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management of itp .pdf


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CLINICAL PRACTICE GUIDELINES
August 2006

MOH/P/PAK/115.06 (GU)

MANAGEMENT
OF
IMMUNE THROMBOCYTOPENIC
PURPURA

BE R

S A TU

I•
AKT
•BERUSAHA•BERB

MINISTRY OF HEALTH MALAYSIA

ACADEMY OF MEDICINE

Statement of Intent
This clinical practice guideline is meant to be a guide for clinical
practice, based on the best available evidence at the time of
development. Adherence to these guidelines may not necessarily
ensure the best outcome in every case. Every health care provider
is responsible for the management of his/her unique patient based
on the clinical picture presented by the patient and the management
options available locally.

Review of the Guidelines
This guideline was issued in August 2006 and will be reviewed in
August 2008 or sooner if new evidence becomes available.

CPG Secretariat
c/o Health Technology Assessment Unit
Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Parcel E,
Government Office Complex,
62590, Putrajaya.
Available on the following website :

http//www.moh.gov.my
http://www.acadmed.org.my

GUIDELINES DEVELOPMENT AND OBJECTIVES

Guideline Development
The development group for this guideline comprised of paediatricians,
physicians, haematologists and an obstetrician from the Ministry of Health
Malaysia and Ministry of Education.
The evidence search was carried out using Pubmed, Ovid and general
search engines with ‘idiopathic thrombocytopenic purpura’; ‘immune
thrombocytopenic purpura’; ‘platelet count’; autoimmune thrombocytopenic
purpura’; ‘refractory thrombocytopenic purpura’; ITP; thrombocytopenia AND
therapy as the key words. For paediatric AND pregnancy articles the previous
search terms were combined with ‘child’ and ‘children’ and pregnancy
respectively. The search excluded secondary causes of ITP e.g. ‘drug
induced thrombocytopenia’; ‘secondary immune thrombocytopenia’.
“Related articles were selected and out of these, relevant articles were
chosen and graded using the modified version of those used by the Catalonia
Agency for Health Technology Assessment (CAHTA) Spain.
This guideline was also adapted from other international guidelines on
Management of Idiopathic Thrombocytopenic Purpura which include
Guidelines for the Investigation and Management of Idiopathic
Thrombocytopenic Purpura in Adults, Children and in Pregnancy by British
Society for Haematology and Idiopathic Thrombocytopenic Purpura: A
practice guideline by American Society of Haematology. This guideline is
also based on the findings of a systematic review of current medical
literature, taking into consideration local practices. The draft guideline was
posted on both the Ministry of Health Malaysia and Academy of Medicine,
Malaysia websites for comment and feedback. This guideline has also been
presented to the Technical Advisory Committee for Clinical Practice
Guidelines and the Health Technology Assessment and Clinical Practice
Guidelines Council, Ministry of Health Malaysia for review and approval.
A systematic approach to the treatment modalities was suggested depending
on the conditions associated with ITP. This is summarised as an algorithm
of management of ITP in adults, children and pregnancy.

i

Objectives
The main aim of the guideline is to enable practitioners to make informed
evidence based decisions on the diagnosis and management of Immune
Thrombocytopenic Purpura (primary or idiopathic).

Clinical Questions
The clinical questions of this guideline are:
i)
What is the clinical spectrum of Immune Thrombocytopenic Purpura?
ii)
How is Immune Thrombocytopenic Purpura diagnosed?
iii)
How can patients with Immune Thrombocytopenic Purpura be treated
optimally?

Target Population
This guideline is developed for the management of patients with Immune
Thrombocytopenic Purpura in children, adults and pregnant mothers.

Target Group
This guideline is applicable to all primary care providers, physicians,
paediatricians, obstetricians and others involved in treating patients with
Immune Thrombocytopenic Purpura.

ii

GUIDELINE DEVELOPMENT GROUP
CHAIRPERSON
Dr. Jameela Sathar
Consultant Haematologist
Hospital Ampang
Selangor
MEMBERS
Dr.Soo Thian Lian
Consultant Paediatrician
Hospital Queen Elizabeth
Sabah

Dr. Sinari Salleh
Consultant Haematologist
Hospital Sultanah Aminah
Johor Bahru, Johor

Dr. Goh Ai Sim
Consultant Haematologist
Hospital Pulau Pinang
Pulau Pinang

Dr. Mahfuzah Mohamed
Paediatric Haemato-Oncologist
Paediatric Institute
Hospital Kuala Lumpur

Dr. Ong Swee Gaik
Consultant Rheumatalogist
Hospital Selayang
Selangor

Dr Eeson Sinthamoney
Obstetrician and Gynaecologist
Hospital Ampang
Selangor

Dr Ho Lee Ming
Physician
Hospital Pakar Sultanah Fatimah
Muar, Johor

Assoc Professor Hany Ariffin
Consultant Paediatrician
University Malaya Medical Centre
Kuala Lumpur

COORDINATORS
Dr Sheamini Sivasampu
Principal Assistant Director
Health Technology Assessment Unit
Medical Development Division
Ministry of Health Malaysia

Dr S Sivalal
Deputy Director
Health Technology Assessment Unit
Medical Development Division
Ministry of Health Malaysia
Mr. Ganesan a/l Thankaveloo
Senior Medical Assistant
Health Technology Assessment Unit
Medical Development Division
Ministry of Health Malaysia

iii

SPECIALIST REVIEWERS (in alphabetical order)
The draft guideline was reviewed by a panel of independent expert referees,
who were asked to comment primarily on the comprehensiveness and accuracy
of interpretation of the evidence supporting the recommendations in the guideline.

