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  • 1
    Language: English
    In: The lancet oncology, 2013, Vol.14 (3), p.210-218
    Description: Summary Background Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. Methods A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes—including operative findings, complications, mortality, and results at pathological examination—are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov , number NCT00297791. Findings The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100–400] vs 400 mL [200–700], p〈0·0001); however, laparoscopic procedures took longer (240 min [184–300] vs 188 min [150–240]; p〈0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0–3·0] vs 3·0 days [2·0–4·0]; p〈0·0001) and hospital stay was shorter (8·0 days [6·0–13·0] vs 9·0 days [7·0–14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (〈2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0–4·8] vs 3·0 cm [1·8–5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. Interpretation In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint—locoregional recurrence—are expected by the end of 2013. Funding Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.
    Subject(s): Adult ; Aged ; Aged, 80 and over ; Colorectal cancer ; Europe ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Laparoscopic surgery ; Laparoscopy ; Laparoscopy - methods ; Lymph Nodes - surgery ; Male ; Middle Aged ; Neoplasm Recurrence, Local - surgery ; Neoplasm Staging ; Rectal Neoplasms - pathology ; Rectal Neoplasms - radiotherapy ; Rectal Neoplasms - surgery ; Treatment Outcome
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
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  • 2
    Language: English
    In: Journal of allergy and clinical immunology, 2013, Vol.132 (2), p.353-360.e2
    Description: Background Subcutaneous allergen immunotherapy (SCIT) and sublingual allergen immunotherapy (SLIT) are safe and effective treatments of allergic rhinitis, but high levels of compliance and persistence are crucial to achieving the desired clinical effects. Objective Our objective was to assess levels and predictors of compliance and persistence among grass pollen, tree pollen, and house dust mite immunotherapy users in real life and to estimate the costs of premature discontinuation. Methods We performed a retrospective analysis of a community pharmacy database from The Netherlands containing data from 6486 patients starting immunotherapy for 1 or more of the allergens of interest between 1994 and 2009. Two thousand seven hundred ninety-six patients received SCIT, and 3690 received SLIT. Time to treatment discontinuation was analyzed and included Cox proportional hazard models with time-dependent covariates, where appropriate. Results Overall, only 18% of users reached the minimally required duration of treatment of 3 years (SCIT, 23%; SLIT, 7%). Median durations for SCIT and SLIT users were 1.7 and 0.6 years, respectively ( P  〈 .001). Other independent predictors of premature discontinuation were prescriber, with patients of general practitioners demonstrating longer persistence than those of allergologists and other medical specialists; single-allergen immunotherapy, lower socioeconomic status; and younger age. Of the persistent patients, 56% were never late in picking up their medication from the pharmacy. Direct medication costs per nonpersistent patient discontinuing in the third year of treatment were €3800, an amount that was largely misspent. Conclusion Real-life persistence is better in SCIT users than in SLIT users, although it is low overall. There is an urgent need for further identification of potential barriers and measures that will enhance persistence and compliance.
