共查询到20条相似文献,搜索用时 31 毫秒
1.
Background
Gonadotrophins are routinely administered in assisted reproductive technology (ART) treatment protocols. Recombinant human follicle-stimulating hormone (r-hFSH; follitropin alfa) and recombinant human luteinizing hormone (r-hLH; lutropin alfa) can be administered individually or in a fixed combination. The ability to vary the FSH to LH dose ratio in a single injection without compromising the bioactivity of either gonadotrophin or generating losses of active principle is important for physicians and patients alike. 相似文献2.
J Thomas Welcker Frank Nawroth Wilma Bilger 《Reproductive biology and endocrinology : RB&E》2010,8(1):111
Background
Self-administration of recombinant human follicle-stimulating hormone (r-hFSH) can be performed using injection pen devices by women undergoing assisted reproductive technology procedures. The objective of this study was to explore the use of the prefilled follitropin alfa pen in routine assisted reproductive technology procedures in Germany. 相似文献3.
Fritz Sörgel Ursula Thyroff-Friesinger Andrea Vetter Bernhard Vens-Cappell Martina Kinzig 《BMC clinical pharmacology》2009,9(1):10-9
Background
HX575 is a human recombinant epoetin alfa that was approved for use in Europe in 2007 under the European Medicines Agency biosimilar approval pathway. Therefore, in order to demonstrate the bioequivalence of HX575 to an existing epoetin alfa, the pharmacokinetic and pharmacodynamic response to steady state circulating concentrations of HX575 and a comparator epoetin alfa were compared following multiple intravenous administrations. 相似文献4.
Background
Activated drotrecogin alfa (human activated protein C, rhAPC), is produced by recombinant DNA technology, and purports to improve clinical outcomes by counteracting the inflammatory and thrombotic consequences of severe sepsis. Controversy exists around the clinical benefits of this drug and an updated economic study that considers this variability is needed.Methods
A systematic literature review was performed using Medline, Embase and the International Network of Agencies for Health Technology Assessment (INAHTA) databases to determine efficacy, safety and previous economic studies. Our economic model was populated with systematic estimates of these parameters and with population life tables for longer term survival information. Monte Carlo simulations were used to estimate the incremental cost-effectiveness ratios (ICERs) and variance for the decision analytic models.Results
Two randomized clinical trials (RCTS) of drotrecogin alfa in adults with severe sepsis and 8 previous economic studies were identified. Although associated with statistical heterogeneity, a pooled analysis of the RCTs did not show a statistically significant 28-day mortality benefit for drotrecogin alfa compared to placebo either for all patients (RR: 0.93, 95% CI: 0.69, 1.26) or those at highest risk as measured by APACHE II ≥ 25 (RR: 0.90, 95% CI: 0.54, 1.49). Our economic analysis based on the totality of the available clinical evidence suggests that the cost-effectiveness of drotrecogin alfa is uncertain (< 59% probability that incremental cost-effectiveness ratio (ICER) life year gained (LYG) ≤ $50,000/LYG) when applied to all patients with severe sepsis. The economic attractiveness of this therapy improves when administered to those at highest risk as assessed by APACHE II ≥ 25 (93% probability ICER ≤ $50,000/LYG) but these results are not robust to different measures of disease severity.Conclusion
The evidence supporting the clinical and economic attractiveness of drotrecogin alfa is not conclusive and further research appears to be indicated. 相似文献5.
Background
The structural integrity of recombinant proteins is of critical importance to their application as clinical treatments. Recombinant growth hormone preparations have been examined by several methodologies. In this study recombinant human growth hormone (rhGH; Genotropin?), expressed in E. coli K12, was structurally analyzed by two-dimensional gel electrophoresis and MALDI-TOF-TOF, LC-MS and LC-MS/ MS sequencing of the resolved peptides. 相似文献6.
