Bmc Med
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Randomized Controlled Trial Multicenter Study
Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial.
Pyrotinib (an irreversible pan-ErbB inhibitor) plus capecitabine has survival benefits and acceptable tolerability in patients with HER2-positive metastatic breast cancer. We further assessed addition of pyrotinib to trastuzumab and docetaxel in the neoadjuvant setting. ⋯ The primary endpoint of the study was met. Neoadjuvant pyrotinib, trastuzumab, and docetaxel significantly improved the tpCR rate compared with placebo, trastuzumab, and docetaxel, with manageable toxicity, providing a new option for HER2-positive early or locally advanced breast cancer.
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Randomized Controlled Trial
A digital application and augmented physician rounds reduce postoperative pain and opioid consumption after primary total knee replacement (TKR): a randomized clinical trial.
Severe postoperative pain not only is a considerable burden for patients but also leads to overprescription of opioids, resulting in considerable health concerns. The remarkable development of new technologies in the health care system provides novel treatment opportunities in this area and could exploit the additional placebo effect, provide added value for patients, and at the same time support hospital staff. We aimed to test the pain- and opioid intake-reducing effects of enhanced postoperative pain management by boosting pain medication by using a technical application and/or augmented physician rounds. ⋯ The combination of an innovative digital app, which implements open drug administration and augmented physician rounds that support the doctor-patient relationship can significantly improve postoperative pain management.
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Randomized Controlled Trial
Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine.
Numerous vaccine strategies are being advanced to control SARS-CoV-2, the cause of the COVID-19 pandemic. EuCorVac-19 (ECV19) is a recombinant protein nanoparticle vaccine that displays the SARS-CoV-2 receptor-binding domain (RBD) on immunogenic nanoliposomes. ⋯ ECV19 was generally well-tolerated and induced antibodies in a dose-dependent manner that neutralized SARS-CoV-2. The unique liposome display approach of ECV19, which lacks any immunogenic protein components besides the antigen itself, coupled with the lack of increased adverse events during boosting suggest the vaccine platform may be amenable to multiple boosting regimes in the future. Taken together, these findings motivate further investigation of ECV19 in larger scale clinical testing that is underway.
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Randomized Controlled Trial
Prednisolone does not improve olfactory function after COVID-19: a randomized, double-blind, placebo-controlled trial.
Prednisolone has been suggested as a treatment for olfactory disorders after COVID-19, but evidence is scarce. Hence, we aimed to determine the efficacy of a short oral prednisolone treatment on patients with persistent olfactory disorders after COVID-19. ⋯ This trial shows that prednisolone does not improve olfactory function after COVID-19. Therefore, we recommend not prescribing prednisolone for patients with persistent olfactory disorders after COVID-19.
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Randomized Controlled Trial
Optimal target of LDL cholesterol level for statin treatment: challenges to monotonic relationship with cardiovascular events.
Aggressive lipid lowering by high-dose statin treatment has been established for the secondary prevention of coronary artery disease (CAD). Regarding the low-density lipoprotein cholesterol (LDL-C) level, however, the "The lower is the better" concept has been controversial to date. We hypothesized that there is an optimal LDL-C level, i.e., a "threshold" value, below which the incidence of cardiovascular events is no longer reduced. We undertook a subanalysis of the REAL-CAD study to explore whether such an optimal target LDL-C level exists by a novel analysis procedure to verify the existence of a monotonic relationship. ⋯ Our analysis model suggests that a "threshold" value of LDL-C might exist for the secondary prevention of cardiovascular events in Japanese patients with CAD, and this threshold might be 70 mg/dl for primary composite outcomes.