Incidence of leprosy in Firozabad district (Uttar Pradesh).

OBJECTIVE: To assess incidence of leprosy in Firozabad District (U.P.). MATERIALS AND METHODS: A random sample of 148,061 population was covered by this second survey, spread over 259 units (230 rural/29 urban). The survey was conducted between March 2011 and November 2012. Clinically confirmed cases detected in known disease-free population were labeled as incident cases and treated. RESULTS: The overall incidence rate of leprosy was found to be 3.4 per 10,000 person years; In healthy contacts it was 3.1, in paucibacillary contacts 29.7 while it was 89.3 in multibacillary contacts. The differences in incidence rate of these three groups were significant (P < 0.001). Incidence rate was significantly higher by age; 1.1 in persons <15 years to 8.0 in those >44 years of age, and in high endemicity areas with three or more cases. In terms of incidence rate ratio (95% confidence interval), the incidence for ages 15-24 years was 3.2 times significantly higher than for those under 15 years, 5.3 times (4.3-6.5) in ages 30-44 years and 7.0 times (5.6-8.7) for age ≥45 years. Incidence rate ratio was also significantly higher in paucibacillary contacts, by 9.5 times (7.0-13.0) and 27.7 times (18.8-40.6) in multibacillary contacts, as compared to healthy controls. Incidence rate ratio (95% confidence interval) was significantly higher by 2.9 times (2.4-3.5) in areas with endemicity status of 3 to 5 cases and by 2.0 times (1.6-2.5) in areas with >5 cases as compared to areas with no endemicity. It was 2.4 times more (1.6-3.5) in Narkhi, 2.4 times higher (1.7-3.5) in Tundla and 3.0 times higher (2.1-4.5) in Aravon blocks than in Aeka block of the district. Incidence rate was also found to be significantly higher (3.7) among females, 1.3 times higher (1.1-1.5) than in males (2.9). Incidence rate ratio (95% confidence interval) was also 2.5 times higher (1.2-5.1) among persons having reported disease of greater than 4 years in comparison to 1.5 in persons having disease for 2 to 3 years. LIMITATIONS OF STUDY: None to the best of our knowledge. CONCLUSION: The present study suggests that incidence rate of leprosy is significantly higher among persons of above 15 years, in females, among contacts of paucibacillary/multibacillary disease, in areas where >3 leprosy cases were found and in Tundla, Narkhi and Aravon blocks in Firozabad district.

A randomized controlled trial to compare cure and relapse rate of paucibacillary multidrug therapy with monthly rifampicin, ofloxacin, and minocycline among paucibacillary leprosy patients in Agra District, India.

OBJECTIVES: To study cure rate and relapse rate of standard World Health Organization paucibacillary multidrug therapy (PB-MDT) with monthly rifampicin, ofloxacin, and minocycline for six months (ROM-6) among paucibacillary leprosy patients. METHODS: A total of 268 patients, detected during active search in Agra district during 2001-2004, who had paucibacillary (PB) leprosy having 1-5 skin lesions and/or one nerve thickening/tenderness, were allocated, using random number tables, to two treatment groups; PB-MDT and ROM-6. On the first day of the month, dose of PB-MDT and of the ROM were given under supervision for 6 months. After completion of drug therapy, patients were followed every 6 months for first 5 years and later annually for next 3 years for monitoring disease status, cure rates, reactions and relapses. Cηi σθuαρε test was used to compare relapse rates. RESULTS: The cure rate at 2 years was 99% in ROM-6 and 97.0% in PB-MDT group, of those who completed treatment and the difference was statistically not significant. At 5 years, only 88 patients in PB-MDT group and 90 patients in ROM-6 group could be followed; all were observed to be cured. However, during the period of 5-8 years, 3 of 67 patients in PB-MDT group and 1 of 73 in ROM-6 group were observed to have relapsed. In all, 10 relapses were noted (3 in ROM-6 and 7 in PB-MDT group) giving a relapse rate of 1.10/100 person years in PB-MDT and 0.435/100 person years in ROM groups (P = 0.053 ; statistically not significant). Of the 10 relapses, 5 occurred within 5 years (3 in PB-MDT group and 2 in ROM-6), 4 during 5-8 years (3 in PB-MDT and 1 in ROM-6), and 1 occurred in MDT group after 8 years. LIMITATION: A number of patients were lost to follow up after release from treatment and thus actual number of relapses in the study could not be assessed. Additionally, diagnosis was purely clinical and histology could not be done for reasons related to functional difficulties in the field. CONCLUSION: The study shows that PB-MDT and ROM-6 have almost similar acceptability, cure rate and relapse rate.

