Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A
Lian-Han Shang1,2,3, Guo-Hui Fan1,2,4, Li-Ping Chen5
1Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, National Center for Respiratory Medicine, China-Japan Friendship Hospital, Beijing, 100029, China.
Objective:
To investigate the effect and safety of Andrographolide Sulfonate (AS) Injection for adjunctive treatment of non-severe community-acquired pneumonia (CAP) in adults.
Methods:
This is a multicenter, randomized, double-blind, and placebo-controlled trial. Adult patients with non-severe CAP were randomly assigned in a 1:1 ratio to the AS or control group using a stratified block randomization method. Patients received either intravenous AS Injection (500 mg once per day) or placebo for 5 d. Both groups were treated with guideline-based standard therapy simultaneously. The primary outcome was time to clinical stability. Secondary outcomes were initial treatment failure rate, time to fever recovery, length of hospital stay, duration of intravenous antibiotic treatment, and cost of hospitalization. Safety outcomes included adverse events (AEs) and serious AEs.
Results:
From September 2016 to April 2019, 482 patients were randomized into AS or control group (241 cases per group), and all were included in the intention-to-treat (ITT) analysis. The median time to clinical stability was 1 h shorter in the AS group than that in the control group [hazard ratio (HR) 1.440; 95% confidence interval (CI) 1.194, 1.736; log rank P<0.01]. AS group had 5 h shorter median time to fever recovery than the control group (HR 1.461; 95% CI 1.150, 1.857; log rank P<0.01). The initial treatment failure rate was significantly lower in the AS group than that in the control group (6.3% vs. 16.0%, P<0.01). There was no statistically significant difference in the length of hospital stay, duration of intravenous antibiotics treatment, and cost of hospitalization between groups (P>0.05). The proportion of patients with at least 1 AE was 41.5% in the AS group and 40.6% in the control group.
Conclusions:
Adjunctive AS Injection probably accelerates the clinical stability and lowers the initial treatment failure rate in adult hospitalized patients with non-severe CAP, but the absolute clinical benefits are marginal. Its use should take into account efficacy, safety, cost, and Chinese medicine syndrome classification. (Trial registration No. NCT02913118).
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