Cows’ milk protein allergy

‘I am aware of the demands of good academic pattern and the possible punishments for any braches ‘

Cows ‘ milk protein allergy normally occurs in early childhood and can be a effect of IGE mediated immune procedures or non-IGE mediated procedures.

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  • Perform a literature reappraisal and so compose a study to compare IGE mediated and non-IGE mediated cattles ‘ milk protein allergic reaction with specific mentions to the clinical presentation, immunopathology, diagnostic trials and long term forecast for the patients. Throughout the study, you should associate the clinical manifestations to the underlying immunological procedures.
  • Imagine that you are a wellness professional providing service to the parents of a kid who has merely been diagnosed with the cow milk protein allergic reaction. Compare the advice that you would supply if the implicit in disease procedure was IGE mediated or non-IGE mediated. How these differences influence the psychological facets of the parent and kid ‘s life.

Literature Reappraisal:

Background: Cow ‘s milk allergic reaction has complex upsets and many milk proteins have been attributed in the allergenic responses.

Aims: To compare IGE mediated and non-IGE mediated cow ‘s milk protein allergic reaction with specific mentions to the clinical presentation, immunopathology, diagnostic trials and long term forecast for the patients.

Methods: An electronic literature hunt of MEDLINE, MEDSCAPE, GOOGLE SCHOLAR for the period ( November 2001-November 2009 ) . Using the text Human, English, Cow ‘s milk allergic reaction protein, IGE mediated, Non mediated, epidemiology, immunopathology, clinical presentation, symptoms, marks, diagnosing, Skin asshole Test, RAST Test, Patch Test Management, Milk Formula. Cow ‘s milk allergy Prognosis.

Consequences: 23 has been published in primer Diaries. Out of entire. 345 publications identified and abstract read.

  • 99 Excluded no specific relevancy to cattles milk allergic reaction
  • 201was older than 8 old ages.
  • 10 was no English Language.
  • 9 non Human

Decisions:

There are a great trade of differences between IGE mediated and Non IGE mediated cow ‘s milk allergic reaction in the signifier of epidemiology, immunopathology, diagnosing and intervention.

Abbreviations: Cows ‘ milk allergic reaction ( CMA ) , Immunoglobulin E ( IgE ) Food allergic reaction ( FA ) , Radioimmunoassay trial ( RAST ) Skin Prick Test ( SPT ) .

The Report:

Introduction

In Part 1

The essay gives an overview about nutrient allergic reaction definition, prevalence of cow’s Milk allergic reaction, particularly in UK. Furthermore, It discusses the epidemiology and natural history, underlying mechanisms and the most of import symptoms of the both Types of IGE mediated and non IGE mediated nutrient allergic reaction. Furthermore, it gives overview on the most of import diagnostic trials.

In portion 2

It discusses the professional advice for the parents of a kid have cattles ‘ milk. Allergy and comparing the differences between forecast and direction if The underlying mechanisms of his allergic reactions IgE or not IgE mediated reactions.

Definition of Food Allergy

Adverse reaction to nutrient should be called nutrient hypersensitivity, When Immunologic mechanisms have been demonstrated, the appropriate term. Is nutrient allergic reaction, and if the function of IgE is highlighted the term is IgE-mediated nutrient allergic reaction, all other reactions, antecedently sometimes referred to as nutrient.

Intolerance should be referred to as no allergic nutrient hypersensitivity, terrible generalized allergic reactions to nutrient can be classified as anaphylaxis” ( 1 ) Prevalence of cow ‘s milk allergic reaction:

Worldwide, the prevalence of cow ‘s milk allergic reaction is variable, for illustration, in UK:

“Milk allergic reaction is estimated to impact 2 % of babies and immature kids in the UK population. The prevalence of Cows ‘ milk allergic reaction ( CMA ) varies with age, with highest prevalence in early childhood ( 2-6 % ) and diminishing prevalence with increasing age. The incidence in maturity is merely 0.1-0.5 % . ‘ ( 2 ) .

Non -IgE cattles ‘ milk allergic reaction has a great trade “It is estimated that up to 50 % of paediatric cow ‘s milk allergic reaction is non-IgE- mediated” ( 3 ) .

