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World Health Organization : Year 1999 ; The Special Programme for Research and Training in Tropical Diseases Ide Thelep, No. 99.1, Pages P81-161: Discussion and Conclusions

By World Health Organization

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Book Id: WPLBN0000115132
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Reproduction Date: 2005

Title: World Health Organization : Year 1999 ; The Special Programme for Research and Training in Tropical Diseases Ide Thelep, No. 99.1, Pages P81-161: Discussion and Conclusions  
Author: World Health Organization
Volume:
Language: English
Subject: Health., Public health, Wellness programs
Collections: Medical Library Collection, World Health Collection
Historic
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Publisher: World Health Organization

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Health Organization, B. W. (n.d.). World Health Organization : Year 1999 ; The Special Programme for Research and Training in Tropical Diseases Ide Thelep, No. 99.1, Pages P81-161. Retrieved from http://gutenberg.cc/


Description
Medical Reference Publication

Excerpt
At the time that the THELEP programme began, the two major concerns of the scientists working in the area of chemotherapy were the phenomena of microbial persistence and drug-resistance. It appeared certain that relapse caused by the emergence of drug-resistant Mycobacterium leprae could be prevented by employing combined (multidrug) therapy, particularly combinations including rifampicin, which was known to exert a powerfully bactericidal action against the organism. It was also clear that control of leprosy by chemotherapy would be possible only if chemotherapy of finite duration were curative; long experience with dapsone as monotherapy had demonstrated that neither patients nor the treatment services could be expected to comply with treatment of indefinitely long duration. However, rifampicin as monotherapy had recently been shown to be incapable of eradicating M leprae. And it was feared that persistence of viable organisms in the lepromatous patient, whose immune response to the organism was known to be deficient, would lead inevitably to relapse after cessation of the chemotherapy. Workers hoped that a multidrug regimen could be discovered that was curative -- i.e., capable of eradicating persisting A4 Eeprae, thereby preventing relapse.

Table of Contents
CONTENTS 1. INTRODUCTION....................................................2 2. Standard chemotherapy t r i a l protocol . . . . . . . . . . . . . . . . . . . . . . 5 2.1 General scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.2 Ethical considerations ..............................................6 2.3 Patient intake and assignment . . . . . . . . . . . . . . . . . . . . . . 7 2.4 Conduct of the trial: short-term phase . . . . . . . . . . . . . . . . . 8 2.4.1 I n i t i a l examination . . . . . . . . . . . . . . . . . . . . . . . 2.4.2 Examinations during treatment . . . . . . . . . . . . . . . . . . 2.5 Conduct of the t r i a l : longer-term phase . . . . . . . . . . . . . . . . . 2.6 Removal from the t r i a l . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7 Reporting; organization; coordination; evaluation; publication . . . . 2.8 Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 . Regimens t o be tested . . . . . . . . . . . . . . ; . . . . . . . . . . . . . . 4 . Literature cited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 5 . Appendices 5.1 Cliaicalexaminati&forleprosy . . . . . . . . . . . . . . . . . . . . 15 5.2 LI (LLs) leprosy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 5.3 LeprOmiP testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 5.4 . Dapsone analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 5.5 Smear technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 6 5.6 . Nasal smears . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.7 Measurement of theBI . . . . . . . . . . . . . . . . . . . . . . . . . . 28 9k;s biopsy technique . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Reparation of specimens for shipment . . . . . . . . . . . . . . . . . . 32 Processing specimens for animal inocuiation . . . . . . . . . . . . . . . 35 Exclusion of tuberculosis . . . . . . . . . . . . . . . . . . . . . . . 40 Management 'of parasitic infestation. syphilis . . . . . . . . . . . . . . . 41 Management of reversal reactions . . . . . . . . . . . . . . . . . . . . 43 HanagementofENL . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Patient consent form . . . . . . . . . . . . . . . . . . . . . . . . . . 46 m i t o r i n g for adverse reactions to drugs . . . . . . . . . . . . . . . . 48 Adjustment of drug dosages accordin'g to body weight . . . . . . . . . . . 50 F o m . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51

 
 



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