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ABSTRACT: Potential adverse effects of antidepressants during pregnancy have caused concern about their use. There are, however, very limited detailed data on patterns of antidepressant prescribing in pregnancy.
To examine secular trends in prescribing during pregnancy, to assess whether pregnancy is a major determinant for stopping antidepressants, and to identify characteristics of those who stopped antidepressants during pregnancy.
In this cohort study, we obtained data on 114,999 pregnant women (median age at delivery, 30.5 years [interquartile range, 26-34 years]) who had a live birth between 1992 and 2006 and 22,677 nonpregnant women from The Health Improvement Network primary care database, one of the largest sources of continuous anonymized primary care data in the United Kingdom and broadly representative of UK general practice. This database includes information on age, sex, medical diagnosis and symptoms, health promotion activities, referrals to secondary care, and prescriptions for each registered individual. The database also holds information about social deprivation as measured using quintiles of the Townsend score. We used Cox regression analysis to compare time to last prescription in pregnant versus nonpregnant women and to identify characteristics of those women who stopped antidepressants during pregnancy.
Antidepressant prescribing in pregnancy increased nearly 4-fold from 1992 to 2006 (relative risk = 3.87; 95% CI, 1.73-8.66; P < .001). Since 2001, approximately 3% of the cohort received antidepressants at some stage during pregnancy. Selective serotonin reuptake inhibitors accounted for approximately 80% of the prescribed antidepressants. Antidepressants were more likely to be stopped in pregnant than in nonpregnant women, in particular during the first 6 weeks of pregnancy (hazard ratio = 5.19; 95% CI, 4.85-5.56; P < .001). Only 10% of women treated before pregnancy still received antidepressants at the start of the third trimester. In contrast, 35% of nonpregnant women were still treated after a similar time period.
Although antidepressant prescribing in pregnancy increased nearly 4-fold from 1992 to 2006, pregnancy was a major determinant of cessation of antidepressant medication, and most women did not receive further antidepressant prescriptions beyond 6 weeks of gestation. This finding may be explained by concerns about potential adverse effects of the medications, even though these concerns need to be balanced against the potential harm of inadequate treatment of depression during pregnancy.
The Journal of Clinical Psychiatry 03/2011; 72(7):979-85. · 5.80 Impact Factor
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ABSTRACT: Gastro-oesophageal reflux (GOR) is common and usually self-limiting in infants. Cisapride, a pro-kinetic agent, was commonly prescribed until reports of possible serious adverse events were associated with its use.
To determine the effectiveness of cisapride versus placebo or non-surgical treatments for symptoms of GOR.
We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Specialised Register and Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE, reference lists of relevant review articles and searched in the Science Citation Index for all the trials identified. All searches were updated in February 2009.
Randomised controlled trials comparing oral cisapride therapy with placebo or other non-surgical treatments for children diagnosed with GOR were included. We excluded trials with a majority of participants less than 28 days of age.
Primary outcomes were a change in symptoms at the end of treatment, presence of adverse events, occurrence of clinical complications and weight gain. Secondary outcomes included physiological measures of GOR or histological evidence of oesophagitis. We dichotomised symptoms into 'same or worse' versus 'improved' and calculated summary odds ratios (OR). Continuous measures of GOR (for example reflux index) were summarised as a weighted mean difference. All outcomes were analysed using a random-effects method.
Ten trials in total met the inclusion criteria. Nine trials compared cisapride with placebo or no treatment, of which eight (262 participants) reported data on symptoms of gastro-oesophageal reflux. There was no statistically significant difference between the two interventions (OR 0.34; 95% CI 0.10 to 1.19) for 'same or worse' versus 'improved symptoms' at the end of treatment. There was significant heterogeneity between the studies, suggesting publication bias. Four studies reported adverse events (mainly diarrhoea); this difference was not statistically significant (OR 1.80; 95% CI 0.87 to 3.70). Another trial found no difference in the electrocardiographic QTc interval after three to eight weeks of treatment. Cisapride significantly reduced the reflux index (weighted mean difference -6.49; 95% CI -10.13 to -2.85; P = 0.0005). Other measures of oesophageal pH monitoring did not reach significance. One included study compared cisapride with Gaviscon (with no statistically significant difference). One small study found no evidence of benefit on frequency of regurgitation or weight gain after treatment with cisapride versus no treatment, carob bean or corn syrup thickeners.
