The INFIR Cohort Study: investigating prediction, detection and pathogenesis of neuropathy and reactions in leprosy. Methods and baseline results of a cohort of multibacillary leprosy patients in North India

Brakel, Wim H. van; Nicholls, Peter; Das, Lakshmi; Barkataki, Pramila; Suneetha, Sujai; Jadhav, R. S.; Maddali, Pranava; Lockwood, Diana N J; Wilder‐Smith, Einar; Desikan, K. V.

doi:10.47276/lr.76.1.14

Cited by 120 publications

(48 citation statements)

References 17 publications

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“…Patients who had a reaction or sensory or motor impairment at diagnosis were excluded from this analysis. The study subjects were at different stages of their disease, as reported earlier [39] . A brief summary is given in the Results section below.…”

Section: Methodsmentioning

confidence: 99%

“…Outcome events for this analysis were sensory impairment (SI) and motor impairment (MI), as detected by the MFT and VMT (for definitions see Text S1 ). The techniques have been described elsewhere [39] . ‘New impairment’ of a neurological parameter was defined as ‘impairment which was not present at any earlier follow-up visit’.…”

Section: Methodsmentioning

confidence: 99%

“…The monofilaments used were 200 mg, 2 g, 4 g, 10 g and 300 g. Normal thresholds were 200 mg for the hand and 2 g for the foot (excluding the heel) [43] . The test sites and scoring methods have been described elsewhere [39] .…”

Section: Methodsmentioning

confidence: 99%

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Early Diagnosis of Neuropathy in Leprosy—Comparing Diagnostic Tests in a Large Prospective Study (the INFIR Cohort Study)

et al. 2008

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BackgroundLeprosy is the most frequent treatable neuromuscular disease. Yet, every year, thousands of patients develop permanent peripheral nerve damage as a result of leprosy. Since early detection and treatment of neuropathy in leprosy has strong preventive potential, we conducted a cohort study to determine which test detects this neuropathy earliest.Methods and FindingsOne hundred and eighty-eight multibacillary (MB) leprosy patients were selected from a cohort of 303 and followed for 2 years after diagnosis. Nerve function was evaluated at each visit using nerve conduction (NC), quantitative thermal sensory testing and vibrometry, dynamometry, monofilament testing (MFT), and voluntary muscle testing (VMT). Study outcomes were sensory and motor impairment detected by MFT or VMT. Seventy-four of 188 patients (39%) had a reaction, neuritis, or new nerve function impairment (NFI) event during a 2-year follow-up. Sub-clinical neuropathy was extensive (20%–50%), even in patients who did not develop an outcome event. Sensory nerve action potential (SNAP) amplitudes, compound motor action potential (CMAP) velocities, and warm detection thresholds (WDT) were most frequently affected, with SNAP impairment frequencies ranging from 30% (median) to 69% (sural). Velocity was impaired in up to 43% of motor nerves. WDTs were more frequently affected than cold detection thresholds (29% versus 13%, ulnar nerve). Impairment of SNC and warm perception often preceded deterioration in MF or VMT scores by 12 weeks or more.ConclusionsA large proportion of leprosy patients have subclinical neuropathy that was not evident when only MFT and VMT were used. SNC was the most frequently and earliest affected test, closely followed by WDT. They are promising tests for improving early detection of neuropathy, as they often became abnormal 12 weeks or more before an abnormal monofilament test. Changes in MFT and VMT score mirrored changes in neurophysiology, confirming their validity as screening tests.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Early Diagnosis of Neuropathy in Leprosy—Comparing Diagnostic Tests in a Large Prospective Study (the INFIR Cohort Study)

et al. 2008

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“…However, the observed incidence rates of neuritis and type 2 reactions and cumulative risk of neuritis (1.94% and 6.63% in PB and MB, respectively) and type 2 reactions (0.16% and 2.43% in PB and MB, respectively) were lower than those reported in the literature. For instance, the overall incidence of neuritis reported ranges between 6.1 and 34 per cent 23 24 25 26 27 28 29 . Similarly, reported rates (range) of type 2 reactions are higher in hospital-based studies (overall: 2-28.9%) than in the field leprosy programmes (overall: 0.2-4.6%; MB: 1-8.9%) 23 24 25 26 27 30 31 32 34 .…”

Section: Discussionmentioning

confidence: 99%

International open trial of uniform multidrug therapy regimen for leprosy patients

