The optimal treatment of port-wine stains is laser-induced selective photothermolysis. Lesion color and location and the age of the patient are reported to influence the therapeutic outcome. This study was initiated to analyze the outcome not only by the clinical response of lightening, but also in terms of photothermally induced necrosis to the vessel wall. Punch biopsy specimens were taken from 51 patients before treatment. Post-treatment biopsies were taken after exposure to a pulsed dye laser (585-nm wavelength, 0.45-ms pulse length) with an irradiant fluence of 6.5 J/cm2. Vessel diameter, depth, and wall thickness were measured in all histologic slides. The viability of the vessel walls was evaluated using an enzyme histochemical method. Port-wine stains with good blanching had significantly more superficially located vessels than the moderate and poor responders (p < 0.000). The moderate and good responding lesions consisted of moderate-sized vessels with diameters of 38 +/- 17 micrometers and 38 +/- 19 micrometers (mean +/- SD), respectively. The lesions showing poor blanching had significantly smaller vessels, with a diameter of 19 +/- 6.5 micrometers < 0.000). Analyses of the post-treatment specimens showed that coagulated vessels were superficially located and of moderate size, whereas the viable vessels were small with a median diameter of 14 micrometers. The probability of coagulation correlated with the thickness of the vessel wall. These data indicate that the therapeutic outcome of port-wine stains can be improved by using the lesional vessel parameters to select the optimal laser wavelength, pulse duration, and dose.
Background and objectivesThe 52‐week, randomized, double‐blind, noninferiority, government‐funded NOR‐SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT‐P13 was not inferior to continued treatment with infliximab originator. The NOR‐SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT‐P13 throughout the 78‐week study period (maintenance group) versus patients switched to CT‐P13 at week 52 (switch group). The primary outcome was disease worsening during follow‐up based on disease‐specific composite measures.MethodsPatients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.ResultsBaseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per‐protocol set). Adjusted risk difference was 5.9% (95% CI −1.1 to 12.9). Frequency of adverse events, anti‐drug antibodies, changes in generic disease variables and disease‐specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.ConclusionThe NOR‐SWITCH extension showed no difference in safety and efficacy between patients who maintained CT‐P13 and patients who switched from originator infliximab to CT‐P13, supporting that switching from originator infliximab to CT‐P13 is safe and efficacious.
Pulsed dye lasers permit effective treatment of port-wine stains without a significant risk of complications. However, epidermal damage manifested by weeping or crusting of the treated area have been reported in 48-83% of patients, and transient hyperpigmentation after treatment is observed in 10-57%. Theoretically, the epidermis can be protected from thermal damage with the use of the concept of selective epidermal cooling.This study examined the clinical effects of rapid cooling of the epidermis with a liquid refrigerant R-134a (boiling point - 26.5 double daggerC) during pulsed dye laser therapy. In 23 patients with port-wine stains, a 50-ms-long cooling pulse delivered immediately prior to laser irradiation with a fluence of 6.0 J cm(-2) significantly reduced the pain, and shortened the period with purpura without compromising the clinical blanching. Cooling periods longer than 60 ms, as well as additional cooling pulses immediately after laser exposure, reduced the blanching in areas irradiated with 6.0 J cm(-2).Post-treatment hyperpigmentation was not prevented with dynamic cooling.
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