CN117180361B - Traditional Chinese medicine for treating spleen deficiency and qi stagnation combined with damp-heat type ulcerative colitis - Google Patents
Traditional Chinese medicine for treating spleen deficiency and qi stagnation combined with damp-heat type ulcerative colitis Download PDFInfo
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Abstract
Description
一、技术领域1. Technical Field
本发明涉及医药领域,特别是一种治疗脾虚气滞兼湿热型溃疡性结肠炎的中药。The invention relates to the field of medicine, in particular to a traditional Chinese medicine for treating spleen deficiency, qi stagnation and damp-heat type ulcerative colitis.
二、背景技术2. Background Technology
慢性非特异性溃疡性结肠炎(UC)是以腹泻、粘液脓血便、腹痛、里急后重等为主要症状,以结肠慢性炎症和溃疡形成为病理特点的一种消化道疾病。该病在欧美发达地区发病率较高,约为10万分之18,近年来由于生活水平的不断提高,饮食结构、生活习惯的改变,加之检查技术的提高,发病率亦呈逐年上升趋势。由于本病治愈难度大,且又常易复发,并与结肠癌的发病存在一定关系,因此被世界卫生组织列为现代难治病之一。Chronic nonspecific ulcerative colitis (UC) is a digestive tract disease with diarrhea, bloody stools, abdominal pain, tenesmus, etc. as the main symptoms, and chronic inflammation and ulcer formation of the colon as the pathological characteristics. The disease has a high incidence rate in developed areas of Europe and the United States, about 18 per 100,000. In recent years, due to the continuous improvement of living standards, changes in dietary structure and living habits, and the improvement of examination technology, the incidence rate has also shown an upward trend year by year. Because the disease is difficult to cure, it is often prone to recurrence, and it has a certain relationship with the incidence of colon cancer, it is listed as one of the modern intractable diseases by the World Health Organization.
根据《炎症性肠病诊断与治疗的共识意见(2018年·北京)》将UC分为初发型和慢性复发型,且临床上慢性复发型较多见。本病的发病特点是“屡发暂愈”,病程长,反复发作,有长短不等的缓解期。大部分病人随病情发展会进入慢性复发型UC阶段。《素问·脏气法时论》云:“脾病者,......虚则腹满肠鸣,飧泄,食不化。”《景岳全书》亦云:“泄泻之本,无不由于脾胃。”脾胃虚弱,湿浊、气机阻滞在UC的发病中具有重要意义。慢性复发型UC疾病过程是邪正交争过程。发作期多因饮食不节、感受外邪、情绪刺激等损伤脾胃,致脾失健运,痰湿内生,湿热蕴结,气血凝滞,损伤肠道致UC复发。而UC反复发作又可加重脾虚,故在UC发病中脾虚为本,并贯穿疾病始终。虚中必有滞,气虚无力推动,出现气滞。《医学求是》所云:“升降之权,又在中气,中气旺则脾升而胃降,藏象得以轮旋,中气败则脾郁而胃逆。”UC反复发作,损伤脾胃,致中气虚,气机郁滞,升降失常,津液运行受阻,聚而生湿。脾胃虚弱除影响中焦气机外,亦影响肠腑气机。小肠泌别清浊,大肠传导糟粕,二者均以通降为顺,且均依赖于胃气之通降,脾虚致中焦气机郁滞,胃气不降,气虚推动无力致肠腑传化失常,腑气不通,其传导、排泄糟粕之功减,则出现腹胀、排便不尽等症状表现。肠腑迂曲盘旋,传导失职,湿热浊毒易稽留期间,日久损伤肠道;脾主运化,脾虚运化失职,痰湿内生,下趋肠道,淤积日久化热,湿热内生,血败肉腐,故见粘液脓血便,腹痛等症。在临床上慢性复发型UC以脾虚为本,合并有气滞湿热的病机所在,活动期以邪实为主。脾主运化水湿,脾越虚,气滞越重,湿邪日渐积聚,致湿邪越重,而湿性重着粘滞,易于阻滞气机,进一步加重气机郁滞。湿易兼夹它邪而为病,湿阻日久,郁而化热,热郁湿蒸,留滞大肠,气滞、湿热相合,胶着难分,使得本病缠绵,难以速已。因此研制新的治疗溃疡性结肠炎的药物势在必行。According to the "Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018·Beijing)", UC is divided into primary and chronic relapsing types, and the chronic relapsing type is more common clinically. The characteristics of the disease are "repeated relapses and temporary recovery", long course of disease, repeated attacks, and remission periods of varying lengths. Most patients will enter the chronic relapsing UC stage as the disease progresses. "Suwen·Zangqi Fa Shi Lun" says: "For spleen disease, ... deficiency will cause abdominal distension, intestinal rumbling, diarrhea, and indigestion." "Jingyue Quanshu" also says: "The root of diarrhea is all due to the spleen and stomach." Spleen and stomach weakness, dampness, and qi stagnation are of great significance in the onset of UC. The disease process of chronic relapsing UC is a process of fighting between evil and righteousness. During the attack period, the spleen and stomach are often damaged by improper diet, external evil, emotional stimulation, etc., resulting in spleen dysfunction, endogenous