独活寄生汤颗粒治疗肾虚型腰椎骨关节炎的临床疗效观察
摘要
腰椎骨关节炎指发生于腰椎的骨关节炎,是腰椎间盘退变狭窄,椎体边缘退变增生及椎体间小关节因退变形成的骨关节病变和由此产生的一系列症状。临床以慢性下腰痛持续或间断发作为主要症状。西医治疗主要采用非甾体抗炎药,通过抑制环氧化酶阻断花生四烯酸代谢,抑制前列腺素合成,以起到抗炎、镇痛作用,从而改善临床症状,但它同时也削弱了前列腺素的生理保护作用,造成严重的胃十二指肠和肾脏损害,NASIDs药物还具有破坏软骨作用,尤其是在腰椎骨关节炎高发的中老年人群更为突出。目前尚缺乏安全有效的治疗药物和方法。
腰椎骨关节炎结合临床表现,属于祖国医学“痹证”、“腰痛”范畴,中医学对这类疾病认识的历史很长,早在《内经》就有曰:“腰为肾之府,转摇不能,肾将惫矣。”《证治准绳腰痛》曰:“有风、有湿、有寒、有热、有闪挫、有瘀血、有滞气、有痰积,皆标也;肾虚其本也。”上述说本病与肾关系最为密切,肾虚是发病的关键所在。现代中医认为,本病总属本虚标实。虚者肝肾不足,筋骨失充,实者寒湿,淤血痹阻,经脉不利。血脉不通。治疗不外乎补肝肾,强筋骨,祛风散寒除湿,通血活络为原则。
独活寄生汤取自千金要方,本方补肝肾,祛风湿,标本兼治。该方以熟地、牛膝、杜仲、桑寄生补益肝肾,当归、川芎、芍药、党参、茯苓、甘草以益气血,独活、秦艽、防风、细辛、桂枝以除风寒湿邪。是治疗肾虚型腰椎骨质增生的常用方剂。
目前对中医药治疗腰椎骨关节炎的临床研究多集中于某一方一药简单的疗效观察,很多研究缺乏科学的研究方法,缺乏统一的诊断标准,疗效判定标准也不统一,而且有关治疗腰椎骨关节炎疗效评价方面,单纯用死亡率、患病率、缓解率,有效率等传统评价指标,这些指标已不能真实地反映出腰椎骨关节炎患者对疾病的体验和治疗的综合反应,不能全面地评判干预措施的效果,最终不能满足群体对健康的新要求。研究的结果不能真实反映药物的疗效,不利于中医药治疗腰椎骨关节炎的推广
目的:基于以上背景我们设计了独活寄生汤治疗腰椎骨关节炎疗效评价的实验方案。通过对腰椎骨关节炎患者临床症状改善评价及生存质量改善评价,以期对独活寄生汤颗粒治疗腰椎骨关节炎的临床疗效作出正确的评价。
方法:收集入组53例符合诊断标准、纳入标准、排除标准的腰椎骨关节炎患者,采用独活寄生汤颗粒治疗3个月,分别在治疗前、治疗一个月、治疗两个月、治疗结束时采用视觉模拟评分法对观察患者对疗效的评价、医生对疗效的评价;患者对腰部疼痛的评价、患者对腰部压痛的评价、患者对腰部运动障碍的评价;采用生存质量SF-36问卷,分别在治疗前、治疗一个月、治疗两个月、治疗结束时对独活寄生汤颗粒对腰椎骨关节炎患者生存质量的影响进行研究。
结果:
1、独活寄生汤颗粒治疗一个月后,患者及医生对包括对腰部疼痛、伴随症状、日常活动及工作的总体评价就有所改善;两个月后,患者和医生的总体评价继续改善,与一个月时相比,差异有显著意义,治疗结束时,患者和医生的总体评价与治疗前比较明显改善,统计学比较有显著性差异。
2、治疗结果显示,在治疗一个月后,患者的腰部疼痛症状有所改善,与治疗前相比,差异有显著意义;两个月后,腰部疼痛继续减轻,与治疗前相比,差异有显著意义,治疗结束时,腰部疼痛明显减轻,统计学比较有显著性差异。在治疗一个月后,患者的腰部压痛症状有所改善,但与治疗前相比,差异没有显著意义;两个月后,腰部压痛继续减轻,与治疗前相比,差异有显著意义,治疗结束时,腰部压痛明显减轻,统计学比较有显著性差异。
3、结果显示,治疗一个月时,生理功能(PF)、生理角色限制(RP)、躯体疼痛(BP)、总体健康(GH)、活力(VT)、社会功能(SF)、情感角色限制(RE)、心理健康(MH)均有所改善,但无统计学差异;治疗两个月时,患者的PF、BP、GH、SF明显改善,与治疗前相比,有显著性差异;治疗3个月时,患者的PF、BP、GH、SF继续改善,与治疗前相比,有显著性差异。但患者的RP、VT、RE、MH虽也有一定改善,但仍无统计学差异。
结论:
1、提示独活寄生汤颗粒治疗2个月可以出现明显疗效。
腰椎骨关节炎归属中医“痹证”、“腰痛”范畴,祖国医学认为“腰为肾之府”,“肾立骨”,按照经络循行的部位,腰椎属督脉循行的部分,足太阳膀胱经循行于腰两侧,与足少阴肾经相互表里。因此,肾气、督脉、膀胱经气的充盛维系着腰部的正常活动功能。人到中年,肾气渐亏,腠理空虚,风寒湿邪乘虚而入,血脉凝滞不通,痹阻督脉,“不通则痛”。独活寄生汤取自千金要方,本方补肝肾,祛风湿,标本兼治。该方以熟地、牛膝、杜仲、桑寄生补益肝肾,当归、川芎、芍药、党参、茯苓、甘草以益气血,独活、秦艽、防风、细辛、桂枝以除风寒湿邪,针对腰椎骨关节炎的病因病机,故治疗后,患者及医生对包括腰部疼痛、伴随症状、日常活动及工作的总体评价均明显改善,由于腰椎骨关节炎的形成是一个长期的过程,前来求诊的患者都有较长的病程,经过各种治疗不理想,。肾虚之本逐渐严重,邪易祛,正难扶,所以,治疗不是一个短期的过程,
