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Safe Treatment Option (safe + treatment_option)
Selected AbstractsTreatment of linear and spider telangiectasia with an intense pulsed light sourceJOURNAL OF COSMETIC DERMATOLOGY, Issue 4 2004R A Retamar Summary Background, The flashlamp-pumped pulsed dye laser (585 and 577 nm) has proved to be an effective and safe treatment option in the therapy of linear and spider facial telangiectasia. Nevertheless, the postoperative purpura, which most patients see as cosmetically disfiguring, has always been a matter of concern. Aims, To test the effectiveness and safety of an intense pulsed light source (IPLS), which emits non-coherent light adjustable within the 515,1200 nm range, in the treatment of linear and spider facial telangiectasia. Patients & Methods, One hundred and forty patients with linear and stellate facial telangiectasia were treated with an IPLS. Results, In 94 (67.1%) the results were considered excellent (clearance of 80,100%), 43 (30.7%) showed good results (clearance of 40,80%) and in 3 patients (2.1%) the results were poor (clearance < 40%). Post-treatment side effects were minimal and well tolerated. There were no instances of scarring or other permanent side effects. Owing to the large spot size, a large area could be treated within one session. No anaesthesia was required. Conclusion, IPLS is a highly effective and comparably safe therapeutic alternative to the pulsed dye laser in the treatment of facial telangiectasia. The rate of cosmetically relevant side effects is considerably smaller, patient compliance is excellent and the method can easily be applied in an outpatient setting. [source] Biosurgery in wound healing , the renaissance of maggot therapyJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 4 2000Uwe Wollina Abstract Chronic wounds are a challenge for modern health care. A basic principle of treatment is the removal of sloughy, necrotic, devitalized tissue to prevent wound infection and delayed healing. Biosurgery (syn. maggot or larval therapy) is a promising adjunct to the whole spectrum of topical treatment methods, in particular for debridement. The term ,biosurgery' describes the use of living maggots on wounds to remove devitalized tissue, decrease the risk of infection and improve wound healing. The present paper gives a brief review of history, entomology, biochemistry and medical indications of biosurgery and the practical handling of maggots. We also provide some clinical data from the literature and our own experience in a wound care unit. Biosurgery is an effective and safe treatment option for debridement and disinfection. [source] Oral, colonic-release low-molecular-weight heparin: an initial open study of Parnaparin-MMX for the treatment of mild-to-moderate left-sided ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2008L. PASTORELLI Summary Background, Efficacy of heparin and low-molecular-weight heparins (LMWHs) in inflammatory bowel disease (IBD) treatment has been suggested. The multimatrix oral formulation MMX releases active drugs in the colon, avoiding systemic absorption. Parnaparin sodium is the LMWH chosen to be carried in the MMX formulation. Aim, To assess the safety of three different oral dosages (70, 140 and 210 mg once daily) of Parnaparin-MMX (CB-01-05) in left-sided ulcerative colitis (UC). Methods, Left-sided UC patients, with a mild-to-moderate relapse were enrolled. All patients received Parnaparin-MMX for 8 weeks. Clinical Activity Index (CAI), Disease Activity Index (DAI), Endoscopic Activity Index and IBD-QoL were assessed throughout the study. A strict clinical and laboratory follow-up, including assessment of anti-factor Xa activity, was performed. Clinical remission was defined as CAI <4. Results, Ten UC patients were enrolled. One patient retired for clinical deterioration. No relevant side effects, including either interference with haemostasis parameters or increased bleeding, were observed. At the end of the treatment, seven patients (70%) were in clinical remission, only one achieving endoscopic healing. Mean final CAI, DAI and IBD-QoL scores were significantly improved from baseline. Conclusions, Parnaparin-MMX appears to be a safe treatment option in mild-to-moderate UC. Controlled studies are warranted. [source] Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled studyALLERGY, Issue 4 2010T. Zuberbier To cite this article: Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antépara I, Jáuregui I, Valiente R, the Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65: 516,528. Abstract Background:, Bilastine is a novel nonsedative H1 -receptor antagonist, which may be used for the symptomatic treatment of chronic idiopathic urticaria (CU). The aim of this study was to compare the clinical efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg and placebo in CU patients with moderate-to-severe symptoms. Methods:, Overall 525 male and female subjects aged 18,70 years were randomized to receive bilastine 20 mg, levocetirizine 5 mg or placebo, once daily for 28 days, in double-blind manner, in 46 centres across Europe and Argentina. Patients rated symptoms of pruritus, number of wheals, and maximum size of wheals (on predefined scales) as reflective (over past 12 h) symptoms twice daily, for assessment of change from baseline in the total symptoms scores (TSS) over 28 days as the primary efficacy