WHO multidrug therapy for leprosy: epidemiology of default in treatment in Agra district, Uttar Pradesh, India.

AIM: To study the magnitude of default, time of default, its causes, and final clinical outcome. METHODS: Data collected in active surveys in Agra is analyzed. Patients were given treatment after medical confirmation and were followed up. The treatment default and other clinical outcomes were recorded. RESULTS: Patients who defaulted have comparable demographic characteristics. However, among defaulters more women (62.7% in PB, 42.6% in MB) were seen than those in treatment completers (PB 52.7% and MB 35.9%). Nerve involvement was high in treatment completers: 45.7% in PB and 91.3% in MB leprosy. Overall default rate was lower (14.8%) in ROM than (28.8%) in standard MDT for PB leprosy (χ 1 (2) = 11.6, P = 0.001) and also for MB leprosy: 9.1% in ROM compared to 34.5% in MDT (χ 1 (2) = 6.0, P = 0.015). Default rate was not different (28.8% versus 34.5%, P > 0.05) in both types of leprosy given MDT. Most patients defaulted at early stage of treatment and mainly due to manageable side effects. CONCLUSION: The default in standard MDT both for PB and MB leprosy was observed to be significantly higher than in ROM treatment. Most defaults occurred at early stage of treatment and major contribution of default is due to side effects like drowsiness, weakness, vomiting, diarrhea, and so forth, related to poor general health. Although about half of the defaulters were observed to be cured 2.2% in PB-MDT and 10.9% of MB-MDT developed disability. This is an issue due to default. Attempts are needed to increase treatment compliance. The use of specially designed disease related health education along with easily administered drug regimens may help to reduce default.

Detection of previously undetected leprosy cases in Firozabad District (U.P.), India during 2006-2009: a short communication.

OBJECTIVES: This study was initiated to assess the extent of undetected (new) leprosy cases in Firozabad District of U.P. METHODS: A sample survey of more than 980,000 people was undertaken in nine blocks of the district during October 2006 to March 2009, using a household questionnaire and a cross section survey. RESULTS: A total of 774 previously undetected cases were detected (7.57 NCDR/10,000 population) over the 2.5 year period of the survey. The characteristics of previously undetected cases are described by age, sex, classification, urban/rural residence and disability. CONCLUSION: There are many undetected leprosy patients in the community. Active surveys can help in detecting previously undetected cases. The current programme is based on information, education and communication (IEC) to encourage case reporting. IEC activities should be designed in such a way that people can suspect leprosy and are self-motivated to know about free treatment, its availability, and effectiveness.

Twelve months fixed duration WHO multidrug therapy for multibacillary leprosy: incidence of relapses in Agra field based cohort study.

BACKGROUND & OBJECTIVES: The reported low relapse rates after 24 months multidrug therapy (MDT) for multibacillary leprosy (MB) led to the recommendation of reducing duration of therapy to 12 months. However, only a few reports exist on long term follow up data after 12 months fixed duration therapy (FDT). The present study was done to assess the incidence of relapse in MB leprosy patients after 12 months treatment. METHODS: The leprosy patients detected in field surveys during 2001-2006 in Agra district, Uttar Pradesh, India, were put on WHO-MDT and followed up for treatment completion, relapse, reactions and development of disability. The assessment was done clinically by following up the patients until January 2011. Data collected were analyzed for risk and survival analysis. RESULTS: The incidence of relapse was found to be 1.97/100 person years of follow up. The incidence of relapse by age (34 yr vs >34 yr), sex (male vs female), delay in detection (<36 months vs >36 months) and smear status (smear +ve vs -ve) was not found to be significantly different but patients with no nerve involvement were observed to have significantly higher relapses than those with three or more nerve involvement (P<0.05). Similarly, borderline-borderline and BB with reaction (BB/BBR) patients were observed to have significantly high relapses than among those with borderline tuberculoid or BT with reaction (BT/BTR) or borderline lipromatous/lepromatous/neuritic (BL/LL/N) type of leprosy (P<0.01). INTERPRETATION & CONCLUSION: From the observations in the study, it can be suggested that relapses occur in 12 months FDT and almost as much as reported in 24 months FDT for MB leprosy. Although, early relapses may be due to insufficient treatment, late relapses may be due to persistent dormant mycobacteria. However, a study relating to immunological response of treatment and change in immunological profile relating to the occurrence of relapses and its clinical correlates may suggest better information on causes of relapses.

