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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5195_Библиотеки_им_академика_М_И_Перельмана.pdf
With such a legacy, it is easy to understand, appreciate, and acknowledge Dr.
Yaffe as the Father of Pediatric Clinical Pharmacology.
Michael D. Reed
George Giacoia
Johannes N. van den Anker
Jacob V. Aranda
Reprinted with permission from Giacoia G, Reed MD. Sumner J. Yaffe: The father of pediatric clinical
pharmacology. J Pediatr Pharmacol Ther 2011;16(3):162–166.
Foreword
It has been almost 10 years since the publication of the fourth edition of
Neonatal and Pediatric Pharmacology: Therapeutic Principles in
Practice, and we continue to make great strides in the evaluation of pediatric
therapeutics. Since the last edition, advancements have been made in cell and
gene therapy and treatments available for rare diseases, with data available
for a range of pediatric patients that could potentially benefit from therapy.
New drug and biologic products have been evaluated in pediatric patients for
most of the therapeutic areas, including infectious diseases, cancer, and
chronic diseases.
Dr. Sumner J. Yaffe was a visionary in his appreciation of the importance
of clinical pharmacology in the study of products to treat children when he
established a network of Pediatric Pharmacology Research Units in 1994,
funded by the National Institute of Child Health and Development (NICHD).
These efforts have been supported by the legislative mandates, the Best
Pharmaceuticals for Children Act (BPCA), and the Pediatric Research
Equity Act (PREA). The BPCA and PREA, initiated in 2002 and 2003,
respectively, were made permanent by the Food and Drug Administration
Safety and Innovation Act (FDASIA) in 2012. The BPCA encourages the
developers of drug and biologic products to undertake studies in the
pediatric population in exchange for an exclusivity incentive. There is also a
part of the BPCA to support the study of off-patent drugs through NICHD.
The Pediatric Trials Network, coordinated by the Duke Clinical Research
Institute as part of the NICHD/BPCA program, has enrolled more than 7,000
children in studies of more than 70 drugs. The PREA requires a pediatric
assessment for certain drug and biologic products unless a waiver or deferral
has been obtained. Between 1998 and 2019, there have been more than 800
pediatric labeling changes, with approximately two-thirds having studies
done under the PREA.
Significant work in the basic sciences continues to support the
development of pediatric therapeutics. New information on the ontogeny of
systems involved in the absorption, distribution, metabolism, and excretion
(ADME) of drugs and biologics has been especially important in efforts to
identify optimal dosing for neonates and infants and has been critical in the
establishment of physiologically based pharmacokinetic models. Innovative
approaches to study pediatric therapeutics, such as novel trial designs,
modeling, and simulation of doses, and the development of age-appropriate
formulations and therapeutic drug monitoring assays that require small blood
volumes, have encouraged the ability to obtain information in neonatal and
pediatric patients. As with all the previous editions of this book, key subject
matter experts have contributed to this edition, detailing information on
therapeutic approaches to neonatal brain injury, seizures, hyperbilirubinemia,
apnea, cancer, and pain and withdrawal syndromes, as well as approaches to
treatment and prevention of diseases in the areas of ophthalmology, infectious
diseases, gastroenterology, endocrinology, neurology, psychology, and
pulmonology. Although it is an exciting time in the development of
therapeutics for pediatric patients, potential safety issues must be evaluated.
Unique considerations include length of therapy, exposure during vulnerable
periods of growth and development, and the ontogeny of ADME
characteristics that might influence the approach to dosing. To efficiently
study new pediatric therapeutics, collaborative global resources, including
sites with experience in collecting regulatory-ready data, are being
established.
This book, with its unique and comprehensive approach to neonatal and
pediatric pharmacology, will help guide treatment of newborns and children
with information on optimal dosing approaches and benefit–risk
considerations associated with therapeutic use in pediatric patients.
Dr. Susan McCune, MD
Preface to the
Fourth
Edition
Neonatal and pediatric pharmacology and drug therapy may be viewed as
corrective and manipulative physiology and biochemistry for the fetus,
newborn infant, and growing child using drugs, biologic and molecular
entities. Drugs are used to correct physiologic, molecular, and biochemical
as well as disease-related abnormalities that occur during pre- and postnatal
periods, extrauterine adaptation, and growth and development to adulthood.
As advances in the knowledge of diseases and their diagnoses are made,
the complexities of treatment, particularly by drugs, increase in tandem.
Therapeutic drug exposure and administration in the newborn and children
has increased over the years. Moreover, the number of drugs available to
physicians and health care givers continues to increase. There is an
increasing variety of antimicrobials, cardiovascular drugs, diuretics,
immunosuppressants and immunomodulators, antivirals, biologic, and other
drugs for the management of sick newborn and children. Safe and effective
use of these agents in infants and children requires adequate knowledge of
their pharmacologic properties, including drug action, metabolism, and
disposition.
