四妙散颗粒治疗湿热蕴结型急性痛风性节炎的临床研究
摘要
痛风是嘌呤代谢紊乱所致的疾病,以高尿酸血症为临床特征。痛风的临床表现主要有急慢性痛风性关节炎、关节畸形、尿路结石、肾脏病变等,其中以关节疼痛为主要症状,发作时给患者造成很大痛苦,严重影响患者的日常生活。目前对痛风的治疗,临床上常用秋水仙碱、非甾体消炎止痛药、肾上腺糖皮质激素及丙磺舒、痛风利仙、别嘌呤醇等,虽也能缓解急性关节炎症状,有一定降低血尿酸的作用,但并不能解决体内嘌呤代谢紊乱问题,且药物的毒副反应明显。
痛风性关节炎属中医“痹证”,“历节病”等范畴。我们认为,痛风的病因病机为饮食不节、形体肥胖、起居不慎为基本病因,脾肾亏虚、清浊不分、热毒为患是病机关键。热毒、痰浊、瘀血交相为患是主要病理产物。在急性发作期,湿热蕴结者较为多见。此时相当于中医的“热痹”。中医治疗痛风有悠久的历史,现代中医对痛风的研究也比较丰富。
痹证的治疗原则是祛风、除湿、散寒、清热、通经络、止疼痛,热痹的治疗应清热除湿,活血通络止痛。四妙散由黄柏、苍术、牛膝、薏苡仁组成,方中以黄柏清热燥湿为君;苍术燥湿健脾为臣;牛膝补肝肾,强筋骨,活血通经,兼可引药下行同时为佐使药;薏苡仁渗湿泄浊,导湿热于小便出,为佐药,苍术和薏苡仁配伍,强化健脾利湿之功,断湿热之源,全方共奏清热、利湿、活血之功,是治疗下肢痿弱,足膝红肿,筋骨疼痛,关节屈伸不利之热痹的良方。实验结果表明,四妙散对二甲苯所致耳廓肿胀及醋酸所致小鼠腹腔毛细血管通透性增高有明显的抑制作用,说明其可以抑制毛细血管扩张,通透性增加,渗出性水肿为主的急性炎症早期反应。此外其对小鼠醋酸扭体反应有明显的抑制作用,并能明显延长热刺激小鼠痛阈值,表明四妙散对不同刺激引起的疼痛均有良好的镇痛效果,可缓解临床炎症反应引起的疼痛,并可降低高尿酸血症小鼠的尿酸水平。
对四妙散治疗痛风性关节炎的临床研究文献较多,但对痛风的辨证分型不明确,疗效判断标准也不太统一,很多临床研究缺乏规范的疗效标准,基于此不足,我们选择属于湿热蕴结型急性痛风性关节炎患者进行研究,研究四妙散治疗的疗效,为四妙散治疗湿热蕴结型急性期痛风性关节炎临床推广提供依据。
1、方法
本研究采用治疗前后对照的方法,入组80例符合湿热蕴结型痛风的患者,采用四妙散颗粒进行治疗,疗程为7天,分别在2天、4天、7天检测患者关节炎疼痛缓解时间、局部红肿消退时间以及关节肿痛指数(包括关节休息痛、关节压痛、关节肿胀度),各关节肿痛指数=[(治疗前肿痛总分数—治疗后肿痛总分数)/治疗前肿痛总分数]×100%。分别计算治疗前、治疗2天、4天、7天时关节肿痛指数。然后根据卫生部《中药新药临床研究指导原则》对疗效进行判断。
2、结果
2.1研究显示,经治疗,大多数痛风患者急性关节炎的关节疼痛症状得到缓解,平均缓解时间约为2天,关节红肿消失时间平均约3至4天。
2.2研究显示,治疗前,关节肿痛指数评分较高,治疗2天后,关节肿痛指数有所降低,与治疗前比较,差异没有显著意义;治疗4天后,关节肿痛指数继续降低,与治疗前比较,差异显著;治疗7天后,关节肿痛指数明显降低,与治疗前比较,差异非常显著。
2.3研究显示,四妙散治疗急性痛风性关节炎湿热蕴结型临床治愈19人,占23.75%,显效41人,占51.25%,有效14人,占17.5%,无效6人,占7.5%,总有效率为92.5%。
3、结论
3.1四妙散快速消除关节红肿,减轻关节疼痛。研究中患者均属于湿热内蕴导致的关节炎,故用清热祛湿,通络止痛的四妙散可以清楚体内的湿热,通畅痹阻的关节气血,故可以收到消肿止痛之效。
3.2四妙散明显降低关节肿痛指数。由于清除了痹阻关节的湿热之邪,消除了关节肿胀、疼痛,同时可以减轻关节压痛,故可以较全面的改善关节情况,降低关节肿痛指数。
3.3四妙散治疗急性痛风性关节炎湿热蕴结型疗效确切。治疗一周后,由于患者体内湿热之邪逐渐被清除,被痹阻的关节气血得到畅通,“通而不痛”所以关节疼痛、肿胀、压痛得到改善,关节功能得到恢复,患者生活质量明显改善,部分患者痊愈,大部分患者能恢复基本的工作生活。
3.4痛风需要综合治疗。痛风的产生与发作与生活方式密切相关,故在药物治疗的同时,要坚持低嘌呤饮食,多饮水,避免寒冷潮湿劳累等诱因,急性发作时关节要适当休息,才能更快控制发作,预防复发。
本研究为四妙散治疗湿热蕴结型急性痛风性关节炎提供了临床依据,有助于推广纯中医中药治疗痛风的临床应用。
Gout is a crystal deposition disease hallmarked by elevated levels of uric acid in the bloodstream.It is characterized by excruciating,sudden, burning pain caused by chronic and acute gouty arthritis.Other symptoms include joint deformation,urinary stones and kidney disease.The first line of treatment is pain relief,and the drug options are non-steroidal anti-inflammatory drugs,colchicine and oral glucocorticoids,such as probenecid,narcaricin and allopurinol.Though they act in lowering the blood uric acid level,they do not modify and regulate the system's uric acid metabolism,thus often causing adverse reactions to drug.
