目的评估皮肤病生活质量指数（dermatology life quality index，DLQ1）在寻常性银屑病患者进行临床研究中的临床最小重要差值（minimal clinical important differences，MCID）。方法依托在2个中心进行的临床试验“耳穴贴压加西药局...目的评估皮肤病生活质量指数（dermatology life quality index，DLQ1）在寻常性银屑病患者进行临床研究中的临床最小重要差值（minimal clinical important differences，MCID）。方法依托在2个中心进行的临床试验“耳穴贴压加西药局部用药治疗寻常性银屑病的随机对照研究”（注册号为：ChiCTR—TRC．14004916）进行评估。该研究纳入100例合格病例，随机分成治疗组（51例）采用耳穴叠加得肤宝外用治疗和对照组（49例）单纯采用得肤宝外用治疗。在治疗的0周、4周让患者自行填写DLQI进行生活质量评估，并采用分布法和效标法分别对DLQI的耳穴治疗寻常性银屑病患者中MCID进行估算。结果在这个临床研究中，采用分布法估算的DLQI的MCID波动于0．23—2．58之间，采用效标法估算的MCID值为2．53。结论本研究中DLQI的临床最小重要差异值为2．53，代表患者评分下降2．53时皮损达到好转；使用效标法和分布法评估DLQI的MCID，对临床及量表研究具有重要的参考价值。展开更多
目的研发中央随机分配管理系统(web-based central randomization management system,WCRMS)。方法采用软件研发中的生命周期法,将整个系统开发过程划分为系统规划、系统分析、系统设计、系统实施以及系统维护5个阶段进行系统研制。基...目的研发中央随机分配管理系统(web-based central randomization management system,WCRMS)。方法采用软件研发中的生命周期法,将整个系统开发过程划分为系统规划、系统分析、系统设计、系统实施以及系统维护5个阶段进行系统研制。基于国际临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)标准进行数据库设计,采用模型-视图-控制器(Model View Controller,MVC)模式架构,web服务器采用稳定的tomcat,数据库连接池技术采用Proxool。结果我们成功的研制了中央随机分配管理系统,并且经过多次测试,证明该系统具有稳定性、可靠性和实时性。目前该系统正稳定运行中,它可以支持多个研究设计(多中心/单中心、盲法/非盲)、样本量大小不一的临床研究同时进行,支持设盲研究紧急揭盲、动态药物管理。结论基于CDISC标准的数据库设计,保证了数据标准化与规范化,使系统能更好地与电子数据采集EDC系统进行对接。利用本系统,可使得随机分配隐藏更加可靠,也可使项目管理员通过实时监测项目各分中心进度,采取对应措施,缩短临床研究周期、保证试验质量,从而提高整个研究的效率。展开更多
Objective： To investigate whether the serum levels of inflammation-related cytokines might be different between the healthy individuals and the psoriatic patients diagnosed of three varied Chinese medicine （CM） syn...Objective： To investigate whether the serum levels of inflammation-related cytokines might be different between the healthy individuals and the psoriatic patients diagnosed of three varied Chinese medicine （CM） syndromes [blood-stasis syndrome （BSS）, blood-dryness syndrome （BDS） and wind-heat syndrome （WHS）]. Methods： A total of 62 psoriatic patients were recruited and assigned to 3 groups according to their CM syndromes, including 27 patients of BSS, 21 of BDS and 14 of WHS. Another 20 sex- and age- matched healthy subjects were enrolled into the control group. Serum concentrations of multiple cytokines, including monocyte chemotactic protein-1 （MCP-1）, macrophage inflammatory protein-1α （MIP-1α）, soluble CD40 ligand （SCD40L）, tumor necrosis factor-α （TNF-α）, epidermal growth factor （EGF）, interleukin-8 （IL-8）, interleukin-17 （IL-17）, interferon γ inducible protein-10 （IP-10） and vascular endothelial growth factor （VEGF）, were measured by a multiplexed flow cytometric assay. Results： The circulating levels of MIP-1α, TNF-α, IL-8, and IP-10 were significantly increased in the psoriatic patients compared with the healthy controls （P〈0.01）. Male and female patients tended to have higher serum levels of MCP-1 and IP-10, respectively （P〈0.05）. Interestingly, compared with the control group, 6 out of the 9 cytokines （MCP-1, MIP-1α, TNF-α, EGF, IL-8 and IP-10） were substantially increased in the BSS group （P〈0.05 or P〈0.01）, whereas only MIP-1α and IL-8 levels were elevated in the BDS group （P〈0.05 or P〈0.01） concurrent with lowered concentrations of SCD40L and IL-17 （P〈0.05）. In the WHS group, MIP-1α was the only cytokine whose level was evidently increased （P〈0.01）, in contrast to IL-17 which was decreased as compared with the control （P〈0.05）. The psoriatic patients overall owned higher levels of MIP-1 a and IL-8 in the circulation which were comparable among the 3 groups of CM syndromes （P〈0.01）. In contrast, TNF-α level of the BSS group was the highest among the three （P〈0.01）, followed by the BDS and the WHS groups. Conclusions： The expression profiles of cytokines in the circulation might not be necessarily identical for psoriatic patients with different CM syndromes. Accordingly, the serum concentrations of certain cytokines could potentially be used as the ancillary indices for the clinical classification of psoriatic CM syndromes.展开更多
