中药芪参活血颗粒在重度脓毒症治疗中的作用

Therapeutic Effect of Qishenhuoxue Granule on Severe Sepsis

目的探讨中药芪参活血颗粒在重度脓毒症治疗中的作用。方法采用多中心、前瞻、随机、对照队列研究方法,对2005年至2006年北京地区5所医院167例脓毒症患者进行治疗,入选患者按信封随机法分为单纯西药治疗组(85例)和中西医结合治疗组(82例),分析比较2组之间炎性反应因子、凝血指标、病情危重程度评分、住ICU时间及28d病死率的差异。结果1)中西医结合组治疗后IL-6、TNF-α和D-dimer水平较单纯西药组明显下降,差异有统计学意义(P<0.05);2)中西医结合治疗组患者住ICU时间较单纯西药组患者明显缩短,差异有统计学意义(P<0.05);3)2组之间Marshall评分、APACHEⅡ评分差异无统计学意义;4)中西医结合组28d病死率为24.4%,低于单纯西医治疗组(38.8%),差异有统计学意义(P=0.048);5)临床应用芪参活血颗粒治疗重度脓毒症未发生严重不良反应。结论应用中药芪参活血颗粒进行中西医结合治疗重度脓毒症可显著降低炎性反应因子IL-6及TNF-α水平,降低凝血指标D-dimer水平,缩短住ICU时间,提高28d生存率。

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 11 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.