CN115381875B - 一种用于外痔及混合痔术后的中药组合物、洗剂与应用 - Google Patents
一种用于外痔及混合痔术后的中药组合物、洗剂与应用 Download PDFInfo
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Abstract
本发明提供一种用于外痔及混合痔术后的中药组合物、洗剂与应用,该用于外痔及混合痔术后的中药组合物包括以下重量份的原料:野菊花8~15份,槐花8~15份,金银花8~15份,黄连8~15份,五倍子5~10份,诃子5~10份,延胡索5~10份,乌梅5~10份,白矾2~4份。使用本发明中药组合物制备的肛门洗剂,止痛效果好,可改善血液循环,利于肉芽组织生长和创面恢复,可使得患者住院时间和创面愈合时间明显缩短。在混合痔术后应用本发明肛门洗剂熏洗坐浴可对各项症状起到缓解作用,使得患者住院时间和愈合时间缩短,具有较好的使用舒适感,而且减少了药物使用量,降低药物成本,缩短了用药时间,利于临床推广应用。
Description
技术领域
本发明涉及外痔及混合痔术后药物领域,特别涉及一种用于外痔及混合痔术后的中药组合物、洗剂与应用。
背景技术
混合痔是肛门疾病的主要类型,由内痔和外痔静脉曲张与动静脉沟通吻合所致,可发生在任何年龄段,疾病发生后多表现为便血、肿物脱出、瘙痒和疼痛,病情严重者需行手术治疗。但此病术后创面特殊,患者排便情况的存在可使得创面出现水肿、感染、疼痛等情况,延长患者住院时间和创面愈合时间。中医学将手术创面归至“溃疡”范畴,应以疏经通络、调节气血为治疗原则,以改善患者血液循环。
熏洗坐浴是治疗肛门疾病的常用疗法,可散瘀化滞、疏通气血、消肿止痛、解毒脱腐。现代研究认为,予以熏洗坐浴方案,可扩张患处血管,能够改善局部和全身血液循环,缓解末梢神经刺激进而充分发挥治疗效果。较之于其他给药方式,中药坐浴可直接于患处发挥作用,可使药物经皮肤或创面直达患处;通过热力作用,可促进局部血液运行,增强机体抗病能力,改善局部功能;可使局部处于清洁干燥状态,刺激少,使得创面快速愈合。
“肛门洗剂促进痔术后创面愈合效果观察”该论文记载“肛门洗剂由苦参,五倍子,蛇床子,苍耳子,地肤子,乳香,没药,威灵仙,明矾,冰片组成,上药制粉,及部分药物浓缩后制成散剂,150g/袋包装”。该肛门洗剂能够促进痔术后创面愈合,但需要用药6~15天,每天使用2次,每次150g,用药量较多,其中乳香、没药费用较高,患者经济负担重。
目前市场上肛门洗剂在使用效果、使用舒适性、经济成本等多因素难以达到一致理想状态,导致临床应用推广受限。故急需一种中药配方用于混合痔术后,显著改善使用效果,而且提高使用舒适性,还减少药物使用量,降低药物成本。
发明内容
鉴于此,本发明提出一种用于外痔及混合痔术后的中药组合物、洗剂与应用。
本发明的技术方案是这样实现的:
本发明提供一种用于外痔及混合痔术后的中药组合物,包括以下原料:槐花、野菊花、金银花、五倍子、黄连、诃子、乌梅、元胡、冰片和白矾。按重量份计各原料:野菊花8~15份,槐花8~15份,金银花8~15份,黄连8~15份,五倍子5~10份,诃子5~10份,延胡索5~10份,乌梅5~10份,白矾2~4份。
混合痔即为里外痔,位于肛门同一齿线上下,内外相连,界限模糊,括约肌间沟消失,部分内痔和外痔形成一体,被称作是混合痔。痔形成受多种因素影响,习惯性便秘、腹压上升、直肠与肛管慢性炎症、刺激性饮食与长期饮酒均可导致混合痔的发生。
中医学认为,气血壅滞、湿热下注为痔形成的辨证基础,在术后创面愈合这一环节中,需遵循治病求本的原则。对混合痔手术患者予以观察,发现湿热未尽,气血凝滞致使经络受阻,进而影响创面愈合。
