^ Volume 68,

INTERNATIONAL JOURNAL OF LEPROSY

Number 3
Printed in the U.S.A.
(ISSN 0148-
916X)

Efficacy of Single-Dose ROM Therapy Plus Low-Dose

Convit Vaccine as an Adjuvant for Treatment of
Paucibacillary Leprosy Patients with a Single Skin
Lesioni
Vivek Majumder, Bibhuti Saha, Sunil Kumar Hajra,
Surajit Kumar Biswas, and Kunal Saha2
Received for publication on 24 January
2000. Ac-cepted for publication in revised
form on 12 July 2000.
We have just begun a new 2 V. Majumder, M.B.B.S., Medical
millennium, but our hope to Officer; B. Saha, M.D., D.T.M.&H.,
achieve the tall objective of a Assistant Professor; S. K. Hajra,
M.B.B.S., D.C.P., Ph.D., Reader (Retired);
world without leprosy in the near S. K. Biswas, M.D., Lecturer, Department
future of Leprology, School of Tropical
(8) seems to be remote. It is Medicine, Calcutta, India. K. Saha,
now being real-ized that a poor M.Sc., M.B.B.S., Ph.D. (U.S.A.), Professor
endemic country like India, with of Im-munology (Retired), Delhi
its present socioeconomic University, Delhi, India.
disparity, lacking determination Reprint requests to Kunal Saha,
or political will, is far from Ph.D., 45-A Sova Bazar Street,
eradicating leprosy with the Calcutta 700 005, India.
current World Health
Organization-recommended
multidrug therapy (WHO/MDT)
[Saha, K. Why India will not be
able to eradicate Hansen's
disease by 2000. The National
Leprosy Control Program;
achievements, faults and failure.
Parts I and II. The Star 2 (1997)
11-15; 3 (1997) 12-15]. In 1997
the Health Ministry of India
reported 400,000 new leprosy
cases [News and Notes. Lepr.
Rev. 69 (1998) 316]. Perhaps
there are more hidden cases,
more so in the unap-proachable
areas [Ganapati, R., et al. Re-lapse
in multibacillary leprosy after ri-
fampicin and ofioxacin treatment
(Abstract) 20th Biennial
Conference of the Indian As-
sociation of Leprologists, Bhopal,
1991]. It has been claimed that
50% or more of these cases are
being detected at a stage when
the only visible sign of the
disease is a single
 more severe form of illness and
even develop nerve damage (3).
Keeping in mind that leprosy
patients with SSL might harbor
skin lesion (SSL) (16). A recent only one million Mycobacterium
case-detec-tion drive employing a leprae or less, a multicen-tric trial
modified Leprosy Elimination of treatment of PB leprosy
Campaign (MLEC) in India patients with SSL with a single
confirmed 454,290 new leprosy dose of rifampin (600 mg),
cases while examining 645 ofloxacin (400 mg) and minocy-
million people. Of these 454,290 cline (100 mg) (ROM) was
cases, 53,120 (11.69%) of the pa- undertaken by the WHO which
tients had SSL (Report of showed encouraging re-sults (13).
modified leprosy elimination The rationale for this treatment
campaign. NLO Bull. 27 (1999) was: a) it was operationally
97-103]. In an earlier survey simple because of the economy of
during 1990-1995 in Gudiyatham manpower and other re-sources
Taluk, South In-dia, 794 new and b) the few bacilli within
cases of leprosy among chil-dren monolesions would be killed by a
ranging in age from 1 to 14 years single dose of the three
were detected. Of them, 83% had bacteriocidal drugs and
SSL (12). eliminated by the immune system
It is known that lesions in of the body (4). However, leprosy
60% to 70% of paucibacillary is not an infec-tious disease like
(PB) patients regress sponta- uncomplicated gonococ-cal
neously without any treatment gonorrhoea which, although an
(6). How-ever, a good number of intracel-lular bacterial disease,
cases may eventu-ally develop a can be successfully treated by a
single megadose of penicillin.

