调肠理气法治疗慢性功能性便秘气秘证的临床及实验研究
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摘要
目的、意义
气秘证是慢性功能性便秘(CFC)的主要证型,目前对CFC的发病机制尚未完全阐明。导师罗云坚教授通过大量的临床研究及结合古代中医文献及现代医学研究认为CFC气秘证的整个病理过程以气滞和/或脾虚为本,热结为标,在治疗慢性功能性便秘过程中创调畅理气法以顺气降逆,益气清肠,并以此法为原则在四磨饮基础上加减成方,研制调肠理气片治疗慢性功能性便秘。本课题通过文献研究、动物实验临床疗效观察研究不同浓度调肠理气片与泽马可片比较对小鼠通便功能的影响;不同浓度调肠理气片与泽马可片比较对豚鼠离体回肠平滑肌和结肠平滑肌肌张力影响及作用持续时间;调肠理气片与泽马可片比较临床疗效、对肛门直肠动力学影响,分析其可能机理。目前研究表明,肛门直肠动力异常与其发病密切相关。肛门直肠测压是近年来肛门直肠动力学检查较先进的方法。不少学者认为肛门直肠动力异常可表现为肛门直肠压力、感觉及排便功能的异常,因此研究调肠理气片与泽马可片比较直肠压力、感觉、排便功能变化,有助于阐明CFC气秘证的实质及调肠理气法治疗CFC气秘证可能作用途径。
研究方法
本课题分文献研究、动物实验、临床研究三部分。文献研究主要从中西医两方面系统对CFC研究现状进行阐述。动物实验:一、采用粪便色点法、炭末排出时间测定法、炭末小肠推进法研究不同浓度的调肠理气片与泽马可片比较对便秘气秘证模型小鼠排便功能的影响;二、研究不同浓度调肠理气片与泽马可片比较对豚鼠离体回肠平滑肌、结肠平滑肌肌张力及持续时间影响。临床研究:一、主要为疗效观察,采用随机、对照的原则,以调肠理气片与泽马可对照治疗CFC,通过对CFC气秘证患者的症状、体征、病情程度、生活质量、远期疗效等方面进行观察,评价调肠理气片的临床疗效。疗程包括2周基线期和4周治疗期,并比较调肠理气片与泽马可对直肠压力、感觉阈值及排便功能的影响。
研究结果
文献研究全面研究了CFC病因病机、诊断治疗、肛门直肠动力学的研究现状,为本课题研究找到了思路。动物实验研究结果:(一)不同浓度调肠理气片与泽马可片比较对小鼠排便功能的影响:(1)炭末推进率实验:各用药组均较模型对照组炭末推进率增高,除调肠理气片低剂量组与空白对照组比较统计学差异显著外(P<0.01),其余各组炭末推进率均接近正常,统计学无明显差异(P>0.05),且调肠理气片中剂量组炭末推进率较调肠理气片低剂量组高(P<0.01),其他组间比较无统计学意义(P>0.05)。(2)首粒黑便排出时间测定:各用药组首粒黑便排出时间均较模
Objective and Significance:Chronic functional constipation (CFC) belongs to the category of the constipation of TCM .QI sickness syndrome is most common in CFC .So far the pathogenesis of CFC is not very clear yet. My tutor, Professor YunJian Luo, consider the basic of the pathogenesis of QI sickness syndrome of CFC is Qi stagnation and/or Qi deficiency, and some can produce heat syndrome through many clinical research combined literature research of TCM and modern medicine. In therapeutics he created the method of transferring function of intestines and regulating the flow of vital energy (TCLQ) to guide Qi downwards and benefits vital energy, used this principle of TCLQ method to make a prescription named TCLQ Tablets at the basic of SiMO soup add and decrease .Transferring intestine's function and regulating the flow of vital energy are the main therapeutic method. But the curative effect of the therapeutic method of TCLQ needs further verifying.Through the research using Animal studies and Clinical research, we find that there is a different effect from TCLQ in terms of density compare with Tegaserod Hydrogen Maleate Tablets (THM Tablets) on the intestinal movement of constipated model mice;the different effect from TCLQ Tablets difference density compare with THM Tablets on isolated intestinal smooth muscle and the time of this effect on guinea pigs;the effect of TCLQ Tablets compare with THM Tablets on the Clinical research, Anorectal Kinetics , analyze the possible mechanismAt present Research indicates that changes of anorectal manometry are closely related to what's happening. Anorectal manometry is more advanced method in recent years in terms of checking unusual change of annrectal motility. Many scholars think unusual
change of annrectal motility can show changes of rectal sentation functions, annrectal defecate function. So compare to the curative effect and the change of anorectal manometry is more useful at clarifying the essence of the syndrome of Qi stagnation and the mechanism of the recipe of DCLQ on treating CFC. Methods:This thesis includes three parts :the literature review > animal studies and clinical research. Literature review explained from two respects of traditional Chinese and western medicine about many directions of CFC mainly. Animal studies : 1 The effect of difference density TCLQ Tablets compare THM Tablets on the propulsive movement -. the time course for the excretion of carbon powder and The count of excrement in five hour of constipated model mice;2 The effect of difference density TCLQ Tablets compare THM Tablets on isolated intestinal smooth muscle and the time of this effect of guinea pigs . 