Objective: To evaluate the effectiveness double cervical cerclage in reducing antenatal complications and improve perinatal outcomes.
Methods: We searched Medline, Scopus, Clinicaltrials.org, The Cochrane Central Register of Controlled Trials and Google Scholar search engines.
Results: Six studies were included that involved 880 women. Double cerclage was significantly superior to single cerclage in reducing preterm births <34?weeks (734 cases, OR 0.59, 95% CI 0.40, 0.86) and preterm births <28?weeks (645 cases, OR 0.43, 95% CI 0.26–0.73). It also significantly increased the gestational age (380 cases, MD 2.63, 95% CI 0.87, 4.39). However, as a technique, it failed to improve the rates of preterm births <37?weeks (740 cases, OR 0.98, 95% CI 0.72, 1.34) the incidence of chorioamnionitis (740 cases, OR 0.83, 95% CI 0.51, 1.36) and the occurrence of preterm premature rupture of the membranes (796 cases, OR 1.32, 95% CI 0.95, 1.82).
Conclusions: It seems that double cerclage effectively increases the gestational age at delivery and decreases the rates of extremely premature births. However, as a procedure, it does not reduce the incidence of antenatal morbidity or the neonatal death rates. Further research is needed in the field as our meta-analysis is limited by the small number of enrolled studies. 相似文献
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
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
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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The endothelium of the vessel wall as a barrier between blood and the subendothelial matrix proteins is essential for preventing thrombus formation and subsequent atherosclerosis development. Atherosclerosis is an inflammatory disease in which immune and autoimmune mechanisms are involved. Recently, it was demonstrated that endothelial cells in the vessel wall can be damaged not only by classic risk factors, such as hyperlipidemia, smoking and disturbed blood flow, but also (auto)immune reactions to autoantigens present in the cell surface, among which heat shock protein 60 (HSP60) was mostly studied. HSP60 normally located in mitochondria can be translocated into the cell member in response to stress stimuli. Meanwhile, autoantibodies against HSP60 are present in most subjects, especially patients with heart attack and stroke. These autoantibodies may bind to HSP60 expressed in endothelial cells resulting in the cell damage, subsequently initiating the formation of atherosclerotic lesions. Based on the recent progress in the research field, the present review will update the mechanisms of immune response to endothelial cells by which cell damage can initiate the development of atherosclerosis. 相似文献