三仁汤加减治疗湿热内蕴型功能性消化不良的临床疗效及机理研究
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摘要
功能性消化不良(functional dyspepsia, FD)是一种常见的功能性胃肠道疾病,具有上腹疼痛或不适(包括上腹饱胀、早饱、恶心呕吐、烧灼感、嗳气以及难以描述的上腹部不适感)等症状。根据消化不良症状的病因,可分为器质性消化不良和功能性消化不良,本文所研究的是经检查排除了消化性溃疡、反流性食管炎、上消化道肿瘤等器质性疾病的“功能性消化不良”。此病约占胃肠道专科门诊患者的1/3以上,症状可持续发作或反复发作,但规定病程一般超过1个月以上。FD的病因目前尚未完全阐明,主要有胃排空的延迟、胃容受扩张能力的下降及内脏的敏感性增强、感染因素、精神心理因素、遗传易感性和某些胃肠激素等相关。西医治疗以服用促胃肠动力药、西甲硅油乳剂、抗焦虑和抑郁药物、抑制胃酸分泌药及根除幽门螺杆菌(Hp)为主。由于患者常有诸多症状,但多次接受检查,均无无结构或器质性病变,或可解释症状的依据,常多处就医,服用多种药物,疗效不一定满意,严重影响着患者和家人的身心健康,消耗了大量的医疗资源。
中医虽然没有功能性消化不良的病名,按其临床症状,可归属于祖国医学中“痞满”、“嘈杂”、“泛酸”、“胃痛”等范畴。然而其主要病位在胃及以上腹部饱胀、早饱、疼痛或不适等胃肠道运动障碍的主要临床表现特点与祖国医学的“痞满”最为相似,因此现代医学研究,一般将FD归为传统医学“痞满”一证加以论述。早在《黄帝内经》就有本病的记载,称为痞、满、痞塞、痞膈等,历经二千多年,积累了丰富的治疗经验。且现代研究证实中医药治疗FD为多靶点治疗,不良反应少,所以对中医药治疗功能性消化不良临床疗效的研究符合临床实际需要,且具有良好的经济效益和社会效益。本病的发生多为内外因相互作用而致。外因是由于感受寒邪、湿邪、热邪等,内因则由于情志失调、脾胃虚弱等致气机不运,升降失调。临床可见脾胃虚寒、肝郁气滞、胃阴亏.虚、痰浊中阻、饮食停滞等多种证型,而临床因湿热气候或过食肥甘厚味而致湿热内蕴型功能性消化不良在岭南多见。因湿热为病多以脾胃为病变中心,故治湿方临床多被用于治疗消化系统疾病,且疗效显著。
三仁汤出自温病大家吴鞠通《温病条辨》,由杏仁、飞滑石、白通草、白蔻仁竹叶、厚朴、生薏仁、半夏组成,《温病条辨·上焦·湿温》43条说：“头痛恶寒,身重疼痛,舌白不渴,脉弦细而濡,面色淡黄,胸闷不饥,午后身热,状若阴虚,病难速已,名曰湿温。汗之则神昏耳聋,甚则目瞑不欲言,下之则洞泄,润之则病深不解,长夏深秋冬日同法,三仁汤主之。”方中杏仁宣利上焦肺气,正如吴鞠通自注中说：“惟以三仁汤轻开上焦肺气,盖肺主一身之气,气化则湿亦化也”；白蔻仁芳香化湿,行气宽中,畅中焦之脾气；薏苡仁甘淡性寒,利湿清热而健脾,可以疏导下焦,使湿热从小便而去。配伍滑石之甘淡性寒,利湿清热而解暑；通草,竹叶甘寒淡渗,以助清利湿热之力；半夏、厚朴辛苦性温,行气化湿,散结除痞,既助行气化湿之功,又使诸药寒凉而不碍湿。诸药相合,宣上、畅中、渗下,使湿热之邪从三焦分消,则诸症自解。本方原为湿温初起而设,但是在现代临床其使用范围却越来越广,涉及隶属于内科、儿科、妇科、皮肤科等科系的各类疾病,并且取得了令人满意的疗效,其中消化系统疾病占了相当大的比例。究其原因,湿热之为病,乃“太阴内伤,湿饮停聚,客邪再至,内外相引,故病湿热”,以脾胃为病变中心,多有脾胃内伤,故治疗湿热方常可用来治疗脾胃病,正如《谦斋医学讲稿》说：“三仁汤为湿温证的通用方。它的配伍,用杏仁辛宣肺气,以开其上；蔻仁、厚朴、半夏苦辛温通,以降其中；薏苡仁、通草、滑石淡渗湿热,以利其下。虽然三焦兼顾,其实偏重中焦。”临床上根据其清利湿热,宣畅气机功能,许多医家用之治疗消化系统疾病疾病见湿热内阻,气机不畅之证,疗效显著,但对其治疗功能性消化不良的疗效尚缺乏大样本观察及机理研究。
本研究首先采用文献评述的形式对功能性消化不良的古代文献与现代研究进行整理,分析功能性消化不良的证型特点与临床治疗现状,以期总结功能性消化不良的中医辨证规律,以便更好地指导临床实践和进一步提高临床疗效,为丰富和完善因地制宜的中医理论提供临床及理论依据。然后通过将辨病为功能性消化不良患者根据中医辨证属湿热内蕴证者纳入临床观察病例,随机分为中药三仁汤治疗组与西药西沙比利治疗对照组,比较分析两组患者的临床症状积分及实验指标的异同,探讨三仁汤治疗中医辨证属湿热内蕴证型功能性消化不良的作用机理,为其进一步临床运用及推广提供科学依据。
目的
科学客观地评价运用三仁汤加减治疗湿热内蕴证型功能性消化不良的临床疗效及其安全性,探讨其作用机理,为其临床进一步推广应用提供科学的临床及理论依据。
方法
选取病证诊断标准及自拟湿热内蕴证诊断标准符合2002年5月国家药品监督管理局颁布的《中药新药临床研究指导原则(试行)》“痞满”、且西医诊断为功能性消化不良的患者例80例,采用查随机数字表的完全随机化方法随机分为治疗组50例,对照组30例,治疗组服用加减三仁汤(杏仁9g、白蔻仁9g、薏苡仁18g、厚朴9g、半夏12g、茯苓15g、陈皮6g、黄芩6g、白芍9g、竹叶6g),对照组服用西沙比利片,统计两组治疗前后症候积分、中医证候疗效、胃排空功能,检测外周血胃动素(MOT)、胃泌素(GAS)值。结果采用SPSS13.0统计软件分析,根据不同资料采用不同的统计方法如分类资料选用χ2检验,两样本均数比较采用t检验或秩和检验,自身前后比较运用配对t检验或Wilcoxon配对秩和检验,等级资料采用Raddit分析。
结果
