[Multi-drug therapy trials for leprosy in Senegal: first observations relative to liver tolerance of multibacillary patients. Therapeutic consequences].Acta Leprol. 1986 Oct-Dec; 4(4):427-44.AL
The authors have studied tolerance of multibacillary patients to 4 MDT regimens. These 4 regimens consist of: One supervised part in which RMP-ETH combination in once-monthly administered; furthermore, in 2 of these regimens, is included one "starter phase" with daily doses of that combination for 2 months. One self-administered part during which CLO is associated either to DDS for new cases, or to ETH for relapses. Clinical Supervision: Out to 310 multibacillary patients, 7 cases of hepatitis with or without icterus, but no death due to the treatment. Interruptions of MDT have been temporary and have been observed in 0.9 to 5.6% of the patients according to the therapeutic regimen. Checking SGOT: The SGOT were abnormally high in 16.3% of the patients before treatment. These pre-existing liver damages do not favour the appearance of intolerance disorders. During MDT, abnormal increases in SGOT are observed in 27% of the patients but there is no exact correlation between the absorbed doses of ETH and the frequency in SGOT increases. The clinical or biological evidence of liver damages occur rather early (1st, 2nd month) in regimens with "starter phase", and later (4th-8th month) in those without "starter phase". But introduction of "Starter phase" does not increase the global frequency of such intolerance accidents. ETH combined with RMP, must be used under steady clinical and biological supervision. Recalling the results of a previous survey, the authors consider that a long duration of MDT is not necessary. For the multibacillary leprosy treatment, they propose a diphasic regimen, more easily applicable in the field than the WHO protocols. In this diphasic regimen, the only part which must be supervised is the initial "starter phase" of 2 month. It consists of daily administration of 3 antibacillary drug among which RMP and ETH. The second phase is a relay treatment using 2 drugs, CLO combined with DDS or ETH, self-administered until smear negativity.