Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an openlabel non-inferiority randomized controlled trial
Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an openlabel non-inferiority randomized controlled trial
复制标题
必敏汤治疗常年性过敏性鼻炎的疗效：开放标签非劣效性随机对照试验
DOI：
10.1186/s13063-019-3763-z
复制
发表时间：
2019-12-30
期刊：
影响因子：
2.5
通讯作者：
Wang, Junge
中科院分区：
文献类型：
--
作者：
Zhao, Jingyi;Yan, Xinyu;Wang, Junge
背景
变应性鼻炎是一种常见的过敏性疾病。它影响着世界各地的人们，中医药在AR患者中越来越受欢迎，因为它具有明确的临床效果，而且不良反应很少。肺气虚寒证是变应性鼻炎的常见证型，中药鼻敏汤是治疗肺气虚寒证的常用方剂，本研究比较了中药鼻敏汤与常规药物氯雷他定、氟替卡松鼻喷雾剂治疗肺气虚寒证变应性鼻炎的临床疗效。
方法
该研究是一项开放标签非劣效性随机对照试验。2017年1月至2018年4月，北京中医医院中心计算机系统将108例19 - 60岁LQDCS AR患者按1：1比例随机分配至BMD组或对照组。共有98名参与者完成了研究（BMD组n = 51，对照组n = 47）。BMD组给予BMD治疗，对照组给予氟替卡松喷鼻剂和氯雷他定片治疗，疗程均为4周。主要结局是基线和治疗结束时总鼻症状评分（TNSS）的变化。鼻结膜炎生活质量问卷（RQLQ）、鼻阻力和声学阻力参数的变化是次要结局。记录治疗引起的所有副作用。
结果
治疗4周后，两组的总TNSS与基线相比均显著降低（P 0.05）。未观察到TNSS评分变化的显著组间差异[-0.298（95%置信区间-0.640至0.140）]，其在定义的非劣效性界值范围内。两组的RQLQ均较基线显著降低（P 0.001），但BMD组的降低更明显（P 0.001）。治疗后，两组之间的鼻阻力、鼻体积或鼻最小横截面积无显著差异（P 0.05）。
结论
这些发现表明，BMD有助于缓解常年性AR的症状，并改善鼻炎相关的生活质量。我们的研究表明，对于LQDCS的AR患者，BMD不劣于氯雷他定片剂和氟替卡松鼻喷雾剂。
试验注册
中国临床试验注册中心，ChiCTR-INR-16010063。于2016年12月2日注册。
Background
Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray.
Methods
The study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded.
Results
After the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P 0.05). No significant between-groups differences were observed for changes in TNSS scores [− 0.298 (95% confidence interval −0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P 0.001) from baseline, though a more obvious reduction was observed for the BMD group (P 0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P 0.05).
Conclusions
These findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS.
Trial registration
Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.