Abstract:

BACKGROUND: The degenerative changes of heart disease in the elderly and the decrease of immune function of the body make the elderly patients with heart failure vulnerable to the infection of pathogenic bacteria. Tanreqing injection, a traditional Chinese compound medicine, has the functions of clearing heat, eliminating phlegm and detoxifying, and can be used to treat pulmonary infection.
OBJECTIVE: To hypothesize that Tanreqing injection combined with ambroxol hydrochloride, a mucolytic drug, can effectively alleviate pulmonary infection and improve cardiac function in elderly patients with heart failure and pulmonary infection caused by degenerative heart disease.
METHODS: This prospective, single-center, parallel, randomized, controlled clinical trial will include 320 patients with heart failure combined with pulmonary infection induced by senile degenerative heart disease from Sanya People’s Hospital, Sanya, China. All patients will receive conventional anti-heart failure treatment, and will be equally and randomly divided into a control group and a trial group. The patients in the control group will be treated with intravenous infusion of ambroxol hydrochloride. The patients in the trial group will be treated with intravenous infusion of ambroxol hydrochloride and Tanreqing injection. The treatment will be lasted for 7 days. Patient recruitment and data collection will begin on July 1, 2019 and end on August 30, 2021. Analysis of the results will be performed from September 10 to 30, 2021. This study will be scheduled to end on December 30, 2021. This study was approved by the Medical Ethics Committee of Sanya People’s Hospital in October 2015 (approval No. S2015-065-03). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves.
RESULTS AND CONCLUSION: (1) The primary outcome measure is total effective rate 7 days after treatment. (2) The secondary outcome measures are left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular ejection fraction, left ventricular fractional shortening, number of pathogenic bacteria in the lung, serum procalcitonin and C-reactive protein level changes before and 7 days after treatment, as well as incidence of adverse reactions 7 days after treatment. (3) Our pilot study involved 120 patients with senile heart failure from May 2016 to October 2017. These patients were randomly assigned to trial and control groups (n=60 per group). The results showed that Gram-positive bacteria were the main pathogens of pulmonary infection in senile patients with heart failure. The positive rate of Gram-positive bacteria was 53.7% in both control and trial groups. After treatment, the number of pathogenic bacteria in the trial group was remarkably lower than that in the control group (control group: trial group=17 strains: 11 strains). Compared with that before treatment, left ventricular end-diastolic diameter, left ventricular end-systolic diameter and left ventricular ejection fraction were significantly lower (P < 0.05), but left ventricular fractional shortening was significantly higher (P < 0.05), and serum procalcitonin and C-reactive protein levels were significantly decreased (P < 0.05) in both trial and control groups after treatment. Moreover, the changes of the above indicators were more significant in the trial group than in the control group (P < 0.05). (4) The results of the present study will confirm that Tanreqing injection combined with ambroxol hydrochloride can noticeably improve the cardiac function of senile patients with heart failure, and can obviously mitigate pulmonary infection caused by pathogenic bacteria. This study will identify adverse drug reactions due to degenerative heart disease. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1900022879) on April 29, 2019. Protocol version: 1.0. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.

Key words: Tanreqing injection, ambroxol hydrochloride, senile, heart failure, pulmonary infection, pathogenic bacteria, cardiac function, degenerative heart disease in the elderly