1、从临床观察显示,两组治疗后各项症状、体征均有明显改善作用,且与治疗前比较有统计学差异(P<0.05)。治疗后两组比较,对胃脘痞满、食欲减退、口苦或粘、口干舌燥、口渴不欲饮、全身及四肢困重、大便稀溏的改善作用差异无统计学意义(P≥0.05)；对恶心呕吐的改善作用差异有统计学意义,治疗组优于对照组(P<0.05)。
2、与治疗前比较,治疗组治疗后MTL、GAS均升高,而且差异有统计学意义(P<0.05)；治疗后两组之间比较,MTL差异无统计学意义(P>0.05),但GAS差异有统计学意义(P>0.05),对照组明显高于治疗组。
3、两组均能促进患者胃排空,对照组总有效率(76.7%)大于治疗组(72.0%),但经检验,两组间胃排空疗效比较差异无统计学意义(P>0.05)。
4、治疗后治疗组的总有效率(92.0%)大于对照组的总有效率(80.0%),但两组疗效比较无统计学差异(P>0.05)。
5、治疗期间两组患者均无明显的不适及不良反应,治疗前后三大常规及肝肾功能等实验室指标检测结果均未见明显异常改变。临床观察表明两组的药物均具有较好的安全性。
结论
从临床观察显示,三仁汤组治疗后的主要临床症状、体征均有较为明显的改善,且与治疗前相比有统计学差异(P<0.05)。对恶心呕吐的改善作用优于对照组(P<0.05),可能与方中半夏、厚朴降逆止呕较强有关。三仁汤还可促进患者胃排空,可能与方中厚朴、白豆蔻、陈皮等促进胃肠蠕动功能相关。实验结果显示,三仁汤加减能提高患者血清MTL、GAS含量,提示其可能通过促进胃肠运动、刺激胃酸等的分泌,从而达到改善患者消化功能效果。本课题研究提示中医药清热利湿为功能性消化不良湿热内蕴证的重要治疗法则,但由于时间比较紧迫和自身精力等方面的限制,本实验只是对三仁汤加减治疗湿热内蕴型功能性消化不良做了相对简单的临床症状、体征等观察和相关实验室指标检测,且无临床长期随访监测,故尚不能深刻揭示三仁汤加减治疗功能性消化不良的机理。且目前尚无统一的功能性消化不良湿热内蕴证的临床观测指标,期望在以后的研究中得以逐步加强和完善。所以,本人认为应深入对此病在病因、发病机制等方面研究的基础上,进一步深化研究,建立比较完善统一的临床观测指标,建立更为理想的动物实验模型,拓展研究范围。
Functional dyspepsia is one of common functional diseases in gastrointestinal tact。According to statistics it accounts for one-three of gastrointestinal outpatients. It has clinical syndrome including upper abdominal pain, epigastric distention, early full, belching, poor appetite, nausea, vomiting and so on without organic disease which can cause those syndrome. Its course is more than one month and its symptoms last or recurrent attack. Etiology of functional dyspepsia is unknown, and according to current reports, its occur is mainly related with delay of gastric emptying, decrease of gastric accommodation capacity expansion, increase of gastric sensitivity, infection, psycho-mental factors, genetic predisposition and some gut hormone.It's treated by gastrointestinal dynamic promoting drugs, Simethicone Emulsion, antianxiety, antidepression, antisecrettory of gastric acid and eradication of helicobacter pylori. Patients always have a lot of symptoms, see different doctors and have many kinds of medicines without organic disorders and bases to explain symptoms, so it is no satisfied effects and impacts patients' and family members' physical and mental health. It expends large quantity of medicine resources.
Though there is no the disease of functional dyspepsia, according to it's manifestation, it belongs to "distention and fullness","stomach pain","gastric upset","pantothenic acid" and so on. It is always classified as distention and fullness" to discuss because the main clinic characteristics is upper gastric discomfort, abdominal distention and early full.
