特应性皮炎中医药治疗临床疗效评价
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摘要
目的：通过开放性、多中心、随机对照临床试验,综合评价镇心安神法治疗特应性皮炎的临床疗效、安全性、复发率及对患者生活质量的改善情况,并通过治疗前后相关免疫学指标的检测,初步探讨其可能的作用机制,以证明镇心安神法的有效性、安全性及科学性。
方法：1.随机方法：采用分层、区组随机的方法。运用SAS统计软件,按参加单位的病例分配数及两组1：1的随机比例生成随机数字分组表。该表交课题负责单位及数据管理托管单位两处妥善保管(随机数字表的产生和保管由第三方—中国中医科学院基础研究所临床疗效评价中心负责),采用临床研究中心随机网络申请随机编码方案。本次研究共入选210例AD患者,均来自中国中医科学院西苑医院、中南大学湘雅二医院、首都医科大学附属北京中医医院、首都医科大学附属北京儿童医院、复旦大学附属华山医院门诊患者,符合Hanifin和Rajka标准的西医诊断标准和中医辨证分型标准。中药试验组105例,脱落9例,西医对照组105例,脱落7例,剔除2例。最终完成实验的患者共192例,其中中药组96例,对照组96例。中药组患者再根据中医辨证分型标准分为风湿蕴肤证和血虚风燥证两型。2.治疗方法：中药组风湿蕴肤型给予中药饮片1号方内服加患处冷湿敷,血虚风燥型给予中药饮片2号方内服加患处冷湿敷。中药饮片1号方药物组成：生龙骨30g,煅牡蛎30g,连皮茯苓30g,淡竹叶15g；中药饮片2号方药物组成：生龙骨30g,煅牡蛎30g,骨碎补10g,地肤子30g。用法用量：成人及12岁以上儿童给予中药饮片1、2号方原剂量,7-12岁儿童给予中药饮片1、2号方原剂量的1/2,水煎服,煎煮及服用方法均遵循SOP,150ml/次,2次/日。同时外用中药饮片1或2号方冷湿敷患处,方法：内服中药煎煮2遍后,加自来水1500毫升,先用武火煎沸,后改用文火再煎5分钟后,取第三次药液,放置至≤30℃,待用,使用无菌纱布折叠成四层,同皮损大小,将纱布置于药液中浸湿后拿出,轻拧至纱布不滴水为度,外敷于皮损处,每日2次,每次20分钟,早晚各1次。西药组给予口服氯雷他定片,成人及12岁以上儿童,10mg/次,7-12岁儿童如体重≥30kg,10mg／次,7-12岁儿童如体重≤30kg,5mg/次,1次/日,每晚服用；同时使用0.1%丁酸氢化可的松乳膏外涂患处,2次/日。两组均连续治疗8周。3.观察方法：患者在初诊及治疗后第1周、第2周、第4周和第8周分别填写观察病历,记录皮肤病变面积、皮损严重程度、瘙痒及影响睡眠程度、SCORAD评分及皮肤病生活质量量表,询问用药的依从性,记录不良反应,靶皮损拍照,并记录复发情况。4.疗效评定方法：①病情严重度分值标准：采用欧洲特应性皮炎研究组(ETFAD)提出的评分标准(SCORAD评分),包括客观体征皮肤病变范围(A)、皮损严重程度(B)和主观症状瘙痒和影响睡眠程度(C)评分进行疗效判定。②疗效判定标准：按四级疗效标准评定(尼莫地平法),分为临床痊愈：皮损全部消退,瘙痒症状消失,总治疗率≥90%；显效：皮损大部分消退,瘙痒明显减轻,60%≤总治疗率<90%；进步：皮损部分消退,瘙痒症状有所改善,20%≤总治疗率<60%；无效：皮损消退不明显,瘙痒未见减轻或临床症状反见恶化,总疗效率<20%。总有效率以临床痊愈、显效、进步之和计。③生活质量评价标准：成人及12岁以上儿童使用皮肤病生活质量量表(DLQI),7-12岁儿童使用皮肤病儿童生活质量量表(CDLQI)；调查内容涉及皮肤病在过去7天对患者造成的影响,包括生理、心理、社会活动、人际交往、家庭、治疗等6方面,每一题采用4级计分法,总分30分。④复发率评价：两组的痊愈及显效患者均随访3个月,观察评价复发率。⑤免疫学指标的检测：采集中药试验组患者于治疗前后及健康对照志愿者30例,分别检测末梢血嗜酸性粒细胞(EOS)计数,血清总IgE水平和嗜酸性粒细胞阳离子蛋白(ECP)水平,以观察镇心安神法对免疫功能的影响,初步探讨其可能的作用机制。5.安全性评价方法：记录患者血常规、尿常规和肝、肾功能,安全等级,不良反应的发生情况；6.统计学方法：采用SAS6.12统计软件进行统计分析,P<0.05具有显著性差异。
