Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLoS Negl Trop Dis. 2012;6(6):e1702. doi: 10.1371/journal.pntd.0001702. Epub 2012 Jun 26.
The ILEP Nerve Function Impairment in Reaction (INFIR) is a cohort study designed to identify predictors of reactions and nerve function impairment in leprosy. The aim was to study correlations between clinical and histological diagnosis of reactions.
METHODOLOGY/PRINCIPAL FINDINGS: Three hundred and three newly diagnosed patients with World Health Organization multibacillary (MB) leprosy from two centres in India were enrolled in the study. Skin biopsies taken at enrolment were assessed using a standardised proforma to collect data on the histological diagnosis of leprosy, leprosy reactions and the certainty level of the diagnosis. The pathologist diagnosed definite or probable Type 1 Reactions (T1R) in 113 of 265 biopsies from patients at risk of developing reactions whereas clinicians diagnosed skin only reactions in 39 patients and 19 with skin and nerve involvement. Patients with Borderline Tuberculoid (BT) leprosy had a clinical diagnosis rate of reactions of 43% and a histological diagnosis rate of 61%; for patients with Borderline Lepromatous (BL) leprosy the clinical and histological diagnosis rates were 53.7% and 46.2% respectively. The sensitivity and specificity of clinical diagnosis for T1R was 53.1% and 61.9% for BT patients and 61.1% and 71.0% for BL patients. Erythema Nodosum Leprosum (ENL) was diagnosed clinically in two patients but histologically in 13 patients. The Ridley-Jopling classification of patients (n = 303) was 42.8% BT, 27.4% BL, 9.4% Lepromatous Leprosy (LL), 13.0% Indeterminate and 7.4% with non-specific inflammation. This data shows that MB classification is very heterogeneous and encompasses patients with no detectable bacteria and high immunological activity through to patients with high bacterial loads.
CONCLUSIONS/SIGNIFICANCE: Leprosy reactions may be under-diagnosed by clinicians and increasing biopsy rates would help in the diagnosis of reactions. Future studies should look at sub-clinical T1R and ENL and whether they have impact on clinical outcomes.
ILEP 神经功能损伤反应（INFIR）是一项队列研究，旨在确定麻风病反应和神经功能损伤的预测因素。目的是研究临床和组织学诊断反应之间的相关性。
方法/主要发现：本研究纳入了来自印度两个中心的 303 名新诊断的世界卫生组织多菌型（MB）麻风病患者。在入组时采集的皮肤活检标本采用标准化表格进行评估，以收集麻风病的组织学诊断、麻风病反应以及诊断确定性水平的数据。病理学家在 265 份有发生反应风险的患者活检标本中诊断出 113 例明确或可能的 1 型反应（T1R），而临床医生诊断出 39 例皮肤仅有反应，19 例皮肤和神经受累。边界结核样型（BT）麻风病患者的临床反应诊断率为 43%，组织学诊断率为 61%；边界偏瘤型（BL）麻风病患者的临床和组织学诊断率分别为 53.7%和 46.2%。BT 患者 T1R 的临床诊断敏感性和特异性分别为 53.1%和 61.9%，BL 患者分别为 61.1%和 71.0%。临床上诊断为结节性红斑性麻风（ENL）的患者有 2 例，而组织学诊断的患者有 13 例。303 例患者的 Ridley-Jopling 分类为 42.8%BT、27.4%BL、9.4%LL、13.0%未定类和 7.4%非特异性炎症。这些数据表明，MB 分类非常混杂，涵盖了从无细菌可检测到的患者到具有高细菌负荷的患者，免疫活性也从低到高。
结论/意义：临床医生可能会漏诊麻风病反应，增加活检率有助于诊断反应。未来的研究应该关注亚临床 T1R 和 ENL，以及它们是否对临床结果有影响。
