复方红升丹散对小鼠皮肤溃疡及麻风溃疡患者的疗效评价  

Clinical evaluation of compound Hongshengdan powder on ulcers in mice model and in leprosy patients

作　　者：孙秋雁 易丹丹[2] 顾玉莲 高峡 SUN Qiu-yan;YI Dan-dan;GU Yu-lian;GAO Xia(Wuhan Institute of Dermatology and Venereology,Wuhan 430030,Hubei Province,China;School of Pharmacy,Huazhong University of Science and Technology,Wuhan 430030,Hubei Province,China)

机构地区：[1]武汉市皮肤病防治院,湖北武汉430030 [2]华中科技大学药学院,湖北武汉430030

出　　处：《中国临床药理学杂志》2020年第6期617-620,共4页The Chinese Journal of Clinical Pharmacology

基　　金：武汉市卫生计生科研基金资助项目(WZ17D12)。

摘　　要：目的考察复方红升丹散用于小鼠皮肤溃疡和临床麻风溃疡治疗的有效性。方法建立小鼠全层皮肤切口模型,随机分为对照组和低、中、高剂量实验组,每组15只,24 h后开始给药,每3 d换药1次。对照组小鼠未给予治疗。低、中、高剂量实验组分别用50,100,200 mg·mL^-1复方红升丹散制备的油性混悬液均匀涂布于伤口表面。治疗期间每天观察小鼠创面,术后第7,14和21天计算创面愈合率,第14和21天进行HE染色,观察创面组织病理学形态。临床研究对象为30例麻风合并溃疡患者,随机分为试验组和对照组。对照组给予生理盐水常规治疗,试验组根据溃疡面积的大小将复方红升丹散(0.1~0.3 g)均匀撒到溃疡表面,依次用无菌白凡士林纱布和胶布固定。2组每周换药1次,持续1个月。评价溃疡愈合情况及治疗过程中药物不良反应发生情况。结果术后第7,14和21天,中剂量组小鼠伤口愈合率分别为(23.2±7.9)%,(70.7±7.1)%和(89.6±2.9)%,高剂量实验组分别为(23.3±10.7)%,(65.0±4.4)%,(89.7±2.6)%,对照组分别为(3.7±5.7)%,(52.5±8.8)%,(77.7±8.7)%,中剂量实验组与对照组比较,差异有统计学意义,但中、高剂量实验组差异无统计学意义,高剂量实验组出现明显毒性反应。术后第14天,实验组小鼠炎性细胞浸润程度明显高于对照组,新生毛细血管与胶原纤维的量随用药剂量的增大而增多。第21天,实验组小鼠炎性细胞数量降低,随着用药剂量的增大,新生毛细血管及胶原纤维的量进一步增加,胶原纤维的排列趋于有序化。试验组患者用药1个月后,坏死组织明显减少,新生肉芽生长良好,溃疡治愈率为66.67%,明显高于对照组的18.75%(P<0.05)。试验组和对照组均未出现明显药物不良反应。结论复方红升丹散具有较强祛腐生肌作用,对麻风病溃疡的治疗具有较好效果。Objective To investigate the therapeutic effects of compound Hongshengdan powder on ulcers in mice model and in leprosy patients.Methods An ulcer model was established on the back of Kunming mice,then randomly divided into control group and low,middle,high dose test groups with 15 mice in each group.At 24 h after ulcer creation,control group was received no treatment,50,100,200 mg·mL^-1 oil suspension of compound Hongshengdan were applied on the skin wound every 3 d in low,middle and high dose test groups.The skin wounds were observed everyday for 21 d.On 14 and 21 d post wound creation,the area of the wound was calculated and wound reduction percentage were determined.Skin tissue samples around the wound were collected and evaluated by HE staining on 7,14 and 21 d post wound creation.Clinically,30 leprosy patients with ulcers were enrolled in the study,who were randomly divided into treatment and control groups.Patients in control group were received normal saline therapy.The treatment group was given compound Hongshengdan powder on the ulcer areas,followed by wrapping with vaseline and adhesive bandages.The treatment for both groups were applied once a week for one month.The healing process of the ulcers and adverse drug reactions in two groups were evaluated.Results The wound reduction percentages on 7,14 and 21 d post wound creation in middle dose test group were(23.2±7.9)%,(70.7±7.1)%,(89.6±2.9)%,high dose test group were(23.3±10.7)%,(65.0±4.4)%,(89.7±2.6)%,control group were(3.7±5.7)%,(52.5±8.8)%,(77.7±8.7)%.There was significant difference between middle dose test group and control group,there was no significant difference between middle and high dose test groups.There was a significant toxic response in high dose test group.On 14 d,a significant greater amount of inflammatory cells was found in test groups compared with control group and the newly grown blood vessels and fibroblasts increased with increasing dosage.On 21 d,no inflammatory cells were found in the newly grown skins,and increased n

关 键 词：红升丹 溃疡 麻风 

分 类 号：R28[医药卫生—中药学]