CN112451605B - 一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方 - Google Patents
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,其组成成份主要有茯苓、马齿苋、败酱草、徐长卿、鸡矢藤、紫珠叶、五倍子、棕榈炭、大黄炭、槐花炭、血余炭、枯矾;本发明的中药灌肠方具有健脾祛湿、清热解毒、止血治痢作用,经临床研究表明,该中药灌肠方疗效显著,应用方便,安全可靠,患者易于接受,便于临床推广,对于慢性溃疡性结肠炎活动期中医辨证属于脾虚湿热证的治疗具有十分重要的临床价值。
Description
技术领域
本发明涉及慢性溃疡性结肠炎领域,尤其涉及一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方。
背景技术
溃疡性结肠炎是一种以侵犯大肠黏膜与黏膜下层为主的炎症性肠病,同时溃疡性结肠炎是以持续或反复发作的腹泻、黏液脓血便伴腹痛、里急后重和不同程度的全身症状为表现的一种疾病,临床上往往反复发作迁延至数月乃至数年,现有溃疡性结肠炎的治疗药物存在费用高、部分患者因症状反复、疗效不满意等问题,因此目前尚无治疗溃疡性结肠炎的理想药物,部分重症患者临床常需采用手术等综合治疗措施。
发明内容
针对现有医疗不足之处,本发明提供了一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方。
为解决上述技术问题,本发明采用的技术方案是:
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,由以下重量份的原料制成:茯苓5.0~7.0份、马齿苋5.0~7.0份、败酱草3.5~5.5份、徐长卿3.5~5.5份、鸡矢藤3.5~5.5份、紫珠叶2.0~4.0份、五倍子2.0~4.0份、棕榈炭2.0~4.0份、大黄炭2.0~4.0份、槐花炭2.0~4.0份、血余炭2.0~4.0份、枯矾2.0~4.0份。
优选地,所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方由以下重量份的原料制成:茯苓5.5~6.5份、马齿苋5.5~6.5份、败酱草4.0~5.0份、徐长卿4.0~5.0份、鸡矢藤4.0~5.0份、紫珠叶2.5~3.5份、五倍子2.5~3.5份、棕榈炭2.5~3.5份、大黄炭2.5~3.5份、槐花炭2.5~3.5份、血余炭2.5~3.5份、枯矾2.5~3.5份。
优选地,所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方由以下重量份的原料制成:茯苓6.0份、马齿苋6.0份、败酱草4.5份、徐长卿4.5份、鸡矢藤4.5份、紫珠叶3.0份、五倍子3.0份、棕榈炭3.0份、大黄炭3.0份、槐花炭3.0份、血余炭3.0份、枯矾3.0份。
优选地,所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方中,原料的重量份每1份为10g。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的制备方法,包括以下步骤:
一、按重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、将打碎的混合原料加入砂锅或不锈钢锅内,加水没过药面,浸泡60分钟,之后加热煮沸60分钟,滤取煎煮液,药渣加水再次煎煮60分钟,合并两次煎煮液,静置并滤除沉淀物,取药液200mL分装于250mL输液瓶中,115℃灭菌40分钟,即得治疗慢性溃疡性结肠炎的中药灌肠方;或者
