Compassionate Use of Yuanjiang Decoction, a Traditional Chinese Medicinal Prescription, for Symptomatic Bradyarrhythmia.
Compassionate Use of Yuanjiang Decoction, a Traditional Chinese Medicinal Prescription, for Symptomatic Bradyarrhythmia.
复制标题
富有同情的汤（一种传统的中国药物处方）对有症状的心律失常的使用。
DOI：
10.3389/fphar.2022.764930
复制
发表时间：
2022
影响因子：
5.6
通讯作者：
中科院分区：
文献类型：
--
作者：
背景：对于有症状的缓慢性心律失常没有有效的药物治疗，特别是在低社会经济地位（SES）人群中。 目的：探讨中药复方元江汤治疗症状性缓慢性心律失常的安全性和有效性。 方法：这项同情使用研究于2019年1月至2020年1月在中国北京进行。入选者口服元江汤（由6味中药组成）200 ml，每日2次，疗程16周。采用意向治疗（ITT）方法进行分析。主要结局指标是在16周时获得良好治疗结局的参与者比例。 结果：截至2020年1月，共纳入184例患者。经过16周的治疗，12名参与者失去联系，21名参与者终止了本研究，脱落率为17.93%。最常见的治疗相关不良事件是口干（6.52%）、便秘（6.45%）和嗜睡（3.26%）。治疗效果良好的患者比例4周时为65.22%，8周时为59.78（OR：1.11，95%CI：0.71-1.73），12周时为61.41%（OR：1.16，95%CI：0.92-1.45），16周时为60.87%（OR：1.15，95%CI：0.98-1.35）。在多因素回归分析中，在16周时良好的治疗结果与完成至少8周的治疗显著相关（OR：2.053，95%CI：1.064-3.560），而不良治疗结局与房室传导阻滞显著相关（OR：0.255，95%CI：0.083-0.784）、目前吸烟（OR：0.343，95%CI：0.027-0.487）、治疗前1个月晕厥（OR：0.321，95%CI：0.114-0.904）。 结论：该研究显示了元江汤治疗慢性乙型肝炎的良好疗效，且无严重不良反应。这项研究确定了可能影响结果的几个关键因素。这些发现有助于为大规模随机临床试验的设计提供信息并评估其可行性。
Background: No effective medication is available for symptomatic bradyarrhythmia, particularly in low socioeconomic status (SES) population. Objective: To explore the safety and efficacy of Yuanjiang decoction, a traditional Chinese medicinal prescription, for symptomatic bradyarrhythmia on a compassionate-use basis. Methods: This compassionate-use study was conducted in Beijing, China between January 2019 and January 2020. Eligible participants were recruited and treated with Yuanjiang decoction (composed of 6 Chinese herbal medicines), 200 ml twice daily for 16 weeks. Analyses were done with the intention-to-treat (ITT) approach. The primary outcome measure was the proportion of participants who achieved a favorable treatment outcome at 16 weeks. Results: As of January 2020, 184 patients were included. After 16-weeks treatment, 12 participants were lost to contact while 21 participants were terminated from this study, with a drop-out rate of 17.93%. The most common treatment-related adverse events were xerostomia (6.52%), constipation (6.45%) and sleepiness (3.26%). The proportion of participants with favorable treatment outcome was 65.22% at 4 weeks, 59.78% at 8 weeks (OR: 1.11, 95% CI: 0.71–1.73), 61.41% at 12 weeks (OR: 1.16, 95% CI: 0.92–1.45) and 60.87% at 16 weeks (OR: 1.15, 95% CI: 0.98–1.35). In the multifactor regression analysis, the favorable treatment outcome at 16 weeks was significantly associated with completing at least 8 weeks treatment (OR: 2.053, 95% CI: 1.064–3.560), while unfavorable treatment outcome was significantly associated with an atrioventricular block (OR: 0.255, 95% CI: 0.083–0.784), current smoking (OR: 0.343, 95% CI: 0.027–0.487), and syncope in the month before treatment (OR: 0.321, 95%CI: 0.114–0.904). Conclusion: This compassionate-use study showed encouraging outcomes of treatment with Yuanjiang decoction, without serious adverse events. This study identified several key factors that may affect outcomes. These findings helped inform the design and assess the feasibility of a large-scale randomized clinical trial.
登录
查看更多内容
DOI：
10.19540/j.cnki.cjcmm.20180226.002
发表时间：
2018-05-01
期刊：
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
影响因子：
--
作者：
Dong, Yan;Yao, Kui-Wu;Wang, Jie
通讯作者：
Wang, Jie
影响因子：
24
作者：
George, Jacob;Hussain, Muhammad;Lang, Chim C.
通讯作者：
Lang, Chim C.
影响因子：
5.4
作者：
Heinrich, Michael;Appendino, Giovanni;Viljoen, Alvaro
通讯作者：
Viljoen, Alvaro
影响因子：
9.8
作者：
Breivik, H.;Borchgrevink, P. C.;Stubhaug, A.
通讯作者：
Stubhaug, A.
影响因子：
24
作者：
Kusumoto, Fred M.;Schoenfeld, Mark H.;Wijeysundera, Duminda N.
通讯作者：
Wijeysundera, Duminda N.