phlegm and dampness, accumulation of dampness and heat, stagnation of qi and blood, and damage to the intestines, causing UC relapses. Repeated attacks of UC can aggravate spleen deficiency, so spleen deficiency is the root of UC and runs through the disease. Deficiency will inevitably lead to stagnation, and qi deficiency is unable to push, resulting in qi stagnation. "Medical Truth" says: "The power of ascending and descending lies in the middle qi. When the middle qi is strong, the spleen rises and the stomach descends, and the zang-fu organs rotate. When the middle qi is weak, the spleen is depressed and the stomach is reversed." UC recurs repeatedly, damaging the spleen and stomach, causing middle qi deficiency, qi stagnation, abnormal ascending and descending, obstruction of the movement of body fluids, and accumulation of dampness. In addition to affecting the qi of the middle jiao, weak spleen and stomach also affect the qi of the intestines and viscera. The small intestine separates the clear and turbid, and the large intestine transmits the dregs. Both are smooth when they descend, and both rely on the descending of stomach qi. Spleen deficiency causes qi stagnation in the middle jiao, and stomach qi does not descend. Qi deficiency is unable to push, resulting in abnormal intestinal and visceral transmission and transformation, and visceral qi is blocked. Its transmission and excretion of dregs are reduced, resulting in symptoms such as abdominal distension and incomplete defecation. The intestines are tortuous and the transmission is not in good working order. Damp-heat turbidity and toxins are easily retained during this period, which damages the intestines over time. The spleen is responsible for transportation and transformation. When the spleen is deficient and fails to transport and transform, phlegm and dampness are generated internally and move downward to the intestines. The stagnation of phlegm and dampness over time turns into heat. Damp-heat is generated internally, and blood is rotten and the flesh is rotten. Therefore, symptoms such as mucus, pus and blood in the stool and abdominal pain are seen. Clinically, chronic relapsing UC is based on spleen deficiency, combined with the pathogenesis of qi stagnation and dampness and heat. The active period is dominated by pathogenic factors. The spleen is responsible for transportation and transformation of water and dampness. The weaker the spleen, the more severe the qi stagnation. Dampness accumulates day by day, causing the dampness to become heavier. The heavy and sticky nature of dampness is easy to block the qi mechanism, further aggravating the stagnation of qi mechanism. Dampness is easy to be combined with other pathogens and cause disease. Dampness is blocked for a long time, and it turns into heat. Heat is stagnant and dampness steams, which stays in the large intestine. Qi stagnation, dampness and heat are combined, and it is difficult to distinguish them, making this disease lingering and difficult to cure quickly. Therefore, it is imperative to develop new drugs for the treatment of ulcerative colitis.
三、发明内容III. Summary of the invention
针对上述情况,为解决现有技术之缺陷,本发明之目的就是提供一种治疗溃疡性结肠炎的中药,可有效解决脾虚气滞兼湿热型溃疡性结肠炎的用药问题。In view of the above situation, in order to solve the defects of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine for treating ulcerative colitis, which can effectively solve the medication problem of ulcerative colitis of spleen deficiency, qi stagnation and damp-heat type.
