CN111529645B - 一种治疗肾虚络瘀型糖尿病肾病ⅳ期的药物 - Google Patents
一种治疗肾虚络瘀型糖尿病肾病ⅳ期的药物 Download PDFInfo
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- CN111529645B CN111529645B CN202010298259.4A CN202010298259A CN111529645B CN 111529645 B CN111529645 B CN 111529645B CN 202010298259 A CN202010298259 A CN 202010298259A CN 111529645 B CN111529645 B CN 111529645B
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Abstract
一种治疗肾虚络瘀型糖尿病肾病Ⅳ期的药物,其组成为:生黄芪25‑35g,生牡蛎25‑35g,土茯苓25‑35g,芡实25‑35g,蛇舌草13‑18g,鬼箭羽8‑15g,丹参8‑13g,生地8‑12g,山药7‑12g,山茱萸8‑12g,桑螵蛸5‑12g。本发明在滋膵益肾方基础上去玄参、苍术、葛根、红花、泽泻、金樱子,加用生牡蛎、蛇舌草、鬼箭羽、丹参、桑螵蛸而成,加强活血散结、祛瘀通络、清热解毒功效,从而达到改善肾功能,减少尿蛋白作用。
Description
技术领域
本发明涉及一种治疗肾虚络瘀型糖尿病肾病Ⅳ期的药物,具体地说是在经验方滋膵益肾方基础上加减方而成的药物。
背景技术
糖尿病肾病(diabetic nephropathy,DN)是糖尿病常见而难治的微血管并发症,是患者致死、致残主要原因之一。早期发现肾脏损害,寻求积极有效治疗手段,使DN(Ⅳ期)病情得到最大程度控制,对延缓患者病情发展,提高患者生活质量具有重大意义。现代研究表明,DN的发生发展与高血糖引起的蛋白非酶糖基化、高血黏度、血流动力学异常等密切相关。目前《中国2型糖尿病防治指南》推荐采用血管紧张素转化酶抑制剂和血管紧张素Ⅱ受体拮抗剂治疗DN(Ⅳ期),同时改善血液高凝状态,改善氧化应激环境,尽管现代医学在治疗DN上已形成较规范的治疗方案,但疗效仍不理想,不能控制临床DN的自然进程。
DN(Ⅳ期)属中医学“下消”、“尿浊”、“水肿”等范畴。消渴病早期由于阴虚燥热,继而气阴两虚已成共识,而随之病情进展,气虚运血无力,阴虚血行艰涩,血液运行不畅,瘀血形成,久而伤及肾之络脉,从而导致DN的发生发展。脾肾亏虚,水湿浊邪内停,血脉壅滞,形成恶性循环。“血不利则为水”,瘀血阻滞脉络,致使脉内的津液不能输布,脉外的津液不能还流,或脏腑气化行水的功能失调,故见浮肿等症。总之,“脾肾亏损”、“肾失气化、封藏”、“瘀浊阻络”,导致精微物质下泄,肾精亏损,呈现本虚标实、虚实夹杂的病机,病程缠绵难愈。基本病机为正虚邪实,正虚以脾肾虚弱为主,邪实以风邪、水湿、湿热、瘀血为主。大量的临床研究已经证实中医药在减少DN蛋白漏出、改善肾功能方面具有相对明显的优势,尤其是根据DN病因病机,结合临床经验总结出治疗肾虚络瘀型糖尿病肾病(Ⅳ期)经验方滋脺益肾方,其对于改善患者腰酸、浮肿、头晕乏力等症状方面取得一定疗效,但在改善患者肾功能,减少尿蛋白方面,疗效仍有待提高。因此,寻求积极有效治疗手段,使DN肾功能损害得到最大程度控制,对延缓患者病情发展,改善远期预后具有重大意义。