2、独活寄生汤颗粒治疗一个月明显缓解腰痛,治疗二个月缓解腰部压痛及腰部运动障碍。
和腰部压痛、腰部活动障碍相比,独活寄生汤对腰部疼痛起效较快,治疗一个月后腰痛就有明显好转,统计学有差异,而腰部压痛和腰部活动障碍要平均两个月左右才见到有统计学差异的疗效。除患者病程长,肾虚日渐显著,正气难补益之外,还可能与药物剂型有关,“汤者荡也”,用汤剂可更快荡涤邪气,“丸者缓也”,“散者散也”,独活寄生汤颗粒相当与丸散剂,药效发挥慢,但对于病位深在骨与关节的疾病,非荡涤可治,需缓缓扶正补虚收功,治疗是一个长期的过程,但由于治疗时间长,天天煎煮汤剂不甚方便,尤其在生活节奏加快的当今社会,更难坚持,所以长期应用颗粒剂比较现实。
3、独活寄生汤颗粒可以改善患者生存质量。
治疗后,患者的生理功能改善,这与症状缓解,活动能力改善有关;躯体疼痛明显减轻,这与临床观察方面一致:总体健康明显改善,由于腰部是人体主要负重和活动部位,腰部疼痛的好转,活动障碍的改善可明显提高患者的总体健康;社会功能改善,由于疼痛不适的好转,活动能力的提高,活动范围的增加,故可改善患者的社会功能,从事家务及日常工作的能力提高,对改善患者的生存质量非常有益。但研究显示,对患者的生理角色限制、活力、情感角色限制、心理健康改善没有统计学差异,提示,虽然治疗3个月后,临床症状明显好转,但由于疾病只能控制,不能痊愈,还是或多或少影响到患者的生理和心理健康。是否继续治疗,能继续改善患者的生存质量,值得进一步研究。
以上研究结果充分显示了独活寄生汤颗粒治疗肾虚型腰椎骨关节炎疗效确切,能明显改善患者的临床症状,改善患者的生存质量。本研究为中医药治疗骨关节退行性疾病的临床疗效提供了一定的依据。
Lumbar osteoarthritis refers to the osteoarthritis which takes place in the lumbar vertebras.It refers to the osteoarthritis caused by the narrowed and degenerative lumbar intervertebral ligament,the degeneration and hyperplasy of the vertebra body margin and the degeneration of the I-B minor joints and refers to a series of symptoms caused by them.Its main clinical symptoms are the chronic continuous or interrupted lower back pain.The Western Medicine therapy mainly adopts non-steroidal anti-inflammatory drug(NSAID) which inhibits the epoxidase' blocking the arachidonic acid metabolism and inhibits prostaglandin synthesis,so as to inhibit inflammation and pain and improve the clinical symptoms.At the same time,however,it can weaken the physiological protection of prostaglandin,cause serious impairment to stomach duodenum and kidney and damage the cartilage,especially among the aged population among whom lumbar osteoarthritis has high occurrence.At present safe and efficient medicine or therapies are not available.