结果：1.两组各项症状改善情况的比较：中药组与西药组各自治疗前后各项症状评分比较均有显著性差异(P<0.05),两组治疗后症状评分比较无显著性差异(P>0.05),其中中药组治疗前与治疗2周后各项症状即得到改善,具体表现在皮损严重程度和瘙痒及影响睡眠程度上,但皮肤病变面积改善不明显,持续治疗8周后以上症状均得到明显改善；风湿蕴肤证组与血虚风燥证组各项症状改善情况相当,风湿蕴肤证组患者起效略早于血虚风燥证组患者,但两组治疗前及治疗8周后各项评分比较无显著性差异(P>0.05)。2.两组疗效比较：治疗组总有效率为88.54%,对照组总有效率为83.33%,两组比较差异无统计学意义(P>0.05)。3.复发率比较：西药组相对起效快,治疗1周后各项症状即得到改善,但随治疗时间延长疗效不显。对两组中痊愈和显效患者进行了3月的随访,试验组复发11例,复发率为20.37%,复发时间(37.28±8.51天)较迟,对照组复发25例,复发率为52.08%,复发时间(12.35±4.67天)较早,两组比较,差异有显著性意义(P<0.05)。4.生活质量比较：中药组与西药组患者各自治疗前后生活质量改善均有显著性差异,具体表现在自觉症状、休闲活动、人际交往、工作学习、日常生活、治疗的影响等方面,两组治疗后比较无显著性差异(P>0.05),风湿蕴肤证组与血虚风燥证组各自生活质量改善亦均有显著性差异(P<0.05),但两组治疗后比较无显著性差异(P>0.05)；同时生活质量评分与SCORAD分值的相关分析发现各组治疗前生活质量评分总分与SCORAD分值均呈正相关(P<0.05)、治疗前后生活质量评分总分差值与SCORAD分值差值亦均呈正相关(P<0.05)。5.相关免疫指标分析：AD患者治疗前血清总IgE、ECP水平显著高于健康对照组(P<0.01),采用镇心安神法治疗后,随着疾病病情得到控制,血清总IgE、ECP水平显著降低,与治疗前相比差异显著(P<0.01)；末梢血EOS计数与健康对照组相比及治疗前、后相比均无显著性差异(P>0.05),说明EOS可能跟病情变化无显著相关。6.安全性比较：治疗期间中药组2例初次服药后胃肠道不适,嘱饭后温服后缓解；西药组有2例患者出现轻度头晕、嗜睡,2例患者于治疗8周后尿常规示尿潜血(++),嘱2次复查后正常；两组比较差异无统计学意义；未发现与药物有关和可能有关的严重不良反应,病人全身和局部耐受性好。
结论：镇心安神法治疗特应性皮炎可以显著改善患者各项症状及生活质量,疗效与氯雷他定片联合0.1%丁酸氢化可的松乳膏的疗效相当,且安全性高、主要优势体现在明显降低了特应性皮炎的复发率；治疗2周后睡眠质量、瘙痒情况和皮损严重程度即得到改善,持续治疗8周以上为宜,长期治疗对皮肤病变面积的改善最为显著；对急性发作期证属风湿蕴肤证患者疗效优于慢性期证属血虚风燥证患者,但镇心安神法对此两型的各项症状及生活质量的改善情况效果相当；患者生活质量评分可以反映病情的轻重、生活质量的改善情况可以反映疗效的高低；中药组治疗后可显著降低患者的血清总IgE、ECP水平,显示其可能的作用机制为减轻变态反应、调节免疫功能。镇心安神法组方用药以镇心安神为主,辅以清心止痒、补益脾肾；全方紧扣病机,又与现代医学理论相辅相成,不仅可减轻AD的皮损及严重程度；还可清心止痒,阻断患者瘙痒——搔抓的的恶性循环；同时可改善患者的睡眠质量,有利于患儿的生长发育及缓解精神压力；通过补益脾肾,改善患者的体质,防止复发。并通过随访镇心安神法治疗停药后3个月的患者,结果显示镇心安神法确实可减少特应性皮炎的复发率,对改善患者过敏体质具有较好的作用。由此可见,镇心安神法是治疗特应性皮炎的有效方法,且安全性高,值得进一步的研究和推广。
创新点：在此次研究中,我们采用了目前临床诊断AD的“金标准”Hanifin和Rajka标准严格纳入病例,进行了多中心、大样本、随机临床对照试验；使用用国际公认的AD严重程度评分标准(SCORAD评分)对镇心安神法治疗特应性皮炎治疗前、后的症状和体征进行了综合客观的评分；结合皮肤病生活质量指数量表评分和免疫学指标的检测,系统评价了镇心安神法的疗效及安全性,并揭示了其可能的作用机制。以上为本课题的创新之处。既往中医药治疗AD多采用清热利湿,健脾渗湿,养血祛风等方法治疗,但本课题从心神论治特应性皮炎,取得较好临床疗效,对中医临床治疗皮肤科多发的皮炎、湿疹、瘙痒诸症亦开辟了个新的思路和方法。
Objective:To evaluate the efficacy, safety, recurrence rate and the improvement of patient's quality of life of Suppress-The-Heart-and-Calm-The-Mind Method in treatment of atopic dermatitis with open, multicenter, randomized controlled clinical trials, and trying to prove the efficacy, safety and scientific of this method by exploring its possible mechanism.