采用YFY13/3A型号的煎药机,将3~6剂药物原料装入一次性滤袋内,以一剂药物1000mL水混合浸泡30分钟,之后密闭煎煮30分钟,滤取煎煮液,在无菌条件下密封成每袋200mL药液,即得治疗慢性溃疡性结肠炎的中药灌肠方。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的应用,每次200mL,保留灌肠,一日2次,连续灌肠14天后停灌1天。
组方依据:根据现有慢性溃疡性结肠炎患者症状反复、疗效不佳以及治疗药物费用高的问题,通过多年临床试验并参考大量循证医学资料,研制成中药灌肠方,经临床研究观察发现具有较好的止泻及止血作用。给药途径之所以选择灌肠方,正如清代名医吴师机在《理瀹骈文》中所述“外治之理,亦即内治之理。……外治之药,亦即内治之药……”,主要是说外治与内治的道理是相同的,内服的药物也可以通过外用灌肠吸收而发挥作用。
组方分析:本发明治疗慢性溃疡性结肠炎活动期脾虚湿热证的中药灌肠方,茯苓健脾渗湿,马齿苋清热解毒、止血治痢,二者共为主药;败酱草清热解毒、消痈止痛,徐长卿解毒消肿、祛风止痛,鸡矢藤健胃止痛、解毒治痢,紫珠收敛止血、清热解毒,四者辅助君药,共为臣药;五倍子涩肠止泻、收敛止血,棕榈炭、血余炭、槐花炭、大黄炭收敛止血,五者共为佐药;枯矾燥湿、止泻、止血,为使药。全方合用共奏健脾祛湿、清热解毒、止血治痢的作用。
本发明的有益效果:
1.本发明中药灌肠方在慢性溃疡性结肠炎活动期的治疗中具有独特疗效,经过保留灌肠,一方面药物能够直接作用于肠道黏膜发挥清热解毒、止血治痢的作用,另一方面通过肠道黏膜吸收,也可作用于脾胃,从而起到调整脏腑功能,发挥健脾祛湿的功效。
2.本发明中药保留灌肠可以使药物直达病所,提高局部药物浓度,同时避免了口服的首过消除作用,减少肝脏代谢,减少对胃的刺激,减少毒副反应,达到清洁肠道、祛腐生肌、收敛止血,恢复肠黏膜屏障功能及调节肠道菌群的作用。中药灌肠经肠道黏膜吸收后可直接进入血液,促进血液循环,增强消化功能,有健脾渗湿、解毒止血、止泻治痢作用,加速溃疡性结肠炎的康复,克服了部分患者因长期口服药物治疗效果不佳的弊端。
3.本发明中药灌肠方具有健脾祛湿、清热解毒、止血治痢的功效,临床有效率在90%以上,且药源充足,加工制作容易,应用方便,无耐药性及不良反应发生,更有利于临床药效的发挥,降低了溃疡性结肠炎患者的用药风险。
4.本发明中药灌肠方疗效显著,操作简便,安全可靠,患者易于接受,便于临床推广,对于溃疡性结肠炎的治疗具有十分重要的临床价值。
具体实施方式
下面结合具体实施例对本发明技术方案作进一步的详细描述,以使本领域的技术人员可以更好的理解本发明并能予以实施,但所举实施例不作为对本发明的限定。
实施例1
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,由以下重量份的原料制成:茯苓5.0份、马齿苋5.0份、败酱草3.5份、徐长卿3.5份、鸡矢藤3.5份、紫珠叶2.0份、五倍子2.0份、棕榈炭2.0份、大黄炭2.0份、槐花炭2.0份、血余炭2.0份、枯矾2.0份。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的制备方法,包括以下步骤:
一、按以上重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、将打碎的混合原料加入砂锅或不锈钢锅内,加水没过药面,浸泡60分钟,之后加热煮沸60分钟,滤取煎煮液,药渣加水再次煎煮1小时,合并两次煎煮液,静置并滤除沉淀物,取药液200mL分装于250mL输液瓶中,115℃灭菌40分钟,即得治疗慢性溃疡性结肠炎的中药灌肠方。
实施例2
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,由以下重量份的原料制成:茯苓5.5份、马齿苋5.5份、败酱草4.0份、徐长卿4.0份、鸡矢藤4.0份、紫珠叶2.5份、五倍子2.5份、棕榈炭2.5份、大黄炭2.5份、槐花炭2.5份、血余炭2.5份、枯矾2.5份。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的制备方法,包括以下步骤:
一、按以上重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、将打碎的混合原料加入砂锅或不锈钢锅内,加水没过药面,浸泡60分钟,之后加热煮沸60分钟,滤取煎煮液,药渣加水再次煎煮60分钟,合并两次煎煮液,静置并滤除沉淀物,取药液200mL分装于250mL输液瓶中,115℃灭菌40分钟,即得治疗慢性溃疡性结肠炎的中药灌肠方。
实施例3
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,由以下重量份的原料制成:茯苓6.0份、马齿苋6.0份、败酱草4.5份、徐长卿4.5份、鸡矢藤4.5份、紫珠叶3.0份、五倍子3.0份、棕榈炭3.0份、大黄炭3.0份、槐花炭3.0份、血余炭3.0份、枯矾3.0份。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的制备方法,包括以下步骤:
一、按以上重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、将打碎的混合原料加入砂锅或不锈钢锅内,加水没过药面,浸泡60分钟,之后加热煮沸60分钟,滤取煎煮液,药渣加水再次煎煮60分钟,合并两次煎煮液,静置并滤除沉淀物,取药液200mL分装于250mL输液瓶中,115℃灭菌40分钟,即得治疗慢性溃疡性结肠炎的中药灌肠方。
实施例4
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,由以下重量份的原料制成:茯苓6.5份、马齿苋6.5份、败酱草5.0份、徐长卿5.0份、鸡矢藤5.0份、紫珠叶3.5份、五倍子3.5份、棕榈炭3.5份、大黄炭3.5份、槐花炭3.5份、血余炭3.5份、枯矾3.5份。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的制备方法,包括以下步骤:
一、按以上重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、将打碎的混合原料加入砂锅或不锈钢锅内,加水没过药面,浸泡60分钟,之后加热煮沸60分钟,滤取煎煮液,药渣加水再次煎煮60分钟,合并两次煎煮液,静置并滤除沉淀物,取药液200mL分装于250mL输液瓶中,115℃灭菌40分钟,即得治疗慢性溃疡性结肠炎的中药灌肠方。
实施例5
一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方,由以下重量份的原料制成:茯苓7.0份、马齿苋7.0份、败酱草5.5份、徐长卿5.5份、鸡矢藤5.5份、紫珠叶4.0份、五倍子4.0份、棕榈炭4.0份、大黄炭4.0份、槐花炭4.0份、血余炭4.0份、枯矾4.0份。
所述治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠方的制备方法,包括以下步骤:
一、按以上重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、取4剂以上药物原料,将打碎的混合原料装入一次性滤袋内,放入YFY13/3A型号的煎药机中,以一剂药物1000mL水先混合浸泡30分钟,之后密闭煎煮30分钟,结束后滤取煎煮液,在无菌条件下密封成每袋200mL药液,即得治疗慢性溃疡性结肠炎的中药灌肠方。
临床疗效实验
以下是本发明所制备的中药灌肠方的临床疗效观察:
1.一般资料
(1)纳入标准:西医诊断参照中华医学会消化病学分会炎症性肠病协作组制定的《对我国炎症性肠病诊断治疗规范的共识意见》(2012年)且最近1年内肝功能、肾功能、血、尿、便常规检查无明显异常者。中医辨证符合溃疡性结肠炎并脾虚湿热证,中医诊断标准参照中华中医药学会脾胃病分会制定的《溃疡性结肠炎中医诊疗专家共识意见》(2017年)。