Lumbar osteoarthritis belongs to the category of arthromyodynia and lumbago of Chinese Medicine which has discussed this disease for a long time in history.Internal Classics notes that waist houses the kidney;if the waist can' t move around,the kidney will be exhausted.Standards for Diagnosis and Treatment wind,dampness,coldness,heat,sudden sprain and contusion, stagnated blood,obscure complexion and phlegm are all signs;the root is kidney deficiency.These indicate the close relationship between lumbar osteoarthritis and kidney and kidney deficiency is the key cause.Modern Chinese Medicine considers that this disease is asthenia in origin and sthenia in superficiality.The asthenia indicates the liver and kidney deficiency, tendons and bones' loss of nutrition;the sthenia refers to cold dampness, blood stagnation,meridians and collaterals and blood vessels not smooth.The treatment principles should be to reinforce liver and kidney,strengthen tendons and bones,disperse wind,coldness and dampness,smooth the blood and activate the collaterals.
Angelicae Pubescentis and Loranthi Decoction comes from Valuable Prescriptions Worth A Thousand Gold which reinforces liver and kidney and disperse wind,coldness and dampness,and treat both signs and roots of diseases.It consists of prepared rhizome of rehmannia,achyranthis,eucommia bark and Chinese taxillus herb to reinforce liver and kidney,angelica, Szechwan lovage rhizome,paeonia,radix codonopsitis,hoelen and sweet root to replenish blood and qi and angelica tuhov,largeleaf gentian root, saposhnikoviae radix and asiasarum and ramulus cinnamoni to disperse wind, coldness and dampness evil factors.It' s the common prescription for the lumbar vertebra hyperosteogeny of the type of kidney deficiency.
The current clinical researches on lumbar osteoarthritis with Chinese Medicine mainly focus on the efficacy observation of certain prescription or drug.These lack of scientific research methods,unified diagnosis standard and efficacy standard.In efficacy evaluation,these mainly adopt the traditional indexes like morbidity rate,attack rate,remission rate and effective power,etc.These indexes can' t truly reflect the patients' comprehensive response to treatment nor comprehensively evaluate the intervention effect and finally can't meet the population's new requirements for health.The research results can't fully reflect the drug's efficacy and is not useful for the promotion of lumbar osteoarthritis treatment with Chinese Medicine.
Aim:based on the background mentioned above,we designed the trial plan of lumbar osteoarthritis treatment efficacy evaluation with Angelicae Pubescentis and Loranthi Decoction.By evaluating the patients' clinical symptom improvement and life quality improvement,we hope that accurate evaluation will be made on the lumbar osteoarthritis treatment efficacy evaluation with Angelicae Pubescentis and Loranthi Decoction.
Methods:Collect 53 lumbar osteoarthritis patients who meet the diagnosis, inclusion and exclusion criteria,give treatment with Angelicae Pubescentis and Loranthi Decoction granules for 3 months,and at the period of before treatment,1 month after treatment,2 months after treatment and at the end of the treatment respectively observe patients' evaluation on efficacy, doctors' evaluation on efficacy,patients' evaluation on lumbar pain,lumbar pressing pain and lumbar movement difficulties with Visual Analogue Scale; research on the effect of Angelicae Pubescentis and Loranthi Decoction granules on the patients' life quality.