It's reported in "Huangdi's Internal Classics" as "Pi"、"Mang""Pimang"、"Pige" and so on. To this day,
There are plenty of therapeutic experiences in about2,000years and multitarget therapy without side effect in modern pharmocology and clinical research, so the curative effect observation on treating functional dyspepsia by tradition Chinese medicine and pharmacy answers for clinical need and will have good social and financial benefits. It occurs by interaction of endopathic and exopathic factors. Its exopathogen is cold, damp and heat devil while endopathic is sentiment imbalance and weakness of the spleen and stomach. There are the syndromes of deficiency-cold of spleen and stomach, stagnation Qi due to liver depression, deficiency of spleen Yin, stagnation of turbid phlegm in middle-Jiao, retention of food and drink, et al. There are much more the syndrome with endoretention of damp and heat in Southe of the five ridges because of damp and heat climate and over-eating of fat and sweet food. The spleen and stomach is the pathological center of damp and heat, so the prescription to damp is always used to treat diseases of digestive system and have significant effects.
Three-seed Decotion appears in Detailed Analysis of Epidemic Warm Diseases wrriten by Wu Jutong. It's composed of Xingren, Huashi, Tongcao, Baikouren, Zhuye, Houpu, Yiren and Banxia. It's set up to treat the beginning in damp thermosis, which shows headache, aversion to cold, light complexion, heavy and pain in body, fever in the afternoon, chest distress and no hungry. But prescriptions to treat damp and heat can be used to treat diseases of spleen and stomach, it's pathological center spleen and stomach and always has the deficiency of spleen and stomach. According to its function of clear damp and heat and smooth Qi activity, It was used to treat disease of digestive system with endoretention of damp and heat and Qi stagnation and had significant curative effect. But there was no observation of large sample and mechanism study.
Firstly, we analyzed the characteristic of functional dyspepsia's syndrome and current situation of therapy for summarize differentiating rules in order to improve clinical therapeutic effects and enhance theory of environmen concerned therapy.
