Effectiveness of anisodamine for the treatment of critically ill patients with septic shock: a multicentre randomized controlled trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).

[The effects of ω-3 fish oil lipid emulsion on inflammation-immune response and organ function in patients with severe acute pancreatitis].

OBJECTIVE: To investigate the effects of ω-3 fish oil lipid emulsion via vein on the inflammatory response, immune and organ function in patients with severe acute pancreatitis. METHODS: A total of 53 patients with severe acute pancreatitis were randomized into conventional therapy plus fish oil group (FO group) and conventional therapy group (CON group). The patients in FO group were treat with ω-3 fish oil lipid emulsion (0.2 g×kg(-1)×d(-1), 10%) based on conventional therapy for 14 days. The level of C-reactive protein (CRP), TG and TC were detected before treatment and at day 7 and day 14 after treatment. CD(4)(+), CD(4)(+)/CD(8)(+) and C(3), C(4) were also detected at day 1 and day 14 after treatment. At the same time, acute physiology and chronic health evaluation II score (APACHEII score), intra-abdominal pressure, negative fluid balance time, enteral nutrition start-time and ICU stay time were observed and recorded. RESULTS: Forty-five out of 53 patients were finally recruited into results statistics. The level of CD(4)(+), CD(4)(+)/CD(8)(+) and C(3) at day 14 after treatment in FO groups improved significantly than that in the CON group (P < 0.05). The levels of CRP, intra-abdominal pressure and APACHE II score at day 7 and day 14 in FO group descended more obviously than that in the CON group (P < 0.05). The negative liquid balance time in FO group (3.55 ± 0.86)days was obvious shorter than that in CON group (4.61 ± 1.12) days, while enteral nutrition start-time (3.86 ± 1.17) days was significantly earlier compared with CON group (5.30 ± 1.61) days (P < 0.05), however ICU stay time and 28 days mortality rate had no significant difference between the two groups. CONCLUSIONS: ω-3 fish oil lipid emulsion can decrease the inflammatory response and the negative liquid balance time, improve the immune function and restore bowel function in severe acute pancreatitis patients. Therefore, it maybe provide a new and effective means for severe acute pancreatitis.