Ponnaiah

Mehendale

Nagaraju

et al. 2016

Indian Journal of Medical Research

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Background & objectives: Uniform therapy for all leprosy patients will simplify leprosy treatment. In this context, we evaluated six-month multidrug therapy (MDT) currently recommended for multibacillary (MB) patients as uniform MDT (U-MDT) in a single-arm open trial under programme conditions. Primary objective was to determine efficacy to prevent five-year cumulative five per cent relapse. Secondary objectives were to assess acceptability, safety and compliance. Methods: Newly detected, treatment-naive leprosy patients were enrolled in India (six sites) and P. R. China (two sites). Primary outcome was clinically confirmed relapse of occurrence of one or more new skin patches consistent with leprosy, without evidence of reactions post-treatment. Event rates per 100 person years as well as five-year cumulative risk of relapse, were calculated. Results: A total of 2091 paucibacillary (PB) and 1298 MB leprosy patients were recruited from the 3437 patients screened. Among PB, two relapsed (rate=0.023; risk=0.11%), eight had suspected adverse drug reactions (ADRs) (rate=0.79) and rate of new lesions due toreactions was 0.24 (n=23). Rates of neuritis, type 1 and type 2 reactions were 0.39 (n=37), 0.54 (n=51) and 0.03 (n=3), respectively. Among MB, four relapsed (rate=0.07; risk=0.37%) and 16 had suspected ADR (rate=2.64). Rate of new lesions due to reactions among MB was 1.34 (n=76) and rates of neuritis, type 1 and type 2 reactions were 1.37 (n=78), 2.01 (n=114) and 0.49 (n=28), respectively. Compliance to U-MDT was 99 per cent. Skin pigmentation due to clofazimine was of short duration and acceptable. Interpretation & conclusions: We observed low relapse, minimal ADR and other adverse clinical events. Clofazimine-related pigmentation was acceptable. Evidence supports introduction of U-MDT in national leprosy programmes. [CTRI No: 2012/ 05/ 002696]

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“…Patients presenting with thickened peripheral nerves and nerve palsy are often diagnosed as Hansen’s disease (HD) in endemic areas when other diagnostic tests come back inconclusive[ 1 - 4 ]. These patients may be thus treated with long term empirical multi-drug therapy for the same[ 3 - 6 ].…”

Section: Introductionmentioning

confidence: 99%

Cystic lesions of peripheral nerves: Are we missing the diagnosis of the intraneural ganglion cyst?

Panwar

Mathew

Thomas

2017

WJR

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AIMTo highlight the salient magnetic resonance imaging (MRI) features of the intraneural ganglion cyst (INGC) of various peripheral nerves for their precise diagnosis and to differentiate them from other intra and extra-neural cystic lesions.METHODSA retrospective analysis of the magnetic resonance (MR) images of a cohort of 245 patients presenting with nerve palsy involving different peripheral nerves was done. MR images were analyzed for the presence of a nerve lesion, and if found, it was further characterized as solid or cystic. The serial axial, coronal and sagittal MR images of the lesions diagnosed as INGC were studied for their pattern and the anatomical extent along the course of the affected nerve and its branches. Its relation to identifiable anatomical landmarks, intra-articular communication and presence of denervation changes in the muscles supplied by involved nerve was also studied.RESULTSA total of 45 cystic lesions in the intra or extraneural locations of the nerves were identified from the 245 MR scans done for patients presenting with nerve palsy. Out of these 45 cystic lesions, 13 were diagnosed to have INGC of a peripheral nerve on MRI. The other cystic lesions included extraneural ganglion cyst, paralabral cyst impinging upon the suprascapular nerve, cystic schwannoma and nerve abscesses related to Hansen’s disease involving various peripheral nerves. Thirteen lesions of INGC were identified in 12 patients. Seven of these affected the common peroneal nerve with one patient having a bilateral involvement. Two lesions each were noted in the tibial and suprascapular nerves, and one each in the obturator and proximal sciatic nerve. An intra-articular connection along the articular branch was demonstrated in 12 out of 13 lesions. Varying stages of denervation atrophy of the supplied muscles of the affected nerves were seen in 7 cases. Out of these 13 lesions in 12 patients, 6 underwent surgery.CONCLUSIONINGC is an important cause of reversible mono-neuropathy if diagnosed early and surgically treated. Its classic MRI pattern differentiates it from other lesions of the peripheral nerve and aid in its therapeutic planning. In each case, the joint connection has to be identified preoperatively, and the same should be excised during surgery to prevent further cyst recurrence.

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The INFIR Cohort Study: investigating prediction, detection and pathogenesis of neuropathy and reactions in leprosy. Methods and baseline results of a cohort of multibacillary leprosy patients in North India

Cited by 120 publications

References 17 publications

Early Diagnosis of Neuropathy in Leprosy—Comparing Diagnostic Tests in a Large Prospective Study (the INFIR Cohort Study)

Early Diagnosis of Neuropathy in Leprosy—Comparing Diagnostic Tests in a Large Prospective Study (the INFIR Cohort Study)

International open trial of uniform multidrug therapy regimen for leprosy patients

Cystic lesions of peripheral nerves: Are we missing the diagnosis of the intraneural ganglion cyst?

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