传统芩柏膏、细化芩柏膏加凉血活血汤治疗进行期银屑病临床及实验研究

【作者】 徐佳；

【导师】 瞿幸；

【作者基本信息】 北京中医药大学 ， 中医外科， 2007， 硕士

【摘要】 研究目的:1.观察传统芩柏膏、细化芩柏膏治疗进行期银屑病血热证的临床疗效及安全性,并进一步观察上述两种药物对皮损单项症状(红斑、鳞屑、浸润、瘙痒)的作用;2.观察传统芩柏膏、细化芩柏膏在对雌激素期小鼠阴道上皮细胞有丝分裂及对小鼠尾部鳞片表皮角化过程的影响,进一步评价传统芩柏膏、细化芩柏膏对进行期银屑病血热证的临床疗效。研究方法:1.采用前瞻性、随机、阳性药物及空白药物(白凡士林)对照的评价方法,客观评价传统芩柏膏、细化芩柏膏的疗效及安全性;2.通过雌激素周期中小鼠阴道上皮增生活跃,鼠尾鳞片缺乏颗粒层,有角化不全的特点,模拟银屑病表皮动力学紊乱模型,观察传统芩柏膏组、细化芩柏膏组、白凡士林组、模型对照组的组织病理学改变。研究结果:本项研究共入组进行期银屑病血热证患者60例,传统芩柏膏组、细化芩柏膏、空白药物(白凡士林)组各20例。经统计分析,两组中药组及空白组治疗后皮损面积及局部PASI评分较治疗前明显降低,有极显著性差异;治疗后细化芩柏膏组皮损评分较传统芩柏膏组低,两组间评分无显著性差异;两组中药治疗后较空白组均有极显著性差异。在治疗过程中,第2、4、6周传统芩柏膏组与细化芩柏膏组之间总分比较有显著性差异。三组综合疗效分析,传统芩柏膏组总有效率为70%,细化芩柏膏组总有效率为80%,空白药物组总有效率为45%。采用秩和检验进行统计分析,两组中药组无显著性差异,两组与空白组有显著性差异。三组单项症状比较,三组均能显著改善进行期银屑病血热证皮损的红斑、鳞屑、浸润、瘙痒症状,在鳞屑、浸润、瘙痒方面中药组明显优于空白药物组,具有显著性差异;两组中药组之间治疗后无显著性差异,而在治疗过程中,在改善红斑、浸润、瘙痒的时间上,尤其瘙痒方面,细化芩柏膏更优于传统芩柏膏。传统芩柏膏组1例患者初用时有轻度发红、刺激感觉,继续用药5天后不适感消失;细化芩柏膏组、白凡士林膏组无不良事件发生。采用雌激素期小鼠阴道上皮及小鼠尾部鳞片表皮制备银屑病模型,通过分组给药分别观察对雌激素期小鼠阴道上皮有丝分裂的影响和对小鼠尾部鳞片表皮角化的影响。组织HE染色显示,传统芩柏膏与细化芩柏膏均可显著抑制小鼠阴道上皮有丝分裂,细化芩柏膏更优于传统芩柏膏,两组之间存在显著性差异;而空白药物组可促进小鼠阴道上皮有丝分裂。传统芩柏膏与细化芩柏膏均可显著促成鼠尾鳞片表皮的颗粒层的形成,传统芩柏膏与细化芩柏膏之间无明显差异,两组与空白药物组之间具有显著性差异。结论:传统芩柏膏、细化芩柏膏能够显著改善进行期银屑病血热证皮损的面积以及症状,降低皮损局部改良PASI评分。细化芩柏膏在疗效上更优于传统芩柏膏。通过动物实验证明了两组中药膏均可显著抑制小鼠阴道上皮有丝分裂,促成鼠尾鳞片表皮的颗粒层的形成。更多还原

【Abstract】 Objectives:①The present study was designated to investigate the effects and safety of Qingbai ointment and ultrafine Qingbai ointment, when they were used to treat blood heat syndrome of psoriasis, and to assess the improvement of the symptoms(erythema, plaque, scale and pruritus) made by these two ointments.②To investigate the influence on the mitosis of vaginal epithelium in estrogen mice, and the process of keratinization in the mouse-tails’flakes, after topical use of these two ointments.Methods:①Sixty psoriasis patients differentiated to blood heat syndrome(active stage of psoriasis vulgaris) were randomized into 3 groups: Qingbai ointments were used in group A(n=20), which were ultrafine Qingbai ointment in group B(n=20) and white Vaseline in group C(n=20). This prospective, randomized, controlled study assessed the effects and safety of Qingbai ointment and ultrafine Qingbai ointment, by calculating focal Psoriasis Area and Severity Index (PASI) score, and evaluating the symptoms prior and post treatment.②Qingbai ointment, ultrafine Qingbai ointment, and white Vaseline were respectively used in the vagina of mice which were injected with estrogen and tails of normal mice.Results: After 8 weeks’treatment, the total effective rate was 70% of group A, 80% of group B, and 45% of group C. The rank sum test showed that there was no statistical significance between group A and group B, but statistical significances between Chinese herbs groups (group A and group B) and Vaseline group. And there were statistical significances between group A and group B in the 2nd, 4th, 6th week.Psoriasis patients’symptoms of erythema, plaque, scale and pruritus were notably alleviated in all of the 3 groups. Considering of scale, plaque and pruritus, there were statistical significances between Chinese herbs groups (group A and group B) and Vaseline group, none of group A and group B. But the duration of these 3 symptoms, especially pruritus, was shorter of group B than group A. No side effect was found in group B and C, but a little irritation was found in one case in group A.After HE staining, it showed that the mitosis of estrogen mouse vaginal epithelium were obviously inhibited in group A and group B, the latter were inhibited more obviously and there was statistical significance between group A and group B, while promoted in group C. The formation of the granular layers in the flakes of the mouse-tails was facilitated in Chinese herbs groups, but no statistical significance between the two groups.Conclusion: The placebo-controlled study showed that a significant effect on PASI and subjective symptoms of Qingbai ointment and ultrafine Qingbai ointment topically applied with the active stage of psoriasis vulgaris, and the latter was better. This finding is supported by the biopsy results from the open study, showing the inhabited mitosis of estrogen mouse and the facilitated formation of the granular layers in the flakes of the mouse-tails.更多还原