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PubMed1986

Superiority of the neonatally thymectomized Lewis rat (NTLR) to monitor a clinical trial in lepromatous leprosy of the two regimens of rifampin and dapsone.

The ability of the neonatally thymectomized Lewis rat (NTLR) and the congenitally athymic (nude) rat systems to detect low numbers of viable Mycobacterium leprae in tissues from lepromatous leprosy patients undergoing short-course chemotherapy was compared with that of the commonly employed mouse foot pad assay. Fifteen previously untreated lepromatous patients were randomly assigned to treatment regimens of either a single initial 1500 mg dose of rifampin plus daily doses of 100 mg of dapsone, or weekly doses of 900 mg of rifampin plus daily doses of 100 mg of dapsone. Four skin biopsies from each patient taken sequentially up to one month after initiation of therapy were used as the source of the M. leprae inocula. Only 2 of 57 skin biopsies (2%) proved positive for viable M. leprae following direct inoculation into mouse foot pads. However, 30 of 58 patient biopsies (52%) provided positive for viable M. leprae following direct passage into NTLR foot pads or in subsequent mouse subpassage. In contrast, the nude rat was observed to be a poor monitor of such trials. Although not statistically significant, the regimen consisting of a single dose of rifampin plus daily dapsone resulted in a lower percentage of biopsies found to contain viable M. leprae at each of the four sampling intervals.

Animals↗
PubMedDate not supplied

Effect of clofazimine and dapsone on rifampicin (Lositril) pharmacokinetics in multibacillary and paucibacillary leprosy cases.

A comparative pharmacokinetic study of Lositril (rifampicin) was carried out in six multibacillary and twelve paucibacillary leprosy cases. The type of leprosy had no significant effect on rifampicin pharmacokinetics. The effect of dapsone and clofazimine when given separately and in combination was studied on rifampicin pharmacokinetics in each group of six patients. Within group comparison revealed that clofazimine reduced rifampicin absorption significantly (P less than 0.01) and prolonged the time to reach the peak serum concentration (P less than 0.01). Since MCR and Ke were also reduced significantly in RC group, as compared with RDC group (P less than 0.02 and P less than 0.05 respectively), no significant alteration was seen in overall Auc and Cmax, although t0.05 was increased significantly (P less than 0.02) in RC Group. Dapsone alone did not produce any significant alteration in rifampicin pharmacokinetics parameters, while dapsone with clofazimine reduced rifampicin 1h serum levels (P less than 0.05) and Auc (P less than 0.05) significantly. Of the three groups, except RC group, both RDC and RD groups were homogeneous Ka, avd, Cmax and Auc/t0.5 ratio of RC group were significantly different from those in RD group. While Ka and avd were significantly less (P less than 0.05 and less than 0.001 respectively) and Cmax and Auc/t0.5 ratio were significantly more (P less than 0.01) in RC group. Since clofazimine reduced rifampicin absorption, the difference in Ka and tp became more significant in the post-regimen phase (P less than 0.01).

Adolescent↗
PubMed1984

Dapsone and human polymorphonuclear leucocyte chemotaxis in dermatitis herpetiformis.

Polymorphonuclear leucocyte chemotaxis was investigated in 6 patients with active dermatitis herpetiformis in the untreated state and when under control with Dapsone. Control studies were undertaken in 7 healthy volunteers. No significant difference in chemotaxis was demonstrated between the active, treated and control groups. Furthermore, when Dapsone in physiological concentrations was added separately in all three groups there was no additional effect on chemotaxis. These results clearly show that polymorphonuclear leucocytes from active untreated dermatitis herpetiformis have normal chemotactic activity compared with those from the same patients in the treated state and controls. Additional Dapsone did not alter these findings.

Adult↗
PubMed1984

[Chronic atrophic polychondritis. Critical analysis of the therapeutic efficacy of dapsone. 2 cases].

Dapsone has been used since 1976 in the treatment of relapsing polychondritis. A critical analysis of its therapeutic effectiveness based on 2 personal cases and 14 cases reported in the literature, all treated with dapsone alone, showed that treatment had to be discontinued in 4 on account of side effects (haemolytic anaemia, erythema multiforme, somnolence, headache, nausea); 1 patient showed no improvement and 5 relapsed; 6 responded favourably and without relapse during a 3 months' to 4 years' follow-up. Considering the unpredictable course of relapsing polychondritis and the fact that some of its clinical manifestations, notably auricular chondritis, may spontaneously resolve, the response of the disease to dapsone is difficult to establish and requires to be confirmed by a controlled clinical trial.