本发明解决的技术方案是,该中药是由以下重量计的原料药物制成:木香10-15g、藿香10-15g、香附15-20g、炙黄芪15-30g、葛根10-15g、黄芩12-15g、黄连6-10g、马齿苋20-30g、紫草5-10g、鱼腥草5-10g、甘草3-5g,其中,将上述原料药物混合在一起,加水400-600ml,在18-25℃下,浸泡15-25分钟,然后武火烧开,再转文火,煎煮20-30min,过滤,得滤液,备用;滤渣加水300-400ml,武火烧开后,转文火,煎煮10-15min,过滤,弃去滤渣,得滤液,合并两次滤液,浓缩至两次加水量的1/2~1/3,即得。The technical solution of the present invention is that the traditional Chinese medicine is prepared from the following raw materials by weight: 10-15g of costusroot, 10-15g of patchouli, 15-20g of cyperus, 15-30g of roasted astragalus, 10-15g of kudzu root, 12-15g of scutellaria, 6-10g of coptis root, 20-30g of purslane, 5-10g of lithospermum, 5-10g of houttuynia, and 3-5g of liquorice, wherein the above raw materials are mixed in Together, add 400-600ml of water, soak for 15-25 minutes at 18-25℃, then boil over high heat, then turn to low heat, boil for 20-30min, filter, and obtain the filtrate for later use; add 300-400ml of water to the residue, boil over high heat, then turn to low heat, boil for 10-15min, filter, discard the residue, and obtain the filtrate, combine the two filtrates, and concentrate to 1/2~1/3 of the amount of water added twice.
本发明原料丰富,制备方法简单,成本低,易服用,效果好,在治疗上通补兼施,以通为主。通即疏通,寓“通因通用”之意,UC为病多存在肠腑湿热内蕴,气滞血瘀等失通的病机,结合“六腑以通为用,以降为顺”的生理特点,在治疗上采用“通因通用”之法,运用具有通利气机,清热化湿之品,邪去则正安,使脾胃升降有序,腑气通调,是治疗脾虚气滞兼湿热型溃疡性结肠炎药物上创新。The invention has abundant raw materials, simple preparation method, low cost, easy to take, good effect, and is used for both dredging and tonifying in treatment, with dredging as the main method. Dredging means unblocking, which implies the meaning of "dredging for the general purpose". UC is a disease with internal damp-heat in the intestines and viscera, qi stagnation and blood stasis and other pathological disorders. Combined with the physiological characteristics of "the six viscera are used for dredging and descending for compliance", the method of "dredging for the general purpose" is adopted in treatment, and products with the functions of dredging qi, clearing away heat and removing dampness are used. When the evil is removed, the body is at peace, the spleen and stomach rise and fall in order, and the visceral qi is regulated. It is an innovation in the medicine for treating spleen deficiency, qi stagnation and damp-heat type ulcerative colitis.
四、具体实施方式4. Specific implementation methods
以下结合实施例对本发明的具体实施方式作进一步详细说明。The specific implementation modes of the present invention are further described in detail below in conjunction with the embodiments.
实施例1Example 1
本发明在具体实施时,可由以下重量计的原料药物制成:木香10g、藿香10g、香附15g、炙黄芪15g、葛根10g、黄芩12g、黄连6g、马齿苋20g、紫草5g、鱼腥草5g、甘草3g,其中,将上述原料药物混合在一起,加水400ml,在18℃下,浸泡15分钟,然后武火烧开,再转文火,煎煮20min,过滤,得滤液,备用;滤渣加水300ml,武火烧开后,转文火,煎煮10min,过滤,弃去滤渣,得滤液,合并两次滤液,浓缩至两次加水量的1/2,即得。When the present invention is implemented, it can be prepared from the following raw materials by weight: 10g of costusroot, 10g of patchouli, 15g of cyperus, 15g of roasted astragalus, 10g of kudzu root, 12g of scutellaria, 6g of coptis, 20g of purslane, 5g of lithospermum, 5g of houttuynia, and 3g of liquorice, wherein the raw materials are mixed together, 400ml of water is added, and the mixture is soaked at 18°C for 15 minutes, then boiled over high heat, then turned to low heat, decocted for 20 minutes, filtered, and a filtrate is obtained for standby use; 300ml of water is added to the filter residue, boiled over high heat, then turned to low heat, decocted for 10 minutes, filtered, the filter residue is discarded, a filtrate is obtained, the two filtrates are combined, and concentrated to 1/2 of the amount of water added twice, thereby obtaining the product.