Epidemiology and natural history:

( Woods et al, 2002 ) states that: “ CMA, the immune system is falsely programmed to respond to innocuous milk protein. Allergy symptom consequence from the collateral harm to tissues caused by the immune system ‘s deviant inflammatory response. “ ( 4 )

Food Allergy has implicit in mechanisms As Dr. Motala ( 2002 ) stats:

“The GI piece of land processes ingested nutrient for soaking up. It neutralizes foreign antigens and blocks them from come ining the circulation. Enzymes from salivary, stomachic, pancreatic and enteric secernments, combined with chew, stomachic acid, and vermiculation, cut down ingested substances to little sugars, peptides and fats.” ( 5 )

Dr. Motala adds ” A failure to develop tolerance or a dislocation in tolerance consequences in inordinate production of food-specific IgE antibodies” ( 5 ) Adulthood of the unsusceptibility system after birth can be responsible as ( Henriksen et al, 2000 ) States “Cow ‘s Milk is the most often encountered dietetic allergen in babyhood when the immune system is comparatively immature aand susceptible to sensitisation from environmental antigens” ( 6 )

Pathology and immunology

CMA is a Complex upset and different milk proteins have integrated in the allerginic reactions and they have shown to incorporate multiple allergenic Antigenic determinants as ( Sampson et al 2002 ) concludes:

“Information sing the immunodominant antigenic determinants in ?- and ?-casein may be of import for understanding the pathophysiology and natural history of CMA. CMA has different pathological factors can play a function in the immunology procedure. For illustration, “ Differences in antigenic determinants acknowledgment may be utile in placing kids who will hold relentless milk hypersensitivity.” ( 7 )

Breast eating could play a function in sensitisation to overawe milk as ( SchulmeisterU et al2008 ) stats: after analysing the specificity and possible biological relevancy of IgE responsiveness to human milk antigens in milk-allergic patients. By analysing the sera from milk-allergic kids and grownups by IgE immunoblotting. IgE cross- responsiveness between milk antigens was studied by immunoblot suppression experiments. They conclude that: “IgE responsiveness to human milk in milk-allergic patients can be due to cross- sensitisation and echt sensitisation to human milk and may do allergic symptoms. IgE-mediated sensitisation to human milk is common in milk- allergic patients and may necessitate diagnostic testing and monitoring” ( 8 )

Allergic reactions to overawe ‘s milk are driven by more than one immunological mechanism. It is non a individual disease, but perchance involves different types of immunological mechanisms and by and large classified into IGE -mediated allergy and non-IGE mediated allergic reaction.

Many differences between the two reactions. IgE mediated reactions are rapid and can impact the tegument and can take to anaphylaxis daze. However, non IgE mediated are late reactions after hours or yearss and chiefly affects the GI piece of land with some exclusions as ( Sampson HA 2004 ) provinces. : “IgE-mediated reactions develop when food-specific IgE antibodies shacking on mast cells and basophils come into contact with and adhere go arounding nutrient allergens and activate the cells to let go of powerful go-betweens and cytokines. ( 9 ) .

And he adds”

“.In IgE-mediated reactions are typically rapid in oncoming, largely involve the tegument, and may take to anaphylaxis ; whereas non-IgE-mediated upsets become apparent hours to yearss after allergen consumption, and largely manifest in the GI piece of land. IgE-mediated GI upsets include the GI anaphylaxis and unwritten allergic reaction syndrome. Non-IgE-mediated GI allergic upsets include nutrient protein-induced enter inflammatory bowel disease, proctocolitis and enteropathy. Some GI diseases, such as eosinophilic esophagitis and stomach flu, involve both IgE and non-IgE- mediated mechanisms.” ( 9 )

What is IGE?

“Immunoglobulin E ( IGE ) is a category of antibody ( or Immunoglobulin isotype that has merely been found in mamales.It dramas an of import function in allergic reaction, and is particularly associated with type 1 hypersensitivity. IgE relicts an immune response by adhering to Fc receptors found on the surface of mast cells.“ ( 10 ) . ‘”In 1966, immunoglobulin E or IgE, was discovered by two separate research squads, by hubby and married woman squad, Teruko and Kimshige Ishikaza in the US and Gunnar Johanssen and Hans Bennich at Uppsala University infirmary. The squads could show a clear connexion between allergic symptoms and IgE antibodies. “ ( 11 )

Diagnosis of Cows ‘ Milk Allergy:

Diagnosis of Cow ‘s milk allergic reaction could be by History, clinical scrutiny, Skin. Prick Pest ( SPT ) , Specific IgE ( Radioimmunoassay trial, RAST ) , Enzyme-linked immunochemical assay ( ELISA ) , and chemoimmunoessay ) and Double-blind, placebo-controlled nutrient challenge ( DBPCFC ) or Open Food Challenge trials.

