改良玉屏风散用于气虚体质老年人预防普通感冒:对照试验

Yiu Lin Wong, Jialing Zhang, Linda L. D. Zhong, David Moher, Zhaoxiang Bian
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引用次数: 0

摘要

改良玉屏风散(MJWB)可预防气虚体质老年人的普通感冒。在此之前,没有对照试验证据能够阐明中医体质理论中的 "治未病 "概念。该理论明确指出,增强气虚体质并调节其功能状态可预防普通感冒的发生。这项对照试验(ClinicalTrials.gov 识别码 NCT05640570)的研究对象是每年至少发生一次普通感冒的气虚体质香港老人。两个共同主要结果是气虚体质临床特征总分和普通感冒发病率。在为期 3 个月的预防研究中,109 名参与者中有 98 人(89.9%)完成了 "蠲痹活血汤 "治疗,109 名对照组参与者中有 100 人(91.7%)完成了治疗。与对照组相比,MJWB 能明显改善气虚体质的临床特征(平均差异 -2.9,95% CI -4.5 至 -1.3,P < 0.001)。它尤其改善了三个临床特征:"容易疲倦"(平均差异-0.6,95% CI -0.8至-0.3,p < 0.001)、"呼吸急促"(平均差异-0.2,95% CI -0.4至-0.1,p = 0.012)和 "缺乏活力"(平均差异-0.3,95% CI -0.5至-0.0,p = 0.021)。与预防基线相比,MJWB 组的 IgG 也有明显改善(p < 0.001)。然而,普通感冒发病率(奇数比 0.9,95% CI 0.5 至 1.6,p = 0.756)、持续天数(平均差 0.1,95% CI -1.4 至 1.5,p = 0.929)和中医综合征总分(平均差 -7.1,95% CI -21.6 至 7.4,p = 0.336)在两组之间没有差异。MJWB能明显改善气虚体质的临床特征和IgG水平,表明MJWB可能对参与者的相关临床症状及其潜在后果有所帮助。在普通感冒的发病率、持续时间和普通感冒症状评分方面,使用 "美芝活血汤 "者与未使用者之间没有明显的统计学差异。值得进行大规模试验,进一步研究麦积温丸对普通感冒的预防效果,以及气虚体质临床特征和 IgG 水平的改善是否有助于预防老年人普通感冒。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Modified Jade Wind-Barrier Formula (MJWB) for Preventing Common Cold in Elderly with Qi-deficiency Constitution: A Controlled Trial
The modified Jade Wind-Barrier formula (MJWB) may prevent the common cold in the elderly with a Qi-deficiency Constitution. Previously, no controlled trial evidence existed to illuminate the concept of “preventive treatment of disease” as outlined in the constitution theory of Traditional Chinese Medicine. This theory distinctly suggests that enhancing the Qi-deficiency Constitution and modulating its functional state can prevent the occurrence of the common cold. This controlled trial (ClinicalTrials.gov identifier NCT05640570) targeted Hong Kong elderly with Qi-deficiency Constitution with at least one common cold incidence per year. The two co-primary outcomes are the total score of the Qi-deficiency Constitution clinical features and the incidence of the common cold. Throughout the 3-month prevention study, 98 out of 109 (89.9%) participants in the MJWB arm and 100 out of 109 (91.7%) participants in the control arm finished the trial. MJWB significantly improved the clinical features of the Qi-deficiency Constitution compared to that in the control arm (mean difference -2.9, 95% CI -4.5 to -1.3, p < 0.001). It particularly improved the three clinical features: “Easily get tired” (mean difference -0.6, 95% CI -0.8 to -0.3, p < 0.001), “Shortness of breath” (mean difference -0.2, 95% CI -0.4 to -0.1, p = 0.012), and “Lack of energy” (mean difference -0.3, 95% CI -0.5 to -0.0, p = 0.021). MJWB also significantly improved IgG (p < 0.001) compared with the baseline of prevention among the MJWB arm. However, the common cold incidence (odd ratio 0.9, 95% CI 0.5 to 1.6, p = 0.756), the number of persistent days (mean difference 0.1, 95% CI -1.4 to 1.5, p = 0.929), and the total Traditional Chinese Medicine syndrome score (mean difference -7.1, 95% CI -21.6 to 7.4, p = 0.336) showed no difference between the two arms. MJWB can significantly improve the Qi-deficiency Constitution clinical features and the IgG level, suggesting that MJWB may be helpful for participants regarding the related clinical symptoms and their potential consequences. There is no statistically significant difference in the common cold incidence, the duration of its persistence, or the common cold symptom scores when comparing the MJWB users and the non-users. A large-scale trial is worth further investigating the preventive effect of MJWB for the common cold and whether the Qi-deficiency Constitution clinical features and the IgG level improvements can help prevent the common cold in the elderly.
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