CN114425061A - 一种治疗湿热蕴结型皮肤瘙痒的药物组合物 - Google Patents
一种治疗湿热蕴结型皮肤瘙痒的药物组合物 Download PDFInfo
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Abstract
本发明提供了一种治疗湿热蕴结型皮肤瘙痒的药物组合物,它是由下述重量份的原料制备而成:马齿苋25~35份、蛇床子25~35份、地肤子15~25份、炒露蜂房15~25份、白鲜皮5~15份、花椒5~15份、生大黄10~20份、千里光10~20份。本发明组合物具有清热燥湿、凉血消肿、祛风止痒的作用,外洗于患处,有效成分经皮肤吸收后直达病所,具有作用直接、见效快、方便简洁、毒副作用小等特点,全方共奏清热燥湿、凉血消肿、祛风止痒之功,用于治疗皮肤瘙痒症方面效果显著。
Description
技术领域
本发明具体涉及一种治疗湿热蕴结型皮肤瘙痒的药物组合物。
背景技术
皮肤瘙痒是皮肤类疾病最常见的症状,而皮肤瘙痒症也是皮肤科最常见的疾病之一,女性多于男性,亚洲人多于白种人,秋冬季节发病更为常见。其发病率随年龄增加而逐渐升高,国外流行病学研究显示,65岁门诊患者发病率为12%,85岁以上患者发病率为20%。作为老年人最常见的皮肤疾患,我国尚缺乏相关流行病学数据,对老年皮肤瘙痒症的诊断和治疗仍不规范。皮肤瘙痒症是以自觉皮肤瘙痒而无原发性皮肤损害为主要临床表现的常见皮肤疾病。常发于腿部、背部、头皮、手背等部位,伴有疼痛、热感、冷感及皮肤干燥等相关症状,易诱发睡眠障碍、糖尿病、心血管疾病等。目前,现代医学对其发病机制及致病因素尚未完全明确,认为与患者皮脂腺的功能降低、皮肤干燥及退行性萎缩、糖尿病、贫血、肾病、甲状腺功能异常、肝胆疾病、便秘、心理疾病等因素有关。
《内经》中有关于本病的论述“诸痛痒疮,皆属于心”。《圣济总录》提出“论曰风瘙痒者,表虚卫气不足,风邪乘之,血脉留滞,中外鼓作,变而生热,热则瘙痒”。《诸病源候论》认为“风瘙痒者,是体虚受风,风入腠理,与血气相搏,而俱往来在于皮肤之间。邪气微,不能冲击为痛,故瘙痒也”。《银海精微》认为“痒极难忍者,肝经受热,胆因虚热,风邪攻充,肝含热极,肝受风之燥动,木摇风动,其痒发焉”。《秘传证治要诀及类方》提出“血虚皮肤燥痒者,宜四物汤”。《丹溪心法》亦有阐述“诸痒为虚,血不荣于肌腠,所以痒也。当用滋补药以养阴血,血和肌泽,痒自不作”。总体病因病机可概括为卫外不固,风、湿、热邪蕴于肌肤,与气血相搏结,瘀而化热,热微则痒;或因血虚生风,肌肤失养所致。治疗多采用养血润燥、清热除湿、祛风止痒之法。
目前,治疗皮肤瘙痒症的西药方案不多,治疗效果也并不十分明确。且西医治疗常给予抗组胺类药物、免疫调节类药物、激素类药物内服联合外用治疗,存在远期效果欠佳、副作用较多、复发率高等缺点,严重影响患者身心健康。近几年对于中药外用治疗皮肤瘙痒的研究越来越多,研究表明,止痒中药中,以清热药、祛风湿药、攻毒杀虫止痒药为主,药物性味归经以苦辛味、温平寒性、肝肺脾经药为主,以祛风、清热、燥湿、养血润燥为原则选取相应的中药进行治疗,其中以地肤子、苦参、白鲜皮、蛇床子的支持度最高,但组方后在治疗湿热蕴结型皮肤瘙痒方面效果欠佳,其治疗皮肤瘙痒的效果仍有待提高。
发明内容