Six months fixed duration multidrug therapy in paucibacillary leprosy: risk of relapse and disability in Agra PB cohort study.

BACKGROUND: Many studies have focused on multidrug therapy (MDT) for multibacillary (MB) leprosy and rarely on long-term outcome of paucibacillary (PB) leprosy having recommendation of therapy for 6 months fixed duration therapy for PB patients. Studies on measuring risk of disability are rare. The present study is to assess the cure; default, relapse and disability in a prospective cohort of PB leprosy during follow-up of >4 years after treatment. DESIGN: Prospective. SETTING: Primary in our field area of Agra District. PARTICIPANTS: 920 PB leprosy patients entered the study, 621 completed treatment, 599 followed finally including 271 males, no ethnic differentiation, patients of all age groups except for children below 5 years and old persons above 70 years were not included. TREATMENT: 6 months fixed duration MDT as recommended by WHO. PRIMARY AND SECONDARY OUTCOMES: Treatment completion, cure, relapse and development of disability based on clinical assessment by well-experienced doctors. STATISTICAL METHODS: Data have been analysed using SPSS software, risk is computed as incidence per 100 person-years (PY) and test of significance used. RESULTS: Study reports 91% cure rate. Incidence of relapse was 1.3/100 PY with no significant variation by age, sex, delay in detection, patches and nerves. Crude incidence of disability was 2.2% and varied significantly by age and nerve thickening but not by sex, number of patches, nerves and delay in treatment. Incidence of disability was 0.50/100 PY in treatment completed and 0.43 among defaulters. CONCLUSION: The study concludes that relapses do occur after MDT treatment but at the level of 1-2%, incidence of disability remains low (<1/100 PY) in PB leprosy. Low incidence of relapse and disability suggests that 6 months therapy is quite effective. However, further improvement may help to improve its efficacy. Longer follow-up may add to efficacy measures.

Florid reactive periostitis ossificans of long bones and digits associated with reaction in a patient with leprosy.

Florid reactive periostitis ossificans is a rare bone lesion usually occurring in the small, tubular bones of the hands and feet. This entity is a benign and aggressive periosteal reaction associated with soft tissue swelling that appears similar to a bone lesion that radiographically and clinically mimics an infectious or neoplastic process. Typically the lesions occurs in an adolescent or young adult and presents as a small area of painful swelling and erythema over the affected bone. The cause of florid reactive periostitis ossificans is not exactly known though many authors have postulated varied etiopathogenesis for the same condition. In this report, is a very rare and unusual example of this entity that has been observed in association with erythema nodosum leprosum (ENL) a type 2 lepra reaction in a Leprosy patient.

Risk of developing disability in pre and post-multidrug therapy treatment among multibacillary leprosy: Agra MB Cohort study.

OBJECTIVES: If leprosy is a public health problem, it is due to the disabilities it causes. Surprisingly little is known about the risk of disabilities. Even now, mainly cross-sectional studies report disability prevalence. The present study aims to report the risk of disability in pre and post-WHO multidrug therapy (MDT) in multibacillary leprosy patients and to assess the extent of the incidence of disability. METHODS: The study design is prospective and the setting is an institutional field area. Patients were detected during 2001-6 field surveys. Of the 289 multibacillary patients, 146 completed the study. Both sexes were involved. The primary outcome planned was to study cure of disease, relapses and disability in patients receiving MDT. The secondary outcome was to measure reaction and default. Assessment was done clinically. Data have been analysed using SPSS software, logistic, survival analysis was performed and the χ(2) test of significance was used. RESULTS: An important risk factor was found to be three or more nerves involved with odds of 3.73 (1.24-11.2), and delay in treatment; 2.27 (1.04-4.96) at the pre-MDT stage and three or more nerves involved with odds of 2.81 (1.0-7.9) at the post-MDT stage. The incidence of disability was found to be 2.74/100 person-years; 2.69 in the MDT arm and 2.84 in defaulters, with slightly higher disability among early defaulters (3.08) than among late defaulters (2.30). The study suggests that the incidence of disability could be slightly higher if treatment is not completed. CONCLUSION: Early treatment for leprosy is a must for reducing the risk of disability, and treatment delay would increase the risk of disability. It is important to note that the incidence of disability between defaulters and those completing treatment was not found to be significantly different.

A randomised controlled trial assessing the effect of adding clarithromycin to rifampicin, ofloxacin and minocycline in the treatment of single lesion paucibacillary leprosy in Agra District, India.

