Na Huang, Yat Hoi Tam, Zhitong Zhang, Xingyu Kao, Zhen Yang, Weixian Xu, Kang Yuan, Mingfeng He, Jingli Chen
{"title":"大柴胡煎剂治疗败血症的有效性和安全性：随机对照试验","authors":"Na Huang, Yat Hoi Tam, Zhitong Zhang, Xingyu Kao, Zhen Yang, Weixian Xu, Kang Yuan, Mingfeng He, Jingli Chen","doi":"10.1016/j.phymed.2024.156311","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Sepsis is a critical condition characterized by multi-organ dysfunction (MODS) that presents significant treatment challenges. Traditional Chinese medicine (TCM), particularly Dachaihu decoction (DCH), has shown potential in addressing sepsis-related complications.</p><p><strong>Purpose: </strong>To comprehensively evaluate the efficacy and safety of DCH in the treatment of sepsis.</p><p><strong>Methods: </strong>Eligible septic patients were randomly assigned to either the DCH or control group in a 1:1 ratio. The intervention course lasted for 3 days. Primary outcomes were 28-day all-cause mortality, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Secondary outcomes were assessed through various clinical parameters, including: (1) inflammatory markers; (2) liver function indices; (3) renal function markers; (4) gastrointestinal function metrics and (5) coagulation parameters.</p><p><strong>Results: </strong>70 septic patients were included in the full analysis set. No significant difference in 28-day all-cause mortality was observed between the control and DCH groups (10 (28.6 %) vs. 9 (25.7 %), p = 0.788). However, DCH significantly reduced SOFA score (-3.0 (interquartile range, IQR, -5.5, -2.0) vs. 0.0 (IQR, -3.5, 0.0), p = 0.025), APACHE II score (-4.0 (IQR, -8.0, -2.0) vs. 0.0 (IQR, -2.0, 2.0), p < 0.001), aspartate transaminase (-12.70 (IQR, -76.15, -3.35) vs. 2.40 (IQR, -8.05, 10.55), p = 0.001), total bilirubin (-2.30 (IQR, -7.45, 3.62) vs. 1.80 (IQR, -2.35, 11.25), p = 0.028), acute gastrointestinal injury grade (R¯, 26.04 vs. 44.96, p < 0.001), gastrointestinal dysfunction score (-5.0 (IQR, -6.0, -2.5) vs. -1.0 (IQR, -2.0, 0.5), p < 0.001), serum intestinal fatty acid-binding protein (-334.5 (IQR, -375.4, -288.8) vs. -34.8 (IQR, -104.2, -34.0), p < 0.001), and increased citrulline levels (6.97 (IQR, 6.76, 7.62) vs. 0.70 (IQR, -1.30, 2.83), p < 0.001), and also inhibiting platelet loss (-2.0 (IQR, -30.5, 45.5) vs. -26.0 (IQR, -65.0, 9.5), p = 0.043). Additionally, DCH demonstrated improvements in inflammation, renal function, and coagulation, with fewer serious adverse events reported in the DCH group (2.44 % vs. 7.32 %, p = 0.305).</p><p><strong>Conclusion: </strong>DCH is both effective and safe in treating septic MODS. Nonetheless, further research is required to refine study designs and enhance outcomes for septic patients.</p>","PeriodicalId":20212,"journal":{"name":"Phytomedicine","volume":"136 ","pages":"156311"},"PeriodicalIF":6.7000,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of Dachaihu decoction for sepsis: A randomized controlled trial.\",\"authors\":\"Na Huang, Yat Hoi Tam, Zhitong Zhang, Xingyu Kao, Zhen Yang, Weixian Xu, Kang Yuan, Mingfeng He, Jingli Chen\",\"doi\":\"10.1016/j.phymed.2024.156311\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Sepsis is a critical condition characterized by multi-organ dysfunction (MODS) that presents significant treatment challenges. Traditional Chinese medicine (TCM), particularly Dachaihu decoction (DCH), has shown potential in addressing sepsis-related complications.</p><p><strong>Purpose: </strong>To comprehensively evaluate the efficacy and safety of DCH in the treatment of sepsis.</p><p><strong>Methods: </strong>Eligible septic patients were randomly assigned to either the DCH or control group in a 1:1 ratio. The intervention course lasted for 3 days. Primary outcomes were 28-day all-cause mortality, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Secondary outcomes were assessed through various clinical parameters, including: (1) inflammatory markers; (2) liver function indices; (3) renal function markers; (4) gastrointestinal function metrics and (5) coagulation parameters.