为解决上述问题,本发明提供了一种治疗湿热蕴结型皮肤瘙痒的药物组合物,它是由下述重量配比的原料制备而成:
马齿苋25~35份、蛇床子25~35份、地肤子15~25份、露蜂房15~25份、白鲜皮5~15份、花椒5~15份、大黄10~20份、千里光10~20份。
进一步地,它是由下述重量配比的原料制备而成:
马齿苋30份、蛇床子30份、地肤子20份、露蜂房20份、白鲜皮10 份、花椒10份、大黄15份、千里光15份。
进一步地,所述露蜂房为炒露蜂房;所述大黄为生大黄。
进一步地,它是原料的粉,或水或有机溶剂提取物,加上药学上可接受的辅料制备而成的制剂。
更进一步地,所述制剂为外用制剂。
更进一步地,所述外用制剂为溶液剂、膏剂、栓剂。
本发明还提供了一种前述药物组合物的制备方法,它包括以下步骤:
(1)按配比称取原料;
(2)取花椒,加水蒸馏提取芳香水,备用;花椒药渣与其余原料混合,加水煎煮,水煎液,滤过,滤液浓缩,离心,收集溶液;
(3)将步骤(2)所得溶液和芳香水混合、加入药学上可接受的辅料,混匀,即得。
进一步地,步骤2)所述芳香水是花椒的1倍量ml/g;步骤3)所述溶液和芳香水混合后的体积为原料总量的0.7~1.5倍。
本发明最后提供了一种前述的药物组合物在制备治疗皮肤瘙痒的药物中的用途。
进一步地,所述药物是治疗湿热蕴结型皮肤瘙痒的药物。
本发明药物组合物,基于名老中医验方、临床实效、数据挖掘和用药规律等各个方面成型。采用中药熏洗可使药液直达病所,加快局部血液循环和淋巴回流,改善毛细血管通透性,从而达到清热燥湿、养血活血、祛风止痒之功效。本发明各药味中马齿苋:酸、寒。归肝、大肠经。清热解毒,凉血止血,止痢。治疗热毒血痢,痈肿疔疮,湿疹,丹毒,蛇虫咬伤,便血,痔血,崩漏下血。药理作用:马齿苋具有多重药理作用,包括调血脂、抗动脉粥样硬化、抗炎、镇痛、抑菌、抗肿瘤、抗氧化、抗衰老、保肝、增强机体免疫力、对骨骼肌和平滑肌的作用等,可用于治疗糖尿病、高脂血症、癌症、 AD、PD及支气管哮喘等,其中镇痛、抗炎、抑菌尤为显著,马齿苋作为清热解毒药,具有较强的镇痛、抗炎活性。马齿苋是一种广谱的抗菌药,被称为“天然抗生素”,它对多种细菌具有抑制作用,其鲜品对大肠杆菌、金黄色葡萄球菌、沙门菌、变形杆菌、志贺菌、枯草芽胞杆菌等有抑制作用,干品水浸液和醇提液对大肠埃希菌、金黄色葡萄球菌、毛霉、黑曲霉有较强的体外抑制作用。马齿苋对不同的菌种抑制效果有所差别,比较马齿苋汁对大肠杆菌、痢疾杆菌、金黄色葡萄球菌和枯草杆菌4种菌种的抑制效果,发现马齿苋汁对痢疾杆菌的抑制作用最强,其次是大肠杆菌。马齿苋的多糖类成分和黄酮类成分的抑菌作用已有报道,可抑制酵母菌、醋酸菌、黑曲霉和大肠杆菌等,抑菌机制可能是阻止或延缓菌体进入生长对数期,破坏细胞壁和细胞膜的结构完整性,改变细胞膜的通透性,抑制菌体蛋白质的合成。
花椒:辛温,归脾胃肾经。功效温中止痛,杀虫止痒。治疗虫积腹痛,湿疹,阴痒。单用煎液作保留灌肠,用治小儿蛲虫病,肛周瘙痒;近年来研究发现,花椒具有扩张血管,抑菌,对局部有麻醉止痛作用;其挥发油对11种皮肤癣菌和4种深部真菌有一定的抑制和杀死作用,其中羊毛小孢子菌和红色毛癣菌最敏感,并能杀疥螨等。古籍文献:《神农本草经》载,花椒“昧辛, 温,主治风邪气,温中,除寒痹,坚齿明目,逐下气".《本草纲目》云:“椒,纯阳之物, 其味辛而麻,其气温以热.人肺散寒,治咳嗽;人脾除湿,治风寒湿痹,水肿泻痢;人右肾补火,治阳衰溲数,足弱久痢诸症"。《神农本草经》:“主邪气咳逆,温中,逐骨节皮肤死肌,寒痹,下气。”
