It is now widely recognised that the serious problems in leprosy control programmes
have been encountered by the widespread emergence of DDS-resistant strains of
Mycobacterium leprae among lepromatous patients who have been treated with DDS
monotherapy, and among those infected from DDS-resistant cases and it is generally
agreed that the only potentially successful method of preventing the present situation
from becoming more serious is to initiate the treatment of all new and relapsed
lepromatous patients with combination of at least two or more anti-leprosy drugs. The
followings are the results of our clinical study on combined therapy in lepromatous
leprosy.
1. Combined therapy with regimen I-A (DDS 100mg daily ×－＋ Rifampicin 1,200mg
single dose) was given to 10 previously untreated DDS-sensitive new lepromatous
patients and the following results were obtained with 48 months' observation.
(1) Skill lesions were shown definite improvement in all cases.
(2) Neurological findings and disability were shown slight improvement.
(3) In skin smears, MI declining was rather slow than in I-D trial group and it took
about 12 months to become MI 0%, and BI was decreased only 0.7＋ during 48 months'
treatment.
(4) 79% of trial cases had occurred ENL reaction at about six months after initiation
of treatment.
(5) There were no severe drug allergy and toxicity and well-tolerated in all cases.
2. Combined therapy with I-D (DDS 100mg daily ×－＋ Rifampicin 1,200mg single
dose Prothionanlide 375 mg daily × 8 weeks) was given to 15 previously untreated
DDS-sensitive new lepromatous patients and the following results were obtained with 36
months' observation.
(1) Skin lesions were shown definite improvement in all like in I-A trial group.
(2) Neurological findings and disability were shown moderate improvement which is
better than in I-A trial group.
(3) In skin smears, MI declining was quicker than in I-A trial group and it tools
about 9 months to become MI 0%, tut BI Ivas not decreased during 20 months'
treatment.
(4) 60% of this trial group had occurred ENL reaction at about 12 months after
initiation of treatment.
(5) Many patients had high units of SGPT after taking prothionamide, but it became
normal after stop prothionamide.
3. Combined therapy with Ⅱ-A (Clofafimine 50mg daily ×－＋ Rifampicin 600mg
daily × 4 weeks) was given to 9 proven DDS-resistant relapsed lepromatous patients
and the following results were obtained with 18 months' observation.
(1) Skin lesions were shown definite improvement in all cases.
(2) Neurological findings and disability were shown gradual deterioration in all.
(3) In skin smears, MI declining was relatively rapid and it took about 9 months to
become MI 0%, and BI was decreased 0.8＋after 18 months' treatment.
(4) 44% of this trial cases had occurred ENL reaction at about 9 months after
initiation of treatment.
(5) As side-effects of regimen, skin pigmentation and xeroderma had appeared in all
cases. This is mainly due to clofazimine intake.
4. Combined therapy with Ⅱ∼D (Rifampicin 600mg daily×8 weeks, afterwards 600mg
daily × 2 consecutive days monthly ×－＋ prothionamide 375mg daily × 8 weeks and
then Thiacetazone 150mg daily ×－) was given to 6 proven DDS-resistant relapsed
lepromatous patients and the following results were obtained with 18 months'
observation.
(1) Skin lesions were shown definite improvement in all cases.
(2) Neurological findings and disability were shown gradual deterioration like in Ⅱ-A
group.
(3) In skin smears, fill declining was rapid like Ⅱ-A group and it took average 9
months to become MI 0%, and BI was rather increased unlikely in Ⅱ-A trial group.
(4) 50% of this trial group had occurred ENL reaction at six months after initiation of
treatment.
(5) Some cases had high unit of SGPT without clinical symptoms. This is probably
due to either prothionamide or thiacetazone.
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