    Subject(s): Abridged Index Medicus ; adherence ; Administration, Sublingual ; Adult ; Allergens ; Allergens - administration & dosage ; Allergens - immunology ; Allergic reaction ; Allergic rhinitis ; Allergy ; Allergy and Immunology ; Animals ; Biological and medical sciences ; compliance ; cost ; Desensitization, Immunologic - economics ; Desensitization, Immunologic - methods ; Desensitization, Immunologic - psychology ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Humans ; Immunotherapy ; Injections, Subcutaneous ; Male ; Medical sciences ; Middle Aged ; Netherlands ; Patient Compliance - psychology ; Patient Compliance - statistics & numerical data ; persistence ; Poaceae - immunology ; Pollen - immunology ; Pyroglyphidae ; Retrospective Studies ; Rhinitis, Allergic ; Rhinitis, Allergic, Perennial - etiology ; Rhinitis, Allergic, Perennial - therapy ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; specific allergen immunotherapy ; subcutaneous ; subcutaneous allergen immunotherapy ; sublingual ; sublingual allergen immunotherapy ; Trees - immunology
    ISSN: 0091-6749
    E-ISSN: 1097-6825
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
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  • 3
    Language: English
    In: Clinical infectious diseases, 2008-05-01, Vol.46 (9), p.1401-1408
    Description: Background. Invasive pulmonary aspergillosis (IPA) is a significant problem in patients with chemotherapy-induced prolonged neutropenia. Because pulmonary deposition of conidia is the first step in developing IPA, we hypothesized that inhalation of liposomal amphotericin B would prevent IPA. Methods. We performed a randomized, placebo-controlled trial of patients with hematologic disease with expected neutropenia for ⩾10 days. Patients were randomized to receive liposomal amphotericin B or placebo inhalation twice a week, using an adaptive aerosol delivery system, until neutrophil counts increased to 〉300 cells/mm3. In subsequent neutropenic episodes, the assigned treatment was restarted. The primary end point was the occurrence of IPA according to European Organization for Research and the Treatment of Cancer-Mycoses Study Group definitions. Kaplan-Meier curves were compared with log-rank tests for intent-to-treat and on-treatment populations. Results. A total of 271 patients were studied during 407 neutropenic episodes. According to the intent-to-treat analysis, 18 of 132 patients in the placebo group developed IPA versus 6 of 139 patients in the liposomal amphotericin B group (odds ratio, 0.26; 95% confidence interval, 0.09–0.72; P=.005). According to the on-treatment analysis, 13 of 97 patients receiving placebo versus 2 of 91 receiving liposomal amphotericin B developed IPA (odds ratio, 0.14; 95% confidence interval, 0.02–0.66; P=.007). Some adverse effects, but none serious, in the liposomal amphotericin B group were reported, most frequently coughing (16 patients vs. 1 patient; P=.002). Conclusion. In high-risk patients, prophylactic inhalation of liposomal amphotericin B significantly reduced the incidence of IPA.
    Subject(s): Administration, Inhalation ; Adolescent ; Adult ; Aerosol therapy ; Aerosols ; Aged ; Amphotericin B ; Amphotericin B - administration & dosage ; Amphotericin B - therapeutic use ; Antifungal Agents - administration & dosage ; Antifungal Agents - therapeutic use ; Articles and Commentaries ; Aspergillosis - etiology ; Aspergillosis - prevention & control ; Aspergillus ; Chemotherapy ; Dosage and administration ; Female ; Humans ; Inhalation ; Invasive pulmonary aspergillosis ; Kaplan-Meier Estimate ; Lung Diseases, Fungal - etiology ; Lung Diseases, Fungal - prevention & control ; Male ; Middle Aged ; Mortality ; Neutropenia ; Neutropenia - complications ; Neutrophils ; Placebos ; Prevention ; Pulmonary aspergillosis ; Research ; Respiratory therapy ; Treatment Outcome ; Usage
    ISSN: 1058-4838
    E-ISSN: 1537-6591
    Source: JSTOR Life Sciences
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
    Source: Alma/SFX Local Collection
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  • 4
    Language: English
    In: Critical care (London, England), 2013-07-24, Vol.17 (4), p.R151-R151
    Description: textabstractIntroduction: Newborns in need of extracorporeal membrane oxygenation (ECMO) support are at high risk of developing acute kidney injury (AKI). AKI may occur as part of multiple organ failure and can be aggravated by exposure to components of the extracorporeal circuit. AKI necessitates adjustment of dosage of renally eliminated drugs and avoidance of nephrotoxic drugs. We aimed to define systematically the incidence and clinical course of AKI in critically ill neonates receiving ECMO support. Methods: This study reviewed prospectively collected clinical data (including age, diagnosis, ECMO course, and serum creatinine (SCr)) of all ECMO-treated neonates within our institution spanning a 14-year period. AKI was defined by using the Risk, Injury, Failure, Loss of renal function, and End-stage renal disease (RIFLE) classification. SCr data were reviewed per ECMO day and compared with age-specific SCr reference values. Accordingly, patients were assigned to RIFLE categories (Risk, Injury, or Failure as 150%, 200%, or 300% of median SCr reference values). Data are presented as median and interquartile range (IQR) or number and percentage. Results: Of 242 patients included, 179 (74%) survived. Median age at the start of