本发明研制肛门洗剂,其成分包括槐花、野菊花、金银花、五倍子、黄连、诃子、乌梅、元胡、冰片和白矾。方中野菊花性辛味苦,归心、肝、肺经,有清热解毒、散辛降苦之效,可用于治疗热毒疮痈之症。金银花性寒、味微苦,归心、肺、胃和大肠经,可清热解毒、疏风散热,予以煎煮,可吞噬白细胞,具有明显的解热镇痛与抗炎之效。槐花凉血止血作用明显,可用于血热引起的各种出血症状,归大肠经,治疗便血、痔血之症效果尤为显著。黄连性寒味苦,归心、肝、胃和大肠经,可有泻火解毒、清热之效,将其制成药膏,于患者外敷,可促进创面愈合。五倍子可清热杀虫、解毒止血、祛湿敛疮,可用来治疗肿痛和肠道下坠之症,外用此药对皮肤进行熏洗,可发挥祛风除湿的作用。诃子,苦,酸,涩,平,其含有的鞣制有收敛之效,对诃子素予以提取,可有解痉之效。元胡也被称作是延胡索,性温、味苦,归心、肝、脾、肺经,可行气止痛、活血化瘀,可使气血运行,通则不痛,该药物中含有多种生物碱成分,镇痛镇静之效尤为显著。乌梅味酸涩、性平,可消疮毒,治疗胬肉外突,可制成注射液对痔疮和息肉进行治疗。白矾可清热解毒、止血敛汗、燥湿杀虫;冰片可散热祛火、消散肿痛,可引药入肉,具有镇痛、去腐之效。纵观全方,共奏清热燥湿、活血化瘀、泻火解毒、生肌止痛之效,使得创面愈合时间缩短。
进一步的,按重量份计各原料:野菊花9~11份,槐花9~11份,金银花9~11份,黄连9~11份,五倍子7.5~8.5份,诃子7.5~8.5份,延胡索7.5~8.5份,乌梅7.5~8.5份,白矾2~4份。
更进一步的,按重量份计各原料:野菊花10份,槐花10份,金银花10份,黄连10份,五倍子8份,诃子8份,延胡索8份,乌梅8份,白矾3份。
优选地,本发明用于外痔及混合痔术后的中药组合物由以下重量原料制得:野菊花10g、槐花10g、金银花10g、黄连10g、五倍子8g、诃子8g、延胡索8g、乌梅8g、白矾3g。
一种用于外痔及混合痔术后的肛门洗剂,由本发明任一项所述的中药组合物制得。其制备方法:按照配方用量取各原料,混合粉碎得药粉,即得。肛门洗剂使用方法:将药粉加入温开水中稀释,调整水温38℃-40℃,所述药粉与温开水的料液比g/mL为75:900-1100,用于坐浴熏洗肛门,熏洗时间为10-20min。
将上述中药组合物应用于制备用于外痔及混合痔术后的药物。
与现有技术相比,本发明的有益效果是:
(1)使用本发明中药组合物制备的肛门洗剂,止痛效果好,可改善血液循环,利于肉芽组织生长和创面恢复,可使得患者住院时间和创面愈合时间明显缩短,适用于混合痔、外痔等术后患者使用。
(2)在混合痔术后应用本发明肛门洗剂熏洗坐浴可对各项症状起到缓解作用,有效促进混合痔术后创面愈合,而且具有较好的使用舒适感,在保证疗效前提,相比之前药物减少了药物使用量,降低药物成本,缩短了用药时间,利于临床推广应用。
(3)本发明中药组合物,其中野菊花,槐花,金银花,黄连为君药;五倍子,乌梅为臣药;诃子,延胡索和白矾为佐使药。诸药合用,协同增效,共奏清热燥湿、泻火解毒、活血化瘀、生肌止痛之功效,不但改善血液循环,而且促进肉芽组织生长和创面恢复,可使得患者住院时间和创面愈合时间明显缩短,显著提高混合痔术后患者使用效果。
其中,方中野菊花,清热解毒,清肝平肝。槐花,凉血止血,善清泻大肠之火而止血。金银花,清热解毒,疏散风热。黄连,清热燥湿,泻火解毒。三药同为君药,共奏清热燥湿、泻火解毒、凉血止血之功。
五倍子,清热杀虫,收湿敛疮,可涩肠、止血、解毒、敛湿;乌梅,外用能消疮毒,可治胬肉外突等。共助君药清热燥湿、解毒、止血。
诃子所含鞣质有收敛作用,所含诃子素有罂粟碱样的解痉作用。延胡索活血化瘀、行气止痛。延胡索辛散、苦泄、温通,既入血分,又入气分,既能行血中之气,又能行气中之血,气畅血行,通则不痛。共助君臣药清热燥湿、解毒、止血同时,起到解痉止痛作用。
白矾,清热解毒,燥湿杀虫,止血敛汗,煅用燥湿之力尤著;助君药、臣药清热燥湿、解毒、止血。
附图说明
图1为本发明实施例1肛门洗剂。
具体实施方式
为了更好理解本发明技术内容,下面提供具体实施例,对本发明做进一步的说明。
本发明实施例所用的实验方法如无特殊说明,均为常规方法。
本发明实施例所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
