Septic shock is characterized by an uncontrolled inflammatory response and microcirculatory dysfunction. There is currently no specific agent for treating septic shock. Anisodamine is an agent extracted from traditional Chinese medicine with potent anti-inflammatory effects. However, its clinical effectiveness remains largely unknown. In a multicentre, open-label trial, we randomly assigned adults with septic shock to receive either usual care or anisodamine (0.1–0.5 mg per kilogram of body weight per hour), with the anisodamine doses adjusted by clinicians in accordance with the patients’ shock status. The primary end point was death on hospital discharge. The secondary end points were ventilator-free days at 28 days, vasopressor-free days at 28 days, serum lactate and sequential organ failure assessment (SOFA) score from days 0 to 6. The differences in the primary and secondary outcomes were compared between the treatment and usual care groups with the χ2 test, Student’s t test or rank-sum test, as appropriate. The false discovery rate was controlled for multiple testing. Of the 469 patients screened, 355 were assigned to receive the trial drug and were included in the analyses—181 patients received anisodamine, and 174 were in the usual care group. We found no difference between the usual care and anisodamine groups in hospital mortality (36% vs. 30%; p = 0.348), or ventilator-free days (median [Q1, Q3], 24.4 [5.9, 28] vs. 26.0 [8.5, 28]; p = 0.411). The serum lactate levels were significantly lower in the treated group than in the usual care group after day 3. Patients in the treated group were less likely to receive vasopressors than those in the usual care group (OR [95% CI] 0.84 [0.50, 0.93] for day 5 and 0.66 [0.37, 0.95] for day 6). There is no evidence that anisodamine can reduce hospital mortality among critically ill adults with septic shock treated in the intensive care unit. Trial registration ClinicalTrials.gov ( NCT02442440 ; Registered on 13 April 2015).

中文翻译：

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山莨菪碱治疗感染性休克重症患者的有效性：一项多中心随机对照试验

感染性休克的特征是不受控制的炎症反应和微循环功能障碍。目前没有治疗感染性休克的特异性药物。山莨菪碱是一种从中药中提取的具有强抗炎作用的药剂。然而，它的临床有效性在很大程度上仍然未知。在一项多中心、开放标签试验中，我们将感染性休克的成人随机分配接受常规护理或山莨菪碱（0.1-0.5 mg/kg 体重/小时），临床医生根据患者的情况调整山莨菪碱的剂量。震惊状态。主要终点是出院时死亡。次要终点是第 28 天无呼吸机天数、第 28 天无血管加压药天数、血清乳酸和第 0 天至第 6 天的序贯器官衰竭评估 (SOFA) 评分。酌情采用 χ2 检验、Student's t 检验或秩和检验比较治疗组和常规护理组的主要和次要结局差异。多次测试控制了错误发现率。在筛选的 469 名患者中，355 名被分配接受试验药物并被纳入分析——181 名患者接受山莨菪碱，174 名在常规护理组。我们发现常规治疗组和山莨菪碱组在住院死亡率（36% vs. 30%；p = 0.348）或无呼吸机天数（中位数 [Q1, Q3], 24.4 [5.9, 28] vs. 26.0 [ 8.5, 28]；p = 0.411)。第 3 天后，治疗组的血清乳酸水平显着低于常规护理组。治疗组患者接受血管加压药的可能性低于常规治疗组（第 5 天的 OR [95% CI] 0.84 [0.50, 0.93] 和第 6 天的 0.66 [0.37, 0.95]）。没有证据表明山莨菪碱可以降低重症监护室治疗的感染性休克重症成人的住院死亡率。试验注册 ClinicalTrials.gov（NCT02442440；2015 年 4 月 13 日注册）。