An open, randomized comparative trial of two antivenoms for the treatment of envenoming by Sri Lankan Russell's viper (Daboia russelii russelii)

An open, randomized comparative trial of two antivenoms for the treatment of envenoming by Sri Lankan Russell's viper (Daboia russelii russelii)
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DOI:
10.1016/s0035-9203(01)90339-6
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发表时间:
2001-01-01
影响因子:
2.2
通讯作者:
Warrell, DA
Warrell, DA
中科院分区:
医学4区
文献类型:
--
作者:
Ariaratnam, CA;Sjöström, L;Warrell, DA

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罗素毒蛇(Daboia russelii russelii)是斯里兰卡发病率和死亡率的重要原因。在1985年的一项研究中,高达20克剂量的哈夫金马多特异性抗蛇毒血清被证明对清除抗原血症无效,并引起高发生率的类过敏反应。一种新的、单特异性的绵羊Fabantivenom (PolongaTAb(TM))已经针对斯里兰卡罗素蝰蛇的毒液开发出来,为了评估其安全性和有效性,我们(1997年)将其与该国目前使用的Haffkine抗蛇毒血清进行了公开、随机比较。Russell毒蛇咬伤后出现全身中毒的患者随机接受初始静脉注射剂量1 g PolongaTAb (n = 23)或10 g Haffkine抗蛇毒血清(n = 20)。在22例患者中,只有9例(41%)使用一剂PolongaTAb可永久恢复血液凝固性,13例需要重复给药,而大多数患者(14/20,70%)在使用一剂Haffkine抗蛇毒血清后可恢复血液凝固性。在Haffkine组中,局部肿胀和全身症状有更快消退的趋势。蛇毒抗原血症在Haffkine组消除得更快,绵羊Fab从循环中清除的速度比马F(ab')更快(2)。为了评估安全性,密切观察患者的不良反应。在使用Haffkine抗蛇毒血清出现严重反应后,该组所有后续患者均预防性使用氢化可的松和氯苯那敏。尽管如此,与PolongaTAb组相比,Haffkine组的不良反应发生率明显高于PolongaTAb组(81%比48%),前者组有4例患者发生严重过敏反应。总之,新的抗蛇毒血清比Haffkine抗蛇毒血清更安全,但为了避免重复剂量,在治疗斯里兰卡罗素毒蛇中毒时,需要高于Ig的初始剂量。这一较大剂量的安全性有待进一步研究。
Russell's viper (Daboia russelii russelii) is an important cause of morbidity and mortality in Sri Lanka. In a study in 1985, Haffkine equine polyspecific antivenom in doses up to 20 g proved ineffective in clearing antigenaemia and caused a high incidence of anaphylactoid reactions. A new, monospecific ovine Fabantivenom (PolongaTAb(TM)) has been developed against the venom of Sri Lankan Russell's viper and, to assess its safety and efficacy, we carried out (in 1997) an open, randomized comparison of this with the Haffkine antivenom currently in use in the country. Patients with systemic envenoming following Russell's viper bite were randomized to receive an initial intravenous dose of either 1 g of PolongaTAb (n = 23) or 10 g of Haffkine antivenom (n = 20). One dose of PolongaTAb permanently restored blood coagulability in only 9 (41%) of 22 patients and 13 needed repeated doses, whereas the majority (14/20; 70%) had restored coagulability after 1 dose of Haffkine antivenom. There was a tendency towards more rapid resolution of local swelling and systemic manifestations in the Haffkine group. Venom antigenaemia was eliminated more quickly in the Haffkine group and ovine Fab was cleared from the circulation more rapidly than equine F(ab')(2). To evaluate safety, patients were closely observed for adverse reactions. Following a severe reaction with Haffkine antivenom all subsequent patients in this group were treated prophylactically with hydrocortisone and chlorpheniramine. Despite this, the incidence of adverse reactions was significantly higher in the Haffkine group compared with the PolongaTAb group (81% compared with 48%) and 4 patients had a severe anaphylactic reaction in the former group. In conclusion, the new antivenom is safer than Haffkine antivenom but, to avoid repeated doses, an initial dose higher than Ig is needed in the treatment of Sri Lankan Russell's viper envenoming. The safety of this larger dose is the subject of further studies.