Hasin Tal, Davidovitch Nadav, Cohen Regev, Dagan Tsachi, Romem Ayal, Orr Nadav, Klement Eyal, Lubezky Nir, Kayouf Raid, Sela Tamar, Keller Nathan, Derazne Estela, Halperin Tamar, Yavzori Miri, Grotto Itamar, Cohen Dani
Medical Corps, Israel Defense Force, Military Post 02149, , Tel Aviv, Israel.
N Engl J Med. 2006 Jul 13;355(2):148-55. doi: 10.1056/NEJMoa053884.
Tick-borne relapsing fever (TBRF) is an acute febrile illness. In Israel, TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We examined the safety and efficacy of postexposure treatment to prevent TBRF.
In a double-blind, placebo-controlled trial, 93 healthy subjects with suspected tick exposure (52 with signs of tick bites and 41 close contacts--those without signs but with a similar risk of contact with ticks) were randomly assigned to receive either doxycycline (Dexxon, in a dose of 200 mg the first day and then 100 mg per day for four days) or placebo after presumed exposure to TBRF. Cases of TBRF were defined by fever and a positive blood smear. Serologic analysis for cross-reactivity to Borrelia burgdorferi and polymerase chain reaction (PCR) for the borrelia glpQ gene were also performed.
After randomization, 47 subjects (26 with signs of tick bites and 21 close contacts) received doxycycline. Forty-six other subjects (26 with signs of tick bites and 20 close contacts) received placebo. All 10 cases of TBRF identified by a positive blood smear were in the placebo group of subjects with signs of a tick bite (P<0.001). These findings suggested a 100 percent efficacy of preemptive treatment (95 percent confidence interval, 46 to 100 percent). PCR for the borrelia glpQ gene was negative at baseline for all subjects and subsequently positive in all subjects with fever and a positive blood smear. Seroconversion was detected in eight of nine cases of TBRF. PCR and serum samples were negative for all of the other subjects tested. No major treatment-associated adverse effects were identified.
Treatment with doxycycline is safe and efficacious in preventing TBRF after suspected exposure to ticks in a high-risk environment. (ClinicalTrials.gov number, NCT00237016 [ClinicalTrials.gov].).
蜱传回归热(TBRF)是一种急性发热性疾病。在以色列,TBRF由波斯疏螺旋体引起,通过托氏钝缘蜱传播。我们研究了暴露后预防TBRF治疗的安全性和有效性。
在一项双盲、安慰剂对照试验中,93名疑似蜱暴露的健康受试者(52名有蜱叮咬迹象,41名密切接触者——无迹象但有类似蜱接触风险者)在假定暴露于TBRF后被随机分配接受强力霉素(第一天剂量200mg,随后4天每天100mg)或安慰剂。TBRF病例根据发热和血涂片阳性定义。还进行了针对伯氏疏螺旋体的交叉反应血清学分析以及针对疏螺旋体glpQ基因的聚合酶链反应(PCR)。
随机分组后,47名受试者(26名有蜱叮咬迹象,21名密切接触者)接受了强力霉素。另外46名受试者(26名有蜱叮咬迹象,20名密切接触者)接受了安慰剂。通过血涂片阳性确定的所有10例TBRF病例均在有蜱叮咬迹象的受试者安慰剂组中(P<0.001)。这些发现表明先发治疗的有效率为100%(95%置信区间,46%至100%)。所有受试者基线时疏螺旋体glpQ基因的PCR均为阴性,随后所有发热且血涂片阳性的受试者均为阳性。9例TBRF病例中有8例检测到血清转化。所有其他检测受试者的PCR和血清样本均为阴性。未发现与治疗相关的重大不良反应。
在高风险环境中疑似蜱暴露后,使用强力霉素治疗预防TBRF是安全有效的。(ClinicalTrials.gov编号,NCT00237016 [ClinicalTrials.gov]。)