Chen Z L, Tang Q G, Wang Z M, Chen J
Zeng Yi Hospital, Shanghai, China.
Lepr Rev. 1993 Jun;64(2):117-27.
Although local reactions, including erythema, induration and ulcers, appeared in every patient after the injection of the combined HKML+BCG vaccine, they were accepted by the patients. There was no tendency for the local reaction to become aggravated after repeated vaccination. However, systemic reactions, mainly iridocyclitis and complaint of numbness of the fingers and toes, became quite common after the 5th vaccination and therefore significantly reduced the acceptability of vaccine by injection. It seems that repeated vaccination might activate the iridocyclitis, but the relationship between the complaint of numbness and vaccination has not been well established. Neither typical ENL nor reversal reaction had been observed throughout the trial. A significant proportion of patients converted to SMLA positivity after repeated vaccination. However, it seems the positive status was not stable as many of them reverted to negative after the following vaccination. After the 7th vaccination, the positive conversion rate to SMLA-I was 45% and to SMLA-II was 35%. After the 8th vaccination, 66.7% of patients converted to Mitsuda reaction positive, which has been confirmed by histopathological examination. Nevertheless, further follow-up is required in order to determine whether or not such conversion will be of a long duration. The reactions to SMLA-I and SMLA-II were associated but only correlated at a moderate level. Overall, the positive conversion rate to SMLA-I was significantly higher than that to SMLA-II after repeated vaccination. Neither the early reaction nor the late (Mitsuda) reaction of the lepromin test were correlated to either SMLA reaction. The repeated vaccination of HKML+BCG vaccine did not affect the weakly-positive anti-PGL-1 Mycobacterium leprae antibody level seen in the skin-smear negative lepromatous patients participating in this study.
尽管在注射HKML+卡介苗联合疫苗后，每位患者均出现了包括红斑、硬结和溃疡在内的局部反应，但患者均能接受。重复接种后，局部反应并无加重的趋势。然而，全身反应主要为虹膜睫状体炎以及手指和脚趾麻木感，在第5次接种后变得相当常见，因此显著降低了疫苗注射的可接受性。似乎重复接种可能会引发虹膜睫状体炎，但麻木感与接种之间的关系尚未明确确立。在整个试验过程中均未观察到典型的结节性红斑或逆向反应。相当一部分患者在重复接种后转为SMLA阳性。然而，这种阳性状态似乎并不稳定，因为许多患者在后续接种后又恢复为阴性。第7次接种后，SMLA-I的阳性转化率为45%，SMLA-II的阳性转化率为35%。第8次接种后，66.7%的患者转为 Mitsuda反应阳性，这已通过组织病理学检查得到证实。尽管如此，仍需要进一步随访以确定这种转化是否会持续较长时间。对SMLA-I和SMLA-II的反应相关，但仅呈中度相关。总体而言，重复接种后SMLA-I的阳性转化率显著高于SMLA-II。麻风菌素试验的早期反应和晚期（Mitsuda）反应均与SMLA反应无关。参与本研究的皮肤涂片阴性的瘤型麻风患者中，HKML+卡介苗联合疫苗的重复接种并未影响其弱阳性抗PGL-1麻风杆菌抗体水平。
