Shetty Vanaja Prabhakar, Khambati Fatema Abbas, Ghate Sunil Dattatraya, Capadia Gospi Dolly, Pai Vivek Vasudev, Ganapati Ramaswamy
The Foundation for Medical Research, 84-A, R.G. Thadani Marg, Worli, Mumbai 400 018, India.
Lepr Rev. 2010 Mar;81(1):41-58.
To investigate effects of therapeutic usage of corticosteroids on M. leprae killing and clearance, on clearance of granuloma and on nerve damage in multibacillary (MB) leprosy patients.
From a cohort of 400 untreated MB patients, a comparable group of 100 each receiving MDT + steroids (group A) vs MDT alone (group B) were assessed at 18 months as compared to month zero with respect to clinical and granuloma regression, M. leprae killing and clearance, and nerve functions. Analysis was performed using SPSS version 10.0. The significance of association was tested using Chi square and Fisher's exact tests.
Regression of lesions assessed clinically and by histopathology was seen in 52% and 53% patients in group A and 46% and 63% in B respectively (P not significant). Clearance of bacteria assessed by bacteriological index (BI) in slit skin smears (SSS) and extent and intensity of antigen using anti-BCG staining were also comparable in the two groups. Multiplication of M. leprae in the mouse foot pad (MFP) indicating the presence of viable bacilli was seen in 14% and 16% of SSS positive BL-LLs patients in groups A and B respectively (P not significant). The occurrence of viable M. leprae was higher among patients with repeat reaction (19%) than single (11%). Using clinical tests (nerve palpation, monofilament and voluntary muscle testing), the proportion of sensory and motor nerves showing improvement or deterioration were similar in the two groups. However using nerve conduction studies, the overall proportion of nerves showing deterioration (22%) was significantly higher than improvement (9%) (P < 0.001).
Treatment with MDT + corticosteroids does not adversely affect the clearance of granuloma, M. leprae and/or its antigens and M. leprae killing. However the continued presence of viable bacteria in > 14% of BL-LLs patients indicate that 12 months of MDT may be insufficient for complete bacterial killing. In both groups nerve conduction studies indicated that deterioration of nerves was high suggesting, MDT + corticosteroids was not very efficacious in the prevention or reversal of nerve damage. A better immuno-modulatory drug or a modified corticosteroid regime is needed.
探讨皮质类固醇激素治疗对多菌型（MB）麻风患者杀灭和清除麻风杆菌、清除肉芽肿以及神经损伤的影响。
从400例未经治疗的MB患者队列中，选取100例接受多药联合化疗（MDT）加类固醇激素治疗的患者（A组）和100例仅接受MDT治疗的患者（B组）进行对比研究。在18个月时对两组患者进行评估，并与治疗前（零月）对比，评估内容包括临床症状和肉芽肿消退情况、麻风杆菌的杀灭和清除情况以及神经功能。使用SPSS 10.0软件进行分析。采用卡方检验和Fisher精确检验来检验相关性的显著性。
临床评估和组织病理学评估显示，A组分别有52%和53%的患者病变消退，B组分别为46%和63%（P值无显著性差异）。通过皮肤涂片细菌学指数（BI）评估细菌清除情况，以及使用抗卡介苗染色评估抗原的范围和强度，两组结果也具有可比性。A组和B组分别有14%和16%的皮肤涂片阳性的瘤型-界线类偏瘤型（BL-LL）患者的小鼠足垫（MFP）中出现麻风杆菌增殖，提示存在活的麻风杆菌（P值无显著性差异）。复发反应患者中活的麻风杆菌出现率（19%）高于单次反应患者（11%）。通过临床检查（神经触诊、单丝检查和随意肌检查）发现，两组中感觉神经和运动神经改善或恶化的比例相似。然而，通过神经传导研究发现，神经功能恶化的总体比例（22%）显著高于改善的比例（9%）（P<0.001）。
MDT加皮质类固醇激素治疗对肉芽肿、麻风杆菌及其抗原的清除以及麻风杆菌的杀灭无不良影响。然而，超过14%的BL-LL患者中持续存在活细菌，这表明12个月的MDT治疗可能不足以完全杀灭细菌。两组的神经传导研究均表明神经功能恶化程度较高，提示MDT加皮质类固醇激素在预防或逆转神经损伤方面效果不佳。需要更好的免疫调节药物或改良的皮质类固醇激素治疗方案。