In Traditional Chinese Medicine,gout is categorized in the "Bi"-syndrome and "Li Jie".We believe that it's caused by poor diet and nutrition,overweight and obesity,and poor habits.The etiology has to do with poor constitution of the spleen and kidneys,thus affecting the system' s ability to properly excrete unwanted wastes from the body,which then forming harmful toxins,such as excess heat,dampness,and blood stagnation.In acute cases,both heat and dampness' s activity is at its peak, thus noted to belong to the TCM category of "Heat Bi" syndrome.
The treatment of gout by ways of TCM has its long history;vast amount of research has been done in this field.Its treatment is based on relieving the dampness,coldness,and easing the heat that' s blocking the channels, the cause of pain.The treatment of "Heat Bi" syndrome is therefore cooling down the heat and promoting blood circulation to alleviate meridian obstruction.Simiaosan is the formulation composed of huangbai,cangzhu, niuxi,and yiyiren.Huangbai is the most essential heat-reducing ingredient in this formula,while cangzhu removes dampness by strengthening the spleen function.Niuxi tones the liver and kidney function,promotes blood circulation and removes blockage in the meridians.Yiyiren is a diuretic which induces urination,thus allowing the dampness to leave the system.The combined use of cangzhu and yiyiren works to tone the spleen function which help to regulate the body fluid.In all,the complete formulation brings about a reliable treatment for "Heat Bi" syndrome,characterized by weakness of the lower extremity,inflammation of the knees and feet,pain and stiffness in the joints.Lab experiments have been done to prove that Simiaosan can suppress the dilation of capillaries,increase permeability,thus reducing the inflammatory reaction during acute gouty arthritis.Moreover,Simiaosan can elevate the threshold of pain in lab mice,thus able to manage pain as a result of inflammation as well as reducing the increased level of blood uric acid.
Considerable research regarding the use of Simiaosan in the treatment of gout has been done.With regards to the individual gout syndromes,studies are limited,its diagnosis is not standardized,and clinical research lacks the criteria of curative effect.Thus,this study' s objective is to observe the curative effect of Simiaosan in the treatment of acute gouty arthritis caused by heat-damp syndrome.
