CN111529640A - 一种预防术后肠息肉复发的中药组合物和中药制剂 - Google Patents
一种预防术后肠息肉复发的中药组合物和中药制剂 Download PDFInfo
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Abstract
本发明公开一种预防术后肠息肉复发的中药组合物,涉及中药技术领域;所述中药组合物包括:桂枝12‑18份、茯苓12‑18份、牡丹皮7‑13份、炒桃仁7‑13份、赤芍15‑25份、黄连3‑5份、皂刺12‑18份、红藤12‑18份、藤梨根12‑18份和炒薏苡仁12‑18份。本申请的中医组合物不仅可以预防息肉的复发还能调整或逆转患者整体病态因素,使患者恢复健康体质,增强抗病能力;经临床观察,大肠息肉术后服用本申请的中药组合物可缓解症状、预防复发,疗效显著,且无明显副作用,具有良好的临床应用价值。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种预防术后肠息肉复发的中药组合物和中药制剂。
背景技术
近年来,随着人们生活水平的提高,其日常生活习惯与饮食结构发生了较大的变化,大肠息肉在人们年龄的增长下发病率也在随之增高;大肠息肉作为一种在结肠黏膜表面隆起性病变的常见及多发疾病。当前在大肠息肉疾病的临床治疗中,主要是高频电切术,但因病理性质不明朗,因此无论是前期的防治与筛查,还是在内镜下切除术后的复查都只有依靠镜下检查,这不仅给患者带来了极大的身体上的痛苦,也造成了一定的经济压力,同时对于医疗资源的应用也是一种浪费。在大肠息肉内镜下切除术后,因绒毛管状腺瘤的病理类型、息肉多发且>20mm、患者年龄大等,这都会导致大肠息肉的复发率增高;经统计发现,经肠镜切除后大肠息肉复发率仍高达44%以上。因此做好术后大肠息肉的预防复发工作对患者的身体健康的恢复与日常生活质量的改善有着积极作用。但在目前对于如何提高长期的治疗效果,减少患有肠息肉患者的复发率,减轻腹部症状或排便异常等症状并没有好的医疗手段和药物。
发明内容
为了解决上述问题,本发明针提供一种预防术后肠息肉复发的中药组合物和中药制剂
为了实现上述目的,本发明采用的技术方案之一为:一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝10-20份、茯苓10-20份、牡丹皮5-15份、炒桃仁5-15份、赤芍10-30份、黄连2-6份、皂刺10-20份、红藤10-20份、藤梨根10-20份和炒薏苡仁10-20份。
进一步地,所述组合物包括以下组分:桂枝12-18份、茯苓12-18份、牡丹皮7-13份、炒桃仁7-13份、赤芍15-25份、黄连3-5份、皂刺12-18份、红藤12-18份、藤梨根12-18份和炒薏苡仁12-18份。
更进一步地,所述组合物包括以下组分:桂枝14-16份、茯苓14-16份、牡丹皮9-11份、炒桃仁9-11份、赤芍18-22份、黄连3-5份、皂刺14-16份、红藤14-16份、藤梨根14-16份和炒薏苡仁14-16份。
更进一步地,所述组合物包括以下组分:桂枝15份、茯苓15份、牡丹皮10份、炒桃仁10份、赤芍20份、黄连4份、皂刺15份、红藤15份、藤梨根15份和炒薏苡仁15份。
本发明采用的技术方案之二为:一种预防术后肠息肉复发的中药制剂,包括上述技术方案任一所述的中药组合物和药学上可接受的辅料。
进一步地,所述剂型为散剂、颗粒剂、丸剂、片剂或胶囊剂。
本发明的有益效果:
本发明的方剂中桂枝味辛甘性温,温通经脉而行瘀滞为君药。桃仁味苦甘平,活血化瘀,助君药以化瘀;丹皮味苦性微寒,散血祛瘀,清退瘀热;芍药味酸性微寒,养血和血,三者共为臣药;茯苓甘淡性平,健脾利湿,以助消徵之力为佐药;佐药黄连、红藤、薏苡仁清热燥湿;佐药皂角刺消肿排脓、佐药藤梨根清热消肿。全方配伍合理,立法周全,用药周到,具有活血化瘀,清热燥湿,和血消肿之功。
