Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial

Lian-Han Shang^{1

2

3}, Guo-Hui Fan^{1

2

4}, Li-Ping Chen⁵, Jian-Hua Liu⁶, Xiao-Ge Wang⁷, Bo Liu⁸, Gui-Zhen Tian⁹, Xi-Sheng Chen¹⁰, Jia-Xing Yu¹¹, Guo-Ru Yang¹², Xin Su¹³, Xue-Dong Liu¹⁴, Yu-Ping Li¹⁵, Shu-Feng Xu¹⁶, Yu-Hong Lin¹⁷, Jie Cao¹⁸, Wei Zhang¹⁹, Wen-Shuai Feng²⁰, Zhi-Gang Cai²¹, Qi-Hu Wang²², Jin-Xiang Wang²³, Yu-Guang Wang²⁴, Jin Chen²⁵, Yong-Xiang Zhang²⁶, Xiao-Jing Cui^{27

28}

Affiliations

¹ Department 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.
² Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, 100029, China.
³ Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
⁴ Department of Clinical Research and Data Management, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, 100029, China.
⁵ Department of Pulmonary and Critical Care Medicine, The Second Hospital Affiliated to Shenyang Medical College, Shenyang, 110002, China.
⁶ Department of Pulmonary and Critical Care Medicine, Beijing Huairou Hospital, Beijing, 101400, China.
⁷ Department of Pulmonary and Critical Care Medicine, The Fourth Affiliated Hospital of China Medical University, Shenyang, 110032, China.
⁸ Department of Pulmonary and Critical Care Medicine, Zibo Linzi District People's Hospital, Zibo, Shandong Province, 255400, China.
⁹ Department of Respiratory Medicine, Beijing Dawanglu Emergency Hospital, Beijing, 100026, China.
¹⁰ Department of Respiratory Medicine, Beijing Shunyi Hospital, Beijing, 101300, China.
¹¹ Department of Pulmonary and Critical Care Medicine, Hegang People's Hospital, Hegang, Heilongjiang Province, 154100, China.
¹² Department of Pulmonary and Critical Care Medicine, Weifang No. 2 People's Hospital, Weifang, Shandong Province, 261041, China.
¹³ Department of Pulmonary and Critical Care Medicine, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, 210031, China.
¹⁴ Department of Pulmonary and Critical Care Medicine, Qingdao Municipal Hospital, Qingdao, Shandong Province, 266011, China.
¹⁵ Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, China.
¹⁶ Department of Pulmonary and Critical Care Medicine, The First Hospital of Qinhuangdao, Qinhuangdao, Hebei Province, 066000, China.
¹⁷ Department of Respiratory Medicine, Northeast International Hospital, Shenyang, 110623, China.
¹⁸ Department of Pulmonary and Critical Care Medicine, Tianjin Medical University General Hospital, Tianjin, 300052, China.
¹⁹ Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
²⁰ Department of Pulmonary and Critical Care Medicine, Gongyi City People's Hospital, Zhengzhou, 451200, China.
²¹ Department of Pulmonary and Critical Care Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.
²² Department of Respiratory Medicine, Muping Hospital of Traditional Chinese Medicine, Yantai, Shandong Province, 264100, China.
²³ Department of Pulmonary and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, 101100, China.
²⁴ Department of Respiratory Medicine, Beijing Hospital of Traditional Chinese Medicine, Beijing, 100010, China.
²⁵ Department of Pulmonary and Critical Care Medicine, Beijing Fuxing Hospital, Beijing, 100038, China.
²⁶ Department of Pulmonary and Critical Care Medicine, Beijing Daxing District People's Hospital, Beijing, 102600, China.
²⁷ Department 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. cuixiaojing86@163.com.
²⁸ Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, 100029, China. cuixiaojing86@163.com.

PMID: 41489779
DOI: 10.1007/s11655-025-3932-8

Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial

Lian-Han Shang et al. Chin J Integr Med. 2026.

. 2026 Jan 5.

doi: 10.1007/s11655-025-3932-8. Online ahead of print.

Authors

Affiliations

¹ Department 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.
² Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, 100029, China.
³ Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
⁴ Department of Clinical Research and Data Management, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, 100029, China.
⁵ Department of Pulmonary and Critical Care Medicine, The Second Hospital Affiliated to Shenyang Medical College, Shenyang, 110002, China.
⁶ Department of Pulmonary and Critical Care Medicine, Beijing Huairou Hospital, Beijing, 101400, China.
⁷ Department of Pulmonary and Critical Care Medicine, The Fourth Affiliated Hospital of China Medical University, Shenyang, 110032, China.
⁸ Department of Pulmonary and Critical Care Medicine, Zibo Linzi District People's Hospital, Zibo, Shandong Province, 255400, China.
⁹ Department of Respiratory Medicine, Beijing Dawanglu Emergency Hospital, Beijing, 100026, China.
¹⁰ Department of Respiratory Medicine, Beijing Shunyi Hospital, Beijing, 101300, China.
¹¹ Department of Pulmonary and Critical Care Medicine, Hegang People's Hospital, Hegang, Heilongjiang Province, 154100, China.
¹² Department of Pulmonary and Critical Care Medicine, Weifang No. 2 People's Hospital, Weifang, Shandong Province, 261041, China.
¹³ Department of Pulmonary and Critical Care Medicine, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, 210031, China.
¹⁴ Department of Pulmonary and Critical Care Medicine, Qingdao Municipal Hospital, Qingdao, Shandong Province, 266011, China.
¹⁵ Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, China.
¹⁶ Department of Pulmonary and Critical Care Medicine, The First Hospital of Qinhuangdao, Qinhuangdao, Hebei Province, 066000, China.
¹⁷ Department of Respiratory Medicine, Northeast International Hospital, Shenyang, 110623, China.
¹⁸ Department of Pulmonary and Critical Care Medicine, Tianjin Medical University General Hospital, Tianjin, 300052, China.
¹⁹ Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
²⁰ Department of Pulmonary and Critical Care Medicine, Gongyi City People's Hospital, Zhengzhou, 451200, China.
²¹ Department of Pulmonary and Critical Care Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.
²² Department of Respiratory Medicine, Muping Hospital of Traditional Chinese Medicine, Yantai, Shandong Province, 264100, China.
²³ Department of Pulmonary and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, 101100, China.
²⁴ Department of Respiratory Medicine, Beijing Hospital of Traditional Chinese Medicine, Beijing, 100010, China.
²⁵ Department of Pulmonary and Critical Care Medicine, Beijing Fuxing Hospital, Beijing, 100038, China.
²⁶ Department of Pulmonary and Critical Care Medicine, Beijing Daxing District People's Hospital, Beijing, 102600, China.
²⁷ Department 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. cuixiaojing86@163.com.
²⁸ Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, 100029, China. cuixiaojing86@163.com.

PMID: 41489779
DOI: 10.1007/s11655-025-3932-8

Abstract

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).

Keywords: Andrographolide Sulfonate Injection; Chinese medicine; community acquired pneumonia; placebo; randomized controlled trial.

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Conflict of interest statement

Conflict of Interest. Jiangxi Qingfeng Pharmaceutical Co., Ltd. provided partial funding for the project, but did not participate in the study design, data collection, data analysis, data interpretation, or writing of the report.

References

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Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial

Affiliations

Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial

Authors

Affiliations

Abstract

Conflict of interest statement

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials

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