ABSTRACT
BACKGROUND: Published reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. METHODS: This open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response. RESULTS: Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response. CONCLUSIONS: Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.
Subject(s)
Antibodies, Monoclonal, Humanized , Biomarkers, Pharmacological/analysis , COVID-19 , Drug Monitoring/methods , Interleukin-6 , Pneumonia, Viral , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/pharmacokinetics , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/physiopathology , COVID-19/therapy , Female , Humans , Immunologic Factors/administration & dosage , Immunologic Factors/pharmacokinetics , Infusions, Intravenous , Interleukin-6/antagonists & inhibitors , Interleukin-6/blood , Italy/epidemiology , Male , Oximetry/methods , Oxygen Inhalation Therapy/methods , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/etiology , Predictive Value of Tests , Respiratory Function Tests/methods , SARS-CoV-2/isolation & purification , Treatment OutcomeABSTRACT
The aim of this study was to describe and evaluate the laparoscopic treatment of esophageal achalasia in nine patients over a 35-month period. Five trocars were used to perform a Heller's myotomy to completely eliminate the cardial high-pressure zone, under manometric control. Intraoperative manometry also was used to calibrate a pick degrees 360 Rossetti's antireflux wrap. A complete regression of symptoms was observed postoperatively in seven of nine patients (77.8%); in two patients (22.2%) a moderate dysphagia persisted, but it disappeared 3 and 6 months, respectively. Only one intraoperative complication (esophageal perforation, recognized and laparoscopically repaired) occurred. At the present follow-up of 18 +/- 5.34 months (range 6-35), no dysphagia or symptoms related to reflux have been observed. Laparoscopic treatment of esophageal achalasia is considered a safe and effective procedure, and the results of this procedure are comparable with those of the open technique. Advantages common to other laparoscopic techniques are emphasized.
