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Biomedical subjects

A Morabito

Publications and source records attributed to A Morabito.

At least 19 recordsLinked to original sources
PubMed2006

Wall or machine suction rectal biopsy for Hirschsprung's disease: a simple modified technique can improve the adequacy of biopsy.

Suction rectal biopsy (SRB) may not include sufficient submucosa for histological diagnosis of Hirschsprung's disease (HD) and a repeat biopsy is required. Substitution of the conventional syringe for sustained suction from a machine or wall suction unit could provide a more consistently adequate tissue biopsy. This study was conducted to compare the adequacy of SRB specimens using a conventional method of syringe suction (SSRB) with those taken by wall or machine suction (WSRB). Hospital records of patients who had a SRB between 2002 and 2004 were studied retrospectively. The biopsy was considered inadequate if there was insufficient submucosa and a repeat specimen was requested. SSRB were taken using the conventional SSRB technique. WSRB were taken with the same Noblett forceps but with suction from wall suction or from a portable suction machine. Ninety-five infants had 103 SRB, 24 had WSRB and all (100%) were adequate for histopathological diagnosis or exclusion of HD. Seventy nine conventional SSRB were undertaken in 71 infants of which 64 (81.02%) were adequate. The difference in adequacy between WSRB and SSRB was statistically significant (P = 0.02). There were no instances of haemorrhage or bowel perforation in either subgroup. WSRB with the Noblett biopsy forceps is more likely to produce an adequate specimen and to reduce the incidence of repeat biopsies.

Biopsy↗
PubMed2006

Early and five-year amputation and survival rate of diabetic patients with critical limb ischemia: data of a cohort study of 564 patients.

OBJECTIVE: To evaluate the early and late major amputation and survival rates and related risk factors in diabetic patients with critical limb ischemia (CLI). DESIGN: Retrospective study. METHODS: Revascularization feasibility, major amputation, survival rate and related risk factors were recorded in 564 diabetic patients consecutively hospitalized for CLI from 1999 to 2003 and followed until June 2005. RESULTS: Peripheral angioplasty (PTA) was carried out in 420 (74.5%), bypass graft (BPG) in 117 (20.7%) patients. In 27 (4.8%) patients both PTA and BPG were not possible. Twenty-three above-the-ankle amputations (4.1%) were performed at 30 days: 6 in PTA patients, 3 in BPG patients, 14 in non revascularized patients. In the follow-up of 558 patients (98.9%), 62 repeated PTAs and 9 new BPGs, 32 new major amputations (16 in PTA patients, 14 in BPG patients and 2 in non-revascularized patients) were performed. Major amputation was associated with absence of revascularization (OR 35.9, p < 0.001, CI 12.9-99.7), occlusion of each of the three crural arteries (OR 8.20, p = 0.022, CI 1.35-49.6), wound infection (OR 2.1, p = 0.004 CI 1.3-3.6), dialysis (OR 4.7, p = 0.001 CI 1.9-11.7) increase in TcPO2 after revascularization (OR 0.80, p < 0.001 CI 0.74-0.87). One hundred seventy three patients died during follow-up and this was associated with age (HR 1.05, p < 0.001 CI 1.03-1.07), history of cardiac disease (HR 2.16, p < 0.001 CI 1.53-3.06), dialysis (HR 3.52, p < 0.001 CI 2.08-5.97), absence of revascularization (HR 1.68, p < 0.001, CI 1.29-2.19) and impaired ejection fraction (HR 1.08, p < 0.001, CI 1.05-1.09). CONCLUSIONS: In diabetic patients with CLI the revascularization is feasible in most cases and allows a low rate of early major amputation. This rate is higher in the follow-up period. Major amputation is very high in patients where revascularization is not feasible while the high mortality rate is due to the serious comorbidities observed in these patients.

Aged↗
PubMed2006

Is epirubicin effective in first-line chemotherapy of metastatic breast cancer (MBC) after an epirubicin-containing adjuvant treatment? A single centre phase III trial.