Objective：To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula（银屑灵优化方） on psoriasis vulgaris.Methods：A randomized controlled single-blind clinical trial on 84 out...Objective：To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula（银屑灵优化方） on psoriasis vulgaris.Methods：A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted.The patients were randomized to a treatment group（43 cases treated by auricular therapy combined with optimized Yinxieling Formula） and a control group （41 cases treated by optimized Yinxieling Formula alone） according to a random number generated by SPSS 17.0 software.The treatment duration for both groups was 8 weeks.The therapeutic effect was comprehensively measured by the primary outcome measure[Psoriasis Area and Severity Index（PASI） reduction rate]and the secondary outcome measure[PASI,Visual Analogue Scale（VAS）,Dermatology Life Quality Index（DLQI）, Self-rating Depression Scale（SDS）,and Self-rating Anxiety Scale（SAS）].The outcomes of both groups were obtained and compared before and after the intervention.Results：The PASI reduction rate in the treatment group was 74.4%（32/43）,which was higher than that in the control group（36.6%,15/41,P0.01）.The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group （P0.01）.With stratified analysis,there were significant differences between the PASI scores in the following subgroups：age 18-30,baseline PASI10 and stable stage（P0.05）.DLQI decreased in both groups on some categories after treatment,but there were no significant differences between the two groups in SDS,SAS and VAS（P0.05）.No obvious adverse reactions were found in either group.Conclusion：The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.展开更多
文摘目的评估皮肤病生活质量指数（dermatology life quality index，DLQ1）在寻常性银屑病患者进行临床研究中的临床最小重要差值（minimal clinical important differences，MCID）。方法依托在2个中心进行的临床试验“耳穴贴压加西药局部用药治疗寻常性银屑病的随机对照研究”（注册号为：ChiCTR—TRC．14004916）进行评估。该研究纳入100例合格病例，随机分成治疗组（51例）采用耳穴叠加得肤宝外用治疗和对照组（49例）单纯采用得肤宝外用治疗。在治疗的0周、4周让患者自行填写DLQI进行生活质量评估，并采用分布法和效标法分别对DLQI的耳穴治疗寻常性银屑病患者中MCID进行估算。结果在这个临床研究中，采用分布法估算的DLQI的MCID波动于0．23—2．58之间，采用效标法估算的MCID值为2．53。结论本研究中DLQI的临床最小重要差异值为2．53，代表患者评分下降2．53时皮损达到好转；使用效标法和分布法评估DLQI的MCID，对临床及量表研究具有重要的参考价值。
基金Supported by the Financial Industry Technology Research and Development Program of Guangdong Province,China(No.201105)
文摘Objective： To investigate whether the serum levels of inflammation-related cytokines might be different between the healthy individuals and the psoriatic patients diagnosed of three varied Chinese medicine （CM） syndromes [blood-stasis syndrome （BSS）, blood-dryness syndrome （BDS） and wind-heat syndrome （WHS）]. Methods： A total of 62 psoriatic patients were recruited and assigned to 3 groups according to their CM syndromes, including 27 patients of BSS, 21 of BDS and 14 of WHS. Another 20 sex- and age- matched healthy subjects were enrolled into the control group. Serum concentrations of multiple cytokines, including