Zheng Rui, Zhang Li, Tian Ran, Li Nan, Lei Xiang, Jing Li, Liu Si, Feng Zhiqiao, Shou Songtao, Shang Hongcai
Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. Corresponding author: Shang Hongcai, Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China, Email:
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Aug;27(8):682-6. doi: 10.3760/cma.j.issn.2095-4352.2015.08.013.
To assess the efficacy and safety of Xuebijing injection for the treatment of severe acute pancreatitis ( SAP ).
An extensive search of related literatures from the Cochrane Library, EMBASE, China Biology Medicine ( CBM ), CNKI, VIP and Wanfang data up to March 2014 was performed. Randomized controlled trials ( RCTs ) regarding Xuebijing injection for the treatment of SAP were collected regardless of languages. Jadad scale was taken for quality evaluation of the included studies by two researchers. The patients in control group were given conventional treatment, and those of the Xuebijing group were given Xuebijing injection on the top of conventional treatment. The Cochrane Collaboration RevMan 5.2 software was used for data analysis regarding the effect of Xuebijing injection on the mortality, incidence of complication, effective rate, the length of stay in hospital, and the safety of the drug in patients with SAP.
A total of 15 published reports meeting the inclusion criteria were enrolled. The methodological quality of the trials was low. Meta analysis showed that the mortality in Xuebijing group was significantly lower [ odds ratio ( OR ) = 0.37, 95% confidence interval ( 95%CI ) = 0.17 - 0.77, P = 0.008 ], and the incidence of complication was also significantly decreased ( OR = 0.26, 95%CI = 0.14 - 0.45, P < 0.000 01 ) as compared with those of control group. The effective rate in Xuebijing group was significantly higher than that of the control group [ relative risk ( RR ) = 0.85, 95%CI = 0.80-0.91, P < 0.000 01 ]. The length of stay in hospital in Xuebijing group was significantly shorter than that of the control group [ mean difference ( MD ) = -5.28, 95%CI = -6.69 to -3.86, P < 0.000 01 ]. Adverse reactions of Xuebijing injection were reported in 2 studies. The adverse reaction in one study was headache and nausea, which were relieved by adjusting the speed of intravenous infusion, and mild rash was reported in another case, and it disappeared after the withdrawal of Xuebijing.
The currently available evidence shows that Xuebijing injection may have some therapeutic effect on SAP. Because of the low methodological quality of the included trials, multi-center and high-quality RCTs with large sample sizes are needed to provide stronger evidence.
评估血必净注射液治疗重症急性胰腺炎（SAP）的有效性和安全性。
全面检索截至2014年3月Cochrane图书馆、EMBASE、中国生物医学文献数据库（CBM）、中国知网（CNKI）、维普资讯（VIP）和万方数据中的相关文献。收集关于血必净注射液治疗SAP的随机对照试验（RCT），不限语言。由两名研究人员采用Jadad量表对纳入研究进行质量评估。对照组患者给予常规治疗，血必净组患者在常规治疗基础上加用血必净注射液。使用Cochrane协作网RevMan 5.2软件对血必净注射液对SAP患者死亡率、并发症发生率、有效率、住院时间及药物安全性的影响进行数据分析。
共纳入15篇符合纳入标准的发表报告。试验的方法学质量较低。Meta分析显示，血必净组死亡率显著降低[比值比（OR）=0.37，95%置信区间（95%CI）=0.17 - 0.77，P = 0.008]，并发症发生率也显著降低（OR = 0.26，95%CI = 0.14 - 0.45，P < 0.000 01），与对照组相比。血必净组有效率显著高于对照组[相对危险度（RR）=0.85，95%CI = 0.80 - 0.91，P < 0.000 01]。血必净组住院时间显著短于对照组[平均差（MD）=-5.28，95%CI = -6.69至-3.86，P < 0.000 01]。2项研究报告了血必净注射液的不良反应。一项研究中的不良反应为头痛和恶心，但通过调整静脉滴注速度得到缓解，另一例报告有轻度皮疹，停用血必净后皮疹消失。
现有证据表明血必净注射液对SAP可能有一定治疗作用。由于纳入试验的方法学质量较低，需要开展多中心、大样本的高质量RCT以提供更有力的证据。