History would be the first and of import measure, because of full history pickings by utilizing a well designed questioner including household, pastand environmental immunisation history, school and baby’s room nutrient, and nutritionary tendencies in the household. Without full history pickings, we can non get down any farther probes. As AAAAI ( 2006 ) Work Group Report states”History pickings is one of the most of import diagnostic tools in medical specialty. In some instances it can be the most unequivocal one, particularly in the field of allergy” ( 12 )

( Brill H ) states that “Milk protein allergic reaction is a recognized job in the first twelvemonth of life ; cow ‘s milk protein allergic reaction is the most common such as allergic reaction. Diagnosis is suspected on history entirely, with laboratory ratings playing a encouraging function. Confirmation requires riddance and reintroduction of the suspected allergen. “ ( 13 )

Skin asshole testing is playing a function in the diagnosing of CMA. It is cheep, fast consequence within 20 proceedingss, no specific demands. We have to utilize standardised allergens. It is available from different US and European companies with different form and techniques of the prick lancets. However, we could utilize fresh milk alternatively. Although, the specificity of allergen tegument asshole proving to name clinically relevant nutrient allergic reaction is controversial. It could be a usher for nutrient challenge testes to diminish the unneeded challenge ‘s trials. To make the trial patient must halt taking antihistamines for a hebdomad before the trial. Unfortunately, can acquire false consequences with demographic tegument or eczema patients or non specific Skin sensitiveness.

Specific IGE Trials are depending on different types of marker.

For illustrations: Radioimmunoassay ( RAST ) , Enzyme-linked immunochemical assay ( ELISA ) , and chemoimmunoessay. All have a significance function in allergy proving If related to the history and clinical presentation of the disease. However, it is. more dearly-won than SPT.

Food Challenges or ( Double-blind, placebo-controlled nutrient challenge, DBPCFC ) . It is the gilded criterion for nutrient allergic reaction testing, it needs particular safeguards, resuscitation installations must be available, we could utilize active ingredient or placebo in different yearss.

( R. Sporik, D. J. Hill & A ; C. S. Hosking ) have studied five 100 and 55 challenges were undertaken in 467 kids: 339 challenges to overawe milk, 121 to egg, and 95 to peanut. They reach to decisions that:

“In this high hazard referral population it was possible to specify skin wale diameters to egg, milk and peanut above which unfastened unwritten nutrient challenges were positive ( 100 % specificity ) . By using these measurings they need for formal nutrient challenges can be reduced” ( 14 )

Skin Patch trial has a small clinical importance. It might be holding a function in Eczema. However, new spot proving have a significance function. As Dr. DuPont and his carbon monoxide research workers have been conducted a prospective survey to compare the new trial with a conventional spot trial for cow ‘s milk allergy.. ( 15 )

Other types of Test could be used. For illustration, Basophil Hisamine release Test, Cellular Allergen Stimulation Test. IgG, Ig1, Iga and serum tryptase. In suspected instances of non IgE cattles ‘ milk allergic reaction. For illustration, Dietary protein enterocolitis, occurs chiefly in the first month of life, the baby coming with drawn-out purging 1 to 3 hours after feeding ( both chest and bottle ) , Irritability, bloody diarrhoea, abdominal distention, and mother complaining of he is in failure to boom.

By clinical scrutinies and probes, we could happen that the patient might hold distended venters, mild dehydrated, babe is below the mean weight. Complete blood images ( CBC ) might demo the patient had mild anaemia. Neutrophil count might be increased. The degrees of IgE antibodies against milk with a normal scope and no other allergens. Stool analysis: bloody mucose, no parasite. Skin prick trial is negative on the most common inhalant or nutrient allergens. Jejunal biopsy specimens reveal flattened villi, hydrops, increased Numberss of lymph cells.