地肤子:辛、苦,寒。归肾、膀胱经。利尿通淋,清热利湿止痒。治疗阴痒带下,风疹,湿疹。古籍文献:《滇南本草》:“利膀胱小便积热,洗皮肤之风,疗妇人诸经客热,清利胎热,妇人湿热带下用之良”。地肤子水浸剂对许兰氏黄癣菌、奥杜盎氏小芽孢癣菌、铁锈色小芽孢癣菌等多种皮肤真菌,均有不同程度的抑制作用。地肤子水提物有抑制单核巨噬系统的吞噬功能及迟发型超敏反应(DTH)。
蛇床子:辛、苦,温。归肾经。杀虫止痒,燥湿祛风,温肾壮阳。为皮肤及妇科病常用药,常与苦参、黄柏等配伍,且较多外用。《千金方》则单用研粉,猪脂调之外涂,治疗疥癣瘙痒。古籍文献:《神农本草经》:“主男子阴痿湿痒,妇人阴中肿痛,除痹气,利关节,癫痫,恶疮。”《药性论》:“主大风身痒,煎汤浴之瘥。”药理作用:对耐药性金黄色葡萄球菌、绿脓杆菌及皮肤癣菌有抑制作用;杀灭阴道滴虫。所含的花椒毒酚有较强的抗炎和镇痛作用。
白鲜皮:苦、微辛,寒。归肝胆脾胃肺膀胱经。清热燥湿,解毒,祛风。治疗阴部湿痒,湿疹,湿热疮毒,疥癣。辛苦温燥,有杀虫止痒,燥湿祛风诸作用。为皮肤及妇科病常用药,常与苦参、黄柏、白矾等配伍,且较多外用。治阴部瘙痒,与白矾煎汤频洗,如《濒湖集简方》;现临床治滴虫性阴道炎较常用。古籍文献:《神农本草经》:“主头风,黄疸,咳逆,淋沥。女子阴中肿痛,湿痹死肌,不可屈伸起止行步。《药性论》”治一切热毒风、恶风,风疮疥癣赤烂,眉发脱脆,皮肌急,壮热恶寒”。药理作用:本品水浸剂对堇色毛癣菌、同心性毛癣菌、许兰氏黄癣菌、奥杜盎氏小芽孢癣菌、铁锈色小芽孢癣菌、羊毛状小芽孢癣菌、腹股沟表皮癣菌、星形奴卡氏菌等多种致病性真菌有不同程度的抑制作用,并有解热作用。
千里光:性味苦,寒。归肺、肝经。功效:清热解毒,清肝明目,利湿。主治:痈肿疮毒,感冒发热,目赤肿痛,泄泻痢疾,皮肤湿疹。可单用鲜品,水煎内服并外洗,再将其捣烂外敷患处,或与金银花、野菊花、蒲公英等同用。千里光又可用治水火烫伤及褥疮、下肢溃疡等症,如《江西草药》用治烫火伤,以千里光8份、白及2份,水煎浓汁外搽。历代医书均将其作为治疮要药记载。民谚亦曰“一人识得千里光,全家世代不长疮”。临床应用痈肿疖毒、干湿癣疮、湿疹烫伤和痰痒等皮肤病疗效显著。药理作用:千里光提取物具有高效广谱抗菌作用,千里光全草含毛食黄素、菊黄质、黄酮贰和酚类。药理研究表明千里光提取物具有广谱抗菌作用,对金黄色葡萄球菌、绿脓杆菌和絮状表皮癣菌等常见侵染皮肤的致病菌有明显的抑制和杀灭作用。其有效作用浓度为2mg/ml。因此,千里光作为皮肤洗剂的功能性原料是非常适宜的。千里光提取物对于最易侵染人皮肤的金黄葡萄球菌和絮状表皮癣菌有极强的抗菌作用,对白色念珠菌和石膏样癣菌也有较强的抗菌作用。《滇南本草》:“洗疥癞癣疮,去皮肤风热。”
蜂房:味甘,性平。归胃经。功效:攻毒杀虫,祛风止痛。主治:皮肤顽癣,鹅掌风,牙痛,风湿痹痛。蜂房质轻,且性善走窜,能祛风止痛、止痒。药理作用:露蜂房水提取液对急性和慢性炎症均能抑制,主要对慢性疼痛有镇痛作用。此外,还有降压、扩张血管、强心、抗癌、抑菌及驱蛔虫、绦虫作用。《本草纲目》:“露蜂房,阳明药也。外科齿科及他病用之者,亦皆取其以毒攻毒,兼杀虫之功耳。”