2 Clinical research divided into two parts mainly xlinical observing and the research of intervention on annrectal motility. Clinical observation adopted at random ,by the contrasting principle. The recipe of TCLQ- TiaoChangLiQi Tablets(TCLQT) was observing medicine.Maren Capsule(MRC) is contrasting medicine.We divided two groups:35 cases in the observing group was treated by TCLQT and 31 cases in the controlling one was treated by MRC.We mainly observed such respects as symptoms ,signs , conditional degree of disease , long-term curative effect before and after treatment of the therapeutic method of TCLQ.The intervening reseach on annrectal motility adopted anorectal manometry to examine the change of rectal sentation functions? annrectal and defecate function of Qi stagtation type of CFC before and after treatment of TCLQT, contrasting by THM Tablets. Results:The literature review clarified the present condition of CFC and annrectal motility reseach and found the clue to study the disease.Animal studies :1 the effect of difference density TCLQ Tablets compare THM Tablets on the intestinal movement of constipated model mice.(l) The propulsive rate of carbon powder: Each medicatine group improve the propulsive rate of carbon powder contrasting by model control group. Except TCL the other groups all get close to normal ,there weren't have significant diferences(P>0.05),and TCM was better than TCL(P<0.01).The other compare between groups weren't have significant diferences(P>0.05).(2) The time course for the excretion of carbon powder : The time of each medicatine group were shorter than model control group(P<0.01).The time of TCH group were shorter than THM Tablets(P<0.05) and TCM(P<0.05)> TCL(P<0.01).(3) The count of excrement in five hour of constipated model mice: Except TCL had significant
difference contrasting by blank group(P<0.01), the others groups weren't have significant difference(P>0.05).TCH better than THM> TCM and TCL(P<0.01~0.05).THM and TCM better than TCL(P<0.05).2 The effect of difference density TCLQ Tablets compare THM Tablets on isolated intestinal smooth muscle and the time of this effect of constipated model mice:(l)Effect of TCLQ Tablets on the Activity of isolated small intestinal smooth muscle of Guinea Pigs and the time cause of this effect: After administration every group enhance the small intestinal smooth muscle activity as compared with that Control Group(P<0.01).There had no significant difference in TCL> TCH and THM(P>0.05).But the time cause TCH was longer than THM(P<0.05),There was not have significant differet between TCH and TCL(P>0.05).(2) Effect of TCLQ Tablets on the Activity of isolated colon smooth muscle of Guinea Pigs and the time cause of this effect: After administration every group enhance the colon smooth muscle activity as compared with that Control Group(P<0.01).There had significant difference between TCL and THM(P<0.05).But the time cause TCH was longer than THM(P<0.05),There was not have significant differet between TCH and THM(P>0.05), but the time cause TCH was significant longer than THM(P<0.05).Clinical observation indicated: (l)By the look of overall curative effect, among 35 cases in observing groups, it was 94.3% to be always effective. Fully the recovering rate was 25.7% among them. The Significantly effective rate was 45.7%. The effective rate was 22.9%.The ineffective rate was 5.7%;Among 34 Control Groups the overall curative effective rate was 91.2%, fully the recovering rate was 23.5% among them.The Significantly effective rate was 41.2%. The effective rate was 26.5%. The ineffective rate was 8.8%. Dealt with statistics between two groups(P>0.05), it wasn't had significance difference. Observing group's curative effect was similar to Control Group's.The observation index of clinical symptom of the two groups except in the feeling of defecation not be finished observing group was better than control group ,P<0.01, the others observation index wasn't had significance difference , P>0.05;There had significant difference in every observation index in observing group before treatment and after treatment ,P<0.01~0.05;Control group except in the feeling of defecation not be finished had no significance difference, P>0.05 , the others all had significant improve, p<0.01.By the look of the curative effect of the TCM syndromes: among 35 cases in observing groups, fully the recovering rate was31.4% among them. The Significantly effective rate was 45.7%. The effective rate was 20.0%.The ineffective rate was 2.9%;Among 34 Control Groups, fully the recovering rate was 17.6% among them.The Significantly effective rate was 23.5%. The effective rate was 44.1%. The ineffective rate was 14.7% .