实施例2Example 2
本发明在具体实施时,还可由以下重量计的原料药物制成:木香12g、藿香12g、香附17g、炙黄芪22g、葛根12g、黄芩13g、黄连8g、马齿苋25g、紫草7g、鱼腥草7g、甘草4g,其中,将上述原料药物混合在一起,加水500ml,在21℃下,浸泡20分钟,然后武火烧开,再转文火,煎煮25min,过滤,得滤液,备用;滤渣加水350ml,武火烧开后,转文火,煎煮12min,过滤,弃去滤渣,得滤液,合并两次滤液,浓缩至两次加水量的1/3,即得。When the present invention is implemented, it can also be prepared from the following raw materials by weight: 12g of costusroot, 12g of patchouli, 17g of cyperus, 22g of roasted astragalus, 12g of kudzu root, 13g of scutellaria, 8g of coptis, 25g of purslane, 7g of lithospermum, 7g of houttuynia, and 4g of liquorice, wherein the raw materials are mixed together, 500ml of water is added, and the mixture is soaked at 21°C for 20 minutes, then boiled over high heat, then turned to low heat, decocted for 25 minutes, filtered, and a filtrate is obtained for standby use; 350ml of water is added to the filter residue, boiled over high heat, then turned to low heat, decocted for 12 minutes, filtered, the filter residue is discarded, a filtrate is obtained, the two filtrates are combined, and concentrated to 1/3 of the amount of water added twice.
实施例3Example 3
本发明在具体实施时,还可由以下重量计的原料药物制成:木香15g、藿香15g、香附20g、炙黄芪30g、葛根15g、黄芩15g、黄连10g、马齿苋30g、紫草10g、鱼腥草10g、甘草5g,其中,将上述原料药物混合在一起,加水600ml,在25℃下,浸泡25分钟,然后武火烧开,再转文火,煎煮30min,过滤,得滤液,备用;滤渣加水400ml,武火烧开后,转文火,煎煮10-15min,过滤,弃去滤渣,得滤液,合并两次滤液,浓缩至两次加水量的1/3,即得。When the present invention is implemented, it can also be prepared from the following raw materials by weight: 15g of costus root, 15g of patchouli, 20g of cyperus, 30g of roasted astragalus, 15g of kudzu root, 15g of scutellaria, 10g of coptis root, 30g of purslane, 10g of lithospermum, 10g of houttuynia, and 5g of liquorice, wherein the raw materials are mixed together, added with 600ml of water, soaked at 25°C for 25 minutes, then boiled over high heat, then turned to low heat, decocted for 30min, filtered, and filtrate was obtained for standby use; 400ml of water was added to the filter residue, boiled over high heat, then turned to low heat, decocted for 10-15min, filtered, the filter residue was discarded, a filtrate was obtained, the two filtrates were combined, and concentrated to 1/3 of the amount of water added twice.