28
3
284^International Journal of Leprosy^ 2000
TABLE 1. Clinicai features of single skin lesions in paucibacillary leprosy patients and
their histological classification.
Morphology of Patients Clinicai Histological
single skin lesions' classificatio classification and
Hypopigmented or IO n no.
erythematous macule Indetermin Indeterminat 10
with ill-defined 4 ate e
margin TT TT 3
Hypopigmented or
erythematous macule
with well-detined 6 BT 1
margin TT TT 5
Hypopigmented or
erythematous macule BT 1
with raised margin 4
Erythematous TT TI' 2
uniformly BT 2
raised lesion with
well- BT BT 44
defined margin 44 BT BT 12
Hypopigmented or
erythematous macule
with broken margin 12 BT BT 8
Erythematous raised
lesion with broken
margin and spreading
to form satellite 8 BT BT 4
Ring lesion with
raised margin 4
Hypopigmented or
erythematous annular
lesion with papules
at margin
'The clinical features were classified
into eight types.
bacillated Mitsuda-re-sponsive
lepromatous leprosy patients
Moreover the study group did not with MDT for 2 years pus six
take into account the fact that T injections of low-dose Convit
cells play a pivotal role for ki I ling vaccine, which showed en-
and elimination of M. leprae couraging results (7). The
(9). Further, acid-fast bacilli (AFB) present study has been
(persis-ters) might persist undertaken to treat lepromin-
intracellularly even after clinicai respon-sive PB leprosy patients
cure with MDT although the pa- with SSL employ-ing a single
tients could mount a Type IV dose of ROM plus two injec-tions
hypersensitiv-ity granulomatous of low-dose Convit vaccine. The
reaction against M. lep-rae. They re-
may multiply at any moment
causing relapse, the mechanism
of which is yet not fully
understood ('). Thus, although
SSL is morphologically a
localized patch, it is a
generalized disease.
Keeping in mind the relation of
impair-ment of specific cell-
mediated immunity against M.
leprae with the development of
leprosy, Majumder and his
associates ear-lier treated highly
sults of the chemo-immunotherapy
have been compared with the
results of treatment of similar
patients with a single dose of ROM
therapy only. The rationale for
adding low-dose Convit vaccine to
ROM therapy was to confer on the
macrophages the ca-pacity to
quickly clear intracellular M. lep-rae
after they were killed by ROM
therapy.
MATERIALS AND
METHODS
Ninety, fresh, untreated leprosy
patients (18 males and 72
females) were selected for the
trial from the Out-Patients'
Department of the School of
Tropical Medicine, Cal-cutta,
India. Their age range was from
15 to 60 years. Children below
the age of 15 years and pregnant
and lactating women were
excluded from the study. The
study extended from January
1998 to November 1999. The
diagnosis of leprosy was based on
thorough clinical examinations,
bacteri-ological (slit-skin smear
test) and histologi-cal findings as
well as lepromin testing. All
patients were Mitsuda reactive
and smear negative. Based on the
clinical features, SSL patients
were classified into eight types
68, 3^Majumder, et al.: Single-Dose ROM Plus Vaccine^285
TABLE 2. Distribution of single lesion Location of SSL
on the body.4 The majority of monolesions
Área of lesion No. were found on the uncovered parts
patients of the body, being de-tected by the
^ (N = patients themselves (Table 2).
Elbowh 90)
21
Arm
^
8 Grouping of patients
Hand (dorsum)
^
Ninety patients were divided
and fingerh 9 into two groups: a) Test group
Kneeh
^
13
Forearm`
^
7 included 60 patients and b)
^
Foot and toes 6 control group included 30
Leg'
^
^ 5 patients (Table 3). The grouping
Thig ^ 2 was done after matching the
h
Cheek ^ 5 types of clinical features and
` histological types of SSL as far
Forehe ^
6
as possible.
ad`
Back of 4
trunk
^
ROM therapy
Front of trunk 2
^ 2 Rifampin (600 mg), ofloxacin
Neck
(400 mg) and minocycline (100
BT lesions were seen everywhere.
These lesions often started as a small mg) were given once to ali
hypopigmented patch which slowly patients.
grew larger and margins spread at
places to form satellites.