Method:1.Randomly assigning patients to Traditional Chinese Medicine test group and the Western Medicine control group with a ratio of1:1using stratified, block randomization method. The Traditional Chinese Medicine test group was further divided into two types:Wind-Dampness-Stagnating-Skin and Syndrome-of-Wind-and Dryness-due-to-Blood-Deficiency by symptoms and signs.2. Treatment. The Chinese medicine group included96cases. Oral administration and using externally of Chinese Herbal Medicine No.1or Chinese Herbal Medicine No.2. Ingredients of Chinese Herbal Medicine No.1:Raw Os Draconis30g, Calcined Concha Osterae30g, Poria with peel30g, Herba Lophatheri15g. Ingredients of Chinese Herbal Medicine No.2:Raw Os Draconis30g, Calcined Concha Osterae30g, Rhizoma Drynariae10g, Fructus Kochiae30g. Taking the extract twice a day and covering the affected part with the same extract twice a day for8weeks. The western medicine included96cases, taking Loratadine tablets orally once a night and smearing0.1%Hydrocortisone Butyrate cream twice a day for8weeks. Visits were scheduled on preliminary diagnosis (before treatment),1,2,4weeks after treatment and the end of the treatment. Recorded the change of symptoms and the physical signs, including lesion area of skin, disease severity, pruritus degree, SCORAD score, dermatology life quality index, adverse reaction, recurrence rate, ect. Took photos for targeted skin lesions at every visit.4. Efficacy was evaluated by investigator observation and patientself-assessment before and after the therapy. Efficacy criteria refer to "scoring atopic dermatitis (SCORAD)" instituted by European Task Force on Atopic Dermatitis (ETFAD) and evaluation of quality of life refer to dermatology life quality index(DLQI) for adult and children dermatology life quality index(CDLQI) for children.5.Safety was evaluated by recording patients'blood, urine, liver and kidney function, safety class and the occurrence of adverse reactions.6.Statistical methods:Using SAS6.12Statistical software, P<0.05means significant.