    Subject(s): acute kidney injury ; Acute Kidney Injury - diagnosis ; Acute Kidney Injury - etiology ; Acute Kidney Injury - mortality ; Acute renal failure ; Chronic kidney failure ; Cohort Studies ; Critical care ; Critical Illness - therapy ; extracorporeal membrane oxygenation (ECMO) ; Extracorporeal Membrane Oxygenation - adverse effects ; Female ; Humans ; Infant, Newborn ; Infants (Newborn) ; Kaplan-Meier Estimate ; Male ; Nitric oxide ; Prospective Studies ; Research ; RIFLE ; serum creatinine ; Terminally ill children
    ISSN: 1364-8535
    E-ISSN: 1466-609X
    Source: BioMedCentral Open Access
    Source: PubMed Central
    Source: Alma/SFX Local Collection
    Source: DOAJ Directory of Open Access Journals - Not for CDI Discovery
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  • 5
    Language: English
    In: Neurology, 2012, Vol.79 (3), p.261-266
    Description: There is increasing evidence that vitamin D can be protective against the development of multiple sclerosis (MS), but it may also be beneficial for the clinical course of the disease. Our objective was to prospectively investigate if 25-hydroxy-vitamin D (25-OH-D) levels are associated with exacerbation risk in MS in a study with frequent serum measurements. This was a prospective longitudinal study in 73 patients with relapsing-remitting MS. Blood samples for 25-OH-D measurements were taken every 8 weeks. Associations between 25-OH-D levels and exacerbation rates were assessed using Poisson regression (generalized estimating equations) with the individual serum levels as time-dependent variable. During follow-up (mean 1.7 years), 58 patients experienced a total of 139 exacerbations. Monthly moving averages of 25-OH-D levels were categorized into low (〈50 nmol/L), medium (50-100 nmol/L), and high (〉100 nmol/L) levels. Exacerbation risk decreased significantly with higher serum vitamin D levels: respective relative exacerbation rates for the medium and high-level category as compared to the low-level category were 0.7 and 0.5 (p value for trend: p = 0.007). The association between 25-OH-D concentrations and exacerbation rate was log linear without a threshold. With each doubling of the serum 25-OH-D concentration the exacerbation rate decreased by 27% (95% confidence interval 8%-42%, p = 0.008). Our finding that higher vitamin D levels are associated with decreased exacerbation risk in relapsing-remitting MS suggests a beneficial effect of vitamin D on disease course in MS. However, the possibility of reverse causality cannot be ruled out completely. Randomized intervention studies are therefore needed to investigate the effect of vitamin D supplementation in MS.
    Subject(s): Abridged Index Medicus ; Adolescent ; Adult ; Algorithms ; Biological and medical sciences ; European Continental Ancestry Group ; Female ; Follow-Up Studies ; Humans ; Infection - complications ; Longitudinal Studies ; Male ; Medical sciences ; Middle Aged ; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Multiple Sclerosis, Relapsing-Remitting - blood ; Multiple Sclerosis, Relapsing-Remitting - complications ; Multiple Sclerosis, Relapsing-Remitting - physiopathology ; Neurologic Examination ; Neurology ; Nonlinear Dynamics ; Poisson Distribution ; Prospective Studies ; Recurrence ; Risk ; Vitamin D - analogs & derivatives ; Vitamin D - blood ; Young Adult
    ISSN: 0028-3878
    E-ISSN: 1526-632X
    Source: Hellenic Academic Libraries Link
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  • 6
    Language: English
    In: World journal of surgery, 2010-01-01, Vol.34 (1), p.20-27
    Description: Background: Several studies have been performed to identify risk factors for abdominal wound dehiscence. No risk model had yet been developed for the general surgical population. The objective of the present study was to identify independent risk factors for abdominal wound dehiscence and to develop a risk model to recognize high-risk patients. Identification of high-risk patients offers opportunities for intervention strategies. Methods: Medical registers from January 1985 to December 2005 were searched. Patients who had primarily undergone appendectomies or nonsurgical (e.g., urological) operations were excluded. Each patient with abdominal wound dehiscence was matched with three controls by systematic random sampling. Putative relevant patient-related, operation-related, and postoperative variables were evaluated in univariate analysis and subsequently entered in multivariate stepwise logistic regression models to delineate major independent predictors of abdominal wound dehiscence. A risk model was developed, which was validated in a population of patients who had undergone operation between January and December 2006. Results: A total of 363 cases and 1,089 controls were analyzed. Major independent risk factors were age, gender, chronic pulmonary disease, ascites, jaundice, anemia, emergency surgery, type of surgery, postoperative coughing, and wound infection. In the validation population, risk scores were significantly higher (P 〈 0.001) for patients with abdominal wound dehiscence (n = 19) compared to those without (n = 677). Resulting scores ranged from 0 to 8.5, and the risk for abdominal wound dehiscence over this range increased exponentially from 0.02% to 70.1%. Conclusions: The validated risk model shows high predictive value for abdominal wound dehiscence and may help to identify patients at increased risk.
