CN116211990A - 一种治疗糖尿病突发性耳聋的中药组合 - Google Patents
一种治疗糖尿病突发性耳聋的中药组合 Download PDFInfo
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- CN116211990A CN116211990A CN202310031065.1A CN202310031065A CN116211990A CN 116211990 A CN116211990 A CN 116211990A CN 202310031065 A CN202310031065 A CN 202310031065A CN 116211990 A CN116211990 A CN 116211990A
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Abstract
本发明公开了一种治疗糖尿病突发性耳聋的中药组合,主要解决现有技术中存在的现有高压氧仅是治标的方法,目前的药物治疗只能改善突发性耳聋的症状,治愈效果并不佳的问题。该一种治疗糖尿病突发性耳聋的中药组合由以下组分组成:红花,桂枝,干姜,黄连,蛇舌草,何首乌,决明子,蒲公英,丹参,菟丝子,楮实子,石菖蒲,香附,地龙,鸡血藤,三七,五味子,知母,唇香草。通过上述方案,本发明达到了相互协同在治疗突发性耳聋的同时,防治了其他症状避免了耳聋症状的加重,本发明的药物组合气血兼顾,使耳脉得以灌注,耳聋复聪。
Description
技术领域
本发明涉及治疗糖尿病中药技术领域,具体地说,是涉及一种治疗糖尿病突发性耳聋的中药组合。
背景技术
糖尿病是一种以高血糖为特征的代谢性疾病。高血糖则是由于胰岛素分泌缺陷或其生物作用受损,或两者兼有引起。长期存在的高血糖,导致各种组织,特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍。
对于糖尿病的患者,如果比较严重的话,有可能会出现突发性耳聋,这种情况主要是因为糖尿病时间比较长导致神经系统病变,主要是末梢神经,也可能是末梢血管循环出现问题,有可能引起听力逐渐下降或者突发性耳聋。
现糖尿病在检查或有严重症状之前是不易被查出的,现有治疗糖尿病引起的突发性耳聋一般采用高压氧或药物治疗,高压氧仅是治标的方法,不能阻断糖尿病各病症之间的相互影响,目前的药物治疗只能改善突发性耳聋的症状,治愈效果并不佳。
发明内容
本发明的目的在于提供一种治疗糖尿病突发性耳聋的中药组合,以解决现有高压氧仅是治标的方法,目前的药物治疗只能改善突发性耳聋的症状,治愈效果并不佳的问题。
为了解决上述问题,本发明提供如下技术方案:
一种治疗糖尿病突发性耳聋的中药组合由以下组分组成:
红花,桂枝,干姜,黄连,蛇舌草,何首乌,决明子,蒲公英,丹参,菟丝子、楮实子,石菖蒲,香附,地龙,鸡血藤,三七,五味子,知母,唇香草。
优选的,各组分的重量份为:红花5-10份,桂枝5-15份,干姜8-15份,黄连3-8份,蛇舌草20-35份,何首乌20-40份,决明子20-40份,蒲公英10-20份、丹参10-20份,菟丝子8-15份、楮实子8-15份,石菖蒲10-20份,香附10-20份、地龙3-8份,鸡血藤5-15份,三七10-20份,五味子8-15份,知母10-20份,唇香草5-10份。
优选的,其由以下组分及重量份组成:红花8份,桂枝10份,干姜10份,黄连5份,蛇舌草25份,何首乌25份,决明子25份,蒲公英15份、丹参15份,菟丝子10份、楮实子10份,石菖蒲15份,香附15份、地龙5份,鸡血藤10份,三七15份,五味子10份,知母15份,唇香草8份。