Professor Abdul Rahman Jamal
Senior Consultant Paediatric Haematologist-Oncologist
Hospital Universiti Kebangsaan Malaysia
Dr Lin Hai Peng
Senior Consultant Paediatric Haematologist-Oncologist
Subang Jaya Medical Centre
Selangor
Dr Chang Kian Meng
Head of Department and Consultant Haematologist
Department of Hematology
Hospital Kuala Lumpur
Dr Mukundan Krishnan
Head of Department and Senior Consultant Obstretic And Gynaecologist
Department Obstretic & Gynaecology
Hospital Ipoh
Dr Ng Siew Hian
Head of Department and Senior Consultant Anaesthesiologist
Department of Anaesthesiology
Hospital Kuala Lumpur
Dr V Purushothaman
Senior Consultant Haematologist
Hospital Kuala Lumpur
Dr Raman Subramaniam
Senior Consultant Obstretic And Gynaecologist
Fetal Medicine & Gynaecology Centre
Kuala Lumpur

iv

TABLE OF CONTENTS
Guideline Development And Objectives
Clinical Practice Guidelines Development Group
Specialist Reviewers

i
iii
iv

1.

INTRODUCTION

1

2.

ITP IN ADULTS

1

2.1

Clinical Features

1

2.2

Diagnosis
a.
Clinical
b.
Laboratory

1
1
3

2.3

Management of Chronic ITP

4

a.

First Line Treatment
i.
Corticosteroids
ii.
Intravenous Immunoglobulin

4
4
5

b.

Second Line Treatment
i.
Splenectomy
Predicting response to splenectomy
Post operative complications
Accessory spleen
ii.
Danazol
iii.
Azathioprine
iv.
Dapsone
v.
Anti-D7

5
5
6
6
6
7
7
7

c.

Treatment Refractory ITP
i.
Eradication of Helicobacter Pylori
ii.
Intravenous Immunoglobulin
iii.
Vinca Alkaloids
iv.
High Dose Methylprednisolone
v.
Cyclosporin A
vi.
Mycophenolate Mofetil
vii.
Anti-CD20 antibody (Rituximab)
viii. Combination therapy
ix.
Others

8
8
8
8
8
8
9
9
9
9

d.

Emergency Treatment

9

v

3.

4.

ITP IN CHILDREN

11

3.1
3.2
3.3
3.4

12
13
14
14

Management of Acute ITP
Management of Chronic ITP
Refractory ITP
Emergency Treatment

ITP IN PREGNANCY

16

4.1

16
16
16
17
18
19
20

4.2

Diagnosis
a.
Clinical
b.
Laboratory
Management
a.
Management before 36 weeks
b.
Management after 36 weeks
c.
Management in labour

5

NEONATAL CARE

6.

ALGORITHM
6.1
6.2
6.3

7.

21

Treatment Algorithm : ITP in Adults
Treatment Algorithm : ITP in Children
Treatment Algorithm : ITP in Pregnancy

22
23
24

REFERENCES

25

ACKNOWLEDGEMENTS
DISCLOSURE STATEMENT
SOURCES OF FUNDING

34
34
34

vi

1.
INTRODUCTION
Immune thrombocytopenic purpura (ITP) affects both children and adults. It
is an autoimmune disorder characterised by persistent thrombocytopenia
(peripheral platelet count of less than 150 x109/L) due to autoantibody binding
to platelet antigen(s) causing their premature destruction by the reticuloendothelial system, in particular the spleen.
In childhood, the peak age is 2-4 years, girls and boys are equally affected,
and in most children the disease is self-limiting with spontaneous recovery
occurring in several weeks to several months. In adults, ITP is most common
among young women and the disease is more insidious in its onset and
chronic in its course 1 Level 9. The true incidence of ITP is still unknown. In
children, the overall incidence of ITP is 4 – 5.3 per 100,000 2 Level 8 ; 3 Level 6. It
has been reported that the incidence of chronic adult ITP is around 5.8-6.6
new cases per 100,000 population per year in the USA 4 Level 9.
2.

ITP IN ADULTS

2.1 Clinical Features
In adults, ITP typically has an insidious onset, with no prodromal illness.
Symptoms and signs are highly variable, ranging from the common
asymptomatic patient with mild bruising or mucosal bleeding to frank
haemorrhage from any site, the most serious of which is intracranial.
The most common manifestation in ITP is mucocutaneous bleeding with
purpura, epistaxis, gingival bleeding and menorrhagia. Overall, bleeding
symptoms are uncommon unless the ITP is severe (platelet count < 30x109/
l) 1 Level 9. The degree of bleeding is largely dependent on the platelet count
and patients with platelet counts below 10x109/l (and usually below 5x109/l)
are at greatest risk of bleeding, including intracranial haemorrhage.
2.2 Diagnosis
There is no gold standard diagnostic test to confirm ITP. The diagnosis of
ITP remains clinical and is based principally on the exclusion of other causes
of thrombocytopenia by the history, physical examination, full blood count,
peripheral blood film and autoimmune screen.
a.
Clinical
ITP can be defined as isolated thrombocytopenia with no clinically apparent
associated conditions or other causes of thrombocytopenia (e.g. HIV
1


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