The aim of the study was to demonstrate the superiority of docetaxel and epirubicin vs docetaxel alone as first-line therapy in metastatic breast cancer patients pretreated with adjuvant or neoadjuvant epirubicin. We compared single agent docetaxel 100 mg m-2 (D) with the combination of docetaxel 80 mg m-2 and epirubicin 75 mg m-2 (ED). The response rate (72 vs 79%), the progression-free survival (median 9 vs 11 months) and the overall survival (median 18 vs 21 months) were not significantly different between the ED (n=26) and D arms (n=25), respectively. Leucopaenia, nausea and stomatitis were significantly worse with ED. In conclusion, epirubicin should not be administered in combination with taxanes in metastatic breast cancer patients relapsed after an anthracycline-based adjuvant or neoadjuvant therapy.

Adult↗
PubMed2006

Stroke Unit care in Italy. Results from PROSIT (Project on Stroke Services in Italy). A nationwide study.

The future challenge for improving stroke patients' outcome will be to implement new Stroke Units (SUs) worldwide. However the best SU model remains uncertain. The aim of this study was to evaluate the number of SUs and the quality characteristics of acute stroke care in Italy. We conducted a SU survey in Italy, interviewing the directors of the hospital wards that discharged at least 50 acute stroke patients a year. A SU was defined as an acute ward area with stroke-dedicated beds and staff. To compare the quality of care provided in SUs with that in general wards (GWs) we investigated the characteristics of five domains: hospital setting, unit setting, staffing, process of care and diagnostic investigations. We identified 68 SUs and 677 GWs. Multivariate logistic regression analyses demonstrated that SUs compared to GWs had higher quality scores in unit setting (ROC area=0.9721), staffing (ROC area=0.8760) and care organisation (ROC area=0.7984). The hospital setting (ROC area=0.7033) and the availability of rapid diagnostic investigations (ROC area=0.7164) had lower power in discriminating SU from GW. In Italy in 2003/04 only 9% of the hospital services had organised SU care. The study demonstrated that SUs admitted more than 100 patients per year, had more monitoring equipment and staffing time, and practised multidisciplinary meetings and early mobilisation. The utility of these structural and performance characteristics needs validation from outcome studies.

Female↗
PubMed2006

Restoration of posterior aspect of rhabdosphincter shortens continence time after radical retropubic prostatectomy.

PURPOSE: Prolonged postoperative incontinence is a major drawback of RRP. Age, scars in the rhabdosphincter, nonnerve sparing surgery and postoperative sphincter insufficiency can cause temporary or definitive urinary incontinence. We believe that sphincter deficiency is the main cause of early incontinence. Urinary leakage results from the shortening of anatomical and functional sphincter length due to caudal retraction of the urethral sphincteric complex and disruption of the median posterior fibrous raphe. We describe a modification of the Walsh RRP that overcomes caudal retraction, reconstructs the posterior fibrous raphe and decreases time to continence. The primary study end point was early continence rate assessment. Long-term continence (1 year) and erectile function assessment were secondary end points. MATERIALS AND METHODS: To avoid caudal retraction of the urethrosphincteric complex, before completing the vesicourethral anastomosis the posterior semicircumference of the sphincter is joined to the residuum of Denonvilliers' fascia and fixed to the posterior bladder wall 1 to 2 cm cranial and dorsal to the new bladder neck. Vesicourethral anastomosis is subsequently performed with care taken not to involve the neurovascular bundles. A total of 161 patients with clinically confined disease underwent modified RRP (group 1). They were compared with a historical series of 50 patients who underwent standard RRP (group 2). Early continence was defined as no pad use but patients using 1 diaper were also considered continent. Continence, assessed prospectively as the number of pads daily, was evaluated 3, 30 and 90 days, and 1 year after catheter removal. The continence state was assessed by a multivariate logistic model. Erectile function was evaluated using the International Index of Erectile Function questionnaire preoperatively and after 18 months in patients younger than 65 years who underwent nerve sparing surgery. RESULTS: In group 1, 116 (72%), 127 (78.8%) and 139 patients (86.3%) were continent 3, 30 and 90 days after catheter removal compared with 7 (14%), 15 (30%) and 23 (46%), respectively, in group 2. One-year continence rates were 96% and 90%, respectively. Erectile function was similar in groups 1 and 2 (46% and 42%, respectively). Multivariate analysis showed that continence was significantly influenced by operation type, stage and patient age. CONCLUSIONS: Careful reconstruction of the posterior aspect of the rhabdosphincter markedly shortens time to continence.