    Subject(s): Abdomen - surgery ; Abdominal Surgery ; Adult ; Age Factors ; Aged ; Article ; Biological and medical sciences ; Cardiac Surgery ; Case-Control Studies ; Comorbidity ; Female ; General aspects ; General Surgery ; Humans ; Logistic Models ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Probability ; Registries ; Risk Assessment - methods ; Risk Factors ; ROC Curve ; Sex Factors ; Surgery ; Surgical Wound Dehiscence - etiology ; Thoracic Surgery ; Vascular Surgery
    ISSN: 0364-2313
    E-ISSN: 1432-2323
    Source: Alma/SFX Local Collection
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  • 7
    Language: English
    In: Annals of surgery, 2004-01-01, Vol.240 (4), p.578-585
    Description: OBJECTIVE: The objective of this study was to determine the best treatment of incisional hernia, taking into account recurrence, complications, discomfort, cosmetic result, and patient satisfaction. BACKGROUND: Long-term results of incisional hernia repair are lacking. Retrospective studies and the midterm results of this study indicate that mesh repair is superior to suture repair. However, many surgeons are still performing suture repair. METHODS: Between 1992 and 1998, a multicenter trial was performed, in which 181 eligible patients with a primary or first-time recurrent midline incisional hernia were randomly assigned to suture or mesh repair. In 2003, follow-up was updated. RESULTS: Median follow-up was 75 months for suture repair and 81 months for mesh repair patients. The 10-year cumulative rate of recurrence was 63% for suture repair and 32% for mesh repair (P 〈 0.001). Abdominal aneurysm (P = 0.01) and wound infection (P = 0.02) were identified as independent risk factors for recurrence. In patients with small incisional hernias, the recurrence rates were 67% after suture repair and 17% after mesh repair (P = 0.003). One hundred twenty-six patients completed long-term follow-up (median follow-up 98 months). In the mesh repair group, 17% suffered a complication, compared with 8% in the suture repair group (P = 0.17). Abdominal pain was more frequent in suture repair patients (P = 0.01), but there was no difference in scar pain, cosmetic result, and patient satisfaction. CONCLUSIONS: Mesh repair results in a lower recurrence rate and less abdominal pain and does not result in more complications than suture repair. Suture repair of incisional hernia should be abandoned.