本发明上述药物的有效组合,互相支持,并经科学制备,具有理气健脾,清热利湿之功,方中木香调和诸气,芳香又可醒脾,能促进气机调畅,助脾气健运;香附具理气解郁止痛之功效,“得木香则疏滞和中”,香附、木香,一疏胃肠气闭,一疏肝胃气滞,两者共用以疏调三焦气机;藿香理气和中,醒脾助运,芳化湿浊,能够去除中焦痰湿。三者为君药,共用以疏通脾,胃肠腑气机,醒脾助运,葛根、黄芩、黄连为治疗湿热证UC的常用药物,功用清热利湿,止泻止痢共用为臣。黄芪具补气之功,炙用则加强补中气之功,运用炙黄芪补益中焦脾气以固本,脾胃健运则气机流通,湿邪无由可生;此外,黄芪具敛疮生肌之功,有助于促进肠道溃疡愈合;马齿苋、鱼腥草、紫草助清热凉血,祛除湿热浊毒之邪共用为佐。甘草调和诸药为使,且有健脾补气之功。全方通补兼施,以通为主,通即疏通脾胃肠腑气机,去除湿热之邪;补即补脾以固护后天之本,并经实验取得了非常好的有益技术效果,相关实验资料如下:The effective combination of the above drugs of the present invention supports each other and is scientifically prepared. It has the functions of regulating qi and strengthening the spleen, clearing away heat and removing dampness. The costus root in the prescription harmonizes various qi, and its fragrance can also wake up the spleen, promote the smooth flow of qi, and help the spleen function; Cyperus rotundus has the effect of regulating qi, relieving depression and relieving pain, "with costus root, stagnation and harmonizing the middle", Cyperus rotundus and costus root, one relieves gastrointestinal qi stagnation, and the other relieves liver and stomach qi stagnation, and the two are used together to regulate the qi of the three burners; Patchouli regulates qi and harmonizes the middle, wakes up the spleen and helps function, and aromaticizes dampness and turbidity, and can remove phlegm and dampness in the middle burner. The three are monarch drugs, and are used together to dredge the spleen, gastrointestinal viscera qi, wake up the spleen and help function, and Pueraria root, Scutellaria baicalensis, and Coptis chinensis are commonly used drugs for treating damp-heat syndrome UC, and their functions are clearing heat and removing dampness, stopping diarrhea and dysentery, and they are used together as ministers. Astragalus has the function of replenishing qi, and roasting it can strengthen the function of replenishing the middle qi. Roasting Astragalus can replenish the spleen qi in the middle jiao to consolidate the foundation. When the spleen and stomach are healthy, the qi can flow smoothly and dampness cannot be generated. In addition, Astragalus has the function of astringing sores and promoting tissue regeneration, which helps to promote the healing of intestinal ulcers. Purslane, Houttuynia cordata, and Lithospermum officinale can help clear heat and cool blood, and can be used as adjuvants to remove dampness, heat, turbidity and toxins. Licorice is used to harmonize the various medicines, and it has the function of strengthening the spleen and replenishing qi. The whole prescription is used for both unblocking and replenishing, with unblocking as the main method. Unblocking means unblocking the spleen, stomach, intestines and qi, and removing dampness and heat; replenishing means replenishing the spleen to protect the acquired foundation, and experiments have achieved very good beneficial technical effects. The relevant experimental data are as follows:
1病例来源1 Case source
本研究选择2021年12月-2022年12月河南中医药大学第一附属医院消化科住院部就诊的62例慢性复发型活动期轻中度(脾虚气滞兼湿热型)UC患者作为研究对象。This study selected 62 patients with chronic relapsing active mild to moderate (spleen deficiency, qi stagnation and damp-heat type) UC who visited the inpatient department of the Department of Gastroenterology of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from December 2021 to December 2022 as the research subjects.
2诊断标准2 Diagnostic criteria
2.1西医诊断标准参照《溃疡性结肠炎中西医结合诊疗共识意见(2017)》2.1 Western medicine diagnostic criteria refer to the "Consensus on the diagnosis and treatment of ulcerative colitis with integrated Chinese and Western medicine (2017)"
1)临床表现:①疾病活动期以腹痛、腹泻、粘液脓血便、里急后重为主,症状多反复,病程多大于4-6周;②病情严重或急性起病时可伴有不同程度全身症状;③肠外表现多发生于皮肤、关节、眼等部位。1) Clinical manifestations: ① During the active phase of the disease, symptoms include abdominal pain, diarrhea, bloody and mucus-purulent stools, and tenesmus. The symptoms often recur, and the course of the disease is usually longer than 4-6 weeks. ② When the disease is severe or acute, it may be accompanied by systemic symptoms of varying degrees. ③ Extraintestinal manifestations often occur in the skin, joints, eyes, and other parts of the body.