大黄:性味苦,寒。入胃、大肠、肝经。功效:泻下攻积,清热泻火,凉血解毒,止血,逐瘀通经,利湿退黄。药理作用:大黄能增加肠蠕动,抑制肠内水分吸收,促进排便;大黄有抗感染作用,对多种革兰阳性和阴性细菌均有抑制作用,其中最敏感的为葡萄球菌和链球菌,其次为白喉杆菌、伤寒和副伤寒杆菌、肺炎双球菌、痢疾杆菌等;对流感病毒也有抑制作用;由于鞣质所致,故泻后又有便秘现象;有利胆和健胃作用;此外,还有止血、保肝、降压、降低血清胆固醇等作用。大黄有抗病原微生物作用:体外实验证明,对大黄较敏感的有厌氧菌、金黄色葡萄球菌、淋病双球菌、链球菌,其次是白喉、炭疽、伤寒和痢疾杆菌等。以金黄色葡萄球菌最为敏感,最低抑菌浓度为156mg/ml,大黄提取液对寄生于皮肤的毛癣菌黄癣菌等也有抗菌作用。此外,大黄对某些真菌、阿米巴原虫、阴道滴虫和血吸虫等均有一定的抑制作用。其抑菌的有效成分是游离的甙元、芦荟大黄素、大黄素、大黄酸。《神农本草经》:味苦,寒。主下瘀血,下闭,寒热,破癥瘕积聚,留饮宿食,荡涤肠胃,推陈致新,通利水谷道,调中化食,安和五脏。
本发明组合物中各药味配伍精当,君药马齿苋清热燥湿止痒,臣药地肤子、蛇床子清热利湿、杀虫止痒,去皮肤中积热,除皮肤外湿痒;佐药千里光清热燥湿止痒,白鲜皮清热祛风解毒;使药花椒、炒露蜂房祛风止痒,生大黄凉血消肿。全方配伍共奏清热燥湿、凉血消肿、祛风止痒之功效。
本发明组合物具有清热燥湿、凉血消肿、祛风止痒的作用,外洗于患处,有效成分经皮肤吸收后直达病所,具有作用直接、见效快、方便简洁、毒副作用小等特点,全方共奏清热燥湿、凉血消肿、祛风止痒之功,用于治疗皮肤瘙痒症方面效果显著。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
附图说明
图1方剂各各药味方解图
图2四项目瘙痒量表(Four-item Itch Questionnaire,FIIQ)
图3视觉模拟评分法(Visual Analogue Scale,VAS)
具体实施方式
实施例1、本发明药物的制备
配方:马齿苋30克、蛇床子30克、地肤子20克、炒露蜂房20克、白鲜皮10克、花椒10克、生大黄15克、千里光15克。
制备方法:花椒加水蒸馏提取,得10ml芳香水,备用;花椒药渣与马齿苋等其他7种药味加水煎煮提取,合并水煎液,滤过,滤液浓缩,离心除杂;加入备制完成的芳香水、防腐剂,混匀,制得150ml溶液,分装,即得。
实施例2、本发明药物的制备
配方:蛇床子25克、地肤子15克、炒露蜂房15克、白鲜皮5克、花椒 5克、生大黄10克、马齿苋25克、千里光10克。
制备方法:花椒加水蒸馏提取,得5ml芳香水,备用;花椒药渣与蛇床子等其他7种药味加水煎煮提取,合并水煎液,滤过,滤液浓缩,离心除杂;加入备制完成的芳香水、防腐剂,混匀,制得150ml溶液,分装,即得。
实施例3、本发明药物的制备
配方:蛇床子35克、地肤子25克、炒露蜂房25克、白鲜15克、花椒 15克、生大黄20克、马齿苋35克、千里光20克。
制备方法:花椒加水蒸馏提取,得15ml芳香水,备用;花椒药渣与蛇床子等其他7种药味加水煎煮提取,合并水煎液,滤过,滤液浓缩,离心除杂;加入备制完成的芳香水、防腐剂,混匀,制得150ml溶液,分装,即得。
以下通过试验例来说明本发明的有益效果以及比较疗效。
试验例1临床试验
1 诊断标准
1.1 西医诊断标准