Part 2

Professional advices to the parents:

First of wholly, holding a kid with the nutrient allergic reactions is a large job for the household. But, if this nutrient is milk it would be another narrative. Because, it means that the kid will confront a batch of jobs for all his life. Many inquiries will look. For illustration, what type of nutrient could replace the cattles ‘ milk? . How can forestall the kid from eating milk or milk merchandises? We should give multivitamins for the kid? A batch of inquiries in the head of parents and we can non disregard the Psychological facets behind.

We should confront the job as one portion, direction and forecast. We have to exemplify for the parents, how is the advancement of the instance through the infant/child life? As Brill H provinces: “Management includes diet alteration for nursing female parents and hydrolyzed expressions for formula-fed babies. Measuring the underlying immunopathology can help in finding prognosis.” ( 13 )

The forecast of non Ige and IgE mediated reactions. Dietary protein enterocolitis syndrome as a non IgE reaction might be extended to other parts of the intestine or outgrow as Dr.Sicherer ( 2003 ) provinces: “The enteral redness may be limited to mild proctitis, pancolitis, or true enterocolitis with esophagitis, gastritis, enteropathy, and colitis” and he added: “Most babies outgrow the allergic reaction by age 2 or 3 old ages, but some seem to keep hypersensitivity into childhood“ ( 16 )

IgE mediated allergy reaction have a different forecast. For illustration, designation of isotopes could assist Children, who have a relentless cow ‘s milk allergic reactions besides have high degrees of IgE to linear isotopes on as1-casein. ( Chatchatee et al 2008 ) have been studied both IgE and IgG-binding antigenic determinants. on as1-casein to find whether the forms of antigenic determinant acknowledgment are associated with the natural history of cow milk allergic reaction. And conclude “Screening for these antibodies may let clinicians to place kids who have this relentless hypersensitivity “ ( 17 )

IgE could be besides as forecasters for tolerance and responsiveness subsequently in the child life as ( Garcia-Ara MC et Al ) concludes in this survey: & A ; ldquo

“ Monitorization of specific IgE concentration for milk and casein by CAP system in allergic kids to CMPs allows us to foretell, to a high grade of chance, clinical responsiveness. Age factor must be taken into history to measure the specific IgE degrees which are forecasters of tolerance or clinical reactivity.” ( 18 ) For the long term forecast, it needs from parents to follow the clinician as a usher for diagnosing and intervention. This reappraisal would assist clinicians in many facets to assist their patients “ diagnostic ratings ( skin asshole testing or measuring of food-specific serum IgE degrees ; indicants for diagnostic challenges for suspected IgE- and non-IgE-mediated nutrient allergic reaction ) . ( two ) Dietary intervention. ( three ) appraisal of response to intervention. ( four ) differential diagnosing and farther diagnostic work-up in non-responders. ( 5 ) follow-up appraisal of tolerance development. ( six ) recommendations for farther referral. ( 19 )

Clinicians should cognize from parents the exact atopic household history the kid. If the kid has been definite atopic history. So the clinician has to put an action program for following up though, the following 10 old ages of the child life. The forecast of cattles ‘ milk allergic reaction is depending on the atopic position of the kid as shown on a large cohort survey of 1.749 neonates, evaluated for CMA.

From 1995 -2009 ) and follow up have been over the period of 15 old ages with perennial disputing trial every 6 months. From the same birth cohort, 276 babies were indiscriminately selected at birth for prospective non-interventional follow- up in order to look into the natural class of sensitisation and development of atopic disease during childhood. The decision is The highest rate of sensitisation ( 53 % ) was found among kids with current asthma at 10 old ages of age.” ( 20 )

For the intervention, the kid should halt cattles ‘ milk and we could give the baby another provender expression. For illustration. Partially or full hydrolyzed. The new recommendation is to give an expensively hydrolyzed expression “according to the consequences of a recent randomized controlled survey, merely an extensively hydrolysated expression, and non a partly hydrolysated expression, significantly decreased the prevalence of cow ‘s milk allergy” ( 21 )

However, a great trade of kids can non digest the extensively hydrolysated expression ( EHF ) . So, we can bespeak for him Soya expression ( SF ) or Amino Acid based Formula. ( AAF ) . In this systemic reappraisal, we found an interesting consequence comparing cattles ‘ milk ( CM ) or cattles ‘ milk based Formula. “This systematic reappraisal shows clinical benefit from usage of AAF in both symptoms and growing in babies and kids with CMA who fail to digest eHF.” ( 22 )

Eating out might beis a large job. For the or kid hold Adrenalin Auto Injector ( Epipen or Anapen ) at least 2 injectors with long termination day of the months. They should larn. How can utilize in instance of anaphylaxis and when can give the 2nd dosage? . The kid should keep a card ( any colour, the card informs that kid has a milk allergic reaction. The Nursery should cognize the exact type of the kid allergic reaction, what nutrient can eat or non? . and inform them to should give the kid 5ml antihistamines. , when any marks of allergic reaction started. After that they should name for exigency or travel to the nearest medical exigency installation.

