Background:Benvitimod cream,a novel synthetic small molecule,was effective in treating mild-to-moderate plaque psoriasis.We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in...Background:Benvitimod cream,a novel synthetic small molecule,was effective in treating mild-to-moderate plaque psoriasis.We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.Methods:We randomly assigned 686 patients(2:1:1)to receive 1%benvitimod cream,0.005%calcipotriol ointment or placebo twice a day for 12 weeks.The primary efficacy end points were the percentage of patients with a 75%or greater reduction from baseline in the psoriasis area and severity index(PASI 75)score and with a score of 0 or 1 in static physician’s global assessment(sPGA)at week 12.Results:The results showed that 50.4%of patients in the benvitimod group achieved PASI 75,which was significantly higher than that in the calcipotriol(38.5%,P<0.05)and placebo(13.9%,P<0.05)groups.The proportion of patients achieving an sPGA score 0 or 1 was 66.3%in the benvitimod group and 63.9%in the calcipotriol group,which were both significantly higher than that in the placebo group(34%,P<0.05).In the long-term follow-up study,50.8%of patients experienced recurrence.After retreatment with 1%benvitimod,73.3%of patients achieved an sPGA score of 0 or 1 again at week 52.Adverse events included application site irritation,follicular papules,and contact dermatitis.No systemic adverse reactions were reported.Conclusion:During this 12-week study,benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.展开更多
Background The body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index was shown at predicting the risk of death, exacerbation and disease severity among patients with COPD, but few studies...Background The body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index was shown at predicting the risk of death, exacerbation and disease severity among patients with COPD, but few studies verified relationship between BODE index and health related quality of life (HRQoL) among Chinese COPD patients. The objective of this study was to evaluate the relationship between BODE index and HRQoL in cross-sectional and longitudinal association analyses. Methods A multi-center prospective cohort study was initially conducted in 491 stable COPD patients in Beijing, China. Health status (HRQoL) was assessed by St. George's Respiratory Questionnaire (SGRQ); the BODE index was calculated for each patient; dyspnea was assessed using the 5-grade Medical Research Council dyspnea scale. Other measurements included socio-demographic, body mass index (BMI), lung function test and 6-minute-walk test (6MWT). Patients were then followed monthly for 12 months. Results Only 450 patients completed the 1-year follow up and were enrolled in our present analyses. Mean age was (65.2 ±10.6)years,' men 309 (68.7%). The BODE index was categorized into 4 subgroups: 0-2, 3-4, 5-6 and 7-10. At baseline BODE index was gradually increased with baseline total SGRQ and SGRQ subscales (P trend 〈0.001). For individual components of BODE index, with the decrease of airflow limitation, and 6MWD, and with the increase of Medical Research Council (MRC) dyspnea grade, total SGRQ and SGRQ subscales were increased correspondingly, P trend 〈0.05, respectively. Similar association patterns were found between baseline BODE index and its individual components and mean SGRQ scores at the end of 1-year follow up. By multiple linear regression analyses, baseline BODE index was not only significantly associated with SGRQ score at baseline but also with SGRQ score at the end of 1-year follow up after adjustment for age, male, current smoking, 13s being 0.434 and 0.378, respectively. Conclusio展开更多
近年来,肿瘤患者健康相关生命质量(health-related quality of life,HRQOL)评价越来越受关注,相关评价方法在国外也得到广泛应用。本文着重介绍肿瘤患者健康相关生命质量的概况、研究与应用进展,以及生命质量的相关测量工具的使用。对...近年来,肿瘤患者健康相关生命质量(health-related quality of life,HRQOL)评价越来越受关注,相关评价方法在国外也得到广泛应用。本文着重介绍肿瘤患者健康相关生命质量的概况、研究与应用进展,以及生命质量的相关测量工具的使用。对肿瘤患者健康相关生命质量评价研究的特点进行了探讨。展开更多
基金Beijing Wenfeng Tianji Pharma Ltd.and the grant from National Science and Technology Major Project of the Ministry of Science and Technology of China(No.2011ZX09101-006-02)。
文摘Background:Benvitimod cream,a novel synthetic small molecule,was effective in treating mild-to-moderate plaque psoriasis.We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.Methods:We randomly assigned 686 patients(2:1:1)to receive 1%benvitimod cream,0.005%calcipotriol ointment or placebo twice a day for 12 weeks.The primary efficacy end points were the percentage of patients with a 75%or greater reduction from baseline in the psoriasis area and severity index(PASI 75)score and with a score of 0 or 1 in static physician’s global assessment(sPGA)at week 12.Results:The results showed that 50.4%of patients in the benvitimod group achieved PASI 75,which was significantly higher than that in the calcipotriol(38.5%,P<0.05)and placebo(13.9%,P<0.05)groups.The proportion of patients achieving an sPGA score 0 or 1 was 66.3%in the benvitimod group and 63.9%in the calcipotriol group,which were both significantly higher than that in the placebo group(34%,P<0.05).In the long-term follow-up study,50.8%of patients experienced recurrence.After retreatment with 1%benvitimod,73.3%of patients achieved an sPGA score of 0 or 1 again at week 52.Adverse events included application site irritation,follicular papules,and contact dermatitis.No systemic adverse reactions were reported.Conclusion:During this 12-week study,benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.
文摘Background The body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index was shown at predicting the risk of death, exacerbation and disease severity among patients with COPD, but few studies verified relationship between BODE index and health related quality of life (HRQoL) among Chinese COPD patients. The objective of this study was to evaluate the relationship between BODE index and HRQoL in cross-sectional and longitudinal association analyses. Methods A multi-center prospective cohort study was initially conducted in 491 stable COPD patients in Beijing, China. Health status (HRQoL) was assessed by St. George's Respiratory Questionnaire (SGRQ); the BODE index was calculated for each patient; dyspnea was assessed using the 5-grade Medical Research Council dyspnea scale. Other measurements included socio-demographic, body mass index (BMI), lung function test and 6-minute-walk test (6MWT). Patients were then followed monthly for 12 months. Results Only 450 patients completed the 1-year follow up and were enrolled in our present analyses. Mean age was (65.2 ±10.6)years,' men 309 (68.7%). The BODE index was categorized into 4 subgroups: 0-2, 3-4, 5-6 and 7-10. At baseline BODE index was gradually increased with baseline total SGRQ and SGRQ subscales (P trend 〈0.001). For individual components of BODE index, with the decrease of airflow limitation, and 6MWD, and with the increase of Medical Research Council (MRC) dyspnea grade, total SGRQ and SGRQ subscales were increased correspondingly, P trend 〈0.05, respectively. Similar association patterns were found between baseline BODE index and its individual components and mean SGRQ scores at the end of 1-year follow up. By multiple linear regression analyses, baseline BODE index was not only significantly associated with SGRQ score at baseline but also with SGRQ score at the end of 1-year follow up after adjustment for age, male, current smoking, 13s being 0.434 and 0.378, respectively. Conclusio
文摘近年来,肿瘤患者健康相关生命质量(health-related quality of life,HRQOL)评价越来越受关注,相关评价方法在国外也得到广泛应用。本文着重介绍肿瘤患者健康相关生命质量的概况、研究与应用进展,以及生命质量的相关测量工具的使用。对肿瘤患者健康相关生命质量评价研究的特点进行了探讨。