参照《2020guidelines for the diagnosis and treatment of cutaneouspruritus》制定,符合皮肤瘙痒症的临床标准,具体如下:
(1)皮肤瘙痒症:一种以在几乎正常的皮肤或没有明显损伤的皮肤上瘙痒为特征的疾病(可能会出现擦伤和/或由于抓挠造成的色素沉着)。
a、全身性瘙痒症(无皮肤炎症):指在较广范围内出现瘙痒,而非局限于身体某一特定部位,包括:特发性瘙痒症、老年人瘙痒症、症状性瘙痒症、妊娠相关性瘙痒症、药物性瘙痒、心因性瘙痒。
b、局部瘙痒症(无皮肤炎症):身体某一特定部位出现的固定的、局部的瘙痒,包括:肛门-生殖器瘙痒症、头皮瘙痒症、感觉异常疼痛和肱桡动脉瘙痒。
(2)临床症状:主要表现为全身瘙痒症状。全身性瘙痒的特征是全身瘙痒,但没有明显的皮肤损伤,可能引起瘙痒。瘙痒是持续性的或阵发性的,导致夜间入睡困难。瘙痒症状有多种。在由肾衰竭、透析或胆汁淤积引起的瘙痒中,可能会经历“来自体内的瘙痒”或“突然的瘙痒发作”。
(3)实验室检查:
a、目视检查/身体检查:皮肤是否干燥。排除可能引起全身瘙痒的潜在疾病。
b、若病因不明,长期瘙痒,需考虑内脏恶性肿瘤的可能性。患者必须接受粪便潜血检查、肿瘤标记物测量和影像学评估,如胸部X光和ct对比。
c、如果经过上述广泛的检查仍不能确定原因,则需要考虑由精神障碍引起的瘙痒的可能性。
参照《慢性瘙痒管理指南(2018版)》制定,符合皮肤瘙痒症临床标准,具体如下:
(1)皮肤源性瘙痒:多种皮肤病常伴瘙痒,特别是特应性皮炎、银屑病等炎症性皮肤病。通常有以下特征:
①有原发皮损;
②瘙痒的部位与皮损的部位常一致;
③瘙痒程度与病情轻重和疾病的状态有关,活动期常较严重,随着病情好转逐渐减轻或消失;
④不同皮肤病表现的瘙痒有各自的特征。
(2)系统性瘙痒:即系统性疾病伴发瘙痒。有以下特点:
①缺乏原发皮损,或继发痒疹或慢性单纯性苔藓;
②可发生于疾病任何阶段,甚至成为疾病早期诊断的唯一线索;
③不同疾病瘙痒的发生机制和诱因复杂且差异较大,但临床表现多缺乏特征性;
④瘙痒发生率及程度与原发病轻重多不呈平行关系;
⑤瘙痒通常顽固,常规处理难以奏效,积极治疗原发病可减轻瘙痒,但也可能无效。
(3)神经源性瘙痒:其特征为:
①多为局限性;
②间断性发作;
③常伴有感觉异常或感觉减退;
④可与病理学疼痛合并存在。周围神经病变引起的瘙痒显著多于中枢神经病变。
(4)精神障碍性瘙痒:其特征为:
①瘙痒程度与情绪状态相平行;
②缺乏原发皮损,但可以见到神经官能症性表皮剥脱等继发损害;
③通常睡眠不间断;
④外用药物疗效较差。
(5)药物源性瘙痒:主要指由药物诱发的无原发性皮肤或黏膜损害的瘙痒,不包括药疹伴发的瘙痒。临床上也可观察到因搔抓产生的表皮剥脱、鳞屑、苔藓样变等继发性皮损。几乎任何药物都可能导致瘙痒。依据用药史与瘙痒发生的关系,停药后症状消失,再次给予疑似药物仍出现瘙痒,并排除疾病本身的因素,可考虑为药物源性瘙痒。
(6)特殊人群的瘙痒:
①老年性瘙痒:指原因不明、缺乏原发皮疹、发生于老年人的瘙痒,其发生与皮肤屏障功能衰退关系密切,但神经老化和免疫失衡在发病中也发挥重要作用。半数以上患者发生在腿部,其次是背部、头皮和手臂等,通常呈对称性。绝大部分患者每天发作,以晚上为甚。老年性瘙痒患者需要排除合并症及药物因素。
