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91.
Despite the widespread usage of oxytocin, there is still no consensus on its mode of administration. The scope of the present meta-analysis was to assess the effect of oxytocin discontinuation after the active phase of labor is established on maternal fetal and neonatal outcomes. We searched Medline, Scopus, Popline, ClinicalTrials.gov and Google Scholar databases. Eight studies were finally retrieved, which involved 1232 parturient. We observed significantly decreased rates of cesarean sections among parturient that discontinued oxytocin (OR 0.51, 95% CI 0.35, 0.74) as well as decreased rates of uterine hyperstimulation (OR 0.33, 95% CI 0.19, 0.58). Similarly, cases of non-reassuring fetal heart rates were fewer among women that did not receive oxytocin after the establishment of the active phase of labor (OR 0.63, 95% CI 0.41, 0.97). Keeping in mind the aforementioned maternal and neonatal adverse effects that seem to result from infusion of oxytocin until delivery, future practice should aim towards its discontinuation after the establishment of the active phase of labor, as it does not seem to influence the total duration of labor. Future studies should aim towards specific populations of parturient in order to clarify whether different approaches are needed.  相似文献   
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OBJECTIVES: This study was designed to evaluate whether rapid endothelialization of stainless steel stents with a functional endothelium prevents stent thrombosis and reduces the restenotic process. BACKGROUND: A "pro-healing" approach for prevention of post-stenting restenosis is theoretically favored over the use of cytotoxic or cytostatic local pharmacologic therapies. It is believed that the central role of the vascular endothelium is to maintain quiescence of the underlying media and adventitia. METHODS: Sixteen patients with de novo coronary artery disease were successfully treated with implantation of endothelial progenitor cell (EPC) capture stents. RESULTS: Complete procedural and angiographic success was achieved in all 16 patients. The nine-month composite major adverse cardiac and cerebrovascular events (MACCE) rate was 6.3% as a result of a symptom-driven target vessel revascularization in a single patient. There were no other MACCE despite only one month of clopidogrel treatment. At six-month follow-up, mean angiographic late luminal loss was 0.63 +/- 0.52 mm, and percent stent volume obstruction by intravascular ultrasound analysis was 27.2 +/- 20.9%. CONCLUSIONS: This first human clinical investigation of this technology demonstrates that the EPC capture coronary stent is safe and feasible for the treatment of de novo coronary artery disease. Further developments in this technology are warranted to evaluate the efficacy of this device for the treatment of coronary artery disease.  相似文献   
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Purpose

With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies. In this article, we assess the current body of switching data available for approved or proposed biosimilars of anticancer mAbs.

Methods

PubMed was systematically searched and ClinicalTrials.gov and abstract databases of selected congresses were hand-searched to identify all switching studies including biosimilars of anticancer mAbs.

Findings

We identified 8 switching studies with biosimilars of rituximab (CT-P10, GP2013, PF-05280586, and BCD-020) and trastuzumab (ABP 980). Two were performed in oncology indications and the other 6 in rheumatoid arthritis (RA). Key elements of a well-designed switching study, such as randomization and blinding, were contained in several of the studies, but significant limitations were also present. The most frequent limitations were low statistical power because of small patient numbers, lack of an appropriate control arm, short follow-up, chosen outcome measures, and (for studies performed in RA) the concern whether switching data can be extrapolated to oncology indications. Accordingly, the data from these studies need to be interpreted with caution. Of note, all identified studies included a single switch only, whereas multiple switches may occur in the real-world setting. The scientific need to evaluate the impact of repeated switching has been recognized by the US Food and Drug Administration, who incorporated such a requirement in its draft guidance on interchangeability.

Implications

From the scarce data available, the consequences of switching between reference product mAbs and their biosimilar(s) in the oncology setting are as yet unknown. Additional clinical evidence from well-designed switching studies is needed to guide switching decisions.  相似文献   
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Cardiovascular Drugs and Therapy - Sacubitril/valsartan, vericiguat, and the sodium-glucose co-transporter-2 inhibitors (SGLT2i) dapagliflozin and empagliflozin proved effective in phase 3 trials...  相似文献   
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Purpose

Patients with patent foramen ovale (PFO) and cryptogenic ischemic stroke (CS) are at risk for stroke recurrence. The optimal antithrombotic strategy in patients who undergo medical management is still debated.

Methods

We systematically searched the literature for studies that reported on cerebrovascular event recurrences and/or death in patients with PFO treated with oral anticoagulation (OAC) or antiplatelet therapy (APT) for secondary prevention of CS. The efficacy endpoints were stroke recurrence and the composite of stroke, transient ischemic attack or all-cause death. Major bleedings represented the safety endpoint.

Results

A total of 16 studies with 3953 patients (OAC?=?1527, APT?=?2426) were included. Weighted mean follow-up was 2.9 years. OAC was associated with a significant reduction in the risk of stroke compared with APT (RR 0.65; 95% CI 0.44–0.95; ARR 2%, NNT 49), while no difference was found regarding the composite outcome (RR 0.78; 95% CI 0.57–1.07) and the safety outcome (RR 1.57; 95% CI 0.85–2.90; p?=?0.15).

Conclusions

OAC was more effective than APT in reducing the risk of stroke recurrence in patients with PFO and CS, without a significant increase in the risk of major bleedings. Our findings support the need for further randomized data focused on the comparison of antithrombotic strategies in this setting.

  相似文献   
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Heart Failure Reviews - Neuromuscular diseases (NMDs) include a broad spectrum of disorders that affect motor unit in every possible site, extending from the cell body of peripheral nerves to the...  相似文献   
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