AIM: To assess if there is any additional short and long-term effect of adding clarithromycin to rifampicin, ofloxacin and minocycline (ROM), the combination here after called C-ROM, in treating single lesion PB leprosy detected in the field. METHODS: 300 patients, detected on active search in Agra district, who had single lesion leprosy but no nerve thickening, were randomly allocated (using random number table) to two treatment groups, 151 to ROM and 149 to C-ROM. All th patients were given single dose of ROM or C-ROM and followed up every 6 months for disease status, cure rate, reaction and relapse. Survival analysis was used to compare relapse rate. RESULTS: The cure rate at 2 years was 93.1% in ROM and 91.4% in C-ROM group. By this time three relapses had occurred in the ROM group while two patients were found to have relapsed in the C-ROM group. Thus, there was no statistical difference in relapse rates (2.1% vs. 1.41%, P = 0.287) in the two groups. Long term observations over 3-5 years revealed nine relapses (five in ROM, four in C-ROM) giving relapse rate of 1.05/100 Person years in ROM and 0.90/100 person years in C-ROM group--again no significant difference was observed (P = 0.87). CONCLUSION: The study shows that addition of clarithromycin to ROM does not significantly improve the efficacy as measured in terms of cure rates and relapse rates in single skin lesion leprosy patients.

Leprosy scenario in Agra: epidemiological observations from rapid population survey 2004-06.

This study based on rapid survey methodology examining 17.86 lakhs population revealed that leprosy prevalence in Agra District is 6.1/10,000 during 2004-06, with 97.2% of the cases detected for the first time. Although leprosy is still endemic but all the leprosy indicators have shown positive change since last survey in 2001-03. The results seem promising to achieve elimination target (<1/10,000) since prevalence/10,000 population declined from 16.4 in 2001-03 to 6.1 in 2004-06, MB rate from 22.3 to 17.1, Mean duration of disease at detection (months) from 32.3 to 22.9, per cent new cases increased from 88.2% to 97.2% and visible disability (Grade > or = 2) rate declined from 4.8% to 2.36% over this period. The data on patients with incomplete history of treatment (prevalent) but having active disease indicate that only about 3% (31/1090) had approached the health center for treatment. Of these 31 patients, 29% defaulted from treatment and still have active disease and 75.2% (23/31) had MB disease indicating a pattern of late reporting to health system. This study suggests that repeat surveys are useful to detect cases for treatment and seems the key to achieve leprosy elimination or even eradication at district level in all endemic districts.

Incidence of leprosy in Agra district.

This study presents estimates of incidence of leprosy among the familial contacts (FC) and non-familial contacts (NFC) of leprosy patients in Agra, a district endemic for leprosy. The study covers 42,113 persons followed up for 123,951.2 person years (PY) during which 77 individuals developed leprosy giving an incidence of 6.2/10,000 PY in the total leprosy-free population studied (TLPS). The incidence rate in NFCs was observed to be 4.6/10,000 PY while the FCs had a significantly higher incidence rate of 67.6/10,000 PY (P < 0.001). Incidence rate among the FC of paucibacillary leprosy (PB) patients was 41.0/10,000 PY while the corresponding figure for multibacillary leprosy (MB) contacts was 131.3/10,000 PY (P < 0.05). Applying methods of survival analysis, the incidence rate at the end of 1 year was observed to be 4-0 (per 10,000), increased to 12.0 by 2 years and 18.0 at the end of 3 years in TLPS. The incidence rate was almost similar in both the sexes and was found to increase significantly with age. The observations clearly indicate that leprosy is still endemic in the area and transmission continues.

Prevalence of leprosy in Agra District (U.P.) India from 2001 to 20031.