②孕妇瘙痒:妊娠期因体内新陈代谢、免疫、内分泌改变,具有一些特有的皮肤病,如妊娠期肝内胆汁淤积症、妊娠痒疹、妊娠多形疹、妊娠类天疱疮,这些疾病均伴有瘙痒。孕妇瘙痒也可发生在孕前已存在的皮肤病加重的情况下。
③儿童瘙痒:主要见于特应性皮炎,但也可见于遗传性疾病如胆道闭锁、家族性高胆红素综合征、多囊肾等。儿童发生药物源性瘙痒概率较小,可能与用药种类较少有关。部分患者有瘙痒、疼痛;
1.2中医诊断标准
参照《中医外科学》(新世纪第四版)、《中医外科学》(新世纪第二版)制定,具体如下:
(1)风瘙痒是一种无明显原发性皮肤损害而以瘙痒为主要症状的的皮肤感觉异常的皮肤病,亦称痒风。《外科证治全书.痒风》记载:“遍身瘙痒,并无疥疮,搔之不止。”其临床特点是:皮肤阵发性瘙痒,搔抓后常出现抓痕、血痂、色素沉着和苔藓样变等继发性损害。
(2)临床表现:瘙痒为本病的主要症状,瘙痒为阵发性,白天轻,夜间重,亦因饮酒、情绪变化、受热、搔抓、摩擦后发作或加重。无原发性皮损,由于连续反复搔抓,可引起抓痕、表皮剥脱和血痂,日久皮肤可出现肥厚、苔藓样变、色素沉着以及湿疹样变。
(3)证治标准——湿热蕴结证
证候:瘙痒不止,抓破后脂水淋漓;伴口干口苦,胸胁闷胀,小便黄赤,大便秘结;舌红,苔黄腻,脉滑数。
辨证分析:饮食不节,脾失健运,湿热内生,蕴结于肌肤,化热生风,内不得疏泄,外不得透达,故见皮肤瘙痒不止,抓破后脂水淋漓;肝胆实热则口苦口干,胸胁闷胀,小便黄赤,大便秘结;舌红、苔黄腻、脉滑数为湿热蕴结之象。
2病例纳入标准
(1)患者符合皮肤瘙痒症的西医诊断标准;
(2)符合中医风瘙痒湿热蕴结证的诊断;
(3)年龄在18至60岁之间;
(4)未确诊其他皮肤病;
(5)2周内无系统使用皮质类固醇激素,1周内无内服抗组胺药物史和 (或)外用皮质类固醇、激素药物史;
(6)自愿参加并签署知情同意书。
3排除标准
参考2015年欧洲慢性瘙痒指南
(1)既往有原发性皮肤病,如银屑病、过敏性皮炎等引起的瘙痒;
(2)既往有系统性疾病引起的瘙痒包括:但不限于胆汁淤积的肝脏疾病、慢性肾功能不全、艾滋病等。
(3)正在使用药物(降糖方案以外的药物)导致不良反应引起的瘙痒;
(4)糖尿病酮症酸中毒、糖尿病高渗性昏迷的患者;
(5)临床资料不完整、无法配合完成评估及精神障碍者;
(6)不符合中医风瘙痒湿热蕴结证的证型诊断。
4治疗方案
治疗组:纳入患者25例,予以本发明药物组合物(按实施例1制备的)泡浴瘙痒部位,每日一次,每次取150ml药物组合物,以1:500的比例兑温水,水量以完全浸没瘙痒面积为宜,水温38-40℃,泡浴15-20min。疗程为4 周。
对照组:纳入患者20例,予以现有专利CN107158291一种治疗皮肤瘙痒的中药组合物及其制备方法所提及的药物组合物(玄参20份、苦参30份、蛇床子30份、地肤子30份、土茯苓30份、黄柏10份、花椒6份、千里光20份) 按其制备方法,以1:500的比例兑温水,水量以完全浸没瘙痒面积为宜,水温38-40℃,泡浴15-20min,每日一次,水量以完全浸没瘙痒面积为宜,泡浴15-20min。疗程为4周。
5 疗效观察
5.1 有效性指标
主要指标:瘙痒评分
5.1.1瘙痒评分方法
治疗前、治疗后第2周、第4周、第8周进行四项目瘙痒量表(FIIQ)、视觉模拟评分法(Visual Analogue Scale,VAS)评分,治疗结束后一月电话回访患者满意度。