Aged↗
PubMed2006

"Total Gastric Dissociation (TGD)" in difficult clinical situations.

BACKGROUND: Since the first report by Bianchi in 1997, TOGD has been found to be safe and effective in patients with gastro-oesophageal reflux (GOR) with neurological impairment. This paper explores the versatility of total gastric dissociation (TGD) in difficult clinical situations. METHODS: The medical records of 11 neurologically normal children treated with TGD and gastrostomy after failure of conventional procedures between 1999 and 2004 were reviewed with respect to demographic data, initial diagnosis, previous operations, postoperative complications, feeding pattern, and follow-up. RESULTS: There were 7 males and 4 females. The mean age at operation was 52.7 months (24 to 72 m). The indications were severe colo-oesophageal reflux in 3; 1 post-fundoplication necrotic stomach; 1 gastric remnant after subtotal gastrectomy for bleeding; 1 microgastria; 2 with severe oesophageal obstruction following repeated failed repair of congenital stenosis of the oesophagus and after fundoplication; 1 congenital short oesophagus with left-sided congenital diaphragmatic hernia; and 2 with severe dysfunctional oesophagus following repair of congenital tracheo-oesophageal cleft. Full oral or gastrostomy feeding was established by the 5th postoperative day. The average follow-up was 47.2 months (24-72 months). There were 4 late deaths in the group: 2 with respiratory failure, 1 with sepsis secondary to peritonitis (small bowel herniation into the thorax) and 1 with pneumococcal infection. Seven patients are alive and thriving with markedly reduced episodes of chest infections and hospitalizations. CONCLUSIONS: In this study TGD presented with no peri-operative morbidity and mortality and had good long-term results. The procedure offers a safe alternative for neurologically normal children after the failure of conventional surgical procedures.

Anastomosis, Roux-en-Y↗
PubMed2006

Methodology of clinical trials with new molecular-targeted agents: where do we stand?

In recent years, we have witnessed growing interest in the methodology of clinical trials with molecular-targeted agents. In phase I studies, alternative end points to toxicity have been proposed to define the optimal biological dose: the identification of a 'target effect', the measurement of 'surrogates' for biological activity and the assessment of drug plasma levels. However, these end points are not routinely incorporated into the study design and have rarely formed the primary basis for dose selection. In phase II studies, response rate remains the preferred end point in the early evaluation of new drugs. However, this approach might lead to rejection of potentially useful drugs when significant tumor shrinkage cannot be demonstrated. Therefore, a number of alternative end points have been proposed for agents that are not expected to cause a major tumor regression: time to progression, progression-free survival, overall survival, early progression rate and growth modulation index. In phase III trials, where efficacy in terms of survival remains the most important goal of the research, the major issues are the adequate selection of patients and the optimal clinical setting of evaluation of drugs. In conclusion, many important questions regarding the methodology of clinical research with target-based agents remain open and need to be defined by research in the near future.

Antineoplastic Agents↗
PubMed2005

Clinically significant gastro-oesophageal reflux following oesophageal flap repair for oesophageal atresia and tracheo-oesophageal fistula.