Secondly, we observed the clinical efficacy of the Functional Dyspepsia with Damp-heat syndrome treated by the Modified Three-seed Decoction to exploit its mechanism of action and provide scientific foundation for its clinical use.
Objective
To estimate the clinical effect and safty of modified Sanren dectotion in treatment functional dyspepesia with damp-heat syndrome and establish foundation for further clinical and theoretical study.
Method
Objects meet with the differentiation standard of damp-heat syndrome and diagnostic criteria of Pimang and functional dyspepsia. Objects were devided into the treatment modified Sanren dectotion and the control group with Cisapride. Examined and compared the clinical efficacy, therapeutic effect of TCM syndrome, and function of gastric emptying, to evaluate the scores of motilin and gastrin in peripheral blood. Grouped data was analyzed by X2test and ranked data was analyzed by rank sum test. Two sample means and were compared by t test or rank sum test. Self circa were compared by matched-pairs t test or rank sum test.
Result
1. After treatment, signs and symptoms in two groups had meliorated obviously, the difference was significant comparing with before treatment. Between two groups, the difference wasn't significant in amendment of stomach full, poor appetite, bitter or sticking taste of mouth, dry mouth and tongue, thirsty without drink desire, heavy body and limbs, loose stool and so on. The treatment group had more effective than the control group in meliorating nausea and vomiting and the difference was significant.
2. After treatment, MTL and GAS in treatment group had increased obviously, the difference was significant comparing with before treatment. The difference of MTL wasn't significant between two groups after treatment, but the difference of GAS was significant.
3. The gastric emptying in two groups had been promoted and total rate in control group (76.7%) was higher than in treatment group (72.0%), but the difference wasn't significant after test (P>0.05)
4. The total effective rate in treatment group (92.0%) was higher than in control group (80.0%), but the difference wasn't significant after test (P>0.05)
5. All paitents had no side effects and abnormal changes in the index of blood, urina, excrement and liver and kidney function. Clinical research showed that both of drugs had high safty.
Conclusion
The results show that the Modified Sanren Decoction can meliorate sings and symptoms obviously, the difference was significant comparing with before treatment (P<0.05). It's improvement to nausea and vomiting surpassed to Cisapride and can improve gastric emptying and had a notable clinical effect.