Result:1. Comparison of improvement of symptoms between2groups:Both Chinese medicine group and western medicine group experienced significant improvement (P<0.05). The Comparison between2groups were not significant (P>0.05). The Traditional Chinese Medicine group showed improvement in2weeks after the beginning of treatment in terms of the severity of skin lesions and sleep, but the improvement of area of skin lesions were not significant. All symptoms were improved after8weeks of treatment. Both subgroups, Wind-Dampness-Stagnating-Skin group and Syndrome-of-Wind-and Dryness-due-to-Blood-Deficiency group, showed equal improvement, but the subgroup of Wind-Dampness-Stagnating-Skin group take effect earlier than another. There were no significant difference (P>0.05) between2groups after8weeks' treatment.2. Comparison of effectiveness between2groups:the total effective rate in treatment group is88.54%and83.33%in controlled group which showed no Statistically significant (P>0.05).3. Comparison of Recurrence rate:The western medicine group showed an effect rapidly for their improvement after a week of treatment, but the effect were not significant with the treatment lasted. In a follow-up visit to cured and effective patients in both groups after3months, there were11of recurrence in treatment group, the recurrence rate is20.37%, recurrence time (37.28±8.51days) is respectively later. There were25recurrence in controlled group, the recurrence rate is20.37%, recurrence time (12.35±4.67days) is respectively earlier. The difference between2groups are significant (P<0.05).4. Comparison of DLQI\CDLQI scores:Both Chinese medicine group and western medicine group experienced significant improvement respectively in symptoms and feelings,daily activities,leisure and total DLQI\CDLQI scores,but there was no significant difference between two groups(P>0.05). Both syndrome of wind-dampness stagnating skin group and syndrome of wind and dryness due to blood deficiency group experienced significant improvement respectively, with non-significance difference between them (P>0.05). Relevant analysis found that DLQI and CDLQI scores were positively related to the SCORAD scores(P<0.05).5. Immune indicators analysis:serum total IgE, ECP level in AD patients before treatment was significantly higher than the healthy control group (P<0.01). After treated with Suppress-The-Heart-and-Calm-The-Mind Method, serum total IgE, ECP level had been significantly lowered (P<0.01) with the disease condition under control. Peripheral blood EOS counts showed no significant difference (P>0.05) before and after treatment and compared with the healthy control group, indicating the EOS may have no significant relation with state of the illness.6.Comparison of security between2groups:In chinese medicine group,1patient had gastrointestinal discomfort after taking the initial chinese medication during treatment,but was relieved quickly after telling him the the correct way of taking chinese medicine.In western medicine group, there are two cases of patients with mild dizziness, drowsiness. The difference was not statistically significant.Never found the drug-related and possibly related serious adverse reactions.
Conclusion:Suppress-The-Heart-and-Calm-The-Mind Method can significantly improve the symptoms and quality of life of patients suffering from atopic dermatitis and have a similar effect with the western medicine group. Its main advantage is reflected in the significantly reduced the recurrence rate of atopic dermatitis and safe,comparing western medicine.2weeks after treatment symptoms and signs can be improved. Long-term treatment by long-mu liquid can achieve a significant improvement which is superior to the patients who use western medicine. After treatment the quality of life of the patients is improved. Long-mu liquid in the treatment of Syndrome of wind-dampness stagnating skin is superior to syndrome of wind and dryness due to blood deficiency. At the same time DLQI and CDLQI scores are positively related to SCORAD scores. Serum total IgE, ECP level had been significantly lowered in TCM group, which shows the possible mechanism is to reduce the allergy and regulate the immune function.
