Rupatadine, a novel nonsedating second-generation H1-antihistamine with antiplatelet-activating factor activity, has been used in the treatment of allergic rhinitis and urticaria in European countries since 2003. However, its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU) are unknown.
Methods
We conducted a prospective, multicenter, randomized, placebo-controlled, double-blind study in adolescent and adult CSU outpatients aged 12 to < 65 years (JAPIC-CTI No. 152786). Overall, 94, 91, and 92 eligible patients orally received placebo, rupatadine 10 mg, and 20 mg once daily for 2 weeks, respectively. The primary endpoint was change from baseline to the second week of treatment in total pruritus score (TPS, sum of daytime and nighttime pruritus scores).
Results
The results yielded a least squares mean TPS difference of ?1.956 between rupatadine 10 mg versus placebo, and ?2.121 between rupatadine 20 mg versus placebo (analysis of covariance, both P < 0.001). The incidence of adverse events was 8.5% for placebo, 20.9% for rupatadine 10 mg, and 17.4% for rupatadine 20 mg. Somnolence was the only adverse drug reaction to rupatadine reported in 2 or more subjects. No serious or clinically significant adverse events were observed.
Conclusions
The primary and secondary efficacy endpoints consistently favored rupatadine 10 and 20 mg doses over the placebo. No noteworthy dose-related increase in the incidence of adverse drug reactions was observed. Rupatadine is safe and effective at a dose of 10 mg once daily, and can be safely increased to 20 mg once daily, as necessary. 相似文献
There is a range of psoriasis treatments available, from topical applications to biologic therapy, with corresponding cost variations. The efficacy of each treatment is usually evaluated by objective measures such as the Psoriasis Area and Severity Index (PASI) or subjective measures such as the Dermatology Life Quality Index (DLQI). However, the social and economic impacts of psoriasis, including cost‐effectiveness, have not been assessed in Japan. The EuroQol 5‐Dimension (EQ‐5D) is a generic instrument used worldwide to calculate quality‐adjusted life years, on which calculations of treatment cost‐effectiveness are based. We conducted a pilot study to determine the cost‐effectiveness of psoriasis treatment in Japan. We administered a questionnaire to 133 patients with psoriasis (105 men and 28 women) who visited four university hospitals in Fukuoka Prefecture. The questionnaire covered medical costs, satisfaction and willingness to pay (WTP), and we investigated the relationships between these items. PASI was evaluated by physicians. More participants indicated satisfaction with treatment in the group paying less than ¥5000/month. WTP, PASI and EQ‐5D showed little correlation. However, the DLQI and EQ‐5D showed a moderate correlation (r = 0.472). WTP seemed more dependent on participants' economic backgrounds. We found that it was difficult to reflect the PASI with the EQ‐5D. However, the DLQI may be used to estimate the cost–benefit relationship in patients with psoriasis. This is the first study to evaluate the EQ‐5D in patients with psoriasis in Japan. 相似文献
目的观察川百止痒洗剂联合0.1%糠酸莫米松乳膏治疗湿疹的有效性与安全性。方法采用随机、单盲、平行对照的方法对63例湿疹患者应用川百止痒洗剂联合0.1%糠酸莫米松乳膏外用治疗,同时设立对照组64例单独外用0.1%糠酸莫米松乳膏,治疗12天后评价疗效,并进行皮肤病生活质量指数(dermatology life quality index,DLQI)问卷调查。结果试验组总有效率为87.30%,与对照组70.31%相比有统计学差异(P<0.01);DLQI总分两组均下降,但无统计学差异(P=0.8775);试验组和对照组发生局部刺激反应分别为6.3%和7.8%,无统计学差异(Fisher校正χ2检验P=1.0000)。结论川百止痒洗剂联合0.1%糠酸莫米松乳膏治疗湿疹较为有效、安全。 相似文献
Introduction: Psoriasis is a common, immune-mediated skin disease often associated with significant physical and psychosocial impairment. Antipsoriatic biologic agents offer patients unparalleled treatment potential in regard to greater skin clearance and overall improved quality of life. Evaluation of the therapeutic efficacy of biologic agents on the full psoriasis disease burden must account for their impact on both physical symptoms, as well as patient-reported, health-related quality of life (HRQoL) measurements.
Areas covered: Results from numerous clinical trials demonstrate the significant clinical efficacy of biological agents targeting tumor necrosis factor-α (TNF-α) and the interleukin (IL)-12/23 and IL-17 immune pathways. However, relatively limited data is available evaluating their full effect on quality of life outcomes. This review will discuss the most relevant and up-to-date clinical data on HRQoL measurements related to treatment with these aforementioned biologic agents.
Expert commentary: Patient-reported outcomes (i.e. Dermatology Life Quality Index) are being used with increasing frequency in clinical trials, and provide valuable information on the impact of psoriasis on numerous aspects of day-to-day living. These outcomes must also be incorporated in clinical practice, in addition to physical assessment of disease severity, treatment decisions, and therapeutic response in the psoriasis patient population. 相似文献
Plaque psoriasis is a debilitating condition that significantly affects patient well-being. Limited data are available regarding the effect of psoriasis and treatment on health-related quality of life (HRQoL) and work ability among Taiwanese patients.To document and compare HRQoL, treatment satisfaction, and work disability among Taiwanese patients with current and past moderate-to-severe plaque psoriasis.
Methods
This was a multicenter, non-interventional, cross-sectional study of adult patients with moderate-to-severe plaque psoriasis. During a single clinic visit, each patient was assessed for body surface area (BSA) involvement, Psoriasis Area Severity Index (PASI), Dermatology Life Quality Index (DLQI), Euro Quality of Life-5 Dimensions (EQ-5D), 10-level satisfaction scale for psoriasis treatment, and Working Productivity and Activity Impairment (WPAI). Multivariate regression was used to identify factors associated with HRQoL and work disability.
Results
A total of 305 patients were included within the analysis. The mean PASI score was 11.83, and the mean BSA involvement was 20.90%. The mean EQ-5D score was 65.68 and the mean DLQI score was 12.55. Fewer than half of patients (45.68%) indicated they were satisfied with the standard therapy they were currently receiving. Among employed patients, the mean reduction in on-the-job effectiveness was 32.09% and the mean reduction in overall productivity was 33.48%. The regression analysis indicated that patients with more severe psoriasis defined by PASI scores show a greater impact in quality of life and impairment in work disability; and that patients who were satisfied with current standard treatment had a better quality of life.
Conclusion
The effect of psoriasis on HRQoL among patients with psoriasis in Taiwan is substantial, with fewer than half of patients reporting satisfaction with therapeutic options. 相似文献