盐酸伐昔洛韦治疗小儿水痘的随机对照多中心试验

[Randomized controlled multi-center trial for treatment of varicella in pediatric patients with hydrochloride valacyclovir].

作者信息

Yu Hui, Zhu Qi-rong, Wang Zhong-lin, Li Yue-fang, Wang Xiao-hong

机构信息

Department of Infectious Diseases, Children's Hospital of Fudan University, Shanghai 200032, China.

出版信息

Zhonghua Er Ke Za Zhi. 2008 Jun;46(6):454-6; discussion 456-7.

PMID:19099786

Abstract

OBJECTIVE

To evaluate the efficacy and safety of hydrochloride valacyclovir in treatment of varicella in pediatric patients between April 2006 and March 2007.

METHODS

A randomized controlled multi-center clinical trial was conducted in 5 pediatric centers, i.e., Children's Hospital of Fudan University, Children's Hospital of Zhejiang University, Children's Hospital of Nanjing Medical University, Pediatric Department of Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology and Children's Hospital, Chongqing University of Medical Sciences. Patients who were clinically diagnosed as varicella without any complications and were beyond 3 years of age were enrolled into the study from the out-patient clinics. The subjects were divided into two groups randomly, one was treated with hydrochloride valacyclovir, the other with ribavirin. There were 128 cases in the group treated with hydrochloride valacyclovir and 132 cases in control group treated with ribavirin. The treatment duration of two groups was five days. The clinical efficacy and safety were evaluated after the first day and the fourth day of the treatment and within three days after the end of the treatment. The clinical efficacy was assessed by efficacy index.

RESULTS

(1) The efficacy index on the fourth day of the therapy (0.80 +/- 0.24) in the valacyclovir group was significantly higher than that of ribavirin control group (0.59 +/- 0.37) (t = 5.42, P < 0.01). The efficacy index at the end of the treatment (0.86 +/- 0.14) in the hydrochloride valacyclovir group was also significantly higher than that (0.70 +/- 0.30) of the ribavirin control group (t = 5.43, P < 0.01). (2) In the valacyclovir and ribavirin groups, the effective rates on the fourth day of the therapy were 94.53% and 72.7% respectively (chi2) = 22.38, P < 0.01). The effective rates at the end of the therapy were 99.2% and 88.6%, respectively (chi(2) = 12.60, P < 0.01). The rates of cure of the two groups were 33.6% and 25.0% (chi2) = 2.32, P > 0.05). (3) No severe adverse drug reactions were observed in any of the two groups.

CONCLUSIONS

The hydrochloride valacyclovir was safe, reliable and convenient in treatment of uncomplicated varicella in children.

摘要

目的

评价2006年4月至2007年3月期间盐酸伐昔洛韦治疗小儿水痘的疗效及安全性。

方法

在5家儿科中心进行随机对照多中心临床试验，这5家中心分别为复旦大学附属儿科医院、浙江大学医学院附属儿童医院、南京医科大学附属儿童医院、华中科技大学同济医学院附属同济医院儿科及重庆医科大学附属儿童医院。将门诊临床诊断为水痘且无任何并发症、年龄大于3岁的患者纳入研究。受试者随机分为两组，一组接受盐酸伐昔洛韦治疗，另一组接受利巴韦林治疗。盐酸伐昔洛韦治疗组128例，利巴韦林对照组132例。两组治疗疗程均为5天。在治疗第1天、第4天及治疗结束后3天内评估临床疗效及安全性。临床疗效采用疗效指数进行评估。

结果

（1）伐昔洛韦组治疗第4天的疗效指数（0.80±0.24）显著高于利巴韦林对照组（0.59±0.37）（t = 5.42，P < 0.01）。盐酸伐昔洛韦组治疗结束时的疗效指数（0.86±0.14）也显著高于利巴韦林对照组（0.70±0.30）（t = 5.43，P < 0.01）。（2）伐昔洛韦组和利巴韦林组治疗第4天的有效率分别为94.53%和72.7%（χ² = 22.38，P < 0.01）。治疗结束时的有效率分别为99.2%和88.6%（χ² = 12.60，P < 0.01）。两组的治愈率分别为33.6%和25.0%（χ² = 2.32，P > 0.05）。（3）两组均未观察到严重药物不良反应。