优选的,所述中药组合的剂型为汤剂、丸剂、散剂、膏剂、丹剂、冲剂、口服液、胶囊剂、片剂中任一种。
所述药物组合水煎煮方法包括的步骤为:称取原料药和水的重量份以原料:水为1:10,用清水浸泡1小时后取出,,大火熬至沸腾,改用小火煎煮30分钟,将药液滤出。再加入清水,大火熬至沸腾,改用小火煎煮15分钟,滤出药液。两次煎出药液混合,早、晚饭后服用。
与现有技术相比,本发明具有以下有益效果:
本发明以桂枝和干姜改善糖尿病引起的神经病变,以鸡血藤营养神经,以黄连和蛇舌草改善糖尿病引起的肾病尿蛋白升高的情况,以何首乌和决明子改善糖尿病引起的胃轻瘫及视力降低的情况,以蒲公英,丹参,菟丝子,楮实子组合滋补肝肾、活血化瘀、疏肝清热,以石菖蒲宣通耳窍,香附行气通脉,地龙疏通经络,在配以红花活血及三七,五味子,知母,改善糖尿病引起的突发性耳聋,唇香草为新疆特色维吾尔药材资源,具有芳香开窍、清利头目功效,可有效改善耳聋患者耳内微循环、修复损伤的耳蜗毛细胞。各药物组分相互协同改善糖尿病可能引起的其他症状隔断了糖尿病引起的各症状之间的连带反应,本发明对糖尿病可能引起的其他症状做预防作用,且相互协同在治疗突发性耳聋的同时,防治了其他症状避免了耳聋症状的加重,本发明的药物组合气血兼顾、通补兼施、标本兼顾使耳脉得以灌注,在耳聋症状得缓解“治标”的同时,以滋补肝肾、补肾填精的治则治法纠正耳聋发生的根本原因已达到“治本”之目的。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图,其中:
图1不同时间内大鼠体重的变化。
图2不同时间内大鼠血糖的变化
具体实施方式
下面结合实施例对本发明作进一步说明,本发明的实施方式包括但不限于下列实施例。
实施例1
一种治疗糖尿病突发性耳聋的中药组合其组分及重量份组成为:红花5份,桂枝5份,干姜8份,黄连3份,蛇舌草20份,何首乌20份,决明子20份,蒲公英10份、丹参10份,菟丝子8份、楮实子8份,石菖蒲10份,香附10份、地龙3份,鸡血藤5份,三七10份,五味子8份,知母10份,唇香草5份。
实施例2
一种治疗糖尿病突发性耳聋的中药组合其组分及重量份组成为:红花8份,桂枝10份,干姜10份,黄连5份,蛇舌草25份,何首乌25份,决明子25份,蒲公英15份、丹参15份,菟丝子10份、楮实子10份,石菖蒲15份,香附15份、地龙5份,鸡血藤10份,三七15份,五味子10份,知母15份,唇香草8份。
实施例3
一种治疗糖尿病突发性耳聋的中药组合其组分及重量份组成为:红花10份,桂枝15份,干姜15份,黄连8份,蛇舌草35份,何首乌40份,决明子40份,蒲公英20份、丹参20份,菟丝子15份、楮实子15份,石菖蒲20份,香附20份、地龙8份,鸡血藤15份,三七20份,五味子15份,知母20份,唇香草10份。
动物实验部分
1材料与方法
1.1材料
1.1.1动物
45只6周龄雄性SPF级wistar大鼠,体质量为200±20g,购自新疆医科大学动物实验中心,许可证号为SCXK2018-0002,动物饲养于新疆医科大学动物实验中心SPF级动物室内。
1.1.1饲料和药材
高糖高脂饲料配比:基础饲料52.6%、猪油10%、蔗糖13%、蛋黄粉15%、酪蛋白5%、胆固醇1.2%、胆酸盐0.2%、维生素混合物0.5%、麦芽糊精1.5%、矿物混合物1%,购自北京博爱港生物技术有限公司
1.1.3主要的试剂及仪器