Dealt with statistics between two groups(P<0.05), it had significance difference. Observing group's curative effect was better than Control Group's . From main syndromes : (1) The effect of primary TCM syndromes : observing groups and control group in times of defecate and the condition of exertion of defecation had no significant difference(P>0.05);Observing groups was better than control group in weary and short breath syndrome , Dealt with statistics P<0.01. Two groups all made stool properties improve , stool number of times increase , defecate time shorten each time, but only observing groups in weary and short breath syndrome after treating, dealt with by statistics, there were significant difference( P <0.01);The control group had no significant difference in these two syndromes . (2) By the look from following symptom of constipation , the observing group had improvement in various degree in vultus colorless^ dizziness n anorexia % rugitusN picture of the tongue and pulse tracings the observing group was obviously superior to control group (P<0.01~0.05);The observing groups had improvement in various degree in the every following symptom of Qi stagnation syndrome after treatment, P<0.01-0.05;The control group had improvement in various degree in the part following symptom of Qi stagnation syndrome except cardiopalmus^ dizziness > picture of the tongue and pulse tracings , P<0.01 . In addition, the lighter the conditional degree of disease was, the better the curative effect was;The shorter the course of disease was, the better curative effect was.It showed that anorectal motility intervenes the result of study: (1) Archo-pressure of the observing group compare with the control group before and after treatment: Archo-pressure of the observing group compare with the control group before and after treatment had not significant difference(P>0.05).(2) Archo- sensation function of the observing group compare with the control group before and after treatment: Archo-sensation function(rectal sensation volume thresholds and rectal maximum tolerable volume thresholds) of the observing group compare with the control group before treatment had not significant difference(P>0.05).After treantment the two thresholds was degraded(P<0.01),and the observing group were superior to the control group(P<0.01~ 0.05).(3) Archo- defecate function of the observing group compare with the control group before and after treatment:The two groups had no significant difference in inhibitory reflex before and after treatment(P>0.05). The two groups had no significant difference in defectation reflex before treatment(P>0.05). The two groups had part recover in defectation reflex after treatment,but the observing group was superior to the control group(P<0.05). Conclusions: '>Animal studies discover that TCH was superior to THM> TCL and TCM at d€$cate function of model mice .And this research found the ascendancy mainly appearance at
colon . The effect of difference density TCLQ Tablets compare THM Tablets on isolated small intestinal smooth muscle of Guinea Pigs had not significant difference, The time of this effect TCH was longer than THM Tablets. The effect on isolated colon smooth muscle of Guinea Pigs THM superior to TCL ,but had not significant differece to TCH ,but the time of this effect TCH was longer than THM Tablets.Clinical observation is pointed out: the observing group and the control group's medicine have good treatment to patients of Qi stagnation type of CFC. Overall curative effect of The recipe ofDCLQ-TiaoChangLiQiTablets(TCLQT) is similar to that of THM at the same time. Two groups' medicine has certain curative effect to improvement of clinical symptoms. But TCLQT's improvement is superior to THM's.These patients of Qi stagnation type of CFC may have unusual rectal sentation functions and poor coordination of rectal sphincter of threshold value. The recipe of TCLQ Tablets can effectively treat patients of Qi stagnation type of CFC. Mechanisms that it functions may degrade rectal sensation volume thresholds and rectal maximum tolerable volume thresholds and raise harmony of rectal sphincter of threshold value.
