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臨床試驗的科學原理 台北醫學大學 醫學科學研究所 許重義
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What is the most widely read book on medicine? It is Merck Manual !
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Western vs. Eastern
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In Medicine, which world advances faster and is more successful? Eastern or Western?
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Amazon.com
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This is serious stuff. The most widely used medical text in the world. Ref. Amazon. com
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“more than 10 million copies sold in 18 languages since it was first published in 1899 “
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the oldest continuously Published general medical text in the English language.
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The year 1999 marks a milestone in medical publishing —the 100th anniversary of The Merck Manual
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The Merck Manual: A Century of Medical Publishing and Practice
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A Century of Trust The Merck Manual: Centennial Edition
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What a century for advances in medicine!
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Keryn AG Lane Executive Editor Merck Manuals Robert Berkow Editor-in-Chief Merck Manuals
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The history of the Manual provides a wonderful overview of how medical practice has changed.
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The first edition reveals a remarkable reliance on poisons, such as strychnine and arsenic.
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Arsenic was listed as a medication for more than 100 diseases, including jaundice, hydrophobia, elephantiasis, and impotence.
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Tobacco was recommended to treat asthma
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The first edition was an instant success!
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A book reviewer in the Chicago Medical Recorder commented: “Although this little book is gotten out by a manufacturing firm----, it nonetheless is of such merit -----.”
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Dr M R Dinkelspiel, the 7 th edition (1940) editor noted that therapy was approached not as a science, but as an art.”
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The ninth edition (1956) reflected the growing list of corticosteroids for pain.
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The 12th edition (1972) contained many new chapters, for example, on coronary care units, cardiovascular and malignant diseases, immunology and genetics, and the chemotherapy of psychiatric disorders.
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As an interesting endnote, all people who purchase the 17th edition of The Merck Manual during its centennial year will receive a facsimile copy of the first edition.
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Readers can then see for themselves how much medicine has changed during this century.
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What about oriental medicine? How much has been advanced in herbal medicine in the past 100 years?
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In the USA, herbal medicine pills are noted frequently to contain western medications such as steroid (cortical), chemotherapeutic agents (method rebate), anticonvulsants (Dilating) and others.
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Based on the 100 years of experience with Merck Manual, could we, the doctors, be looked back “stupid” in year 2099?
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In the 18 th Century Doctors are killing patients with arsenic, strychnine and other poisons
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100 years from now how the contemporary doctors then would see their counterparts 100 years earlier?
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Traffic death in the US: 50,000 a year
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Death caused by healthcare professionals in the US: 100,000 a year!
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Death caused by medications prescribed by doctors in the US 200,000 a year!
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Health care professionals and the medications they prescribed kill 6 times more people than traffic accident in the US
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Are you convinced that doctors kill patients?
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In Israel A nation-wide physician strike in 1972 lowered the mortality in the nation by more than 50%
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In Los Angeles, California A partial physician strike lowered the mortality in the city by 18%
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In Bogota, Columbia A partial physician strike lowered the mortality in the city by 36%
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In Singapore, Hong Kong and Taiwan SARS mortalities were more than 10%
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In Vietnam SARS mortality was 5 %
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In Vietnam There were no modern meds such as antiviral agents or steroids to treated patients
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In Vietnam There were no advanced facilities such as negative pressure wards or respirators to support incubated patients
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In medical practice Doing nothing could be better than meds or interventions such as surgeries
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In medical practice The first thing every doctor should know is Do no harm
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How do we know the meds we give to patients are helpful to patients?
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How do we prove the meds we prescribe to patients are helpful scientifically?
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It takes rigorously designed clinical trials to confirm the efficacy of a drug.
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The gold standards for the criteria to establish drug efficacy was established by Food and Drug Administration (FDA) in the US
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FDA established its reputation in a well known act to prohibits the use of thalidomide in the US when it was widely used in the Europe for a number of diseases in the 50s.
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FDA, with its authoritative measures, sets very high standards to approve drugs that are to be approved for prescriptions by doctors in the US.
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The rest of the world has since adapted FDA protocols in approving prescription medications.
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FDA specifically asks if a new drug is safe makes patient better keeps patient live longer
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A new drug to be approved by FDA entails extensive preclinical and clinical tests to fulfill the 3 major criteria on safety, quality of life and longevity.
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A new drug may take 7-10 years to go from the lab bench to bedside and costs hundreds of millions in US dollars to get FDA approval.
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Drug Development and Approval Process
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