Comparing infusion-related reactions of the first full dose (600 mg) biosimilar ocrelizumab administration with the standard divided protocol in multiple sclerosis patients: a randomized controlled trial study.

BACKGROUND: Ocrelizumab is a humanized antiCD20, thought to be a highly effective disease-modifying therapy (DMT). Its most frequent adverse effects are infusion-related reactions (IRRs). To reduce these reactions, the first dose of ocrelizumab is administered as two 300 mg infusions separated by two weeks. However, in the phase II trial of ocrelizumab, severe IRRs were not significantly different between two doses of 600 mg dose (two separate 300 mg doses) and 2000 mg dose (two separate 1000 mg doses). We compared the IRRs in undivided full (one 600 mg) and divided (two 300 mg) doses of ocrelizumab which is the standard protocol. METHODS: MS patients (relapsing or primary progressive MS) who are selected to receive ocrelizumab by neurologist or MS fellowship were enrolled in an open-label randomized controlled trial. Iranian biosimilar of the drug (Xacrel® by Cinnagen, approved by the Iranian Food and Drug Administration in 2021) was used. The participants received the first dose of ocrelizumab as either one 600 mg dose in one session or two 300 mg doses in two weeks apart. IRRs during or in the first 24 h after infusion were recorded. RESULTS: Of 332 participants, 150 received two 300 mg doses, and 182 received one 600 mg dose (by random selection). Life-threatening adverse effects were not observed in both groups. Overnight admission or permanent drug discontinuation was not needed. Temporary drug discontinuation was significantly higher in the one 600 mg dose group (p-value < 0.001). During the infusions, malaise (p-value: 0.003), skin reactions (p-value: 0.04), throat swelling (p-value: 0.03), and dyspnea (p-value: 0.01) were significantly increased in the intervention group. However, in the first 24 h, there was no significant difference between two different treatment protocols (one 600 mg dose or two 300 mg doses) in the onset of IRRS (p-value: 0.12). CONCLUSION: These findings suggest one 600 mg dose of ocrelizumab administration for the first dose is relatively safe. With some protocol modifications, it could lead to fewer patient referrals, saving time and cost and improvement the access for patients.

Effect of Arch Size and Implant Angulations on the Accuracy of Implant Impressions.

PURPOSE: To evaluate the effects of arch size and implant angulation on the accuracy of implant impressions. MATERIALS AND METHODS: Four different resin models (small and large) of edentulous maxilla were fabricated and four implants were inserted (Blossom®, ø 4.75 × 10 mm) in each model. Implants were either parallel or angled 25° buccally. Forty working casts (small parallel, small angled, large parallel, and large angled) were fabricated in dental stone (n=10). For each implant, linear and angular displacements were measured using a coordinate-measuring machine (CMM) and mean values were analyzed by univariate analysis (α = 0.05). RESULTS: Arch size did not affect the linear or angular displacement (P ⟩ .05). However, the implant angulation had a marked influence on the linear displacement (P ⟨ .05). The largest linear displacement occurred in implant no. 4 of angled small groups. CONCLUSION: Regardless of arch size, linear and angular accuracy of implant impression varied with the implant angulation.

Seasonal variation in the chemical composition, antioxidant activity, and total phenolic content of Artemisia absinthium essential oils.

BACKGROUND: The genus Artemisia belonging to the Compositae (Asteraceae) family and many traditional uses from the Artemisia species were reported. Artemisia absinthium is one of the species in this genus and commonly used in the food industry in the preparation of aperitifs, bitters, and spirits. OBJECTIVE: Evaluation of the effect of different harvesting stages on the composition of essential oil and antioxidant capacity of A. absinthium. MATERIALS AND METHODS: Essential oils from the aerial parts of A. absinthium, collected in three stages (preflowering, flowering, and after-flowering) from plants grown in the North Khorasan province of Iran were obtained by steam distillation and the chemical composition of the oils was analyzed by gas chromatography-mass spectrometry and antioxidant activity and total phenolic content were determined by 2-diphenyl-1-picrylhydrazyl assay and Folin-Ciocalteu method. RESULTS: Analysis of the isolated oils revealed the presence of 44 compounds, mainly alpha-pinene, sabinene, beta-pinene, alpha-phellandrene, p-cymene and chamazulene. Alpha-phellandrene, and chamazulene were major compounds in preflowering stage, but beta-pinene and alpha-phellandrene were major in flowering and past-flowering stages. Flowering stage had highest yield and after flowering stage had lowest yield. The essential oil of preflowering stage had the highest amount of antioxidant compound (chamazulene). Preflowering stage with highest amount of phenolic compounds had the strongest antioxidant activity with the lowest amount of EC50. CONCLUSION: This study showed that the harvesting stage had significant effects on chemical composition and antioxidant properties of essential oils, and chamazulene is main compound for antioxidant activity in A. absinthium.

Antibacterial activity of the essential oil from Cymbopogon nervatus inflorescence.

Antibacterial activity of essential oil of dried inflorescence of Cymbopogon nervatus was investigated. The essential oil remarkably inhibited the growth of tested bacteria except for Salmonella typhi. The maximum activity was against Shigella dysenteriae and Klebsiella pneumoniae.

Dexamethasone levels in treated pregnant women and newborn infants.

Dexamethasone concentration was measured in plasma and amniotic fluid by radioimmunoassay using a rabbit antiserum raised against DX-hemisuccinate-albumin. Recoveries of added tracers averaged 70% after paper chromatography. The within- and between-assay coefficients of variation averaged 10%. The lower limit of detection was 0.2 mug/dl when 0.4 ml of plasma was assayed. Ten healthy pregnant women at term had cesarean sections 8 to 11 hours following administration of 8 mg of DX orally. DX levels in maternal vein, in umbilical vein and artery, and in amniotic fluid averaged 2.2, 2.9, 2.6, and 2.5 mug/dl, respectively. Although cortisol levels were markedly suppressed, the total relative glucocorticoid activity in blood of fetuses treated with DX far exceeded that of the untreated group.

Myogenesis of avian striated muscle in vitro: role of collagen in myofiber formation.

The complex chemical environment required for the development of the myofiber (myotube) from embryonic avian muscle myoblasts in vitro has been simplified. Myotube formation is shown to occur in the presence of insulin, a low-molecular-weight (fusion) factor obtained from embryo extract, and a collagen substratum. In the absence of collagen, globular structures are formed which are microscopically identical to the globular syncytial structures previously described [de la Haba and Amundsen (1972) Proc. Nat. Acad. Sci. USA 69, 1131-1135]. A high-molecular-weight fraction from embryo extract will also promote myotube formation in the presence of the fusion factor. This fraction is shown to contain (a) collagen, which promotes myotube formation, and (b) an additional factor which also promotes myotube formation, and which we tentatively hypothsize to be an inducer of collagen synthesis by myogenic cells.