Clinically significant gastro-oesophageal reflux (GOR) following oesophageal atresia and tracheo-oesophageal fistula (OA/TOF) repair is commonly considered normal sequela after repair. A retrospective review of patients operated on by two consultants was undertaken. All patients underwent oesophageal tailoring and augmentation for reconstruction of their oesophagus. The presence of clinically significant GOR was confirmed by contrast swallows, 24 hour pH study and endoscopy. Clinically significant GOR occurred in 7 (13%) of the 54 patients operated for OA and TOF. Two patients responded to non-surgical management. Four children (one with extensive tracheo-bronchomalacia and one with CHARGE association) had anti-reflux surgery (three Nissen and one Thal). We believe that oesophageal tailoring and augmentation for reconstruction of the oesophagus has the advantage of creating a more uniform oesophagus thus avoiding swallowing difficulty, bolus obstruction and the need of oesophageal dilatations too often accepted as integral to the problem following OA repair.

Esophageal Atresia↗
PubMed2005

Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003.

OBJECTIVE: To evaluate the effectiveness of peripheral angioplasty (PTA) as the first-choice revascularisation procedure in diabetic patients with critical limb ischemia (CLI). DESIGN: Prospective study. METHODS: PTA was employed as first choice revascularisation in a consecutive series of diabetic patients hospitalized for CLI between January 1999 and December 2003. RESULTS: PTA was successful performed in 993 patients. Seventeen (1.7%) major amputations were carried out. One death and 33 non-fatal complications were observed. Mean follow-up was 26+/-15 months. Clinical restenosis was observed in 87 patients. The 5 years primary patency was 88%, 95% CI 86-91%. During follow-up 119 (12.0%) patients died at a rate of 6.7% per year. CONCLUSIONS: PTA as the first choice revascularisation procedure is feasible, safe and effective for limb salvage in a high percentage of diabetic patients. Clinical restenosis was an infrequent event and PTA could successfully be repeated in most cases.

Aged↗
PubMed2005

Stroke units and general wards in seven Italian regions: the PROSIT study.

PROSIT (research PROject on Stroke services in ITaly) is a study performed to evaluate number and work organisation of acute in-hospital services (stroke units, SU) and general wards (GW), in seven Italian regions (Liguria, Lombardia, Lazio, Veneto, Friuli-Venezia-Giulia, Emilia Romagna, Toscana), which have a population of 29,169,811 inhabitants and a relative ratio of 225/100,000 hospitalisations for acute stroke. The registers of hospital discharges from January to December 1999 were looked at identify to services recording at least 50 acute stroke discharges (DRG14) per year. A structured questionnaire investigating stroke service characteristics was submitted to the doctors in charge of the identified units and completed in the presence of an external observer between October 2000 and February 2001. SUs were identified as units with dedicated beds (at least 80%) and team (at least 1 physician and 1 nurse) for acute stroke patients. SUs are still uncommon in many Italian regions because only, as 7% of the wards evaluated were found to be a SU and less than 10% of acute stroke patients resulted to be admitted to a SU. Great heterogeneity was found between the different regions surveyed. The most striking differences between SUs and GW were related to the staffing and care organisation, with higher number/patients ratio in SUs as far as physicians and nurses, speech therapists and social workers were concerned.

Age Factors↗
PubMed2005

Clinical benefit of intermittent administration of imatinib in a patient with metastatic gastrointestinal stromal tumour.

Gastrointestinal stromal tumours (GISTs) are mesenchymal tumours of the gastrointestinal tract, resistant to conventional chemotherapy and radiotherapy, but responsive to imatinib. Acquired resistance to imatinib has been reported in some patients, and several studies have suggested the possibility of overcoming imatinib resistance by increasing the dose of the drug. This case shows the possibility of obtaining clinical benefit with intermittent administration of imatinib in a patient who developed acquired resistance to a high dose of the drug.

Aged↗
PubMed2005

Therapy of breast cancer with molecular targeting agents.