'Lesions on elbow, knee and hand Vaccine
were often ac-companied with a few Low-dose Convit vaccine (')
scars due to trauma. contained 1.6 x 107 heat-killed
Indeterminate leprosy lesions were
often found on the face, forearm and M. leprae (A) in 0.1 ml saline and
leg. 1.5 x 107 BCG (Japan) in 0.1 ml
saline.
(Table 1). Patients with palpable Treatment administered
nerves were excluded from the At the start of treatment,
study. SSL patients were tested patients in both groups were
for thennal, touch. and pain sen- each given a single dose of ROM;
sations which were impaired in in addition, the test group was
ai! patients. Histological staging ad-ministered two injections of
of SSL cases was based upon the low-dose Con-vit vaccine, one
criteria of Ridley and Jopling. initially and another after 3
There were 10 indeterminate, 9 months. Ali patients were
TT and 71 BT leprosy patients. followed up clin-ically every 2
Lepromin test-ing was performed weeks from the beginning of
employing standard WHO treatment for 6 months and
armadillo-derived lepromin. Late thereafter every month for
lepromin responsiveness was another 6 months. At the end of
recorded and graded as the first 6 months bacteriological,
described by Jopling and histolog-ical and immunological
McDougall (5). Six patients (lepromin test) as-sessments
showed 1+, 20 showed 2+ and were repeated.
64 showed 3+ positivity.

TABLE 3. Grouping of patients.a

Group No. Types of morphology of single lesion"
and histology
^ Type 3 Type 4 Type 5 Type 6 Type 7 Type
Type 1^Type 8
2
Test 60 2 4 2 27 9 6 3
Indeterminate TT 2 TT BT BT BT I3T
TT
Control 30 BT BT 2 2 15 3 2 1
1
3^2 2
Indeterminate^ TT 1 TT 1 BT BT BT BT
TT
BT 1 BT 1
Test group was given single-dose ROM therapy and two injections of low-
dose Convit vaccine; the control group was given only single-dose ROM therapy.
Eight types of morphology of single lesions have been described in Table 1.
Number of patients in each type of single skin lesion.
'Number of patients with different histological classifications.
286^ International Journal of Leprosy^ 2000

TABLE 4. Comparison of clinicai and histological outcomes of the treatment of paucibacil-laty

leprosy patients with single skin lesion employing ROM plus vaccine with that of similar pa-tients
with ROM alone.
^
Clinicai outcome Histolog cal
outcome
Group^No.
Resolution^Regression^Active^No^Granuloma or
healing^or quiescent (Treatment
failure)^granuloma^present
Test 60 20' 29 18.3% 42 18
(ROM + 30 33.3% 48.3% 70% 30%
vaccine)
Control 4 19 7' 16 14
(ROM) 13.3% 63.3% 23.3% 53.3% 46.6%
'In one patient the SSL healed but on the eighth month a new lesion appeared
on bis back.
In one BT patient the size of the lesion increased with thickening of the posterior
branch of the antibrachial
nerve.
SSL in five patients became prominent and started to increase in size; of these
five patients one developed thickening of the superficial branch of the radial nerve
and another developed thickening of the superficial branch of the ulnar nerve. Two
patients developed a new lesion on another part of their bodies.
popigmentation or erythema
became faint, no visible margin);
RESULTS c) active or treatment failure
(faint hypopigmentation or
Out of 90 patients with SSL, erythema with visible margin and
71(82%), 9 no decrease in size and
(6.6%) and 10(11.4%) patients infiltration) (Table 4). Resolution
had BT, TT and indeterminate and regression were taken as
leprosy, respectively. The size of clinicai benefits. Scarring was
the lesions varied from 1/2 to 2 due to collagen damage fol-
inches (approximately 1.3 to 5.1 lowing immunological insult and
cm) in diameter. There were 48 derma! re-action (15).