Leprosy prevalence has reportedly declined all over the world, but six countries, including India, are still endemic for the disease. India alone contributes about 60% to the world's leprosy case load, with the major share from its northern states. The present study done in Agra district was based on a randomly-selected sample of over 10% of the population, spread across 300 villages and 16 urban units of the district. A house-to-house survey was conducted from July 2001 to July 2003 in all the 26 selected panchayats (300 villages), all the 11 block headquarters which have an urban component, and 5 (out of 20) localities in Agra city. A population of 361,321 persons was examined for leprosy. A total of 592 leprosy cases [new and cases yet to complete a full course of multi-drug therapy (M.D.T.)] were found, giving a prevalence rate of 16.4/10,000 population. Although the overall prevalence was found to be similar in both rural and urban areas, there were pockets with high prevalence. More cases were detected in the eastern side of Agra (31.4/10,000 in Fatehabad and 28.5/10,000 in Bah Tahsils). Overall, the multibacillary (MB) leprosy rate was 22.3% and the child leprosy rate 8.4%. Of the 592 cases, 523 (88.3%) were new untreated cases, giving a new case detection rate of 14.5/10,000. The MB rate was 17% (89/523), and the child leprosy rate was 8.4% (44/523) among the new patients. The grade 2 deformity rate was found to be 4.8% (25/523) among these cases. The duration of disease among new cases was 32.3 months as compared to 48.1 months among prevalent (registered) cases (i.e., patients who had been diagnosed earlier and had yet to complete a full course of M.D.T.). The large number of undetected cases found in this survey suggests the need for continued intensive health education campaigns and case detection activities. This study highlights the fact that a large number of leprosy cases go undetected in the present integrated system which is mainly based on voluntary reporting of cases.

Nerve thickening in leprosy patients and risk of paralytic deformities: a field based study in Agra, India.

This paper examines the extent of nerve thickening among leprosy patients detected in the field in Agra district. All the clinically diagnosed leprosy patients were examined in detailed for thickening of local cutaneous nerves and peripheral nerve trunks. In each case all the major nerve trunks in both upper and lower extremities, forehead and neck were examined for thickening. Nerve thickening was found in 94% of multibacillary (MB) patients and among 52% paucibacillary (PB) patients. Nerve thickening was found to be more in males, in prevalent cases than in new (untreated) cases and increased significantly with age and delay in diagnosis (P<0.001). Visible deformities of grade > or =2 were found in 10% (58/573) of the leprosy patients; paralytic deformity accounted for 78% (45/58). Claw hand alone or in combination was seen in 82% (37/45) of patients with paralytic deformities. Risk (odd ratio) for deformities was observed to be high (15-18 times) with increasing number of nerves among patients with neuritic leprosy but correlated with delay in diagnosis of over 5 years. Likewise, deformities were more often seen in those with skin lesions, provided they had > or =3 thickened nerves. Findings suggest that early detection and treatment is useful in preventing deformities.

Pulsed corticosteroid therapy in patients with chronic recurrent ENL: a pilot study

A pilot study has been undertaken to compare the efficacy of small dose pulsed betamethasone therapy with need based oral steroids in chronic recurrent erythema nodosum leprosum (ENL) patients. Though this mode of therapy was well tolerated, no advantage with intermettnt steroid administration was observed. This coul have been on account of small dose of steroid given monthly. Treatment of chronic recurrent erythema nodosum leprosum (ENL) patients continues to be unsatisfactory, particularly, because of non-availability of thalidomide. Though corticosteroids are effective in suppressing all the manifestations and even restoring partially or fully the functional impairment, their side effects and dependence are equally troublesome. Based on (a) the reported efficacy and safety of intermittent use of corticosteroids in several immune complex mediated disorders (Cathcart et al 1976, Kimberly et al 1979), Lieblin et al 1981 and Pasricah & Gupta 1984) and (b) ENL (type II) reactions having similar pathology, a pilot study has been undertaken to see the efficacy and the tolerance of pulsed steroids in chronic ENL patients

Pulsed corticosteroid therapy in patients with chronic recurrent ENL: a pilot study.

A pilot study has been undertaken to compare the efficacy of small dose pulsed betamethasone therapy with need based oral steroids in chronic recurrent erythema nodosum leprosum (ENL) patients. Though this mode of therapy was well tolerated, no advantage with intermittent steroid administration was observed. This could have been on account of small dose of steroid given monthly. Treatment of chronic recurrent erythema nodosum leprosum (ENL) patients continues to be unsatisfactory, particularly, because of nonavailability of thalidomide. Though corticosteroids are effective in suppressing all the manifestations and even restoring partially or fully the functional impairment, their side effects and dependence are equally troublesome. Based on (a) the reported efficacy and safety of intermittent use of corticosteroids in several immune complex mediated disorders (Cathcart et al 1976, Kimberly et al 1979), Liebling et al 1981 and Pasricha & Gupta 1984) and (b) ENL (type II) reactions having similar pathology, a pilot study has been undertaken to see the efficacy and the tolerance of pulsed steroids in chronic ENL patients.

