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亚砷酸 30cH 预防 DPT-HepB-脊灰疫苗接种后发热发作的疗效 - 一项随机、双盲、安慰剂对照临床试验。

Efficacy of Arsenicum album 30cH in preventing febrile episodes following DPT-HepB-Polio vaccination - a randomized, double-blind, placebo-controlled clinical trial.

机构信息

Dept. of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Drainage Canal Road, Doomurjala, Howrah, Pin code 711104, West Bengal, India.

Dept. of Community Medicine, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Drainage Canal Road, Doomurjala, Howrah, West Bengal, 711104 India.

出版信息

Complement Ther Med. 2018 Feb;36:59-62. doi: 10.1016/j.ctim.2017.11.020. Epub 2017 Dec 2.

DOI:10.1016/j.ctim.2017.11.020
PMID:29458932
Abstract

BACKGROUND

Among the post-immunization adverse events, especially of Diphtheria-Pertusis-Tetanus (DPT), fever is a common systemic reaction. There is anecdotal support for the use of the homeopathic medicine Arsenicum album in preventing post-vaccination fever. The investigators intended to evaluate its efficacy in preventing febrile episodes following vaccination.

METHODS

In the community medicine out-patient of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India, between August 2014 and January 2017, a double-blind, randomized, placebo-controlled trial was conducted on 120 children (verum: 60, placebo: 60) who presented for the 2nd and 3rd dose of DPT-HepB-Polio vaccination and reported febrile episodes following the 1st dose. Intervention used was Arsenicum album 30cH 6 doses or placebo (indistinguishable from verum), thrice daily for two subsequent days. Parents were advised to report any event of febrile attacks within 48h of vaccination, either directly or over telephone.

RESULTS

The groups were comparable at baseline. Children reporting fever after the 2nd dose was 29.8% and 30.4% respectively for the homeopathy group and control group respectively [Relative Risk (RR)=1.008] with no significant difference (P=0.951) between groups. Again after the 3rd dose, children reporting fever were 31.5% and 28.3% respectively for the homeopathy group and control group respectively (RR=0.956) with no significant difference (P=0.719) between groups.

CONCLUSION

Empirically selected Arsenicum album 30cH could not produce differentiable effect from placebo in preventing febrile episodes following DPT-HepB-Polio vaccination. [Trial registration: CTRI/2017/02/007939].

摘要

背景

在疫苗接种后的不良反应中,发热是一种常见的全身反应。有传闻支持使用顺势疗法药物砷剂来预防接种后发热。研究人员旨在评估其在预防接种后发热发作中的疗效。

方法

在印度西孟加拉邦 Mahesh Bhattacharyya 顺势疗法医学院和医院的社区医学门诊,2014 年 8 月至 2017 年 1 月期间,对 120 名儿童(真药组:60 名,安慰剂组:60 名)进行了双盲、随机、安慰剂对照试验,这些儿童在接受第 2 剂和第 3 剂 DPT-乙肝-Polio 疫苗接种后出现发热症状,并在第 1 剂后出现发热症状。干预措施是使用砷剂 30cH 6 剂或安慰剂(与真药无法区分),连续 2 天每天 3 次。父母被建议在接种后 48 小时内直接或通过电话报告任何发热发作事件。

结果

两组在基线时具有可比性。接受第 2 剂疫苗后报告发热的儿童,顺势疗法组和对照组分别为 29.8%和 30.4%[相对风险(RR)=1.008],两组之间无显著差异(P=0.951)。再次接受第 3 剂疫苗后,报告发热的儿童,顺势疗法组和对照组分别为 31.5%和 28.3%[RR=0.956],两组之间无显著差异(P=0.719)。

结论

经验性选择的砷剂 30cH 不能在预防 DPT-乙肝-Polio 疫苗接种后发热发作方面产生与安慰剂不同的效果。[临床试验注册号: CTRI/2017/02/007939]

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