Innovative Points:Most previous TCM treatment on AD use clear heat and drain dampness, fortify the spleen and drain dampness, nourish the blood and dispel wind methods. However, we focus on aspects of heart and spirit on this topic and observed good clinical results, which opened brand new ways and methods on treatments of dermatitis, eczema and itching.
方法：1.随机方法：采用分层、区组随机的方法。运用SAS统计软件,按参加单位的病例分配数及两组1：1的随机比例生成随机数字分组表。该表交课题负责单位及数据管理托管单位两处妥善保管(随机数字表的产生和保管由第三方—中国中医科学院基础研究所临床疗效评价中心负责),采用临床研究中心随机网络申请随机编码方案。本次研究共入选210例AD患者,均来自中国中医科学院西苑医院、中南大学湘雅二医院、首都医科大学附属北京中医医院、首都医科大学附属北京儿童医院、复旦大学附属华山医院门诊患者,符合Hanifin和Rajka标准的西医诊断标准和中医辨证分型标准。中药试验组105例,脱落9例,西医对照组105例,脱落7例,剔除2例。最终完成实验的患者共192例,其中中药组96例,对照组96例。中药组患者再根据中医辨证分型标准分为风湿蕴肤证和血虚风燥证两型。2.治疗方法：中药组风湿蕴肤型给予中药饮片1号方内服加患处冷湿敷,血虚风燥型给予中药饮片2号方内服加患处冷湿敷。中药饮片1号方药物组成：生龙骨30g,煅牡蛎30g,连皮茯苓30g,淡竹叶15g；中药饮片2号方药物组成：生龙骨30g,煅牡蛎30g,骨碎补10g,地肤子30g。用法用量：成人及12岁以上儿童给予中药饮片1、2号方原剂量,7-12岁儿童给予中药饮片1、2号方原剂量的1/2,水煎服,煎煮及服用方法均遵循SOP,150ml/次,2次/日。同时外用中药饮片1或2号方冷湿敷患处,方法：内服中药煎煮2遍后,加自来水1500毫升,先用武火煎沸,后改用文火再煎5分钟后,取第三次药液,放置至≤30℃,待用,使用无菌纱布折叠成四层,同皮损大小,将纱布置于药液中浸湿后拿出,轻拧至纱布不滴水为度,外敷于皮损处,每日2次,每次20分钟,早晚各1次。西药组给予口服氯雷他定片,成人及12岁以上儿童,10mg/次,7-12岁儿童如体重≥30kg,10mg／次,7-12岁儿童如体重≤30kg,5mg/次,1次/日,每晚服用；同时使用0.1%丁酸氢化可的松乳膏外涂患处,2次/日。两组均连续治疗8周。3.观察方法：患者在初诊及治疗后第1周、第2周、第4周和第8周分别填写观察病历,记录皮肤病变面积、皮损严重程度、瘙痒及影响睡眠程度、SCORAD评分及皮肤病生活质量量表,询问用药的依从性,记录不良反应,靶皮损拍照,并记录复发情况。4.疗效评定方法：①病情严重度分值标准：采用欧洲特应性皮炎研究组(ETFAD)提出的评分标准(SCORAD评分),包括客观体征皮肤病变范围(A)、皮损严重程度(B)和主观症状瘙痒和影响睡眠程度(C)评分进行疗效判定。②疗效判定标准：按四级疗效标准评定(尼莫地平法),分为临床痊愈：皮损全部消退,瘙痒症状消失,总治疗率≥90%；显效：皮损大部分消退,瘙痒明显减轻,60%≤总治疗率<90%；进步：皮损部分消退,瘙痒症状有所改善,20%≤总治疗率<60%；无效：皮损消退不明显,瘙痒未见减轻或临床症状反见恶化,总疗效率<20%。总有效率以临床痊愈、显效、进步之和计。③生活质量评价标准：成人及12岁以上儿童使用皮肤病生活质量量表(DLQI),7-12岁儿童使用皮肤病儿童生活质量量表(CDLQI)；调查内容涉及皮肤病在过去7天对患者造成的影响,包括生理、心理、社会活动、人际交往、家庭、治疗等6方面,每一题采用4级计分法,总分30分。④复发率评价：两组的痊愈及显效患者均随访3个月,观察评价复发率。⑤免疫学指标的检测：采集中药试验组患者于治疗前后及健康对照志愿者30例,分别检测末梢血嗜酸性粒细胞(EOS)计数,血清总IgE水平和嗜酸性粒细胞阳离子蛋白(ECP)水平,以观察镇心安神法对免疫功能的影响,初步探讨其可能的作用机制。5.安全性评价方法：记录患者血常规、尿常规和肝、肾功能,安全等级,不良反应的发生情况；6.统计学方法：采用SAS6.12统计软件进行统计分析,P<0.05具有显著性差异。