链脲佐菌素(Meilunbio,货号:MB-1227-1),粪便NDA提取试剂盒(北京索莱宝科技有限公司,货号:Cat#D2700),IgG、IgM、cAMP和cGMP(上海江莱生物科技有限公司,货号:JL11091、JL10678、JL10117、JL11179)。
1.2糖尿病耳聋动物模型建立
75只雄性wistar大鼠,适应性喂养3天后,将其随机分为正常组(NC组;15只)和造模组(60只)。正常组喂养普通饲料,造模组喂养高糖高脂饲料。喂养8周后,大鼠禁食不禁水12h,用0.1mol/L的枸橼酸缓冲液将STZ稀释成1%的溶液,现配现用。按STZ为25mg/kg的剂量,模型组大鼠一次性腹腔注射STZ,正常组大鼠注射同等剂量的枸橼酸盐缓冲液,一周后检测血糖,血糖≧16.7mmom/mL的大鼠,即为2型糖尿病大鼠。随后持续喂养高糖高脂饲料,期间检测模型大鼠的ABR值,当糖尿病大鼠继续喂药高脂高糖饲料8周时,糖尿病大鼠接受听性脑干反应测试(ABR)阈值≥40dBnHL,视为T2DM耳聋大鼠模型造模成功。
1.3分组及给药
将造模成功的大鼠随机分为两组,分别为糖尿病耳聋模型组(M组)和中药配方颗粒(ZYPF)组,每组15只。按照人服用剂量换算本发明的中药配方颗粒组(ZYPF1、ZYPF2、ZYPF3)分别使用实施例1,实施例2和实施例3配方制成的中药配方颗粒,分别灌胃给药1.215g/kg,正常组和模型组分别给予同体积生理盐水灌胃。每天一次,连续灌胃8周。
1.4生化指标检测
1.4.1各组大鼠血糖和体重
每周检测一次各组大鼠体重,并使用血糖仪通过尾尖取血检测大鼠血糖水平。
1.4.2各组大鼠血清各项指标
每组随机取8只大鼠血清,采用全自动生化分析仪对胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL-C)、高密度脂蛋白(HDL-C)、血清肌酐(SCr)、尿氮素(BUN)进行测定。采用ELISA检测血清中IgG、IgM、cAMP和cGMP的含量,并计算cAMP/cGMP值。
1.5统计分析
SPSS22软件对数据进行统计分析,数据用均数±标准差表示,采用单因素方差分析,p<0.05表示有统计学差异,用GraphPadPrism8进行柱状图分析。
2结果
2.1中药配方颗粒对糖尿病耳聋大鼠体重和血糖的影响
检测不同时间内各组大鼠的血糖(图1)和体重(图2),由检测结果可知相较于正常组,模型大鼠表现出明显的体重降低,随机血糖升高的症状(p<0.05或p<0.01);干预ZYPF1、ZYPF2、ZYPF3颗粒后,体重并未发生明显的改变,但血糖从第4周期,ZYPF1、ZYPF2、ZYPF3组随机血糖水平明显低于模型组(p<0.05或p<0.01)。
2.2中药配方颗粒对糖尿病耳聋大鼠血脂四项、SCr和BUN的影响
通过检测各组大鼠血清生化指标可知(表1),相较于正常大鼠,糖尿病耳聋大鼠血清的血脂四项(TG、TC、LDL-C和HDL-H)、SCr和BUN明显升高(p<0.05或p<0.01),上述结果表明大鼠已出现明显的高脂血症和肾功能损伤。干预ZYPF1、ZYPF2、ZYPF3颗粒后,上述指标明显改善(p<0.05或p<0.01)。
注:*表示与正常组相比:*p<0.05,**p<0.01;#表示与模型组相比:#p<0.05,##p<0.01
2.3中药配方颗粒对糖尿病耳聋大鼠IgG、IgM、cAMP、cGMP含量及cAMP/cGMP的影响
由表2可知,相较于正常组,气阴两虚证DN大鼠血清中IgG、IgM和cGMP的含量明显降低,cAMP的含量和cAMP/cGMP比值明显增加(p<0.05或p<0.01)。干预ZYPF1、ZYPF2、ZYPF3颗粒后,模型大鼠上述指标具有不同程度改善(p<0.05或p<0.01)。