The fourth edition of Neonatal and Pediatric Pharmacology:
Therapeutic Principles in Practice has been substantially revised to meet
the current needs of clinicians, pharmacologists, pharmacists, and other
health care givers. The book has expanded to 66 chapters in this edition, plus
drug formularies for newborns and children. This edition is designed to
provide relevant information on drugs and their uses in newborn infants,
older infants, children, and adolescents. It was proposed as a quick reference
for busy clinicians, house staff, students, nurses, pharmacists, and health care
providers. It may also serve as a general and basic reference for teaching
neonatal and pediatric pharmacology. It is also hoped that researchers will
find it useful to understand the unique characteristics and dynamic changes in
drug requirements and action during a period of intense growth and
development. The mechanisms of drug actions, the evidence of drug efficacy
in certain disease states, dose, therapeutic guidelines, and drug toxicities are
emphasized. The book was organized to parallel the distinct periods of early
human development. Special sections useful in drug therapy such as
therapeutic drug monitoring, adverse drug reactions, and epidemiologic
considerations are also included. The unraveling of some of the secrets of the
human genome has resulted in major progress and challenges in the
understanding of drug disposition and pharmacologic effects in humans and
personalized drug therapies. A chapter is devoted to this issue in this book.
The importance of pharmacogenetics and pharmacogenomics in clinical
therapeutics in children and in pediatric drug trials and drug development
can no longer be ignored. Developmental changes in receptors, drugmetabolizing enzymes, transporters, and ion channels may have impact on the
efficacy and safety of drugs in children. The determinants of drug action,
metabolism, and disposition are multifaceted, and the impact of the
variations in the human genome, the environment demographics, and other
factors will remain a major challenge in the immediate future.
Drugs are double-edged swords; although they can cure illnesses and
restore health and well-being, they can also produce unwanted and, at times,
unanticipated toxicities. The rational, intelligent, and safe use of drugs
springs mainly from understanding their actions, uses, problems, and
limitations. This understanding, in turn, will permit selection of the
appropriate drug and prescription of the optimal dosage. It is our utmost
desire that this textbook can help those providers of care to newborns and
children to maximize the benefits of pharmacologic agents while averting
their adverse effects. Identified areas of ignorance or concern should
stimulate further research to minimize the unknowns in neonatal and pediatric
drug therapy. Thus, this book will advance and promote the health and
wellness in newborns and children.
Sumner J. Yaffe
Jacob V. Aranda
Preface to the
Fifth Edition
Developmental pharmacotherapeutics may be simplistically viewed as the
use of drugs, biologics, and molecular entities to correct, restore, and
manipulate aberrant molecular biology, physiology, and biochemistry in the
fetus, newborn infant, growing child, and adolescent. Drugs preserve
wellness as they rectify and amend physiologic, molecular, and biochemical
lesions as well as disease-related abnormalities that may occur during preand postnatal periods, extrauterine adaptation, growth, and development to
adulthood. The knowledge on diseases and their diagnoses and therapies
inexorably advances. Drug exposures in newborns and children have also
increased over the years. There is an increasing variety and number of
antimicrobials, cardiovascular drugs, diuretics, immunosuppressants and
immunomodulators, antivirals, biologics, and other drugs for the management
of sick newborns, children, and adolescents. Safe and effective use of these
agents in these populations requires adequate knowledge of their
pharmacologic properties, including drug action, metabolism, disposition,
and safe and efficacious drug dosing regimens that are appropriate for age
and maturity.
The fifth edition of Yaffe and Aranda’s Neonatal and Pediatric
Pharmacology: Therapeutic Principles in Practice has been substantially
revised to meet the current needs of clinicians, nurses, pharmacologists,
pharmacists, researchers, and other health care providers. A completely new
section on biologic pharmacology reflects the knowledge explosion and
development of biologic entities, including monoclonal antibodies, vaccines,
stem cells, erythropoietin, and pulmonary surfactant in neonatal and pediatric
therapies. As novel diseases like the Coronavirus (COVID-19) or SARSCoV-2 global pandemic emerge, new and old drugs must be developed,
tested, and “repurposed” to prevent viral entry and replication as well as to
avert or modulate severe pathophysiologic states such as the cytokine storm.
New chapters in the fifth edition such as antimalarial drugs, cardiovascular
pharmacology, antiarrhythmic drugs, and others provide new information that
may improve therapeutic outcomes.