Method:
This study is a controlled experiment,monitoring the before and after effect of prescribing Simiaosan granules to 80 gouty arthritis patients diagnosed with heat-damp syndrome.The treatment period is 7 continuous days. On the second,forth and seventh day,the time for the joint pain to alleviate, the time for the swelling to diminish and the level of pain(including the pain at rest,under pressure,and during swelling) are recorded.The index of pain expressed in percentage can then be calculated.Subsequently,the curative effect can be determined according to The Guide to Clinical Study of Chinese Medicine and New Drugs,released by the National Department of Health.
Results:
1.After treatment,most patients are able to manage the pain better.On average,the pain relieving time is approximately 2 days,and the time to reduce the joint swelling is about 3 to 4 days.
2.After 2 days of treatment,the index of pain is lower than that of before treatment,yet,the difference is not statistically significant.After 4 days of treatment,the index continues to decrease,when compared with that of before treatment,the difference is statistically significant.After 7 days of treatment,the index drastically dropped as compared with before treatment,thus,the difference is very significant.
3.The treatment using Simiaosan in acute gouty arthritis with heat-damp syndrome resulted in the following:19 patients clinically cured(23.75%), 14 patients very effective(51.25%),14 patients effect(17.5%),and 6 patients ineffective(7.5%).
Conclusions:
1.Simiaosan can relief the swelling and pain of the arthritic joint.In the experiment,all patients are diagnosed with the heat-damp syndrome.The treatment with Simiaosan is effect due to its ability to alleviate the heat and dampness,and to promote blood circulation to reduce meridian obstruction.
2.Simiaosan significantly reduced the index of pain.By removing the excess heat and dampness in the joints,the pain and swelling both reduced as a consequent.
3.The curative effect of treating acute gouty patients with heat-damp syndrome with Simiaosan is significant.After a week' s treatment,the excess heat and dampness in the body are readily removed,the joints are less painful and swollen;thus,the index of pain is observed to be significantly lower.
4.Gout requires a combined therapy.In addition to medical care,the patients also need to pay attention to their daily habits.For instance,a low purina diet and frequent water consumption are important.Moreover, adequate rest of the joint in acute attacks is part of a good prognosis and prevention.
This study not only provides clinical evidence for the treatment of acute gouty arthritis with heat-damp syndrome with Simiaosan,but also helps to promote TCM therapy in clinical practice.
