Balfour H H, Kelly J M, Suarez C S, Heussner R C, Englund J A, Crane D D, McGuirt P V, Clemmer A F, Aeppli D M
Department of Laboratory Medicine and Pathology, University of Minnesota Health Sciences Center, Minneapolis 55455.
J Pediatr. 1990 Apr;116(4):633-9. doi: 10.1016/s0022-3476(05)81618-x.
To determine whether acyclovir administered orally affects the duration and severity of varicella in otherwise normal children.
Randomized, placebo-controlled, double-blind trial.
Patients' residence and university hospital clinic.
One hundred five children between 5 and 16 years of age with laboratory-confirmed varicella entered the study. Of the 102 who were included in the final analysis, 50 received acyclovir and 52 received placebo.
Placebo or acyclovir was given orally four times daily, for 5 to 7 days. The acyclovir dose was adjusted as follows: 5 to 7 years of age, 20 mg/kg; 7 to 12 years, 15 mg/kg; and 12 to 16 years, 10 mg/kg.
Acyclovir recipients, compared with the placebo group, defervesced sooner (median, 1 day vs 2 days; p = 0.001), experienced onset of cutaneous healing sooner, as reflected by a decrease in number of lesions (median, 3 days vs 2 days; p = 0.002), and had fewer skin lesions (median, 500 vs 336; p = 0.02). Acyclovir did not significantly change the rate of complications of varicella (10% in the acyclovir group vs 13.5% among placebo subjects). Adverse drug effects were not observed. Acyclovir recipients had lower geometric mean serum antibody titers to varicella-zoster virus than their placebo counterparts 4 weeks after the onset of illness, but antibody titers in both groups were similar 1 year later.
These results provide evidence that acyclovir is useful and well tolerated for treatment of varicella in otherwise healthy children.
确定口服阿昔洛韦是否会影响健康儿童水痘的病程和严重程度。
随机、安慰剂对照、双盲试验。
患者家中及大学医院门诊。
105名5至16岁实验室确诊为水痘的儿童进入研究。最终纳入分析的102名儿童中,50名接受阿昔洛韦治疗,52名接受安慰剂治疗。
安慰剂或阿昔洛韦每日口服4次,持续5至7天。阿昔洛韦剂量调整如下:5至7岁,20mg/kg;7至12岁,15mg/kg;12至16岁,10mg/kg。
与安慰剂组相比,接受阿昔洛韦治疗的患者退热更快(中位数,1天对2天;p = 0.001),皮肤愈合开始更早,表现为皮疹数量减少(中位数,3天对2天;p = 0.002),且皮肤损伤更少(中位数,500对336;p = 0.02)。阿昔洛韦并未显著改变水痘并发症的发生率(阿昔洛韦组为10%,安慰剂组为13.5%)。未观察到药物不良反应。发病4周后,接受阿昔洛韦治疗的患者水痘-带状疱疹病毒的几何平均血清抗体滴度低于安慰剂组,但两组1年后的抗体滴度相似。
这些结果表明,阿昔洛韦对治疗健康儿童的水痘有效且耐受性良好。