INTERNAL IONA', JOURNAL OF LEPROSY^ Volume .50, Number 3

Printed in the U.S.A.

A Study of 922 Bacteriologically PositiveLeprosy Cases'

Kumudchandra K. Koticha, P. R. Raveendran Nair, and Parsharam S. Juwatkar 2

In an earlier study we reported (') bac-teriologic follow up of lepromatous caseswith respect to their age, sex, stage of dis-ease, reactional episodes and treatment sta-tus. In that study, the age and sex of thepatients had no bearing on the attainmentof bacteriologic negativity, but the stage ofthe disease was significantly related to thetime required to attain negativity. Earlylepromatous cases became negative soonerthan more advanced, nodular cases. Recur-rent reactions delayed the time required toreach negativity. A majority of the patientsthat had remained positive had taken dap-sone (DDS) for less than 36 months. A ma-jority of those patients who had taken DDSfor more than 48 months had become neg-ative.

In the present study in addition to lep-romatous cases, other bacteriologicallypositive cases, namely borderline (compa-rable to BB and BL in the Ridley-Joplingclassification) (2 ) and reactional tuberculoid(RT) (comparable to BT) are also includedto study the relationship, if any, betweenattainment of negativity and regularity oftreatment, type of leprosy, reactions, sex,and age of the patients. We wished to com-pute the approximate period of DDS treat-ment required for rendering different typesof bacteriologically positive patients nega-tive, and to study at least the major factorswhich affect the time required to attain bac-teriologic negativity.

MATERIALS AND METHODSIn this retrospective study, records of 922

initially positive cases (492 lepromatous, 222borderline, and 208 reactional tuberculoid)

' Received for publication on 21 May 1981; acceptedfor publication in revised form on 14 April 1982.

K. K. Koticha, M.B.B.S., D.V. & D., D.P.FL,P.D.E.C.D. (Prague/Delhi), Superintendent; P. R. R.Nair, M.Sc., D.P.S., Research Assistant (Statistician);P. S. Juwatkar, D.M.L.T., Laboratory Technician,Acworth Leprosy Hospital, Wadala, Bombay-400031,India.

were studied from our out-patient registersfrom 1 January 1962 through 31 December1974 (13 years).

Routine bacteriologic assessments aredone in lepromatous patients by removingwedge-shaped pieces of skin from one el-bow and one ear and pressing the tissue ona microscope slide to make an impressionsmear. For borderline and reactional tuber-culoid cases, one of the pieces of skin isremoved from one ear and the other froman active-looking lesion. The slides arestained by the Ziehl-Neelsen method; 100microscopic fields ( x600) are examined andthe results expressed on the Ridley scale("). For the purposes of the present study,the findings were noted only as either pos-itive or negative. Bacteriology is routinelydone twice a year, except for certificationpurposes, when it is done more often. Apatient who is negative (no acid-fast bacilliseen in 100 microscopic fields) thrice con-secutively is termed negative and, in thiscase, the date of the first negative bacteri-ology is taken to he the time the patientbecame bacteriologically negative.

All patients who had taken DDS (600 mgweekly for adults) for at least six monthsout of the year for a period of five years (orless than five years if the patient had be-come negative) were included in the study.Patients were termed regular if their actualperiod of treatment (the time for which theyhad collected DDS for out-patient treat-ment) was 75% or more of the total periodof treatment. Those who collected suffi-cient DDS for treatment for a period lessthan 75°, of the total span of treatment aretermed irregular.

Statistical analysis was by means of thechi-square test.

RESULTS AND DISCUSSIONRegularity of treatment. Of these 922 ini-

tially bacteriologically positive patients fol-lowed for at least five years on DDS mono-therapy (or until attaining negativity), all

330

50, 3^Koticha, et al.: Study of 922 Positive Cases^331

took DDS monotherapy at least 50% of thetime as measured by collecting medicationfrom the clinic. Of these 922 patients, 634took treatment regularly (.-̂ -75% of thetreatment period) and 288 were irregular(collecting sufficient medication for 50% to75% of the treatment period). Overall, 57.4%of the regular patients become bacteriolog-ically negative during the period of thestudy; while only 20.8% of the irregular pa-tients become negative. These differencesare highly significant (p < 0.001). Thus,regularity of treatment is significantly as-sociated with the attainment of bacterio-logic negativity. To evaluate the remainingfactors affecting the results of treatment,only the 634 regular cases were consideredin the evaluation.