Aged↗
PubMedDate not supplied

Once monthly rifampicin (1200 mg) plus daily dapsone (100 mg) and clofazimine (100 mg) in the initial treatment of lepromatous leprosy.

The therapeutic effect of rifampicin 1200 mg once monthly and 100 mg clofazimine daily for the first six months of treatment was evaluated in 30 patients of bacteriologically positive lepromatous leprosy patients. Moderate to marked clinical improvement was seen in all the patients and a very rapid bacteriological regression as indicated by the decrease in bacteriological and morphological indices of the skin within one week. Seven patients become MI negative at one month and three months and 13 at the end of nine months. Two patients became MI and BI negative at the end of six months and six at the end of nine months. These observations clearly establish the high therapeutic efficacy and practicability of the three drug regimen. Once monthly rifampicin is highly effective and well tolerated, and has many advantages like low cost, better patient compliance and reliability of the treatment. Addition of clofazimine to rifampicin and dapsone prevents the emergence of E.N.L. reactions which were seen during treatment with once monthly rifampicin and daily dapsone. This regimen is thus ideal for initial, intensive treatment of lepromatous leprosy and may help in preventing the spread of the disease and development of dapsone resistance.

Adult↗
PubMed1984

Vitamin E and dapsone-induced hemolysis.

Sixteen patients, each receiving 100 mg of dapsone per day, were studied for evidence of hemolysis. Vitamin E (dl-alpha tocopherol acetate), 800 mg/day, was then administered for up to three months, and dapsone therapy was continued at the same dose. Hemolysis factors were reexamined immediately prior to cessation of vitamin E therapy. No substantial change was demonstrable for levels of hemoglobin, reticulocyte count, and haptoglobin at the end of vitamin E therapy, despite a significant rise in serum vitamin E levels. Erythrocyte survival measured in four patients before and at the end of vitamin E therapy also showed no substantial change. Erythrocyte Heinz body count, however, fell in nine of 15 patients studied, and none showed an increase in this measurement while receiving vitamin E. We conclude that in patients receiving dapsone at 100 mg/day, vitamin E therapy at 800 mg/day does not substantially ameliorate the hemolytic effect of this drug.

Adult↗
PubMed1984

Rheumatoid arthritis: the effects of treatment with dapsone on hemoglobin.

Hemoglobin concentration (Hb) was measured at 6 week intervals for up to a year in 84 patients with rheumatoid arthritis treated with dapsone. During the first 6 weeks, mean Hb decreased from 12.0 to 11.0 g/dl (p less than 0.001). Falls in Hb occurred in 81% of patients but exceeded 2 g/dl in only 10%. After more than 6 weeks of treatment mean Hb increased, though a few individuals became anemic during this period. Anemia led to discontinuation of dapsone in 5 (6%) patients. Men and patients receiving corticosteroids had higher pretreatment Hb values; after falls in mean Hb at 6 weeks, recovery was more rapid in these 2 subgroups. Changes in Hb produced by 100 mg and 150 mg dapsone daily were similar.

Adult↗
PubMed1983

Operational study to monitor the regularity of dapsone intake by leprosy out-patients.

319 leprosy patients, attending our Mobile Treatment Unit, were monitored for their regularity of dapsone intake by (1) Physical verification of DDS tablets; and (2) Spot test, in the field. The consistency in regularity of DDS intake by these patients, was monitored at two more occasions at the interval of about two months. Only 36% patients were regular in attending the clinics. On an average one patient would miss about one third of the clinics in a year. The number of patients taking regular treatment increased from 62% (I round) to 79% (in III round). Approximately 10% patients collected DDS tablets from clinic but never ingested them; and 3% to 7% patients removed Dapsone tablets regularly but ingested none of it, as indicated by negative spot tests. The spot test was found to be positive in about 86% patients, and had a very good correlation (98%) with DDS/Cr. ratio. Both the methods of monitoring were found to be operationally very feasible and reliable under field conditions, hence can be used together to monitor the dapsone intake by leprosy patients, in National Leprosy Control Programme.

Adolescent↗
PubMed1983

A comparison of screening tests for dapsone in urine.

