CN116585404B - 一种治疗成人单纯性皮肤瘙痒症的外用中药组合物及制备方法 - Google Patents
一种治疗成人单纯性皮肤瘙痒症的外用中药组合物及制备方法 Download PDFInfo
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Abstract
本发明属于中医药领域,具体涉及一种治疗成人单纯性皮肤瘙痒症的中药组合物及制备方法,该中药组合物主要组分按重量份计为:薄荷30‑40份、雷公藤20‑30份、蝉蜕10‑20份、蜂房10‑20份、花椒15‑30份、炉甘石20‑30份、海桐皮15‑30份、马齿苋20‑30份、透骨草15‑30份、浮萍20‑30份、芒硝20‑30份、甘草10‑18份,该中药组合物内以清热解毒、燥湿止痒,外以消炎杀菌、消肿生肌,诸药合用,对成人单纯性皮肤瘙痒症疗效显著。
Description
技术领域
本发明属于中医药领域,具体涉及一种治疗成人单纯性皮肤瘙痒症的中药组合物及制备方法。
背景技术
单纯性皮肤瘙痒症是一类较为多见的皮肤病,缺乏确切的全身性病因,无原发性皮肤病,临床症状只有皮肤瘙痒,但是久而久之会出现抓痕、血痂、色素沉着及苔藓样变化等继发损害,具有病程较长、治疗难度大、预后差,易反复的特点,严重影响患者的心理状态及日常生活。其病因和发病机制极为复杂,与皮肤干燥有一定相关性,也与内分泌功能障碍、性激素分泌不足所致的皮脂腺、汗腺分泌异常以及皮肤萎缩等因素有直接关系。各种因素导致机体产生瘙痒介质,皮肤感受器将瘙痒介质的刺激传递到大脑皮层,就产生了瘙痒的感觉。中医认为,本病隶属于“痒风”、“风瘙痒”的范畴。《诸病源候论·风瘙痒候》:“风瘙痒者,是体虚受风,风入腠理,与血气相搏……故但瘙痒也。”因风热、风寒或湿热之邪,蕴于肌肤不得疏泄而致瘙痒;或因风邪久留体内化火生燥以致津血枯涩,肌肤失于濡养而致瘙痒发生。而《素问吴注·卷二十二》言:“热甚则痛,热微则痒,疮则热灼之所致也,故火潘肌肉,进则痛,远则痒,灼干火则烂而疮也,心为火,故属焉。”以及《类经·疾病类》亦曰:“热甚则疮痛,热微则疮痒,心属火,其化热,故疮疡皆属心也。”,均认为瘙痒与体内热邪不能透散有关。热邪夹杂着血中热毒,蕴结在皮肤上有关。风热之邪,如果透过皮肤、毛孔,能够被正气排出体外,那么瘙痒自然即可缓解。如果肌表出现问题,风热等邪淤堵在肌肤毛孔,就容易出现瘙痒,甚至起痒疹等。《素问·至真要大论篇》言“诸痛痒疮,皆属于心”,认为瘙痒责之于心。另外,还有因虚致痒,如《杂病源流犀烛·筋骨皮肉毛发病源流》云:“血虚之痒,虫行皮中,风邪之痒,痒甚难忍,皮虚之痒,或肝肾阴亏、精血不足、年老体衰,无以充养,阴虚血燥风动而致痒。”《丹溪心法·疠风》亦有论述:“身上虚痒,血不荣于肌腠,所以痒也。”当人体出现阴虚或者血虚等症状,体内的垃圾物质含量相对自然增加,湿毒、热毒等蕴结皮肤引起瘙痒。
当前临床上治疗成人单纯性皮肤瘙痒症的方法众多,大多以口服抗组胺药、5-羟色胺受体拮抗剂、三环类抗抑郁药、烟酰胺等,外用钙调神经磷酸酶抑制剂、保湿剂、止痒剂、糖皮质激素等,但临床疗效并不乐观且伴有不同程度的副作用,例如嗜睡、头晕、恶心、心律失常、依赖性及耐药性等。
因此,如何治疗成人单纯性皮肤瘙痒症,成为当前亟待解决的医疗问题,也是未来研究的方向所在。
发明内容
针对现有技术的存在的技术问题,结合祖国传统医学理论,本发明提供了一种治疗成人单纯性皮肤瘙痒症的中药组合物及制备方法,该组合物内以清热解毒、燥湿止痒,外以消炎杀菌、调肤止痒,诸药合用,对成人单纯性皮肤瘙痒症疗效显著。
发明人在临床实践过程中发现,成人单纯性皮肤瘙痒症的病人存在邪毒蕴结、肌肤失养的病机,而目前的中医治疗尚无针对此种病机的临床指南和治疗标准。因此以上述“成人单纯性皮肤瘙痒症的病人存在邪毒蕴结、肌肤失养的病机”为基础,发明人研究出内以清热解毒、燥湿止痒,外以消炎杀菌、调肤止痒的中药组合物,具体技术方案如下:
一种用于治疗成人单纯性皮肤瘙痒症的中药组合物,其主要组分按重量份计为:
薄荷30-40份、雷公藤20-30份、蝉蜕10-20份、蜂房10-20份、花椒15-30份、炉甘石20-30份、海桐皮15-30份、马齿苋20-30份、透骨草15-30份、浮萍20-30份、芒硝20-30份、甘草10-18份。上述用量范围内可以获得较好的治疗效果,药物用量过大或者过小均会导致组方所围绕的病机主次发生变化。