The Modified Sanren Decoction increased the scores of MTL、GAS, which suggested that it can promote gastrointestinal motility and stimulate gastric acid secretion to improve digestive function. This study showed cleaning away heat and promoting damp is the key therapeutical rule of treating functional dyspepsia, but this study can't bring to light the therapeutical mechanism because just simple clinical observation and index and without long term follow-up visit and monitoring. There aren't unified index to observe functional syspepsia so experiments about it have poor repetitive. We shall study further and wider and set up unified index and establish more perfect animal experiment model.
中医虽然没有功能性消化不良的病名,按其临床症状,可归属于祖国医学中“痞满”、“嘈杂”、“泛酸”、“胃痛”等范畴。然而其主要病位在胃及以上腹部饱胀、早饱、疼痛或不适等胃肠道运动障碍的主要临床表现特点与祖国医学的“痞满”最为相似,因此现代医学研究,一般将FD归为传统医学“痞满”一证加以论述。早在《黄帝内经》就有本病的记载,称为痞、满、痞塞、痞膈等,历经二千多年,积累了丰富的治疗经验。且现代研究证实中医药治疗FD为多靶点治疗,不良反应少,所以对中医药治疗功能性消化不良临床疗效的研究符合临床实际需要,且具有良好的经济效益和社会效益。本病的发生多为内外因相互作用而致。外因是由于感受寒邪、湿邪、热邪等,内因则由于情志失调、脾胃虚弱等致气机不运,升降失调。临床可见脾胃虚寒、肝郁气滞、胃阴亏.虚、痰浊中阻、饮食停滞等多种证型,而临床因湿热气候或过食肥甘厚味而致湿热内蕴型功能性消化不良在岭南多见。因湿热为病多以脾胃为病变中心,故治湿方临床多被用于治疗消化系统疾病,且疗效显著。
三仁汤出自温病大家吴鞠通《温病条辨》,由杏仁、飞滑石、白通草、白蔻仁竹叶、厚朴、生薏仁、半夏组成,《温病条辨·上焦·湿温》43条说：“头痛恶寒,身重疼痛,舌白不渴,脉弦细而濡,面色淡黄,胸闷不饥,午后身热,状若阴虚,病难速已,名曰湿温。汗之则神昏耳聋,甚则目瞑不欲言,下之则洞泄,润之则病深不解,长夏深秋冬日同法,三仁汤主之。”方中杏仁宣利上焦肺气,正如吴鞠通自注中说：“惟以三仁汤轻开上焦肺气,盖肺主一身之气,气化则湿亦化也”；白蔻仁芳香化湿,行气宽中,畅中焦之脾气；薏苡仁甘淡性寒,利湿清热而健脾,可以疏导下焦,使湿热从小便而去。配伍滑石之甘淡性寒,利湿清热而解暑；通草,竹叶甘寒淡渗,以助清利湿热之力；半夏、厚朴辛苦性温,行气化湿,散结除痞,既助行气化湿之功,又使诸药寒凉而不碍湿。诸药相合,宣上、畅中、渗下,使湿热之邪从三焦分消,则诸症自解。本方原为湿温初起而设,但是在现代临床其使用范围却越来越广,涉及隶属于内科、儿科、妇科、皮肤科等科系的各类疾病,并且取得了令人满意的疗效,其中消化系统疾病占了相当大的比例。究其原因,湿热之为病,乃“太阴内伤,湿饮停聚,客邪再至,内外相引,故病湿热”,以脾胃为病变中心,多有脾胃内伤,故治疗湿热方常可用来治疗脾胃病,正如《谦斋医学讲稿》说：“三仁汤为湿温证的通用方。它的配伍,用杏仁辛宣肺气,以开其上；蔻仁、厚朴、半夏苦辛温通,以降其中；薏苡仁、通草、滑石淡渗湿热,以利其下。虽然三焦兼顾,其实偏重中焦。”临床上根据其清利湿热,宣畅气机功能,许多医家用之治疗消化系统疾病疾病见湿热内阻,气机不畅之证,疗效显著,但对其治疗功能性消化不良的疗效尚缺乏大样本观察及机理研究。
本研究首先采用文献评述的形式对功能性消化不良的古代文献与现代研究进行整理,分析功能性消化不良的证型特点与临床治疗现状,以期总结功能性消化不良的中医辨证规律,以便更好地指导临床实践和进一步提高临床疗效,为丰富和完善因地制宜的中医理论提供临床及理论依据。然后通过将辨病为功能性消化不良患者根据中医辨证属湿热内蕴证者纳入临床观察病例,随机分为中药三仁汤治疗组与西药西沙比利治疗对照组,比较分析两组患者的临床症状积分及实验指标的异同,探讨三仁汤治疗中医辨证属湿热内蕴证型功能性消化不良的作用机理,为其进一步临床运用及推广提供科学依据。
目的
科学客观地评价运用三仁汤加减治疗湿热内蕴证型功能性消化不良的临床疗效及其安全性,探讨其作用机理,为其临床进一步推广应用提供科学的临床及理论依据。
方法
选取病证诊断标准及自拟湿热内蕴证诊断标准符合2002年5月国家药品监督管理局颁布的《中药新药临床研究指导原则(试行)》“痞满”、且西医诊断为功能性消化不良的患者例80例,采用查随机数字表的完全随机化方法随机分为治疗组50例,对照组30例,治疗组服用加减三仁汤(杏仁9g、白蔻仁9g、薏苡仁18g、厚朴9g、半夏12g、茯苓15g、陈皮6g、黄芩6g、白芍9g、竹叶6g),对照组服用西沙比利片,统计两组治疗前后症候积分、中医证候疗效、胃排空功能,检测外周血胃动素(MOT)、胃泌素(GAS)值。结果采用SPSS13.0统计软件分析,根据不同资料采用不同的统计方法如分类资料选用χ2检验,两样本均数比较采用t检验或秩和检验,自身前后比较运用配对t检验或Wilcoxon配对秩和检验,等级资料采用Raddit分析。
结果
1、从临床观察显示,两组治疗后各项症状、体征均有明显改善作用,且与治疗前比较有统计学差异(P<0.05)。治疗后两组比较,对胃脘痞满、食欲减退、口苦或粘、口干舌燥、口渴不欲饮、全身及四肢困重、大便稀溏的改善作用差异无统计学意义(P≥0.05)；对恶心呕吐的改善作用差异有统计学意义,治疗组优于对照组(P<0.05)。
2、与治疗前比较,治疗组治疗后MTL、GAS均升高,而且差异有统计学意义(P<0.05)；治疗后两组之间比较,MTL差异无统计学意义(P>0.05),但GAS差异有统计学意义(P>0.05),对照组明显高于治疗组。
3、两组均能促进患者胃排空,对照组总有效率(76.7%)大于治疗组(72.0%),但经检验,两组间胃排空疗效比较差异无统计学意义(P>0.05)。
4、治疗后治疗组的总有效率(92.0%)大于对照组的总有效率(80.0%),但两组疗效比较无统计学差异(P>0.05)。
5、治疗期间两组患者均无明显的不适及不良反应,治疗前后三大常规及肝肾功能等实验室指标检测结果均未见明显异常改变。临床观察表明两组的药物均具有较好的安全性。
结论
从临床观察显示,三仁汤组治疗后的主要临床症状、体征均有较为明显的改善,且与治疗前相比有统计学差异(P<0.05)。对恶心呕吐的改善作用优于对照组(P<0.05),可能与方中半夏、厚朴降逆止呕较强有关。三仁汤还可促进患者胃排空,可能与方中厚朴、白豆蔻、陈皮等促进胃肠蠕动功能相关。实验结果显示,三仁汤加减能提高患者血清MTL、GAS含量,提示其可能通过促进胃肠运动、刺激胃酸等的分泌,从而达到改善患者消化功能效果。本课题研究提示中医药清热利湿为功能性消化不良湿热内蕴证的重要治疗法则,但由于时间比较紧迫和自身精力等方面的限制,本实验只是对三仁汤加减治疗湿热内蕴型功能性消化不良做了相对简单的临床症状、体征等观察和相关实验室指标检测,且无临床长期随访监测,故尚不能深刻揭示三仁汤加减治疗功能性消化不良的机理。且目前尚无统一的功能性消化不良湿热内蕴证的临床观测指标,期望在以后的研究中得以逐步加强和完善。所以,本人认为应深入对此病在病因、发病机制等方面研究的基础上,进一步深化研究,建立比较完善统一的临床观测指标,建立更为理想的动物实验模型,拓展研究范围。