We found no clear evidence that cisapride reduces symptoms of GOR. Due to reports of fatal cardiac arrhythmias or sudden death, from July 2000 in the USA and Europe cisapride was restricted to a limited access programme supervised by a paediatric gastrologist.
Cochrane database of systematic reviews (Online) 01/2010; · 5.72 Impact Factor
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Mario Cortina-Borja,
Hooi Kuan Tan,
Martine Wallon,
Malgorzata Paul,
Andrea Prusa,
Wilma Buffolano,
Gunilla Malm,
Alison Salt,
Katherine Freeman,
Eskild Petersen, Ruth E Gilbert
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ABSTRACT: The effectiveness of prenatal treatment to prevent serious neurological sequelae (SNSD) of congenital toxoplasmosis is not known.
Congenital toxoplasmosis was prospectively identified by universal prenatal or neonatal screening in 14 European centres and children were followed for a median of 4 years. We evaluated determinants of postnatal death or SNSD defined by one or more of functional neurological abnormalities, severe bilateral visual impairment, or pregnancy termination for confirmed congenital toxoplasmosis. Two-thirds of the cohort received prenatal treatment (189/293; 65%). 23/293 (8%) fetuses developed SNSD of which nine were pregnancy terminations. Prenatal treatment reduced the risk of SNSD. The odds ratio for prenatal treatment, adjusted for gestational age at maternal seroconversion, was 0.24 (95% Bayesian credible intervals 0.07-0.71). This effect was robust to most sensitivity analyses. The number of infected fetuses needed to be treated to prevent one case of SNSD was three (95% Bayesian credible intervals 2-15) after maternal seroconversion at 10 weeks, and 18 (9-75) at 30 weeks of gestation. Pyrimethamine-sulphonamide treatment did not reduce SNSD compared with spiramycin alone (adjusted odds ratio 0.78, 0.21-2.95). The proportion of live-born infants with intracranial lesions detected postnatally who developed SNSD was 31.0% (17.0%-38.1%).
The finding that prenatal treatment reduced the risk of SNSD in infected fetuses should be interpreted with caution because of the low number of SNSD cases and uncertainty about the timing of maternal seroconversion. As these are observational data, policy decisions about screening require further evidence from a randomized trial of prenatal screening and from cost-effectiveness analyses that take into account the incidence and prevalence of maternal infection. Please see later in the article for the Editors' Summary.
PLoS Medicine 01/2010; 7(10). · 16.27 Impact Factor
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ABSTRACT: Analysing human genetic variation provides a powerful tool in understanding risk factors for disease. Toxoplasma gondii acquired by the mother can be transmitted to the fetus. Infants with the most severe clinical signs in brain and eye are those infected early in pregnancy when fetal immunity is least well developed. Genetic analysis could provide unique insight into events in utero that are otherwise difficult to determine. We tested the hypothesis that propensity for T. gondii to cause eye disease is associated with genes previously implicated in congenital or juvenile onset ocular disease. Using mother-child pairs from Europe (EMSCOT) and child/parent trios from North America (NCCCTS), we demonstrated that ocular and brain disease in congenital toxoplasmosis associate with polymorphisms in ABCA4 encoding ATP-binding cassette transporter, subfamily A, member 4 previously associated with juvenile onset retinal dystrophies including Stargardt's disease. Polymorphisms at COL2A1 encoding type II collagen, previously associated with Stickler syndrome, associated only with ocular disease in congenital toxoplasmosis. Experimental studies showed that both ABCA4 and COL2A1 show isoform-specific epigenetic modifications consistent with imprinting, which provided an explanation for the patterns of inheritance observed. These genetic and epigenetic risk factors provide unique insight into molecular pathways in the pathogenesis of disease.