(2)排除标准:①重度溃疡性结肠炎、肠道占位性病变及其他严重并发症者;②妊娠或哺乳期妇女;③有严重肝肾功能不全、患恶性肿瘤,以及经麻醉师评估不能耐受全麻的;④心脑血管疾病者;⑤合并其他免疫性、器官衰竭等疾病者;⑥合并有精神病患者;⑦合并有其它严重传染病者,如肺结核、抗HIV阳性者;⑧过敏体质及对多种药物过敏者,⑨近3月内曾参加其他临床试验者。
(3)病例选择:选择符合纳入标准属于西医慢性溃疡性结肠炎诊断标准,病情分期为活动期,病情程度为轻、中度,中医辨证为脾虚湿热证患者共66例,随机分为观察组与对照组各33例。观察组33例中脱落1例男性,剩余32例,其中男性18例,女性14例;年龄(37.68±10.52)岁。对照组33例中,脱落1例女性,剩余32例,其中男性19例,女性12例;年龄(38.26±9.75)岁。
2.治疗方法
(1)对照组:给予西医常规疗法:美沙拉嗪肠溶片(每片0.25g,葵花药业集团佳木斯鹿灵制药有限公司生产,国药准字H19980148),每次1g,每日4次,口服。
(2)观察组:在对照组治疗基础上,加用中药保留灌肠方,每次200mL,每日2次,治疗4周后改为每日1次,保留灌肠,连续灌肠14天后休息1天。灌肠方法:灌肠液温度以(39±0.5)℃为宜,先取左侧卧位,充分暴露臀部,铺治疗巾,抬高臀部约10cm,润滑肛管前端,肛管***直肠15cm,视患者的耐受情况,调整灌肠给药速度,通常为80滴/min。***调整:若直肠、乙状结肠和左半结肠溃疡,取左侧卧位,并尽可能延长灌肠液保留时间;若溃疡面广泛或波及全结肠,则依次取左侧卧位、平卧位及右侧卧位各20min,然后取舒适***静卧。
(3)疗程:两组均治疗8周为1疗程。
3.疗效标准
(1)综合疗效评价标准
临床治愈:症状体征消失,腹痛、腹泻、脓血便完全消失;Mayo评分内镜亚评分的绝对分为0分或1分。
显效:症状明显减轻,腹痛、腹泻、脓血便明显减轻;总Mayo评分≤2分且无单个分项评分>1分。
好转:症状减轻,腹痛、腹泻、脓血便相对消失;Mayo评分内镜亚评分相对于基线下降至少1分。
无效:未达到以上标准,病情无改善或恶化者。
(2)证候疗效评价标准
参照2002年5月中国医药科技出版社出版的《中药新药临床研究原则》
临床治愈:症状及体征消失或者基本消失,证候积分减少≥95%。
显效:症状及体征明显改善,证候积分减少≥70%。
有效:症状及体征明显好转,证候积分减少≥30%。
无效:症状及体征均无明显好转,甚或加重,证候积分减少达不到30%。
计算公式(尼莫地平法)为:[(治疗前积分-治疗后积分)÷治疗前积分]×100%
(3)肠镜下炎症疗效评价参照溃疡性结肠炎中医诊疗专家共识意见(2017年),采用改良的Mayo活动指数。
临床有效:总Mayo评分从基线水平降低≥30%或≥3分,同时伴有便血亚评分降低≥1分或便血亚评分的绝对分为0分或1分。
临床缓解:总Mayo评分≤2分且无单个分项评分>1分。
内镜应答:Mayo评分内镜亚评分相对于基线下降至少1分。
黏膜愈合:Mayo评分内镜亚评分的绝对分为0分或1分。
4.统计方法
数据采用SPSS19.0统计分析软件处理。计量资料以(x±s)表示,组间比较采用t检验(或校正t检验);计数资料以百分率表示,组间比较采用x2检验;等级资料采用秩和H检验,以P<0.05为差异有显著性统计学意义。
5.结果
(1)两组综合疗效比较,见表1
表1观察组与对照组综合疗效比较〔例(%)〕
注:△观察组与对照组疗效比较,差异有显著性统计学意义(P<0.05)
观察组32例中,临床治愈11例,显效14例,有效5例,无效2例,总有效率为93.75%;对照组32例中临床治愈8例,显效12例,有效7例,无效5例,总有效率为84.38%。经统计学处理,治疗组疗效明显优于对照组(P<0.05)。
(2)两组证候疗效比较,见表2
表2观察组与对照组证候疗效比较〔例(%)〕
