Background and Aim: Sarcopenia has been proven to be a risk factor after pancreatoduodenectomy (PD). We aimed to evaluate if decreased psoas muscle area and density shown in CT scan, as measures for sarcopenia, were associated with postoperative major complications and adverse outcomes in patients who underwent PD. Patients and Methods: We analyzed 152 consecutive patients who underwent open PD. Total psoas area and muscle attenuation were measured on CT images at the level of the third lumbar vertebra. Total psoas area index (TPAI) was calculated, the cut-off values of TPAI were estimated and validated. The relationship between radiographic characters and outcomes was analyzed. Results: The optimal cut-off values of TPAI were 4.78 cm2/m2 for males and 3.46 cm2/m2 for females. The values were validated by outcomes with significant differences in the rate of major complications, re-operation, length of stay, and total cost. The prevalence of TPAI-defined sarcopenia and sarcopenic overweight/obesity was 38.8% and 17.1% in total. In multivariate logistic regression, rate of major complications was associated with TPAI [OR=0.605, 95% CI (0.414, 0.883), P=0.009], TPAI-defined sarcopenia [OR=8.256, 95% CI (2.890, 23.583), P=0.000] and sarcopenic overweight/obesity [OR=7.462, 95% CI (2.084, 26.724), P=0.002]; meanwhile, NRS2002-defined nutritional risk and GLIM-defined malnutrition did not show relationship with major complications. Conclusion: Both sarcopenia and sarcopenic overweight/obesity determined by new TPAI cut-off values were associated with a higher rate of major complications and adverse outcomes in Chinese patients undergoing open PD whereas usual nutritional assessment was not.
Background: Tigecycline, a first-in-class broad-spectrum glycylcycline antibiotic, has broad-spectrum in vitro activity against bacteria commonly encountered in complicated intra-abdominal infections (cIAIs), including aerobic and facultative Gram-positive and Gram-negative bacteria and anaerobic bacteria. In the current trial, tigecycline was evaluated for safety and efficacy vs. imipenem/cilastatin in hospitalized Chinese patients with cIAIs. Methods: In this phase 3, multicenter, open-label study, patients were randomly assigned to receive IV tigecycline or imipenem/cilastatin for ≤2 weeks. The primary efficacy endpoints were clinical response at the test-of-cure visit (12-37 days after therapy) for the microbiologic modified intent-to-treat and microbiologically evaluable populations. Because the study was not powered to demonstrate non-inferiority between tigecycline and imipenem/cilastatin, no formal statistical analysis was performed. Two-sided 95% confidence intervals (CIs) were calculated for the response rates in each treatment group and for differences between treatment groups for descriptive purposes. Results: One hundred ninety-nine patients received ≥1 dose of study drug and comprised the modified intent-to-treat population. In the microbiologically evaluable population, 86.5% (45 of 52) of tigecycline- and 97.9% (47 of 48) of imipenem/cilastatin-treated patients were cured at the test-of-cure assessment (12-37 days after therapy); in the microbiologic modified intent-to-treat population, cure rates were 81.7% (49 of 60) and 90.9% (50 of 55), respectively. The overall incidence of treatment-emergent adverse events was 80.4% for tigecycline vs. 53.9% after imipenem/cilastatin therapy (P < 0.001), primarily due to gastrointestinal-related events, especially nausea (21.6% vs. 3.9%; P < 0.001) and vomiting (12.4% vs. 2.0%; P = 0.005). Conclusions: Clinical cure rates for tigecycline were consistent with those found in global cIAI studies. The overall safety profile was also consistent with that observed in global studies of tigecycline for treatment of cIAI, as well as that observed in analyses of Chinese patients in those studies; no novel trends were observed. Trial Registration: ClinicalTrials.gov NCT00136201
12 May 2020 in The Journal of nutrition, health and aging
Background & aims The Global Leadership Initiative on Malnutrition (GLIM) is new criteria for diagnosing malnutrition that need validation adjusted to race. Our aim is to determine the optimal reference values of calf circumference (CC), investigate the prevalence of GLIM-defined malnutrition based on different screening tools in inpatients over 70 years old in China and assess its relationship with clinical outcomes. Methods We designed two continuity studies by analyzing a prospective multicenter database. First, we estimated and validated the CC cut-off values by receiver operating characteristic analyses against in-hospital mortality. Then the patients who were at risk by NRS 2002, MNA-SF and MUST were assessed by the GLIM criteria using the new CC values. Some clinical parameters and outcome data were evaluated. Results The optimal cut-off values of CC were 29.6 cm for male patients and 27.5 cm for female patients. The prevalence of GLIM-defined malnutrition was 27.5% by using NRS2002, 32.6% by using MNA-SF and 25.4% by using MUST. Patients with GLIM-defined malnutrition showed significantly worse values in BMI, total protein, albumin, neutrophil/lymphocyte ratio, CC, rate of complication, in-hospital mortality, length of stay, and total hospital cost than normal patients. Multivariate logistic regression showed the odds ratio of in-hospital mortality was significantly associated with GLIM defined malnutrition by using MNA-SF [OR = 1.231, 95%CI (1.022, 1.484), P = 0.029]. Conclusions The Chinese reference values of CC for inpatients over 70 years old were validated by in-hospital mortality, which could be implemented in GLIM criteria. And this population possessed a high prevalence of nutrition risk and malnutrition. GLIM criteria with MNA-SF seems to be the first choice to diagnose malnutrition.
Ous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group (injected with hemocoagulase Agkistrodon at 2 U, n=324) or a control group (injected with hemocoagulase Atrox, n=108). The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was (36.8±18.7) seconds; the hemorrhagic volume was (3.77±3.93) g; and the hemorrhagic volume per unit area was (0.091±0.125) g/cm2. In the control group, the corresponding values were (38.1±19.7) seconds, (4.00±4.75) g, and (0.095±0.101) g/cm2, respectively. No significant difference in values existed between the two groups (P >0.05). Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery....
Background. Clinically relevant postoperative pancreatic fistula (CR‐POPF) is a severe complication which may be caused by a perioperative nutrition problem. We aimed to study whether patients with high nutritional risk (NRS2002 score ≥ 5) might benefit from preoperative nutrition support regarding the risk of CR‐POPF after open pancreaticoduodenectomy. Methods. Consecutive patients undergoing open pancreaticoduodenectomy with complete record of NRS2002 at two Chinese institutions between 2013 and 2018 were analysed. CR‐POPF was diagnosed following the 2016 ISGPS criteria. Nutrition support included oral nutrition supplement and enteral and parenteral nutrition. Clinical and economic outcomes were analysed. Results. 522 cases were included. 135 cases (25.9%) were at high nutritional risk (NRS2002 score ≥ 5), among which 41 cases (30.4%) received preoperative nutrition support. The CR‐POPF rate was significantly lower in the preoperative nutrition support group compared with the no nutrition support group (12.2% versus 28.7%, P = 0.038). Multivariate analysis showed that preoperative nutrition support was a protective factor for CR‐POPF in patients at high risk [OR 0.339, 95% CI (0.115‐0.965), P = 0.039]. Higher albumin and a larger diameter of the main pancreatic duct were found to be other protectors for CR‐POPF. Conclusions. Patients with high nutritional risk (NRS2002 score ≥ 5) may profit from preoperative nutritional support manifested in the reduction of CR‐POPF.