Abstract: Objective To study the therapeutic effect of Qishenhuoxue Granule on severe sepsis. Methods The study was a prospective, randomized, multipal centered trail. One hundred and sixty-seven eligible patients with severe sepsis from 5 hospitals were enrolled and randomly divided into two groups: eighty-five in control group and 82 in herbal treatment group. Patients were monitored for changes in laboratory variables including TNF-α, IL-6, IL-10, and D-dimer et al, as well as calculations of Marshall score, APACHE Ⅱ score,the length of staying in ICU and rate of 28-day death. Results In the herbal treatment group, IL-6, TNF-α and D-dimer levels were significantly decreased, the length of staying in ICU was shortened after therapy(P<0.05) and the rate of death from any cause within 28 days after treatment was lower than that of the control group. As for mean scores of both Marshall and APACHE Ⅱ scoring systems, no significant difference was found between them. Conclusion Chinese herbal preparation of Qishenhuoxue Granule could reduce the blood levels of IL-6, TNF-α and D-dimer, shorten the length of ICU staying, and reduce the rate of death from any cause at 28 days, and have an acceptable safety profile.

Key words: sepsis, inflammatory cytokines, D-dimer, Qishenhuoxue Granule