超微枳术丸对脾虚气滞型功能性消化不良的临床与实验研究
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摘要
1目的：
探讨超微枳术丸对脾虚气滞型功能性消化不良的临床安全性、有效性,并从胃肠运动、相关胃肠激素方面阐明其作用机制。
2方法：
2.1通过古代和现代文献整理,复习功能性消化不良的中西医诊疗规律。
2.2遵循随机、盲法原则,选取符合脾虚气滞型功能性消化不良患者60例,随机分为治疗组与对照组,分别给予1／3量超微枳术丸和全量传统枳术丸,治疗14天,观察治疗前后患者胃肠排空功能、症状和胃肠激素水平,评价其疗效。
2.3采用不规则喂养法复制胃肠排空障碍模型,随机分为模型组、传统枳术丸组、1／3量超微枳术丸组,分别给予不同处理,观察动物炭末推进情况、胃内残留率,采用放免法检测血清胃动素、胃泌素水平。
3结果：
3.1文献研究：
痞满(功能性消化不良)病情缠绵,病因多为饮食失常、劳累过度、内伤七情等损伤脾胃,导致脾虚气弱,运化无力,郁而不行,最终中焦气机紊乱,脾胃升降失常,气机不畅,脾失健运,气机壅滞,胃失和降,受纳不畅,多出现脾虚气滞型痞满证候,脾虚气滞为其基本病机,脾胃虚弱是本,气滞为标,虚中夹实。病性虚多于实,病位多在脾、肝、胃。
3.2临床研究：
3.2.1基线期结果：
治疗组与对照组在疗前性别构成、年龄、生命体征等一般情况方面、各症候等级及症候总积分方面、血浆胃动素、胃泌素水平、胃排空功能方面比较,差异均无统计学意义(P>0.05),具有可比性。
3.2.2疗效结果：
3.2.2.1治疗组治疗前后比较：
各症候较治疗前均有不同程度好转,除恶心、呕吐两项症候积分与疗前比较差异无统计学意义(P>0.05)外,余各项症候与疗前比较差异均有显著统计学意义(P<0.01)；血浆胃动素、胃泌素水平显著提高,与疗前比较差异均有显著统计学意义(P<0.01)；胃排空功能显著改善,与疗前比较差异有显著统计学意义(P<0.01)。
3.2.2.2对照组治疗前后比较：
各症候较治疗前均有不同程度好转,除恶心、呕吐、嗳气三项症候积分与疗前比较差异无统计学意义(P>0.05)外,余各项症候与疗前比较差异具有统计学或显著统计学意义(P<0.01—P＜0.05)；血浆胃动素、胃泌素水平显著提高,与疗前比较差异均有显著统计学意义(P<0.01)；胃排空功能显著改善,与疗前比较差异有显著统计学意义(P<0.01)。
3.2.2.3治疗组与对照组治疗后比较：
治疗组与对照组症候群疗效率和总有效率比较,差异均无统计学意义(P>0.05)；各症候等级比较,症候群中的胃脘痞闷、嗳气两项症候的疗效,1／3量超微枳术丸组优于传统枳术丸组,差异有显著统计学意义(P<0.01),脘腹胀、纳呆两项症候的疗效1／3量超微枳术丸组优于传统枳术丸组,差异具有统计学意义(P<0.05),余各项症候指标两组差异无统计学意义(P>0.05)；症候总积分比较,1／3量超微枳术丸组优于传统枳术丸组,差异有统计学意义(P<0.05)；血浆胃动素、胃泌素水平比较,1／3量超微枳术丸组均优于传统枳术丸组,差异均具统计学意义(P<0.05)；胃排空功能比较,差异无统计学意义(P>0.05)。
3.3实验研究：
3.3.1两给药组对炭末推进率的影响比较：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)；1／3量超微枳术丸组与传统枳术丸组比较,差异无统计学意义(P>0.05)。3.3.2两给药组对胃残留率的影响比较：给药2周后两给药组与模型组比较,均有降低,差异均具统计学意义(P<0.05)；1／3量超微枳术丸组与传统枳术丸组比较,差异无统计学意义(P>0.05)。
3.3.3两给药组对胃动素水平的影响比较：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)；1／3量超微枳术丸与传统枳术丸组比较,差异无统计学意义(P>0.05)。
3.3.4两给药组对胃泌素水平的影响比较：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)；1／3量超微枳术丸与传统枳术丸组比较,差异无统计学意义(P>0.05)。
3.3.5两给药组对CCK及受体mRNA的影响：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)。
结论：
1枳术丸能有效地改善脾虚气滞型FD患者的胃肠排空和症状,1／3量超微枳术丸疗效与全量传统枳术丸相当。
2枳术丸能促进FD小鼠胃肠蠕动、减少胃内残留,调节胃肠激素水平。
3枳术丸能升高FD小鼠十二指肠黏膜CCKmRNA及胃底部CCK-A受体mRNA的表达水平,从而升高血浆CCK水平及胃底处CCK-A受体的数量。
Objective:Discussed the clinical safety and effectiveness of ultra-powder Zhizhu Pill's on patients with functional dyspepsia in syndrome of deficiency of spleen's function and congestion of gas-movements, and clarified its mechanism from aspects of gastrointestinal movements and hormone-regulating.
