Objective To study the advantages of heat and moisture exchangers compared with heated humidifiers in reducing the incidence of ventilator-associated pneumonia ( VAP) . Methods We searched PubMed as well as reference lists from publications to collect randomized controlled trials which comparing heat and moisture exchangers with heated humidifiers in preventing VAP for mechanically ventilated patients. Meta-analysis was performed using software Review Manager 5. 0. Results Fifteen randomized controlled trials were included. There was no difference in incidence of VAP among the patients managed with moisture exchangers or heated humidifiers ( OR1. 18, 95% CI [ 0. 96, 1. 44] ) . The subgroup of patients using moisture exchangers had lower VAP incidence compared with those using heated humidifiers without heated wire circuits ( OR 1. 39, 95% CI [ 1. 08, 1. 79] ) . There were no differences between the compared groups in mortality, length of intensive care unit stay, or duration of mechanical ventilation. Conclusion The available evidence indicates that moisture exchangers are superior to heated humidifiers without heated wire circuits, and not to heated humidifiers with heated wire circuits to prevent VAP.
Objective To analyze the withdrawal reason of natalizumab in depth based on the serious adverse reaction reports and approval channel, and to provide decision references for more safe and effective report method of other biologicals. Methods We searched MEDLINE, EMbase, and the official websites of Food and Drug Administration (FDA) for case reports, approval channel, and the relevant information of drug marketing or withdrawal. Results Four case reports and fourteen official reports were included. Three cases of progressive multifocal leukoencephalopathy (PML) were reported in the clinical trials after natalizumab’s initially approval with two dead and one disabled, which could be retrieved by hemodialysis (2 cases hitherto). Consequently, multiple sclerosis (MS) patients were willing to bear the risk. Two cases of natalizumab-related PML (0.06‰) were confirmed in 32 000 patients without death report after two years of its remarketing, in July 2008. Another PML patient was reported in October 2008. Because of its non-substitutability for treating MS and Crohn disease (CD), FDA announced that patients could still use natalizumab under the close monitoring. Conclusion (1) The most serious adverse reaction of treating MS and CD with natalizumab is PML, but it can be preventable and curable now. The monitoring findings of efficacy and adverse reaction during the postmarketing indicate that the review system is perfect and practicable relatively, and can give references for other high-risk drugs on the fast or standard approval channel, for example, Chinese medicine injection can draw lessons from it. (2) The remarketing of natalizumab not only provide significant risk management precedent for other drug-development firms, but also brings hope to the remarketing or relaunching clinical trials for the suspected sideeffect drugs. (3) Because of the fast-track reviewing of natalizumab and the overlap between the research of Good Clinical Practice (GCP) and the post-marketing evaluation, we should continue to track the information and provide new evidence.
ObjectivesTo systematically review the efficacy and safety of plasminogen activator assist external ventricular drainage in cerebral hemorrhage.MethodsPubMed, EMbase, The Cochrane Library, CNKI, VIP, CBM and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of plasminogen activator assist external ventricular drainage in cerebral hemorrhage from inception to March 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 23 RCTs involving 1 560 patients were included. The results of meta-analysis showed that, compared with the blank control or placebo, the addition of plasminogen activator urokinase after puncture and drainage could improve the clinical efficacy (RR=1.36, 95%CI 1.26 to 1.47, P<0.000 01), shorten removal time of hematoma (MD=−3.37, 95%CI −3.89 to −2.85, P<0.000 01), reduce postoperative re-bleeding rate (Peto OR=0.30, 95%CI 0.18 to 0.51, P<0.000 01), reduce the incidence of intracranial infection (Peto OR=0.47, 95%CI 0.25 to 0.87, P=0.02), and reduce mortality (Peto OR=0.45, 95%CI 0.27 to 0.76, P=0.003). The differences were statistically significant between two groups.ConclusionsCurrent evidence shows that the combination with urokinase can improve curative effect of hypertension cerebral hemorrhage patients with external ventricular drainage. In reducing hemorrhage, intracranial infection and mortality, urokinase also has great curative effect. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.