Functional dyspepsia is one of common functional diseases in gastrointestinal tact。According to statistics it accounts for one-three of gastrointestinal outpatients. It has clinical syndrome including upper abdominal pain, epigastric distention, early full, belching, poor appetite, nausea, vomiting and so on without organic disease which can cause those syndrome. Its course is more than one month and its symptoms last or recurrent attack. Etiology of functional dyspepsia is unknown, and according to current reports, its occur is mainly related with delay of gastric emptying, decrease of gastric accommodation capacity expansion, increase of gastric sensitivity, infection, psycho-mental factors, genetic predisposition and some gut hormone.It's treated by gastrointestinal dynamic promoting drugs, Simethicone Emulsion, antianxiety, antidepression, antisecrettory of gastric acid and eradication of helicobacter pylori. Patients always have a lot of symptoms, see different doctors and have many kinds of medicines without organic disorders and bases to explain symptoms, so it is no satisfied effects and impacts patients' and family members' physical and mental health. It expends large quantity of medicine resources.
Though there is no the disease of functional dyspepsia, according to it's manifestation, it belongs to "distention and fullness","stomach pain","gastric upset","pantothenic acid" and so on. It is always classified as distention and fullness" to discuss because the main clinic characteristics is upper gastric discomfort, abdominal distention and early full.
It's reported in "Huangdi's Internal Classics" as "Pi"、"Mang""Pimang"、"Pige" and so on. To this day,
There are plenty of therapeutic experiences in about2,000years and multitarget therapy without side effect in modern pharmocology and clinical research, so the curative effect observation on treating functional dyspepsia by tradition Chinese medicine and pharmacy answers for clinical need and will have good social and financial benefits. It occurs by interaction of endopathic and exopathic factors. Its exopathogen is cold, damp and heat devil while endopathic is sentiment imbalance and weakness of the spleen and stomach. There are the syndromes of deficiency-cold of spleen and stomach, stagnation Qi due to liver depression, deficiency of spleen Yin, stagnation of turbid phlegm in middle-Jiao, retention of food and drink, et al. There are much more the syndrome with endoretention of damp and heat in Southe of the five ridges because of damp and heat climate and over-eating of fat and sweet food. The spleen and stomach is the pathological center of damp and heat, so the prescription to damp is always used to treat diseases of digestive system and have significant effects.