现代药理研究认为,桂枝具有扩张血管、抑制组胺、镇痛抗菌之效,茯苓可镇静、抑菌,牡丹皮有抑制血小板凝聚及抗炎、解热作用,赤芍有解痉、镇痛、抗炎作用,炒桃仁有显著抑制血凝作用,本申请中将诸药合用,可降低血液黏稠度,避免血小板聚集,促进纤维蛋白溶解,从而改善肠道及肠周围微循环,改善腹部不适、腹痛、腹胀、排便异常等诸症状,疗效俱佳。
本申请的中医组合物不仅可以预防息肉的复发还能通过调整、逆转患者整体病态因素,使患者恢复健康体质,增强抗病能力;经临床观察,大肠息肉术后服用本申请的中药组合物可缓解症状、预防复发,疗效显著,且无明显副作用,具有良好的临床应用价值。
除了上面所描述的目的、特征和优点之外,本发明还有其它的目的、特征和优点。下面将对本发明作进一步详细的说明。
附图说明
构成本申请的一部分的附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。
图1是本发明实施例的患者1术前大肠的镜检图;
图2是本发明实施例的患者1术后11个月后的大肠镜检图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅用以解释本发明,并不用于限定本发明。
本发明实施例提供的种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝10-20份、茯苓10-20份、牡丹皮5-15份、炒桃仁5-15份、赤芍10-30份、黄连2-6份、皂刺10-20份、红藤10-20份、藤梨根10-20份和炒薏苡仁10-20份。
本申请组合物的药理分析:
赤芍:为芍药科芍药属植物芍药或川赤芍的干燥根。具有清热凉血,活血祛瘀的功效。主治温毒发斑,血热吐衄,目赤肿痛,痈肿疮疡,肝郁胁痛,经闭痛经,癥瘕腹痛,跌打损伤。
红藤:别名大血藤,为木通科植物大血藤的茎。其性味苦平,归大肠经,能清热解毒,祛风活血止痛,消瘀散结,杀虫,利尿通淋,可治疗肠痈腹痛、热毒疮疡、跌打损伤、风湿痹痛、经闭痛经、绦虫、蛔虫等。
皂刺:别名皂角刺,辛,温。归肝、胃经。消肿托毒,排脓,杀虫,用于痈疽初起或脓成不溃;外治疥癣麻风。
藤梨根:酸、涩,凉。清热解毒,清热利湿,防肿瘤抗癌,祛风除湿,利尿止血,解毒消肿,消化不良、呕吐、风湿痹痛、风湿骨痛、消化道癌肿、消化道肿瘤、痈疡疮疖、风湿骨痛及黄疸等症。
中医学认为大肠息肉属于“癥瘕”“肠蕈”“肠中”“积聚”“脏毒”等范畴。最早见于《灵枢·水胀篇》:“肠蕈何如?寒气客于肠外,与卫气相搏,气不得荣,因有所系,癖而内着,恶气乃起,息肉乃生,其始生者,大如鸡卵。”其与先天禀赋不足、正气内虚、感受外邪、饮食不节或七情不和、损伤脾胃等因素相关。脾失健运、肝郁气滞,继而经脉阻滞、气机不利、痰湿瘀血内生,壅滞肠道。故湿热、寒湿、湿浊、痰浊、瘀血是病因。治疗重在活血祛瘀,化痰散结。治疗应遵循非破不行,非温不化,非行不散的原则。
本发明的选方中桂枝味辛甘性温,温通经脉而行瘀滞为君药。桃仁味苦甘平,活血化瘀,助君药以化瘀;丹皮味苦性微寒,散血祛瘀,清退瘀热;芍药味酸性微寒,养血和血,三者共为臣药;茯苓甘淡性平,健脾利湿,以助消徵之力为佐药;佐药黄连、红藤、薏苡仁清热燥湿;佐药皂角刺消肿排脓、佐药藤梨根清热消肿。全方配伍合理,立法周全,用药周到,具有活血化瘀,清热燥湿,和血消肿之功。
现代药理研究认为,桂枝具有扩张血管、抑制组胺、镇痛抗菌之效,茯苓可镇静、抑菌,牡丹皮有抑制血小板凝聚及抗炎、解热作用,赤芍有解痉、镇痛、抗炎作用,桃仁有显著抑制血凝作用。诸药合用,可降低血液黏稠度,避免血小板聚集,促进纤维蛋白溶解,从而改善肠道及肠周围微循环,改善腹部不适、腹痛、腹胀、排便异常等诸症状疗效俱佳。