BT, 5 TT and 7 indetermi-nate Histological outcome. The
leprosy patients in the test group histological outcome was of two
and 23 BT, 4 TT and 3 types: a) no granuloma and b)
indeterminate leprosy patients in granuloma persisting (Table 4).
the control group. The clinical No granuloma or histological
features of SSL in our leprosy resolution was
patients showed macular, raised
or ring lesions, 64 of which were
active and tended to spread and
form satellites. This indicated
that our hospital-based study
included an advanced form of
SSL.
Criteria of assessment of
clinicai and histological
outcome following treatment
Clinicai outcome. The clinicai
outcome was of three types: a)
resolution and healing with or
without scar formation; b)
regres-sion or quiescent
(decrease in size, hy-
taken as a histological benefit.
It is a silent process which does
not leave apparent fi-brosis
(16). The presence of
granuloma shows a
preponderance of young macro-
phages with few vacules (15).
There was no adverse drug
reaction dur-ing the course of
treatment and follow-up period.
Complete return of sensations
was observed in 24 patients
showing clinicai resolution;
partial improvement of sensa-
tions was seen in 48 cases
showing guies-cent lesions and
no improvement of sensa-tions
was observed in 18 active or
treat-ment-failure cases (Table
4).
Comparison of clinicai,
histological and
immunological outcome in
patients receiving ROM plus
vaccine or ROM
Clinicai benefit. In the test
group, 49 out of the total of 60
patients (81.6%) (20 re-solved; 29
regressed) showed clinical bene-
fit; whereas in the control group
23 out of the total of 30 patients
(76.6%) (4 resolved; 9 regressed)
showed clinical benefit (Table 4).
The difference was statistically
signifi-cant (x2 = 6.62; 0.02> p
>0.01).
Resolved skin lesions in the
test and con-trol groups were
33.3% and 13.3%, respec-tively
(Table 4). The difference was
statisti-cally significant (x2 =
6.70; 0.01> p >0.001).
Scarring of lesion in the test
group was
28% and 13.3% in the control
group (Table
4). The difference was not
statistically sig-nificant (x2 =
1.99; 0.2> p >0.1).
There were 11 treatment
failures (18.3%) out of the 60
cases in the test group and 7
68, 3^Majumder, et al.: Single-Dose ROM Plus Vaccine^287
In a field study like that
(23.3%) out of 30 cases of the conducted by the WHO, an
control group (Table 4). Among accurate diagnosis of SSL, espe-
the 11 treatment-failure cases in cially in females belonging to
the test group one BT patient conservative Indian society, was
pre-sented features of upgrading difficult, if not impossi-ble. Often
reaction in the skin lesion and in a patient with SSL in the exposed
the posterior antibrachial part might have one or more
cutaneous nerve. Another patient lesions in un-exposed areas.
suffered a relapse after 8 months Since our study was hospital
(Table 4). based, we could very cautiously
Ali seven treatment-failure confirm our diagnosis.
cases in the control group Furthermore, a single skin le-sion
downgraded. Two cases showed is morphologically as well as
neuritis of the superficial radial histolog-ically heterogeneous.
cu-taneous and superficial branch SSL sizes in our pa-tients varied
of the ulnar nerve (Table 4). The from 1/2 to 2 inches and clinical
percentage of compli-cations, features were variable (Table 1).
such as clinicai worsening of the There were 64 active SSL, which
disease, neuritis and relapse, was tended to
signifi-cantly less in the test
group than in the con-trol group
(x2 = 10.38; 0.1> p >0.05).
Histological benefit. In the test
group the histological benefit
(disappearance of granuloma)
was observed in 42 (70%) out of
the 60 patients while in the
control group granuloma
disappeared in 16 (53.3%) of the
30 cases. The difference was not
statisti-cally significant (x2 =
3.46; 0.1 > p >0.05).
Immunological benefit. Before
starting treatment the degree of
lepromin positivity was 1+ in 6
patients, 2+ in 20 patients and
3+ in 64 patients.
In the test group one BT
patient with an initial lepromin
positivity of 1+ upgraded to 2+,
and two other BT patients with
an ini-
tial 2+ positivity upgraded to 3+
following the administration of
ROM plus vaccine. In the
remaining patients the lepromin
reactiv-ity showed no change. In
the control group there was no
change in the lepromin status
following ROM therapy.
