丹归活血合剂治疗白癜风——单中心随机双盲对照临床试验
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摘要
目的观察中药复方丹归活血合剂治疗白癜风的有效性与安全性,开展院内制剂规范化临床研究。方法采用前瞻性随机双盲对照方法,将171例白癜风患者分为中药组(丹归活血合剂口服加0.05%卤米松乳膏外用,89例)和对照组(安慰剂口服加卤米松乳膏外用,82例),3个月后评价色素情况。结果中药组总有效率57.30%,对照组总有效率40.24%,两组差异有显著统计学意义(P<0.05);中药组白斑消退率为35.09%,而对照组为18.48%,两组差异有显著统计学意义(P<0.001)。不良反应发生率中药组为6.74%,对照组为6.10%,主要是胃肠道反应,能耐受,两组差异无统计学意义(P>0.05)。结论丹归活血合剂治疗白癜风疗效肯定,安全性良好。
Objective To assess the efficacy and safety of Dangui-Huoxue mixture in vitiligo treatment. Methods A prospective 3-mon,randomized,double blind,placebo-controlled study was conducted in 171 patients,in which 89 patients as the case group treated by Dangui-Huoxue mixture orally combined with 0.05% halometasone cream while 82 patients as the control group treated by placebo orally combined with halometasone cream.Assessment of repigmentation was performed 3 months after the procedure. Results Higher efficiency was observed in the case group(57.30%) compared with that in control group(40.24%)(P<0.05).Dangui-Huoxue mixture showed improvement effect in vitiligo area scoring index(VASI) which was 35.09% in case group vs.18.48% in control group(P<0.001).Adverse events were minor in both groups mainly shown as tolerable gastrointestinal reaction.There was no significant difference between the two groups(P>0.05).Conclusions Dangui-Huoxue mixture provided significant repigmentation in vitiligo and may offer a valuable therapeutic option.
Objective To assess the efficacy and safety of Dangui-Huoxue mixture in vitiligo treatment. Methods A prospective 3-mon,randomized,double blind,placebo-controlled study was conducted in 171 patients,in which 89 patients as the case group treated by Dangui-Huoxue mixture orally combined with 0.05% halometasone cream while 82 patients as the control group treated by placebo orally combined with halometasone cream.Assessment of repigmentation was performed 3 months after the procedure. Results Higher efficiency was observed in the case group(57.30%) compared with that in control group(40.24%)(P<0.05).Dangui-Huoxue mixture showed improvement effect in vitiligo area scoring index(VASI) which was 35.09% in case group vs.18.48% in control group(P<0.001).Adverse events were minor in both groups mainly shown as tolerable gastrointestinal reaction.There was no significant difference between the two groups(P>0.05).Conclusions Dangui-Huoxue mixture provided significant repigmentation in vitiligo and may offer a valuable therapeutic option.
引文
[1] 中华中医药学会皮肤科分会.白癜风中医治疗专家共识[J].中国中西医结合皮肤性病学杂志,2017,16(2):191-192.
[2] 王锐华.中药白斑颗粒治疗白癜风患者的疗效分析[J].福建医药杂志,2017,39(6):125-127.
[3] 中国中西医结合学会皮肤性病专业委员会色素病学组.白癜风诊疗共识(2014版)[J].中华皮肤科杂志,2014,47 (1):69-71.
[4] TAIEB A,ALOMAR A,BOHM M,et al.Guidelines for the management of vitiligo:the European Dermatology Forum consensus[J].Br J Dermatol,2013,168(1):5-19.
[5] IBBOTSON SH.A Perspective on the use of NB-UVB phototherapy vs. PUVA photochemotherapy[J].Front Med (Lausanne), 2018,5:184.
[6] EL-ZAWAHRY BM,ESMAT B,BASSIOUNY D,et al. Effect of procedural-related variables on melanocyte-keratinocyte suspension transplantation in nonsegmental stable vitiligo:a clinical and immunocytochemical study[J].Dermatol Surg,2017,43(2):226-235.
[7] NAOKI O,TAMIO S,MARI WK,et al.Guidelines for the diagnosis and treatment of vitiligo in Japan[J].J Dermatol,2013,40(1):1-11.
[8] ROTHSTEIN B,JOSHIPURA D,SARAIYA A,et al.Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib[J].J Am Acad Dermatol,2017,76(6):1-8.
[9] 刘爱民,刘硕.白癜风的中医辨证与治疗[J].皮肤科学通报,2017,34(6):662-664.
[10] 马丽华,兰东.从风论治难治性白癜风体会[J].临床医药文献杂志,2018,5(3):108-109.
[11] 张弘.白癜风中药内服方剂的组方原则及用药探析[J].中医中药,2011,1(18):72.
[2] 王锐华.中药白斑颗粒治疗白癜风患者的疗效分析[J].福建医药杂志,2017,39(6):125-127.
[3] 中国中西医结合学会皮肤性病专业委员会色素病学组.白癜风诊疗共识(2014版)[J].中华皮肤科杂志,2014,47 (1):69-71.
[4] TAIEB A,ALOMAR A,BOHM M,et al.Guidelines for the management of vitiligo:the European Dermatology Forum consensus[J].Br J Dermatol,2013,168(1):5-19.
[5] IBBOTSON SH.A Perspective on the use of NB-UVB phototherapy vs. PUVA photochemotherapy[J].Front Med (Lausanne), 2018,5:184.
[6] EL-ZAWAHRY BM,ESMAT B,BASSIOUNY D,et al. Effect of procedural-related variables on melanocyte-keratinocyte suspension transplantation in nonsegmental stable vitiligo:a clinical and immunocytochemical study[J].Dermatol Surg,2017,43(2):226-235.
[7] NAOKI O,TAMIO S,MARI WK,et al.Guidelines for the diagnosis and treatment of vitiligo in Japan[J].J Dermatol,2013,40(1):1-11.
[8] ROTHSTEIN B,JOSHIPURA D,SARAIYA A,et al.Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib[J].J Am Acad Dermatol,2017,76(6):1-8.
[9] 刘爱民,刘硕.白癜风的中医辨证与治疗[J].皮肤科学通报,2017,34(6):662-664.
[10] 马丽华,兰东.从风论治难治性白癜风体会[J].临床医药文献杂志,2018,5(3):108-109.
[11] 张弘.白癜风中药内服方剂的组方原则及用药探析[J].中医中药,2011,1(18):72.