Methods:
1 Through the collection of ancient and modern literature, review the displines of diagnosis and treatment on functional dyspepsia both in Western and Chinese medicine.
2 60 patients of functional dyspepsia with the type of the the deficiency of spleen's function and congestion of gas-movements were selected, following the principles of evidence-based medicine and DME,randomly divided into treatment group and control group, were correspondly given 1/3 the volume of AMD Zhizhu traditional pills and total Zhizhu pills, during the treatment of 14 days, observed the patients'gastrointestinal emptying-function, symptoms and gastrointestinal hormone levels before and after treatment to evaluate their curative effect.
3 Copied the model group of gastrointestinal-emptying impediment by the method of irregular-feeding, randomly divided the mice into model group, traditional Zhizhu pill group,1/3 the volume of AMD Zhizhu pill group, distinctly given different treatment to observe the situation of animals' carbonpowder-promoting,the residual rate in stomach, to examinate the level of motilin, gastrin in plasma, using the method of radioimmunoassay.
Results:
1 Literature Study:Swelling of the Spleen and stomach (functional dyspepsia)has long course of disease, causes of this disease always include eating-disorders、overwork、injuries on the spleen and stomach, leading to the deficiency and poor-transporting of spleen and gas's function、gas-movements disorder in the spleen and stomach movements, finally leads to disharmony of spleen and stomach、deficiency syndrome of spleen and stomach's function and swelling of the spleen and stomach. The deficiency of spleen's function and congestion of gas-movements is the basic mechanism,the essence is the weakness of spleen and stomach,the representation is the congestion of gas-movements. The nature of Fd is weakness together with fullness, weakness is much obvious than fullness.Infection position always relay to spleen, liver, stomach.
2 Clinical Research:
2.1 The results of the baseline period:
Before treatment, there was no statistical significance (P> 0.05)at the differences between treatment group and control group on the aspects of general situation such as gender composition, age, life symptom, on the aspects of each symptom's degree and symptom's total score,on the aspects of the levels of motilin and gastrin in plasma, on the aspects of the function of gastric-emptying, two groups have the commeasurability.
2.2 The cruative effect Results:
Comparison of the treatment group before and after treatment:Every symptoms's degree have improved with various degree's compared with pre-treatment.With the exception of two syndromes'scores of nauseat and vomity's differences between before and after treatment had no statistical significance (P> 0.05),the other symptoms'differences all had significant statistical significance (P< 0.01); the levels of motilin and gastrin in plasma were significantly increased compared with pre-treatment, the differences had significant statistical significance (P<0.01); the function of gastric-emptying improved significantly compared with pre-treatment, the differences had significant statistical significance (P<0.01).
Comparison of the control group before and after treatment:Every symptoms's degree have improved with various degree's compared with pre-treatment.With the exception of three syndromes'scores of nauseat、vomity and eructation's differences between before and after treatment had no statistical significance (P> 0.05), the other symptoms'differences all had statistical significance or significant statistical significance (P< 0.01-P< 0.05); the levels of motilin and gastrin in plasma were significantly increased compared with pre-treatment, the differences had significant statistical significance (P<0.01); the function of gastric-emptying improved significantly compared with pre-treatment, the differences had significant statistical significance (P<0.01).
