Department of Emergency Medicine, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Shock. 2022 Sep 1;58(3):196-203. doi: 10.1097/SHK.0000000000001975. Epub 2022 Aug 8.
Background and Objective: The optimization of macrocirculatory hemodynamics is recommended by current sepsis guidelines. However, microcirculatory dysfunction is considered the cause of severe sepsis. In the present study, we designed to verify whether the application of Shenfu injection (SFI) restores microcirculation, thereby improving tissue perfusion and inhibiting organ dysfunction, resulting in improved outcomes. Design: We conducted a prospective, single-center, randomized, double-blind, placebo-controlled clinical trial. Intervention: Patients were randomly assigned to group receiving SFI (n = 20) or placebo (n = 20) for 5 days. We administered SFI or glucose injection for 5 days and blinded the investigators and clinical staff by applying light-proof infusion equipment that concealed therapy allocation. Measurements and Results: We measured the systemic dynamics and lactate levels, biomarkers of endothelial dysfunction, and inflammatory cytokines in the plasma. The parameters of sublingual microcirculation were assessed using side-stream dark-field imaging. Sequential Organ Failure Assessment (SOFA) score, Acute Physiology and Chronic Health Evaluation (APACHE) score, total dose, and duration of vasopressor use, emergency intensive care unit (EICU) stay, and 28-day mortality were evaluated. After treatment with SFI, the disturbance of the sublingual microcirculation was considerably alleviated, as indicated by the significant increase in total vessel density, perfused vessel density, and microvascular flow index. Moreover, the plasma biomarker levels of endothelial dysfunction, including Ang-2, Syn-1, and ET-1, were reversed after SFI treatment. Importantly, the SFI group had a more favorable prognosis than the control group in terms of the APACHE-II score, SOFA score, duration of vasopressor administration, and length of EICU stay. However, the difference in mortality at day 28 was not statistically different between the SFI (15%, 3/20) and placebo (25%, 5/20) groups ( P = 0.693). Conclusions : Shenfu injection provided apparent effects in improving sublingual microcirculatory perfusion in patients with septic shock, and this protection may be related with the inhibition of endothelial dysfunction and vasodilatory effects.
目前的脓毒症指南推荐优化宏观循环血液动力学。然而，微循环功能障碍被认为是严重脓毒症的原因。在本研究中，我们旨在验证参附注射液（SFI）的应用是否能恢复微循环，从而改善组织灌注，抑制器官功能障碍，改善预后。
我们进行了一项前瞻性、单中心、随机、双盲、安慰剂对照的临床试验。
患者随机分为 SFI 组（n = 20）或安慰剂组（n = 20），治疗 5 天。我们给予 SFI 或葡萄糖注射液治疗 5 天，并使用避光输液设备使研究人员和临床工作人员设盲，从而隐藏治疗分配。
我们测量了全身动力学和乳酸水平、内皮功能障碍的生物标志物以及血浆中的炎症细胞因子。使用边流暗场成像评估舌下微循环参数。评估序贯器官衰竭评估（SOFA）评分、急性生理学和慢性健康评估（APACHE）评分、总剂量和血管加压药使用时间、急诊重症监护病房（EICU）停留时间和 28 天死亡率。用 SFI 治疗后，舌下微循环的紊乱明显缓解，总血管密度、灌注血管密度和微血管血流指数显著增加。此外，SFI 治疗后内皮功能障碍的血浆生物标志物水平，包括 Ang-2、Syn-1 和 ET-1，也得到逆转。重要的是，与对照组相比，SFI 组在 APACHE-II 评分、SOFA 评分、血管加压药使用时间和 EICU 停留时间方面预后更好。然而，SFI（15%，3/20）和安慰剂（25%，5/20）组在第 28 天的死亡率差异无统计学意义（P = 0.693）。
参附注射液在改善感染性休克患者舌下微循环灌注方面具有明显疗效，这种保护作用可能与抑制内皮功能障碍和血管舒张作用有关。
