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A 33 year old male Nigerian presented with widespread involvement of peripheral nerves, several of which were tender and painful. Nerve biopsies confirmed the presence of Mycobacterium leprae in both endoneurial and perineurial areas, mainly in foamy macrophages (Virchow cells), but there were also large accumulations of an amorphous, acid-fast and alcohol-fast material which was not obviously of bacterial origin. Appropriate stains indicated that this had many characteristics of lipofuscin. Although not previously known, it was at this stage discovered that the patient had received treatment with anti-leprosy drugs nearly three years before presentation in this country. One of these was clofazimine, an aniline aposafranine derivative known to produce a ceroid-like pigment in the tissues of patients treated with this drug or lepromatous leprosy.

The authors report 3 cases of temporary generalized lymphoadenopathy directly related to Lamprene (Clofazimine) consumption. It appears that this side effect has never been reported in the literature.

The acceptance of the WHO regimen in a group of 220 patients was approximately 84.5%. Only 11% abandoned the treatment, and the substitution of ethionamide or prothionamide for clofazimine due to excessive hyperpigmentation was necessary in only eight cases. The WHO regimens adopted provided a more frequent (monthly) relationship between the patients and their health service. It was necessary to: a) reorganize the technical-administrative infrastructure, with the intention of providing an improved service to the patients for treatment and control; and b) pay more attention to the problem of deformities and health education activities. As for the side effects of the drugs, 54 patients showed alterations in their liver function tests, which were usually mild and which resolved despite continuation of the treatment. Of the reactional episodes observed during MDT, it would not appear that the therapeutic regimens contributed to their occurrence or aggravation.

The data of thirty patients who completed two years of multi-drug therapy (MDT) is analysed in regard to clinical improvement, occurrence of reactions, bacteriological response and compliance to therapy.

Since its isolation less than 20 years ago, cyclosporine has become one of the major drugs in the armamentarium of transplant surgeons. A serendipitous event in 1979 suggested the drug might offer significant benefits in patients with psoriasis. Multiple trials have subsequently confirmed its usefulness in psoriasis at steadily decreasing dosages. Administered orally, the drug must be taken in a ritualistic fashion as it tends to sequestrate on the sides of the glass. A routine determination of blood levels becomes important in order to maintain the peak and trough concentrations within a relatively narrow window of safety. Depending on the particular assay used, significant differences in concentrations appear, making knowledge of the laboratory's normal values essential. Blood levels of cyclosporine vary with multiple drugs, including erythromycin, prednisone, and ketoconazole. The drug acts principally via its interference with the function of the helper T lymphocytes. Clofazimine (Lamprene) offers another weapon, especially for therapy of resistant pustulosis of the palms and soles.

Six cases of oral hyperpigmentation in HIV-infected patients are reported. While in two patients the lesions could be related to systemic clofazimine or ketoconazole therapy, in the other patients the cause remained unknown. Clinically, the pigmentations were characterized by a sudden onset and the appearance of well-defined, brown-black macules in the buccal mucosa, the gingiva, the hard palate, or the lateral borders of the tongue. In one patient, longitudinal hyperpigmented striae were observed on all fingernails and toenails. Histologically, hyperpigmentations associated with systemic medication revealed accumulation of melanin in phagocytes and extracellularly within the connective tissue. In those lesions with unknown cause, melanin was restricted to keratinocytes of the basal cell layer or to extracellular foci in the lamina propria. The clinical and histologic findings, as well as differential diagnosis, are discussed.

Two cases of lepromatous leprosy with erythema nodosum leprosum who were on high doses of clofazimine, showed discoloration of nail plate, subungual hyperkeratosis and onycholysis. These nail changes gradually disappeared when the dose of clofazimine was reduced.

Seven patients with pyoderma gangrenosum have been treated with clofazimine. In contrast to the beneficial effect described in other articles only one healed. (Received March 27, 1983.)

Eight out of 30 cases of Borderline Lepromatous and Lepromatous Leprosy suffering with chronic recurrent lepra reactions failed to respond to clofazimine therapy. Three of the eight were steroid dependent. All the eight patients are doing well after weaning off the clofazimine. Lymphadenitis in post clofazimine reactional status was presenting feature in present retrospective study.

During treatment of multibacillary leprosy with the combination rifampin (RMP) 600 mg, ethionamide (ETH) 500 mg, and either dapsone (DDS) or clofazimine (CLO) 100 mg, hepatotoxicity was observed in 4.5% of 596 patients. Hepatitis appeared after 5-186 days, with a mean of 93 days and a median of 76 days. Mortality was 26%. ETH and DDS or CLO were administered daily in all regimens in which hepatitis occurred. RMP was given either daily or daily during the first two weeks or eight weeks, followed by a once-weekly dose. It is concluded that the combination RMP + ETH is the toxic component. In some patient groups there was a high correlation of toxicity with age. A regimen in which RMP was administered only twice a week during three months was not accompanied by hepatotoxicity. Future studies should show if reduction of the daily dose of ETH or reduction of the duration of the administration of RMP + ETH might reduce the incidence of hepatotoxicity while conserving the efficacy.

A case of Clofazimine enteropathy is reported, diagnosed on the demonstration of red brown birefringent crystals in the small bowel mucosa and submucosa as well as in the mesenteric lymph nodes whereas the clinical and radiological signs appear to be non specific. After the withdrawal of the drug, a clear improvement of the symptoms was achieved only under a gluten free diet. The possibility of such accidents, sometimes lethal, suggests the restriction of clofazimine to leprosy.

Thirty-three active multibacillary patients from nine counties of Weifang Prefecture, Shandong Province, and 47 active cases from Menla County, Yunnan Province, People's Republic of China, were treated with 24 and 27 months of multidrug therapy (MDT), respectively, in 1983. Clinical assessments, smears, and histopathologic examinations were carried out independently by study teams from the Institutes of Dermatology of these two provinces. Reexaminations at 12-14 months and at termination of therapy showed marked improvement, and there was continued improvement at 12-18 and 33 months on follow up. Conversion of the bacterial index to negativity was 0/33, 5/47 for the patients from Shandong and Yunnan provinces, respectively, at the end of MDT and 2/33 at 12 months' and 17/47 at 18 months' follow up, which increased to 21/33 and 26/44 at 33 months' follow up. Regression of specific infiltration was about 21%-100% after 24-27 months of MDT; further regression to 95%-100% occurred at 33 months' follow up.