Effects of Shenfu Injection in the Treatment of Septic Shock Patients: A Multicenter, Controlled, Randomized, Open-Label Trial.
Effects of Shenfu Injection in the Treatment of Septic Shock Patients: A Multicenter, Controlled, Randomized, Open-Label Trial.
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DOI：
10.1155/2016/2565169
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Yu X
中科院分区：
文献类型：
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作者：
Li Y;Zhang X;Lin P;Qiu H;Wei J;Cao Y;Pan S;Walline J;Qian C;Shan Z;Yu X
研究了参附对感染性休克患者复苏期间生化参数和生存的影响。这是一项多中心、对照、随机、开放标签试验，对来自中国七个医疗中心的 210 名感染性休克患者进行了研究。他们被随机分配服用参附或生理盐水。主要结果是乳酸清除率。次要结局是休克指数正常化、升压药剂量、ICU 住院时间、住院时间和死亡率。共有 199 名患者完成了试验。血压、心率和其他常规实验室测试显示各组之间没有差异。两组之间的乳酸水平和乳酸清除率相似。两组之间的住院时间和 ICU 住院时间相似。当考虑所有患者时，两组的7天和28天死亡率相似，但当仅考虑乳酸水平≥4.5mmol/L的患者时，参附组的7天生存率优于对照组（7天：83.3% vs 54.5%，P = 0.034；28天：72.7% vs 47.6%，P = 0.092）。参附可改善乳酸清除率受损（≥4.5mmol/L）患者的7天生存率，但其作用机制尚不清楚。需要进一步的研究来表征参附输注后的血流动力学变化。该试验已在 ChiCTR-TRC-11001369 上注册。
The effect of Shenfu on biochemical parameters and survival during resuscitation in patients with septic shock was examined. This was a multicenter, controlled, randomized, open-label trial carried out in 210 patients with septic shock from seven medical centers in China. They were randomized to Shenfu or saline. The primary outcome was lactate clearance. The secondary outcomes were shock index normalization, dose of vasopressors, ICU stay, hospital stay, and mortality. A total of 199 patients completed the trial. Blood pressure, heart rate, and other routine lab tests showed no difference between the groups. Lactate levels and lactate clearance were similar between the two groups. Hospital and ICU stay were similar between the two groups. When considering all patients, the 7- and 28-day mortality were similar between the two groups, but when considering only patients with lactate levels ≥4.5 mmol/L, the Shenfu group showed a better 7-day survival than the control group (7 days: 83.3% versus 54.5%, P = 0.034; 28 days: 72.7% versus 47.6%, P = 0.092). Shenfu may improve the 7-day survival in patients with impaired lactate clearance (≥4.5 mmol/L), but the mechanism for this effect is unclear. Additional studies are necessary to characterize the hemodynamic changes after Shenfu infusion. This trial is registered with ChiCTR-TRC-11001369.