    Subject(s): Abridged Index Medicus ; Adult ; Aged ; Aged, 80 and over ; Aortic Aneurysm, Abdominal - complications ; Cicatrix - etiology ; Comparative Study ; Esthetics ; Female ; Follow-Up Studies ; Hernia, Ventral - etiology ; Hernia, Ventral - surgery ; Hernia, Ventral/etiology/surgery ; Humans ; Intestinal Obstruction - etiology ; Laparotomy - adverse effects ; Longitudinal Studies ; Male ; Middle Aged ; Original and Discussions ; Pain, Postoperative - etiology ; Patient Satisfaction ; Polypropylenes ; Postoperative Complications - surgery ; Recurrence ; Risk Factors ; Surgical Mesh ; Surgical Wound Infection - complications ; Sutures
    ISSN: 0003-4932
    E-ISSN: 1528-1140
    Source: Hellenic Academic Libraries Link
    Source: PubMed Central
    Source: Alma/SFX Local Collection
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  • 8
    Language: English
    In: Haematologica (Roma), 2014-01-01, Vol.99 (11), p.1716-1721
    Description: textabstractWe prospectively studied the incidence and clinical course of hypertriglyceridemia and hypercholesterolemia during very prolonged use of asparaginase in relation to levels of asparaginase activity in children with acute lymphoblastic leukemia. We also evaluated the incidence of pancreatitis, thrombosis, hyperammonemia and central neurotoxicity and their association with asparaginase activity levels. Eighty-nine patients were treated according to the Dutch Childhood Oncology Group Acute Lymphoblastic Leukemia 10 medium-risk intensification protocol, which includes 15 doses of PEGasparaginase (2,500 IU/m2) over 30 weeks. Erwinia asparaginase (20,000 IU/m2) was administered when allergy to or silent inactivation of PEGasparaginase occurred. Triglyceride, cholesterol and ammonia levels increased rapidly in children treated with PEGasparaginase and remained temporarily elevated, but normalized after administration of the last asparaginase dose. Among the patients treated with PEGasparaginase, hypertriglyceridemia and hypercholesterolemia (grade 3/4) were found in 47% and 25%, respectively. The correlation between PEGasparaginase activity levels and triglyceride levels was strongest at week 5 (Spearman correlation coefficient=0.36, P=0.005). The triglyceride levels were higher in children ≥10 years old than in younger patients (〈10 years old) after adjustment for type of asparaginase preparation: median 4.9 mmol/L versus 1.6 mmol/L (P〈0.001). In patients receiving Erwinia asparaginase, triglyceride levels increased in the first weeks as well, but no grade 3/4 dyslipidemia was found. Hyperammonemia (grade 3/4) was only found in patients treated with Erwinia asparaginase (9%). Thrombosis occurred in 4.5%, pancreatitis in 7%, and central neurotoxicity in 9% of patients using either of the two agents; these toxicities were not related to levels of asparaginase activity or to tr
    Subject(s): Adolescent ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Asparaginase - administration & dosage ; Asparaginase - adverse effects ; Asparaginase - blood ; Asparaginase - therapeutic use ; Child ; Child, Preschool ; Drug Administration Schedule ; Dyslipidemias - blood ; Dyslipidemias - diagnosis ; Dyslipidemias - etiology ; Female ; Humans ; Infant ; Lipids - blood ; Male ; Pancreatitis - diagnosis ; Pancreatitis - etiology ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - complications ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy ; Thrombosis - diagnosis ; Thrombosis - etiology
    ISSN: 0390-6078
    E-ISSN: 1592-8721
    Source: HighWire Press (Free Journals)
    Source: PubMed Central
    Source: DOAJ Directory of Open Access Journals - Not for CDI Discovery
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  • 9
    Language: English
    In: Blood, 2014-03-27, Vol.123 (13), p.2026-2033
    Description: This study prospectively analyzed the efficacy of very prolonged courses of pegylated Escherichia coli asparaginase (PEGasparaginase) and Erwinia asparaginase in pediatric acute lymphoblastic leukemia (ALL) patients. Patients received 15 PEGasparaginase infusions (2500 IU/m2 every 2 weeks) in intensification after receiving native E coli asparaginase in induction. In case of allergy to or silent inactivation of PEGasparaginase, Erwinia asparaginase (20 000 IU/m2 2-3 times weekly) was given. Eighty-nine patients were enrolled in the PEGasparaginase study. Twenty (22%) of the PEGasparaginase–treated patients developed an allergy; 7 (8%) showed silent inactivation. The PEGasparaginase level was 0 in all allergic patients (grade 1-4). Patients without hypersensitivity to PEGasparaginase had serum mean trough levels of 899 U/L. Fifty-nine patients were included in the Erwinia asparaginase study; 2 (3%) developed an allergy and none silent inactivation. Ninety-six percent had at least 1 trough level ≥100 U/L. The serum asparagine level was not always completely depleted with Erwinia asparaginase in contrast to PEGasparaginase. The presence of asparaginase antibodies was related to allergies and silent inactivation, but with low specificity (64%). Use of native E coli asparaginase in induction leads to high hypersensitivity rates to PEGasparaginase in intensification. Therefore, PEGasparaginase should be used upfront in induction, and we suggest that the dose could be lowered. Switching to Erwinia asparaginase leads to effective asparaginase levels in most patients. Therapeutic drug monitoring has been added to our ALL-11 protocol to individualize asparaginase therapy. •Use of native E coli asparaginase in induction leads to high hypersensitivity rates to PEGasparaginase in intensification.•Switching to Erwinia asparaginase leads to effective asparaginase activity levels in most patients who experienced an allergy to PEGasparaginase.
