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中药补中益气汤对人流感疫苗接种后抗体滴度无影响:一项随机、安慰剂对照、双盲试验。

No effect of a traditional Chinese medicine, Hochu-ekki-to, on antibody titer after influenza vaccination in man: a randomized, placebo-controlled, double-blind trial.

作者信息

Hamazaki K, Sawazaki S, Itomura M, Huan M, Shibahara N, Kawakita T, Kobayashi S, Hamazaki T

机构信息

Division of Clinical Application, Department of Clinical Sciences, Institute of Natural Medicine, University of Toyama, Toyama-city, Toyama 9300194, Japan.

出版信息

Phytomedicine. 2007 Jan;14(1):11-4. doi: 10.1016/j.phymed.2006.02.002. Epub 2006 Apr 27.

Abstract

BACKGROUND

It was shown that a traditional Chinese medicine, Hochu-ekki-to (HET), had adjuvant effects in influenza vaccination in an animal experiment. This, however, could not be assessed in a clinical study.

METHODS

Thirty-two healthy subjects were randomly assigned to two groups (control and HET groups) in a double-blind manner. HET subjects (n=17) took 7.5 g of HET/day for two weeks; control subjects took the same amount of indistinguishable placebo. Then subjects were vaccinated against influenza (H1N1, H3N2 and B/Shandong). Hemagglutinin titers and natural killer (NK) activity were measured at weeks 0, 1, 2, 4, and 12.

RESULTS

Antiinfluenza titers against the three viruses were increased continuously for the first two weeks and leveled off. However, there were no significant differences in any titers between the two groups. NK activity peaked at week 2 without any inter-group differences.

CONCLUSION

We could not find any adjuvant effects of HET in this experimental condition.

摘要

背景

在一项动物实验中表明,一种中药,补中益气汤(HET),在流感疫苗接种中具有佐剂作用。然而,这在临床研究中无法评估。

方法

32名健康受试者以双盲方式随机分为两组(对照组和HET组)。HET组受试者(n = 17)每天服用7.5克HET,持续两周;对照组受试者服用等量难以区分的安慰剂。然后受试者接种流感疫苗(H1N1、H3N2和B/山东株)。在第0、1、2、4和12周测量血凝素滴度和自然杀伤(NK)活性。

结果

针对三种病毒的抗流感滴度在前两周持续升高,之后趋于平稳。然而,两组之间的任何滴度均无显著差异。NK活性在第2周达到峰值,组间无差异。

结论

在本实验条件下,我们未发现HET有任何佐剂作用。

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