气秘证是慢性功能性便秘(CFC)的主要证型,目前对CFC的发病机制尚未完全阐明。导师罗云坚教授通过大量的临床研究及结合古代中医文献及现代医学研究认为CFC气秘证的整个病理过程以气滞和/或脾虚为本,热结为标,在治疗慢性功能性便秘过程中创调畅理气法以顺气降逆,益气清肠,并以此法为原则在四磨饮基础上加减成方,研制调肠理气片治疗慢性功能性便秘。本课题通过文献研究、动物实验临床疗效观察研究不同浓度调肠理气片与泽马可片比较对小鼠通便功能的影响;不同浓度调肠理气片与泽马可片比较对豚鼠离体回肠平滑肌和结肠平滑肌肌张力影响及作用持续时间;调肠理气片与泽马可片比较临床疗效、对肛门直肠动力学影响,分析其可能机理。目前研究表明,肛门直肠动力异常与其发病密切相关。肛门直肠测压是近年来肛门直肠动力学检查较先进的方法。不少学者认为肛门直肠动力异常可表现为肛门直肠压力、感觉及排便功能的异常,因此研究调肠理气片与泽马可片比较直肠压力、感觉、排便功能变化,有助于阐明CFC气秘证的实质及调肠理气法治疗CFC气秘证可能作用途径。
研究方法
本课题分文献研究、动物实验、临床研究三部分。文献研究主要从中西医两方面系统对CFC研究现状进行阐述。动物实验:一、采用粪便色点法、炭末排出时间测定法、炭末小肠推进法研究不同浓度的调肠理气片与泽马可片比较对便秘气秘证模型小鼠排便功能的影响;二、研究不同浓度调肠理气片与泽马可片比较对豚鼠离体回肠平滑肌、结肠平滑肌肌张力及持续时间影响。临床研究:一、主要为疗效观察,采用随机、对照的原则,以调肠理气片与泽马可对照治疗CFC,通过对CFC气秘证患者的症状、体征、病情程度、生活质量、远期疗效等方面进行观察,评价调肠理气片的临床疗效。疗程包括2周基线期和4周治疗期,并比较调肠理气片与泽马可对直肠压力、感觉阈值及排便功能的影响。
研究结果
文献研究全面研究了CFC病因病机、诊断治疗、肛门直肠动力学的研究现状,为本课题研究找到了思路。动物实验研究结果:(一)不同浓度调肠理气片与泽马可片比较对小鼠排便功能的影响:(1)炭末推进率实验:各用药组均较模型对照组炭末推进率增高,除调肠理气片低剂量组与空白对照组比较统计学差异显著外(P<0.01),其余各组炭末推进率均接近正常,统计学无明显差异(P>0.05),且调肠理气片中剂量组炭末推进率较调肠理气片低剂量组高(P<0.01),其他组间比较无统计学意义(P>0.05)。(2)首粒黑便排出时间测定:各用药组首粒黑便排出时间均较模
Objective and Significance:Chronic functional constipation (CFC) belongs to the category of the constipation of TCM .QI sickness syndrome is most common in CFC .So far the pathogenesis of CFC is not very clear yet. My tutor, Professor YunJian Luo, consider the basic of the pathogenesis of QI sickness syndrome of CFC is Qi stagnation and/or Qi deficiency, and some can produce heat syndrome through many clinical research combined literature research of TCM and modern medicine. In therapeutics he created the method of transferring function of intestines and regulating the flow of vital energy (TCLQ) to guide Qi downwards and benefits vital energy, used this principle of TCLQ method to make a prescription named TCLQ Tablets at the basic of SiMO soup add and decrease .Transferring intestine's function and regulating the flow of vital energy are the main therapeutic method. But the curative effect of the therapeutic method of TCLQ needs further verifying.Through the research using Animal studies and Clinical research, we find that there is a different effect from TCLQ in terms of density compare with Tegaserod Hydrogen Maleate Tablets (THM Tablets) on the intestinal movement of constipated model mice;the different effect from TCLQ Tablets difference density compare with THM Tablets on isolated intestinal smooth muscle and the time of this effect on guinea pigs;the effect of TCLQ Tablets compare with THM Tablets on the Clinical research, Anorectal Kinetics , analyze the possible mechanismAt present Research indicates that changes of anorectal manometry are closely related to what's happening. Anorectal manometry is more advanced method in recent years in terms of checking unusual change of annrectal motility. Many scholars think unusual
change of annrectal motility can show changes of rectal sentation functions, annrectal defecate function. So compare to the curative effect and the change of anorectal manometry is more useful at clarifying the essence of the syndrome of Qi stagnation and the mechanism of the recipe of DCLQ on treating CFC. Methods:This thesis includes three parts :the literature review > animal studies and clinical research. Literature review explained from two respects of traditional Chinese and western medicine about many directions of CFC mainly. Animal studies : 1 The effect of difference density TCLQ Tablets compare THM Tablets on the propulsive movement -. the time course for the excretion of carbon powder and The count of excrement in five hour of constipated model mice;2 The effect of difference density TCLQ Tablets compare THM Tablets on isolated intestinal smooth muscle and the time of this effect of guinea pigs . 