measure. Changes in reflective and instantaneous symptoms scores, Dermatology Life Quality Index (DLQI), and CU-associated discomfort and sleep disturbance were assessed as secondary outcomes. Safety was assessed according to adverse events, laboratory tests and electrocardiograms. Results:, Bilastine reduced patients' mean reflective and instantaneous TSS from baseline to a significantly greater degree than placebo (P < 0.001); from day 2 onwards of treatment. The DLQI, general discomfort, and sleep disruption were also improved significantly in bilastine-treated patients as compared with placebo-treated patients (P < 0.001 for all parameters). Comparison with levocetirizine indicated both treatments to be equally efficacious as well as equally safe and well tolerated as compared with placebo. Conclusions:, Bilastine 20 mg is a novel effective and safe treatment option for the management of CU. [source] Rupatadine in the treatment of chronic idiopathic urticaria: a double-blind, randomized, placebo-controlled multicentre studyALLERGY, Issue 5 2007A. Gimenez-Arnau Background:, Chronic urticaria is one of the most common and disturbing cutaneous condition. The treatment of chronic idiopathic urticaria (CIU) is still a challenge. Antihistamines are recommended as first-line treatment. Rupatadine is a new potent nonsedative anti-H1. Objective:, To study rupatadine efficacy and safety for moderate to severe CIU treatment. Methods:, This randomized, double-blind, placebo-controlled, parallel-group, multicentre, study was designed to assess primarily mean pruritus score (MPS) reduction with rupatadine, 10 and 20 mg, administered once daily for 4 weeks. Three hundred and thirty-three patients with active episodes of moderate-to-severe CIU were included. Results:, A 57.5% (P < 0.005) and 63.3% (P = 0.0001) significative MPS reduction from baseline, was observed at week 4 with 10 and 20 mg rupatadine, respectively, compared with placebo (44.9%). Both doses of rupatadine were not significantly different at any time point, with respect to their effects on pruritus severity, number of wheals and total symptoms scores. Rupatadine 10 mg had an overall better adverse event profile. Conclusion:, Rupatadine 10 mg is a fast, long-acting, efficacious and safe treatment option for the management of patients with moderate-to-severe CIU. [source] Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trialALLERGY, Issue 9 2004B. Brinkhaus Background:, Patients with allergic rhinitis (AR) increasingly use complementary medicine. The aim of this study was to determine whether traditional Chinese therapy is efficacious in patients suffering from seasonal AR. Methods:, Fifty-two patients between the ages of 20 and 58 who had typical symptoms of seasonal AR were assigned randomly and in a blinded fashion to (i) an active treatment group which received a semi-standardized treatment of acupuncture and Chinese herbal medicine, and (ii) a control group which received acupuncture applied to non-acupuncture points in addition to a non-specific Chinese herbal formula. All patients received acupuncture treatment once per week and the respective Chinese herbal formula as a decoction three times daily for a total of 6 weeks. Assessments were performed before, during, and 1 week after treatment. The change in severity of hay fever symptoms was the primary outcome measured on a visual analogue scale (VAS). Results:, Compared with patients in the control group, patients in the active treatment group showed a significant after-treatment improvement on the VAS (P = 0.006) and Rhinitis Quality of Life Questionnaire (P = 0.015). Improvement on the Global Assessment of Change Scale was noted in 85% of active treatment group participants vs 40% in the control group (P = 0.048). No differences between the two groups could be detected with the Allergic Rhinitis Symptom Questionnaire. Both treatments were well-tolerated. Conclusions:, The results of this study suggest that traditional Chinese therapy may be an efficacious and safe treatment option for patients with seasonal AR. [source] Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adultsBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2007Samir K. Gupta What is already known about this subject ,,According to recent literature, the pathophysiologies of allergic rhinitis and chronic idiopathic urticaria are thought to be similar in adults and children. In addition, the response to antihistamine treatment is similar in adults and children, suggesting a similar concentration-response relationship. ,,However, an appropriate dose selection and the pharmacokinetics of desloratadine in children of ,6 months,,2 years old have never been addressed in the literature. What this study adds ,,This study demonstrated that desloratadine syrup offers a safe treatment option for allergic conditions in young children. ,,A suitable dose for children aged ,6 months,<1 year is 1.0 mg, while the corresponding predicted dose for children aged ,1 year,,2 years is 1.25 mg. These paediatric doses yielded similar systemic desloratadine exposures (AUC) to those seen with a typical adult dose of 5.0 mg. Aims The aim of this study was to identify the dose of desloratadine in children aged ,6 months,,2 years that would yield a single-dose target exposure (AUC) comparable with that in adults taking 5 mg desloratadine as syrup. Methods In a phase 1, single-dose, open-label, pharmacokinetic