    Subject(s): 100 ; Abridged Index Medicus ; Adolescent ; Antibodies - blood ; Antineoplastic Agents - therapeutic use ; Asparaginase - administration & dosage ; Asparaginase - immunology ; Child ; Child, Preschool ; Clinical Trials and Observations ; Drug Monitoring ; Erwinia - enzymology ; Escherichia coli Proteins - therapeutic use ; Female ; Humans ; Infant ; Male ; Polyethylene Glycols - administration & dosage ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy ; Time Factors ; Treatment Outcome
    ISSN: 0006-4971
    E-ISSN: 1528-0020
    Source: Alma/SFX Local Collection
    Source: American Society of Hematology
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  • 10
    Language: English
    In: The American journal of clinical nutrition, 2012, Vol.95 (2), p.374-382
    Description: Untreated maternal phenylketonuria or hyperphenylalaninemia may result in nonphenylketonuric offspring with neonatal sequelae, especially intellectual disability, microcephaly, and congenital heart disease (CHD). Dietary treatment to control phenylalanine concentrations can prevent these sequelae. We aimed to present an overview of reported pregnancy complications and neonatal sequelae of maternal phenylketonuria or hyperphenylalaninemia in untreated and treated pregnancies. A MEDLINE and EMBASE search was conducted for case reports and case series that assessed maternal phenylketonuria or hyperphenylalaninemia during pregnancy. Pregnancy complications (spontaneous abortion, intrauterine-fetal-death, and preterm delivery) and neonatal sequelae [small for gestational age (SGA), microcephaly, CHD, intellectual or developmental disabilities (IDDs), and facial dysmorphism (FD)] were analyzed. Fifteen unpublished pregnancies from our clinic were added. We retrieved 196 pregnancies, of which 126 pregnancies were untreated and 70 pregnancies were treated. The occurrence of pregnancy complications was not significantly different between untreated and treated pregnancies. Except for SGA, all neonatal sequelae were more frequent in untreated pregnancies. Moreover, the occurrence of SGA, microcephaly, and IDDs was significantly related to the mean phenylalanine concentration in each trimester, whereas the occurrence of FD was related only to the first trimester. We present the largest cohort of untreated pregnant women with phenylketonuria or hyperphenylalaninemia since 1980. The results follow the general pattern reported by other researchers. We underline that the treatment of pregnant women with phenylketonuria or hyperphenylalaninemia is of great importance to prevent neonatal sequelae. We strongly recommend starting treatment before conception because we showed the deleterious effect of an increased mean first-trimester phenylalanine concentration on FD.
    Subject(s): Abridged Index Medicus ; Biological and medical sciences ; Care and treatment ; Complications and side effects ; Congenital Abnormalities - etiology ; Demographic aspects ; Developmental Disabilities - etiology ; Diseases ; Facial Bones - abnormalities ; Feeding. Feeding behavior ; Female ; Fundamental and applied biological sciences. Psychology ; Humans ; Infant, Newborn ; Infant, Small for Gestational Age ; Infants (Newborn) ; Intellectual Disability - etiology ; Microcephaly - etiology ; Phenylalanine - blood ; Phenylketonuria ; Phenylketonuria, Maternal - blood ; Phenylketonuria, Maternal - therapy ; Pregnancy ; Pregnancy Complications ; Pregnancy Outcome ; Pregnancy Trimesters ; Pregnancy, Complications of ; Research ; Skull - abnormalities ; Vertebrates: anatomy and physiology, studies on body, several organs or systems
    ISSN: 0002-9165
    E-ISSN: 1938-3207
    Source: Alma/SFX Local Collection
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