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E. Niclas Jonsson Rujia Xie Scott F. Marshall Rosalin H. Arends 《British journal of clinical pharmacology》2016,81(4):688-699
AimsThe aims were to 1) develop the pharmacokinetics model to describe and predict observed tanezumab concentrations over time, 2) test possible covariate parameter relationships that could influence clearance and distribution and 3) assess the impact of fixed dosing vs. a dosing regimen adjusted by body weight.MethodsIndividual concentration–time data were determined from 1608 patients in four phase 3 studies conducted to assess efficacy and safety of intravenous tanezumab. Patients received two or three intravenous doses (2.5, 5 or 10 mg) every 8 weeks. Blood samples for assessment of tanezumab PK were collected at baseline, 1 h post‐dose and at weeks 4, 8, 16 and 24 (or early termination) in all studies. Blood samples were collected at week 32 in two studies. Plasma samples were analyzed using a sensitive, specific, validated enzyme‐linked immunosorbent assay.ResultsA two compartment model with parallel linear and non‐linear elimination processes adequately described the data. Population estimates for clearance (CL), central volume (V
1), peripheral volume (V
2), inter‐compartmental clearance, maximum elimination capacity (VM) and concentration at half‐maximum elimination capacity were 0.135 l day–1, 2.71 l, 1.98 l, 0.371 l day–1, 8.03 μg day–1 and 27.7 ng ml–1, respectively. Inter‐individual variability (IIV) was included on CL, V
1, V
2 and VM. A mixture model accounted for the distribution of residual error. While gender, dose and creatinine clearance were significant covariates, only body weight as a covariate of CL, V
1 and V
2 significantly reduced IIV.ConclusionsThe small increase in variability associated with fixed dosing is consistent with other monoclonal antibodies and does not change risk : benefit. 相似文献
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Dr. Arni Raghavendrarao Raghuram M.Ch. Subbiah Kumar MD Kathamuthu Balamurugan DA Arulmurugan DA Ramiah Krishnan M.Ch. Perichiappan Sivakami BS Eluvathingal Varghese John M.Ch. 《Indian Journal of Thoracic and Cardiovascular Surgery》2006,22(3):178-181
Background Beating heart surgery has now become the commonest technique of doing Coronary Artery Bypass Graft Surgery (CABG) in our country.
It is being used even in such high risk situations like diffuse coronary disease and Critical Left Main stem Stenosis (LMCS)
with good results. The aim of this study is to retrospectively review our results in Off-Pump Coronary Artery Bypass Surgery
(OPCAB) in patients with critical left main stem stenosis.
Methods This study is a retrospective analysis of the data of patients who underwent primary coronary artery bypass surgery. During
the period from April 2003 to September 2005 a total of 64 patients underwent OPCAB procedure for critical LMCS. During the
same period 10 patients underwent CABG on Cardio Pulmonary Bypass (CPB). The age range was 36–77yrs. The sex distribution
was M: F 53∶10. Ten patients were done as emergency. 2 of them were on Intra Aortic Balloon Pump (IABP) support preoperatively.
10 patients were high risk with a Euro score of ≥5.
Results Left Internal Mammary Artery (LIMA) was used in 78% of cases. Average grafts per patient was 2.96. The median ventilation
time was 5.91 hrs. New IABP insertion in postoperative period was required in 1 patient. One patient was reexplored for bleeding.
There was one perioperative myocardial infarction. 57% of patients did not need any blood transfusion. There was no conversion
to CPB. There was no operative mortality. Inotropes were used in ten cases.
Conclusions OPCAB is a safe method of revascularization in patients with critical LMCS. Preoperative IABP is useful in patients with cardiogenic
shock. However, there is a place for CPB in patients needing additional procedures like Mitral Valve repair (MV repair) or
Dor's procedure or when the vessels are very diffusely diseased. Those patients who are unstable despite IABP support may
be managed by Beating heart On Pump (BHOP) technique. 相似文献
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