Fife Kenneth H, Warren Terri J, Ferrera R David, Young Douglas G, Justus Scott E, Heitman Catherine K, Burroughs Scott M
Indiana University School of Medicine, Room 435 Emerson Hall, 545 Barnhill Dr, Indianapolis, IN 46202, USA.
Mayo Clin Proc. 2006 Oct;81(10):1321-7. doi: 10.4065/81.10.1321.
To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir in reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in Immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.
From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 6 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-blind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and Instructed to take 2 caplets once daily without regard to meals for 60 days. Daily genital and anal or rectal swabs were self-collected during the 60-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay.
One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 60 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (P < .001), a 58% reduction in subclinical shedding (P < .001), and a 64% reduction in clinical shedding (P = .01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo.
This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy that significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.
确定与安慰剂相比，每日服用1克伐昔洛韦进行抑制性治疗在减少确诊为复发性单纯疱疹病毒2型（HSV-2）生殖器疱疹的免疫功能正常患者的总（临床和亚临床）HSV-2脱落方面的疗效。
从2004年6月18日至2004年12月17日，来自美国27个地点的每年有6次或更多生殖器疱疹复发史的患者按3:1的比例随机分组，接受1克/天的伐昔洛韦或安慰剂。在双盲抑制性治疗期间，为患者提供研究药物（500毫克伐昔洛韦胶囊或匹配的安慰剂），并指示他们每天服用2粒胶囊，不考虑用餐情况，持续60天。在为期60天的研究期间，患者每天自行采集生殖器、肛门或直肠拭子，通过定量型特异性聚合酶链反应测定法评估HSV-2病毒脱落情况。
152名患者被随机纳入本研究，43名接受安慰剂，109名接受1克/天的伐昔洛韦。共有134名患者完成了研究（40名接受安慰剂[93%]，94名接受伐昔洛韦[86%]），18名患者提前退出（3名接受安慰剂[7%]，15名接受伐昔洛韦[14%]）。与安慰剂相比，伐昔洛韦在整个60天内显著降低了总（临床和亚临床）HSV-2脱落的天数百分比。在意向性治疗人群中，总脱落减少了71%（P < .001），亚临床脱落减少了58%（P < .001），临床脱落减少了64%（P = .01）。与安慰剂相比，伐昔洛韦未出现任何显著的毒性作用。
本研究表明，在确诊为复发性HSV-2生殖器疱疹的免疫功能正常患者中，每天服用1克伐昔洛韦，持续60天，通常耐受性良好，是一种有效的抑制性治疗方法，与安慰剂相比，能显著减少总（临床和亚临床）HSV-2脱落。
