• Lu Cheng, Hua Jiang, Mingqi Chen, Qiuhua Chen, Xing Wang, and Jun Lu.
• Department of Intensive Care Unit, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China. Corresponding author: Lu Jun, Email: aztec0403@sina.com.
• Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Jan 1; 31 (1): 73-80.

ObjectiveTo systematically review the effect of Qingre Jiedu and Liangxue Sanyu method in patients with sepsis, and to discuss its effect in the treatment of sepsis.MethodsThe randomized controlled trials (RCTs) on the treatment of Qingre Jiedu and Liangxue Sanyu method for sepsis published on PubMed, Embase, Web of Science, CNKI and Wanfang database from the construction to December 31st, 2017 were searched by electronical way. Conventional treatment measures for sepsis, such as fluid resuscitation, maintenance of hemodynamic stability, anti-infection, improvement of tissue perfusion, maintenance of organ function and nutritional support were used in the control group. While traditional Chinese medicine treatment based on Qingre Jiedu and Liangxue Sanyu method were applied in the experimental group besides the conventional treatment, including Chinese patent medicine or Chinese herbal medicine. The main outcome was 28-day mortality, and the second outcome was acute physiology and chronic health evaluation II (APACHE II), coagulation function, inflammatory mediators, procalcitonin (PCT), lactic acid (Lac), and the length of intensive care unit (ICU) stay. Two researchers independently searched literatures, collected data and evaluated risk bias. The statistical analysis was completed by RevMan 5.3 and STATA 13.0 software. The funnel plot and Egger test were used to evaluate the potential publication bias of the main outcomes.ResultsA total of 20 RCTs were enrolled in this Meta-analysis, including 1 347 patients, with 667 patients in the control group and 680 patients in the experimental group. Comprehensive risk bias assessment showed that the risk bias of 11 RCT items was unknown, and the risk bias of 9 RCT items was high. Meta-analysis results showed that compared with the control group, the 28-day mortality of the experimental group was significantly lowered [relative risk (RR) = 0.54, 95% confidence interval (95%CI) = 0.45-0.65, P < 0.000 01], the 7-day APACHE II score was significantly lowered [mean difference (MD) = -3.86, 95%CI = -4.82 to -2.90, P < 0.000 01], the 7-day prothrombin time (PT) and activated partial thromboplastin time (APTT) were significantly shortened (PT: MD = -1.72, 95%CI = -2.29 to -1.14, P < 0.000 01; APTT: MD = -4.36, 95%CI = -5.81 to -2.91, P < 0.000 01), the 7-day D-dimer was slightly improved (MD = -0.13, 95%CI = -0.37-0.11, P = 0.29), the 10-day interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) were significantly decreased (IL-6: MD = -40.33, 95%CI = -59.55 to -21.11, P < 0.000 1; TNF-α: MD = -7.26, 95%CI = -11.31 to -3.21, P = 0.000 4), the 7-day Lac was significantly declined (MD = -1.30, 95%CI = -1.91 to -0.68, P < 0.000 1), but no significance in PCT (MD = -1.57, 95%CI = -3.25-0.11, P = 0.07) or the length of ICU stay (MD = -4.02, 95%CI = -8.60-0.56, P = 0.09) was found. The results of publication bias assessment showed that 19 studies reported 28-day mortality were basically "funnel-shaped" distribution without potential publication bias (P = 0.336).ConclusionsThe Meta-analysis showed that Qingre Jiedu and Liangxue Sanyu method may reduce the release of inflammatory mediators, improve the coagulation function, and reduce the 28-day mortality in patients with sepsis.

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