摘要
为了系统评价血必净注射液联合西医常规治疗全身炎症反应综合征(systemic inflammatory response syndrome,SIRS)的有效性,该研究检索了CBM、CNKI、Wanfang、VIP、PubMed、EMbase数据库自建库至2020年7月31日收录的,关于血必净注射液联合西医常规治疗SIRS的临床随机对照试验,经筛选后利用RevMan 5.3软件进行Meta分析、TSA 0.9.5.10 beta软件进行序贯分析、GRADEprofiler 3.6.1软件进行证据质量等级评价,最终纳入24篇文献,1 611例患者。Meta分析显示,血必净注射液联合西医常规治疗方案在降低白细胞计数(MD=-2.32,95%CI[-2.44,-2.21],P<0.000 01)、C反应蛋白计数(MD=-22.70,95%CI[-29.61,-15.79],P<0.000 01)、APACHEⅡ评分(MD=-2.15,95%CI[-2.43,-1.87],P<0.000 01)、肿瘤坏死因子α计数(SMD=-1.23,95%CI[-1.48,-0.99],P<0.000 01)、白细胞介素6计数(SMD=-0.92,95%CI[-1.15,-0.69],P<0.000 01),提高治疗有效率(RR=1.39,95%CI[1.23,1.56],P<0.000 01),降低多器官功能障碍发生率(RR=0.47,95%CI[0.35,0.64],P<0.000 01)及病死率(RR=0.22,95%CI[0.13,0.37],P<0.000 01)方面优于单纯西医常规治疗。试验序贯分析显示,在降低多器官功能障碍发生率及C反应蛋白计数方面,累计Z值均穿过了传统界值、TSA界值和期望信息值,达到了所需的病例数;GRADE评价显示证据等级多为低级或极低级。结果表明,血必净注射液联合西医常规治疗SIRS疗效确切,但鉴于纳入的研究质量较低,可能影响结论的可靠性,故今后仍需纳入更多高质量研究来进一步验证,为临床用药提供更好的建议。
To systematically review the efficacy of Xuebijing Injection combined with western medicine in the treatment of systemic inflammatory response syndrome(SIRS). In this study, CBM, CNKI, Wanfang, VIP, PubMed and EMbase databases were retrieved for clinical randomized controlled trials on the effect of Xuebijing Injection combined with western medicine in the treatment of SIRS from the establishment of the database to July 31, 2020. After screening, Meta-analysis was conducted by RevMan 5.3 software, trial sequential analysis was conducted by TSA 0.9.5.10 beta software, and the evidence quality level was evaluated by GRADEprofiler 3.6.1 software. Meta-analysis showed that Xuebijing Injection combined with western medicine could reduce white blood cell count(MD=-2.32, 95%CI[-2.44,-2.21], P<0.000 01), C-reactive protein count(MD=-22.70, 95%CI[-29.61,-15.79], P<0.000 01), APACHE Ⅱ score(MD=-2.15, 95%CI[-2.43,-1.87], P<0.000 01), tumor necrosis factor alpha count(SMD=-1.23, 95%CI[-1.48,-0.99], P<0.000 01) and interleukin-6 count(SMD=-0.92, 95%CI[-1.15,-0.69], P<0.000 01), improve treatment efficiency(RR=1.39, 95%CI[1.23, 1.56], P<0.000 01), reduce incidence of multiple organ dysfunction(RR=0.47, 95%CI[0.35, 0.64], P<0.000 01) and mortality(RR=0.22, 95%CI[0.13, 0.37], P<0.000 01), which were better than western medicine treatment alone. Trial sequential analysis showed that in terms of reducing the incidence of multiple organ dysfunction and C-reactive protein count, the cumulative Z value passed through the traditional threshold, TSA threshold and expected information value, and reached the required number of cases. GRADE evaluation showed that the level of evidence was low or very low. According to the findings, Xuebijing Injection combined with western medicine is effective in treating SIRS. However, as the low quality of the included studies may affect the reliability of the conclusion, more high-quality studies shall be included for further verification in the future, so as to provide better suggestions for clinical medication.
作者
赵哲
胡仕祥
管俊芳
易纪杰
张智伟
陈方圆
徐方飚
ZHAO Zhe;HU Shi-xiang;GUAN Jun-fang;YI Ji-jie;ZHANG Zhi-wei;CHEN Fang-yuan;XU Fang-biao(Henan University of Chinese Medicine,Zhengzhou 450008,China;Henan Provincial Hospital of Traditional Chinese Medicine,Zhengzhou 450002,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第15期3980-3989,共10页
China Journal of Chinese Materia Medica
基金
国家中医药管理局第四批全国优秀中医临床人才研修项目(国中医药人教发[2017]24)
河南中医药科学研究专项(2018ZY2043,2021ZY2049)。
关键词
血必净注射液
全身炎症反应综合征
系统评价
试验序贯分析
GRADE评价
Xuebijing Injection
systemic inflammatory response syndrome
systematic review
trial sequential analysis
GRADE evaluation
作者简介
赵哲,硕士研究生,E-mail:zhao3841881@163.com;通信作者:胡仕祥,硕士生导师,E-mail:shixiang1968hu@163.com。