Bernd Liedert Ulf Forssmann Peter Wolna Michaela Golob Andreas Kovar 《BMC clinical pharmacology》2010,10(1):14
Background
Somatropin is recombinant human growth hormone (GH) used for the treatment of growth failure in children and GH deficiency in adults. Two concentrations of a liquid formulation have been developed: 5.83 and 8.0 mg/mL. This trial compared the pharmacokinetics (PK), safety and tolerability of these two liquid concentrations against the freeze-dried (FD) formulation in healthy volunteers. 相似文献7.
Geoffrey H Trew Adam P Brown Samantha Gillard Stuart Blackmore Christine Clewlow Paul O'Donohoe Radoslaw Wasiak 《Reproductive biology and endocrinology : RB&E》2010,8(1):137
Background
Previous studies have reported conflicting results for the comparative doses of recombinant follicle stimulating hormone (rFSH) and highly purified human menopausal gonadotrophin (hMG-HP) required per cycle of in vitro fertilisation (IVF); the aim of this study was to determine the average total usage of rFSH versus hMG-HP in a 'real-world' setting using routine clinical practice. 相似文献8.
Lise L Kjaergard Kim Krogsgaard Christian Gluud 《BMJ (Clinical research ed.)》2001,323(7322):1151-1155
ObjectiveTo assess the efficacy and safety of interferon alfa with or without ribavirin for treatment of chronic hepatitis C.DesignSystematic review of randomised trials on interferon alfa plus ribavirin combination therapy versus interferon alfa. Patients were naive (not previously treated with interferon), relapsers (transient response to previous interferon therapy), or non-responders (no response to previous interferon therapy).ResultsCompared with interferon, combination therapy reduced the risk of not having a sustained virological response for 6 months by 26% in naive patients (relative risk 0.74, 95% confidence interval 0.70 to 0.78), 33% in relapsers (0.67, 0.57 to 0.78), and 11% in non-responders (0.89, 0.83 to 0.96). Morbidity and mortality showed a non-significant trend in favour of combination therapy (Peto odds ratio 0.45, 0.19 to 1.06). Combination therapy significantly reduced the risk of not having improvement in results of histology by 17% in naive patients (0.83, 0.74 to 0.93) and by 27% in relapsers and non-responders (0.73, 0.66 to 0.82). The risk of treatment discontinuations was significantly higher after combination therapy (1.28, 1.07 to 1.52).ConclusionTreatment with interferon alfa plus ribavirin has a significant beneficial effect on the virological and histological responses of patients with chronic hepatitis C, irrespective of previous treatment. Combination therapy may therefore also be considered appropriate for relapsers and non-responders.
What is already known on this subject
Interferon alfa was the recommended treatment for chronic hepatitis C until the late 1990sCombination therapy is recommended for previously untreated patients with chronic hepatitis C, but the benefit of treating relapsers and non-responders to previous treatment with interferon remains controversialThe effect of treatment on liver related morbidity and mortality has not been establishedWhat this study adds
Combination therapy is more effective in treating hepatitis C than interferon alfa alone in naive patients, relapsers, and non-respondersCombination therapy significantly reduced the risk of not having a sustained virological or histological response irrespective of previous treatment and may therefore also be considered in relapsers and non-responders to previous treatmentThe data indicate a non-significant trend towards a beneficial effect on morbidity plus mortality rates 相似文献9.