优选地,其主要组分按重量份计为:薄荷36-38份、雷公藤24-26份、蝉蜕15-18份、蜂房15-18份、花椒20-25份、炉甘石25-28份、海桐皮18-26份、马齿苋25-28份、透骨草25-29份、浮萍22-24份、芒硝25-30份、甘草12-15份。
更进一步的,发明人对上述的组分进行了合理的优化,最终获得了下述技术方案:该药物的主要组分按重量份计为:薄荷35份、雷公藤24份、蝉蜕15份、蜂房15份、花椒22份、炉甘石25份、海桐皮18份、马齿苋25份、透骨草25份、浮萍22份、芒硝25份、甘草12份。
本发明中药组合物以雷公藤、炉甘石为君药,雷公藤,性凉,味苦、辛,具有祛风除湿,活血通络,消肿止痛,杀虫解毒等功效;炉甘石性平,味甘,归肝经、脾经,具有收敛、止痒、抑菌和轻度防腐等作用,又有保护皮肤、防止摩擦、遮光、除湿、消炎、清凉、干燥、降低外来刺激、防腐收敛、止痒等作用;两药配伍,前者为祛风活血、通络止痒,后者为护肤收敛止痒,一散一收,走守相彰,共奏止痒之效,故为君药;蝉蜕祛风止痒,蜂房杀毒止痒祛风,二药合用,常为祛风止痒药对;花椒,性温,味辛,归脾经、胃经、肾经,具有温中止痛、杀虫止痒之效;浮萍,性寒,味辛,归肺经,轻浮升散,善通毛窍,具有宣散风热,透疹、利尿的功能,攻专斑疹不透,皮肤瘙痒,与花椒配合,一温一寒,一善走内,一善达外,二药相反相成,减缓药物寒热偏性且增止痒之功;海桐皮能行经络,达病所,至皮部,又善入血分及祛风杀虫;透骨草,甘、辛,温,归肝、肺经,祛风除湿、舒筋活络、活血止痛、解毒化疹,配海桐皮合用,燥皮肤之湿,解肌蕴之毒,止痒效著。六药均可止痒,共为臣药。芒硝,咸、苦,寒,归胃经、肺经、脾经、肾经、小肠经、三焦经、大肠经,具有泻热润燥、软坚散结、清火消肿作用,还有清热解毒和活血化瘀之功,可缓解瘙痒皮损处的干燥及肿热,加快局部血液循环,佐助君药增强药效。甘草,甘、平,归心、肺、脾、胃经,具有补脾益气,清热解毒,缓急止痛,调和诸药等功效,甘草在此方剂中既发挥调和诸药功效外,还兼具抗炎止痒作用,为使药。
上述中药组合物中,具体的用药机理如下:
薄荷:味辛,性凉,归肺、肝经,具有有发散风热、透疹解毒、止痒的功效,外用可治皮肤瘙痒、皮疹和湿疹等。因其所含薄荷脑和薄荷油等成分,广泛用于驱风、防腐、消炎、镇痛、止痒、健胃等。现代药理研究发现,薄荷一方面能刺激神经末梢冷感受器而产生冷感,并反向性地造成深部组织血管的变化而起到消炎、止痛、止痒作用,另一方面还可促进透皮吸收。《医学衷中参西录》记载:“薄荷味辛,气清郁香窜,又善表瘾疹,愈皮肤瘙痒。”《本草纲目》记载:“治瘰疬,疮疥,风瘙瘾疹。”
雷公藤:性凉,味苦、辛,有大毒。归心经、肝经。其为卫矛科雷公藤属的木质藤本植物,始载于《神农本草经》,名莽草。具有祛风除湿,活血通络,消肿止痛,杀虫解毒等功效。现代药理学研究证实,雷公藤含有雷公藤碱、雷公藤红素、雷公藤甲素(又称为雷公藤内酯醇)、雷公藤乙素等多种活性成分,对炎症性疾病、皮肤病等具有良好的治疗作用,其中雷公藤多苷可以通过下调H1R、PAR-2、TRPV1、p38 MAPK、p-p38 MAPK蛋白水平来抑制H1R/TRPV1、PAR-2/TRPV1和p38 MAPK等痒觉信号通路的激活,从而发挥其抗瘙痒和抗炎的作用。
蝉蜕:性寒,味甘。归肺经、肝经。能够散风除热、利咽透疹、解痉、退翳。风热之邪容易外束肌肤,导致肌肤不畅通,因此作痒。蝉蜕宣散头风,能疏散风热,透疹止痒,用于风热、风湿相驳结出现的湿疹、皮肤瘙痒,有很好的止痒透疹作用。《本草衍义》:“蝉蜕治头风眩晕,皮肤风热作痒,破伤风及疔肿毒疮,大人失音,小儿禁风天掉。”
蜂房:性平,味甘,入胃经,能够祛风、攻毒、杀虫、止痛。现代药理研究发现,具明显的抗炎、镇痛、抑菌作用。蜂房善于以毒攻毒,还能杀虫,祛风止痒。《日华子本草》:“蜂房煎水洗漱牙齿,止风虫疼痛。”
蝉蜕祛风止痒,蜂房杀毒止痒祛风,二者配合,对于各种风疹瘙痒,湿疹瘙痒,老年阴血亏虚瘙痒及一些原发性瘙痒有很好的止痒作用。既可以入汤药内服,还可以针对局部皮肤瘙痒,局部外用。
花椒:性温,味辛。归脾经、胃经、肾经。温中止痛、杀虫止痒。研究表明,花椒生物碱能较强抑制二甲苯所致小鼠耳肿胀并能轻微缓解分子右旋糖酐-40诱发的小鼠皮肤瘙痒。另外,花椒挥发油成分也有明显抗真菌作用,对多种浅表性皮肤癣菌有较强的抑菌作用。
