The Technique of Evaluating Anti-Ieprosy Medications at the Forschungsinstitut Borstel

This is the first publication of the initial 5-year-period of the eradication programme since its introduction in the Maltese Islands in the second half of 1972. All patients were treated with a combined drug regimen, its chief components being rifampicin (RMP), prothionamide (PTH), isoniazid (INH) and diaminodiphenyl-sulfone (DDS). To simplify the therapeutic technique, PTH, INH and DDS were given as a fixed combination. Other medications, such as DDS-free regimens, were whenever possible also given as fixed combinations. Fixed combinations not only make treatment simpler, but also guarantee a more reliable acceptance of the medication and the adherence to the dosage proportions which play an important role with regard to the effectiveness. For an eradication programme the classification into the different leprosy types plays not a too important role. It was rather our goal to cure each single patient so as to eliminate him as a possible source of infection. Whether or not this goal has been reached was as far as possible related to the results of the bacteriological assessment. Of the originally recorded 210 patients 206 were included in the first part of the programme (groups I–III). By the end of 5 years, a total of 20 patients had left the programme (death or emigration) so that 186 patients remained registered per June, 1977. In 180 cases treatment has been discontinued; 6 patients are still under therapy. The relapse-free observation periods are more than 2 years in 160 patients, more than 3 years in 120 patients, and more than 4 years in 12 patients. 31 patients joined the programme when it was already under way, namely 11 patients in 1973, 9 patients in 1974, 6 patients in 1975, and 5 patients in 1976. These newly registered cases were grouped separately (group IV). 27 patients were found to be bacteriologically positive; 10 of them are meanwhile negative, 11 are still being treated. Under observation without therapy are 19. One patient died of nonspecific disease in 1976. In continuation of the programme we are aiming at (a) conclusive treatment of the rest of the patients who are still under therapy, (b) conclusive treatment of the patients according to group IV, (c) regular observation of all cases for the absence of relapses, and (d) search for new cases and inclusion of such eventually newly identified cases in the programme. Further scientific evaluation of the material, chiefly in the bacteriological, clinical, pathological and genetic field, will require lengthy investigations which we are working at. A larger quantity of well-examined and well-classified material has accumulated since the start of the programme. The material is at the disposal also of all colleagues outside Borstel Institute. Up to the present, we have collected approximately 30,000 histological slides, representing all stages of leprosy, i.e. from the period before, during and after treatment (about 5000 biopsies). The article explains the prerequisites for an eradication programme which in principle can serve as a model for si...

Section: Selection Of the Medicamentsmentioning

confidence: 96%

“…be the most effective ones [13,22,23,26,32], In this sense, therefore, the obtained treatment results can also serve as indicator of the efficacy of these therapy forms and their excellent compatibility even in cases of continuous administration over several years.…”

Section: General Aspectsmentioning

confidence: 99%

Leprosy Eradication Project of Malta

Freerksen¹,

Rosenfeld²

1977

“…Hence it was not our intention to 'evaluate' once again the therapeutic action of antibacterial substances or medica tions by means of 'controlled studies'. Our own experience and more re cent publications [16,20,34,48,51,57,58] rather support our sus picion that this method is too circumstantial, too costly, time-consuming and antiquated to meet the requirements of modern chemotherapeutic re search, a procedure which we cannot expect the patient to submit to and which should be replaced by more efficient methods [17,20].…”

Section: Medicationmentioning

confidence: 96%

“…The antimicrobial action which becomes therapeutically effective in the human organism is determined by the chemosensitivity of the bacte ria, the antimicrobial activity and combinability [17,20] of the selected antimicrobials, the bioavailability in the patient's organism, and the total pharmacokinetic action which the medicaments are exposed to in the or- ganism of the patient. As in other infectious diseases, we have adopted the method of serum activity determination [17,20,[42][43][44][45][46] (if necessary, also that of other body fluids) for the screening of the drugs and working out of the most optimal combination for the individual patient because, if correctly integrated into the overall system, it is the safest indicator of the attainable therapeutic activity ( fig.…”

Section: Own Proceduresmentioning

confidence: 99%

“…As in other infectious diseases, we have adopted the method of serum activity determination [17,20,[42][43][44][45][46] (if necessary, also that of other body fluids) for the screening of the drugs and working out of the most optimal combination for the individual patient because, if correctly integrated into the overall system, it is the safest indicator of the attainable therapeutic activity ( fig. 1).…”

Section: Own Proceduresmentioning

confidence: 99%

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Treatment of Chronic Salmonella Carriers

Freerksen¹,

Rosenfeld²,

Freerksen³

et al. 1977

The present stage of our studies suggests that, provided a highly effective combined therapy is, and can be, carried out correctly, all excreters can be cured of their chronic carrier state by chemotherapy within 8–12 weeks. Although we cannot recommend a universal therapeutic regimen for all patients, a highly effective ‘basic therapy’ (RMP+TSP) is available for the majority of the cases, needing occasional modification, depending on the specific requirements of the individual patient as shown by the result of the serum activity determination. This method saves the patient from toxic inconveniences caused by inadequate treatment, it shortens the treatment time and makes cholecystectomy superfluous – unless it is considered necessary out of a different indication in which case it should certainly be done. We cannot share the often expressed view that Salmonella enteritidis excreters cannot be cured, a view which is found even in the most recent manuals. The same applies to the view that therapy is not necessary because it would delay cure. It is indispensable to establish a close cooperation between the public health authorities and the private physician, and we therefore wish to sincerely thank all colleagues and Public Health Officers for their collaboration.

Combined Therapy in Leprosy

Freerksen¹,

Rosenfeld²,

Bonnici³

et al. 1978

This report is based on data obtained from 64 lepromatous cases. Despite many years of DDS monotherapy, the homogenates from biopsies of these patients revealed 10⁴ or more bacteria. From the beginning of combination therapy with synergisticacting substances (rifampicin + isoprodian (INH + PTH + DDS) the logarithms of the number of bacteria in the homogenates decreased, both during treatment period and during treatment-free observation period (Figs. 3–8). During the whole time biopsies were taken almost monthly. A considerable regression of the bacterial mass or even «negativity» could be observed within a relatively short time. Once started, the process of reduction of bacteria continued also after termination of therapy. To be able to evaluate a medication, therapy-free observation periods (for a minimum of 5 years) are indispensable.