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首页> 外文期刊>BMC Complementary and Alternative Medicine >Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial
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Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial

机译：宣白成气配方作为证候型痰热阻塞肺的慢性阻塞性肺疾病急性加重的辅助治疗：多中心，随机，双盲，安慰剂对照临床试验

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Background Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality. Traditional Chinese medicine (TCM) is used to treat AECOPD as adjunctive therapy. This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs. Methods A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 244 patients were divided into the intervention group (n?=?122, treated with conventional medicine and Xuan Bai Cheng Qi) and the control group (n?=?122, treated with conventional medicine and placebo). Total symptom scores (cough, phlegm, wheezing, chest congestion) before treatment and at 3, 5, 7, 10?days post-treatment were recorded. Lung function, arterial blood gas, serum inflammatory cytokines, oxidation/anti-oxidation index were observed before treatment and at the end of the 10-day treatment. Results A total of 242 patients completed the study. The full analysis set (FAS) population was 244 and the per-protocol analysis set (PPS) population was 229. After the 10-day treatment, symptom scores of the Xuan Bai Cheng Qi group were significantly lower over time compared with the control group (FAS: mean difference -1.84, 95% CI -2.66 to -1.03, P?P?1, FVC, and FEV1%pred were significantly higher over time in the Xuan Bai Cheng Qi group compared with those in the control group (day 10, FAS and PPS: P?2 and PaCO2 were significantly improved in the Xuan Bai Cheng Qi group (day 10, FAS and PPS: P? Conclusions Xuan Bai Cheng Qi formula appears to be a safe and beneficial treatment for AECOPD of phlegm-heat obstructing the lungs syndrome type.
机译：背景技术慢性阻塞性肺疾病（AECOPD）的急性加重是发病和死亡的常见原因。中药（TCM）被用于辅助治疗AECOPD。这项研究旨在评估中医方宣白成气作为AECOPD痰热阻肺证型患者的辅助疗法的疗效和安全性。方法进行了一项多中心，随机，双盲，安慰剂对照的临床试验。共有244例患者被分为干预组（n = 122，用常规药物和宣白成气治疗）和对照组（n = 122，用常规药物和安慰剂治疗）。记录治疗前和治疗后3、5、7、10天的总症状评分（咳嗽，痰多，喘息，胸闷）。在治疗前和治疗10天结束时观察到肺功能，动脉血气，血清炎性细胞因子，氧化/抗氧化指数。结果共有242名患者完成了研究。完整分析集（FAS）人口为244，每方案分析集（PPS）人口为229。治疗10天后，宣白承气组的症状评分随时间推移明显低于对照组（FAS：随时间变化的平均差异为-1.84，95％CI -2.66至-1.03，P？P？1 ，FVC和FEV 1 ％pred随时间显着升高宣白承气组（第10天，FAS和对照组）（第10天，FAS和PPS：P？2 和PaCO 2 显着改善）结论：宣白成气方对痰热阻塞肺证型AECOPD似乎是一种安全有效的治疗方法。

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