注:*表示与正常组相比:*p<0.05,**p<0.01;#表示与模型组相比:#p<0.05,##p<0.01
2.4中药配方颗粒对糖尿病耳聋大鼠ABR阈值的影响
与空白组比较,造模后各组大鼠ABR阈值均显著上升(ABR阈值≥40dBnHL),干预8周期间均维持在较高水平,说明糖尿病耳聋大鼠造模成功。干预ZYPF颗粒8周期间,从第4周期,与模型组比较,ZYPF1、ZYPF2、ZYPF3颗粒组ABR值显著降低(P<0.05);用药8周后,ZYPF1、ZYPF2、ZYPF3颗粒组ABR阈值继续降低(P<0.01)。说明随着时间推移,ZYPF颗粒能显著改善糖尿病耳聋大鼠ABR阈值进而改善大鼠听力水平。
表3造模后及给药4周、给药8周后各组糖尿病耳聋大鼠ABR阈值的变化(dBnHL)
注:*表示与正常组相比:*p<0.05,**p<0.01;#表示与模型组相比:#p<0.05,
##p<0.01
对本发明的中药配方颗粒防治糖尿病耳聋作用进行药效学的研究发现,中药配方颗粒能显著改善糖尿病耳聋模型大鼠的血糖、体重、血脂四项、Scr、BUN水平,纠正模型大鼠的代谢紊乱现象。此外,能提高血清免疫指标IgG、IgM水平,降低cAMP/cGMP比值,一定程度上改善模型大鼠机体免疫水平、恢复机体能量代谢平衡;在此基础上,中药配方颗粒能显著降低模型大鼠ABR阈值,在一定程度上改善模型大鼠的听力水平。总之,中药配方颗粒治疗糖尿病耳聋可有效改善糖尿病耳聋动物模型的各项病理指标。
临床实验部分
1资料与方法
1.1一般资料
选取附属医院2017年1月至2019年9月收治的糖尿病耳聋患者共80例,均为糖尿病导致的突发性耳聋患者,均符合ISO及WHO诊断标准,随机分为治疗组和对照组。对照组患者40例,男25例,女15例;年龄29~78岁,平均年龄(50.3±1.3)岁;轻度15例、中度15例、重度10例;空腹血糖(13.52±2.04)mmol/L。治疗组患者40例,男24例,女16例;年龄32~80岁,平均年龄(52.5±2.1)岁;轻度13例、中度16例、重度11例;空腹血糖(13.74±2.1)mmol/L。
1.2方法
对照组予以常规西药治疗,予以盐酸二甲双胍250~500mg,每日2~3次,密切关注血糖水平,随血糖变化及时调整用药。
治疗组予以本发明的中药配方颗粒治疗,温水冲服,一天两次;药物成分:红花8g,桂枝10g,干姜10g,黄连5g,蛇舌草25g,何首乌25g,决明子25g,蒲公英15g、丹参15g,菟丝子10g、楮实子10g,石菖蒲15g,香附15g、地龙5g,鸡血藤10g,三七15g,五味子10g,知母15g,唇香草8g。
1.3评价标准
观察并对比两组的FBG、P2BG水平。评价两组耳聋疗效:症状明显好转,全频率听阈曲线变为实用听区或相比治疗前好转30dB以上,空腹血糖(FBG)<7.2mmol/L、餐后2小时血糖(P2BG)<8.3mmol/L,血糖较治疗前降低30%以上,为显效;主观症状好转,FBG为7.3~8.3mmol/L、P2BG为8.4~10.0mmol/L,血糖相比治疗前降低10%~29%,为有效;经治疗未见症状好转,听阈曲线上升<15dB,血糖等指标未达到好转标准,为无效。
1.4统计方法
该数据采用SPSS16.0软件对本研究的数据进行统计学的分析,计数资料的对比应用χ2检验,而计量资料的对比应用t检验。
2结果
2.1FBG、P2BG水平