炉甘石:性平,味甘,归肝经、脾经。来源于碳酸盐类矿物菱锌矿(ZnCO3)或水锌矿[Zn5(CO3)2(OH)6],主要成分为天然碳酸锌,经高温煅烧成分分解为氧化锌(ZnO),具有收敛、止痒、抑菌和轻度防腐等作用,兼有保护皮肤、防止摩擦、遮光、除湿、消炎、清凉、干燥、降低外来刺激、防腐收敛、止痒等效果,被广泛应用于皮肤科疾病中,对表面创伤、皮肤炎症等具有较好的治疗效果,可作为收敛保护剂、中度防腐药使用。炉甘石具有消炎、止痒、收敛与滋润保护皮肤的功效,可以加快渗液吸收,在皮肤晾干后可以在表皮形成粉状的保护层,维持皮损病灶局部区域干燥状态,促使病灶区域水分蒸发,从而促使皮温降低,优化治疗效果。
海桐皮:性平,味苦、辛,归肝经,来源于豆科植物刺桐、乔木刺桐的干皮或根皮,功专祛风除湿,通络止痛,杀虫止痒。海桐皮含有生物碱、黄酮、氨基酸和有机酸类等多种化学成分,具有镇痛、镇静、抗菌等作用。《神农本草经疏》载海桐皮“苦能杀虫,平即微寒,湿热去而疥癣除矣”,李时珍言:“海桐皮能行经络,达病所,又入血分及去风杀虫”。
马齿苋:味酸,性寒。归大肠经、肝经,清热解毒、凉血止血。现代药理研究发现,马齿苋可修复皮肤角质层屏障功能,促进上皮细胞功能修复及溃疡的愈合,具有止痒、抗炎、抑菌和调节免疫等多种药理作用,还对大肠杆菌、伤寒杆菌、金黄色葡萄球菌及杜盎氏小芽孢癣菌等致病性皮肤真菌有抑制作用。还有研究表明,马齿苋能降低皮肤组织中HRH1蛋白的水平,抑制瘙痒感觉,间接改善皮损状况,抵抗有害病菌侵染。《冯氏锦囊秘录》言马齿苋可治“两足血风疮,并两肩背风湿疮疼痒至骨”。
透骨草:甘、辛,温。归肝、肺经,祛风除湿、舒筋活络、活血止痛、解毒化疹。配海桐皮,海桐皮苦祛风除湿,通络止痛,杀虫止痒,两药合用,燥皮肤之湿,解肌蕴之毒,其效显著。现代药理学表明,透骨草含生物碱、有机酸、挥发油等,水煎浸泡治疗,可更好地渗透皮肤,抑菌抗炎,杀虫止痒,作用于细菌及真菌寄生的患处,抑制菌群生长,改善患者瘙痒等不适症状。
浮萍:性寒,味辛,归肺经。轻浮升散,善通毛窍,具有宣散风热,透疹、利尿的功能,用于斑疹不透,皮肤瘙痒,水肿,尿少等症。现代药理研究表明,浮萍含有醋酸钾及氯化钾、碘、溴、荭草素、木犀草素-7-单糖苷、牡荆素、谷固醇、堇黄质、棕榈酸等成分,具有强心、利尿、抗凝、止痒等功效。浮萍辛寒之性,轻清透散,疏风清热,风去热散,瘙痒必止。《本草经疏》载:“其体轻浮,其性清燥,能祛湿热之药也。热气郁于皮肤则作痒,味辛而气清寒,故能散皮肤之湿热也。寒能除热,燥能除湿,故下水气。”
芒硝:咸、苦,寒。归胃经、肺经、脾经、肾经、小肠经、三焦经、大肠经,具有泻热润燥、软坚散结、清火消肿功效。芒硝是一种由天然矿物质提炼的含有硫酸钠的结晶体,其主要的成分是硫酸钠,水溶解之后将生成硫酸根离子,作用于皮肤,可引起皮肤表皮层的渗透压上升,消除表皮细胞间水肿,具有较强的水溶性和渗透性,可通过吸收空气中的水分降低患处的温度,达到止痒的作用,同时还可吸收患处的水分,起到消肿、消炎的作用,促进伤口的愈合。其药物的动力学原理是药物中的硫酸钠可以在细胞之间进行扩散,在皮肤表面聚集,而钠离子聚集在表皮细胞间,钠钙离子的反向运作使钙离子运转至表皮肥大细胞,钙离子外流,从而肥大细胞膜处于稳定的状态,防止过敏介质的释放。芒硝中还含有硫酸钙、氯化钠等离子,具有清热解毒和活血化瘀的作用,可消炎、促进血液循环。
甘草:甘、平,归心、肺、脾、胃经,补脾益气,清热解毒,缓急止痛,调和诸药等。研究表明,甘草药用成分主要包括甘草酸、甘草多糖等,具有抗炎、抗病毒、神经保护等作用;甘草及其有效成分的抗炎和免疫调节作用、皮质激素样作用、抗菌、抗病毒、抗肿瘤作用常被皮肤科采用。此外,其中的甘草多糖对T淋巴细胞的增殖具有促进作用,还可提升机体抵抗力。
在上述药物组成的基础上,发明人进一步提供了其制备方法如下:
首先称出各味中药,除薄荷、芒硝和炉甘石之外的余药一起加水至没过药面2-3指为止,浸泡1-2小时;先大火煮沸,之后文火煎熬20-30分钟,将药液过滤出备用;向药渣内再次加水,至没过药渣面1-2指为止,大火煮沸,之后文火煎熬15-20分钟;将药液滤出后与上次药液合并,再次文火煎煮10-15分钟进行浓缩;停火前5分钟放入薄荷,将药液滤出晾凉,再将芒硝溶于药液中,最终将得到的药液与炉甘石均匀混合。
优选地,炉甘石研成≤200目细粉。