Sex. Of the 634 regular cases, 90% weremales. Overall, 57.7% of the males becamenegative during the period of the study ascompared to 54.5% of the females. Thesedifferences are not significant. Thus, gen-der has no bearing on whether or not a pa-tient attains negativity on regular DDSmonotherapy.

Age. The percentage of negatives variedfrom a minimum of 50.0% in the group ofpatients from 0 to 14 years of age to 61.7%in the 45- to 59-year-old age group. Noneof the differences are statistically signifi-cant. Thus, age had no bearing on whetheror not a patient attains negativity on regularDDS monotherapy.

Type of leprosy. Ll or early lepromatouscases have shiny, oily skin, generalized in-filtration, but no distinct patches or nod-ules. L2 or advanced lepromatous casesmay have, in addition, thickening of theskin, skin nodules, loss of eyebrows, a de-pressed bridge of the nose, or a leonine face.Both LI and L2 are usually bacteriologi-cally highly positive (6+ on the Ridley scale)( 3 ). Of the 634 cases, 230 (36%) were L2cases, 81 (13%) were LI, 161 (25%) wereborderline (B), and 162 (26%) were reac-tional tuberculoid (RT) cases. Overall,39.1% of the 230 L2 cases attained negativ-ity during the period of the study; 53.1% ofthe 81 LI cases; 64.1% of the borderlinecases; and 75.9% of the RT cases. Thesedifferences are highly significant (p <0.001). Thus, the type of leprosy has a sig-nificant bearing on whether or not a patientattains negativity on regular DDS treat-

FIG. lb . Percentage of patients attaining bacteri-

ologic negativity in relation to months of treatment and

reactional episodes.

ment. The time required to attain bacteri-ologic negativity for the different types ofpatients is given in Figure la. RT cases be-come negative earlier, followed by border-line patients, and then the lepromatousgroups. This observation was further con-firmed by the study of the relationship be-tween the duration of treatment and the typeof leprosy.

Reactions. During reactions, DDS wasroutinely discontinued. Corticosteriodswere never used systemically. Analgesics,sedatives, antimalarials, and antimonialswere all employed, as needed, for the man-agement of the reactions. Reactions in lep-romatous cases consisted of erythema no-dosum leprosum (ENL). Reactions inborderline cases consisted of both ENL andreversal reactions. Reactional tuberculoidcases experienced reversal reactions. Of the634 regular patients as a whole, 66.3% hadno reactions (NR), 15.1% had a single epi-sode of reaction (SR), and 18.6% had re-current episodes of reactions (RR). Overall,62.1% of the NR group, 65.6% of the SRgroup, and 33.9% of the RR group obtainedbacteriologic negativity during the period of

the study. These differences are highly sig-nificant (p < 0.001). Thus, repeated reac-tions (RR) are associated with a lack of at-taining bacteriologic negativity (Fig. lb).

Duration of treatment. Figure la depictsthe percent of negative cases of each type

of leprosy in relation to the duration oftreatment (yearly class intervals). In lep-romatous (L2 plus L I) cases, 42.8% be-came negative during the period of study.This is the lowest observed among the threetypes. In the early periods of treatment, only

50, 3^Koticha, et al.: Study of 922 Positive Cases^333

a few cases became negative. The mean(±standard deviation) duration of regularDDS therapy necessary for the attainmentof bacteriologic negativity for this group is51 (± 18.9) months. For borderline cases,the mean duration of treatment necessaryto attain negativity is 26.8 (±20.0) months.For reactional tuberculoid cases the meanperiod of treatment to attain negativity is21.6 (±20.5) months.