结果：1.两组各项症状改善情况的比较：中药组与西药组各自治疗前后各项症状评分比较均有显著性差异(P<0.05),两组治疗后症状评分比较无显著性差异(P>0.05),其中中药组治疗前与治疗2周后各项症状即得到改善,具体表现在皮损严重程度和瘙痒及影响睡眠程度上,但皮肤病变面积改善不明显,持续治疗8周后以上症状均得到明显改善；风湿蕴肤证组与血虚风燥证组各项症状改善情况相当,风湿蕴肤证组患者起效略早于血虚风燥证组患者,但两组治疗前及治疗8周后各项评分比较无显著性差异(P>0.05)。2.两组疗效比较：治疗组总有效率为88.54%,对照组总有效率为83.33%,两组比较差异无统计学意义(P>0.05)。3.复发率比较：西药组相对起效快,治疗1周后各项症状即得到改善,但随治疗时间延长疗效不显。对两组中痊愈和显效患者进行了3月的随访,试验组复发11例,复发率为20.37%,复发时间(37.28±8.51天)较迟,对照组复发25例,复发率为52.08%,复发时间(12.35±4.67天)较早,两组比较,差异有显著性意义(P<0.05)。4.生活质量比较：中药组与西药组患者各自治疗前后生活质量改善均有显著性差异,具体表现在自觉症状、休闲活动、人际交往、工作学习、日常生活、治疗的影响等方面,两组治疗后比较无显著性差异(P>0.05),风湿蕴肤证组与血虚风燥证组各自生活质量改善亦均有显著性差异(P<0.05),但两组治疗后比较无显著性差异(P>0.05)；同时生活质量评分与SCORAD分值的相关分析发现各组治疗前生活质量评分总分与SCORAD分值均呈正相关(P<0.05)、治疗前后生活质量评分总分差值与SCORAD分值差值亦均呈正相关(P<0.05)。5.相关免疫指标分析：AD患者治疗前血清总IgE、ECP水平显著高于健康对照组(P<0.01),采用镇心安神法治疗后,随着疾病病情得到控制,血清总IgE、ECP水平显著降低,与治疗前相比差异显著(P<0.01)；末梢血EOS计数与健康对照组相比及治疗前、后相比均无显著性差异(P>0.05),说明EOS可能跟病情变化无显著相关。6.安全性比较：治疗期间中药组2例初次服药后胃肠道不适,嘱饭后温服后缓解；西药组有2例患者出现轻度头晕、嗜睡,2例患者于治疗8周后尿常规示尿潜血(++),嘱2次复查后正常；两组比较差异无统计学意义；未发现与药物有关和可能有关的严重不良反应,病人全身和局部耐受性好。
结论：镇心安神法治疗特应性皮炎可以显著改善患者各项症状及生活质量,疗效与氯雷他定片联合0.1%丁酸氢化可的松乳膏的疗效相当,且安全性高、主要优势体现在明显降低了特应性皮炎的复发率；治疗2周后睡眠质量、瘙痒情况和皮损严重程度即得到改善,持续治疗8周以上为宜,长期治疗对皮肤病变面积的改善最为显著；对急性发作期证属风湿蕴肤证患者疗效优于慢性期证属血虚风燥证患者,但镇心安神法对此两型的各项症状及生活质量的改善情况效果相当；患者生活质量评分可以反映病情的轻重、生活质量的改善情况可以反映疗效的高低；中药组治疗后可显著降低患者的血清总IgE、ECP水平,显示其可能的作用机制为减轻变态反应、调节免疫功能。镇心安神法组方用药以镇心安神为主,辅以清心止痒、补益脾肾；全方紧扣病机,又与现代医学理论相辅相成,不仅可减轻AD的皮损及严重程度；还可清心止痒,阻断患者瘙痒——搔抓的的恶性循环；同时可改善患者的睡眠质量,有利于患儿的生长发育及缓解精神压力；通过补益脾肾,改善患者的体质,防止复发。并通过随访镇心安神法治疗停药后3个月的患者,结果显示镇心安神法确实可减少特应性皮炎的复发率,对改善患者过敏体质具有较好的作用。由此可见,镇心安神法是治疗特应性皮炎的有效方法,且安全性高,值得进一步的研究和推广。
创新点：在此次研究中,我们采用了目前临床诊断AD的“金标准”Hanifin和Rajka标准严格纳入病例,进行了多中心、大样本、随机临床对照试验；使用用国际公认的AD严重程度评分标准(SCORAD评分)对镇心安神法治疗特应性皮炎治疗前、后的症状和体征进行了综合客观的评分；结合皮肤病生活质量指数量表评分和免疫学指标的检测,系统评价了镇心安神法的疗效及安全性,并揭示了其可能的作用机制。以上为本课题的创新之处。既往中医药治疗AD多采用清热利湿,健脾渗湿,养血祛风等方法治疗,但本课题从心神论治特应性皮炎,取得较好临床疗效,对中医临床治疗皮肤科多发的皮炎、湿疹、瘙痒诸症亦开辟了个新的思路和方法。
Objective:To evaluate the efficacy, safety, recurrence rate and the improvement of patient's quality of life of Suppress-The-Heart-and-Calm-The-Mind Method in treatment of atopic dermatitis with open, multicenter, randomized controlled clinical trials, and trying to prove the efficacy, safety and scientific of this method by exploring its possible mechanism.