痛风性关节炎属中医“痹证”,“历节病”等范畴。我们认为,痛风的病因病机为饮食不节、形体肥胖、起居不慎为基本病因,脾肾亏虚、清浊不分、热毒为患是病机关键。热毒、痰浊、瘀血交相为患是主要病理产物。在急性发作期,湿热蕴结者较为多见。此时相当于中医的“热痹”。中医治疗痛风有悠久的历史,现代中医对痛风的研究也比较丰富。
痹证的治疗原则是祛风、除湿、散寒、清热、通经络、止疼痛,热痹的治疗应清热除湿,活血通络止痛。四妙散由黄柏、苍术、牛膝、薏苡仁组成,方中以黄柏清热燥湿为君;苍术燥湿健脾为臣;牛膝补肝肾,强筋骨,活血通经,兼可引药下行同时为佐使药;薏苡仁渗湿泄浊,导湿热于小便出,为佐药,苍术和薏苡仁配伍,强化健脾利湿之功,断湿热之源,全方共奏清热、利湿、活血之功,是治疗下肢痿弱,足膝红肿,筋骨疼痛,关节屈伸不利之热痹的良方。实验结果表明,四妙散对二甲苯所致耳廓肿胀及醋酸所致小鼠腹腔毛细血管通透性增高有明显的抑制作用,说明其可以抑制毛细血管扩张,通透性增加,渗出性水肿为主的急性炎症早期反应。此外其对小鼠醋酸扭体反应有明显的抑制作用,并能明显延长热刺激小鼠痛阈值,表明四妙散对不同刺激引起的疼痛均有良好的镇痛效果,可缓解临床炎症反应引起的疼痛,并可降低高尿酸血症小鼠的尿酸水平。
对四妙散治疗痛风性关节炎的临床研究文献较多,但对痛风的辨证分型不明确,疗效判断标准也不太统一,很多临床研究缺乏规范的疗效标准,基于此不足,我们选择属于湿热蕴结型急性痛风性关节炎患者进行研究,研究四妙散治疗的疗效,为四妙散治疗湿热蕴结型急性期痛风性关节炎临床推广提供依据。
1、方法
本研究采用治疗前后对照的方法,入组80例符合湿热蕴结型痛风的患者,采用四妙散颗粒进行治疗,疗程为7天,分别在2天、4天、7天检测患者关节炎疼痛缓解时间、局部红肿消退时间以及关节肿痛指数(包括关节休息痛、关节压痛、关节肿胀度),各关节肿痛指数=[(治疗前肿痛总分数—治疗后肿痛总分数)/治疗前肿痛总分数]×100%。分别计算治疗前、治疗2天、4天、7天时关节肿痛指数。然后根据卫生部《中药新药临床研究指导原则》对疗效进行判断。
2、结果
2.1研究显示,经治疗,大多数痛风患者急性关节炎的关节疼痛症状得到缓解,平均缓解时间约为2天,关节红肿消失时间平均约3至4天。
2.2研究显示,治疗前,关节肿痛指数评分较高,治疗2天后,关节肿痛指数有所降低,与治疗前比较,差异没有显著意义;治疗4天后,关节肿痛指数继续降低,与治疗前比较,差异显著;治疗7天后,关节肿痛指数明显降低,与治疗前比较,差异非常显著。
2.3研究显示,四妙散治疗急性痛风性关节炎湿热蕴结型临床治愈19人,占23.75%,显效41人,占51.25%,有效14人,占17.5%,无效6人,占7.5%,总有效率为92.5%。
3、结论
3.1四妙散快速消除关节红肿,减轻关节疼痛。研究中患者均属于湿热内蕴导致的关节炎,故用清热祛湿,通络止痛的四妙散可以清楚体内的湿热,通畅痹阻的关节气血,故可以收到消肿止痛之效。
3.2四妙散明显降低关节肿痛指数。由于清除了痹阻关节的湿热之邪,消除了关节肿胀、疼痛,同时可以减轻关节压痛,故可以较全面的改善关节情况,降低关节肿痛指数。
3.3四妙散治疗急性痛风性关节炎湿热蕴结型疗效确切。治疗一周后,由于患者体内湿热之邪逐渐被清除,被痹阻的关节气血得到畅通,“通而不痛”所以关节疼痛、肿胀、压痛得到改善,关节功能得到恢复,患者生活质量明显改善,部分患者痊愈,大部分患者能恢复基本的工作生活。
3.4痛风需要综合治疗。痛风的产生与发作与生活方式密切相关,故在药物治疗的同时,要坚持低嘌呤饮食,多饮水,避免寒冷潮湿劳累等诱因,急性发作时关节要适当休息,才能更快控制发作,预防复发。
本研究为四妙散治疗湿热蕴结型急性痛风性关节炎提供了临床依据,有助于推广纯中医中药治疗痛风的临床应用。
Gout is a crystal deposition disease hallmarked by elevated levels of uric acid in the bloodstream.It is characterized by excruciating,sudden, burning pain caused by chronic and acute gouty arthritis.Other symptoms include joint deformation,urinary stones and kidney disease.The first line of treatment is pain relief,and the drug options are non-steroidal anti-inflammatory drugs,colchicine and oral glucocorticoids,such as probenecid,narcaricin and allopurinol.Though they act in lowering the blood uric acid level,they do not modify and regulate the system's uric acid metabolism,thus often causing adverse reactions to drug.
In Traditional Chinese Medicine,gout is categorized in the "Bi"-syndrome and "Li Jie".We believe that it's caused by poor diet and nutrition,overweight and obesity,and poor habits.The etiology has to do with poor constitution of the spleen and kidneys,thus affecting the system' s ability to properly excrete unwanted wastes from the body,which then forming harmful toxins,such as excess heat,dampness,and blood stagnation.In acute cases,both heat and dampness' s activity is at its peak, thus noted to belong to the TCM category of "Heat Bi" syndrome.