一、肛门洗剂制备
实施例1
肛门洗剂配方组成:野菊花10g,槐花10g,金银花10g,黄连10g,五倍子8g,诃子8g,延胡索8g,乌梅8g,白矾3g。按照配方用量取各原料,混合粉碎,得到混合药粉,即得肛门洗剂,75g/袋。
实施例2
肛门洗剂配方组成:野菊花8g,槐花13g,金银花11g,黄连12g,五倍子5g,诃子10g,延胡索8g,乌梅5g,白矾3g。按照配方用量取各原料,混合粉碎,得到混合药粉,即得肛门洗剂,75g/袋。
二、临床资料
1对象与方法
1.1研究对象研究病例为琼海市中医院肛肠科住院患者,以混合痔手术患者120例为研究对象,研究时间从2013年6月开始到2015年5月结束,随机分组。
对照组58例,31例为男性,27例为女性,最小年龄19岁,最大年龄73岁,均值(48.32±4.12)岁,创面面积5-15cm2,均值(9.78±1.16)cm2,手术类型:28例为混合痔痔切除术,16例为痔切除术+肛门括约肌侧切术,14例为外剥内扎术。
治疗组患者共计62例,34例患者为男性,28例患者为女性,年龄低至23岁,高至74岁,年龄均值(47.48±4.15)岁,创面面积4-17cm2,平均(9.84±1.12)cm2,手术类型:32例为混合痔痔切除术,13例为痔切除术+肛门括约肌侧切术,17例为外剥内扎术。
纳入标准:(1)患者病情与混合痔诊断标准一致;(2)年龄均在18岁及以上;(3)身体状况良好,对所用术式可耐受;(4)患者对研究目的和流程了解,积极主动参与。
排除标准:(1)实质性脏器功能受损,难以正常运行者;(2)存在两种或以上肛门疾病者;(3)保守治疗者;(4)正常妊娠或哺乳等特殊阶段的女性;(5)存在认知障碍无法配合治疗者。
对比组间资料无差异(P>0.05),具有可比性。
1.2方法
对照组:术后第2d起,于患者排便后,使用浓度为1:5000的高锰酸钾溶液坐浴熏洗肛门,先进行15min的熏洗,随即坐浴,将水温控制在38℃-40℃之间,时间同样为15min。上下午各进行1次。
治疗组:使用实施例1的肛门洗剂坐浴熏洗,在1000mL温开水中稀释肛门洗剂,直至水温降至肛周皮肤可耐受,以38℃-40℃之间为佳,协助患者坐在浴液中,指导患者行提肛运动,按照呼吸节奏对肛门予以扩张和收缩,熏洗与坐浴时间与对照组一致,各为15min。
两组术后均遵照医嘱,予以广谱抗生素抗感染,静脉滴注,肛泰软膏2g,肛门部外用,肛泰栓1g,纳肛,每日一次。两组均连续用药5d。
1.3观察指标
1.3.1两组疾病治疗效果比较
根据韩济生院士推荐方法计算治疗效果,视觉模拟评分法(Visual AnalogueScale/Score,VAS)加权值为治疗前后评分差值在治疗前分数中的百分比。
该百分比不低于75%时为显效;
该百分比不低于50%,但未及75%为有效;
该百分比不足50%为无效。
1.3.2两组不同阶段临床症状评分对比
(1)排便出血判定标准:0分为排便未出血;1分为手指沾血或滴血;2分为喷血或射血;3分为便血持续存在有贫血症状。
(2)肿物脱出:0分为未脱出;1分为脱出后自行回纳;2分为脱出物需手动回纳;3分为脱出物回纳后迅速脱出。
(3)肛门坠胀:0分为未产生坠胀感;1分为便后坠胀,持续时间约半小时;1分为便后持续坠胀时间超出半小时;3分为肛门坠胀感长期存在,患者难以忍受。
(4)肛门潮湿:0分为无潮湿感;1分为自觉潮湿,检查结果正常,2分为肛门潮湿、肛周湿润,可通过提肛训练缓解;3分为肛门潮湿明显,经检查可见粪液或黏液存在肛周,经提肛训练难以缓解。
(5)肛门瘙痒:0分为瘙痒感;1分为瘙痒感可忍受;2分为局部用药可使瘙痒感缓解或消除;3分为局部用药对肛门瘙痒无序,患者难以忍受。
(6)肛门水肿:0分为未出现水肿;1分面积不足0.25cm2;2分为0.25cm2<水肿面积<1.00cm2;3分为水肿面积>1.00cm2。
