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- Rasanen, J. E., et al.
(författare)
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5-aminolaevulinic acid nanoemulsion is more effective than methyl-5-aminolaevulinate in daylight photodynamic therapy for actinic keratosis: a nonsponsored randomized double-blind multicentre trial
- 2019
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Ingår i: British Journal of Dermatology. - : Oxford University Press (OUP). - 0007-0963 .- 1365-2133. ; 181:2, s. 265-274
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Tidskriftsartikel (refereegranskat)abstract
- Background Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK). Objectives To assess the clinical efficacy, tolerability and cost-effectiveness of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) compared with MAL in DL-PDT for grade I-II AKs. Methods This nonsponsored, prospective randomized double-blind multicentre trial included 69 patients with 767 grade I-II AKs located symmetrically on the face or scalp. A single DL-PDT was given in a randomized split-face design. The primary outcome was clearance of the AKs at 12 months as assessed by a blinded observer. The secondary outcomes were pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy. Results In the per-patient (half-face) analysis, clearance was better for the BF-200 ALA sides than for those treated with MAL (P = 0 center dot 008). In total, BF-200 ALA cleared 299/375 AKs (79 center dot 7%) and MAL 288/392 (73 center dot 5%) (P = 0 center dot 041). The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1 center dot 51 for BF-200 ALA and 1 center dot 35 for MAL (P = 0 center dot 061). Twenty-six patients had a stronger skin reaction on the BF-200 ALA side, seven on the MAL side and 23 displayed no difference (P = 0 center dot 001). The cosmetic outcome was excellent or good in > 90% of cases with both photosensitizers (P = 1 center dot 000). The cost-effectiveness plane showed that the costs of DL-PDT were similar for both photosensitizers, but the effectiveness was slightly higher for BF-200 ALA. Conclusions Our results indicate that BF-200 ALA is more effective than MAL in DL-PDT for grade I-II AKs. BF-200 ALA provides slightly better value for money than MAL.
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- Eskola, Olli, et al.
(författare)
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Tracer Level Electrophilic Synthesis and Pharmacokinetics of the Hypoxia Tracer [F-18]EF5
- 2012
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Ingår i: Molecular Imaging and Biology. - : Springer Science and Business Media LLC. - 1536-1632 .- 1860-2002. ; 14:2, s. 205-212
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Tidskriftsartikel (refereegranskat)abstract
- 2-(2-nitro-1H-imidazol-1-yl)-N-(2,2,3,3,3-pentafluoropropyl)-acetamide labeled with [F-18]-fluorine ([F-18]EF5), a promising tracer for tumor hypoxia, has previously been synthesized in low yields and low specific radioactivity. In pharmacokinetic evaluations, in the presence of non-radioactive EF5, a uniform and low background uptake and high in vivo stability of [F-18]EF5 have been demonstrated. Our purpose was to increase the specific radioactivity of [F-18]EF5 to enable to study the pharmacokinetics at trace level. [F-18]EF5 was synthesized using high specific radioactivity electrophilic [F-18]F-2 as labelling reagent. Biodistribution of [F-18]EF5 was determined in a prostate tumor mouse model, and formation of radiolabelled metabolites was studied in mouse, rat and human plasma. On average, 595 +/- 153 MBq of [F-18]EF5 was produced. Specific radioactivity was 6.6 +/- 1.9 GBq/mu mol and the radiochemical purity exceeded 99.0%. [F-18]EF5 was distributed uniformly in tissues, with highest uptake in liver, kidney, and intestine. Several radiolabelled metabolites were detected in mouse plasma and tissues, whereas low amounts of metabolites were detected in human and rat plasma. [F-18]EF5 was synthesized by electrophilic labelling with high quality and high yields. Pharmacokinetics of [F-18]EF5 was determined at trace level in several species. Our results suggest that the trace-level approach does not affect the biodistribution of [F-18]EF5. Extensive metabolism was seen in mouse.
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