Results:
1.After one month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the doctors' and patients' general evaluation on lumbar pain,accompanying symptoms,daily activities and work has improved;after 2 months,the general evaluation continuously improve and the difference has statistical significance compared with that 1 month after treatment;at the end of the treatment,the evaluation has obvious improvement compared with that before treatment and has statistical significant difference.
2.After one month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the patients' lumbar pain symptoms improve and the difference has statistical significance compared with that before treatment; after 2 months,the lumbar pain continuously improve and the difference has statistical significance compared with that before treatment;at the end of the treatment,the lumbar pain has obvious improvement and has statistical significant difference.
3.After one month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the patients' PF,RP,BP,GH,VT,ST,RE,MH improve and the difference has no statistical significance;after 2 months,the PF, BP,GS and SF obviously improve and the difference has statistical significance compared with that before treatment;after 3 months' treatment,the PF,BP, GS and SF has continuous improvement and has statistical significant difference compared with that before treatment,but the RP,VT,RE and MH still haven't statistical difference though has improvement at certain level.
Conclusion:
1.Obvious efficacy occurs after 2 months' treatmetn with Angelicae Pubescentis and Loranthi Decoction granules
Lumbar osteoarthritis belongs to the category of arthromyodynia and lumbar pain in Chinese Medicine which considers that waist houses the kidney and kidney supports bones.According to position of the meridians and collaterals' circulation,lumbar belongs to the circulation part of Du-meridian.Foot-taiyang Urinary Bladder Meridians move on both sides of lumbar and form the interior and exterior relationship with Kidney Meridian of Foot-shaoyin.Therefore,kidney qi,Du-meridian and Urinary Bladder Meridian qi maintain the normal function of waist.When people reach middle age,the kidney qi gradually loses,muscle and viscus are void,wind,cold and dampness evils enter,blood vessels stagnate,arthralgia spasm occurs to Du-meridian and pain is caused.Angelicae Pubescentis and Loranthi Decoction comes from Valuable Prescriptions Worth A Thousand Gold which reinforces liver and kidney and disperse wind,coldness and dampness,and treat both signs and roots of diseases.It consists of prepared rhizome of rehmannia,achyranthis, eucommia bark and Chinese taxillus herb to reinforce liver and kidney,angelica, Szechwan lovage rhizome,paeonia,radix codonopsitis,hoelen and sweet root to replenish blood and qi and angelica tuhov,largeleaf gentian root, saposhnikoviae radix and asiasarum and ramulus cinnamoni to disperse wind, coldness and dampness evil factors.This prescription takes into consideration of the etiology and pathogenesis of lumbar osteoarthritis,therefore after treatment,the doctors' and patients' general evaluation on lumbar pain, accompanying symptoms,daily activity and work improve remarkably.As the formation of lumbar osteoarthritis is a long time and patients coming for treatment generally have long disease course whose kidney deficiency is more serious and difficult to support the healthy qi and diminish the evil after unsatisfactory treatment,so the treatment will take a long time.
2.After 1 month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the lumbar pain is obviously relieved and after 2 months the lumbar pain and lumbar movement difficulties are relieved
Compared with treatment of lumbar pressing pain and lumbar movement difficulties,Angelicae Pubescentis and Loranthi Decoction has quicker effect on lumbar pain.After 1 month' s treatment,the lumbar pain obviously improves and has statistical difference while the lumbar pressing pain and lumbar movement difficulties need two months on average to have the efficacy of statistical difference.It may have association with medication dosage form, besides the other factors like the disease course is long,the kidney deficiency is getting serious,the healthy qi is hard to reinforce,etc. Decoction can diminish evil qi more quickly.Angelicae Pubescentis and Loranthi Decoction granules are equivalent to pills and powder and the drug action is slow.However,to the disease deep at bones and joints,decoction must be used.The treatment takes long time,so making decoction is not convenient,especially in the quick-rhythm modern society,therefore granules are more practical.