Method:1.Randomly assigning patients to Traditional Chinese Medicine test group and the Western Medicine control group with a ratio of1:1using stratified, block randomization method. The Traditional Chinese Medicine test group was further divided into two types:Wind-Dampness-Stagnating-Skin and Syndrome-of-Wind-and Dryness-due-to-Blood-Deficiency by symptoms and signs.2. Treatment. The Chinese medicine group included96cases. Oral administration and using externally of Chinese Herbal Medicine No.1or Chinese Herbal Medicine No.2. Ingredients of Chinese Herbal Medicine No.1:Raw Os Draconis30g, Calcined Concha Osterae30g, Poria with peel30g, Herba Lophatheri15g. Ingredients of Chinese Herbal Medicine No.2:Raw Os Draconis30g, Calcined Concha Osterae30g, Rhizoma Drynariae10g, Fructus Kochiae30g. Taking the extract twice a day and covering the affected part with the same extract twice a day for8weeks. The western medicine included96cases, taking Loratadine tablets orally once a night and smearing0.1%Hydrocortisone Butyrate cream twice a day for8weeks. Visits were scheduled on preliminary diagnosis (before treatment),1,2,4weeks after treatment and the end of the treatment. Recorded the change of symptoms and the physical signs, including lesion area of skin, disease severity, pruritus degree, SCORAD score, dermatology life quality index, adverse reaction, recurrence rate, ect. Took photos for targeted skin lesions at every visit.4. Efficacy was evaluated by investigator observation and patientself-assessment before and after the therapy. Efficacy criteria refer to "scoring atopic dermatitis (SCORAD)" instituted by European Task Force on Atopic Dermatitis (ETFAD) and evaluation of quality of life refer to dermatology life quality index(DLQI) for adult and children dermatology life quality index(CDLQI) for children.5.Safety was evaluated by recording patients'blood, urine, liver and kidney function, safety class and the occurrence of adverse reactions.6.Statistical methods:Using SAS6.12Statistical software, P<0.05means significant.