Three-seed Decotion appears in Detailed Analysis of Epidemic Warm Diseases wrriten by Wu Jutong. It's composed of Xingren, Huashi, Tongcao, Baikouren, Zhuye, Houpu, Yiren and Banxia. It's set up to treat the beginning in damp thermosis, which shows headache, aversion to cold, light complexion, heavy and pain in body, fever in the afternoon, chest distress and no hungry. But prescriptions to treat damp and heat can be used to treat diseases of spleen and stomach, it's pathological center spleen and stomach and always has the deficiency of spleen and stomach. According to its function of clear damp and heat and smooth Qi activity, It was used to treat disease of digestive system with endoretention of damp and heat and Qi stagnation and had significant curative effect. But there was no observation of large sample and mechanism study.
Firstly, we analyzed the characteristic of functional dyspepsia's syndrome and current situation of therapy for summarize differentiating rules in order to improve clinical therapeutic effects and enhance theory of environmen concerned therapy.
Secondly, we observed the clinical efficacy of the Functional Dyspepsia with Damp-heat syndrome treated by the Modified Three-seed Decoction to exploit its mechanism of action and provide scientific foundation for its clinical use.
Objective
To estimate the clinical effect and safty of modified Sanren dectotion in treatment functional dyspepesia with damp-heat syndrome and establish foundation for further clinical and theoretical study.
Method
Objects meet with the differentiation standard of damp-heat syndrome and diagnostic criteria of Pimang and functional dyspepsia. Objects were devided into the treatment modified Sanren dectotion and the control group with Cisapride. Examined and compared the clinical efficacy, therapeutic effect of TCM syndrome, and function of gastric emptying, to evaluate the scores of motilin and gastrin in peripheral blood. Grouped data was analyzed by X2test and ranked data was analyzed by rank sum test. Two sample means and were compared by t test or rank sum test. Self circa were compared by matched-pairs t test or rank sum test.
Result
1. After treatment, signs and symptoms in two groups had meliorated obviously, the difference was significant comparing with before treatment. Between two groups, the difference wasn't significant in amendment of stomach full, poor appetite, bitter or sticking taste of mouth, dry mouth and tongue, thirsty without drink desire, heavy body and limbs, loose stool and so on. The treatment group had more effective than the control group in meliorating nausea and vomiting and the difference was significant.
2. After treatment, MTL and GAS in treatment group had increased obviously, the difference was significant comparing with before treatment. The difference of MTL wasn't significant between two groups after treatment, but the difference of GAS was significant.
3. The gastric emptying in two groups had been promoted and total rate in control group (76.7%) was higher than in treatment group (72.0%), but the difference wasn't significant after test (P>0.05)
4. The total effective rate in treatment group (92.0%) was higher than in control group (80.0%), but the difference wasn't significant after test (P>0.05)
5. All paitents had no side effects and abnormal changes in the index of blood, urina, excrement and liver and kidney function. Clinical research showed that both of drugs had high safty.
Conclusion
The results show that the Modified Sanren Decoction can meliorate sings and symptoms obviously, the difference was significant comparing with before treatment (P<0.05). It's improvement to nausea and vomiting surpassed to Cisapride and can improve gastric emptying and had a notable clinical effect.
The Modified Sanren Decoction increased the scores of MTL、GAS, which suggested that it can promote gastrointestinal motility and stimulate gastric acid secretion to improve digestive function. This study showed cleaning away heat and promoting damp is the key therapeutical rule of treating functional dyspepsia, but this study can't bring to light the therapeutical mechanism because just simple clinical observation and index and without long term follow-up visit and monitoring. There aren't unified index to observe functional syspepsia so experiments about it have poor repetitive. We shall study further and wider and set up unified index and establish more perfect animal experiment model.
引文
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