Memórias do Instituto Oswaldo Cruz 04/2009; 104(2):162-9. · 2.15 Impact Factor
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ABSTRACT: Information is needed on whether mastoiditis has increased in association with the decline in antibiotics prescribed to children by primary care physicians in the United Kingdom.
To determine time trends in mastoiditis incidence, the frequency of antecedent otitis media, and the effect of antibiotics for otitis media on the risk of mastoiditis in children.
We conducted a retrospective cohort study by using the UK General Practice Research Database. Children aged 3 months to 15 years between 1990 and 2006 were included. Risk of mastoiditis within 3 months after otitis media diagnosis and the protective effect of antibiotics were determined.
There were 2 622 348 children within the General Practice Research Database; 854 had mastoiditis, only one third of whom (35.7%) had antecedent otitis media. Mastoiditis incidence remained stable between 1990 and 2006 ( approximately 1.2 per 10 000 child-years). Risk of mastoiditis, after otitis media, was 1.8 per 10 000 episodes (139 of 792 623) after antibiotics compared with 3.8 per 10 000 (149 of 389 649) without antibiotics, and increased with age. Antibiotics halved the risk of mastoiditis. General practitioners would need to treat 4831 otitis media episodes with antibiotics to prevent 1 child from developing mastoiditis. If antibiotics were no longer prescribed for otitis media, an extra 255 cases of childhood mastoiditis would occur, but there would be 738 775 fewer antibiotic prescriptions per year in the United Kingdom.
Most children with mastoiditis have not seen their general practitioner for otitis media. Antibiotics halve the risk of mastoiditis, but the high number of episodes needing treatment to prevent 1 case precludes the treatment of otitis media as a strategy for preventing mastoiditis. Although mastoiditis is a serious disease, most children make an uncomplicated recovery after mastoidectomy or intravenous antibiotics. Treating these additional otitis media episodes could pose a larger public health problem in terms of antibiotic resistance.
PEDIATRICS 03/2009; 123(2):424-30. · 4.47 Impact Factor
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ABSTRACT: To analyse changes in clinical indications for community antibiotic prescribing for children in the UK between 1996 and 2006 and relate these findings to the new NICE guidelines for the treatment of upper respiratory tract infections in children. Study
Retrospective cohort study. Method: The IMS Health Mediplus database was used to obtain annual antibiotic prescribing rates and associated clinical indications in 0-18-year-old patients between 1 January 1996 and 31 December 2006 in the UK.
Antibiotic prescribing declined by 24% between 1996 and 2000 but increased again by 10% during 2003-2006. Respiratory tract infection was the most common indication for which an antibiotic was prescribed, followed by "abnormal signs and symptoms", ear and skin infections. Antibiotic prescriptions for respiratory tract infections have decreased by 31% (p<0.01) mainly because of reduced prescribing for lower respiratory tract infections (56% decline, p<0.001) and specific upper respiratory tract infections including tonsillitis/pharyngitis (48% decline, p<0.001) and otitis (46% decline, p<0.001). Prescribing for non-specific upper respiratory tract infection increased fourfold (p<0.001). Prescribing for "abnormal signs and symptoms" increased significantly since 2001 (40% increase, p<0.001).
There has been a marked decrease in community antibiotic prescribing linked to lower respiratory tract infection, tonsillitis, pharyngitis and otitis. Overall prescribing is now increasing again but is associated with non-specific upper respiratory tract infection diagnoses. General practitioners may be avoiding using diagnoses where formal guidance suggests antibiotic prescribing is not indicated. The new NICE guidance on upper respiratory tract infections is at risk of being ignored.
Archives of Disease in Childhood 01/2009; 94(5):337-40. · 2.88 Impact Factor
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ABSTRACT: Clinicians need information on the relative effectiveness of different types of impregnated central venous catheter for serious infection and their relative costs and adverse effects in order to decide which type, if any, to use.