2)结肠镜检查:①肠黏膜损伤多呈连续性、倒灌性,逆行向近端发展;病变起于直肠;②内镜下可见不同程度黏膜损伤,表现为红斑、充血、水肿、糜烂、自发性出血或接触性出血;黏膜血管纹理模糊甚至形态消失;黏膜表面粗糙,呈细颗粒状;③可见结肠袋囊变浅、变钝或消失,假息肉形成。2) Colonoscopy: ① Intestinal mucosal damage is mostly continuous and backwash, developing retrogradely toward the proximal end; the lesions originate from the rectum; ② Endoscopic examination shows varying degrees of mucosal damage, manifested as erythema, congestion, edema, erosion, spontaneous bleeding or contact bleeding; the mucosal vascular texture is blurred or even disappears; the mucosal surface is rough and granular; ③ The colonic pouches may become shallower, blunt or disappear, and pseudopolyps may form.
3)黏膜组织学检查:活动期病理表现主要为:①固有膜内有大量急慢性炎性细胞浸润,存在隐窝炎、隐窝脓肿;②隐窝结构改变,形态、大小不规则,排列紊乱,杯状细胞减少等;③可见黏膜表面糜烂、浅溃疡形成和肉芽组织。3) Mucosal histological examination: The main pathological manifestations in the active stage are: ① There are a large number of acute and chronic inflammatory cell infiltrations in the lamina propria, and there are crypt inflammation and crypt abscesses; ② The crypt structure is changed, with irregular shape and size, disordered arrangement, and a decrease in goblet cells; ③ Erosion, shallow ulcer formation and granulation tissue can be seen on the mucosal surface.
疾病的确诊需同时满足以上三项诊断标准,且排除其他类型肠病。The diagnosis of the disease requires that the above three diagnostic criteria are met at the same time and other types of intestinal diseases are excluded.
2.2中医诊断标准2.2 TCM diagnostic criteria
参照《溃疡性结肠炎中西医结合诊疗共识意见(2017)》、《中药新药临床研究指导原则(试行)》结合临床拟定:With reference to the "Consensus on the Diagnosis and Treatment of Ulcerative Colitis with Integrated Traditional Chinese and Western Medicine (2017)" and "Guidelines for Clinical Research of New Chinese Medicines (Trial)", the following was formulated in combination with clinical practice:
脾虚气滞兼湿热证:Spleen deficiency, qi stagnation and damp-heat syndrome:
主症:①腹泻;②粘液脓血便;③腹胀;④腹痛;⑤里急后重Main symptoms: ① diarrhea; ② bloody stool with mucus and pus; ③ abdominal distension; ④ abdominal pain; ⑤ tenesmus
次症:①纳差;②乏力;③肠鸣矢气;④便而不爽;⑤肛门灼热,舌脉:舌质淡红或红,苔白厚或黄厚,脉弦细或弦滑。Secondary symptoms: ① poor appetite; ② fatigue; ③ intestinal rumbling and flatulence; ④ uncomfortable bowel movements; ⑤ burning sensation in the anus. Tongue and pulse: pale red or red tongue, thick white or thick yellow tongue coating, thin or slippery stringy pulse.
证型确定:具备主症3项加次症3项,参考舌脉,即可诊断。Determination of syndrome type: diagnosis can be made by presenting 3 main symptoms plus 3 secondary symptoms, referring to the tongue and pulse.
3纳入标准3 Inclusion criteria
1)符合慢性复发型活动期轻中度UC的西医诊断标准(改良Mayo评分3-10分);1) Meet the Western medical diagnostic criteria for chronic relapsing active mild to moderate UC (modified Mayo score 3-10 points);
2)中医诊断辨证为脾虚气滞兼湿热型;2) TCM diagnosis of spleen deficiency, qi stagnation and dampness-heat type;
3)年龄:18岁≤年龄≤70岁,男女不限;3) Age: 18 ≤ ≤ 70 years old, regardless of gender;
4)患者依从性好,愿意接受电话、门诊随访,自愿参与本研究,且签订“知情同意书”。4) The patient has good compliance, is willing to accept telephone and outpatient follow-up, voluntarily participates in this study, and signs the "Informed Consent Form".
