ABSTRACT
In a triplicate therapeutic experiment on lepromatous leprosy carried out at two leprosaria in the Philippines and one in the Union of South Africa, two major groups of patients at each institution were treated respectively with diaminodiphenyl sulfone (DDS), and with DDS plus nicotinamide. Tuberculin-negative patients of each group were divided into two subclasses. The patients of one subclass were vaccinated at least once with BCG; those of the other were left unvaccinated. Treatment was continued for 48 weeks. No evidence was found that either supplementary therapy with nicotinamide or vaccination with BCG was advantagenous. Patients of all subclasses showed clinical and bacteriologic improvement, but those treated only with DDS and not vaccinated showed about the same progress as others. Observed clinical improvement was limited to dermatologic lesions; there were no significant changes in the extent of anesthesis associated with any of the therapies. Only 6 of 434 patients at all institutions developed lepromin reactivity of the MItsuda type, and in all of these the size of the reaction was small. The occurrence of the reactional condition, erythema nodosum leprosum, was not associated with either clinical or bacteriologic improvement. It was equally frequent in the two principal therapy groups, was not evoked by BCG vaccination, and was not associated with reactivity to PPD (0.0001 mgm.).
Subject(s)
Leprosy , Leprosy, Lepromatous/classification , Leprosy, Lepromatous/diagnosis , Leprosy, Lepromatous/drug therapyABSTRACT
1- There is described a controllled therapeutic study of lepromatous leprosy which was carried out concurrently at the Central Luzon Sanitarium and the Eversley Childs Sanitarium in the PHilippines, and the Westfort Institution in South Africa. At Central Luzon, 213 patients commenced and 187 completed 48 weeks of treatment; at Eversley Childs, 234 commenced and 202 completed; and at Westfort, 119 commenced and 111 completed. 2- At each institution the patients were dicided into three matched groups, A, B, and C, taking into consideration sex, age, stage of disease, prior sulfone therapy and certain other factors. Group A received diasone (diamidin) in the Standard dosage; Group B received diasone in the same dosage as A, plus isoniazid (INH), 10 mgm. daily per kgm. of body weight; Group C received the same dosage of INH as B, plus 1 gm. dihydrostreptomycin (DHSM) intramuscularly twice weekly. 3- All therapies were well tolerated. The principal cause for discontinuance of treatment was departure from the institution without permission. As the groups were constituted at the end, however, they were comparable to one another inasfar as this could be determined. 4- On completion of treatment the proportion of each group, at each institution, showing clinical improvement was approximately the same. This was true of general improvement and of improvement in specified lesions such as infiltration, ulcers, nodules and others. A very small proportion became worse, and in this respect there was no evident relationship to any particular therapy. 5- No evidence was obtained that clinical improvement may be related to age, sex or other background factors, except prior sulfone therapy and stage of the disease. At all institutions, patients who had received little or no sulfone therapy before entering the study showed a higher clinical improvement rate than those who had been treated for a year or more. Also at all institutions the L2 and L3 patients taken together showed higher proportions of improvemment than those classed as L1. The patients in whom the disease was more advanced, however, were likewise those who on the average had received less sulfones before entering the study. Unfortunately the numbers of cases were too small to yield improvement rates for patients in various stages of the disease classified as to amount of prior sulfone therapy...