We systematically reviewed 37 randomized controlled trials involving 11 586 patients. Only seven studies were classified as good on all measures of study quality. Compared with standard catheters, significant and substantial reductions in catheter-related blood stream infection were found for heparin-coated and antibiotic-impregnated central venous catheters. We found no statistically significant benefits of antiseptic central venous catheters, coated with chlorhexidine and silver sulphadiazine, or sliver-impregnated central venous catheters, compared with standard catheters. The few 'head-to-head' comparisons confirmed the benefits of antibiotic impregnation compared with chlorhexidine and silver sulphadiazine or silver impregnation, but no significant difference was found for heparin-coated compared with silver-impregnated central venous catheters. No studies reported serious adverse events, but there is some evidence of antibiotic resistance from in-vitro studies. No impregnated central venous catheter exists for neonates weighing less than 3 kg, and few studies have been undertaken in larger children.
The most promising options for reducing catheter-related blood stream infection are heparin-coated or antibiotic-impregnated central venous catheters. Large, high-quality randomized controlled trials are needed to evaluate which of these methods is most effective for reducing clinically important consequences of catheter-associated infection.
Current Opinion in Infectious Diseases 07/2008; 21(3):235-45. · 4.93 Impact Factor
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Jill M Ellis,
Hooi Kuan Tan, Ruth E Gilbert,
David P R Muller,
William Henley,
Robert Moy,
Rachel Pumphrey,
Cornelius Ani,
Sarah Davies,
Vanessa Edwards,
Heather Green,
Alison Salt,
Stuart Logan
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ABSTRACT: To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome.
Randomised controlled trial with two by two factorial design.
Children living in the Midlands, Greater London, and the south west of England.
156 infants aged under 7 months with trisomy 21.
Daily oral supplementation with antioxidants (selenium 10 mug, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo.
Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months.
Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval -2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, -1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results.
This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome.
Clinical trials NCT00378456.
BMJ (Clinical research ed.). 04/2008; 336(7644):594-7.
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Sarra E Jamieson,
Lee-Anne de Roubaix,
Mario Cortina-Borja,
Hooi Kuan Tan,
Ernest J Mui,
Heather J Cordell,
Michael J Kirisits,
E Nancy Miller,
Christopher S Peacock,
Aubrey C Hargrave, [......],
Malgorzata Paul,
François Peyron,
Babill Stray-Pedersen,
Andrea-Romana Prusa,
Philippe Thulliez,
Martine Wallon,
Eskild Petersen,
Rima McLeod, Ruth E Gilbert,
Jenefer M Blackwell
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ABSTRACT: Primary Toxoplasma gondii infection during pregnancy can be transmitted to the fetus. At birth, infected infants may have intracranial calcification, hydrocephalus, and retinochoroiditis, and new ocular lesions can occur at any age after birth. Not all children who acquire infection in utero develop these clinical signs of disease. Whilst severity of disease is influenced by trimester in which infection is acquired by the mother, other factors including genetic predisposition may contribute.
In 457 mother-child pairs from Europe, and 149 child/parent trios from North America, we show that ocular and brain disease in congenital toxoplasmosis associate with polymorphisms in ABCA4 encoding ATP-binding cassette transporter, subfamily A, member 4. Polymorphisms at COL2A1 encoding type II collagen associate only with ocular disease. Both loci showed unusual inheritance patterns for the disease allele when comparing outcomes in heterozygous affected children with outcomes in affected children of heterozygous mothers. Modeling suggested either an effect of mother's genotype, or parent-of-origin effects. Experimental studies showed that both ABCA4 and COL2A1 show isoform-specific epigenetic modifications consistent with imprinting.
These associations between clinical outcomes of congenital toxoplasmosis and polymorphisms at ABCA4 and COL2A1 provide novel insight into the molecular pathways that can be affected by congenital infection with this parasite.