DISCUSSION

Single skin lesion (SSL) and

problems of its diagnosis
 quiescent group developed any
spread. The histological spectrum complica-tion during the study
of SSL in our patients extended period. Unexpectedly, one BT
from indeterminate through TT to leprosy patient belonging to the
BT leprosy, and BT leprosy patients test group showed resolution of
were in the majority (82%). On the SSL, but devei-oped a new lesion
other hand, in the WHO field on his back in the eighth month,
survey more cases of indicating relapse (Table 4).
indeterminate and TT leprosy There was no relapse in the
might have been found and control group.
included in their study (13).In the
WHO study patients with nerve Why 18% to 20% of patients with
trunk involvement were excluded. SSL remained active after ROM plus
A recent histological study had vaccine or ROM therapy, respectively
shown that even in-determinate Inadequate clinicai response
leprosy patients might have as- in PB lep-rosy patients
sociated involvement of deep following standard MDT de-
dermal nerves (14).We took special
care to exclude all pa-tients with
any suspected thickening of any
nerve. It must be emphasized that
all of the factors mentioned above
might influence the clinical and
histological outcome of patients
with SSL after ROM therapy.
Clinico-histological outcome of ROM
plus vaccine and ROM therapies
The leprosy laboratory manual
of the WHO classifies activity of
disease into two, i.e., active and
quiescent or in regression (). The
criteria for the assessment of the
clinical outcome in our patients
after treat-ment were of three
types: resolved, re-gressed and
active (Table 4). The histologi-cal
activity is the basis of clinicai
course of the disease, i.e.,
progressive or resolved (15). We
had two classifications for
histological outcome: a) no
granuloma seen (clinically
resolved or healed) and b)
granuloma pre-sent (clinically
active or treatment failure and
some quiescent cases) (Table 4).
Eigh-teen BT cases (11 out of the
60 of the test group patients and
7 out of the 30 control group
patients) remained clinically and
his-tologically active after
treatment. Of them one in the
test group and two in the control
group developed neuritis,
perhaps indicat-ing reversal
reaction. However, none in the
288^International Journal of Leprosy^ 2000
most M. leprae but not persisters.
spite being Mitsuda responsive Neither can it improve the
has been re-ported (2). A few BT bacteria-clearing capac-ity of
leprosy patients might harbor macrophages nor can it boost the
AFB (persisters) in their nerves T-cell function. On the other
even though they became hand, an injec-tion of Convit
clinically inactive fol-lowing MDT vaccine containing M. leprae plus
therapy—an unfortunate fact BCG produces IFN-y, which helps
repeatedly overlooked by many hu-man macrophages to express
field work-ers. These persisters an I-hydrolase enzyme which
might evade the macrophage- converts the circulating in-active
mediated killing of M. leprae, 25-hydroxycholecalciferol
causing reversal reaction and (vitarnin D3) into active
relapse even in lepromin-reactive metabolite, I,25-cholecalcif-erol
patients years after re-lease from (calciferol). This metabolite
treatment. Persisters possess activates the antimycobacterial
highly resistant outer coats and mechanism of the macrophages,
surround themselves with leading to the killing of M. leprae
phenolic glycolipid, which (")• This notion supports our data
scavenges free radicais. They that there were fewer
also release a lipoarabinomannan complications (2.3%) in our test
which blocks the ability of group than in our control group
macrophages to respond to
interferon gamma (IFN-y).