优选地,向药渣内再次加水,水的温度为75-85℃。
具体的一种治疗成人单纯性皮肤瘙痒症的中药组合物的使用方法,利用上述制备方法制备的中药组合物涂抹患处,5-7天为1疗程,病情轻者治疗1个疗程症状即可消失,重者3-4个疗程症状即可消失。
选择炉甘石的主要原因是:
炉甘石是碳酸盐类矿物方解石族菱锌矿Smithsonite的矿石,主要含碳酸锌(ZnCO3)等铅、镉等重金属,口服后在胃内可生成氯化锌等,会刺激腐蚀胃肠道,另外氧化锌进入血液,可使蛋白沉淀,损害脏器,以肾损伤较为明显。因此炉甘石仅可外用,禁内服。使用时一般研成细末,与其他药液混合涂抹患处,既可加快渗液吸收,在皮肤晾干后可以在表皮形成粉状的保护层,又能维持皮损病灶局部区域干燥状态,促使病灶区域水分蒸发,从而促使皮温降低,优化治疗效果。因此,炉甘石研细末涂抹患处疗效最好。
薄荷、芒硝后下的主要原因在于:
薄荷是唇形科植物薄荷Mentha haplocalyx Briq.的地上部分,主要含薄荷脑、薄荷酮等挥发油成分,属于芳香类药材,久煎药性易挥发,故需后下。芒硝(Sodium Sulfate)是一种硫酸盐矿物,其主要的成分是硫酸钠,具有较强的水溶性和渗透性,水溶解之后将生成硫酸根离子,作用于皮肤,可引起皮肤表皮层的渗透压上升,有利于消除表皮细胞间水肿,且能加速炎症消散与吸收。后下其清热消肿之力更强,且不与其他原药材混煎又能避免芒硝用量的损耗,故需后下。
利用上述组方和制备方法获得的药物,应用于临床,疗效十分显著,发明人经过大量临床试验发现,临床治疗上多以口服抗组胺药、5-羟色胺受体拮抗剂、三环类抗抑郁药、烟酰胺等,外用钙调神经磷酸酶抑制剂、保湿剂、止痒剂、糖皮质激素等,但临床疗效并不乐观且伴有不同程度的副作用,例如嗜睡、头晕、恶心、心律失常、依赖性及耐药性等。本发明的中药组合物具有安全且显著的临床疗效,5-7天为1疗程,病情轻者治疗1个疗程症状即可消失,重者3-4个疗程症状即可消失,本发明的中药组合物取得了显著疗效,本发明的技术方案从理论到临床效果都有明显优势,填补了本领域的空白。
综上所述,本发明结合祖国传统医学理论,以“成人单纯性皮肤瘙痒症的病人存在邪毒蕴结、肌肤失养的病机”为基础,提供的一种用于治疗成人单纯性皮肤瘙痒症的中药组合物及制备方法,该组合物内以清热解毒、燥湿止痒,外以消炎杀菌、调肤止痒、调肤止痒,诸药合用,对成人单纯性皮肤瘙痒症疗效显著。
附图说明
图1为病例1治疗前的患处图示;
图2为病例1应用7剂之后的患处图示;
图3为病例2治疗前的患处图示;
图4为病例2应用7+5剂之后的患处图示。
具体实施情况
本发明不受下述实施例的限制,下述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。
实施例1
一种治疗成人单纯性皮肤瘙痒症的中药组合物,由以下药物制得:
薄荷35g(后下)、雷公藤24g、蝉蜕15g、蜂房15g、花椒22g、炉甘石25g(研细末≤200目)、海桐皮18g、马齿苋25g、透骨草25g、浮萍22g、芒硝25g(后下)、甘草12g。
其制备方法如下:
(1)除炉甘石研细末≤200目,薄荷及芒硝后下外,将其他原中药材均匀混合,加入1000ml冷水,浸泡1小时;
(2)将混合好的原料药用大火煮沸,文火煎煮30分钟,用纱布过滤得到滤液和药渣;
(3)将步骤(2)中得到的药渣与800ml热水混合后进行煎煮,热水是温度为80℃的纯净水,大火煮沸,文火煎煮20分钟后再次用纱布过滤得到滤液和药渣;
(4)将步骤(2)中得到的滤液和步骤(3)中得到的滤液混合再文火浓煎10分钟,在最后5分钟时放入薄荷煎煮,然后滤出药液,分出药渣;
(5)将步骤(4)浓缩的药液晾凉,再将芒硝溶于药液中搅匀;
(6)最终将步骤(5)得到的药液与研细的炉甘石粉末均匀混合,即为治疗成人单纯性皮肤瘙痒症的外用中药。
实施例2
一种治疗成人单纯性皮肤瘙痒症的中药组合物,由以下药物制得:
薄荷38g(后下)、雷公藤26g、蝉蜕18g、蜂房18g、花椒25g、炉甘石28g(研细末≤200目)、海桐皮26g、马齿苋28g、透骨草29g、浮萍24g、芒硝28g(后下)、甘草15g。
其制备方法如下:
(1)除炉甘石研细末≤200目,薄荷及芒硝后下外,将其他原中药材均匀混合,加入1500ml冷水,浸泡2小时;
(2)将混合好的原料药用大火煮沸,文火煎煮30分钟,用纱布过滤得到滤液和药渣;