4排除标准4 Exclusion criteria
1)明确诊断为感染性结肠炎、缺血性肠炎、克罗恩病、放射性肠炎等其他肠病患者;1) Patients with a clear diagnosis of infectious colitis, ischemic enteritis, Crohn's disease, radiation enteritis or other intestinal diseases;
2)合并严重并发症如局部狭窄、肠梗阻、中毒性巨结肠、大出血、肠穿孔、(直)结肠癌患者;2) Patients with severe complications such as local stenosis, intestinal obstruction, toxic megacolon, massive bleeding, intestinal perforation, and (rectal) colon cancer;
3)妊娠期、哺乳期妇女,近期有生育计划的患者;3) Pregnant and lactating women, and patients who have plans to have children in the near future;
4)使用其他如免疫抑制剂等影响疗效观察的西药;4) Use of other western medicines such as immunosuppressants that may affect the efficacy observation;
5)具有严重的心、肝、肺、脑、肾、血液系统疾病者,如肿瘤、急性脑出血、急慢性心力衰竭等;5) Those with serious heart, liver, lung, brain, kidney, and blood system diseases, such as tumors, acute cerebral hemorrhage, acute and chronic heart failure, etc.;
6)对本实验所用药物过敏者;6) Those who are allergic to the drugs used in this experiment;
7)同时参与其他课题试验者;7) Participating in other research projects at the same time;
8)患有严重精神心理或智力障碍疾病,无法配合者。8) Those who suffer from severe mental or intellectual disabilities and are unable to cooperate.
其中有任意一项符合即排除。If any of the above items are met, it will be excluded.
5剔除标准5. Elimination criteria
1)依从性差,纳入后不按医嘱服药,无法判定其疗效者;1) Those with poor compliance, who do not take medication as prescribed after inclusion, and whose efficacy cannot be determined;
2)因病情变化改变治疗方案者;2) Those whose treatment plan is changed due to changes in their condition;
3)联合使用其他对实验影响较大的药物;3) Use other drugs that have a significant impact on the experiment;
4)出现过敏反应。4) Allergic reaction occurs.
6脱落标准6 Shedding Standard
1)治疗期间因个人原因自行退出者;1) Those who voluntarily withdraw from treatment due to personal reasons;
2)病历资料不全,无法完成统计分析者。2) Patients whose medical records are incomplete and statistical analysis cannot be completed.
如有以上情况者,详细记录脱落原因及时间。If any of the above situations occur, please record the cause and time of shedding in detail.
7研究分组7 Research Groups
选择2021年12月-2022年12月河南中医药大学第一附属医院消化内科住院部就诊的62例慢性复发型活动期轻中度(脾虚气滞兼湿热型)UC患者作为研究对象。按照就诊顺序从1至62对患者进行编号,运用SPSS27.0生成随机数,按随机分组原则将患者分至治疗组和对照组,每组各31例。A total of 62 patients with chronic relapsing active mild-to-moderate UC (spleen deficiency, qi stagnation and damp-heat type) who visited the Department of Gastroenterology of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from December 2021 to December 2022 were selected as the research subjects. The patients were numbered from 1 to 62 according to the order of visit, and random numbers were generated using SPSS27.0. The patients were divided into the treatment group and the control group according to the random grouping principle, with 31 cases in each group.
8药物治疗8. Medication
对照组:美沙拉嗪肠溶片(250mg×24片,国药准字H19980148,葵花药业集团佳木斯鹿灵制药有限公司),4g/d,分别于三餐及睡前分次口服,1g/次。Control group: mesalazine enteric-coated tablets (250 mg × 24 tablets, national medicine standard number H19980148, Kuihua Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.), 4 g/d, taken orally in divided doses before meals and bedtime, 1 g/time.
治疗组:美沙拉嗪肠溶片(具体用法同对照组)联合本发明中药实施例1,早晚各1次,每次200-300ml。Treatment group: Mesalazine enteric-coated tablets (specific usage is the same as the control group) combined with Chinese medicine Example 1 of the present invention, once in the morning and once in the evening, each time 200-300 ml.
对照组与治疗组均7天为1个疗程,4个疗程后统计疗效。One course of treatment for both the control group and the treatment group was 7 days, and the efficacy was statistically analyzed after 4 courses of treatment.