Interactions among type of leprosy, fre-quency of reactions, and duration of treat-ment (Fig. 2). There were more negativesin the reactional tuberculoid group than inthe borderline group for a similar durationof treatment and for a similar frequency ofreactions. Repeated reactions (RR) delay theattainment of negativity in borderline casesbut not in reactional tuberculoid cases. Apossible reason for this is that reactions inreactional tuberculoid cases are alwaysmilder than those in borderline cases. Thus,DDS was not interrupted in RT cases withrepeated reactions for as long periods as inborderline cases with repeated reactions. Inboth borderline and reactional tuberculoidcases, single reactions do not adversely af-fect the attainment of bacteriologic negativ-ity. The frequency of reactions was not sig-nificantly different between the borderlineand reactional tuberculoid patients.

As expected, the lepromatous cases at-tained bacteriologic negativity at a slowerrate than the borderline and reactional tu-berculoid patients. For similar durations oftreatment, there were less negatives in theL2 group than in the L1 group. Among thelepromatous patients as a whole, single ep-isodes of reaction are associated with morerapid attainment of bacteriologic negativitythan no reactions. Multiple reactions, on theother hand, are associated with delays inattaining negativity. The reasons for this areunknown but the observation has been aconsistent one.

SUMMARYNine hundred twenty-two bacteriologi-

cally positive leprosy cases were registeredover a period of 13 years (1962-1974) at theAcworth Leprosy Hospital in Bombay, andstudied for a minimum period of five years.Two hundred eighty-eight were found totake antileprosy medication irregularly. Theremaining 634 patients, who took their

medication regularly, were analyzed withrespect to the effects of age, sex, type ofdisease, frequency of reactions, and dura-tion of treatment on the attainment of bac-teriologic negativity. Overall, 57.4% of thosepatients taking medication regularly be-came bacteriologically negative: while only20.8% of those taking medication irregular-ly became bacteriologically negative. Ageand sex did not appear to influence the at-tainment of bacteriologic negativity. Thetype of disease, reactions, and duration oftreatment all influenced the time requiredto attain bacteriologic negativity.

RESUMENEn un period() de 13 linos (1962-1974), se registraron

922 casos de lepra bacteriohigicamente positivos, en

el Acworth Leprosy Hospital de Bombay, mismos quese estudiaron por un period() minimo de S afios. Seencontro que 288 pacientes tomaban su medicacien

antileprosa de manera irregular. Los restantes 634 pa-cientes, que si tomaban su medicaciOn en forma re-gular, se analizaron en cuanto a los efectos de la edad,sexo, tipo de enfermedad, frecuencia de reacciones y

duracien del tratamiento, sobre Ia negativizacien bac-

teriolOgica. Globalmente, el 57.4% de los pacientes

bajo tratamiento regular Ilegaron a ser bacteriolcigi-

camente negativos mientras que solo el 20.8% de losirregulares Ilegaron a la negatividad bacteriolOgica. La

edad y el sexo no parecieron influir en la negativiza-cien hacteriolegica. El tipo de enfermedad, de reac-

ciones, y la duracion del tratamiento, influyeron, to-dos, el el tiempo requerido para alcanzar la negatividad

bacteriohigica.

RESUME

Au cours dune periode de 13 ans (1962-1974), on a

enregistre 922 cas de lepre bacteriologiquement posi-tive, suivie pour une periode minimum de 5 ans,

['Acworth Leprosy Hospital a Bombay. On a releve

que 288 de ces malades prenaient leur medicament demaniere irreguliere. Les 634 autres malades, qui pre-

naient leur medicament regulierement. ont ete analy-

ses en vue d'etuclier les effets de rage, du sexo, du

type de la maladie, de Ia frequence des reactions, et

de la duree du traitement, sur revolution bacteriolo-gique. Dans ['ensemble, 57.4% des malades prenantleur medicament regulierement, sont devenus bacte-

riologiquement netzatifs, aloes que settlement 20.8% de

ceux qui prenaient leur medicament irreetdierement,

sont devenus bacteriologiquement negatifs. II nest pasapparu que ['flee ou le sexe influencait la negativation

bacteriologique. Le type de maladie, les reactions, laduree du traitement avaient une influence sur le tempsrequis pour atteindre la negativite bacteriologique.

334^ international lourna/ q/ Leprosy^ 1982

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2. Ri01.1A, D. S. and JOPLING, W. II. Classification

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