastroschisis is independent of the size of the abdominal defect.

The intestinal damage in gastroschisis (GS) has been attributed to a narrow abdominal wall defect (AWD), among other causes, but this causal effect is difficult to prove in humans. The present experimental study was done to ascertain the damaging effect of clinically extrapolable mild and moderate constriction at the AWD on the intestine of fetuses with GS. AWDs of two different sizes were carried out in the fetal rabbit model: small-ring GS (1.5x bowel diameter, SRG) and large-ring GS (3x bowel diameter, LRG); a group of unoperated littermates served as controls. Fetal body weight, intestinal length and weight, bowel diameter and wall thickness, and histology were checked 7 days later. No statistical difference was found in body weight and bowel diameter among the groups. Intestinal length, weight, and wall thickness were significantly different in the GS groups compared to the controls, but no difference was found between the GS groups. Histology did not show venous stasis, ischemic lesions, or differences in the degree of edema between groups SRG and LRG. Mesothelial hyperplasia was seen in both GS groups. The intestinal changes in length, weight, diameter, wall thickness, and histology in GS should thus not be attributed to the diameter of the AWD.

[Intraabdominal metastasis of cerebellar medulloblastoma through ventriculoperitoneal shunt]. / Metástasis intraabdominales de meduloblastoma cerebeloso a través de un catéter de derivación ventriculoperitoneal.

We present a 6-year-old girl with cerebellar medulloblastoma causing obstructive hydrocephalus that was treated by ventriculoperitoneal shunting. The patient subsequently underwent surgical excision of the tumor followed by adjuvant craniospinal radiotherapy. Nine months after shunting, multiple intraabdominal metastatic lesions were found. Although the risk is low, ventriculoperitoneal shunting may facilitate the spread of malignant cells.

[Advantages of primary rhinoplasty in the treatment of lip fissure]. / Ventajas de la rinoplastia primaria en el tratamiento de la fisura labial.

Congenital cleft lip is always associated to nasal deformity. The classical approach has been not to treat the severe nose defects during childhood, in the fear that early surgery would interfere with nasal growth. However, long term follow-up in patients with early conservative rhinoplasty has shown the nose to hold its new shape and its growth to be normal. During the period between november 1996 and november 1998, 22 infants affected with cleft lip underwent early rhinoplasty according to McComb's technique. During the follow-up period (6 months to 30 months) the children had a good nasal growth. The nose tip is in the medial position in all cases, and only the inferior view of the nose shows a discrete nosetril assimetry in some patients.

[Progressive bone elongation of the maxillo-facial area: mandibular distraction]. / Elongación ósea progresiva del área máxilo-facial: distracción mandibular.

Thanks to the distraction osteogenesis technique, it is nowadays possible to create new bone in the facial area. Between january 1997 and march 1999 we have performed 20 such procedures, from which 15 were mandibular. We present our experience in 10 patients with this new technique, 5 unilateral and 5 bilateral. Those were 7 boys and 3 girls, aged 2 to 14 years, affected with hemifacial microsomia, Goldenhar syndrome: 3; retrognatism with severe malocclusion: 4; facial assimetry due temporomandibular joint abnormalities: 2; and facial assimetry: 1. The proposed elongation was achieved in all cases. There was not only a skeletal improvement, but also growth and remodeling of the facial soft tissues. Distraction osteogenesis is the early treatment of the mandibulofacial deformities and offers a great deal of advantages to the growing patient.

[Temporomandibular joint ankylosis (TMA) in children]. / Anquilosis de la articulación temporomandibular (ATM) en la edad pediátrica.

Temporomandibular joint (TMJ) ankylosis is a degenerative disease that produces a limitation of mouth opening. In children, TMJ ankylosis usually presents with facial asymmetry, difficulty in feeding and rarely upper way obstruction. Ankylosis is commonly associated with trauma, infections, systemic and congenital diseases. Diagnosis must be clinical, being CT scan and magnetic resonance imaging (MRI) the most important methods to evaluate this disease. The treatment of TMJ ankylosis requires excision of the involved structures and reconstruction. We present our experience in treatment of the temporomandibular joint ankylosis. We have analysed the following parameters: age, sex, etiology, surgical technique, pre and postoperative oral opening.

[Fractures of the orbit floor]. / Fracturas del suelo de la órbita.

Fractures of the floor are not common during childhood, their main cause being trauma. The mechanism is an increased pressure in the orbital cavity, which breaks at is weakest point, the floor, where soft tissue may be trapped- periorbitary fat, inferior rectus muscle, and inferior oblique muscle. Symptoms are diplopia, enoftalmos, eyelid ptosis and soft tissue haematoma. The diagnosis is made on the clinical and imaging findings, CT-Scan being the most reliable technique. Surgical treatment is necessary when symptoms do not subside and when the muscles or the infraorbitary nerve are compromised. We present four cases of orbit floor fracture which were completely resolved with conservative management (2 cases) or with surgical release of the muscular structures and orbit floor reconstruction (2 cases).