Department of Emergency Medicine, Beijing Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.
Laboratory of Infection and Immunity, Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.
J Tradit Chin Med. 2020 Apr;40(2):317-323.
To evaluate the clinical efficacy and safety of Qiguiyin (QGY) formula in patients with severe pneumonia in China compared with a placebo.
This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group (QGY formula) or the control group (placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include: (a) duration of hospital stay; (b) duration of time in the intensive care unit (ICU) stays; (c) duration of mechanical ventilation; (d) antibiotic DDD value(which means the doses of antibotics during the treatment period); (e) serum procalcitonin (PCT) level; (f) serum C-reactive protein (CRP) level; (g) Pneumonia severity index (PSI) score; (h) Sequential Organ Failure Assessment (SOFA) score; (i) sputum culture results; (j) blood routine examination results; (k) routine urine test results; (l) stool routine examination results; (m) electrocardiogram results; (n) alanine aminotransferase levels; (o) aspartate amino transferase levels; (p) total bilirubin; (q) creatinine levels; (r) urea nitrogen levels; and (s) adverse events.
The protocol has been approved by the Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine, Affiliated with Capital Medical University (2018BL- 053-02). This trial aims to provide evidence for QGY formula combined with conventional therapy in treating patients with severe bacterial pneumonia, and to verify the clinical effectiveness and safety of QGY formula in China compared with placebo. Additionally, this trial will reveal the effect of QGY formula on delaying/reversing the characteristics of drug-resistant bacteria.
在中国，将奇芪饮（QGY）配方与安慰剂相比，评估其在治疗重症肺炎患者中的临床疗效和安全性。
这是一项多中心、双盲、安慰剂对照、随机临床试验，分为两个平行组。将纳入 530 例患者并随机分为实验组（QGY 配方）或对照组（安慰剂）。两组患者的治疗均基于常规疗法。主要结局为 28 天死亡率。次要结局包括：（a）住院时间；（b）重症监护病房（ICU）入住时间；（c）机械通气时间；（d）抗生素 DDD 值（即治疗期间抗生素剂量）；（e）降钙素原（PCT）血清水平；（f）C 反应蛋白（CRP）血清水平；（g）肺炎严重指数（PSI）评分；（h）序贯器官衰竭评估（SOFA）评分；（i）痰培养结果；（j）血常规检查结果；（k）常规尿液检查结果；（l）大便常规检查结果；（m）心电图结果；（n）丙氨酸氨基转移酶水平；（o）天冬氨酸氨基转移酶水平；（p）总胆红素；（q）肌酐水平；（r）尿素氮水平；以及（s）不良事件。
该方案已获得首都医科大学附属北京中医医院伦理委员会的批准（2018BL-053-02）。本试验旨在为 QGY 配方联合常规疗法治疗重症细菌性肺炎患者提供证据，并验证 QGY 配方在中国与安慰剂相比的临床疗效和安全性。此外，本试验将揭示 QGY 配方对延缓/逆转耐药菌特征的作用。
