姜提取物对比氯雷他定治疗变应性鼻炎的随机对照试验。
Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial.
机构信息
Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand.
Department of Otolaryngology, Faculty of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand.
出版信息
BMC Complement Med Ther. 2020 Apr 20;20(1):119. doi: 10.1186/s12906-020-2875-z.
BACKGROUND
Allergic rhinitis (AR) is a non-infectious immune disease and incidents of the disease has continuously increased in Thailand. Ginger, a Thai herb, is used in food and Thai traditional medicine. This study was designed to assess efficacy and safety of ginger extract in comparison with loratadine for AR treatment.
METHODS
AR patients were treated with ginger extract 500 mg (n = 40) against those treated with loratadine 10 mg (n = 40) in a randomized, double-blind, controlled trial for 3 and 6 weeks. The efficacy was evaluated from clinical examinations i.e. total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ). The safety of treatment was measured by blood pressure, blood analysis and history-taking for side effects.
RESULTS
The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups. In acoustic rhinometry measurement, the ginger treated group significantly gradually increased the estimated volume of the nasal cavity and decreased distances from the nostril, but the loratadine treated group did not cause a change. Both groups gave significantly improvement in every aspect of the RQLQ at third weeks. The treatment with ginger extract was as safe as loratadine as shown by renal and liver function results obtained from blood analysis. Both treatments had no effect on blood pressure of the patients.
CONCLUSIONS
The ginger extract is as good as loratadine in improving nasal symptoms and quality of life in AR patients. However, ginger extract caused less side effects especially, drowsiness, fatigue, dizziness and constipation. Therefore, the ginger extract could be used as alternative treatment for patients with AR.
TRIAL REGISTRATION
Registered with ClinicalTrials.gov (Registration number: NCT02576808) on 15 October 2015.
背景
变应性鼻炎（AR）是一种非传染性免疫疾病，在泰国，该病的发病率不断上升。生姜是一种泰国草药，既用于食品也用于泰式传统药物。本研究旨在评估生姜提取物与氯雷他定治疗 AR 的疗效和安全性。
方法
在一项随机、双盲、对照临床试验中，40 例 AR 患者接受生姜提取物 500mg 治疗（n=40），40 例患者接受氯雷他定 10mg 治疗（n=40），疗程为 3 周和 6 周。通过临床检查评估疗效，即总鼻部症状评分（TNSS）、鼻声反射测量的鼻腔横截面积（ARM）和鼻结膜炎生活质量问卷（RQLQ）。通过测量血压、血液分析和询问副作用史来评估治疗的安全性。
结果
结果表明，生姜提取物和氯雷他定治疗组均能显著降低 TNSS 评分，但两组间无显著差异。在声反射测量中，生姜治疗组逐渐显著增加鼻腔估计容积，减小从鼻孔到鼻腔后部的距离，但氯雷他定治疗组未引起变化。两组在 RQLQ 的各个方面均在第 3 周时得到显著改善。如血液分析得出的肾功能和肝功能结果所示，生姜提取物治疗与氯雷他定治疗一样安全。两种治疗方法均未影响患者的血压。
结论
生姜提取物在改善 AR 患者的鼻部症状和生活质量方面与氯雷他定一样有效。然而，生姜提取物引起的副作用较少，特别是嗜睡、疲劳、头晕和便秘。因此，生姜提取物可作为 AR 患者的替代治疗方法。
试验注册
于 2015 年 10 月 15 日在 ClinicalTrials.gov 注册（注册号：NCT02576808）。
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