PLoS ONE 01/2008; 3(6):e2285. · 4.09 Impact Factor
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PLoS neglected tropical diseases 01/2008; · 4.72 Impact Factor
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ABSTRACT: Toxoplasmic retinochoroiditis appears to be more severe in Brazil, where it is a leading cause of blindness, than in Europe, but direct comparisons are lacking. Evidence is accumulating that more virulent genotypes of Toxoplasma gondii predominate in South America.
We compared prospective cohorts of children with congenital toxoplasmosis identified by universal neonatal screening in Brazil and neonatal or prenatal screening in Europe between 1992 and 2003, using the same protocol in both continents.
Three hundred and eleven (311) children had congenital toxoplasmosis: 30 in Brazil and 281 in Europe, where 71 were identified by neonatal screening. Median follow up was 4.1 years in Europe and 3.7 years in Brazil. Relatively more children had retinochoroiditis during the first year in Brazil than in Europe (15/30; 50% versus 29/281; 10%) and the risk of lesions by 4 years of age was much higher: the hazard ratio for Brazil versus Europe was 5.36 (95%CI: 3.17, 9.08). Children in Brazil had larger lesions, which were more likely to be multiple and to affect the posterior pole (p<0.0001). In Brazil, visual impairment (<6/12 Snellen) was predicted for most affected eyes (87%, 27/31), but not in Europe (29%; 20/69, p<0.0001). The size of newly detected lesions decreased with age (p = 0.0007).
T. gondii causes more severe ocular disease in congenitally infected children in Brazil compared with Europe. The marked differences in the frequency, size and multiplicity of retinochoroidal lesions may be due to infection with more virulent genotypes of the parasite that predominate in Brazil but are rarely found in Europe.
PLoS Neglected Tropical Diseases 01/2008; 2(8):e277. · 4.69 Impact Factor
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ABSTRACT: To determine the cost effectiveness of strategies for preventing neonatal infection with group B streptococci and other bacteria in the UK and the value of further information from research.
Use of a decision model to compare the cost effectiveness of prenatal testing for group B streptococcal infection (by polymerase chain reaction or culture), prepartum antibiotic treatment (intravenous penicillin or oral erythromycin), and vaccination during pregnancy (not yet available) for serious bacterial infection in early infancy across 12 maternal risk groups. Model parameters were estimated using multi-parameter evidence synthesis to incorporate all relevant data inputs.
32 systematic reviews were conducted: 14 integrated results from published studies, 24 involved analyses of primary datasets, and five included expert opinion. Main outcomes measures Healthcare costs per quality adjusted life year (QALY) gained.
Current best practice (to treat only high risk women without prior testing for infection) and universal testing by culture or polymerase chain reaction were not cost effective options. Immediate extension of current best practice to treat all women with preterm and high risk term deliveries without testing (11% treated) would result in substantial net benefits. Currently, addition of culture testing for low risk term women, while treating all preterm and high risk term women, would be the most cost effective option (21% treated). If available in the future, vaccination combined with treating all preterm and high risk term women and no testing for low risk women would probably be marginally more cost effective and would limit antibiotic exposure to 11% of women. The value of information is highest (67m pounds sterling) if vaccination is included as an option.
Extension of current best practice to treat all women with preterm and high risk term deliveries is readily achievable and would be beneficial. The choice between adding culture testing for low risk women or vaccination for all should be informed by further research. Trials to evaluate vaccine efficacy should be prioritised.
BMJ (Clinical research ed.). 10/2007; 335(7621):655.
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ABSTRACT: To determine the accuracy of postnatal screening for toxoplasma-specific immunoglobulin (Ig) M and IgA.
Ten centres in three European countries.
We compared results of the first postnatal IgM or IgA test in infants with infected mothers identified by prenatal screening with the reference standard for congenital infection status of specific IgG status at one year of age.