Georg Griesinger Pierre J. M. Verweij Davis Gates Paul Devroey Keith Gordon Barbara J. Stegmann Basil C. Tarlatzis 《PloS one》2016,11(3)
Study Question
What is the threshold for the prediction of moderate to severe or severe ovarian hyperstimulation syndrome (OHSS) based on the number of growing follicles ≥ 11 mm and/or estradiol (E2) levels?Summary Answer
The optimal threshold of follicles ≥11 mm on the day of hCG to identify those at risk was 19 for both moderate to severe OHSS and for severe OHSS. Estradiol (E2) levels were less prognostic of OHSS than the number of follicles ≥ 11 mm.What Is Known Already
In comparison to long gonadotropin-releasing hormone (GnRH) agonist protocols, the risk of severe OHSS is reduced by approximately 50% in a GnRH antagonist protocol for ovarian stimulation prior to in vitro fertilisation (IVF), while the two protocols provide equal chances of pregnancy per initiated cycle. Nevertheless, moderate to severe OHSS may still occur in GnRH antagonist protocols if human chorionic gonadotropin (hCG) is administered to trigger final oocyte maturation, especially in high responder patients. Severe OHSS following hCG trigger may occur with an incidence of 1–2% in a relatively young (aged 18 to 36 years) IVF population treated in a GnRH-antagonist protocol.Study Design, Size, Duration
From the Engage, Ensure and Trust trials, in total, 2,433 women who received hCG for oocyte maturation and for whom the number of follicles ≥ 11 mm and the level of E2 on the day of hCG administration were known were included in the analyses.Participants/Materials, Setting, Methods
The threshold for OHSS prediction of moderate and severe OHSS was assessed in women treated with corifollitropin alfa or daily recombinant follicle stimulation hormone (rFSH) in a gonadotropin-releasing hormone (GnRH)-antagonist protocol. Receiver operating characteristics curve analyses for moderate to severe OHSS and severe OHSS were performed on the combined dataset and the sensitivity and specificity for the optimal threshold of number of follicles ≥ 11 mm, E2 levels on the day of (hCG), and a combination of both, were determined.Main Results and the Role of Chance
The optimal threshold of follicles ≥ 11 mm on the day of hCG to identify those at risk of moderate to severe OHSS was 19 (sensitivity and specificity 62.3% and 75.6%, respectively) and for severe OHSS was also 19 (sensitivity and specificity 74.3% and 75.3%, respectively). The positive and negative predictive values were 6.9% and 98.6%, respectively, for moderate to severe OHSS, and 4.2% and 99.5% for severe OHSS.Limitations, Reasons for Caution
This was a retrospective analysis of combined data from three trials following ovarian stimulation with two different gonadotropins.Wider Implications of the Findings
For patients with 19 follicles or more ≥11 mm on the day of hCG, measures to prevent the development of OHSS should be considered. Secondary preventive measures include cycle cancellation or coasting, use of a GnRH agonist to trigger final oocyte maturation in place of hCG and a freeze all strategy.Trial Registration
ClinicalTrials.gov NCT00702845 NCT00696800 NCT00696878相似文献10.
Philippe Lehert Joan C Schertz Diego Ezcurra 《Reproductive biology and endocrinology : RB&E》2010,8(1):112
Background
Human menopausal gonadotrophins and recombinant human follicle stimulating hormone are the two main gonadotrophin products utilized for controlled ovarian stimulation in assisted reproductive technologies. In this meta-analysis, the number of oocytes was designated as the most relevant endpoint directly resulting from ovarian stimulation, and therefore where the drug effect may be estimated with the best sensitivity. 相似文献11.
G E Fronko R J Suhadolnik E C Vonderheid K Karikó N L Reichenbach K D Chavin E E Henderson 《Biochemical and biophysical research communications》1988,153(1):448-453
Patients with cutaneous T-cell lymphoma (CTCL) were treated with recombinant alfa 2b interferon (rIFN alfa 2b) by intramuscular injection. Therapy-induced changes in Epstein-Barr virus (EBV) induced transformation of patient peripheral blood lymphocytes, 2',5' oligoadenylate (2-5A) synthetase levels and RNase L activation in peripheral blood mononuclear cells were monitored. Inhibition of EBV-induced transformation and elevation of 2-5A synthetase levels correlated with increased activation of RNase L, which provides evidence that intramuscular administration of rIFN alfa 2b induces a sustained anti-EBV state in CTCL patient peripheral blood mononuclear cells which can be detected in vitro. 相似文献
12.