2 Clinical research divided into two parts mainly xlinical observing and the research of intervention on annrectal motility. Clinical observation adopted at random ,by the contrasting principle. The recipe of TCLQ- TiaoChangLiQi Tablets(TCLQT) was observing medicine.Maren Capsule(MRC) is contrasting medicine.We divided two groups:35 cases in the observing group was treated by TCLQT and 31 cases in the controlling one was treated by MRC.We mainly observed such respects as symptoms ,signs , conditional degree of disease , long-term curative effect before and after treatment of the therapeutic method of TCLQ.The intervening reseach on annrectal motility adopted anorectal manometry to examine the change of rectal sentation functions? annrectal and defecate function of Qi stagtation type of CFC before and after treatment of TCLQT, contrasting by THM Tablets. Results:The literature review clarified the present condition of CFC and annrectal motility reseach and found the clue to study the disease.Animal studies :1 the effect of difference density TCLQ Tablets compare THM Tablets on the intestinal movement of constipated model mice.(l) The propulsive rate of carbon powder: Each medicatine group improve the propulsive rate of carbon powder contrasting by model control group. Except TCL the other groups all get close to normal ,there weren't have significant diferences(P>0.05),and TCM was better than TCL(P<0.01).The other compare between groups weren't have significant diferences(P>0.05).(2) The time course for the excretion of carbon powder : The time of each medicatine group were shorter than model control group(P<0.01).The time of TCH group were shorter than THM Tablets(P<0.05) and TCM(P<0.05)> TCL(P<0.01).(3) The count of excrement in five hour of constipated model mice: Except TCL had significant
difference contrasting by blank group(P<0.01), the others groups weren't have significant difference(P>0.05).TCH better than THM> TCM and TCL(P<0.01~0.05).THM and TCM better than TCL(P<0.05).2 The effect of difference density TCLQ Tablets compare THM Tablets on isolated intestinal smooth muscle and the time of this effect of constipated model mice:(l)Effect of TCLQ Tablets on the Activity of isolated small intestinal smooth muscle of Guinea Pigs and the time cause of this effect: After administration every group enhance the small intestinal smooth muscle activity as compared with that Control Group(P<0.01).There had no significant difference in TCL> TCH and THM(P>0.05).But the time cause TCH was longer than THM(P<0.05),There was not have significant differet between TCH and TCL(P>0.05).(2) Effect of TCLQ Tablets on the Activity of isolated colon smooth muscle of Guinea Pigs and the time cause of this effect: After administration every group enhance the colon smooth muscle activity as compared with that Control Group(P<0.01).There had significant difference between TCL and THM(P<0.05).But the time cause TCH was longer than THM(P<0.05),There was not have significant differet between TCH and THM(P>0.05), but the time cause TCH was significant longer than THM(P<0.05).Clinical observation indicated: (l)By the look of overall curative effect, among 35 cases in observing groups, it was 94.3% to be always effective. Fully the recovering rate was 25.7% among them. The Significantly effective rate was 45.7%. The effective rate was 22.9%.The ineffective rate was 5.7%;Among 34 Control Groups the overall curative effective rate was 91.2%, fully the recovering rate was 23.5% among them.The Significantly effective rate was 41.2%. The effective rate was 26.5%. The ineffective rate was 8.8%. Dealt with statistics between two groups(P>0.05), it wasn't had significance difference. Observing group's curative effect was similar to Control Group's.The observation index of clinical symptom of the two groups except in the feeling of defecation not be finished observing group was better than control group ,P<0.01, the others observation index wasn't had significance difference , P>0.05;There had significant difference in every observation index in observing group before treatment and after treatment ,P<0.01~0.05;Control group except in the feeling of defecation not be finished had no significance difference, P>0.05 , the others all had significant improve, p<0.01.By the look of the curative effect of the TCM syndromes: among 35 cases in observing groups, fully the recovering rate was31.4% among them. The Significantly effective rate was 45.7%. The effective rate was 20.0%.The ineffective rate was 2.9%;Among 34 Control Groups, fully the recovering rate was 17.6% among them.The Significantly effective rate was 23.5%. The effective rate was 44.1%. The ineffective rate was 14.7% .