For atopic Eczema instances we should concentrate to handle the tegument. By utilizing Creams, local corticoid and antihistamines. We have to state parents about the importance and the safety of local corticoid and unwritten antihistamines. For illustration “Cetirizine, really safe for long term usage in atopic infants.” ( 23 )

For a wheezing or confirmed wheezing kids, we can follow GINA guidelines in direction of Asthma, by giving short or long acting Beta -agonist plus inhalant corticoids or Leukotrine inhibitors.

Parents should accommodate to Populating with the allergic reaction of their kid. Because cattles ‘ milk allergic reaction might be less harmful to the kid than Diabetes or malignant neoplastic disease and by some of the restricted preventing steps, safety is on custodies.

Quality of life of the kid is really of import. So, by reding the parent to maintain their kid healthy most of the clip, giving him the regular inoculations, handling any other morbidity diseases as Diabetics or Cardivascular upsets and even fast medical attention of any upper respiratory infections.

Balanced diet, besides of import because the lake of milk in his nutrient means the kid will lose of import beginning of Ca, vitamin D.fat soluble vitamins. , P and Mg which are really of import for growing. Regular appraisal and monitoring of growing curve and instruction parametric quantities is curial in the nutrient allergic reaction kids.

Furthermore, we could better the psychological facets on the parents and the kid by presenting them to any on-line support group. They would be experiencing that other households have the same job or more, non merely them. There are some of these organisations in Uk. For illustration, hypertext transfer protocol: //www.allergyuk.org, and hypertext transfer protocol: //www.milk.co.uk. These web sites functioning the parents and the patients and patients as good by giving educational stuff, carry oning a batch of meeting and assist telephone figure in instance for any exigency.

Decisions

Cows ‘ milk allergy a large challenge for the clinicians and research workers. And still large are for argument and treatment in all facets, particularly in the natural history. , epidemiology diagnosing and intervention. More studied are needed to clear up the the differences between Ige and not Ige mediated reactions.

For the patients and their parents, more services are in demand to make full the spread between them and clinician. Furthermore, more clip in audience room, after audience and follow up to affect the parents more in each item in the direction procedure.

Mentions:

  1. hypertext transfer protocol: //eaaci.net/v2/attachments/900_Nomenclature.pdf
  2. hypertext transfer protocol: //www.milk.co.uk.
  3. MaloneyJ ; Nowak-Wegrzyn. Educational clinical instance series for paediatric allergic reaction and immunology: allergic proctocolitis, nutrient protein-induced enterocolitis syndrome and allergic eosinophilic stomach flu with protein-losing gastroenteropathy as manifestations of non-IgE-mediated cow ‘s milk allergic reaction. Pediatr allergy Immunol,2007 ; 18 ( 4 ) :360-7
  4. Forests RK, Thien F, Raven J, Walters EH, Abramson MA, 2002: Prevalence of nutrient allergic reactions in immature grownups and their relationship to asthma, rhinal allergic reactions, and eczema.Ann Allergy Asthma Immunol88:183 -189.
  5. Motala, C: New positions in the diagnosing of nutrient allergic reaction. Current Allergy and Clinical Immunology, September/October 2002, Vol 15, No. 3: 96-100
  6. Henriksen C, Eggesbo M, Halvorsen R, Botten G,2000: Alimentary consumption among two-year-old kids on cattles ‘ milk-restricted diets.Acta Paediatrica89:272 -278.
  7. Designation of IgE and IgG adhering antigenic determinants on ?- and & A ; kapp ; -casein in cow ‘s milk allergic patients P. Chatchatee, K.-M. Jarvinen, L. Bardina, L. Vila, K. Beyer and H. A. Sampson Clinical & A ; Experimental Allergy 2002, Volume 31 Issue 8, Pages1256-1262
  8. SchulmeisterU ; SwobodaI ; QuirceS ; de la HozB ; OllertM ; PauliG ; ValentaR ; SpitzauerS. Sensitization to human milk.Clin Exp Allergy. 2008 ; 38 ( 1 ) :60-8
  9. Sampson HA. Update on nutrient allergic reaction. J Allergy Clin Immunol 2004 ; 113:805-819.
  10. Hannah J. Gould, Brian J. Sutton, Andrew J. Beavil, Rebecca L. Beavil, Natalie McCloskey, Heather A. Coker, David Fear, and Lyn Smurthwaite THE BIOLOGY OF IGE AND THE BASIS OF ALLERGIC DISEASE. Annual Review of Immunology Vol. 21: 579-628 ( Volume publication day of the month April 2003 )
  11. Ishizaka K, Ishizaka T, Hornbrook MM ( 1966 ) . & A ; ldquoPhysico-chemical belongingss of human reaginic antibody. IV. Presence of a alone Ig as a bearer of reaginic activity & A ; ldquo. J. Immunol. 97
  12. AAAAI Work Group Report 2006 Allergy Diagnosis in Clinical Practice hypertext transfer protocol: //www.aaaai.org/members/academy_statements/practice_papers/allergy_diagnosis.pdf.
  13. Brill H. , Approach to milk protein allergic reaction in babies. Canadian Family doctor, 2008 Sep ; 54 ( 9 ) :1258-64.
  14. Specificity of allergen tegument proving in foretelling positive unfastened nutrient challenges to milk, egg and peanut in kids R. Sporik, D. J. Hill & A ; C. S. Hosking Clinical & A ; Exprimenta Allergy, volume 30 Issue 11 Pages 1541-1546 Published Online: 5Sep2008
  15. Paula Moyer, MA New Patch Test Increases Accuracy, Convenience in Diagnosing Cow ‘s Milk Allergy. AAAAI 61st Annual Meeting: Abstract 247. Presented March 20, 2005
  16. Sicherer SH. ( 2003 ) Clinical facets of GI nutrient allergic reaction in childhood. Pediatricss 2003 ; 111:1609-
  17. Chatchatee P, Bardina L, Sampson HA. Designation of IgE adhering antigenic determinants of a-casein in cow milk allergic patients. Program and abstracts of the 56th one-year meeting of the American Academy of Allergy, Asthma and Immunology ; March 3-8, 2008 ; San Diego, Calif. Abstract 558.
  18. Garcia-Ara Mc, Boyano-Martinez MT, Diaz-Pena JM, Martin -Munoz, Martin-Eseban M. Cow ‘s milk-specific Ig E degrees as forecasters of clinical responsiveness in the followup of the cow ‘s milk allergic reaction babies Clin Exp Allergy.2004 June:3 ( 6 ) :866-70
  19. Allen K J, Davidson GP, Day AS, Hill DJ, Kemp AS, Hill DJ, Heine RG Management of cow ‘s milk protein allergic reaction in babies and immature kids: an adept panel position. J Paediatr Child Health 2009 Sep ; 45 ( 9 ) :481-6.
  20. Clinical class of cow ‘s milk protein allergy/intolerance and atopic diseases in childhood Arne Host, , Susanne Halken, Hans P. Jacobsen, Anne E. Christensen, Anne M. Herskind and Karin Plesner Pediatric allergic reaction and Immunology 2002. volume 13 issue 15 pages 23-28
  21. L Businco, G Bruno, PG Giampietro. Prevention and direction of nutrient allergic reaction Acta Paeditrica 2007, volume 88 Issue s 430, pages 104-109. Published On line 2 Jan 2007.
  22. The efficaciousness of aminic acid-based expressions in alleviating the symptoms of cow’s milk allergic reaction: a systematic reappraisal. Clin Exp Allergy. 2007 ; 37 ( 6 ) :808-22 ( ISSN: 0954-7894 ) HillDJ ; MurchSH ; RaffertyK ; WallisP ; GreenCJ
  23. Tamara T. Perry, MD and Robert A. Wood, MD, Baltimore, MD LONG-TERM TREATMENT WITH CETIRIZINE OF INFANTS WITH ATOPIC DERMATITIS: A MULTI-COUNTRY, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL ( THE ETAC TRIAL ) OVER 18 MONTHS PEDIATRICS Vol. 112 No. 2 August 2003, pp. 462
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