Majumder V, Mukerjee A, Hajra S K, Saha B, Saha K
School of Tropical Medicine, Calcutta, India.
Int J Lepr Other Mycobact Dis. 1996 Mar;64(1):26-36.
This report describes a promising mode of treatment of lepromin-unresponsive, far-advanced, lepromatous (LL) leprosy patients with antileprosy vaccines as an adjunct to multidrug therapy (MDT). The Trial Groups included 50 highly bacilliferous, lepromin-negative, untreated LL patients. They were given MDT for 2 years. Of them, 30 patients were administered a mixed antileprosy vaccine containing killed Mycobacterium leprae of human origin plus M. bovis BCG. The remaining 20 patients were given M. bovis BCG. Depending on the severity of lepromin unresponsiveness, they were given one to six inoculations at 3-month intervals. Another 20 similar LL patients were taken in the Control Group. They were given only MDT for 2 years. From the start of the study, all patients belonging to the Trial and Control Groups were followed every 3 months for clinical, bacteriological and immunological outcomes. Within 2 years all 50 patients of the Trial Groups and 19 of the 20 patients of the Control Group became clinically inactive and bacteriologically negative. However, the clinical cure and the falls of the bacterial and morphological indexes were much faster in those patients receiving the mixed vaccine therapy than in those patients who were given BCG plus MDT or only MDT. The immunological improvements in the patients of the Trial and Control Groups were assessed by: a) lepromin testing at the beginning of the study and at 3-month intervals and also by b) the in vitro leukocyte migration inhibition (LMI) test at both the beginning and end of the study. As the patients were given more and more vaccinations, the incidence of lepromin conversion increased, more so in the patients receiving the mixed vaccine. Thus, 63%, 15% and 5% of the patients became lepromin positive in those patients receiving the mixed vaccine, BCG, and MDT only, respectively. Lamentably, the vaccine-induced lepromin positivity was temporary and faded away within several months. At the beginning of the study, the LMI test against specific M. leprae antigen was negative in all patients of both the Trial and Control Groups. After the end of the chemo-immunotherapy schedule, the LMI test became positive in 50% and 20% of LL patients receiving the mixed vaccine and BCG, respectively. None of the Control Group could show LMI positivity after completion of the MDT schedule. These results show that treatment of LL patients with the mixed vaccine and MDT could quickly reverse the clinical course of the disease, remove immunologic anergy in some patients, and induce a rapid decrease in the bacterial load in them.
本报告描述了一种有前景的治疗方案，即使用抗麻风病疫苗作为多药联合疗法（MDT）的辅助手段，治疗对麻风菌素无反应、晚期瘤型（LL）麻风病患者。试验组包括50例未经治疗、麻风菌素阴性、细菌载量高的LL患者。他们接受了2年的MDT治疗。其中，30例患者接种了一种混合抗麻风病疫苗，该疫苗包含人源灭活麻风分枝杆菌加牛分枝杆菌卡介苗（BCG）。其余20例患者接种了BCG。根据麻风菌素无反应的严重程度，每隔3个月给他们进行1至6次接种。对照组纳入了另外20例类似的LL患者。他们仅接受2年的MDT治疗。从研究开始，试验组和对照组的所有患者每3个月接受一次随访，以观察临床、细菌学和免疫学结果。2年内，试验组的所有50例患者以及对照组20例患者中的19例临床症状静止且细菌学检查转为阴性。然而，接受混合疫苗治疗的患者临床治愈以及细菌学和形态学指标下降的速度，比接受卡介苗加MDT或仅接受MDT治疗的患者要快得多。试验组和对照组患者的免疫学改善情况通过以下方式评估：a）在研究开始时以及每隔3个月进行麻风菌素检测，以及b）在研究开始和结束时进行体外白细胞迁移抑制（LMI）试验。随着患者接种疫苗次数的增加，麻风菌素阳转率上升，接受混合疫苗的患者上升幅度更大。因此，接受混合疫苗、BCG和仅接受MDT治疗的患者中，分别有63%、15%和5%的患者麻风菌素转为阳性。遗憾的是，疫苗诱导的麻风菌素阳性是暂时的，几个月内就会消失。研究开始时，试验组和对照组的所有患者针对特异性麻风分枝杆菌抗原的LMI试验均为阴性。化疗免疫治疗方案结束后，接受混合疫苗和BCG治疗的LL患者中，LMI试验分别有50%和20%转为阳性。MDT方案结束后，对照组无一例显示LMI阳性。这些结果表明，用混合疫苗和MDT治疗LL患者可迅速逆转疾病的临床进程，消除部分患者的免疫无反应性，并使他们的细菌载量迅速下降。