Moreover, the infected
macrophages may lose their
efficiency as antigen-presenting
cells ("). These factors might be
the cause of so many patients re-
maining active after ROM plus
vaccine and ROM therapies
(Table 4). Thus, single-dose ROM
therapy, although operationally
simple and economically
advantageous, has its own
inherent shortcomings, namely,
per-sisters may not be killed and
may remain alive in macrophages
which might cause re-action and
relapse. •
How to eliminate persisters;
rationale of ROM plus vaccine
therapy
In a recent study, Chaudhuri, et
al. (2) pointed out that it was not
Mitsuda positiv-ity but the
bacteria-clearing capacity of the
macrophage that was the real
indicator of protective immunity
against M. leprae. This important
macrophage function depends on
the helper T-cell function and
genetically competent
macrophage (2'9). ROM can kill
 treatment of pau-cibacillary
(23.3%). In the test group one leprosy patients with SSL by
patient re-lapsed and another single-dose ROM therapy plus
developed neuritis; in the control two injec-tions of low-dose Convit
group two patients developed vaccine as com-pared to the
neuritis and in five patients the treatment of similar patients with
disease went on a downhill ROM therapy alone. An increase
course (Table 4). VVhy one in the dosage and the number of
patient, although receiving ROM vaccine injec-tions may yield
plus the vaccine, relapsed on the better results.
eighth month after SSL resolved
is not known. Perhaps the
vaccine cannot correct SUMMARY
genetically deter-mined The recent World Health
macrophages, which are Organization multicentric field
susceptible to M. leprae infection study on the treatment of
(9). paucibacillary (PB) leprosy
Comparison of WHO patients with
study with present study
The WHO study was field-
based, while the present study
was hospital-based. The WHO
study was on clinicai assessments
only, while our patients were
assessed both clinically and
histologically and immuno-
logically. Only 0.9% of the
patients receiv-ing ROM in the
WHO study showed treat-ment
failure, while 23.3% of the
patients re-ceiving ROM in our
present study remained clinically
active, indicating treatment fail-
ure. The occurrence of reaction
and neuritis was less in the WHO
study than in the pres-ent study;
thus, only 1.3% of the patients re-
ceiving ROM in the WHO study
developed reaction while 6.6%
patients receiving ROM in the
present study developed neuri-tis
and had mild reactions (Table 4).
The higher incidence of
treatment-failure cases and the
higher occurrence of reversal
reac-tions in the present study
could be attrib-uted to the
inclusion of a large number of
active BT leprosy patients. We do
not know the histological status
of the SSL in the pa-tients of the
WHO study.
We conclude that SSL is not a
single en-tity but is
morphologically and histopatho-
logically heterogeneous. There is
signifi-cant clinicai benefit in the
68, 3^Majumder, et al.: Single-Dose ROM Plus Vaccine^289
Only one patient developed
single skin lesion (SSL) and a neuritis, and in another patient the
single dose of rifampin-ofloxacin- disease relapsed on the eighth
minocycline (ROM) brought new month. On the other hand, the SSL
hope to those who are engaged in in the control patients resolved,
the eradication of leprosy from regressed and re-mained active in
India. Be-ing encouraged by the 13.3%, 63.3% and 23.3% of the
WHO report, we un-dertook the cases, respectively, while the
present hospital-based study and granu-loma disappeared in 53.3%
found that PB leprosy patients with of the cases. In the seven patients
SSL were morphologically and who remained active, the disease
histopatho-logically course was progressive, and two of
heterogeneous. The histological them developed neuritis. The
spectrum of SSL ranged from clinical out-come of the patients
indeterminate through tuberculoid treated with ROM plus low-dose
(TT) to borderline tu-berculoid (BT) Convit vaccine was statistically
leprosy, and most patients had superior to those treated with
active BT leprosy. Ninety new, un- single-dose ROM therapy alone.
treated PB leprosy patients with
SSL were included in the present
study for compara-tive assessment
of the efficacies of ROM and ROM
plus Convit vaccine therapies.
Children, pregnant women,
lactating moth-ers and patients
with any thickening of nerves were
excluded. Ali patients were
bacteriologically negative (skin-
smear test) but lepromin reactive.
The patients were di-vided into two
groups after proper matching for
morphological and histological
status of SSL: a) The test group
included 60 patients and the
control group included 30 patients.