FIIQ量表:分别调查瘙痒分布部位(计分范围1~3分;一个部位瘙痒计1 分,最多得3分,选全身计3分),瘙痒严重程度(计分范围1~5分),瘙痒频率(计分范围1~5分;瘙痒有过4次,每次<10min或有1次瘙痒>10min计1分,以此类推,一直持续计5分),瘙痒对睡眠的影响(计分范围0~6分;无影响计0分,夜痒醒1次计2分,一夜痒醒2次计4分,一夜痒醒3次以上计6分)。量表总分为4个条目的评分总和,总分得分范围3(轻度痒)~19分(最大程度瘙痒)。具体内容见图2。
VAS量表:以10cm长的直线,从左到右为“0”到“10”,依次代表着从“不痒”到“最痒”,中间为瘙痒的不同级别,分值由患者根据自身瘙痒程度选择得出。瘙痒程度与VAS分值呈正比,结果以0~10分计,得分越高,瘙痒愈甚。(具体内容见图3)。
6疗效标准
疗效评定标准,治疗前、治疗后第2周、第4周、第8周进行四项目瘙痒量表(FIIQ)、视觉模拟评分法(Visual Analogue Scale,VAS)评分,对临床疗效进行综合评价。评分越高,说明瘢痕越严重。总评分=FIIQ+VAS。
参照中华人民共和国卫生部制定的《中药新药临床研究指导原则》皮肤瘙痒的疗效评价及有关文献制定。根据积分法判定疗效,疗效判定标准:分痊愈、显效、有效、无效四级;
疗效指数=[(治疗前积分-治疗后积分)÷治疗前积分]×100%
皮肤瘙痒及皮损疗效评定方法
痊愈:疗效指数为100%;
显效:疗效指数为60%-99%
有效:疗效指数为20%-59%
无效:疗效指数<20%
患者满意度评价:非常满意、满意、一般、不满意。满意率=(非常满意+满意)/总数×100%。
7结果
治疗组患者25例,对照组患者20例,根据四项目瘙痒量表(FIIQ)、视觉模拟评分法(Visual Analogue Scale,VAS)评分,从痒的部位、痒的程度、痒的频率、痒对睡眠的影响4个方面分别及综合体现瘙痒治疗的疗效,具体见表1~14。
表1治疗组FIIQ量表总评分
表2对照组FIIQ量表总评分
表3治疗组FIIQ量表痒的部位评分
a.里利氏显著性修正。
表4对照组FIIQ量表痒的部位评分
a.里利氏显著性修正。
表5治疗组FIIQ量表痒的程度评分
a.里利氏显著性修正。
表6对照组FIIQ量表痒的程度评分
a.里利氏显著性修正。
表7治疗组FIIQ量表痒的频率评分
a.里利氏显著性修正。
表8对照组FIIQ量表痒的频率评分
a.里利氏显著性修正。
表9治疗组FIIQ量表痒对睡眠的影响评分
a.里利氏显著性修正。
表10对照组FIIQ量表痒对睡眠的影响评分
a.里利氏显著性修正。
表11治疗组VAS量表瘙痒评分
a.里利氏显著性修正。
表12对照组VAS量表瘙痒评分
a.里利氏显著性修正。
表13治疗组患者满意度调查
表14对照组患者满意度调查
从表1-14可见:经过4周的治疗后,通过FIIQ量表评分,得到本药物组合物(治疗组)的有效率达63.85%,而对照组有效率为48.08%;通过VAS量表评分,得到本药物组合物(治疗组)的有效率达73.08%,而对照组有效率为 58.83%;各项分类评分中本药物组合的治疗有效率均高于对照组;本药物组合物患者满意度为78%,而对照组为45%;总体可见,本药物组合物疗效优于对照组,疗效较佳,值得推广。
