Drug Des Dev Ther
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The efficacy of adding panitumumab to chemotherapy remains controversial in the treatment of metastatic colorectal cancer (mCRC). Thus, we conducted this meta-analysis to assess the efficacy and safety of this combination regimen in patients with mCRC. ⋯ This meta-analysis indicates that the combination of panitumumab and chemotherapy effectively improved PFS and ORR, but it did not prolong OS. However, as the number of studies in the meta-analysis was limited, more large-scale, better-designed RCTs are needed to assess the combination of panitumumab and chemotherapy.
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Comparative Study Controlled Clinical Trial
Efficacy of thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia: a nonrandomized prospective study.
Acute exacerbation (AE) is an important outcome of idiopathic pulmonary fibrosis (IPF) and nonspecific interstitial pneumonia (NSIP). Recombinant human soluble thrombomodulin (rhTM) is a new drug for the treatment of disseminated intravascular coagulation in Japan. The objective of this study was to evaluate the efficacy of rhTM for AE of IPF/NSIP. ⋯ The administration of rhTM is associated with reductions in mortality in patients with AE-IPF/NSIP, without causing adverse events.
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The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER) database and the US Food and Drug Administration Adverse Event Reporting System (FAERS), and how they affect signal detection. ⋯ The FAERS-JP was different from the JADER. Signals derived from both datasets identified different results, but shared certain signals. Discrepancies in type of AEs, drugs reported, and average number of AEs per case were potential contributing factors. This study will help those concerned with pharmacovigilance better understand the use and pitfalls of using spontaneous AE data.
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Review Meta Analysis
Selective oropharyngeal decontamination versus selective digestive decontamination in critically ill patients: a meta-analysis of randomized controlled trials.
Selective digestive decontamination (SDD) and selective oropharyngeal decontamination (SOD) are associated with reduced mortality and infection rates among patients in intensive care units (ICUs); however, whether SOD has a superior effect than SDD remains uncertain. Hence, we conducted a meta-analysis of randomized controlled trials (RCTs) to compare SOD with SDD in terms of clinical outcomes and antimicrobial resistance rates in patients who were critically ill. ⋯ SOD has similar effects as SDD in clinical outcomes, but has higher incidence of ICU-acquired bacteremia, and higher carriage of antibiotic-resistant Gram-negative bacteria. However, due to the high cost of SDD and the increased risk of development of antibiotic resistance with the widespread use of cephalosporins in SDD, we would recommend SOD as prophylactic antibiotic regimens in patients in the ICU. More well-designed, large-scale RCTs are needed to confirm our findings.
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Review Meta Analysis Comparative Study
Combination therapy of fenofibrate and ursodeoxycholic acid in patients with primary biliary cirrhosis who respond incompletely to UDCA monotherapy: a meta-analysis.
Although the effectiveness of treatment with ursodeoxycholic acid (UDCA) and fenofibrate for primary biliary cirrhosis (PBC) has been suggested by small trials, a systematic review to summarize the evidence has not yet been carried out. ⋯ In this meta-analysis, combination therapy with UDCA and fenofibrate was more effective in reducing alkaline phosphatase than UDCA monotherapy, but it did not improve clinical symptoms. There did not appear to be an increase in adverse events with combination therapy.