两组治疗后FBG、P2BG水平均优于治疗前(P<0.05);治疗组治疗后FBG、P2BG水平均优于同期对照组(P<0.05),见表4。
表4:两组治疗前后FBG、P2BG水平比较
注:*表示治疗后优于治疗前,P<0.05;#表示治疗组与对照组有明显差异,P<0.05。
2.2Tch、TG、HDL-C水平
表5:两组治疗前后Tch、TG、HDL-C水平比较
注:*表示治疗后优于治疗前,P<0.05;#表示治疗组与对照组有明显差异,P<0.05。
2.3耳聋疗效
治疗组治愈27例、显效8例、有效4例、无效1例,总有效率97.5%,治愈率、显效率、总有效率均高于对照组(P<0.05),见表6。
表6:两组耳聋疗效对比分析[n(%)]
组别 | 治愈 | 显效 | 有效 | 无效 | 总有效率(%) |
治疗组 | 27*(67.5) | 8(20.0) | 4(10.0) | 1(2.5) | (97.5)* |
对照组 | 18(45.0) | 7(17.5) | 9(22.5) | 6(15.0) | 85.0 |
注:*表示治疗组该项占比与对照组有明显差异,P<0.05
糖尿病可诱发多系统病变,常见的包括耳聋等微血管病变相关并发症。糖尿病属中医“消渴”范畴,于此相关的肺胃津亏、肾阴耗损、阴虚燥热、精血不畅可直接诱发失聪。也有患者因阳亢阴虚而出现耳鸣、眩晕症状。病情进展过程会因脉络烧灼而破裂溢血、影响体内循环而产生血瘀。中医认为,糖尿病耳聋乃血瘀之症,阴虚为本、血瘀为标,活血化瘀便可畅通血脉、调理精气,经脉得血养而治疗耳聋组治疗后Tch、TG、HDL-C、FBG、P2BG水平均优于同期对照组(P<0.05),表明辨证予以中药配方颗粒治疗,可有效改善各项血脂指标;治疗组总有效率97.5%,治愈率、显效率、总有效率均高于对照组(P<0.05),表明中药配方颗粒辨证治疗有显著的综合疗效。
按照上述实施例,便可很好地实现本发明。值得说明的是,基于上述结构设计的前提下,为解决同样的技术问题,即使在本发明上做出的一些无实质性的改动或润色,所采用的技术方案的实质仍然与本发明一样,故其也应当在本发明的保护范围内。
Claims (4)
1.一种治疗糖尿病突发性耳聋的中药组合,其特征在于,其由以下组分组成:红花,桂枝,干姜,黄连,蛇舌草,何首乌,决明子,蒲公英,丹参,菟丝子、楮实子,石菖蒲,香附,地龙,鸡血藤,三七,五味子,知母,唇香草。
2.根据权利要求1所述的一种治疗糖尿病突发性耳聋的中药组合,其特征在于,各组分的重量份为:红花5-10份,桂枝5-15份,干姜8-15份,黄连3-8份,蛇舌草20-35份,何首乌20-40份,决明子20-40份,蒲公英10-20份、丹参10-20份,菟丝子8-15份、楮实子8-15份,石菖蒲10-20份,香附10-20份、地龙3-8份,鸡血藤5-15份,三七10-20份,五味子8-15份,知母10-20份,唇香草5-10份。
3.根据权利要求2所述的一种治疗糖尿病突发性耳聋的中药组合,其特征在于,其由以下组分及重量份组成:红花8份,桂枝10份,干姜10份,黄连5份,蛇舌草25份,何首乌25份,决明子25份,蒲公英15份、丹参15份,菟丝子10份、楮实子10份,石菖蒲15份,香附15份、地龙5份,鸡血藤10份,三七15份,五味子10份,知母15份,唇香草8份。
4.根据权利要求1-3任一项所述的一种治疗糖尿病突发性耳聋的中药组合,其特征在于,所述中药组合的剂型为汤剂、丸剂、散剂、膏剂、丹剂、冲剂、口服液、胶囊剂、片剂中任一种。
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