| Title | Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial |
| Authors | Xie, Sheling Yan, Peng Yao, Chen Yan, Xiaoyan Huo, Yuliang Zhang, Junhua Liu, Si Feng, Zhiqiao Shang, Hongcai Xie, Lixin |
| Affiliation | Chinese Peoples Liberat Army Gen Hosp, Dept Pulm & Crit Care Med, 28 Fuxing Rd, Beijing 100853, Peoples R China Peking Univ, Clin Res Inst, 38 Xueyuan Rd, Beijing 100191, Peoples R China Beijing Blue Balloons Technol Co Ltd, 168 Beiyuan Rd, Beijing 100191, Peoples R China Tianjin Univ Tradit Chinese Med, 312 Anshan West Rd, Tianjin 300193, Peoples R China Tianjin Chase Sun Pharmaceut Co Ltd, Wuqing Dev Area, 20 Quanfa Rd, Tianjin 301700, Peoples R China Beijing Univ Chinese Med, Dongzhimen Hosp, Minist Educ & Beijing, Key Lab Chinese Internal Med, 5 Haiyuncang, Beijing 100700, Peoples R China |
| Keywords | Xuebijing injection Acute exacerbation of chronic obstructive pulmonary disease Efficacy Safety Immunomodulation |
| Issue Date | 2019 |
| Publisher | TRIALS |
| Abstract | Background: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used in Asia as an adjunct treatment for AECOPD to improve the patients' symptoms. Xuebijing (XBJ) injection is one of the major herbal medicines used in TCM. Previous small-sample clinical trials have proven its efficacy and safety in the treatment of AECOPD; however, the current data on XBJ as an adjunct therapy are insufficient. The present study will be a multi-center randomized clinical trial (RCT) to evaluate the efficacy and safety of XBJ injection in AECOPD and explore its influence on the immune function based on the altered levels of T cells. Methods: This study will be a prospective, randomized, placebo-controlled, blinded, multi-center trial. A total of 300 eligible patients will be randomly assigned to the treatment or placebo control group in a 1:1 ratio using a central randomization system. The treatment group will receive routine medication plus XBJ injection, and the control group will receive routine medication plus 0.9% NaCl injection. The patients will receive the corresponding treatment for 5days starting within 24h of enrollment. The primary outcome, the of rate endotracheal intubation, will be evaluated on day 28 after treatment. The secondary outcomes will include changes in immune and inflammatory indicators, respiratory support, mortality rate after 28days, blood gas analysis, improvement in Acute physiology and chronic health evaluation (APACHE) II scores and clinical symptoms, and the length and cost of intensive care unit stay and hospitalization. The safety of the interventions will be assessed throughout the trial. Discussion: This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of XBJ injection as adjuvant therapy for AECOPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of the disease and identify the underlying mechanisms. |
| URI | http://hdl.handle.net/20.500.11897/550619 |
| ISSN | 1745-6215 |
| DOI | 10.1186/s13063-019-3204-z |
| Indexed | SCI(E) EI |
| Appears in Collections: | 医学部待认领 |
