Bharti Omesh Kumar, Madhusudana Shampur Narayan, Gaunta Pyare Lal, Belludi Ashwin Yajaman
a State Institute of Health & Family Welfare Parimahal , Shimla , Himachal Pradesh , India.
b WHO CC for Reference and Research on Rabies Department of Neurovirology NIMHANS , Bangalore , India.
Hum Vaccin Immunother. 2016 Mar 3;12(3):837-42. doi: 10.1080/21645515.2015.1085142.
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.
目前,作为狂犬病暴露后预防(PEP)不可或缺一部分的狂犬病免疫球蛋白(RIG)剂量是根据体重计算的,尽管建议是对伤口进行浸润注射。这种做法需要大量的RIG,这对许多患者来说可能难以承受。在此背景下,我们开展了这项研究,以根据现有科学证据了解是否可以通过仅将被动免疫限制在局部浸润,避免全身肌肉注射,来减少RIG的用量和成本。269例被疑似或确诊患有狂犬病的狗/动物咬伤的III类患者在伤口及其周围浸润注射了马狂犬病免疫球蛋白(ERIGs)。ERIG的用量与伤口的大小和数量成比例,而与他们的体重无关。他们随后接受了常规的皮内狂犬病疫苗接种。按照目前基于体重的建议,所有这些病例需要363瓶RIG,而他们仅需要42瓶5毫升的RIG。RIG的最小用量为0.25毫升,最大用量为8毫升。每位患者平均需要1.26毫升RIG,成本为150卢比(3美元)。所有患者均随访9个月,观察期末他们均健康正常。通过局部浸润,所需RIG量较少,在市场供应短缺时可为所有患者提供RIG。通过快速荧光灶抑制试验(RFFIT)对30例(11%)患者的血清样本进行了狂犬病病毒中和抗体检测,所有样本在第14天的抗体滴度均>0.5 IU/mL。在任何情况下,剂量均不高于基于体重所需的剂量,且未导致免疫抑制。总之,这项初步研究表明,在市场上无法获得或贫困患者无力承担的情况下,应考虑对RIG进行局部浸润。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。