</p><p><strong>Results: </strong>70 septic patients were included in the full analysis set. No significant difference in 28-day all-cause mortality was observed between the control and DCH groups (10 (28.6 %) vs. 9 (25.7 %), p = 0.788). However, DCH significantly reduced SOFA score (-3.0 (interquartile range, IQR, -5.5, -2.0) vs. 0.0 (IQR, -3.5, 0.0), p = 0.025), APACHE II score (-4.0 (IQR, -8.0, -2.0) vs. 0.0 (IQR, -2.0, 2.0), p < 0.001), aspartate transaminase (-12.70 (IQR, -76.15, -3.35) vs. 2.40 (IQR, -8.05, 10.55), p = 0.001), total bilirubin (-2.30 (IQR, -7.45, 3.62) vs. 1.80 (IQR, -2.35, 11.25), p = 0.028), acute gastrointestinal injury grade (R¯, 26.04 vs. 44.96, p < 0.001), gastrointestinal dysfunction score (-5.0 (IQR, -6.0, -2.5) vs. -1.0 (IQR, -2.0, 0.5), p < 0.001), serum intestinal fatty acid-binding protein (-334.5 (IQR, -375.4, -288.8) vs. -34.8 (IQR, -104.2, -34.0), p < 0.001), and increased citrulline levels (6.97 (IQR, 6.76, 7.62) vs. 0.70 (IQR, -1.30, 2.83), p < 0.001), and also inhibiting platelet loss (-2.0 (IQR, -30.5, 45.5) vs. -26.0 (IQR, -65.0, 9.5), p = 0.043). Additionally, DCH demonstrated improvements in inflammation, renal function, and coagulation, with fewer serious adverse events reported in the DCH group (2.44 % vs. 7.32 %, p = 0.305).</p><p><strong>Conclusion: </strong>DCH is both effective and safe in treating septic MODS. Nonetheless, further research is required to refine study designs and enhance outcomes for septic patients.</p>\",\"PeriodicalId\":20212,\"journal\":{\"name\":\"Phytomedicine\",\"volume\":\"136 \",\"pages\":\"156311\"},\"PeriodicalIF\":6.7000,\"publicationDate\":\"2024-12-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phytomedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.phymed.2024.156311\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phytomedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.phymed.2024.156311","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
Efficacy and safety of Dachaihu decoction for sepsis: A randomized controlled trial.
Background: Sepsis is a critical condition characterized by multi-organ dysfunction (MODS) that presents significant treatment challenges. Traditional Chinese medicine (TCM), particularly Dachaihu decoction (DCH), has shown potential in addressing sepsis-related complications.
Purpose: To comprehensively evaluate the efficacy and safety of DCH in the treatment of sepsis.
Methods: Eligible septic patients were randomly assigned to either the DCH or control group in a 1:1 ratio. The intervention course lasted for 3 days. Primary outcomes were 28-day all-cause mortality, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Secondary outcomes were assessed through various clinical parameters, including: (1) inflammatory markers; (2) liver function indices; (3) renal function markers; (4) gastrointestinal function metrics and (5) coagulation parameters.
Results: 70 septic patients were included in the full analysis set. No significant difference in 28-day all-cause mortality was observed between the control and DCH groups (10 (28.6 %) vs. 9 (25.7 %), p = 0.788). However, DCH significantly reduced SOFA score (-3.0 (interquartile range, IQR, -5.5, -2.0) vs. 0.0 (IQR, -3.5, 0.0), p = 0.025), APACHE II score (-4.0 (IQR, -8.0, -2.0) vs. 0.0 (IQR, -2.0, 2.0), p < 0.001), aspartate transaminase (-12.70 (IQR, -76.15, -3.35) vs. 2.40 (IQR, -8.05, 10.55), p = 0.001), total bilirubin (-2.30 (IQR, -7.45, 3.62) vs. 1.80 (IQR, -2.35, 11.25), p = 0.028), acute gastrointestinal injury grade (R¯, 26.04 vs. 44.96, p < 0.001), gastrointestinal dysfunction score (-5.0 (IQR, -6.0, -2.5) vs. -1.0 (IQR, -2.0, 0.5), p < 0.001), serum intestinal fatty acid-binding protein (-334.5 (IQR, -375.4, -288.8) vs. -34.8 (IQR, -104.2, -34.0), p < 0.001), and increased citrulline levels (6.97 (IQR, 6.76, 7.62) vs. 0.70 (IQR, -1.30, 2.83), p < 0.001), and also inhibiting platelet loss (-2.0 (IQR, -30.5, 45.5) vs. -26.0 (IQR, -65.0, 9.5), p = 0.043). Additionally, DCH demonstrated improvements in inflammation, renal function, and coagulation, with fewer serious adverse events reported in the DCH group (2.44 % vs. 7.32 %, p = 0.305).
Conclusion: DCH is both effective and safe in treating septic MODS. Nonetheless, further research is required to refine study designs and enhance outcomes for septic patients.
期刊介绍：
Phytomedicine is a therapy-oriented journal that publishes innovative studies on the efficacy, safety, quality, and mechanisms of action of specified plant extracts, phytopharmaceuticals, and their isolated constituents. This includes clinical, pharmacological, pharmacokinetic, and toxicological studies of herbal medicinal products, preparations, and purified compounds with defined and consistent quality, ensuring reproducible pharmacological activity. Founded in 1994, Phytomedicine aims to focus and stimulate research in this field and establish internationally accepted scientific standards for pharmacological studies, proof of clinical efficacy, and safety of phytomedicines.
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