9疗效评定标准9. Efficacy evaluation criteria
采用《积分法在慢性溃疡性结肠炎诊断分级和疗效评定中的应用研究》中的评分方法(见表1),并以下述公式来评判疗效:The scoring method in the "Study on the Application of Integral Method in the Diagnosis and Grading of Chronic Ulcerative Colitis and Evaluation of Efficacy" (see Table 1) was used, and the efficacy was evaluated by the following formula:
疗效判定值=疗前积分—疗后积分/疗前积分×100%Efficacy judgment value = pre-treatment score - post-treatment score / pre-treatment score × 100%
疗效标准如下:显效:判定值>2/3,有效:1/3<判定值<2/3,无效:判定值<1/3。The efficacy standards are as follows: markedly effective: judgment value > 2/3, effective: 1/3 < judgment value < 2/3, ineffective: judgment value < 1/3.
表1评分标准Table 1 Scoring criteria
10临床疗效评价10 Clinical efficacy evaluation
经统计治疗组无效2例,有效11例,显效16例,临床痊愈2例,总有效率为93.5%,对照组无效7例,有效17例,显效7例,临床痊愈0例,总有效率为77.4%,该组数据为有序等级资料,使用Mann-Whitney U检验,经检验,▲P<0.05,两组间差异有统计学意义,且治疗组疗效优于对照组。According to statistics, there were 2 ineffective cases, 11 effective cases, 16 markedly effective cases, 2 clinically cured cases in the treatment group, and the total effective rate was 93.5%. There were 7 ineffective cases, 17 effective cases, 7 markedly effective cases, 0 clinically cured cases in the control group, and the total effective rate was 77.4%. This group of data was ordered rank data, and the Mann-Whitney U test was used. After testing, ▲ P<0.05, the difference between the two groups was statistically significant, and the therapeutic effect of the treatment group was better than that of the control group.
临床疗效评价[n(%)]Clinical efficacy evaluation [n(%)]
在对上述实施例1实验的同时,对其它实施例也做了同样的实验,均取得了相同或相近似的结果,这里不再一一列举,而且在实验中没有发现任何不良反应,表明用药安全,疗效稳定可靠。While conducting the experiment on the above-mentioned Example 1, the same experiment was also conducted on other examples, and the same or similar results were obtained, which will not be listed here one by one. In addition, no adverse reactions were found in the experiments, indicating that the medication is safe and the efficacy is stable and reliable.
结论in conclusion
由上述可以看出,本发明原料丰富,制备方法简单,易服用,成本低,效果好,组分之间互相支持,具有理气健脾,清热利湿之功效,全方通补兼施,以通为主,通即疏通脾胃肠腑气机,去除湿热之邪;补即补脾以固护后天之本。不仅疗效稳定,且远期疗效好,不容易反复,易被患者接受,有效用于治疗脾虚气滞兼湿热型溃疡性结肠炎,以简、便、廉、验为特点的本发明三香排气饮不仅符合溃疡性结肠炎的发病规律,而且符合中医通补兼施的理论,是治疗溃疡性结肠炎药物上的创新,经济和社会效益巨大。As can be seen from the above, the present invention has abundant raw materials, simple preparation method, easy to take, low cost, good effect, components support each other, has the effects of regulating qi and strengthening spleen, clearing away heat and removing dampness, and the whole prescription is used for both dredging and replenishing, with dredging as the main method, dredging is to dredge the spleen, stomach, intestines and viscera qi mechanism, and remove damp-heat evil; replenishing is to replenish the spleen to protect the acquired foundation. Not only is the efficacy stable, but also the long-term efficacy is good, it is not easy to recur, and it is easily accepted by patients, and is effectively used to treat spleen deficiency, qi stagnation and damp-heat type ulcerative colitis. The three-fragrant decoction of the present invention, which is simple, convenient, cheap and effective, not only conforms to the pathogenesis of ulcerative colitis, but also conforms to the theory of both dredging and replenishing in traditional Chinese medicine, and is an innovation in the treatment of ulcerative colitis medicine, with huge economic and social benefits.
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