The test group was given a single
dose of ROM initially and two
injections of low-dose Convit
vaccine, one initially and the other
at the end of 3 months. b) The
control group was given only a
single dose of ROM initially. Both
groups were followed clini-cally
every 2 weeks for 6 months and
retested for histological,
bacteriological and lepromin status
at the end of 6 months. Thereafter,
they were followed clinically every
month for another 6 months. In the
test group, the SSL resolved in
33.3%, re-gressed in 48.3%, and
remained active in 18.3% of the
patients, while the granuloma
disappeared in 70% of the cases.
 pacientes tratados con ROM más ia
RESUMEN vacuna de Convit de dosis baia fue
El reciente interés de la Organización estadísticamente superior a la evolu-ción
Mundial de la Salud por el estudio y de los tratados con ia terapia de una sola
tratamiento de los pacientes con lepra dosis de ROM.
paucibacilar (PB) y lesiones únicas en la RÉSUMÉ
piei (SSL) con una sola dosis de
rifampina-ofloxacina-minociclina (ROM) L'étude récente sur le terrain,
ha dado nuevas esperanzas a aquellos organisée par l'Or-ganisation mondiale
encargados de la erradicación de ia lepra de ia Santé, concernant le traite-ment de
en Ia India. Estimulados por el reporte la làpre paucibacillaire (PB) avec lésion
de la OMS real-izamos el presente cutanée unique (LCU) par une dose
trabajo intrahospitalario y encon-tramos unique de ri-fampicine associée à
que los pacientes PB con SSL fueron l'ofloxacine et al minocycline (ROM) a
mor-fológicamente e apporté de nouveaux espoirs chez ceux
histopatológicamente heterogéneos. El qui sont engagés dans le programme
expectro histológico de los pacientes con d'éradication de la lépre en Inde.
SSL os-ciló de la tuberculoide subpolar Encouragés par ce rapport de l'OMS,
(BT). La mayoria de los pacientes nous avons entrepris une étude clinique
tuvieron lepra BT activa. En el estudio se basée sur en
incluyeron 90 casos nuevos de lepra PB
con SSL para comparar la eficacia de las
terapias con ROM y ROM más ia vacuna
de Convit. Se excluyeron dei estudio los
Mitos, las mujeres embarazadas, las
madres lac-tantes y los pacientes con
cualquier engrosamiento de nervios.
Todos los pacientes fueron
bacteriológica-mente negativos pero
reactivos a la lepromina. Los pa-cientes
se dividieron en dos grupos con
características morfológicas e
histológicas similares. El grupo de
prueba incluyó 60 pacientes y el grupo
control 30 pa-cientes. El grupo de
prueba recibió una sola dosis de ROM ai
inicio y dos inyecciones de la vacuna de
Con-vit de dosis baia, una ai inicio y otra
ai final dei tercer mes. El grupo control
recibió sólo una dosis de ROM ai inicio.
Ambos grupos fueron evaluados
clinicamente cada dos semanas durante
6 meses y estudiados his-tológica-,
bacteriológica-, e inmunológicamente
(lep-romina) ai final del sexto mes.
Después, los pacientes fueron valorados
clinicamente cada mes durante otros seis
meses. En cl grupo de prueba las SSL se
re-solvieron en 33.3% de los pacientes,
regresaron en 48.3% y permanecieron
activos en 18.3% de ellos, mientras que
el granuloma desapareció en el 70% de
los casos. Solo un paciente desarrolló
neuritis y en otro paciente la enfermedad
reapareció en el octavo mes. Por otro
lado, las SSL en los pacientes dei grupo
con-trol se resolvieron, regresaron o
permanecieron activas en el 13.3%,
63.3% y 23.3% de los cases, respectiva-
mente, mientras que el granuloma
desapareció en el 53.8% de los casos. En
los siete pacientes que per-manecieron
activos el curso de la enfermedad de los
290^ International Joumal of Leprosy^ 2000
associé au vaccin Convit à faible dose fut
hôpital et avons trouvé que les patients statistique-ment plus importante que celle
hanséniens PB avec LCU étaient des patients traités seulement par
morphologiquement et histopatho- administration unique de ROM.
logiquement hétérogènes. Le spectre
hisologique des LCU s'étendait de lèpre
indéterminée à lèpre tubercu-Iffide (TT) en
passant par des lèpres borderline (BT),
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