Comparison of the treatment group and control group after treatment:There was no statistical significance (P> 0.05)at the differences between treatment group and control group on the aspects of curative effect rate of syndrome and total effective rate; as to the degrees of Every symptoms, two syndromes' improvement of swelling of the Spleen and stomach、eructation in 1/3 the volume of AMD Zhizhu Pill group were much superior to the traditional pill group, there was significant statistical significance (P<0.01)at the differences between the two groups,two syndrome's improvement of Stomach's fullness and poor appetite in 1/3 the volume of AMD Zhizhu Pill group were superior to the traditional pill group, there was statistical significance (P<0.05)at the difference between the two groups, the other symptoms'differences all had no statistical significance(P> 0.05) between the two groups;as to the improvement of syndrome total scores,1/3 the volume of AMD Zhizhu Pill group was superior to the traditional pill group,there was statistical significance (P<0.05)at the differences between the two groups; as to the improvement of the levels of motilin and gastrin in plasma,1/3 the volume of AMD Zhizhu Pill group was superior to the traditional pill group,there was statistical significance (P<0.05)at the differences between the two groups; threre was no statistical significance (P> 0.05) on the difference of the function of gastric-emptying between the two groups.
3 Experimental Study:
3.1 Comparison of the two medicine-using groups's effects on the carbonpowder-promoting rate:After 2 weeks'treatment, there was significant improvement in both medicine-using groups, compared with the model group. There was significant statistical significance (P<0.01) at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
3.3.1.2 Comparison of the two medicine-using groups's effects on the residual rate in stomach,:
After 2 weeks'treatment, there was drop in both medicine-using groups, compared with the model group. There was statistical significance (P<0.05)at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
3.2 Comparison of the two medicine-using groups's effects on the level of motilin:After 2 weeks'treatment, there was significant improvement in both medicine-using groups, compared with the model group. There was significant statistical significance (P<0.01) at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
3.3 Comparison of the two medicine-using groups's effects on the level of gastrin:After 2 weeks'treatment, there was significant improvement in both medicine-using groups, compared with the model group. There was significant statistical significance (P<0.01) at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
Conclusion:1 Zhizhu pill can effectively improve symptoms and gastrointestinal-emptying of FD patients with type of the the deficiency of spleen's function and congestion of gas-movements,1/3 the volume of AMD pill Zhizhu and total Zhizhu pills have the equivalent curative effect.
2 Zhizhu pills can promote gastrointestinal peristalsis of FD mice, reduce the residual rate in stomach, regulate the level of gastrointestinal hormones.
3 Zhizhu pills can promote the expression level of CCKmRNA in duodenum mucous membrance and CCK-A acceptor mRNA in fundus ventriculi, increase the level of CCK in plasma and the amount of CCK-A acceptor in fundus ventriculi。
探讨超微枳术丸对脾虚气滞型功能性消化不良的临床安全性、有效性,并从胃肠运动、相关胃肠激素方面阐明其作用机制。
2方法：
2.1通过古代和现代文献整理,复习功能性消化不良的中西医诊疗规律。
2.2遵循随机、盲法原则,选取符合脾虚气滞型功能性消化不良患者60例,随机分为治疗组与对照组,分别给予1／3量超微枳术丸和全量传统枳术丸,治疗14天,观察治疗前后患者胃肠排空功能、症状和胃肠激素水平,评价其疗效。
2.3采用不规则喂养法复制胃肠排空障碍模型,随机分为模型组、传统枳术丸组、1／3量超微枳术丸组,分别给予不同处理,观察动物炭末推进情况、胃内残留率,采用放免法检测血清胃动素、胃泌素水平。
3结果：
3.1文献研究：
痞满(功能性消化不良)病情缠绵,病因多为饮食失常、劳累过度、内伤七情等损伤脾胃,导致脾虚气弱,运化无力,郁而不行,最终中焦气机紊乱,脾胃升降失常,气机不畅,脾失健运,气机壅滞,胃失和降,受纳不畅,多出现脾虚气滞型痞满证候,脾虚气滞为其基本病机,脾胃虚弱是本,气滞为标,虚中夹实。病性虚多于实,病位多在脾、肝、胃。
