Background. The early detection of wearing-off in Parkinson disease (DEEP) observational study demonstrated that women with Parkinson's disease (PD) carry an increased risk (80.1%) for wearing-off (WO). This post hoc analysis of DEEP study evaluates gender differences on WO and associated phenomena. Methods. Patients on dopaminergic treatment for ≥1 year were included in this multicenter observational cross-sectional study. In a single visit, WO was diagnosed based on neurologist assessment as well as the use of the 19-item wearing-off questionnaire (WOQ-19); WO was defined for scores ≥2. Post hoc analyses were conducted to investigate gender difference for demographic and clinical features with respect to WO. Results. Of 617 patients enrolled, 236 were women and 381 were men. Prevalence of WO was higher among women, according to both neurologists' judgment (61.9% versus 53.8%, P = 0.045) and the WOQ-19 analysis (72.5% versus 64.0%, P = 0.034). In patients with WO (WOQ-19), women experienced ≥1 motor symptom in 72.5% versus 64.0% in men and ≥1 nonmotor symptom in 44.5% versus 36.7%, in men. Conclusions. Our results suggest WO as more common among women, for both motor and nonmotor symptoms. Prospective studies are warranted to investigate this potential gender-effect.
Cyclosporine A (CsA) is one of the most effective systemic drugs available for the treatment of psoriasis, as evidenced by the results of several randomized studies and by a prolonged experience in dermatological setting. In clinical practice, CsA is usually used for the induction of psoriasis remission at a daily dose included in the range of 2.5–5 mg/kg and with intermittent short-term regimens, lasting on average 3–6 months. The magnitude and rapidity of response are dose dependent, as well as the risk of development of adverse events. Therefore, the dose should be tailored to patient's needs and general characteristics and adjusted during the treatment course according to both the efficacy and tolerability. Some studies support the feasibility of pulse administration of CsA for a few days per week for both the induction and the maintenance of response in psoriasis patients. This paper will review the data on CsA regimens for plaque-type psoriasis and will focus the attention on dose, treatment duration, novel schedules, and role in combination therapies, including the association with biologicals.
The available information about the effects of pregnancy on psoriasis and those of psoriasis on pregnancy is almost limited, despite the high frequency of the disease in the general population, as well as in women in reproductive years. Considering the existing evidence, pregnancy does not tend to have a negative influence on psoriasis, as in most women who experience a change in the severity and course of their psoriasis during pregnancy, the change is more likely to be reported as an improvement. This assumption can be applied more convincingly to plaque-type psoriasis, while an exception may be represented by generalized pustular psoriasis, which has been somehow linked to impetigo herpetiformis. Conflicting findings emerged from the few available studies that explored the effect of psoriasis on pregnancy outcomes. Recent studies found an association between moderate-to-severe psoriasis and some pregnancy complications, including pregnancy-induced hypertensive diseases, and have emphasized a trend toward a newborn with low birth weight in patients with psoriasis, especially in those suffering from severe forms. The safety profile during pregnancy is not completely known for many drugs used to treat psoriasis. Moisturizers and low- to moderate-potency topical steroids or ultraviolet B phototherapy represent the first-line therapy for pregnant patients. Many dermatologists may, however, recommend discontinuing all drugs during pregnancy, in consideration of medico-legal issues, and also taking into account that common forms of psoriasis do not compromise the maternal and fetal health. Anyway, for those women whose psoriasis improves during pregnancy, the interruption of any therapy for psoriasis can be a reasonable strategy. The objective of this paper was to review the most relevant literature data on psoriasis in pregnancy, trying to give concurrently practical information about clinical and prognostic aspects, as well as counseling and management.
PurposeAim of the study was to determine both clinically and by noninvasive instrumental evaluations the efficacy, tolerability and the duration of the effects of a new hyaluronic acid (HA) gel in human volunteers with moderate aging/photoaging.Patients and methodsEighteen volunteers (35–55 years) were enrolled in this single-center study. The subjects underwent five visits. The first visit was at baseline to determine the adherence to the inclusion criteria, followed by the first injection of the HA-based study product, and the second visit was at 48 hours after the injection. Two months later, a second injection was given (Visit 3) followed by a subsequent visit (Visit 4) after 48 hours. The last visit (Visit 5) was performed 5 months after the first injection. Clinical and instrumental evaluations as well as self-assessment by the subjects were recorded at each visit.ResultsA significant improvement of wrinkles’ grade around the eyes, vertical lip lines and wrinkles’ severity of nasolabial folds was recorded after the first injection and the effect increased after the second injection. Aging/photoaging grade and surface microrelief improved 2 months after the first injection procedure. These clinical improvements were paralleled by amelioration of instrumental skin profilometry and optical colorimetry. The treatments were very well tolerated by the volunteers as determined by the self-grading score.ConclusionThe results confirm the good esthetic performance and the duration of the effect of the HA-based study product (Viscoderm® Hydrobooster) on dynamic facial wrinkles and/or static facial lines. These effects were particularly evident after the second injection and were accompanied by a good tolerability of the product.
