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一项比较丝瓜络复方足跟鼻腔喷雾剂与色甘酸钠喷雾剂治疗季节性变应性鼻炎的疗效和安全性的随机等效性试验。

A randomized equivalence trial comparing the efficacy and safety of Luffa comp.-Heel nasal spray with cromolyn sodium spray in the treatment of seasonal allergic rhinitis.

作者信息

Weiser M, Gegenheimer L H, Klein P

机构信息

Institut für Antihomotoxische Medizin und Grundregulationsforschung, Baden-Baden, Mannheim, Germany.

出版信息

Forsch Komplementarmed. 1999 Jun;6(3):142-8. doi: 10.1159/000021239.

DOI:10.1159/000021239
PMID:10460983
Abstract

BACKGROUND

The objective of the clinical study was to investigate the efficacy and tolerance of a homeopathic nasal spray in cases of hay fever (seasonal allergic rhinitis) in comparison with the conventional intranasal cromolyn sodium therapy.

PATIENTS AND METHODS

In total, 146 outpatients with symptoms of hay fever were enrolled into the clinical study (randomized, double-blind, equivalence trial) (time of treatment: 42 days). The homeopathic remedy (Luffa comp.-Heel trade mark Nasal Spray, dosage: 0.14 ml per application, 4 times per a day / naris) consisted of a fixed combination made up of Luffa operculata, Galphimia glauca, histamine, and sulfur. The main outcome measure of the efficacy was the quality of life as measured by means of the Rhinoconjunctivitis Quality of Life-Questionnaire (RQLQ). The tolerance of the trial medication was registered by means of global assessment, rhinoscopy, recording of adverse events and with the aid of vital and laboratory parameters.

RESULTS

The results of the study demonstrate a quick and lasting effect of the treatment. This effect was independent from the medication applied and produced a nearly complete remission of the hay fever symptoms. The RQLQ global score changed significantly in the course of the treatment, indicating therapeutic equivalence between the two forms of treatment. Adverse systemic effects did not occur. Local adverse events appeared in 3 patients.

CONCLUSIONS

The study proved that, for the treatment of hay fever, the homeopathic nasal spray is as efficient and well tolerable as the conventional therapy with cromolyn sodium.

摘要

背景

本临床研究的目的是比较顺势疗法鼻喷雾剂与传统鼻内用色甘酸钠疗法治疗花粉症(季节性变应性鼻炎)的疗效和耐受性。

患者与方法

共有146例有花粉症症状的门诊患者纳入本临床研究(随机、双盲、等效性试验)(治疗时间:42天)。顺势疗法药物(路发复方——希尔商标鼻喷雾剂,剂量:每次用药0.14 ml,每侧鼻孔每日4次)由丝瓜、羽叶金虎尾、组胺和硫磺组成的固定复方制剂。疗效的主要衡量指标是通过变应性鼻结膜炎生活质量问卷(RQLQ)测量的生活质量。通过整体评估、鼻镜检查、记录不良事件以及借助生命体征和实验室参数来记录试验药物的耐受性。

结果

研究结果表明治疗具有快速且持久的效果。该效果与所应用的药物无关,且使花粉症症状几乎完全缓解。治疗过程中RQLQ总体评分有显著变化,表明两种治疗方式具有治疗等效性。未出现全身性不良反应。3例患者出现局部不良事件。

结论

该研究证明,对于花粉症的治疗,顺势疗法鼻喷雾剂与传统的色甘酸钠疗法一样有效且耐受性良好。

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