Dealt with statistics between two groups(P<0.05), it had significance difference. Observing group's curative effect was better than Control Group's . From main syndromes : (1) The effect of primary TCM syndromes : observing groups and control group in times of defecate and the condition of exertion of defecation had no significant difference(P>0.05);Observing groups was better than control group in weary and short breath syndrome , Dealt with statistics P<0.01. Two groups all made stool properties improve , stool number of times increase , defecate time shorten each time, but only observing groups in weary and short breath syndrome after treating, dealt with by statistics, there were significant difference( P <0.01);The control group had no significant difference in these two syndromes . (2) By the look from following symptom of constipation , the observing group had improvement in various degree in vultus colorless^ dizziness n anorexia % rugitusN picture of the tongue and pulse tracings the observing group was obviously superior to control group (P<0.01~0.05);The observing groups had improvement in various degree in the every following symptom of Qi stagnation syndrome after treatment, P<0.01-0.05;The control group had improvement in various degree in the part following symptom of Qi stagnation syndrome except cardiopalmus^ dizziness > picture of the tongue and pulse tracings , P<0.01 . In addition, the lighter the conditional degree of disease was, the better the curative effect was;The shorter the course of disease was, the better curative effect was.It showed that anorectal motility intervenes the result of study: (1) Archo-pressure of the observing group compare with the control group before and after treatment: Archo-pressure of the observing group compare with the control group before and after treatment had not significant difference(P>0.05).(2) Archo- sensation function of the observing group compare with the control group before and after treatment: Archo-sensation function(rectal sensation volume thresholds and rectal maximum tolerable volume thresholds) of the observing group compare with the control group before treatment had not significant difference(P>0.05).After treantment the two thresholds was degraded(P<0.01),and the observing group were superior to the control group(P<0.01~ 0.05).(3) Archo- defecate function of the observing group compare with the control group before and after treatment:The two groups had no significant difference in inhibitory reflex before and after treatment(P>0.05). The two groups had no significant difference in defectation reflex before treatment(P>0.05). The two groups had part recover in defectation reflex after treatment,but the observing group was superior to the control group(P<0.05). Conclusions: '>Animal studies discover that TCH was superior to THM> TCL and TCM at d€$cate function of model mice .And this research found the ascendancy mainly appearance at
colon . The effect of difference density TCLQ Tablets compare THM Tablets on isolated small intestinal smooth muscle of Guinea Pigs had not significant difference, The time of this effect TCH was longer than THM Tablets. The effect on isolated colon smooth muscle of Guinea Pigs THM superior to TCL ,but had not significant differece to TCH ,but the time of this effect TCH was longer than THM Tablets.Clinical observation is pointed out: the observing group and the control group's medicine have good treatment to patients of Qi stagnation type of CFC. Overall curative effect of The recipe ofDCLQ-TiaoChangLiQiTablets(TCLQT) is similar to that of THM at the same time. Two groups' medicine has certain curative effect to improvement of clinical symptoms. But TCLQT's improvement is superior to THM's.These patients of Qi stagnation type of CFC may have unusual rectal sentation functions and poor coordination of rectal sphincter of threshold value. The recipe of TCLQ Tablets can effectively treat patients of Qi stagnation type of CFC. Mechanisms that it functions may degrade rectal sensation volume thresholds and rectal maximum tolerable volume thresholds and raise harmony of rectal sphincter of threshold value.
引文
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