Immunological profile of treated lepromatous leprosy patients

The immune responses of 19 treated lepromatous patients who had remained smear negative for a long period were assessed for specific cell-mediated immunity (CMI), anti-Mycobacterium leprae antibodies and cytokine release in response to challenge with M. leprae soluble antigen (MLSA). All of these patients remained anergic to Mitsuda lepromin. Lymphoproliferation in response to M. leprae antigen was noted in only two patients. Significant reduction in the phenolic glycolipid I (PGL-I) antibody response in treated patients with no difference in the M. leprae 35-kDa antibody response was observed when these responses were compared with those of active lepromatous patients. More treated patients produced interleukin-2 (IL-2) and interferon gamma (IFN-gamma) than did active patients. On the other hand, fewer treated patients produced IL-10 than did active patients. These limited findings suggest that the host immune response makes an attempt toward upregulation of CMI in some treated LL/BL patients.

Some epidemiological observations on leprosy in India

This population sample survey conducted in rural and urban areas of the Agra District in India showed an active leprosy caseload of 60.1/10,000 in the rural and 39.1/10,000 in the urban areas against a targeted prevalence of < 1/10,000. The disease appeared to be widespread since almost 65% of the villages or urban pockets surveyed had at least one prevalent case of leprosy. Significantly larger numbers of leprosy patients were found among males, agricultural/manual workers, persons with no formal schooling, individuals living in unkept households with dirty surroundings, and among those living in dark and poorly ventilated houses. The epidemiological significance of this study reveals the endemic nature of leprosy in Agra and suggests the need to intensify and widen case-detection activities to achieve leprosy control.

Recidivas en pacientes de lepra multibacilares: resultado de la duración del tratemiento

Se comparan dos grupos de pacientes MB: uno tratado hasta negatividad en frotis (TSN) y el otro con terapia de duración fija (24 dosis MB OMS) (FDT), para determinar los índices de recidivas durante el tratamiento y el período post-tratamiento, encontrando 20 recidivas (2.04/100 pacientes/año) durante el seguimiento de 980.2 personas/año en 260 pacientes tratados en FDT. En el otro grupo , 301 pacientes recibieron tratamiento hasta negativización, detectándose 12 recidivas en 1085.46 personas/año (1.10/100 pacientes año). La comparación de los índices de supervivencia (sin recidivas) revela que aunque no hay diferencia significativa hasta los 4 años, el riesgo de recidiva es significativamente mayor en el grupo FDT durante un período mayor de seguimiento. Además, cuando se compara en los pacientes la carga bacilar inicial, se observa un índice de recidivas mayor en el grupo con IB≥4, significativamente mayor (p<0.01) que en el grupo FDT comparado con el grupo que recibe tratamiento hasta la completa negativización del frotis (4.29 años 1.27/100 pacientes/años). Todos los pacientes con recidivas respondieron al tratamiento con la misma combinación de medicamentos, indicando qu la exacerbación de su condición es por insuficiente tratamiento. Se sugiere para prevenir o reducir recidivas, el continuar cuando sea posible el tratamiento hasta negativización del frotis, al menos en pacientes con IB elevado.

Recidivas en pacientes de lepra multibailares: resultado de la duración del tratamiento

Se comparan dos grupos de pacientes MB: uno tratado hasta negatividad en frotis (TSN) y el otro con terapia de duración fija (24 dosis MB OMS) (FDT), para determinar los índices de recidivas durante el tratamiento y el período post tratamiento, encontrando 20 recidivas (2.04/100 pacientes/año) durante el seguimiento de 980.2 personas/año en 260 pacientes tratados en FDT. En el otro grupo, 301 pacientes recibieron tratamiento hasta negativización. detectándose 12 recidivas en 1085.46 personas/año (l.10/100 pacientes año). La comparación de los índices de supervivencia (sin recidivas) revela que aunque no hay diferencia significativa hasta los 4 años, el riesgo de recidiva es significativamente mayor en el grupo FDT durante un período mayor de seguimiento. Además, cuando se compara en los pacientes la carga bacilar inicial, se observa un índice de recidivas mayor en el grupo con IB_4, significativamente mayor (p<0.01) que en el grupo FDT comparado con el grupo que recibe tratamiento hasta la completa negativización del frotis (4.29 años 1.27/100 pacientes/años).Todos los pacientes con recidivas respondieron al tratamiento con la misma combinación de medicamentos, indicando que la exacerbación de su condición es por insuficiente tratamiento. Se sugiere para prevenir o reducir recidivas, el continuar cuando sea posible el tratamiento hasta negativización del frotis, al menos en pacientes con IB elevado (AU)