Incidence and risk factors for intravenous immunoglobulin-related hemolysis: A systematic review of clinical trial and real-world populations.

Background: Severe hemolysis rarely occurs in patients receiving intravenous immunoglobulin (IVIG) therapy. A systematic review was performed to assess the incidence of IVIG-related hemolysis and the impact of patient and product risk factors.

Study Design And Methods: A systematic literature search for terms related to "IVIG products", "hemolysis," and "adverse events" was conducted in Embase for articles published between January 1, 2015, and May 31, 2021.

Isoagglutinin reduction by a dedicated immunoaffinity chromatography step in the manufacturing process of human immunoglobulin products.

Background: The passive transfer of antibodies specific to blood groups A and B (also called isoagglutinins) contained in immunoglobulin (Ig)G products for intravenous administration (IVIG) is believed to be largely responsible for rare but sometimes serious IVIG-related hemolytic events. We present in this work a modification of the manufacturing process of Privigen-a 10% l-proline-stabilized IVIG product-that allows extensive reduction of isoagglutinin concentrations in the final product.

Study Design And Methods: An additional immunoaffinity chromatography (IAC) step was introduced toward the end of the manufacturing process of Privigen.

Effects of the manufacturing process on the anti-A isoagglutinin titers in intravenous immunoglobulin products.

Background: The first intravenous immunoglobulin G (IVIG) preparations for clinical use were produced from human plasma by Cohn-like fractionation processes. To achieve higher purity and yield, chromatography-based processes were developed. Using two products as examples, we compare the capacity of these two manufacturing processes to reduce the levels of anti-A and anti-B isoagglutinins in IVIG, which are believed to be responsible for rare hemolytic adverse events.

Assessment of the ability of the Privigen® purification process to deplete thrombogenic factor XIa from plasma.

Background And Objectives: Activated clotting factor FXI (FXIa) has been postulated to play a significant role in thromboembolic events potentially associated with the administration of intravenous immunoglobulin. The purpose of this study was to demonstrate that thrombogenic agents, in particular FXIa and FXI, are depleted or inactivated in Privigen(®) .

Materials And Methods: The ability of the purification process to deplete FXIa from plasma was studied.

Influence of inhaled nitric oxide on plasma nitrate concentrations in patients with adult respiratory distress syndrome and sepsis: results of a pilot study.

Study Objective: To measure plasma nitrate concentrations after inhalation of nitric oxide for treatment of adult respiratory distress syndrome (ARDS) and sepsis.

Design: Prospective pilot study.

Setting: Intensive care unit at a university-affiliated hospital.

Single-dose pharmacokinetics of ofloxacin during continuous venovenous hemofiltration in critical care patients.

Background: Ofloxacin is a quinolone administered to patients with severe infections. Pharmacokinetic data on ofloxacin in critically ill patients on renal replacement therapy are sparse and conflicting.

Methods: Eight patients with anuric acute renal failure were administered 400 mg of ofloxacin intravenously.

Endothelial cell compatibility of azithromycin and erythromycin.

Phlebitis is a severe local adverse event related to the use of parenteral macrolides. In order to evaluate the effect of azithromycin and erythromycin on human venous endothelial cells, we set up an in vitro model. The intracellular levels of purine nucleotides, as adenosine 5'-triphosphate (ATP), adenosine 5'-diphosphate (ADP) and guanosine 5'-triphosphate (GTP), were measured by means of high-performance liquid chromatography.

Impact of Mitomycin-C application time on the scleral Mitomycin-C concentration.

The aim of this study was to determine the effect of varying the application time of Mitomycin-C (MMC) on the scleral concentration of MMC. The sclerae of 14 human donor eyes were used for this study. The episcleral sides of the 4 scleral quadrants of each donor eye were exposed for 0.

Intracellular concentration of the HIV protease inhibitors indinavir and saquinavir in human endothelial cells.

Human vascular endothelial cells may serve as targets and a reservoir for human immunodeficiency virus type 1 (HIV-1). The antiviral activity of HIV protease inhibitors is reported to be related directly to the intracellular amount of the drug. To assess intracellular concentrations of two HIV protease inhibitors, human umbilical venous endothelial cells (HUVECs) were exposed for 3 h and 24 h to 100, 10 and 1 mg/L indinavir and saquinavir.

In vitro diffusion of mitomycin-C into human sclera after episcleral application: impact of diffusion time.

The purpose of this study was to investigate the impact of different diffusion times of mitomycin-C (MMC) on the intrascleral concentration vs depth profile of MMC in an experimental model. Scleral quadrants of eight human donor eyes were exposed to sponges soaked with MMC for an application time of 1 min. After irrigation with 40 ml saline, we allowed further diffusion of MMC in the sclera for 1, 5, 14 and 29 min until the specimens were further processed.

Identification of yeast species by fatty acid profiling as measured by gas-liquid chromatography.

An improved rapid method for the identification of yeasts and yeast-like fungi from clinical sources which is based on fatty acid profiles obtained by gas-liquid chromatography (GLC) is described. The fatty acid profile database is based upon internal standardisation and using the relative retention times and the retention index of the analysed fatty acids. Differentiation between yeast species was achieved by the quantitative and qualitative comparison of measured fatty acid profiles with those in the database.

Intrascleral concentration vs depth profile of mitomycin-C after episcleral application: impact of applied concentration and volume of mitomycin-C solution.

The purpose of this study was to investigate the impact of different concentrations and volumes of Mitomycin-C (MMC) on the intrascleral concentration vs depth profile of MMC in an experimental model. The episcleral sides of scleral quadrants of human donor eyes were exposed for 1 min to sponges (corneal light shield, Merocel Corp.) soaked with MMC.