The treatment of gout by ways of TCM has its long history;vast amount of research has been done in this field.Its treatment is based on relieving the dampness,coldness,and easing the heat that' s blocking the channels, the cause of pain.The treatment of "Heat Bi" syndrome is therefore cooling down the heat and promoting blood circulation to alleviate meridian obstruction.Simiaosan is the formulation composed of huangbai,cangzhu, niuxi,and yiyiren.Huangbai is the most essential heat-reducing ingredient in this formula,while cangzhu removes dampness by strengthening the spleen function.Niuxi tones the liver and kidney function,promotes blood circulation and removes blockage in the meridians.Yiyiren is a diuretic which induces urination,thus allowing the dampness to leave the system.The combined use of cangzhu and yiyiren works to tone the spleen function which help to regulate the body fluid.In all,the complete formulation brings about a reliable treatment for "Heat Bi" syndrome,characterized by weakness of the lower extremity,inflammation of the knees and feet,pain and stiffness in the joints.Lab experiments have been done to prove that Simiaosan can suppress the dilation of capillaries,increase permeability,thus reducing the inflammatory reaction during acute gouty arthritis.Moreover,Simiaosan can elevate the threshold of pain in lab mice,thus able to manage pain as a result of inflammation as well as reducing the increased level of blood uric acid.
Considerable research regarding the use of Simiaosan in the treatment of gout has been done.With regards to the individual gout syndromes,studies are limited,its diagnosis is not standardized,and clinical research lacks the criteria of curative effect.Thus,this study' s objective is to observe the curative effect of Simiaosan in the treatment of acute gouty arthritis caused by heat-damp syndrome.
Method:
This study is a controlled experiment,monitoring the before and after effect of prescribing Simiaosan granules to 80 gouty arthritis patients diagnosed with heat-damp syndrome.The treatment period is 7 continuous days. On the second,forth and seventh day,the time for the joint pain to alleviate, the time for the swelling to diminish and the level of pain(including the pain at rest,under pressure,and during swelling) are recorded.The index of pain expressed in percentage can then be calculated.Subsequently,the curative effect can be determined according to The Guide to Clinical Study of Chinese Medicine and New Drugs,released by the National Department of Health.
Results:
1.After treatment,most patients are able to manage the pain better.On average,the pain relieving time is approximately 2 days,and the time to reduce the joint swelling is about 3 to 4 days.
2.After 2 days of treatment,the index of pain is lower than that of before treatment,yet,the difference is not statistically significant.After 4 days of treatment,the index continues to decrease,when compared with that of before treatment,the difference is statistically significant.After 7 days of treatment,the index drastically dropped as compared with before treatment,thus,the difference is very significant.
3.The treatment using Simiaosan in acute gouty arthritis with heat-damp syndrome resulted in the following:19 patients clinically cured(23.75%), 14 patients very effective(51.25%),14 patients effect(17.5%),and 6 patients ineffective(7.5%).
Conclusions:
1.Simiaosan can relief the swelling and pain of the arthritic joint.In the experiment,all patients are diagnosed with the heat-damp syndrome.The treatment with Simiaosan is effect due to its ability to alleviate the heat and dampness,and to promote blood circulation to reduce meridian obstruction.
2.Simiaosan significantly reduced the index of pain.By removing the excess heat and dampness in the joints,the pain and swelling both reduced as a consequent.
3.The curative effect of treating acute gouty patients with heat-damp syndrome with Simiaosan is significant.After a week' s treatment,the excess heat and dampness in the body are readily removed,the joints are less painful and swollen;thus,the index of pain is observed to be significantly lower.
4.Gout requires a combined therapy.In addition to medical care,the patients also need to pay attention to their daily habits.For instance,a low purina diet and frequent water consumption are important.Moreover, adequate rest of the joint in acute attacks is part of a good prognosis and prevention.
This study not only provides clinical evidence for the treatment of acute gouty arthritis with heat-damp syndrome with Simiaosan,but also helps to promote TCM therapy in clinical practice.
引文
[1]王秀莲.痛风病本虚标实论治探讨.山东中医杂志,2001,20(4):199-200
[2]王影.中西医结合治疗原发性痛风探析.实用中医内科杂志,2003,17(5):396
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