发明内容
本发明的目的是提供一种治疗肾虚络瘀型糖尿病肾病Ⅳ期的药物,以进一步提高对肾虚络瘀型糖尿病肾病Ⅳ期的治疗效果。
为实现上述目的,本发明提供的药物是在滋膵益肾方加减而成,其组成为:
生黄芪25-35g,生牡蛎25-35g,土茯苓25-35g,芡实25-35g,蛇舌草13-18g,鬼箭羽8-15g,丹参8-13g,生地8-12g,山药7-12g,山茱萸8-12g,桑螵蛸5-12g。
优选的组成为:生黄芪30g,生牡蛎30g,土茯苓30g,芡实30g,蛇舌草15g,鬼箭羽10g,丹参10g,生地10g,山药10g,山茱萸10g,桑螵蛸10g。
本发明的药物为汤剂。
本发明在滋膵益肾方基础上去玄参、苍术、葛根、红花、泽泻、金樱子,加用生牡蛎、蛇舌草、鬼箭羽、丹参、桑螵蛸而成,加强活血散结、祛瘀通络、清热解毒功效,从而达到改善肾功能,减少尿蛋白作用。
具体实施方式
本发明是在滋膵益肾方基础上去玄参、苍术、葛根、红花、泽泻、金樱子,加用生牡蛎、蛇舌草、鬼箭羽、丹参、桑螵蛸而成。
滋膵益肾方重用黄芪以益气培本,兼能利水;山茱萸、山药固肾补脾,加之生地黄、玄参滋肾清热,苍术健脾燥湿、固本降糖,葛根健脾升阳;芡实、金樱子同用益肾涩精;红花活血通络;土茯苓、泽泻化湿热、利水泄浊,令补益药补而不滞。现代药理研究表明,黄芪具有扩张血管,增加肾血流量,抑制血小板聚集,调节免疫,减少尿蛋白,保护肾脏的作用;土茯苓、金樱子、芡实合用具有固本治标,降低蛋白尿的目的。
本发明是基于中国中医学对糖尿病肾病机理的认识和治疗原则,参考现代药理研究成果,在滋膵益肾方基础上去玄参、苍术、葛根、红花、泽泻、金樱子,加用生牡蛎、蛇舌草、鬼箭羽、丹参、桑螵蛸等五味中药而成,加强活血散结、祛瘀通络、清热解毒功效,从而达到改善肾功能,减少尿蛋白作用。
本发明加入的五味中药中:
生牡蛎:入少阴肾经,具有软坚散结、潜阳补阴等功效,用于瘰疬痰核,症瘕痞块等,与黄芪合用为君,加强补肾正气、散结消症作用。
蛇舌草:功效为清热解毒、消痈,临床用于痈肿疮毒,咽喉肿痛、毒蛇咬伤等症。现代药理研究,有抗菌消炎的作用。能增强机体免疫功能,增强白细胞吞噬功能,较多临床试验证实具有较好的减少尿蛋白作用。
鬼箭羽:为消渴病常用活血药物之一,具有破血散结,同时具有降血糖、改善胰岛素抵抗功效。
丹参:为活血化瘀之要药,现代研究认为有抗凝,促进纤溶,降血脂,抑制粥样斑块形成,增强免疫作用。
桑螵蛸:补肾助阳、固精缩尿,与芡实、生地、山药、山茱萸等同服,加强补肾固涩,同时滋肾阴、补肾阳,阴阳兼顾。
本发明在滋膵益肾方加减而成的药物全方消补同用、阴阳兼顾、标本兼治,共奏补肾活血、散结通络之功。
以下进一步说明本发明的药物对肾虚络瘀型糖尿病肾病Ⅳ期的治疗方法和效果:
1、疾病的诊断标准:西医诊断标准参照1999年WHO公布的糖尿病诊断标准,确诊为2型糖尿病;DN(Ⅳ期)参照Mogensen对DN的分期,尿白蛋白排出率(urinary albuminexcretion rate,UAER)>200μg/min,或24h尿蛋白>0.5g。中医证候标准参照《中药新药临床研究指导原则(试行)》。肾虚络瘀型:腰酸乏力,浮肿头晕,视物模糊,定位刺痛,口干唇燥,失眠心烦,面色晦暗,泡沫尿,舌暗红或暗淡,或有瘀点,脉弦细或沉细。
