| Background:Hand eczema is a kind of inflammatory skin disease that occurs in the hand.It can be manifested as erythema,papule,blister,exudation,and scale,mossization,hyperkeratosis,chapped and other skin lesions with or without pruritus.Because of its symptom characteristics,traditional Chinese medicine classifies it as"E Zhang Feng".Chronic hand eczema is a common disease in the Department of dermatology.Hyperkeratotic hand eczema is the most common in topical chronic eczema,which is persistent and difficult to treat.The research shows that it is the result of the joint action of internal and external factors.External causes are mostly caused by contact with nickel and other alloy products,aromatics,food proteins and other allergens,or contact with acid-base chemicals or irritants such as water and detergent,and mechanical damage such as long-term scratching,trauma,and friction.The internal causes include genetic factors,mental factors,immune status,and hormone level changes.The study found that the highest incidence of eczema was found in the hands and legs.Most patients with hand eczema were housewives and manual workers,and the number of female patients was significantly higher than that of male patients.Chronic hand eczema is mainly characterized by scaling,hyperkeratosis,infiltration,hypertrophy,mossization and chapping.Due to frequent contact with external substances,the condition is stubborn and easy to repeat.In severe cases,if the fingers are slightly active,they will be chapped and bleeding,and often accompanied by severe pruritus.It seriously affects the physical and mental health of patients and the quality of life.Clinically,the topical western medicine preparations for the treatment of hand eczema are mainly glucocorticoids,calcineurin inhibitors and emollients.Systemic treatment can be carried out in case of serious condition,such as alitretinoin,cyclosporine,methotrexate,azathioprine,etc.Patients with stubborn skin lesions can also choose to use narrow-spectrum UVB local irradiation.Although the above methods can achieve certain curative effect,western medicine for the treatment of hand eczema cannot fundamentally solve the problems of patients.Traditional Chinese medicine treatment of eczema has a long history,rich experience,and positive curative effect.It is worthy of further study and development.Traditional Chinese medicine believes that the pathogenesis of eczema is related to external rheumatism,heat and toxin,and internal dysfunction of heart,lung,spleen,liver,and other viscera.In the acute stage,there are two types:Damp heat accumulating in the skin and spleen deficiency and dampness.In the chronic stage,there are blood deficiency and wind dryness,keratosis and hand eczema.Therefore,it is proposed to RunzaoZhiyang decoction with the main effects of relieving itching and dispelling wind,activating blood circulation and moistening dryness.RunzaoZhiyang decoction is an experienced formula of predecessors in the dermatology department of Guang’anmen Hospital.Based on the compound gallnut ointment prepared in the hospital and combined with drugs for relieving wind,moistening dryness,and relieving itching,it has been used in clinic for more than 10 years and has good clinical efficacy.This clinical study adopts a randomized,double-blind and placebocontrolled method to objectively and scientifically evaluate the clinical efficacy and safety of RunzaoZhiyang decoction in the treatment of keratotic hand eczema by observing the improvement of skin lesions and symptoms before and after treatment.It is of great clinical significance to study the traditional Chinese medicine treatment of hyperkeratotic hand eczema.Objective:To observe the clinical efficacy on hyperkeratotic hand eczema treated with topical Chinese herbal RunzaoZhiyang decoction,and to provide data support for clinical application and popularization.Methods:A total of 120 hyperkeratotic hand eczema patients diagnosed and hospitalized from April 2019 to June 2021 were randomly divided into a treatment group and a control group.The treatment group was treated with Runzaozhiyang decoction,while the control group was treated with placebo.Observe the total effective rate,HECSI and adverse reactions.During the test for each patient established clinical case report form,pruritus,erythema level before treatment and weekly visits,infiltration degree and degree of squamous scratches,infiltration hypertrophy moss degree five symptoms and target lesion area of scoring records.The course lasted for 4 weeks.Results:1.Among the subjects,there were 67 males and 31 females,with a male to female ratio of 1:2.16.Most of the subjects were women.There were 18 males and 31 females in the treatment group;there were 13 males and 36 females in the control group.The minimum age of the subjects was 19 years old,and the maximum age was 68 years old.Most of the subjects were in the age group of 56-70 years old,accounting for 51.02%.The shortest course of disease in the treatment group was 4 months and the longest was 30 years,with an average course of 7.27±8.32 years;The shortest course of disease in the control group was 4 months and the longest was 45 years,with an average course of 6.35±7.97 years.Nine subjects had related family history,accounting for 9.2%of the total,including 5 cases in the treatment group and 4 cases in the control group.23.5%of the 98 subjects had previous allergic diseases,mainly allergic rhinitis,urticaria,asthma and contact dermatitis.Seven patients had a history of allergy,and the main allergens were penicillin,sulfonamides,and marine fish.Among the 98 subjects,4 had topical glucocorticoids,4 had traditional Chinese medicine ointment,4 had antibacterial ointment,1 had calcineurin inhibitor,2 had moisturizer,and 3 had oral traditional Chinese medicine treatment.2.After 4 weeks of treatment,in the treatment group,1 patient recovered,13 showed efficacy,22 had efficacy,and 13 had ineffectiveness,resulting in an overall response rate of 73.5%and a cure rate of 28.6%.In the control group,0 patients recovered,3 showed efficacy,22 were responders,and 24 were non responders,resulting in an overall response rate of 51.0%and a cure rate of 6.1%.3.The total effective rate of the treatment group was higher than that of the control group,the difference was statistically significant(P<0.05).4.The scores of HECSI after treatment were different significantly(P<0.05),and the HECSI scores of the observation group were significantly lower than those of the control group.5.The two groups were improved before and after treatment,such as erythema,scaly,moss like changes,chapped and skin lesions.Especially in the area of scaly and moss like changes improvement,the observation group were significantly better than those of the control group.Conclusion:Topical Chinese herbal RunzaoZhiyang decoction has definite efficacy on hyperkeratotic hand eczema,especially in the area of scaly and moss like changes improvement.And it is safe and reliable and is suitable for clinical application and promotion. |