Treatment of hospital-acquired pneumonia with multi-drug resistant organism by Buzhong Yiqi decoction based on Fuzheng Quxie classical prescription: study protocol for a randomized controlled trial

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.

Shen-ling-bai-zhu-san ameliorates inflammation and lung injury by increasing the gut microbiota in the murine model of Streptococcus pneumonia-induced pneumonia

“…Traditional Chinese medicine (TCM) therapy which have the unique profile of multiple target can decrease risks associated with pneumonia. A previous study revealed that Buzhong Yiqi decoction and XueBiJing Injection could reduce the incidence of pneumonia in patients with Severe Community-Acquired Pneumonia [7,8]. TCM therapy alone or in combination with antibiotics reduces treatment failure, time to clinical stability, length of hospital stay, and in-hospital mortality and improves quality of life in community acquired pneumonia patients [9,10].…”

A combination of ultrasonic debridement and topical cortex phellodendri compound fluid in patients with diabetic foot ulcers

“…Patients’ inclusion criteria are diagnosis of diabetes following the 1999 World Health Organization’s criteria, [ 20 ] and patients met the diagnostic criteria of syndromes for DFU. [ 21 ] We recruited patients only with an age of 35 to 70 years and ulcer area of <10 cm 2 . Patients with other complications, including coronary artery disease, kidney disease, liver disease, severe malnutrition, were excluded from our study.…”

Anemoside B4 protects against Klebsiella pneumoniae- and influenza virus FM1-induced pneumonia via the TLR4/Myd88 signaling pathway in mice

“…Traditional Chinese medicine has great potential in the treatment of many inflammatory and immunoregulatory diseases [21,22]. Pulsatilla chinensis (Bunge) Regel, a traditional Chinese herb, has the functions of clearing away heat and detoxification, stopping dysentery and drying dampness, and has a good therapeutic effect on bacteria, virus infection and malignant tumors in clinic [23].…”