3.2临床研究：
3.2.1基线期结果：
治疗组与对照组在疗前性别构成、年龄、生命体征等一般情况方面、各症候等级及症候总积分方面、血浆胃动素、胃泌素水平、胃排空功能方面比较,差异均无统计学意义(P>0.05),具有可比性。
3.2.2疗效结果：
3.2.2.1治疗组治疗前后比较：
各症候较治疗前均有不同程度好转,除恶心、呕吐两项症候积分与疗前比较差异无统计学意义(P>0.05)外,余各项症候与疗前比较差异均有显著统计学意义(P<0.01)；血浆胃动素、胃泌素水平显著提高,与疗前比较差异均有显著统计学意义(P<0.01)；胃排空功能显著改善,与疗前比较差异有显著统计学意义(P<0.01)。
3.2.2.2对照组治疗前后比较：
各症候较治疗前均有不同程度好转,除恶心、呕吐、嗳气三项症候积分与疗前比较差异无统计学意义(P>0.05)外,余各项症候与疗前比较差异具有统计学或显著统计学意义(P<0.01—P＜0.05)；血浆胃动素、胃泌素水平显著提高,与疗前比较差异均有显著统计学意义(P<0.01)；胃排空功能显著改善,与疗前比较差异有显著统计学意义(P<0.01)。
3.2.2.3治疗组与对照组治疗后比较：
治疗组与对照组症候群疗效率和总有效率比较,差异均无统计学意义(P>0.05)；各症候等级比较,症候群中的胃脘痞闷、嗳气两项症候的疗效,1／3量超微枳术丸组优于传统枳术丸组,差异有显著统计学意义(P<0.01),脘腹胀、纳呆两项症候的疗效1／3量超微枳术丸组优于传统枳术丸组,差异具有统计学意义(P<0.05),余各项症候指标两组差异无统计学意义(P>0.05)；症候总积分比较,1／3量超微枳术丸组优于传统枳术丸组,差异有统计学意义(P<0.05)；血浆胃动素、胃泌素水平比较,1／3量超微枳术丸组均优于传统枳术丸组,差异均具统计学意义(P<0.05)；胃排空功能比较,差异无统计学意义(P>0.05)。
3.3实验研究：
3.3.1两给药组对炭末推进率的影响比较：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)；1／3量超微枳术丸组与传统枳术丸组比较,差异无统计学意义(P>0.05)。3.3.2两给药组对胃残留率的影响比较：给药2周后两给药组与模型组比较,均有降低,差异均具统计学意义(P<0.05)；1／3量超微枳术丸组与传统枳术丸组比较,差异无统计学意义(P>0.05)。
3.3.3两给药组对胃动素水平的影响比较：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)；1／3量超微枳术丸与传统枳术丸组比较,差异无统计学意义(P>0.05)。
3.3.4两给药组对胃泌素水平的影响比较：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)；1／3量超微枳术丸与传统枳术丸组比较,差异无统计学意义(P>0.05)。
3.3.5两给药组对CCK及受体mRNA的影响：给药2周后两给药组与模型组比较,均有显著增高,差异均具显著统计学意义(P<0.01)。
结论：
1枳术丸能有效地改善脾虚气滞型FD患者的胃肠排空和症状,1／3量超微枳术丸疗效与全量传统枳术丸相当。
2枳术丸能促进FD小鼠胃肠蠕动、减少胃内残留,调节胃肠激素水平。
3枳术丸能升高FD小鼠十二指肠黏膜CCKmRNA及胃底部CCK-A受体mRNA的表达水平,从而升高血浆CCK水平及胃底处CCK-A受体的数量。
Objective:Discussed the clinical safety and effectiveness of ultra-powder Zhizhu Pill's on patients with functional dyspepsia in syndrome of deficiency of spleen's function and congestion of gas-movements, and clarified its mechanism from aspects of gastrointestinal movements and hormone-regulating.
Methods:
1 Through the collection of ancient and modern literature, review the displines of diagnosis and treatment on functional dyspepsia both in Western and Chinese medicine.
2 60 patients of functional dyspepsia with the type of the the deficiency of spleen's function and congestion of gas-movements were selected, following the principles of evidence-based medicine and DME,randomly divided into treatment group and control group, were correspondly given 1/3 the volume of AMD Zhizhu traditional pills and total Zhizhu pills, during the treatment of 14 days, observed the patients'gastrointestinal emptying-function, symptoms and gastrointestinal hormone levels before and after treatment to evaluate their curative effect.
3 Copied the model group of gastrointestinal-emptying impediment by the method of irregular-feeding, randomly divided the mice into model group, traditional Zhizhu pill group,1/3 the volume of AMD Zhizhu pill group, distinctly given different treatment to observe the situation of animals' carbonpowder-promoting,the residual rate in stomach, to examinate the level of motilin, gastrin in plasma, using the method of radioimmunoassay.
Results:
1 Literature Study:Swelling of the Spleen and stomach (functional dyspepsia)has long course of disease, causes of this disease always include eating-disorders、overwork、injuries on the spleen and stomach, leading to the deficiency and poor-transporting of spleen and gas's function、gas-movements disorder in the spleen and stomach movements, finally leads to disharmony of spleen and stomach、deficiency syndrome of spleen and stomach's function and swelling of the spleen and stomach. The deficiency of spleen's function and congestion of gas-movements is the basic mechanism,the essence is the weakness of spleen and stomach,the representation is the congestion of gas-movements. The nature of Fd is weakness together with fullness, weakness is much obvious than fullness.Infection position always relay to spleen, liver, stomach.