The comparative merits and limitations of three qualitative tests for Dapsone screening in urine viz. the 'Spot-Test' using modified Ehrlich's reagent, 'Tile-Test' employing Bratton-Marshall reagents, and the 'Elisa-Test' were assessed with regard to their sensitivity and operational feasibility. Investigations were carried out on a total of 716 urine specimens of which 268 specimens were collected during surprise visits paid to the patients homes. The others were specimens collected from patients at different time intervals following the administration of 25, 50 and 100 mg of dapsone. The findings were evaluated against their corresponding ratios of the urinary concentrations of Dapsone and its diazotisable metabolites to creatinine. A good correlation was found between the three qualitative tests in general and also in relation to the DDS/C ratios. Operational feasibility under field conditions for spot and tile tests are discussed.

Creatinine↗
PubMed1983

Tile test to monitor the self administration of dapsone by leprosy patients.

The regularity of attendance of leprosy patients at clinic does not correlate well with regularity in drug consumption. This feature has been reported by several workers from different parts of the world. For monitoring self administration periodical check up of urine for drug content is necessary. The dapsone tile test described by Irudayaraj(1981) is performed in porcalein tile with drop of leprosy patient's urine. An appearance of pink colour and its intensity shows the drug content in urine. Instead of porcalein tile a cheap and readily available plastic blistered capsule card was used which is convenient to carry in the field and is disposable. 184 urine samples were collected in field and tested at field clinic by paramedical workers employing dapsone tile test. The same urine samples were later processed for dapsone/creatinine ratio at the laboratory by photoelectric colorimetric investigations. It was found that the results of dapsone tile test in the field correlated well upto 96% with dapsone/creatinine ratio estimations in the laboratory. The tile test in plastic card is simple to perform under field condition and it is reliable too.

Dapsone↗
PubMed1983

Hepatitis in leprosy patients treated by a daily combination of dapsone, rifampin, and a thioamide.

A 13% incidence of hepatitis was observed among 54 cases of multibacillary leprosy treated daily with the three-drug combination of dapsone, rifampin, and a thioamide (ethionamide or prothionamide). No hepatitis was observed among 109 cases of paucibacillary leprosy treated daily with the two-drug combination of dapsone and rifampin. Symptoms were jaundice in five cases and nausea plus vomiting associated with a significant increase of transaminase levels in two cases. In five cases, the symptoms appeared during the first two months of therapy and in two cases, later. Discontinuing treatment with rifampin and the thioamide but not dapsone resulted in recovery. When rifampin was resumed without the thioamide, the hepatitis did not recur. Viral etiology could be eliminated in six cases. Neither sex, age, weight nor the fact that the patient was a new case or a relapse case appeared to be a contributing factor. Hepatotoxicity caused by administration of a thioamide might have been potentiated by the concurrent administration of rifampin.

Adolescent↗
PubMed1984

[Role of dapsone in the treatment of Horton's disease and polymyalgia rheumatica].

The authors report 8 cases of Horton's disease and/or polymyalgia rheumatica treated with prednisone with an initially favourable result. However, the disease progressed despite relatively high dose steroid therapy, complications of which contraindicated increasing the dosage and even necessitated rapid withdrawal of steroids. The association of dapsone 100 mg/day orally had a rapid favourable effect in all 8 cases. However this treatment was well tolerated in only 3 patients and could only be continued in 4 out of the 8 cases. Manifestations of intolerance (methemoglobinaemia) rapidly regressed after withdrawal of dapsone but this was followed by another exacerbation of the disease, resulting in a therapeutic impasse. Despite the incidence of these iatrogenic complications, dapsone would appear to provide a therapeutic option in patients with Horton's disease and/or polymyalgia rheumatica resistant to high dose steroid therapy or in whom complications of steroid therapy impose a reduction in dosage or complete withdrawal of the drug.

Aged↗
PubMed1980

Fluorimetric screening of dapsone in urine for drug trials.

The DDS/Crestinine ratios obtained by the colorimetric and fluorimetric methods for dapsone were compared in healthy controls, out-patients not claiming to have DDS treatment and inpatients receiving DDS. The ratios by fluorimetric method were considerably lower in the untreated cases compared to the colorimetric method. Fluorimetric assay for dapsone in urine can be more advantageously and reliably used for the preliminary screening of dapsone in urine for drug trials.

Clinical Trials as Topic↗
PubMed1981

Activity of the combination of isoniazid, protionamide and dapsone against Mycobacterium leprae and some other mycobacteria.

