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Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 6: 1376 - 1384

DOI: https://doi.org/10.19852/j.cnki.jtcm.2025.06.015

Original Articles

Traditional Chinese Medicine treatment with syndrome differentiation for patients with severe community-acquired pneumonia: a multicenter, randomized, placebo-controlled trial

  • Jiansheng LI ,
  • Haifeng WANG ,
  • Kang ZHANG ,
  • Kai XIE ,
  • Suyun LI ,
  • Chenxi ZHANG ,
  • Yaqing ZHANG
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  • 1 Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou 450046, China
    2 Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou 450046, China
    3 Intensive Care Unit, Zhengzhou 15th People's Hospital, Zhengzhou 450000, China
LI Jiansheng and WANG Haifeng are co-first authors and contributed equally to this work

Received date: 2025-05-22

  Accepted date: 2025-08-25

  Online published: 2025-11-24

Supported by

Mechanism of Qingre jiedu Huatan Formula Regulating Macrophage Mitochondrial Autophagy / NLR family pyrin domain containing 3 Inflammasome Activation and Intervening intestinal-Lung Bacterial Translocation in the Treatment of Severe Pneumonia(82074411);Prevention and Treatment of Respiratory Critical Illness with Traditional Chinese Medicine(22IRTSTHN029);a Randomized Controlled Trial(STG-ZYX02-202204)

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Abstract

OBJECTIVE: To assess the effect of Traditional Chinese Medicine (TCM) treatment with syndrome differentiation in patients with severe community-acquired pneumonia (CAP).

METHODS: A multicenter, randomized, placebo-controlled trial was conducted. Adult patients with severe CAP were randomly allocated to receive conventional medicine treatment (conventional group) or conventional medicine combine with TCM treatment with syndrome differentiation (combination group) underwent a 28-d treatment time. The primary endpoint was treatment failure. Secondary outcomes included time to clinical stability, 28-d mortality, 90-d mortality, length of hospital stay.

RESULTS: A total of 183 patients were included in the intention-to-treat (ITT) population, with 91 allocated to the combination group and 92 to the conventional group. Patients with treatment failure in the combination group (18/91, 19.8%) were lower compared with the conventional group (34/92, 37.0%). Time to clinical stability was shorter in the combination group (11.8 d) than in the conventional group [17.8 d; HR = 2.08, 95% CI (1.38, 3.14); P = 0.001]. The 28-d mortality was lower in the combination group (17.6%) than in the conventional group (31.5%). There was no difference in the length of hospital stay between the two groups (P = 0.901). Adverse events were evenly distributed between the combination and conventional groups (P = 0.837).

CONCLUSION: Among patients with severe CAP, TCM treatment with syndrome differentiation reduced treatment failure, time to clinical stability, and the 28-d mortality and the 90-d mortality among patients admitted to the ward, without an increase in complications.

Key words： community-acquired pneumonia; treatment failure; randomized controlled trial; medicine, Chinese traditional; treatment with syndrome differentiation

Cite this article

Jiansheng LI , Haifeng WANG , Kang ZHANG , Kai XIE , Suyun LI , Chenxi ZHANG , Yaqing ZHANG . Traditional Chinese Medicine treatment with syndrome differentiation for patients with severe community-acquired pneumonia: a multicenter, randomized, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2025 , 45(6) : 1376 -1384 . DOI: 10.19852/j.cnki.jtcm.2025.06.015

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