Qi Ruihan, Zhang Hongchun, Li Demin, Gao Feng, Miao Qing, Chen Sheng, Huang Yan, Wu Lei, Lu Zhenhui, Hu Haibo, Li Erran, Chen Zhibin
Department of Respiratory and Critical Care Medicine, Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, China.
Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing 100029, China.
Evid Based Complement Alternat Med. 2022 Jun 23;2022:7366320. doi: 10.1155/2022/7366320. eCollection 2022.
The study aimed to explore the efficacy and safety of Xinjia Xuanbai Chengqi granules (XJXBCQ) combined with conventional medicine in the treatment of acute exacerbation of chronic pulmonary disease (AECOPD). . This multicentre, double-blind, parallel, placebo-controlled, randomised clinical trial conducted in China from January 2019 to February 2021 recruited 330 participants who were allocated into three groups. All participants underwent conventional basic treatment with oxygen therapy, antibiotics, and a bronchodilator. Besides, group received XJXBCQ granules and budesonide suspension for inhalation; group received XJXBCQ granules and half dosage of budesonide suspension; and group received budesonide suspension and a placebo. All therapies lasted for 5 days, and participants were followed up for 30 days after discharge. The primary outcomes were efficacy, traditional Chinese medicine (TCM) syndrome score, and clinical symptom score. Secondary outcomes included the blood gas analysis, serum inflammatory markers, adverse events, mortality, theoretical discharge time, actual hospitalisation time, proportion of patients requiring invasive mechanical ventilation, proportion of patients transferred to an intensive care unit (ICU), and readmission rate within 30 days after discharge.
XJXBCQ adjunct with conventional treatment could significantly improve the total efficacy ( < 0.05). Meanwhile, group showed significantly better results than group in the TCM syndrome score, phlegm score, and Wexner constipation score ( < 0.05). For modified British medical research council (mMRC), on day 3 (-0.17, 95% confidence interval [CI]: -0.33--0.01) and day 4 (-0.20, 95% CI: -0.39--0.02), group performed statistically better than group . No significant differences in other secondary outcomes were detected.
XJXBCQ is beneficial and safe for AECOPD treatment and could be considered an adjunctive therapy for promoting the relief of clinical symptoms. This trial is registered with ChiCTR1800016915.
本研究旨在探讨新加宣白承气颗粒（XJXBCQ）联合传统药物治疗慢性阻塞性肺疾病急性加重期（AECOPD）的疗效和安全性。这项多中心、双盲、平行、安慰剂对照的随机临床试验于2019年1月至2021年2月在中国进行，招募了330名参与者，他们被分为三组。所有参与者均接受吸氧、抗生素和支气管扩张剂等常规基础治疗。此外，A组接受XJXBCQ颗粒和布地奈德混悬液吸入治疗；B组接受XJXBCQ颗粒和半量布地奈德混悬液治疗；C组接受布地奈德混悬液和安慰剂治疗。所有治疗均持续5天，参与者出院后随访30天。主要结局指标为疗效、中医证候评分和临床症状评分。次要结局指标包括血气分析、血清炎症标志物、不良事件、死亡率、理论出院时间、实际住院时间、需要有创机械通气的患者比例、转入重症监护病房（ICU）的患者比例以及出院后30天内的再入院率。
XJXBCQ辅助常规治疗可显著提高总疗效（P<0.05）。同时，A组在中医证候评分、痰证评分和Wexner便秘评分方面的结果显著优于B组（P<0.05）。对于改良英国医学研究委员会（mMRC）评分，在第3天（-0.17，95%置信区间[CI]：-0.33--0.01）和第4天（-0.20，95%CI：-0.39--0.02），A组的表现统计学上优于B组。在其他次要结局指标方面未检测到显著差异。
XJXBCQ治疗AECOPD有益且安全，可考虑作为促进临床症状缓解的辅助治疗方法。本试验已在中国临床试验注册中心注册，注册号为ChiCTR1800016915。
