Variability in perfusion conditions and set-up parameters used in ex vivo human placenta models: A literature review.

The ex vivo human placenta perfusion model has proven to be clinically relevant to study transfer- and fetal exposure of various drugs. Although the method has existed for a long period, the setup of the perfusion model has not been generalized yet. This review aims to summarize the setups of ex vivo placental perfusion models used to examine drug transfer across the placenta to identify generalized properties and differences across setups. A literature search was carried out in PubMed September 26, 2022. Studies were labeled as relevant when information was reported, between 2000 and 2022, on the setups of ex vivo placental perfusion models used to study drug transfer across the placenta. The placenta perfusion process, and the data extraction, was divided into phases of preparation, control, drug, and experimental reflecting the chronological timeline of the different phases during the entire placental perfusion process. 135 studies describing an ex vivo human placental perfusion experiment were included. Among included studies, the majority (78.5%) analyzed drug perfusion in maternal to fetal direction, 18% evaluated bi-directional drug perfusion, 3% under equilibrium conditions, and one study investigated drug perfusion in fetal to maternal direction. This literature review facilitates the comparison of studies that employ similar placenta perfusion protocols for drug transfer studies and reveals significant disparities in the setup of these ex vivo placental perfusion models. Due to interlaboratory variability, perfusion studies are not readily comparable or interchangeable. Therefore, a stepwise protocol with multiple checkpoints for validating placental perfusion is needed.

A double-blind comparison of oxatomide (R 35 443) and diphenhydramine in the treatment of hay fever.

Ninety-one hay fever patients received either 0.5 mg/kg oxatomide b.i.d. or 0.4 mg/kg diphenhydramine b.i.d. in a two-month double-blind study. If necessary this dose could be doubled. The results showed that fewer oxatomide patients needed to double this starting dose and to use a nasal spray. Oxatomide proved to be more effective than diphenhydramine in limiting the severity of the hay fever attacks, as evidenced by the findings that oxatomide patients had fewer complaint-days, and that more of these patients were rated by the investigators to have excellent or good results. Apart from daytime fatigue, transient in several patients, no oxatomide-induced side-effects were found.

Report on a trial of SCG 2% nasal solution (metered dose) in hayfever.

An analysis has been performed on the results from 18 patients treated with SCG and 14 patients treated with placebo in a double-blind placebo-controlled group comparative trial of SCG 2% nasal solution (metered dose) in hayfever. The two treatment groups were found to be similar with respect to relevant characteristics and pre-trial symptomatology. Analysis of clinician's symptom scorings demonstrated statistically significant differences in favour of SCG for the symptoms Sneezing, Running and Itching. No significant differences between the treatments were found in the statistical analysis of patient diary card total scores. Five assessments of overall response made at the end of treatment gave results highly significantly in favour of SCG.

[Comparative study of a new antihistamine, mequitazine, and placebos]. / Essai comparé d'un nouvel antihistaminique, la méquitazine, et d'un placebo

In a double-blind trial lasting 2 weeks, a new, long-acting antihistamine, Mequitazine, and a placebo, were compared. 115 allergic patients participated in this experiment (mequitazine n = 56, placebo n = 59). Therapeutic results and the effect on diurnal alertness were evaluated by means of a questionnaire filled in daily by the patients. Whether considering the day by day results or the results of the entire treatment period, statistically, Mequitazine (10 mg/24 hrs) is very significantly more active than the placebo. The daytime drowsiness induced by Mequitazine is statistically no greater than that induced by the placebo, whether analyzed on a day by day basis or over the entire treatment period (P = 0.23). The side effects, 8 for Mequitazine, 5 for placebo, are mild and did not lead to discontinuation of the treatment in the Mequitazine group.