(3)将步骤(2)中得到的药渣与1200ml热水混合后进行煎煮,热水是温度为80℃的纯净水,大火煮沸,文火煎煮20分钟后再次用纱布过滤得到滤液和药渣;
(4)将步骤(2)中得到的滤液和步骤(3)中得到的滤液混合再文火浓煎15分钟,在最后5分钟时放入薄荷煎煮,然后滤出药液,分出药渣;
(5)将步骤(4)浓缩的药液晾凉,再将芒硝溶于药液中搅匀;
(6)最终将步骤(5)得到的药液与研细的炉甘石粉末均匀混合,即为治疗成人单纯性皮肤瘙痒症的外用中药。
实施例3
一种治疗成人单纯性皮肤瘙痒症的中药组合物,由以下药物制得:
薄荷36g(后下)、雷公藤24g、蝉蜕16g、蜂房16g、花椒20g、炉甘石28g(研细末≤200目)、海桐皮24g、马齿苋26g、透骨草27g、浮萍22g、芒硝30g(后下),甘草14g。
其制备方法如下:
(1)除炉甘石研细末≤200目,薄荷及芒硝后下外,将其他原中药材均匀混合,加入1200ml冷水,浸泡1.5小时;
(2)将混合好的原料药用大火煮沸,文火煎煮30分钟,用纱布过滤得到滤液和药渣;
(3)将步骤(2)中得到的药渣与1000ml热水混合后进行煎煮,热水是温度为80℃的纯净水,大火煮沸,文火煎煮20分钟后再次用纱布过滤得到滤液和药渣;
(4)将步骤(2)中得到的滤液和步骤(3)中得到的滤液混合再文火浓煎12分钟,在最后5分钟时放入薄荷煎煮,然后滤出药液,分出药渣;
(5)将步骤(4)浓缩的药液晾凉,再将芒硝溶于药液中搅匀;
(6)最终将步骤(5)得到的药液与研细的炉甘石粉末均匀混合,即为治疗成人单纯性皮肤瘙痒症的涂抹中药。
利用上述组方和制备方法获得的药物,应用于临床,疗效十分显著,发明人经过大量临床试验发现,临床治疗上多以口服抗组胺药、5-羟色胺受体拮抗剂、三环类抗抑郁药、烟酰胺等,外用钙调神经磷酸酶抑制剂、保湿剂、止痒剂、糖皮质激素等,但临床疗效并不乐观且伴有不同程度的副作用,例如嗜睡、头晕、恶心、心律失常、依赖性及耐药性等。本发明的中药组合物具有安全且显著的临床疗效,5-7天为1疗程,病情轻者治疗1个疗程症状即可消失,重者3-4个疗程症状即可消失,本发明的中药组合物取得了显著疗效,本发明的技术方案从理论到临床效果都有明显优势,填补了本领域的空白。
实验例
1.临床资料
1.1病例来源
本次研究共纳入64例患者,病例全部来自山东中医药大学第二附属医院针灸科和皮肤科2021年10月至2022年12月门诊就诊患者,均经相关检查证实属于成人单纯性皮肤瘙痒症。
1.2诊断标准
1.2.1全身性皮肤瘙痒症,表现为皮肤瘙痒常呈阵发性,尤以夜间为甚,无任何原发性皮损。病久者可伴有抓痕、血痂、色素沉着、苔藓化等继发性皮损或呈湿疹样变化。
1.2.2局限性皮肤瘙痒症,好发于肛门、外阴及头皮、小腿、外耳道等处。经常搔抓,局部皮肤可有肥厚、湿疹样变或苔藓样变。
1.2.3中医证候诊断标准
风热外侵证:年轻人多见,病属新起。皮肤瘙痒剧烈,热后更甚,抓破呈条状血痂,发病以夏秋季居多,口干、心烦,舌红苔薄黄,脉弦滑或数。
湿热下注证:一般以外阴、肛周、耳后多见,由于不断搔抓,引起表皮剥脱、浸渍,血痂等继发性改变,舌质红、苔黄腻、脉弦滑。
血虚风燥证:一般冬季多见,病程较久,病人全身各处皆可以有瘙痒的感觉,瘙痒的程度不定,常为阵发性,以夜间为重,皮肤干燥脱屑,可见抓痕、血痂、亦可见色素沉着等继发病损,患者常因瘙痒而致失眠或夜寐不安。舌淡苔白或舌红少津、脉弦细。
1.3实施标准
1.3.1纳入标准
①临床资料完整、可靠;②全身皮肤瘙痒,无原发皮肤缺损及破溃;③因搔抓而出现皮肤抓痕等;④依从性好,对本研究知情同意且客观真实填写调查问卷。
1.3.2排除标准
①有明确原发病;②皮肤大面积溃烂或其他类型的瘙痒;③妊娠、哺乳期女性;④对药物有禁忌证或过敏者;⑤合并肝、肾等其他器官严重功能障碍。
1.3.3脱落及剔除标准:
①患者失访。②患者自行退出。③患者未遵从研究方案要求。④患者在研究过程出现不良反应事件。
2.研究方法
2.1研究设计
将纳入的64例患者,采用随机数字表法随机化分为观察组和对照组,两组各32例。观察组应用实施例1的药物组合物治疗(应用实施例1的工艺和用量煎煮获得药液,分早晚两次进行涂抹患处,每次20-30分钟),对照组应用他克莫司软膏(国药准字H20123430,四川明欣药业有限责任公司,每日早、晚于涂抹患处);观察组和对照组均治疗2个疗程,观察两组治疗前后瘙痒症状评分、皮肤瘙痒生活质量(采用本领域常用的DLQD调查问卷表获取相关数据)。疗程结束后将全部数据应用统计学软件SPSS20.0进行统计学分析处理,比较观察组与对照组治疗前后两组之间的差异。