This edition is designed to provide relevant information on drugs and
their uses in newborns, children, and adolescents. It may serve as a quick
reference for busy clinicians, house staff, students, nurses, pharmacists, and
all health care providers. It may be used as a general and basic reference for
teaching neonatal and pediatric pharmacology. It is also hoped that
researchers will find it useful to understand the unique characteristics and
dynamic changes in drug requirements and action during a period of intense
growth and development. The mechanisms of drug actions, the evidence of
drug efficacy in certain disease states, dose, therapeutic guidelines, and drug
toxicities are emphasized. The book was organized to parallel the distinct
periods of early human development. Special sections useful in drug therapy
such as therapeutic drug monitoring, adverse drug reactions, epidemiologic
considerations, clinical trials, and pediatric drug development are also
included. The unraveling of the many secrets of the human genome has
resulted in major progress and challenges in the understanding of drug
disposition and pharmacologic effects in humans and personalized drug
therapies. A chapter is again devoted to this issue in this book. The
importance of pharmacogenetics and pharmacogenomics in clinical
therapeutics in children, in pediatric drug trials, and in drug development can
no longer be ignored. Developmental changes in receptors, drugmetabolizing enzymes, transporters, and ion channels may affect the efficacy
and safety of drugs in children. The determinants of drug action, metabolism,
and disposition are multifaceted, and the impact of the variations in the
human genome, the environment demographics, and other factors remain as
major challenges in pharmacotherapeutics.
Drugs can heal or kill; drugs can cure or harm. Indeed, they are doubleedged swords. They can not only restore health and well-being but also
produce unwanted and unanticipated toxicities. The effective and safe use of
drugs arises from fully understanding their actions, uses, problems,
limitations, and selection of the appropriate drug, using the correct dosing
regimen. This textbook may help care providers to maximize the benefits of
pharmacologic agents while averting their adverse effects. Identified gaps in
knowledge and areas of concern should stimulate further research to bridge
these gaps and to minimize the unknowns in neonatal and pediatric drug
therapy. As in the past four decades, we hope that this book will continue to
help advance and promote the health and wellness in newborns, children, and
adolescents through the safe and wise use of pharmacologic agents.
Jacob V. Aranda
Johannes N. van den Anker
Contributors
Nahed Abdel-Haq, MD
Professor of Pediatrics
Wayne State University/Children’s Hospital of Michigan
Detroit, Michigan
Susan M. Abdel-Rahman, PharmD
Marion Merrell Dow/Missouri Chair in Pediatric Clinical Pharmacology
Chief, Section of Therapeutic Innovation, Children’s Mercy Kansas City
Director, Health Care Innovation, Children’s Mercy Research Institute
Professor of Pediatrics, University of Missouri Kansas City School of Medicine
Kansas City, Missouri
Elissa M. Abrams, MD
Assistant Professor
University of Manitoba
Winnipeg, Manitoba, Canada
Homa K. Ahmadzia, MD/MPH
Assistant Professor
Division of Maternal-Fetal Medicine
Department of Obstetrics & Gynecology
The George Washington University
Washington, District of Columbia
Tageldin M. Ahmed, MBBS, MRCP, MRCPCH
Assistant Professor of Pediatrics
Wayne State University School of Medicine
Division of Pediatric Critical Care
Children’s Hospital of Michigan,
Detroit, Michigan
Zahraa H. Al-Lawati, MD
Physician
Pulmonary Critical Care
Children’s Hospital of Michigan
Detroit, Michigan
Mohammad H. Al-Shaer, PharmD, PhD
Research Assistant Professor
University of Florida
Gainesville, Florida
Wael A. Alghamdi, PharmD, PhD
Assistant Professor
Department of Clinical Pharmacy
College of Pharmacy
King Khalid University
Abha, Saudi Arabia
Karel Allegaert, MD, PhD
Professor
Department of Development and Regeneration
Department of Pharmaceutical and Pharmacological Sciences
Leuven, Belgium
Senior Consultant
Clinical Pharmacy
Erasmus Medical Center
Rotterdam, the Netherlands
Sasha A. Alvarado, DO
Allergy and Immunology Section
Louisiana State University Health Sciences Center
Shreveport, Louisiana
Johannes (John) N. van den Anker, MD, PHD, FCP, FAAP
Evan and Cindy Jones Endowed Chair in Pediatric Clinical Pharmacology
Vice Chair of Pediatrics for Experimental Therapeutics
Chief Division of Clinical Pharmacology
Children’s National Hospital and Professor of Pediatrics
Pharmacology & Physiology, Genomics & Precision Medicine
The George Washington University School of Medicine and Health Sciences
Washington, District of Columbia
Eckenstein-Geigy Distinguished Professor of Pediatric Pharmacology and Pharmacometrics
University Children’s Hospital Basel
University of Basel
Basel, Switzerland