注:△观察组与对照组疗效比较,差异有显著性统计学意义(P<0.05)。
观察组32例中,临床治愈12例,显效14例,有效5例,无效1例,总有效率为96.88%;对照组32例中,临床治愈9例,显效12例,有效7例,无效4例,总有效率为87.50%。经统计学处理,治疗组疗效明显优于对照组(P<0.05)。
(3)两组治疗前后内镜应答率比较,见表3
表3两组治疗前后肠镜下表现改善情况比较〔例(%)〕
注:△观察组与对照组疗效比较,差异有显著性统计学意义。
(4)两组治疗前后Mayo评分改善情况比较,见表4
表4两组治疗前后Mayo评分改善情况比较(x±s)
注:与本组治疗前比较:*P<0.01;治疗后与对照组比较:△P<0.05。
6.不良反应观察:两组患者均未发生明显不良反应。
以上仅为本发明的优选实施例,并非因此限制本发明的专利范围,凡是利用本发明说明书内容所作的等效结构或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (6)
1.一种治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠组合物,其特征在于,由以下重量份的中药原料制成:茯苓5.0 ~ 7.0份、马齿苋5.0 ~ 7.0份、败酱草3.5 ~ 5.5份、徐长卿3.5 ~ 5.5份、鸡矢藤3.5 ~ 5.5份、紫珠叶2.0 ~ 4.0份、五倍子2.0 ~ 4.0份、棕榈炭2.0~ 4.0份、大黄炭2.0 ~4.0份、槐花炭2.0 ~ 4.0份、血余炭2.0 ~ 4.0份、枯矾2.0 ~ 4.0份。
2.根据权利要求1所述的治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠组合物,其特征在于,所述中药原料的重量份为:茯苓5.5 ~ 6.5份、马齿苋5.5 ~ 6.5份、败酱草4.0 ~5.0份、徐长卿4.0 ~ 5.0份、鸡矢藤4.0 ~ 5.0份、紫珠叶2.5 ~ 3.5份、五倍子2.5 ~ 3.5份、棕榈炭2.5 ~ 3.5份、大黄炭2.5 ~ 3.5份、槐花炭2.5 ~ 3.5份、血余炭2.5 ~ 3.5份、枯矾2.5 ~ 3.5份。
3.根据权利要求1所述的治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠组合物,其特征在于,所述中药原料的重量份为:茯苓6.0份、马齿苋6.0份、败酱草4.5份、徐长卿4.5份、鸡矢藤4.5份、紫珠叶3.0份、五倍子3.0份、棕榈炭3.0份、大黄炭3.0份、槐花炭3.0份、血余炭3.0份、枯矾3.0份。
4.根据权利要求1 ~ 3任一项所述的治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠组合物,其特征在于,所述原料重量份每1份为10g。
5.一种权利要求1所述的治疗慢性溃疡性结肠炎活动期脾虚湿热证的灌肠组合物的制备方法,其特征在于,包括以下步骤:
一、按重量份数称取每剂药的原料组分清洗、干燥、打碎;
二、将打碎的混合原料加入砂锅或不锈钢锅内,加水没过药面,浸泡60分钟,之后加热煮沸60分钟,滤取煎煮液,药渣加水再次煎煮60分钟,合并两次煎煮液,静置并滤除沉淀物,取药液200mL分装于250mL输液瓶中,115℃灭菌40分钟,即得治疗慢性溃疡性结肠炎的中药灌肠组合物;或者采用YFY13/3A型号的煎药机,将3 ~ 6剂药物原料装入一次性滤袋内,以一剂药物1000mL水混合浸泡30分钟,之后密闭煎煮30分钟,滤取煎煮液,在无菌条件下密封成每袋200mL药液,即得治疗慢性溃疡性结肠炎的中药灌肠组合物。
6.权利要求1 ~ 4任一项所述的灌肠组合物或权利要求5所述方法制备获得的灌肠组合物在制备治疗慢性溃疡性结肠炎活动期脾虚湿热证药物中的应用。
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