2.2治疗方法
对照组:他克莫司软膏(明之欣),国药准字H20123430,四川明欣药业有限责任公司,于每日早、晚涂抹患处。
观察组:
应用实施例1的工艺和用量煎煮获得药液,分早晚两次进行涂抹患处,每次20-30分钟。
2.3治疗疗程
观察组与对照组:7天为1个疗程,共治疗2个疗程。
2.4观察指标及安全评价标准
2.4.1观察指标
(1)观察比较两组治疗前后瘙痒症状评分:根据国外改良的瘙痒评分等级标准,从瘙痒的程度、发作累及部位及频率等方面对瘙痒进行评估。
①瘙痒程度:采用视觉模拟量表(visuaI analogue scale,VAS)评定,无瘙痒:VAS评分0;轻度瘙痒:VAS评分1~3;中度瘙痒:VAS评分4~6;重度瘙痒:VAS评分7~10。②瘙痒部位:在身体1或2个部位为1分;3个或更多个部位,小于体表面积50%为2分;大于体表面积50%或累及全身为3分。③瘙痒频率:无瘙痒0分;有时瘙痒,持续时间≤30mjn为1分;经常瘙痒,持续时间31min~2h为2分;持续瘙痒,持续时间>2h为3分。皮肤瘙痒总评分:上述3项相加所得:评分分值从0~13分,<3分为轻度瘙痒;4~6分为中度瘙痒:>7分为重度瘙痒。
(2)皮肤瘙痒生活质量评分:评估根据皮肤病生活质量指数(dermatology lifequaIity index,DLQI)进行。皮肤瘙痒生活质量评分包括十个问题,包括生理、心理、社会活动、人际交往等方面。每个问题为4级评分,其中0为没有影响,1为轻度,2为中度,3为重度。满分30分,最低0分,得分越低表明疗效越显著,0~5分为瘙痒对生活质量略微影响,6~10分为轻度影响,11~20分为中度影响,>20分为重度影响。
以上症状及指标在治疗前后分别进行评估。
2.4.2安全性评价标准:
1级:安全,未出现不良反应。
2级:比较安全,不良反应轻微,无需处理可继续用药。
3级:有安全性问题,但不良反应不严重,处理后可继续用药。
4级:有严重安全性问题,处理后不能继续用药。
2.5统计学方法
本研究所有数据均应用统计学软件SPSS20.0进行统计分析处理。所有统计检验均应用双侧检验,其中以P<0.05为差异有统计学意义,以P<0.01为差异性显著。在研究过程中,所有数据均应用均数±标准差表示。组间治疗前和治疗后的比较均分别采用独立样本t检验,组内治疗前和治疗后的比较采用配对样本t检验,非等级的分类资料采用X2检验,等级资料采用秩和检验。
3.研究结果
3.1一般资料
所有患者均来自山东中医药大学第二附属医院针灸科和皮肤科2021年10月至2022年12月门诊就诊患者,共64例,观察组和对照组各32例,两组治疗过程中均未有病例脱落。其中观察组(女性17例,男性15例)年龄最小者18岁,最大者60岁,平均49.78±10.22岁;对照组(女性16例,男性16例)年龄最小者19岁,最大者58岁,平均49.12±9.88岁。经统计分析对比,两组年龄之间无统计学差异(见表1)。
表1两组年龄(岁)分布比较
两组年龄比较采用独立样本t检验,结果显示差异无统计学意义(P>0.05),表明两组年龄之间有可比性。
3.2两组治疗前后瘙痒症状评分比较
表2两组治疗前和治疗后瘙痒症状评分比较
注:与治疗前相比△P<0.05、△△P<0.01,与对照组治疗后相比▲P<0.05、▲▲P<0.01。
经统计学分析,两组治疗前症状积分差异无统计学意义(P>0.05),具有可比性。两组组内治疗前后比较,观察组在瘙痒程度、瘙痒部位、瘙痒频率等症状均较治疗前有明显改善,差异性显著(P<0.01);对照组治疗可改善瘙痒程度及瘙痒频率,其中瘙痒程度改善最显著(P<0.01),在瘙痒部位改善上无明显变化,差异无统计学意义(P>0.05)。治疗后两组比较,在瘙痒程度、部位及频率方面,观察组明显优于对照组,两组统计结果有显著差异(P<0.01)(见表2)。
3.3两组治疗前后DLQI积分比较
表3两组治疗前后的DLQI积分比较
注:与治疗前相比△P<0.05、△△P<0.01,与对照组治疗后相比▲P<0.05、▲▲P<0.01。
