Abstract
BackgroundDrug resistance in China is becoming a more and more serious issue. Infection by drug-resistant bacteria has become a major disease that seriously threatens the health of Chinese people and affects national medical finance. Therefore, it is of great scientific and clinical significance to actively carry out research on the prevention and treatment of infections by multi-drug resistant organisms (MDRO). Previous studies by the authors suggested that patients with hospital-acquired pneumonia caused by MDRO mostly showed the pathological state of “insufficient healthy Qi and internal accumulation of pathogenic Qi” and “acute deficiency syndrome” mainly characterized by Qi deficiency. Buzhong Yiqi decoction is a famous classic prescription in traditional Chinese medicine (TCM) for treating internal damage fever. This study intends to provide an evidence-based rationale for Buzhong Yiqi decoction in treating MDRO hospital-acquired pneumonia by conducting a multi-center randomized controlled clinical study.Methods/designThis study is designed to be a multi-center randomized controlled study in which patients are assigned randomly into control (standard therapy) and trial (standard therapy plus Buzhong Yiqi decoction) groups. The patients will be selected from the emergency department and the ICU inpatient department of five study sites and will all be diagnosed with MDRO hospital-acquired pneumonia and meet the inclusion criteria. Forty patients are to be enrolled in each study site, resulting in a total of 200 patients in the study. The treatment course is 28 days.DiscussionIn this study: (1) the theory of “acute Qi deficiency” in MDRO hospital-acquired pneumonia is put forward for the first time, and the basic theories of TCM are further improved; (2) a multi-center randomized controlled clinical study will be performed for the first time with Buzhong Yiqi decoction, the classic prescription for reinforcing healthy Qi and eliminating pathogenic Qi, providing a reliable evidence-based rationale for the treatment of MDRO pulmonary infection with TCM; (3) the clinical application and modern disease spectrum of Buzhong Yiqi decoction is expanded, and the scientific notion of “treating different diseases with the same method” is enriched further.Trial registrationChina Clinical Trial Registry, ChiCTR1900022429. Registered on April 11, 2019. http://www.chictr.org.cn/listbycreater.aspx.
Highlights
Drug resistance in China is becoming a more and more serious issue
In this study: (1) the theory of “acute Qi deficiency” in multi-drug resistant organisms (MDRO) hospital-acquired pneumonia is put forward for the first time, and the basic theories of traditional Chinese medicine (TCM) are further improved; (2) a multi-center randomized controlled clinical study will be performed for the first time with Buzhong Yiqi decoction, the classic prescription for reinforcing healthy Qi and eliminating pathogenic Qi, providing a reliable evidence-based rationale for the treatment of MDRO pulmonary infection with TCM; (3) the clinical application and modern disease spectrum of Buzhong Yiqi decoction is expanded, and the scientific notion of “treating different diseases with the same method” is enriched further
We propose a multi-center randomized controlled clinical study to demonstrate the efficacy and safety of Buzhong Yiqi decoction in the treatment of MDRO hospital-acquired pneumonia (HAP) and to explore the possible mechanism, provide a reliable evidencebased rationale for the treatment of MDRO pulmonary infection with TCM, further elucidate the scientific notion of “treating different diseases with the same method”, and expand the modern disease spectrum of Buzhong Yiqi decoction
Summary
Infections caused by drug-resistant bacteria have become a major problem that seriously threatens the health of Chinese people and impacts national medical finance. It is of great scientific and clinical significance to actively carry out research on the prevention and treatment of MDRO infections. By analyzing the clearance of drug-resistant pathogens, APECHA II score, CPIS score, TCM diagnostic and therapeutic criteria, mortality and related physical and chemical indicators, this study may confirm the clinical safety and efficacy of Buzhong Yiqi decoction in the treatment of MDRO HAP. Trial status Protocol version 1, 11 February 2018.The recruitment commenced in July 2018 and aims to enroll 200 participants for the trial. It is anticipated that recruitment will end by June 2021
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