(7)肛门疼痛:0分为不存在疼痛感;1分为可忍受的轻微疼痛;2分为疼痛不明显,予以一般止痛药即可缓解;3分为患者肛门处疼痛感难以忍受,表情痛苦,需予以哌替啶类药物方可缓解。
分别在患者治疗后1d和治疗后3d计分,最低0分,最高21分,得分下降提示临床症状缓解。
1.3.3两组患者恢复时间比较
对两组住院时间和创面愈合时间进行比较。其中,住院时间为术后的住院时间;创面愈合时间从术后创面愈合时间。
1.4统计学处理软件SPSS 22.0录入后对数据进行统一处理,临床疗效为无序分类资料,百分数(%)表示,x2检验;症状评分和恢复时间属于名义变量资料,和t表示检验,P不及0.05可见有差异。
2结果
2.1两组疾病治疗效果对比
治疗组总有效率同对照组这一指标对比,存在差异(P<0.05),结果如下表1。
表1两组临床疗效对比[n(%)]
2.2两组不同阶段临床症状评分对比
治疗组治疗1d和3d后的排便出血、肛门坠胀、肛门潮湿、肛门瘙痒和肛门疼痛评分均低于对照组,数据差异明显(P>0.05),两组肛门水肿评分对比无差异(P<0.05),均无肿物脱出情况,结果如下表2-1以及表2-2。
表2-1两组不同阶段临床症状评分对比(分)
表2-2两组不同阶段临床症状评分对比(分)
2.3两组恢复时间对比
治疗组住院时间和创面愈合时间短于对照组,存在数据差异(P<0.05),结果如下表3。
表3两组恢复时间对比结果(d)
综上,临床数据显示,治疗组总有效率高于对照组,症状评分低于对照组,恢复时间短于对照组(P<0.05),表明本发明肛门洗剂止痛效果好,可改善血液循环,利于肉芽组织生长和创面恢复,可使得患者住院时间和创面愈合时间缩短。总之,在混合痔术后应用本发明肛门洗剂熏洗坐浴可对各项症状起到缓解作用,使得患者住院时间和愈合时间缩短,可推广。
另外,在临床应用中,本发明肛门洗剂给予外痔术后患者使用,患者住院时间以及愈合时间也明显缩短,具有显著的效果。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种用于外痔及混合痔术后的中药组合物,其特征在于,由以下重量份的原料制得:野菊花8~15份,槐花8~15份,金银花8~15份,黄连8~15份,五倍子5~10份,诃子5~10份,延胡索5~10份,乌梅5~10份,白矾2~4份。
2.根据权利要求1所述的用于外痔及混合痔术后的中药组合物,其特征在于,由以下重量份的原料制得:野菊花9~11份,槐花9~11份,金银花9~11份,黄连9~11份,五倍子7.5~8.5份,诃子7.5~8.5份,延胡索7.5~8.5份,乌梅7.5~8.5份,白矾2~4份。
3.根据权利要求2所述的用于外痔及混合痔术后的中药组合物,其特征在于,由以下重量份的原料制得:野菊花10份,槐花10份,金银花10份,黄连10份,五倍子8份,诃子8份,延胡索8份,乌梅8份,白矾3份。
4.根据权利要求1所述的用于外痔及混合痔术后的中药组合物,其特征在于,由以下重量原料制得:野菊花10g,槐花10g,金银花10g,黄连10g,五倍子8g,诃子8g,延胡索8g,乌梅8g,白矾3g。
5.一种用于外痔及混合痔术后的肛门洗剂,其特征在于,由权利要求1-4任一项所述的中药组合物制得。
6.根据权利要求5的用于外痔及混合痔术后的肛门洗剂,其特征在于,所述肛门洗剂的制备方法:按照配方用量取各原料,混合粉碎得药粉,即得。
7.根据权利要求6的用于外痔及混合痔术后的肛门洗剂,其特征在于,所述肛门洗剂的使用方法:将药粉加入温开水中稀释,调整水温38℃-40℃,所述药粉与温开水的料液比g/mL为75:900-1100。
8.权利要求1-4任一项所述的中药组合物在制备用于混合痔术后的药物的应用。
9.权利要求1-4任一项所述的中药组合物在制备用于外痔术后的药物的应用。
10.权利要求1-4任一项所述的中药组合物在制备用于外痔和混合痔术后的药物的应用。
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