采用本申请的中医组合物不仅可以预防息肉的复发还能通过调整、逆转患者整体病态因素,使患者恢复健康体质,增强抗病能力;经临床观察,大肠息肉术后服用本申请的中药组合物可缓解症状、预防复发,疗效显著,且无明显副作用,具有良好的临床应用价值。
实施例1
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝10g、茯苓20g、牡丹皮5g、炒桃仁15g、赤芍10g、黄连6g、皂刺10g、红藤20g、藤梨根10g和炒薏苡仁20g。
实施例2
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝20g、茯苓10g、牡丹皮15g、炒桃仁5g、赤芍30g、黄连2g、皂刺20g、红藤10g、藤梨根20g和炒薏苡仁10g。
实施例3
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝12g、茯苓18g、牡丹皮7g、炒桃仁13g、赤芍15g、黄连5g、皂刺12g、红藤18g、藤梨根12g和炒薏苡仁18g。
实施例4
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝18g、茯苓12g、牡丹皮13g、炒桃仁7g、赤芍25g、黄连3g、皂刺18g、红藤12g、藤梨根18g和炒薏苡仁12g。
实施例5
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝14g、茯苓16g、牡丹皮9g、炒桃仁11g、赤芍18g、黄连5g、皂刺14g、红藤16g、藤梨根14g和炒薏苡仁16g。
实施例6
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝16g、茯苓14g、牡丹皮11g、炒桃仁9g、赤芍22g、黄连3g、皂刺16g、红藤14g、藤梨根16g和炒薏苡仁14g。
实施例7
一种预防术后肠息肉复发的中药组合物,所述组合物包括以下组分:桂枝15g、茯苓15g、牡丹皮10g、炒桃仁10g、赤芍20g、黄连4g、皂刺15g、红藤15g、藤梨根15g和炒薏苡仁15g。
实施例8
实施例1-7的中药组合物可以直接煎服,也可以加入药学上可接受的辅料,如矫味剂、粘合剂、溶剂、润滑剂等制备成散剂、颗粒剂、丸剂、片剂、胶囊剂。
实验例
实验地点:陕西中医药大学附属医院
1.1临床资料
本组研究对象为64例大肠息肉术后患者,均为2015年1月-2020年3月在陕西中医药大学附属医院专家门诊及普通门诊的治疗者,经肠镜检查确诊为大肠息肉并行肠镜下息肉电凝电切治疗术。遵循患者就诊的次序随机进行分组,分为治疗组和对照组。治疗组32例,男17例,女15例;年龄27~61岁。对照组32例,男18例,女14例;年龄29~62岁。两组患者在性别、年龄以及临床病症表现方面均无明显差异(P>0.05),具有可比性。
1.2纳入标准
所有纳入者为因各种腹部症状如腹胀腹痛、腹泻、便秘、腹部不适等诸症行肠镜检查确诊为大肠息肉并行大肠息肉电凝电切术的患者。且血、尿、粪三大常规及粪便细菌培养、血糖、肝功能、肾功能、腹部B超检查均无异常。如服用华法林、阿司匹林、氯吡格雷以及活血中成药等抗凝药物者术前停用药物1周以上,签署知情同意并坚持治疗及随访。
1.3排除标准
心、肝、肾等脏器器官严重障碍,恶性血液系统疾病,精神障碍,对所用药物有禁忌,不愿意参与本研究者。
1.4中医证候量化分级
主要症状观察的项目参考《中药新药临床研究指导原则》及《中医消化病诊疗方案》来制定,依据患者的主要症状、体征轻重程度来进行记分:依次记录为无、轻、中、重度四个等级,并分别记录0、2、4、6分。
如下表:
表1中医证候量化分级表
2方法
2.1治疗组
