Masui. The Japanese journal of anesthesiology
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Appropriate and careful interpretation of results from clinical trials is essential for evidence-based medicine. Clinical trials for approval of new drugs and new indications are rigidly designed and conducted in highly selected patients for the safe and strict assessment of efficacy of drugs, and is associated with high internal validity but low generalizability of results. On the other hand, pragmatic trials for the assessment of effectiveness of treatment with approved drugs use less rigid design, for example, unmasked trial treatment and less strict selection of patients, and may be associated with high external but low internal validity. ⋯ However, they may be misled if component end points are of widely differing objectivity and importance to patients. Less objective end points in unmasked trials may also lead to overestimation of effects of intervention. There are many pitfalls in terms of the interpretation of the results from clinical trials, and they must be recognized for evidence-based medicine.
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Idiopathic pulmonary fibrosis (IPF) is a high risk factor for acute exacerbation of interstitial pneumonia (IP) after pulmonary resection. Other risk factors for inducing IP exacerbation are thought to be intraoperative inhalation of high concentration of oxygen, high pressure mechanical ventilation, major thoracic surgery, massive blood transfusion and preoperative chemotherapy and irradiation. The prophylactic strategy for this phenomenon has not been established, although mechanical ventilation by low pressure and low oxygen concentration, minimum invasive surgery and prophylactic administration of steroid, ulinastatin and sivelestat sodium hydride are performed. ⋯ In particular, high concentration of oxygen induces excessive production of ROS. ROS stimulates alveolar macrophages and neutrophils to release inflammatory cytokines, such as TNF-alpha, IL-8, IFN-gamma, IL-6 and IL-1beta. These cytokines injure pulmonary endothelium and alveolus, and atelectasis, pulmonary hemorrhage, lung edema, hyalinization and alveolar thickness occur, and this is a manifestation of ALL Therefore, although there is no evidence, high pressure ventilation and inhalation of high oxygen concentration during anesthesia should be avoided.
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The anesthetic management of Jehovah's Witnesses (JW) patients undergoing open heart surgery with cardiopulmonary bypass (CPB) is associated with a major risk of anemic hypoxia. ⋯ The decrease in Hb level is unavoidable in cardiac surgery with CPB in these JW patients. This survey showed that the decrease in Hb level may be compensated by conserved cardiac output avoiding the decrease of Do2 to its critical level when hypoxia occurs.