In all, 170 infected and 822 uninfected infants were analysed. Overall, IgM or IgA testing detected only 52-55% of infected infants. Sensitivity was highest between one and two weeks after birth and declined thereafter. Specificity was highest from four weeks after birth. For IgM, but not IgA, sensitivity was statistically significantly lower if the mother seroconverted in the first and second trimesters of pregnancy (29% and 34%, respectively) than the third (71%). Prenatal treatment with pyrimethamine-sulphonamide did not significantly reduce IgM or IgA sensitivity. Sensitivity was lowest for the immunofluorescence (IF) IgM test (10%) and the enzyme-linked immunosorbent assay (ELISA) IgM test (29%), but similar for the immunosorbent agglutination assay (ISAGA) IgM (54%), ISAGA IgA (58%) and ELISA IgA (52%) tests. Specificity was significantly lower for the ISAGA IgA test (91%) than for the ISAGA IgM (96%), IF IgM (100%), and ELISA IgA tests (98%).
Poor performance of IgM and IgA tests in the newborn, particularly if the mother seroconverted in early pregnancy, casts doubt on the value of neonatal screening in industrialized countries where the risk of clinical manifestations during childhood is low. More accurate diagnostic tests are needed for newborns identified by prenatal screening.
Journal of Medical Screening 02/2007; 14(1):8-13. · 1.69 Impact Factor
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ABSTRACT: Information is lacking on the effects of congenital toxoplasmosis on development, behavior, and impairment in later childhood, as well as on parental concerns and anxiety. This information is important for counselling parents about the prognosis for an infected child and for policy decisions on screening.
We prospectively studied a cohort of children identified by screening for toxoplasmosis in pregnant women or neonates between 1996 and 2000 in ten European centers. At 3 years of age, parents of children with and without congenital toxoplasmosis were surveyed about their child's development, behavior, and impairment, and about parental concerns and anxiety, using a postal questionnaire.
Parents of 178/223 (80%) infected, and 527/821 (64%) uninfected children responded. We found no evidence that impaired development or behavior were more common in infected children, or that any potential effect of congenital toxoplasmosis was masked by prenatal treatment. Parents of infected children were significantly more anxious and reported more visual problems in their children.
On average, children aged three to four years with congenital toxoplasmosis identified by screening and treated during infancy in this European setting had risks of abnormal development and behavior similar to uninfected children. Parental anxiety about infected children needs to be addressed by clinicians. Future studies with longer follow up and clinician-administered assessments may be better able to detect any subtle differences in child outcomes.
BMC Pediatrics 02/2005; 5:23. · 1.88 Impact Factor
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ABSTRACT: To determine the effectiveness of systemic antibiotic treatment for toxoplasmic retinochoroiditis.
Toxoplasma retinochoroiditis is a significant cause of visual morbidity. Multiple different antibiotic regimens are used, but controversy about treatment effectiveness remains.
Searches were conducted of Cochrane Controlled Trials Register, Medline (1966 onward), Embase (1980 onward), Dissertation Abstracts (1861 onward), Lilacs (1982 onward), and Pascal (1984 onward). Pharmaceutical companies were contacted for unpublished data. Any randomized controlled trials that compared antibiotics versus placebo in immunocompetent patients with toxoplasmic retinochoroiditis were retrieved. Primary outcome measures were long-term visual acuity and risk of recurrent retinochoroiditis. Secondary outcomes included duration and severity of acute symptoms, size of the lesion at end of follow-up, and adverse effects of treatment.
Only 3 studies (total of 173 participants) were randomized controlled trials and hence met the inclusion criteria (level II). All 3 were methodologically poor, and 2 were carried out more than 35 years ago. None reported the effect on long-term visual outcome. We found no evidence for a beneficial effect on the duration and severity of signs of acute toxoplasmic retinochoroiditis (A,II). There was weak evidence for an effect of long-term treatment for chronic recurrent toxoplasmic retinochoroiditis on lesion recurrence. Treatment was associated with adverse effects.
There is a lack of evidence to support routine antibiotic treatment for acute toxoplasmic retinochoroiditis. Placebo-controlled randomized trials of antibiotic treatment in patients presenting with acute or chronic toxoplasmic retinochoroiditis arising in any part of the retina are required.
Ophthalmology 06/2003; 110(5):926-31; quiz 931-2. · 5.45 Impact Factor