大肠息肉电凝电切术后给予常规补液、对症治疗,禁食1-2日后给予本申请实施例7的中药组合物,水煎服,熬得药液约300ml,分早晚2次于饭后1h服。1个月为1疗程,连续治疗3个疗程。并于术后6个月、12个月复查肠镜。
2.2对照组
大肠息肉电凝电切术后给予常规补液、对症治疗,禁食1-2日后给予双歧杆菌乳杆菌三联活菌片(商品名金双歧,由万泽集团旗下内蒙古双奇药业股份有限公司生产,国药准字S19980004),口服,2g/次,3次/日。1个月为1疗程,连续治疗3个疗程。并于术后6个月、12个月复查肠镜。
2.3疗效判定
预防大肠息肉复发的疗效参照《中医病证诊断疗效标准》拟定。“复发”定义为大肠息肉患者行内镜下切除治疗后并明确上一次息肉切除术时已经将所有息肉切除,其后再次行肠镜检查发现大肠息肉。
中医证候疗效参照《中药新药临床研究指导原则》。临床痊愈:症状、体征消失或基本消失,证候积分减少>95%;显效:症状、体征明显有所改善,证候积分减少>70%;有效:症状、体征均见到好转,证候积分减少>30%;无效:症状、体征皆没有明显改善,甚至临床表现有所加重,证候积分减少不足30%。(注:证候积分计算公式(尼莫地平法)为:[(治疗前积分-治疗后积分)/治疗前积分]×100%。)
2.4统计学方法
统计分析采用SPSS 19.0软件,计量资料的比较用t检验;计数资料的比较用x2检验。P<0.05为差异有统计学意义。
3结果
经过3个月的治疗后,临床症状及体征比较,治疗组共32例,其中9例临床痊愈,14例显效,8例有效,1例无效,总有效率为96.87%;对照组共32例,其中临床痊愈3例,显效为6例,有效为11例,无效为12例,总有效率为62.50%。两组经X2检验比较后,得出两组治疗有显著性差异(P<0.05),见表2。
表2两组治疗前后临床症状及体征疗效比较
病历1:患者王某某,以“左下腹隐痛20余年”为主诉于2019年5月2日就诊。结肠镜检查示:升大肠息肉(已钳除),见附图1,病理检查示:(升结肠)腺瘤性息肉。服用活血消肉通肠汤治疗90天后,上症消失。
11个月复查结肠镜示:直肠及全结肠未见异常,结肠镜检查结果见附图2。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (6)
1.一种预防术后肠息肉复发的中药组合物,其特征在于,所述组合物包括以下组分:桂枝10-20份、茯苓10-20份、牡丹皮5-15份、炒桃仁5-15份、赤芍10-30份、黄连2-6份、皂刺10-20份、红藤10-20份、藤梨根10-20份和炒薏苡仁10-20份。
2.根据权利要求1所述的预防术后肠息肉复发的中药组合物,其特征在于,所述组合物包括以下组分:桂枝12-18份、茯苓12-18份、牡丹皮7-13份、炒桃仁7-13份、赤芍15-25份、黄连3-5份、皂刺12-18份、红藤12-18份、藤梨根12-18份和炒薏苡仁12-18份。
3.根据权利要求1所述的预防术后肠息肉复发的中药组合物,其特征在于,所述组合物包括以下组分:桂枝14-16份、茯苓14-16份、牡丹皮9-11份、炒桃仁9-11份、赤芍18-22份、黄连3-5份、皂刺14-16份、红藤14-16份、藤梨根14-16份和炒薏苡仁14-16份。
4.根据权利要求1所述的预防术后肠息肉复发的中药组合物,其特征在于,所述组合物包括以下组分:桂枝15份、茯苓15份、牡丹皮10份、炒桃仁10份、赤芍20份、黄连4份、皂刺15份、红藤15份、藤梨根15份和炒薏苡仁15份。
5.一种预防术后肠息肉复发的中药制剂,其特征在于,包括权利要求1-4任一所述的中药组合物和药学上可接受的辅料。
6.根据权要求5所述的中药制剂,其特征在于,所述剂型为散剂、颗粒剂、丸剂、片剂或胶囊剂。
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