经统计学分析,两组治疗前DLQI积分差异无统计学意义(P>0.05),具有可比性。组内治疗前后比较,观察组和对照组在治疗后均比治疗前改善(P<0.05),且观察组改善明显,差异性显著(P<0.01)。两组间治疗后比较,观察组明显优于对照组,差异性显著(P<0.01)。
(见表3)。
3.4两组治疗前后总有效率比较
表4两组治疗前后总有效率比较
注:与对照组相比△△P<0.01。
经统计学分析,两组治疗前后比较,观察组患者总有效率为96.88%,对照组患者总有效率为78.13%,观察组明显优于对照组,差异性显著(P<0.01)(见表4)。
3.5安全性评价
两组患者在研究过程中均未发生与药物相关的不适症状,未发生不良反应事件,故两药安全性均较好,安全性评价为1级。
综上所述,本发明结合祖国传统医学理论,以“成人单纯性皮肤瘙痒症的病人存在邪毒蕴结、肌肤失养的病机”为基础,提供的一种用于治疗成人单纯性皮肤瘙痒症的中药组合物及制备方法,该组合物内以清热解毒、燥湿止痒,外以消炎杀菌、调肤止痒、调肤止痒,诸药合用,对成人单纯性皮肤瘙痒症疗效显著。
具体病例(详见其他证明文件)
病例1
2022.3.24蔡某,男,1974,背部瘙痒难耐8天。既往体健,1周前无明显诱因出现背部瘙痒,时轻时重,程度显著。查体见:背部散在抓挠现抓痕,显红色,无皮疹、无水泡、无破损,布散整个背部,夜间瘙痒更为显著。眠差、纳可、二便调、舌红苔薄、左脉弦滑、右脉濡弦。诊断:单纯性皮肤瘙痒症。中药外用方:薄荷(后下)35g、雷公藤24g、蝉蜕15g、蜂房15g、花椒22g、炉甘石25g、海桐皮18g、马齿苋25g、透骨草25g、浮萍22g、芒硝(后下)25g、甘草12g,7剂,日1剂,水煎外用,早晚各1次。清淡饮食,禁食辛辣、鱼腥之类,禁用碱性液化用品清洗患处,不适随诊。
2022.4.1背部瘙痒复诊,患者用药后,背部瘙痒症状明显减轻,瘙痒发作次数显著减少,程度显著减轻,夜间睡眠质量明显改善,继续治疗,外用中药方,5剂同前(2022.3.24),日1剂,分早晚2次,遵前医嘱,不适随诊。
病例2
2022.6.22赵某,女,1969,双下肢瘙痒1月余,既往高血压、冠心病史,1月前无明显病因出现双下肢皮肤瘙痒,查体见:双下肢皮肤抓痕,且有明显挠破迦痕,无皮疹,无水泡,瘙痒无明显规律。曾就诊当地皮肤科,诊断为单纯性皮肤瘙痒症,给予外用药膏涂摸(膏体不详)治疗,症状未见明显减轻。眠差、纳差、二便一般、舌红苔白、脉弦细。经诊断:单纯性皮肤瘙痒症,中药外用方(qd):薄荷(后下)35g、雷公藤24g、蝉蜕15g、蜂房15g、花椒22g、炉甘石25g、海桐皮18g、马齿苋25g、透骨草25g、浮萍22g、芒硝(后下)25g、甘草12g,7剂,日1剂,水煎外用,早晚各1次。禁用碱性液体清洗患处,禁抓挠,保持局部清洁,必要时,皮肤病例检查。
2022 6.30病史同前,继续治疗,患者瘙痒明显减轻,原血痂处逐渐脱落,患者睡眠质量有较大的改善,情绪亦明显缓和,欲再要求5剂外用巩固治疗。最中药外用方(qd*5剂):2022.6.22原方稍调整:海桐皮24g、透骨草18g,余不变,继续同前,清淡饮食,保持局部清洁,禁抓挠,不适随诊。
病例3
2022.7.30李某,女,2000.3.21,前胸部瘙痒1周余,既往体健,1周前放假回家后开始出现前胸部瘙痒,无皮疹,无斑点等皮肤异常,夜间为著,自行服用抗过敏药物,症状未见明显减轻,眠差,纳可,二便可,舌尖红,苔白,脉弦。诊断:单纯性皮肤瘙痒症,中药外用方(qd):薄荷(后下)35g、雷公藤24g、蝉蜕15g、蜂房15g、花椒22g、炉甘石28g、海桐皮24g、马齿苋26g、透骨草20g、浮萍25g、芒硝(后下)28g、甘草15g,7剂,日1剂,水煎外用,分早晚2次。禁用碱性洗涤用品,仅禁抓挠,1周后复查。
2022.8.7前胸部皮肤瘙痒症复查,经7剂中药外用治疗后,前胸皮肤瘙痒症状基本消失,偶尔有一次性瘙痒感,且瘙痒程度显著降低,患者主动要求再用3剂,予以疗效巩固,睡眠质量大大提升。继续前方治疗,3剂,水煎外用,日1剂,早晚各1次,清淡饮食,不适随诊。
病例4