Invasive breast cancer is a heterogeneous disease sustained by intercorrelated and complex growth pathways. Classically, human breast carcinoma has been classified for therapeutic purposes in two distinct categories: one hormone-correlated, the other hormone-uncorrelated. However, the recent advancements of the technology applied to molecular biology by genomic and proteomic analyses have suggested that many more factors are involved in breast cancer growth and progression and that some clusters of these distinguish subgroups of patients at different prognosis. The knowledge of the diversities between tumor and normal tissue of origin is the key to identify novel targets for new selective therapeutic strategies. In fact, the principal goal of molecular-targeted therapy is the suppression of the transformed phenotype minimally affecting normal cells. This review focuses on the molecular targeting compounds directed against the known molecular pathways involved in breast cancer such as: type I growth factors (HER-2/neu; epidermal growth factor receptor [EGFR]), angiogenesis, cyclooxigenase-2 (COX-2) and farnesylation. Presently, trastuzumab is the first agent approved for therapy of HER-2/neu overexpressing tumors. Several other compounds directed against different targets have entered clinical evaluation and the preliminary results are here presented and commented. The major challenges on the clinical development of targeted therapy include the proper selection of patients, the identification of the optimal dosage and schedule of administration, the combinations with conventional treatments and the more appropriate therapeutic strategy.

Angiogenesis Inhibitors↗
PubMed2005

Interferon-alpha suppresses liver cell proliferation in patients with chronic hepatitis C virus infection.

SUMMARY: Interferon (IFN) therapy has been shown to reduce the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis C, including virological nonresponders (NR). Whether IFN suppresses liver cell proliferation, i.e. the relevant risk factor for HCC, is unknown. The aim of the study was to evaluate the effect of IFN therapy on liver cell proliferation in chronic hepatitis C. The proliferating cell nuclear antigen-labelling index (PCNA-LI) was assessed prior to and at the end of therapy in the liver of 29 patients with chronic hepatitis C who received 3 MU IFN-alpha2b thrice weekly for 24-48 weeks. Overall, the median value of PCNA-LI was significantly reduced from 2.6% to 1.1% at the end of therapy (P < 0.0001). At baseline, PCNA-LI median values were similar in the 15 virological responders compared with the 14 NRs (2.3%vs 3.4%, P = 0.121) and at the end of therapy, median changes of PCNA-LI (-1.4%vs-1.1%, P = 0.089) were also similar although there was a higher decline of the proliferation index in responders with respect to NRs at the end of therapy (0.7%vs 1.6%, P = 0.004). In the two groups, the rate of fibrosis score reduction was also similar (7%vs 20%, P = 0.326). In contrast, the histological activity index was more often reduced in responders than in NRs both at the >or=2 and >or=4 points reduction level (80%vs 36%, P = 0.02 and 53%vs 14%, P = 0.03, respectively). The study showed a significant suppression of liver cell proliferation in IFN-treated patients with chronic hepatitis C. Although the strongest IFN effect was observed in virological responders, a reduction of proliferative activity was also seen in virological NRs.

Adult↗
PubMed2005

Screening for peripheral arterial disease by means of the ankle-brachial index in newly diagnosed Type 2 diabetic patients.