study in 58 children aged ,6 months,<1 year and ,1 year,,2 years were randomly assigned to desloratadine syrup 0.625 mg (1.25 ml) and 1.25 mg (2.5 ml), respectively. Because the volume of blood that could be collected from individual subjects was limited, a population pharmacokinetic approach was used to estimate the pharmacokinetics of desloratadine. Safety was assessed based on results of screening and postdose physical examinations, laboratory safety tests, vital signs, and adverse events. Results The apparent clearance (CL/F) of desloratadine, population estimate (%CV), in children aged ,6 months,<1 year was 27.8 l h,1 (35) and corresponding values in children ,1 year,,2 years was 35.5 l h,1 (51), compared with 137 l h,1 (58) for adults. The CL/F ratios (children to adults) indicated that doses of 1 mg for ,6 months,<1 year and 1.25 mg for ,1 year,,2 years would result in similar systemic exposure to that observed in adults receiving the recommended 5 mg dose. Desloratadine was well tolerated with no safety issues. Conclusions Doses of 1.0 and 1.25 mg in children aged ,6 months,,2 years should result in an exposure to desloratadine similar to that of adults receiving doses of 5 mg. [source] In vitro and in vivo comparison of two different light sources for topical photodynamic therapyBRITISH JOURNAL OF DERMATOLOGY, Issue 4 2006P. Babilas Summary Background, Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) is an effective and safe treatment option for the treatment of actinic keratosis (AK). Incoherent lamps are often used, matching the absorption maxima of ALA. Objectives, A comparative trial was performed to evaluate the efficacy of recently developed light-emitting diodes (LEDs). Methods, Human epidermal keratinocytes were incubated for 24 h with ALA (100, 200, 300, 400 or 500 ,mol L,1) and irradiated consecutively using either an incoherent halogen lamp (,em = 580,750 nm; 24 J cm,2; 40 mW cm,2) or an LED system (,em = 633 ± 3 nm; 3, 6, 12 or 24 J cm,2; 40 mW cm,2). Topical ALA-PDT was performed on 40 patients with AK (n = 584) in a symmetrical distribution suitable for two-sided comparison. After incubation with ALA (20% in cream base) irradiation was performed with the incoherent lamp (100 J cm,2; 160 mW cm,2) on one side and the LED system (40 J cm,2; 80 mW cm,2) on the opposite side followed by re-evaluation up to 6 months. Results, No significant differences between the LED system (3, 6, 12 or 24 J cm,2) and the incoherent light source (24 J cm,2) regarding cytotoxicity was found in vitro. The complete remission rate yielded in the in vivo investigation was also not significantly different at 6 weeks (P = 0·95), 3 months (P = 0·75) and 6 months (P = 0·61) following therapy. Six weeks following therapy complete remission rates of 84·3% (LED system) and 82·8% (incoherent lamp) were achieved. There was also no significant difference between both light sources regarding pain during light treatment (P = 0·67), patient satisfaction (P = 1·0) or cosmesis (P = 1·0) following therapy. Conclusions, These results show the efficacy of an LED system for ALA-PDT both in vitro and in vivo. ALA-PDT with the LED system showed a noninferiority regarding the clinical outcome in the treatment of AK compared with the incoherent lamp. [source] Skin-sparing mastectomy and immediate reconstruction is an acceptable treatment option for patients with high-risk breast carcinomaCANCER, Issue 5 2005Kevin J. Downes Abstract BACKGROUND Skin-sparing mastectomy (SSM) followed by immediate reconstruction is an effective treatment option for patients with early-stage breast carcinoma, but its use in patients with more advanced disease is controversial. METHODS A retrospective review was performed that included 38 consecutive patients with high-risk breast carcinoma who underwent SSM and immediate reconstruction (between July 1996 and January 2002). Tumor characteristics, type of reconstruction, margin status, timing of adjuvant therapy, postoperative complications, and incidence of recurrence were evaluated. RESULTS High-risk patients (Stage IIA [n = 4 patients] Stage IIB [n = 23 patients] Stage IIIA [n = 8 patients] and Stage IIIB [n = 3 patients]) underwent immediate reconstruction after SSM with the use of a transverse rectus abdominis myocutaneous flap (n = 31 patients), a latissimus dorsi myocutaneous flap plus an implant (n = 3 patients), or tissue expanders with subsequent implant placement (n = 4 patients). The median follow-up was 52.9 months (range, 27.5,92.0 months), and the median time to recurrence has not yet been reached at the time of last follow-up. The median interval from surgery to the initiation of postoperative adjuvant therapy was 38 days (range, 25,238 days). Local recurrence was seen in 1 patient (2.6%), systemic recurrence in was seen in 10 patients (26.3%), and both local and distant metastases in were seen in 2 other patients (5.3%). CONCLUSIONS SSM with immediate reconstruction appeared to be an oncologically safe treatment option for high-risk patients with advanced stages of breast carcinoma. In addition to the aesthetic and psychological benefits of performing SSM with immediate reconstruction, local recurrence rates and disease-free survival were favorable when combined with the use of radiation therapy and adjuvant chemotherapy, as indicated. Cancer 2005. © 2005 American Cancer Society. [source] | ||||||||||