Local infiltration of rabies immunoglobulins without systemic intramuscular administration: An alternative cost effective approach for passive immunization against rabies

Local infiltration of rabies immunoglobulins without systemic intramuscular administration: An alternative cost effective approach for passive immunization against rabies
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DOI:
10.1080/21645515.2015.1085142
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发表时间:
2016-01-01
影响因子:
4.8
通讯作者:
Belludi, Ashwin Yajaman
Belludi, Ashwin Yajaman
中科院分区:
医学3区
文献类型:
--
作者:
Bharti, Omesh Kumar;Madhusudana, Shampur Narayan;Belludi, Ashwin Yajaman

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目前狂犬病免疫球蛋白(RIG)的剂量是狂犬病暴露后预防(PEP)的一个组成部分,是根据体重计算的,尽管建议是渗透到伤口。这种做法需要大量RIG,许多患者可能负担不起。在此背景下,我们开展了这项研究,以了解是否可以根据现有的科学证据,通过限制被动免疫仅局部浸润而避免全身肌肉注射来减少RIG的数量和成本。269例被疑似或确诊狂犬病犬/动物咬伤的III类患者伤口内及周围感染马狂犬病免疫球蛋白(ERIGs)。ERIG的使用数量与伤口的大小和数量成比例,而与体重无关。随后,他们通过皮内途径进行了常规的狂犬病疫苗接种。根据目前基于体重的建议,所有这些病例需要363瓶RIG,而他们只需要42瓶5ml RIG。rig的最小剂量为0.25 ml,最大剂量为8 ml。平均每位患者需要1.26 ml rig,费用为150卢比(3美元)。随访9个月,观察结束时均健康正常。在需要少量RIG的局部渗透下,RIG可以在市场供应短缺时提供给所有患者。采用快速荧光焦点抑制试验(RFFIT)对30例(11%)患者血清进行狂犬病毒中和抗体检测,第14天抗体滴度均为bb0 0.5 IU/mL。在任何情况下,剂量都不高于基于体重的所需剂量,也没有导致免疫抑制。总之,这项试点研究表明,在市场上无法获得或贫困患者负担不起的情况下,需要考虑RIG的局部渗透。这项初步研究需要在其他中心进行更大规模的长期随访,以证实我们的研究结果。
Presently the dose of rabies immunoglobulin (RIG) which is an integral part of rabies post exposure prophylaxis (PEP) is calculated based on body weight though the recommendation is to infiltrate the wound(s). This practice demands large quantities of RIG which may be unaffordable to many patients. In this background, we conducted this study to know if the quantity and cost of RIG can be reduced by restricting passive immunization to local infiltration alone and avoiding systemic intramuscular administration based on the available scientific evidence. Two hundred and sixty nine category III patients bitten by suspect or confirmed rabid dogs/animals were infiltrated with equine rabies immunoglobulin (ERIGs) in and around the wound. The quantity of ERIG used was proportionate to the size and number of wounds irrespective of their body weight. They were followed with a regular course of rabies vaccination by intra-dermal route. As against 363 vials of RIGs required for all these cases as per current recommendation based on body weight, they required only 42 vials of 5ml RIG. Minimum dose of RIGs given was 0.25 ml and maximum dose given was 8 ml. On an average 1.26 ml of RIGs was required per patient that costs Rs. 150 ($3). All the patients were followed for 9 months and they were healthy and normal at the end of observation period. With local infiltration, that required small quantities of RIG, the RIGs could be made available to all patients in times of short supply in the market. A total of 30 (11%) serum samples of patients were tested for rabies virus neutralizing antibodies by the rapid fluorescent focus inhibition test (RFFIT) and all showed antibody titers >0.5 IU/mL by day 14. In no case the dose was higher than that required based on body weight and no immunosuppression resulted. To conclude, this pilot study shows that local infiltration of RIG need to be considered in times of non-availability in the market or unaffordability by poor patients. This preliminary study needs to be done on larger scale in other centers with long term follow up to substantiate the results of our study.