AIM: To evaluate the prevalence of peripheral arterial disease (PAD) with the ankle-brachial index (ABI) in newly diagnosed Type 2 diabetic subjects. METHODS: Between autumn 2002 and spring 2003, 2559 newly diagnosed Type 2 diabetic subjects (about 15% of the cases/year in Italy) were enrolled in 265 diabetology centres. Family history of diabetes, smoking, height, weight, waistline, fasting glycaemia, glycosylated haemoglobin, total and HDL-cholesterol and triglyceride values were collected. Claudication, cyanosis, cold foot, foot hair anomalies, skin thinning and femoral, popliteal, posterior tibial and dorsalis pedis pulses were assessed. The ABI was measured with a portable Doppler continuous-wave instrument. RESULTS: An ABI < 0.9 was found in 539 (21.1%) patients. Claudication was present in 187 (7.3%). Femoral pulse was absent in 218 (8.5%), popliteal in 316 (12.3%), tibial in 563 (22.0%) and dorsalis pedis in 578 (22.6%). Foot cyanosis was observed in 88 (3.4%), cold foot in 359 (13.9%), skin thinning in 468 (18.3%) and hair anomalies in 857 (33.5%). Multivariate analysis of the variables associated with ABI < 0.9 in the univariate analysis confirmed the independent role of age [relative risk (RR) 1.02, P < 0.001, confidence interval (CI) 1.01, 1.04], claudication (RR 4.53, P < 0.001, CI 2.97, 6.93), absence of tibial pulse (RR 3.45, P < or = 0.001. CI 2.54, 4.68) and pedis pulse (RR 1.96, P < or = 0.001, CI 1.4, 2.68). CONCLUSIONS: PAD, as represented by ABI < 0.9, is common in newly diagnosed Type 2 diabetic patients.

Adult↗
PubMed2005

Evaluating the therapeutic approach in pregnancies complicated by borderline glucose intolerance: a randomized clinical trial.

AIMS: Most studies relating minor gestational metabolic alterations to macrosomia refer to glucose intolerance classified on the basis of the National Diabetes Data Group or previous World Health Organization diagnostic thresholds. Our aim was to evaluate the consequences of very mild forms of gestational glucose intolerance, defined by an elevated 50-g glucose challenge test followed by a normal oral glucose tolerance test, using the more restrictive Carpenter and Coustan's criteria (Borderline Gestational Glucose Intolerance, BGGI). METHODS: Three hundred BGGI women were randomly assigned to: Group A (standard management), Group B (dietary treatment and regular monitoring). A control group (C) was also considered. Newborns were classified as macrosomic, large (LGA), or small for gestational age (SGA). RESULTS: The three groups were similar in age, body mass index and parity. Therapy in Group B significantly improved fasting (from 4.68 +/- 0.45 to 4.28 +/- 0.45 mmol/l) and 2-h postprandial glycaemia (from 6.01 +/- 0.57 to 5.13 +/- 0.68 mmol/l). Fasting glycaemia at delivery was significantly lower in B (4.20 +/- 0.38 mmol/l) than in A (4.84 +/- 0.45 mmol/l), and was also lower than in C (4.31 +/- 0.39 mmol/l). Significantly fewer LGA babies were born to Group B (6.0%) than Group A (14.0%) and Group C (9.1%). No difference was found in the SGA rate. The neonatal Ponderal Index was higher (P = 0.030) in group A (2.73 +/- 0.35) than in C (2.64 +/- 0.30) and B (2.64 +/- 0.24). CONCLUSIONS: Even very mild alterations in glucose tolerance can result in excessive or disharmonious fetal growth, which may be prevented by simple, non-invasive therapeutic measures.

Adult↗
PubMed2004

Cisplatin versus carboplatin in combination with mitomycin and vinblastine in advanced non small cell lung cancer. A multicenter, randomized phase III trial.