2、病例的选择:
2.1纳入标准
①年龄30-70岁,男女不限;
②服用类似本方案药物作用的中药患者需停用中药1个月后方可纳入;
③能明确本试验的研究目的和过程,同意并积极配合本临床试验要求,并自愿签署知情同意书者。
2.2排除标准
①1型糖尿病、妊娠糖尿病以及各种胰腺疾病、肝脏疾病、内分泌疾病等继发糖尿病所致的肾病;
②其他如发热、各种感染、运动、心功能不全、原发性肾脏病等原因引起的蛋白尿;
③合并严重高血压、肝功能损害、肾功能损害、心力衰竭、肿瘤等严重疾病者;
④具有精神疾病患者。
3、用药方法;
基础治疗
①优质低蛋白饮食(如牛奶、蛋类以及鱼类、瘦肉等蛋白;):蛋白质摄入量为每日0.8g/kg;
②控制血糖:口服降糖药,和(或)注射胰岛素,使空腹血糖≤7.0mmol/L,餐后2h血糖≤10.0mmol/L,以达到《中国2型糖尿病防治指南》标准;
③降低血压:坎地沙坦8mg,每日1次,口服。将收缩压控制在90~130mmHg,将舒张压控制在60~80mmHg。
(1)对照组胰激肽原酶肠溶片120单位,每日3次,口服。
(2)治疗组1滋膵益肾方口服(生黄芪、芡实、金樱子、土茯苓各30g,葛根20g,生地黄、山茱萸、山药、玄参、苍术、泽泻各15g,红花6g)。
(3)治疗组2本发明滋膵益肾方加减方口服(生黄芪、生牡蛎、土茯苓、芡实各30g,蛇舌草15g,鬼箭羽、丹参、生地、山药、山茱萸、桑螵蛸各10g)。
统一由煎药机专人煎取,并作质量控制,每日1剂,煎取两袋,每袋100mL,早晚各1袋,饭后30min温服。疗程均为8周。
4、观察指标:
(1)临床症状评分参考《中药新药临床研究指导原则》,将患者浮肿、乏力、腰酸、头晕、视物模糊、定位刺痛、心悸、失眠8个临床症状,根据无、轻、中、重4个等级分别计为0、2、4、6分。
(2)检测指标包括肌酐、尿素氮、24h尿蛋白定量、血液流变学指标(血浆黏度)。治疗开始和结束时各检测1次。
5、疗效判定标准:
中医证候疗效判定标准:根据《中药新药临床研究指导原则》制定中医证候疗效判定标准,先采用尼莫地平法计算疗效指数
疗效指数=(治疗前积分-治疗后积分)/治疗前积分×100%。
临床痊愈:临床症状(浮肿、乏力、腰酸、头晕、视物模糊、定位刺痛、心悸、失眠)减轻,疗效指数≥90%;
显效;临床症状明显改善,70%≤疗效指数<90%;
有效:临床症状均有好转,30%≤疗效指数<70%;
无效:临床症状无明显改善,甚或加重,疗效指数<30%。
6、疾病总体的治疗结果;
(1)各组中医证候疗效比较见表1。
(2)各组患者肌酐、尿素氮、24小时尿蛋白以及血粘度水平比较见表2。
表1
与对照组比较##p<0.01,与治疗组1比较*p<0.05。
注:与同组治疗前比较,*P<0.05,**P<0.01;治疗组2差值与对照组差值比较,#P<0.05,##P<0.01;治疗组2差值与治疗组1差值比较,△P<0.05,△△P<0.01。
Claims (2)
1.一种治疗肾虚络瘀型糖尿病肾病Ⅳ期的药物,其组成为:
生黄芪30g,生牡蛎30g,土茯苓30g,芡实30g,蛇舌草15g,鬼箭羽10g,丹参10g,生地10g,山药10g,山茱萸10g,桑螵蛸10g。
2.根据权利要求1所述的药物,其中,所述药物为汤剂。
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