Episodic acyclovir therapy as part of syndromic management among men presenting with genital ulcer disease: is there benefit?
Episodic acyclovir therapy as part of syndromic management among men presenting with genital ulcer disease: is there benefit?
复制标题
情节性阿西克罗维尔疗法是伴有生殖器溃疡疾病的男性中综合症管理的一部分：有益吗？
DOI：
10.1007/s11908-010-0089-0
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发表时间：
2010-09
影响因子：
3.1
通讯作者：
Bachmann LH
中科院分区：
文献类型：
--
作者：
Bachmann LH
AimsTo确定间歇性阿昔洛韦治疗的一部分，对疱疹性生殖器溃疡的持续时间和HIV-1 RNA病变shedding.MethodsA的综合征管理的GUD的影响，共615名男性，年龄范围从18岁至60岁，包括在这个双盲，安慰剂对照试验在南非的三个诊所从2005年3月至2006年12月进行。参与者被随机分配到阿昔洛韦，400毫克，每天三次，为期5天，或安慰剂，添加到常规综合征治疗的GUD。作为标准GUD综合征管理的一部分，所有研究参与者均接受苄星青霉素2.4 MU肌内注射和环丙沙星500 mg口服。参与者接受了采访，生殖器检查，并收集血液用于HIV，HSV-2和梅毒血清学，血浆HIV-1病毒载量和CD 4细胞检测。检测生殖器溃疡中的梅毒螺旋体、杜克雷嗜血杆菌、HSV、沙眼衣原体L1-L3，以及HIV-1 RNA和HSV-2 DNA脱落量。溃疡愈合定义为溃疡面积减少90%或更多或完全上皮再生。溃疡愈合的患者报告也用于确定中位溃疡持续时间。在第2天或第4天、第7天、第14天和第28天对HIV阳性个体进行评估，HIV阴性参与者返回进行定期随访，直到第28天。635人合格，615人随机分配（309人服用阿昔洛韦，306人服用安慰剂），每组28人失访。和那些留在研究中的人。在入组者中，387例（63.0%）为HIV血清阳性，434例（70.6%）为HSV-2血清阳性;生殖器溃疡的73.6%为疱疹性。阿昔洛韦组溃疡出现的中位时间为5.0天，安慰剂组为6.0天（P= 0.08）。治疗组在所有参与者和患有疱疹性溃疡的HIV阳性参与者中平衡。通过自我报告和药丸计数，两组的依从性均> 85%。
AimsTo determine the impact of episodic acyclovir therapy as part of the syndromic management of GUD on herpetic genital ulcer duration and HIV-1 RNA lesional shedding.MethodsA total of 615 men ranging in age from 18 to 60 years were included in this double-blind, placebo-controlled trial conducted in three clinics in South Africa from March 2005 through December 2006. Participants were randomly assigned to either acyclovir, 400 mg three times a day for 5 days or placebo, added to the routine syndromic therapy of GUD. All study participants received benzathine penicillin, 2.4 MU intramuscularly and ciprofloxacin, 500 mg orally as part of standard GUD syndromic management. Participants underwent an interview, genital examination, and collection of blood for HIV, HSV-2 and syphilis serologies, plasma HIV-1 viral load, and CD4 cell testing. Genital ulcers were tested for Treponema pallidum, Haemophilus ducreyi, HSV, Chlamydia trachomatis L1-L3, and for the quantity of HIV-1 RNA and HSV-2 DNA shedding. Ulcer healing was defined as either a reduction of 90% or more of ulcer area or complete reepithelialization. Patient reports of ulcer healing were also used to determine median ulcer duration. HIV-positive individuals were assessed on days 2 or 4, 7, 14, and 28 and HIV-negative participants returned for periodic follow-up visits through day 28.ResultsA total of 1,559 men were screened, 635 were eligible and 615 were randomly assigned (309 to acyclovir and 306 to placebo) with 28 individuals lost to follow-up in each arm. There were no differences by treatment arm and baseline characteristics between individuals lost to follow-up and those who remained in the study. Among the enrollees, 387 (63.0%) were HIV seropositive and 434 (70.6%) were HSV-2 seropositive; 73.6% of the genital ulcers were herpetic. The ulcer had been present a median of 5.0 days before presentation in the acyclovir group vs 6.0 days in the placebo group (P= 0.08). Treatment arms were balanced among all participants and HIV-positive participants with a herpetic ulcer. Adherence was> 85% in both arms by self-report and by pill count.