Background. At present, dermal fillers based on hyaluronic acid (HA) represent the most popular intervention of dermoesthetic medicine for the treatment of skin aging. Recent studies have shown that the combination of HA chains of different lengths and molecular weights improves tissue repair and regeneration through a synergistic mechanism. Profhilo® is a product available that has been on the market since 2015 and is based on stable, hybrid, and cooperative complexes (HyCoCos) produced by means of NAHYCO® Hybrid Technology, which is an innovative thermal process that rules out the use of any chemical reagents. The result is a filler with high biocompatibility and low viscosity that favors optimal diffusion at the tissue level to obtain the target bioremodeling of the facial contour. The objective of this review is to provide data from the overall postmarketing experience after 3 years of use and more than 40,000 patients treated with the medical device. Methods. All spontaneous postmarketing adverse event (AE) reports received from physicians and healthcare professionals worldwide between February 9, 2015, and February 8, 2018, associated with the use of the studied medical device and sent to the IBSA global safety database were analyzed. Results. In total, 12 adverse event reports were logged in the global database, and none were considered serious. Early-onset injection site reactions, i.e., swelling, edema, redness, ecchymosis, and erythema, were the most frequently observed. Late-onset local reactions (e.g., swelling, nodules) followed. The genesis of these reactions was considered, both by the reporting physician and IBSA, as being local reactions of hypersensitivity and/or due to inappropriate injection techniques. In no case was the product held liable for direct damage. All events resolved without any complications according to the treatment guidelines. Two late-onset reactions were collected. Conclusions. Although underreporting of minor events cannot be ruled out, the overall number of reports is very low, thereby supporting the high tolerability and safety of the product. After 3 years of postmarketing experience, the safety profile of the studied medical device is favorable and consistent with the product information.
Cyclosporine (CyA) is a well-known immunosuppressant with a narrow therapeutic window. Its bioavailability is affected by many other traditional drugs and herbal extracts. Cytochrome P-450 isoenzymes CYP3A4 and CYP3A5 and protein P-glycoprotein (P-gp) are involved in CyA bioavailability. Interactions of CyA with herbal extracts are not well known, but, given their increased concomitant use, it is important to know which extracts, many of which are commonly self-prescribed, can affect CyA blood concentrations. Decreased CyA blood concentration has been shown with St John's wort in case reports and, in vivo animal studies, with ginger, liquorice, scutellariae radix, and quercetin. Increased CyA concentration has been reported in patients with grapefruit juice, chamomile, or berberine, and with cannabidiol or resveratrol in animal studies. Effects of Echinacea and Serenoa repens on CyA levels have not been shown consistently, but concomitant use should be avoided. Although findings from animal studies cannot be directly translated into humans, avoiding concomitant use of herbal extracts is prudent until human clinical studies have ruled out any possible interaction. Clinicians should interview their patients carefully about their use of herbal supplements before CyA administration, and those receiving CyA should be warned about possible interactions between herbal preparations and CyA.
We have prospectively evaluated psoriatic arthritis (PsA) patients for (1) seropositivity for former viral infections and seroconversion and (2) efficacy of cyclosporine A (CsA) alone or in combination with other immunosuppressants in a time period of 12 months. Screening included HBV antibodies and antigens, HCV antibodies and RNA, HSV 1-2, HZV, EBV, and CMV IgG, and IgM, HHV-6 DNA, and HIV 1-2 antibodies. PsA was evaluated by the Psoriasis Area Severity Index (PASI), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Visual Analogue Scale (VAS). At baseline, 126 (56%) out of 225 evaluable patients had 2 or more seropositivities indicative of former infections, and 31 patients (13.8%) presented seropositivity for HCV, HBV, HSV-1 and -2, HHV-6, EBV, or parvovirus infection; one of them, positive for HBAg, was treated with lamivudine, while the remaining 30 received no specific treatment. None of the 31 patients developed virus reactivation. A reduction (P < 0.001) of PASI, BASDAI, and VAS scores was observed at 6 and 12 months. The treatment of PsA with CsA as monotherapy or in combination was safe and effective. In vitro experiments and clinical findings, including those from our study, suggest that CsA as monotherapy or in combination with biologics might be the treatment of choice in PsA HCV-positive patients.
Hyaluronic acid (HA)-based injectable filling agents are at the forefront of the current demand for noninvasive dermatological procedures for the correction of age-related soft tissue defects. The present review aims to summarize currently available HA-based products and critically appraise their differences in rheological nature and clinical application. Linear HA (LHA) gels may be supplemented with amino acids, lipoic acid, vitamins, nucleosides, or minerals for synergistic antiaging and antioxidant benefits (polycomponent LHA). HA hydrogels can be generated via chemical or physical crosslinking, which increases their elasticity and decreases viscosity. The performance of crosslinked fillers depends on HA concentration, degree of crosslinking, elastic modulus, cohesivity, and type of crosslinking agent employed. PEG-crosslinked LHA displays improved elasticity and resistance to degradation, and lower swelling rates as compared to BDDE-crosslinked LHA. Physical crosslinking stabilizes HA hydrogels without employing exogenous chemical compounds or altering hyaluronans’ natural molecular structure. Thermally stabilized hybrid cooperative HA complexes (HCC) are a formulation of high- and low-molecular-weight (H-HA and L-HA) hyaluronans, achieving high HA concentration, low viscosity with optimal tissue diffusion, and a duration comparable to weakly cross-linked gel. Our critical analysis evidences the importance of understanding different fillers’ properties to assist physicians in selecting the most appropriate filler for specific uses and for predictable and sustainable results.
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