试验例2典型病例
患者,男,59岁,全身皮肤瘙痒2+月。全身各处未见明显红斑、丘疹、皮肤干燥,皮肤瘙痒明显,夜间尤甚,难以入睡。患者四肢可见明显条状抓痕、血痂。采用本发明药物组合泡浴全身,每日一次,连续8周。患者瘙痒逐步减轻,夜间睡眠好转,四肢条状抓痕减淡,8周治疗后与治疗前相比,FIIQ 量表评分下降7.4分,瘙痒VAS评分下降4.3分。患者对治疗效果满意。
患者,女,45岁,4月前无明显诱因出现下肢外侧皮肤瘙痒,患者可见清晰条状抓痕、血痂,未见干燥、红斑等其他皮损。现抓痕处充血,夜间偶感疼痛、瘙痒。采用本发明药物组合泡浴双下肢,每日一次,连续8周。患者下肢外侧瘙痒明显缓解,患处皮损逐步愈合,疼痛减轻。8周治疗后与治疗前相比,FIIQ量表评分下降5.3分,瘙痒VAS评分下降5.2分。患者对治疗效果满意。
患者,男,78岁,全身皮肤瘙痒反复发作5年余,入冬为甚。既往多次行中西药治疗,疗效甚微。半月前温水浴后瘙痒加剧。现周身皮肤瘙痒,背部尤甚。皮肤干燥、血痕累累,间有皮肤肥厚和色素沉着。采用本发明药物组合泡浴全身,每日一次,连续8周,患者瘙痒明显减轻,患处皮损好转,肥厚减薄,8周治疗后与治疗前相比,FIIQ量表评分下降3.4,瘙痒VAS评分下降 3.6分。患者对治疗效果满意。
综上,本发明组合物针对皮肤瘙痒症,尤其在湿热蕴结证下具有清热燥湿、凉血消肿、祛风止痒的作用,湿敷、药浴泡于患处,能显著改善瘙痒症状,极大的减轻患者的不适,市场应用前景优良。
Claims (10)
1.一种治疗湿热蕴结型皮肤瘙痒的药物组合物,其特征在于:它是由下述重量份的原料制备而成:
马齿苋25~35份、蛇床子25~35份、地肤子15~25份、露蜂房15~25份、白鲜皮5~15份、花椒5~15份、大黄10~20份、千里光10~20份。
2.根据权利要求1所述的药物组合物,其特征在于:它是由下述重量份的原料制备而成:
马齿苋30份、蛇床子30份、地肤子20份、露蜂房20份、白鲜皮10份、花椒10份、大黄15份、千里光15份。
3.根据权利要求1或2所述的药物组合物,其特征在于:所述露蜂房为炒露蜂房;所述大黄为生大黄。
4.根据权利要求1或2所述的药物组合物,其特征在于:它是原料的粉,或水或有机溶剂提取物,加上药学上可接受的辅料制备而成的制剂。
5.根据权利要求4所述的药物组合物,其特征在于:所述制剂为外用制剂。
6.根据权利要求5所述的药物组合物,其特征在于:所述外用制剂为溶液剂、膏剂、栓剂。
7.权利要求1~5任一项所述药物组合物的制备方法,其特征在于:它包括以下步骤:
(1)按照权利要求1所述配比称取原料;
(2)取花椒,加水蒸馏提取芳香水,备用;花椒药渣与其余原料混合,加水煎煮,水煎液,滤过,滤液浓缩,离心,收集溶液;
(3)将步骤(2)所得溶液和芳香水混合、加入药学上可接受的辅料,混匀,即得。
8.根据权利要求7所述的制备方法,其特征在于:步骤2)所述芳香水是花椒的1倍量ml/g;步骤3)所述溶液和芳香水混合后的体积为原料总量的0.7~1.5倍。
9.权利要求1~6任一项所述的药物组合物在制备治疗皮肤瘙痒的药物中的用途。
10.根据权利要求9所述的用途,其特征在于:所述药物是治疗湿热蕴结型皮肤瘙痒的药物。
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