No additive effect was found at the addition of isoniazid to either dapsone or protionamide against M. leprae and against highly dapsone-sensitive in vitro growing Mycobacterium sp. strains. It is concluded that the indication of the administration of isoniazid in leprosy is extremely limited and could only be envisaged as a companion drug in combined therapy of dapsone-resistant multibacillary leprosy in light-skinned people, when aminoglycosides cannot be administered.

Animals↗
PubMed1995

Dapsone-induced hemolytic anemia: role of glucose-6-phosphate dehydrogenase in the hemolytic response of rat erythrocytes to N-hydroxydapsone.

Individuals deficient in erythrocytic glucose-6-phosphate dehydrogenase (G6PD) show about a 2-fold increase in sensitivity toward dapsone-induced hemolytic anemia. Rat studies have shown that the hemolytic activity of dapsone resides in its N-hydroxy metabolites; exposure of rat red cells to N-hydroxy-dapsone in vitro followed by readministration to isologous rats results in premature splenic sequestration of the damaged cells. This study examines the ability of the steroid, epiandrosterone, to inhibit rat red cell G6PD and the effect of such inhibition on the susceptibility of rat red cells to N-hydroxydapsone hemolytic activity. Epiandrosterone was found to inhibit rat red cell G6PD uncompetitively and to suppress red cell hexose monophosphate shunt activity by more than 95%. Epiandrosterone suppression of rat red cell G6PD activity resulted in about a 2-fold increase in sensitivity of the rat cells to N-hydroxydapsone hemolytic activity, and a modest but significant increase in depletion of red cell glutathione. In contrast, suppression of rat red cell catalase activity by aminotriazole had no effect on the hemotoxicity of N-hydroxydapsone. Epiandrosterone appears to be a useful tool to explore the mechanism by which G6PD deficiency enhances susceptibility to hemolytic drugs.

Amitrole↗
PubMed1995

[Therapeutic use of dapsone in dermatitis herpetiformis (Duhring) and in certain inflammatory skin diseases].

After a historical review the authors give a summary about the possibility of clinical practice of Dapson dependly on 20 year literature. They emphasize the newest knowledge of the mechanism of action. The diseases in which the Dapson may be successful are expounded. The adverse effects are presented. In the centre--like the prototype of Dapsone-therapy--there is the dermatitis herpetiformis.

Dapsone↗
PubMed1994

Relapses after a single dose of rifampin in skin-smear negative multibacillary patients after dapsone monotherapy.

Between 1982 and 1985, a single 1500 mg dose of rifampin (RMP) was given to 136 multibacillary leprosy patients who had become clinically inactive and skin-smear negative after various durations of dapsone monotherapy, and then antileprosy chemotherapy was totally stopped. By the end of June 1992, 15 relapses were detected among these patients. The overall relapse rate was 11%; the relapse rate per 100 patient-years was 2.1%, which was the highest among those published to date; the cumulative risk of relapse at year 7 of follow up was 8.8%. All of these figures indicate that the relapse rate among this group was at least the same as in other studies where patients received dapsone monotherapy only. Therefore, the administration of a single large dose of RMP could neither prevent relapse nor reduce its rate among multibacillary patients who had already become clinically and skin-smear negative after dapsone monotherapy.

Adult↗
PubMed1994

Rate of relapse in multibacillary patients after cessation of long-course dapsone monotherapy supplemented by a final supervised single dose of 1500 mg of rifampin.

When multidrug therapy was implemented in Senegal, 406 multibacillary (MB) patients who had been treated for more than 10 years by dapsone alone, and who had become clinically inactive and skin-smear negative, were released from treatment. Of these 406 patients, 298 were given a supervised single dose of 1500 mg of rifampin. Subsequently, 302 of them (229 who had been given rifampin and 73 who had not) were followed up by means of annual clinical and bacteriological examinations. Of the former 229 followed up for a mean period of 4.9 years, 34 patients relapsed (22 males and 12 females), giving a crude relapse rate of 15% and an overall risk of relapse of 3.1 per 100 patient-years. Of the latter 73 followed up for a mean period of 2.4 years, 5 relapsed (4 males and 1 female), giving a crude relapse rate of 6.8% and an overall risk of relapse of 2.9 per 100 patient-years. Such results, which are in agreement with those of a similar study conducted recently in Mali, indicate that the intake of a single dose of 1500 mg of rifampin by MB patients when they are released from long-course dapsone monotherapy does not result in a decrease of the relapse rate. Therefore, MB patients who have been treated with dapsone alone, even for long periods, should be put under multidrug therapy prior to their release from control.

Dapsone↗