玉屏风散预防急性脑血管病患者医院获得性肺炎的随机对照临床研究

Prevention of hospital-acquired pneumonia with Yupingfeng Powder in patients with acute cerebral vascular diseases:a randomized controlled trial

背景:医院获得性肺炎(hospital-acquired pneumonia,HAP)发生率的增加直接影响急性脑血管病患者的预后及生存。如何预防HAP的发生,成为临床医师日益关注的问题。目的:观察玉屏风散预防急性脑血管病患者HAP的临床疗效。设计、场所、对象和干预措施:60例急性脑血管病未合并感染的肺气虚证住院患者均源于上海岳阳中西医结合医院。将其随机分为玉屏风散预防组(预防组)28例,未用玉屏风散组(对照组)32例,两组均在治疗原发疾病,加强营养与支持治疗的基础上,采取严格的预防措施,防止交叉感染,玉屏风散预防组在此基础上加用由玉屏风散组方的中药汤剂预防,观察时间为10d。主要结局指标:观察治疗前后症状、体征,测定体温,检查胸片、血常规、免疫球蛋白A(immunoglobulinA,IgA)、免疫球蛋白G(immunoglobulinG,IgG)、免疫球蛋白M(immunoglobulinM,IgM)以及白细胞介素6(interleukin-6,IL-6)等指标的变化。结果:预防组总有效率与对照组比较,差异有统计学意义(P<0.05),两组总有效率分别为78.57%(22/28)和31.25%(10/32)。预防组HAP的未发生率为82.14%(23/28),对照组HAP的未发生率为56.25%(18/32),两组未发生HAP的百分率比较,差异有统计学意义(P<0.05)。两组患者治疗前白细胞、中性粒细胞、免疫球蛋白(IgA、IgG、IgM)和IL-6比较,差异无统计学意义,具有可比性;治疗后,对照组白细胞、中性粒细胞升高,与预防组比较,差异有统计学意义(P<0.05);两组患者治疗后IgA均无明显变化,对照组IgM水平高于治疗前(P<0.05),但两组IgM比较,差异无统计学意义;预防组治疗前后IgG和IL-6水平比较,差异均有统计学意义(P<0.01),两组治疗后IgG和IL-6水平比较,差异亦有统计学意义(P<0.05)。结论:玉屏风散对预防急性脑血管病患者HAP有较好的疗效,免疫功能有改善趋势,肺气虚症状等指标均有好转,玉屏风散对HAP的预防可作进一步研究。

Background： An increase in the incidence rate of hospital-acquired pneumonia （HAP） has a direct influence on prognosis and survival of patients with acute cerebral vascular diseases （ACVD）, and how to prevent HAP is a growing concern to clinicians.Objective： To study the efficacy of Yupingfeng Powder, a compound traditional Chinese herbal medicine, in preventing HAP in patients with ACVD.Design, setting, participants and interventions： Sixty ACVD patients with lung qi deficiency syndrome without concurrent infections were randomly divided into prevention group （28 cases） and control group （32 cases）. The 60 cases were all from Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine. Tough measures were taken to prevent cross-infection based on treatment of the primary diseases, well nutrition and support therapy. Yupingfeng Powder was used in the prevention group to prevent HAP. The patients were treated for 10 days.Main outcome measures： The clinical symptoms, physical signs, body temperature, and chest X-ray were observed. The changes of blood immunoglobulin A （IgA）, immunoglobulin G （IgG）, immunoglobulin M （IgM） and interleukin-6 （IL-6） were detected before and after treatment.Results： The total response rate in the prevention group was higher than that in the control group （P〈0.05）, and the total response rates were 78.57% （22/28） and 31.25% （10/32） respectively. The incidence rate of HAP in the prevention group was lower than that in the control group. There were no significant differences in white blood cell count, neutrophilic granulocyte count, and the levels of IgA, IgG, IgM and IL-6 between the two groups before treatment. The white blood cell count and neutrophilic granulocyte count in the control group increased after treatment, and there was a significant difference between the two groups （P〈0.05）. There was no significant difference in IgA level in the two groups after treatment, and the IgM levels in the two groups were higher than those before treatment （P〈0.05）, however there was no significant difference in IgM level between the two groups. In the prevention group, there were significant differences in values of IgG and IL-6 between before and after treatmant （P〈0. 01）, and after treatment there were differences in values of IgG and IL-6 between the two groups （P〈0.05）.Conclusion： Yupingfeng Powder has a good clinical effect in prevention of HAP in patients with ACVD, and it can improve the immunological function and relieve the lung qi deficiency symptoms. So the prevention effect of Yupingfeng Powder on HAP is worth being further investigated.