Sabina Paglialunga Alexandre Fisette Mercedes Munkonda Ying Gao Denis Richard Katherine Cianflone 《BMC physiology》2010,10(1):4
Background
Acylation stimulating protein (ASP) is an adipogenic hormone that stimulates triglyceride (TG) synthesis and glucose transport in adipocytes. Previous studies have shown that ASP-deficient C3 knockout mice are hyperphagic yet lean, as they display increased oxygen consumption and fatty acid oxidation compared to wildtype mice. In the present study, antibodies against ASP (Anti-ASP) and human recombinant ASP (rASP) were tested in vitro and in vivo. Continuous administration for 4 weeks via osmotic mini-pump of Anti-ASP or rASP was evaluated in wildtype mice on a high-fat diet (HFD) to examine their effects on body weight, food intake and energy expenditure. 相似文献13.
Sandro C Esteves Joan C Schertz Sidney Verza Jr Danielle T Schneider Silval FC Zabaglia 《Reproductive biology and endocrinology : RB&E》2009,7(1):111-11
Background
Over the last several decades, as a result of an evolution in manufacturing processes, a marked development has been made in the field of gonadotropins for ovarian stimulation. Initially, therapeutic gonadotropins were produced from a simple process of urine extraction and purification; now they are produced via a complex system involving recombinant technology, which yields gonadotropins with high levels of purity, quality, and consistency. 相似文献14.
Stanley CK Cheung Li-zhong Liu Lin-lin Lan Qiao-quan Liu Samuel SM Sun Juliana CN Chan Peter CY Tong 《BMC biotechnology》2011,11(1):37
Background
Human insulin-like growth factor-I (hIGF-I) is a growth factor which is highly resemble to insulin. It is essential for cell proliferation and has been proposed for treatment of various endocrine-associated diseases including growth hormone insensitivity syndrome and diabetes mellitus. In the present study, an efficient plant expression system was developed to produce biologically active recombinant hIGF-I (rhIGF-I) in transgenic rice grains. 相似文献15.
Richard?P?Dickey John?E?Nichols Michael?P?Steinkampf Benjamin?Gocial Melvin?Thornton Bobby?W?Webster Sandra?M?Bello Jack?Crain Dennis?C?Marshall
Background
These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle(R)) and recombinant follitropin-β (Follistim(R)) in women undergoing in vitro fertilization. 相似文献16.
John Brannian Kathleen Eyster Breanne A Mueller Mandi G Bietz Keith Hansen 《Reproductive biology and endocrinology : RB&E》2010,8(1):25
Background
The study was designed to test the hypothesis that granulosa cell (GC) gene expression response differs between recombinant FSH and human menopausal gonadotropin (hMG) stimulation regimens. 相似文献17.
Background
The 2-oxoglutarate-dependent dioxygenases (2ODDs) of gibberellin (GA) biosynthesis have a key role in the metabolism of a major plant hormone. The activity of recombinant GA 2ODDs from many species has been characterised in detail, however little information relates to enzyme purification. Native GA 2ODDs displayed lability during purification. 相似文献18.
Background
The peptide hormone calcitonin (CT) can significantly effect the proliferation rate of CT receptor (CTR) positive human cancer cells. We wish to identify additional human cancers expressing CTRs and assay the effects of CT on their growth rates and signal transduction pathways. 相似文献19.
Jian Guo Andrew V Schally Marta Zarandi Jozsef Varga Peter CK Leung 《Reproductive biology and endocrinology : RB&E》2010,8(1):54
Background
Antagonists of growth hormone-releasing hormone (GHRH) are being developed for the treatment of various human cancers. 相似文献20.
Roslyn Varki Ed Pequignot Mark C Leavitt Andres Ferber Walter K Kraft 《BMC clinical pharmacology》2009,9(1):2-8