Pharmacokinetics of cefpirome during continuous venovenous hemofiltration: rationale for an 8-hour dosing interval.

Objective: Cefpirome is a new semisynthetic cephalosporin, primarily eliminated by the kidneys, that requires dosage adjustment in patients with kidney failure. The optimal dosing regimen of cefpirome in patients with continuous veno-venous hemofiltration (CVVH) is unknown.

Methods: Pharmacokinetic properties of cefpirome were investigated in eight anuric patients with acute kidney failure treated by CVVH.

Serum concentrations of granulocyte-colony stimulating factor in complicated Plasmodium falciparum malaria.

Involvement of neutrophils in the control of blood parasites in malaria has been reported. Both, mononuclear phagocytes and neutrophils are known to be stimulated by cytokines such as TNF-alpha in order to augment the defence potency against the parasites. Previously, it has been shown that serum-G-CSF concentrations are increased in patients with bacterial sepsis.

Intrascleral concentration vs depth profile of mitomycin-C after episcleral application: impact of irrigation.

Mitomycin-C has been reported to cause toxic effects on the ciliary body after episcleral application during glaucoma surgery. We investigated the intrascleral diffusion of mitomycin-C in an experimental model. The episcleral sides of scleral quadrants of 14 human donor eyes were exposed for 5 min to sponges (corneal light shield, Merocel corp.

Homocysteine and laminin are not prognostic markers in patients with septic inflammatory response syndrome.

The aim of this study was to measure plasma homocysteine and laminin concentrations in patients with nonbacteremic systemic inflammatory response syndrome (SIRS) and to compare them with those of a healthy control group. Concerning laminin, significant increased concentrations could be observed in the SIRS group compared to the control group, but for homocysteine, no significance could be observed. In summary, homocysteine and laminin levels are not useful in the prediction of a patient's outcome.

High serum laminin concentrations in patients with Candida sepsis.

Background: Laminin, a major component of the basement membrane, plays a critical role in normal cell adhesion and also during tissue invasion of pathogenic microorganisms.

Materials And Methods: Serum laminin concentrations were determined in 19 patients with Candida albicans sepsis, in 13 patients with bacterial sepsis and in 20 noninfectious controls.

Results: Serum laminin concentrations of both, patients with candidal and bacterial sepsis, were significantly elevated compared to the controls (486 ng mL-1 [155-924], median [range]; P < 0.

Penetration and decay of meropenem into the human aqueous humor and vitreous.

The aim of this study was to determine the penetration of intravenously administered meropenem into the human aqueous humor and vitreous. Thirty patients about to undergo cataract surgery and fourteen patients about to undergo vitrectomy received a 2 g dose of meropenem before surgery. Specimens of aqueous humor or vitreous and blood were obtained intraoperatively and analyzed by high performance liquid chromatography (HPLC).

Serum nitrate concentrations in patients with peripheral arterial occlusive disease.

Background: Nitric oxide (NO), an endogenous product of L-arginine oxidation, seems to account for the vasodilatatory effect of the endothelium-derived relaxing factor. It was the aim of the present study to measure serum nitrate concentrations, the degradation product of nitric oxide in patients with peripheral arterial occlusive disease (PAOD).

Patients And Methods: 20 patients with PAOD in Fontaine stage IIb, 10 patients in stage III and IV respectively were included in the study.

Cytokines in sepsis due to Candida albicans and in bacterial sepsis.

Cytokines, such as tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6) and tumor necrosis factor-soluble receptor (TNF-sR), and adhesion molecules, e.g. vascular adhesion molecule-1 (VCAM-1) and E-selectin, play an important role in the pathogenesis of bacterial sepsis.

A simple HPLC method for monitoring mycophenolic acid and its glucuronidated metabolite in transplant recipients.

Mycophenolic acid (MPA) is nowadays in broad clinical use as a substitute for azathioprine. An immunoassay for MPA recently received approval for clinical applications. The high performance liquid chromatography (HPLC) assay for measuring MPA and its glucuronide conjugate (MPAG) we describe here is not only rapid and simple but also extremely sensitive at plasma levels obtained during standard immunosuppressive regimens.

Continuous infusion versus intermittent administration of meropenem in critically ill patients.

This prospective crossover study compared the pharmacokinetics of meropenem by continuous infusion and by intermittent administration in critically ill patients. Fifteen patients were randomized to receive meropenem either as a 2 g iv loading dose, followed by a 3 g continuous infusion (CI) over 24 h, or by intermittent administration (IA) of 2 g iv every 8 h (q8h). Each regimen was followed for a period of 2 days, succeeded by crossover to the alternative regimen for the same period.

Serum procalcitonin levels in severe Plasmodium falciparum malaria.

Levels of procalcitonin (ProCT) have been found to be elevated in individuals with severe bacterial infections such as sepsis and peritonitis, and this correlates well with the severity of the disease. Recently, increased levels have been described in melioidosis and Plasmodium falciparum malaria. In this study ProCT levels were measured in 27 Thai patients with complicated malaria before and during/after treatment with artesunate and mefloquine.

Short report: total serum levels of the nitric oxide derivatives nitrite/nitrate during microfilarial clearance in human filarial disease.

Nitric oxide (NO) has recently been shown to be cytotoxic to both microfilariae and adult Brugia malayi in vitro and in a murine model, as well against Onchocerca lienalis microfilariae in vitro. We studied the kinetics of nitrite/nitrate, both stable end products of NO, by high-pressure liquid chromatography during microfilaricidal chemotherapy in four filariasis (three Loa loa, and one Onchocerca volvulus) patients. High serum levels of nitrite/nitrate were released during microfilarial clearance and sustained elevated levels were observed six months after chemotherapy, suggesting a role of NO in the elimination of microfilariae in human filariasis.