Intravenous infusion of Chinese medicine Xuebijing for patients with severe pneumonia: a multicenter, randomised, double-blind controlled trial

Abstract

BackgroundSevere pneumonia is associated with high mortality and morbidity, and increased antibiotics resistance in the past decades has further deteriorated its prognosis. In view of the limited range of antibiotics, there is an urgent need to develop new non-antibiotics-based strategies to improve the outcome of severe pneumonia. Furthermore, mortality from severe pneumonia has been largely independent of insulting microbes. Xuebijing, a Chinese medicine extract infusion formula, has been shown to have effects on cytokine reduction, anti-coagulation, and neutralisation of released bacterial cytotoxins. Results of clinical studies show improved outcomes after Xuebijing infusion, including increased survival, reduced hospital admissions, and improved clinical presentations. MethodsTo confirm previous findings, we did a multicenter, double-blinded, randomised trial. Patients who met criteria of severe pneumonia (on the basis of 2007 ATS/IDSA guidelines) were enrolled from 32 tertiary hospitals in China between Dec 1, 2013, and May 30, 2016, after approval from the Institutional Review Board of Zhongshan Hospital. Consent was obtained from all participants. The trial was registered at the Chinese clinical trial registry (ChiCTR-TRC-13003534). Findings710 patients were randomly allocated to receive intravenous injections (100 mL) of 0·9% NaCl BID (control) or Xuebijing (in 0·9% NaCl) BID for 5–7 days. Clinical and laboratory parameters were recorded and analysed for efficacy and safety. Xuebijing infusion reduced mortality compared with control solution (25% in the control group vs 16% in the Xuebijing group; p=0·009), and some patients showed an improved pneumonia severity index (46% in the control group vs 61% in the treatment group; p<0·0001). Similar results were obtained for sequential organ failure assessment, lung injury score, multiple organ dysfunction score, and systemic inflammatory response syndrome after Xuebijing infusion. Chest X-ray image analysis showed a greater resolution of infiltration in the treatment group than in the control group. InterpretationTaken together, Xuebijing infusion combined with standardised treatment could reduce mortality in patients with severe pneumonia, suggesting that Xuebijing could be a potential and promising adjunct therapy in severe pneumonia. FundingThis study was supported by Tianjin Science and Technology committee grant (14ZXLJSY00230) and Tianjin Chase Sun Pharmaceutical.