2 Clinical Research:
2.1 The results of the baseline period:
Before treatment, there was no statistical significance (P> 0.05)at the differences between treatment group and control group on the aspects of general situation such as gender composition, age, life symptom, on the aspects of each symptom's degree and symptom's total score,on the aspects of the levels of motilin and gastrin in plasma, on the aspects of the function of gastric-emptying, two groups have the commeasurability.
2.2 The cruative effect Results:
Comparison of the treatment group before and after treatment:Every symptoms's degree have improved with various degree's compared with pre-treatment.With the exception of two syndromes'scores of nauseat and vomity's differences between before and after treatment had no statistical significance (P> 0.05),the other symptoms'differences all had significant statistical significance (P< 0.01); the levels of motilin and gastrin in plasma were significantly increased compared with pre-treatment, the differences had significant statistical significance (P<0.01); the function of gastric-emptying improved significantly compared with pre-treatment, the differences had significant statistical significance (P<0.01).
Comparison of the control group before and after treatment:Every symptoms's degree have improved with various degree's compared with pre-treatment.With the exception of three syndromes'scores of nauseat、vomity and eructation's differences between before and after treatment had no statistical significance (P> 0.05), the other symptoms'differences all had statistical significance or significant statistical significance (P< 0.01-P< 0.05); the levels of motilin and gastrin in plasma were significantly increased compared with pre-treatment, the differences had significant statistical significance (P<0.01); the function of gastric-emptying improved significantly compared with pre-treatment, the differences had significant statistical significance (P<0.01).
Comparison of the treatment group and control group after treatment:There was no statistical significance (P> 0.05)at the differences between treatment group and control group on the aspects of curative effect rate of syndrome and total effective rate; as to the degrees of Every symptoms, two syndromes' improvement of swelling of the Spleen and stomach、eructation in 1/3 the volume of AMD Zhizhu Pill group were much superior to the traditional pill group, there was significant statistical significance (P<0.01)at the differences between the two groups,two syndrome's improvement of Stomach's fullness and poor appetite in 1/3 the volume of AMD Zhizhu Pill group were superior to the traditional pill group, there was statistical significance (P<0.05)at the difference between the two groups, the other symptoms'differences all had no statistical significance(P> 0.05) between the two groups;as to the improvement of syndrome total scores,1/3 the volume of AMD Zhizhu Pill group was superior to the traditional pill group,there was statistical significance (P<0.05)at the differences between the two groups; as to the improvement of the levels of motilin and gastrin in plasma,1/3 the volume of AMD Zhizhu Pill group was superior to the traditional pill group,there was statistical significance (P<0.05)at the differences between the two groups; threre was no statistical significance (P> 0.05) on the difference of the function of gastric-emptying between the two groups.
3 Experimental Study:
3.1 Comparison of the two medicine-using groups's effects on the carbonpowder-promoting rate:After 2 weeks'treatment, there was significant improvement in both medicine-using groups, compared with the model group. There was significant statistical significance (P<0.01) at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
3.3.1.2 Comparison of the two medicine-using groups's effects on the residual rate in stomach,:
After 2 weeks'treatment, there was drop in both medicine-using groups, compared with the model group. There was statistical significance (P<0.05)at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
3.2 Comparison of the two medicine-using groups's effects on the level of motilin:After 2 weeks'treatment, there was significant improvement in both medicine-using groups, compared with the model group. There was significant statistical significance (P<0.01) at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
3.3 Comparison of the two medicine-using groups's effects on the level of gastrin:After 2 weeks'treatment, there was significant improvement in both medicine-using groups, compared with the model group. There was significant statistical significance (P<0.01) at the differences between two medicine-using groups and model group; threre was no statistical significance (P> 0.05)between 1/3 the volume of AMD Zhizhu Pill group and traditional pill group.
Conclusion:1 Zhizhu pill can effectively improve symptoms and gastrointestinal-emptying of FD patients with type of the the deficiency of spleen's function and congestion of gas-movements,1/3 the volume of AMD pill Zhizhu and total Zhizhu pills have the equivalent curative effect.
2 Zhizhu pills can promote gastrointestinal peristalsis of FD mice, reduce the residual rate in stomach, regulate the level of gastrointestinal hormones.
3 Zhizhu pills can promote the expression level of CCKmRNA in duodenum mucous membrance and CCK-A acceptor mRNA in fundus ventriculi, increase the level of CCK in plasma and the amount of CCK-A acceptor in fundus ventriculi。
引文
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