BACKGROUND: In advanced not selected NSCLC chemotherapy achieved an advantage of approximately 1-2 months on median survival versus best supportive care. Chemotherapy seems to improve symptoms control, even if randomised studies with quality of life as first endpoint are lacking and often chemotherapy toxicity compromises the frail cost/benefit ratio. The aim of the present study is to evaluate the impact on QoL, substituting cisplatin, a pivot drug in NSCLC therapy, with carboplatin, an analogue with an improved toxicity profile. The combination of cisplatin with Mitomycin and Vinblastine was one of the most frequently used in the palliative setting at the time of design of our study. METHODS: Patients were randomized to receive MVP regimen (Mitomycin-C 8 mg/m2 d1, Vinblastine 4 mg/m2 d 1-8, Cisplatin 100 mg/m2 d1) or MVC regimen (Mitomycin-C 8 mg/m2 d1, Vinblastine 4 mg/m2 d 1-8, Carboplatin 300 mg/m2 d1) every 3 weeks. The QoL was evaluated by the Spitzer QL-Index and by the EORTC QLQ-C30+LC 13 questionnaires before chemotherapy, after one cycle, after three cycles, and then every 6 weeks in the first 6 months and every 3 months thenafter. RESULTS: From September 1994 to July 1997, 153 consecutive patients were randomized to MVP (75 patients) or MVC arm (78 patients). Despite difficulties in carrying out and analysing QoL items in such patients, the global QoL evaluated by the Spitzer's questionnaire suggested an advantage for MVC regimen (P=0.05) and a significant difference was observed in global health subdomain (P=0.04). The disease-related symptoms improved with time, and the benefits lasted for the entire treatment period. When evaluated with the EORTC questionnaire there was significantly less nausea and vomiting (P=0.0001), appetite loss (P=0.01), insomnia (P=0.03), constipation (P=0.01) and peripheral neuropathy (P=0.01) in favour of MVC, and a trend for less hair loss (P=0.05). The advantage lasted for all the duration of chemotherapy. No differences were observed in global quality of life subdomain (P=0.40) between the two regimen. QoL was the first endpoint and the statistical power was inadequate to assess other parameters. However, we reported a response rate of 43.1 and 38.6%, respectively, in MVP and MVC arm (P=0.59) and a median survival of 10.2 and 7.2 months, respectively, for cisplatin and carboplatin arm (P=0.39). CONCLUSIONS: The carboplatin containing regimen (MVC) has a significant better toxicity profile than the cisplatin containing (MVP) regimen as proven both by the EORTC questionnaires and by the WHO toxicity data reported by physicians. No significant differences in terms of response rate, time to progression and overall survival were observed between the two regimen. The two chemotherapy regimen showed a similar effectiveness in symptom palliation when evaluated with C30 addendum of EORTC QOL questionnaire. With the Spitzer's questionnaires a trend towards an improved quality of life index was observed during treatment with the carboplatin combination in comparison to the cisplatin combination. This difference, however, was not observed when the global quality of life was evaluated with the EORTC patients compiled questionnaires. A carboplatin containing regimen with better toxicity profile and a similar potentiality for symptoms control offers an option in comparison to similar cisplatin containing combinations in the palliative treatment of advanced NSCLC.

Aged↗
PubMed2004

Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial.

OBJECTIVES: In order to prevent abnormalities of fetal growth still characterizing pregnancies complicated by Gestational Diabetes (GDM), in the present study we evaluated a therapeutic strategy for GDM based on ultrasound (US) measurement of fetal insulin-sensitive tissues. METHODS: All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose; after 2 weeks they were randomized to conventional (C) or modified (M) management. In C the glycemic target (GT) was fixed at 90 fasting/120 post-prandial mg/dl; in M GT varied, according to US measurement of the Abdominal Circumference (AC) centile performed every 2 weeks: 80/100 if AC > or =75th, 100/140 if AC<75th. Therapy was tailored to mean fasting (FG) and postprandial glycemia (PPG). RESULTS: Globally, 229 women completed the study, 78 in C, 151 in M. Use of insulin was 16.7% in C, 30.4% in M (total groups), significantly more frequent in M than in C (59.7% vs 15.4%) when considering only women with AC > or =75th c. Mean metabolic data were similar in the 2 groups, but in M a tightly-optimized subgroup, resulting from the lowering of GT due to AC > or =75th, coexisted with a less-controlled one, whose higher GT was justified by AC<75th. Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%). CONCLUSIONS: Our data show the value of a flexible US-based approach to the treatment of GDM. This model does not necessarily involve a generalized aggressive treatment, allowing to concentrate therapeutical efforts on a small subgroup of women showing indirect US evidence of fetal hyperinsulinization. Such a selective approach allowed to obtain a near-normalization of fetal growth, with clear advantages on global pregnancy outcome.

Adult↗