2022.4.13陈某,男,1977.8.24,腰部皮肤瘙痒症7天,患者7天无明显诱因出现腰部皮肤不适,以瘙痒感为主,无皮疹、无斑点等皮肤异常,夜间发作明显,经服用抗过敏药物症状有所减轻,但仍反复瘙痒难耐,眠差,纳可,可便可,舌红苔黄脉弦。诊断:单纯性皮肤瘙痒症,中药外用方(qd):薄荷(后下)35g、雷公藤24g、蝉蜕15g、蜂房15g、花椒22g、炉甘石25g、海桐皮18g、马齿苋25g、透骨草25g、浮萍22g、芒硝(后下)25g、甘草12g,7剂,日1剂,水煎外用,早晚各1次,两次外用。禁用碱性洗剂用品,禁抓挠,1周后复查。
2022.4.21腰部皮肤瘙痒症治疗后复查,外用洗剂后,患者腰部皮肤瘙痒症状基本消失,偶有一次瘙痒感,发作频率减少,程度明显下降,眠可,纳可,二便可。继续前方巩固疗效,3剂,水煎外用,日1剂,早晚各1次。清淡饮食,不适随诊。
病例5
2022.9.14王某,女1989.11.2左侧肘部内侧瘙痒伴红晕3天,2天前患者无明显有限出现左侧肘关节内侧瘙痒伴外红晕,无水泡,无皮疹,无破碎,瘙痒无时间规律,身体其他部位未见明显异常,舌淡红,苔薄黄,脉数。诊断:单纯性皮肤瘙痒症,中药外用方(qd):薄荷(后下)35g、雷公藤24g、蝉蜕15g、蜂房15g、花椒22g、炉甘石25g、海桐皮18g、马齿苋18g、透骨草25g、浮萍22g、芒硝(后下)25g、甘草12g,5剂,日1剂,水煎外用,分早晚2次。保持局部清洁,禁用碱性洗化用品洗涤患处,随诊。
2022.9.20侧肘部内侧瘙痒基本消失,复查患者外用中药方剂5剂后,自诉左侧肘关节内侧基本无瘙痒,红晕消失,其他无明显异常。不适随诊。
病例6
2022.1.18李某,女,1987.1.31双下肢瘙痒6天,患者6天前无明显诱因出现双下肢皮肤发痒,以双小腿为重,瘙痒剧烈,否认过敏史,未使用药物治疗,予以我院就诊,确诊为单纯性皮肤瘙痒症,舌淡,苔薄黄,脉细数。中药外用方:薄荷(后下)32g、雷公藤24g、蝉蜕12g、蜂房12g、花椒15g、炉甘石24g、海桐皮18g、马齿苋24g、透骨草16g、浮萍22g、芒硝(后下)28g、甘草10g,6剂,日1剂,水煎外用,早/晚2次外用。清淡饮食,不适随诊。
2022.1.25双下肢瘙痒减轻,外用洗剂治疗6天后,症状减轻,双小腿发痒症状减轻,发作频次程度缓解,夜间可安眠,双小腿不适明显改善。舌红苔薄,脉弦。中药外洗继用,5剂,水煎外洗,日1剂,早/晚2次外洗,禁用碱性肥皂,清淡饮食,无辛辣、油腻。
Claims (6)
1.一种治疗成人单纯性皮肤瘙痒症的外用中药组合物,其特征在于:其组成按重量份计为:薄荷30-40份、雷公藤20-30份、蝉蜕10-20份、蜂房10-20份、花椒15-30份、炉甘石20-30份、海桐皮15-30份、马齿苋20-30份、透骨草15-30份、浮萍20-30份、芒硝20-30份、甘草10-18份。
2.根据权利要求1所述的一种治疗成人单纯性皮肤瘙痒症的外用中药组合物,其特征在于:其组成按重量份计为:薄荷36-38份、雷公藤24-26份、蝉蜕15-18份、蜂房15-18份、花椒20-25份、炉甘石25-28份、海桐皮18-26份、马齿苋25-28份、透骨草25-29份、浮萍22-24份、芒硝25-30份、甘草12-15份。
3.根据权利要求1所述的一种治疗成人单纯性皮肤瘙痒症的外用中药组合物,其特征在于:其组成按重量份计为:薄荷35份、雷公藤24份、蝉蜕15份、蜂房15份、花椒22份、炉甘石25份、海桐皮18份、马齿苋25份、透骨草25份、浮萍22份、芒硝25份、甘草12份。
4.权利要求1-3任一一项所述的一种治疗成人单纯性皮肤瘙痒症的外用中药组合物的制备方法,其特征在于:具体步骤如下:首先称出各味中药,除薄荷、芒硝和炉甘石之外的余药一起加水至没过药面2-3指为止,浸泡1-2小时;先大火煮沸,之后文火煎熬20-30分钟,将药液过滤出备用;向药渣内再次加水,至没过药渣面1-2指为止,大火煮沸,之后文火煎熬15-20分钟;将药液滤出后与上次药液合并,再次文火煎煮10-15分钟进行浓缩;停火前5分钟放入薄荷,将药液滤出晾凉,再将芒硝溶于药液中,最终将得到的药液与炉甘石均匀混合。
5.根据权利要求4所述的一种治疗成人单纯性皮肤瘙痒症的外用中药组合物的制备方法,其特征在于:所述炉甘石研成≤200目细粉。
6.根据权利要求4所述的一种治疗成人单纯性皮肤瘙痒症的外用中药组合物的制备方法,其特征在于:所述向药渣内再次加水,水的温度为75-85℃。
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