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肌苷普拉诺贝与阿昔洛韦治疗中国患者复发性唇疱疹和复发性生殖器疱疹的多中心随机研究。

Multicenter randomized study of inosine pranobex versus acyclovir in the treatment of recurrent herpes labialis and recurrent herpes genitalis in Chinese patients.

作者信息

You Yi, Wang Li, Li Yafei, Wang Qianqiu, Cao Shuanglin, Tu Yating, Li Shenqiu, Bai Li, Lu Jianyun, Wei Zhiping, Chen Wenchieh, Hao Fei

机构信息

Department of Dermatology, Southwest Hospital, Nanjing, China.

Department of Epidemiology, College of Preventive Medicine, Third Military Medical University, Chongqing, China.

出版信息

J Dermatol. 2015 Jun;42(6):596-601. doi: 10.1111/1346-8138.12845. Epub 2015 Mar 26.

DOI:10.1111/1346-8138.12845
PMID:25819042
Abstract

The objective of the study is to evaluate the efficacy and safety of oral inosine pranobex as compared with acyclovir in the treatment of recurrent herpes labialis (RHL) and recurrent herpes genitalis (RHG). A multicenter double-blind, double-dummy, randomized, controlled, parallel group trial was conducted in 144 patients with RHL and 144 RHG. Patients were assigned to treatment in one of two groups: (i) inosine pranobex group (active inosine pranobex, 1 g four times daily, and acyclovir placebo); or (ii) acyclovir group (active acyclovir, 200 mg five times daily, and inosine pranobex placebo). The total symptom score (TSS) of patients with RHL did not differ in the inosine pranobex and acyclovir group on the 3rd or 7th day of treatment. There was also no difference in the efficacy rates between the two groups. No difference of TSS was observed between patients with RHG taking inosine pranobex and acyclovir on days 3 or 5 of the treatment, respectively. The short-term clinical recurrence rate of RHG at 3-month follow-up was much lower in the inosine pranobex group than acyclovir group. The incidence of hyperuricemia was higher in the inosine pranobex group than acyclovir group. In conclusion, inosine pranobex was as effective as acyclovir in treating RHL and RHG with significantly greater reduction of the short-term recurrence rate of herpes genitalis at 3-month follow up. Long-term recurrence rates at 6 months or longer remain to be determined. Hyperuricemia should be monitored during the treatment.

摘要

本研究的目的是评估口服异丙肌苷与阿昔洛韦相比,在治疗复发性唇疱疹(RHL)和复发性生殖器疱疹(RHG)方面的疗效和安全性。对144例RHL患者和144例RHG患者进行了一项多中心双盲、双模拟、随机、对照、平行组试验。患者被分配到以下两组之一进行治疗:(i)异丙肌苷组(活性异丙肌苷,每日4次,每次1 g,以及阿昔洛韦安慰剂);或(ii)阿昔洛韦组(活性阿昔洛韦,每日5次,每次200 mg,以及异丙肌苷安慰剂)。在治疗的第3天或第7天,RHL患者的总症状评分(TSS)在异丙肌苷组和阿昔洛韦组中没有差异。两组的有效率也没有差异。在治疗的第3天或第5天,分别服用异丙肌苷和阿昔洛韦的RHG患者之间未观察到TSS差异。在3个月随访时,RHG的短期临床复发率在异丙肌苷组中比阿昔洛韦组低得多。异丙肌苷组的高尿酸血症发生率高于阿昔洛韦组。总之,异丙肌苷在治疗RHL和RHG方面与阿昔洛韦一样有效,在3个月随访时生殖器疱疹的短期复发率显著降低。6个月或更长时间的长期复发率仍有待确定。治疗期间应监测高尿酸血症。

相似文献

1
Multicenter randomized study of inosine pranobex versus acyclovir in the treatment of recurrent herpes labialis and recurrent herpes genitalis in Chinese patients.肌苷普拉诺贝与阿昔洛韦治疗中国患者复发性唇疱疹和复发性生殖器疱疹的多中心随机研究。
J Dermatol. 2015 Jun;42(6):596-601. doi: 10.1111/1346-8138.12845. Epub 2015 Mar 26.
2
Comparative studies of inosine pranobex and acyclovir.肌苷普拉诺贝和阿昔洛韦的对比研究。
Am J Med. 1988 Aug 29;85(2A):7-9.
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Treatment of first-attack genital herpes--acyclovir versus inosine pranobex.初发性生殖器疱疹的治疗——阿昔洛韦与异丙肌苷比较
Lancet. 1987 May 23;1(8543):1171-3. doi: 10.1016/s0140-6736(87)92144-1.
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Suppression of frequently recurring genital herpes: acyclovir v inosine pranobex.频繁复发的生殖器疱疹的抑制作用:阿昔洛韦与异丙肌苷比较
Genitourin Med. 1989 Apr;65(2):103-5. doi: 10.1136/sti.65.2.103.
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Inosine pranobex and mucocutaneous herpes.异丙肌苷与皮肤黏膜疱疹
Lancet. 1985 Jan 26;1(8422):200-1.
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Inosiplex in recurrent herpes simplex infection.肌苷在复发性单纯疱疹感染中的应用。
Lancet. 1982 Oct 23;2(8304):926. doi: 10.1016/s0140-6736(82)90884-4.
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Acyclovir vs isoprinosine (immunovir) for suppression of recurrent genital herpes simplex infection.阿昔洛韦与异丙肌苷(免疫病毒)用于抑制复发性单纯疱疹生殖器感染的比较。
Genitourin Med. 1992 Oct;68(5):312-6. doi: 10.1136/sti.68.5.312.
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Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies.伐昔洛韦预防复发性唇疱疹:2项双盲、安慰剂对照研究。
Cutis. 2003 Mar;71(3):239-42.
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Efficacy of acyclovir in the treatment of recurring herpes labialis, genitalis and acute herpes zoster.阿昔洛韦治疗复发性唇疱疹、生殖器疱疹及急性带状疱疹的疗效。
J Chemother. 1989 Jul;1(4 Suppl):1117-8.
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Oral acyclovir to suppress frequently recurrent herpes labialis. A double-blind, placebo-controlled trial.口服阿昔洛韦抑制复发性唇疱疹。一项双盲、安慰剂对照试验。
Ann Intern Med. 1993 Feb 15;118(4):268-72. doi: 10.7326/0003-4819-118-4-199302150-00004.

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Inosine pranobex is safe and effective for the treatment of subjects with confirmed acute respiratory viral infections: analysis and subgroup analysis from a Phase 4, randomised, placebo-controlled, double-blind study.肌苷普拉诺贝对确诊的急性呼吸道病毒感染患者的治疗安全有效:来自一项4期随机、安慰剂对照、双盲研究的分析和亚组分析。
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