Result:1. Comparison of improvement of symptoms between2groups:Both Chinese medicine group and western medicine group experienced significant improvement (P<0.05). The Comparison between2groups were not significant (P>0.05). The Traditional Chinese Medicine group showed improvement in2weeks after the beginning of treatment in terms of the severity of skin lesions and sleep, but the improvement of area of skin lesions were not significant. All symptoms were improved after8weeks of treatment. Both subgroups, Wind-Dampness-Stagnating-Skin group and Syndrome-of-Wind-and Dryness-due-to-Blood-Deficiency group, showed equal improvement, but the subgroup of Wind-Dampness-Stagnating-Skin group take effect earlier than another. There were no significant difference (P>0.05) between2groups after8weeks' treatment.2. Comparison of effectiveness between2groups:the total effective rate in treatment group is88.54%and83.33%in controlled group which showed no Statistically significant (P>0.05).3. Comparison of Recurrence rate:The western medicine group showed an effect rapidly for their improvement after a week of treatment, but the effect were not significant with the treatment lasted. In a follow-up visit to cured and effective patients in both groups after3months, there were11of recurrence in treatment group, the recurrence rate is20.37%, recurrence time (37.28±8.51days) is respectively later. There were25recurrence in controlled group, the recurrence rate is20.37%, recurrence time (12.35±4.67days) is respectively earlier. The difference between2groups are significant (P<0.05).4. Comparison of DLQI\CDLQI scores:Both Chinese medicine group and western medicine group experienced significant improvement respectively in symptoms and feelings,daily activities,leisure and total DLQI\CDLQI scores,but there was no significant difference between two groups(P>0.05). Both syndrome of wind-dampness stagnating skin group and syndrome of wind and dryness due to blood deficiency group experienced significant improvement respectively, with non-significance difference between them (P>0.05). Relevant analysis found that DLQI and CDLQI scores were positively related to the SCORAD scores(P<0.05).5. Immune indicators analysis:serum total IgE, ECP level in AD patients before treatment was significantly higher than the healthy control group (P<0.01). After treated with Suppress-The-Heart-and-Calm-The-Mind Method, serum total IgE, ECP level had been significantly lowered (P<0.01) with the disease condition under control. Peripheral blood EOS counts showed no significant difference (P>0.05) before and after treatment and compared with the healthy control group, indicating the EOS may have no significant relation with state of the illness.6.Comparison of security between2groups:In chinese medicine group,1patient had gastrointestinal discomfort after taking the initial chinese medication during treatment,but was relieved quickly after telling him the the correct way of taking chinese medicine.In western medicine group, there are two cases of patients with mild dizziness, drowsiness. The difference was not statistically significant.Never found the drug-related and possibly related serious adverse reactions.
Conclusion:Suppress-The-Heart-and-Calm-The-Mind Method can significantly improve the symptoms and quality of life of patients suffering from atopic dermatitis and have a similar effect with the western medicine group. Its main advantage is reflected in the significantly reduced the recurrence rate of atopic dermatitis and safe,comparing western medicine.2weeks after treatment symptoms and signs can be improved. Long-term treatment by long-mu liquid can achieve a significant improvement which is superior to the patients who use western medicine. After treatment the quality of life of the patients is improved. Long-mu liquid in the treatment of Syndrome of wind-dampness stagnating skin is superior to syndrome of wind and dryness due to blood deficiency. At the same time DLQI and CDLQI scores are positively related to SCORAD scores. Serum total IgE, ECP level had been significantly lowered in TCM group, which shows the possible mechanism is to reduce the allergy and regulate the immune function.
Innovative Points:Most previous TCM treatment on AD use clear heat and drain dampness, fortify the spleen and drain dampness, nourish the blood and dispel wind methods. However, we focus on aspects of heart and spirit on this topic and observed good clinical results, which opened brand new ways and methods on treatments of dermatitis, eczema and itching.
引文
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