monocyte chemotactic protein-1 （MCP-1）, macrophage inflammatory protein-1α （MIP-1α）, soluble CD40 ligand （SCD40L）, tumor necrosis factor-α （TNF-α）, epidermal growth factor （EGF）, interleukin-8 （IL-8）, interleukin-17 （IL-17）, interferon γ inducible protein-10 （IP-10） and vascular endothelial growth factor （VEGF）, were measured by a multiplexed flow cytometric assay. Results： The circulating levels of MIP-1α, TNF-α, IL-8, and IP-10 were significantly increased in the psoriatic patients compared with the healthy controls （P〈0.01）. Male and female patients tended to have higher serum levels of MCP-1 and IP-10, respectively （P〈0.05）. Interestingly, compared with the control group, 6 out of the 9 cytokines （MCP-1, MIP-1α, TNF-α, EGF, IL-8 and IP-10） were substantially increased in the BSS group （P〈0.05 or P〈0.01）, whereas only MIP-1α and IL-8 levels were elevated in the BDS group （P〈0.05 or P〈0.01） concurrent with lowered concentrations of SCD40L and IL-17 （P〈0.05）. In the WHS group, MIP-1α was the only cytokine whose level was evidently increased （P〈0.01）, in contrast to IL-17 which was decreased as compared with the control （P〈0.05）. The psoriatic patients overall owned higher levels of MIP-1 a and IL-8 in the circulation which were comparable among the 3 groups of CM syndromes （P〈0.01）. In contrast, TNF-α level of the BSS group was the highest among the three （P〈0.01）, followed by the BDS and the WHS groups. Conclusions： The expression profiles of cytokines in the circulation might not be necessarily identical for psoriatic patients with different CM syndromes. Accordingly, the serum concentrations of certain cytokines could potentially be used as the ancillary indices for the clinical classification of psoriatic CM syndromes.
基金Supported by the Financial Industry Technology Research and Development Program of Guangdong Province(No.201105)
文摘Objective：To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula（银屑灵优化方） on psoriasis vulgaris.Methods：A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted.The patients were randomized to a treatment group（43 cases treated by auricular therapy combined with optimized Yinxieling Formula） and a control group （41 cases treated by optimized Yinxieling Formula alone） according to a random number generated by SPSS 17.0 software.The treatment duration for both groups was 8 weeks.The therapeutic effect was comprehensively measured by the primary outcome measure[Psoriasis Area and Severity Index（PASI） reduction rate]and the secondary outcome measure[PASI,Visual Analogue Scale（VAS）,Dermatology Life Quality Index（DLQI）, Self-rating Depression Scale（SDS）,and Self-rating Anxiety Scale（SAS）].The outcomes of both groups were obtained and compared before and after the intervention.Results：The PASI reduction rate in the treatment group was 74.4%（32/43）,which was higher than that in the control group（36.6%,15/41,P0.01）.The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group （P0.01）.With stratified analysis,there were significant differences between the PASI scores in the following subgroups：age 18-30,baseline PASI10 and stable stage（P0.05）.DLQI decreased in both groups on some categories after treatment,but there were no significant differences between the two groups in SDS,SAS and VAS（P0.05）.No obvious adverse reactions were found in either group.Conclusion：The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.