3.Angelicae Pubescentis and Loranthi Decoction granules can improve patients' life quality
After treatment,the patients' physiological function improves with the release of symptoms and improvement of activity ability;body pain is obviously relieved which is consistent with clinical observation;the general health obviously improves,and the recovery of lumbar pain brings the improvement of activity difficulty as lumbar is the major weight loading and activity part; as the recovery of pain,the improvement of movement ability and the increase of movement range,the social function of patients improves;the ability of housework and daily work improvement is very helpful for the improvement of patients' life quality.However,the research shows that there' s no statistical difference in the improvement of RP,VT,RE and MH.It indicates that though after 3 months' treatment,the clinical symptoms obviously improve;patients' mental and physiological health is affected more or less as the disease can only be controlled but not cured.Whether the further treatment can improve the patients' life quality is worth of further research.
The research results above fully demonstrate the confirmed efficacy of Angelicae Pubescentis and Loranthi Decoction granules on the treatment of lumber vertebra arthritis which can significantly improve the patients' clinical symptoms and improve their life quality.This research provides evidence for the clinical efficacy of Chinese Medicine in the treatment of bone joint regressive diseases.
腰椎骨关节炎结合临床表现,属于祖国医学“痹证”、“腰痛”范畴,中医学对这类疾病认识的历史很长,早在《内经》就有曰:“腰为肾之府,转摇不能,肾将惫矣。”《证治准绳腰痛》曰:“有风、有湿、有寒、有热、有闪挫、有瘀血、有滞气、有痰积,皆标也;肾虚其本也。”上述说本病与肾关系最为密切,肾虚是发病的关键所在。现代中医认为,本病总属本虚标实。虚者肝肾不足,筋骨失充,实者寒湿,淤血痹阻,经脉不利。血脉不通。治疗不外乎补肝肾,强筋骨,祛风散寒除湿,通血活络为原则。
独活寄生汤取自千金要方,本方补肝肾,祛风湿,标本兼治。该方以熟地、牛膝、杜仲、桑寄生补益肝肾,当归、川芎、芍药、党参、茯苓、甘草以益气血,独活、秦艽、防风、细辛、桂枝以除风寒湿邪。是治疗肾虚型腰椎骨质增生的常用方剂。
目前对中医药治疗腰椎骨关节炎的临床研究多集中于某一方一药简单的疗效观察,很多研究缺乏科学的研究方法,缺乏统一的诊断标准,疗效判定标准也不统一,而且有关治疗腰椎骨关节炎疗效评价方面,单纯用死亡率、患病率、缓解率,有效率等传统评价指标,这些指标已不能真实地反映出腰椎骨关节炎患者对疾病的体验和治疗的综合反应,不能全面地评判干预措施的效果,最终不能满足群体对健康的新要求。研究的结果不能真实反映药物的疗效,不利于中医药治疗腰椎骨关节炎的推广
目的:基于以上背景我们设计了独活寄生汤治疗腰椎骨关节炎疗效评价的实验方案。通过对腰椎骨关节炎患者临床症状改善评价及生存质量改善评价,以期对独活寄生汤颗粒治疗腰椎骨关节炎的临床疗效作出正确的评价。
方法:收集入组53例符合诊断标准、纳入标准、排除标准的腰椎骨关节炎患者,采用独活寄生汤颗粒治疗3个月,分别在治疗前、治疗一个月、治疗两个月、治疗结束时采用视觉模拟评分法对观察患者对疗效的评价、医生对疗效的评价;患者对腰部疼痛的评价、患者对腰部压痛的评价、患者对腰部运动障碍的评价;采用生存质量SF-36问卷,分别在治疗前、治疗一个月、治疗两个月、治疗结束时对独活寄生汤颗粒对腰椎骨关节炎患者生存质量的影响进行研究。
结果:
1、独活寄生汤颗粒治疗一个月后,患者及医生对包括对腰部疼痛、伴随症状、日常活动及工作的总体评价就有所改善;两个月后,患者和医生的总体评价继续改善,与一个月时相比,差异有显著意义,治疗结束时,患者和医生的总体评价与治疗前比较明显改善,统计学比较有显著性差异。
2、治疗结果显示,在治疗一个月后,患者的腰部疼痛症状有所改善,与治疗前相比,差异有显著意义;两个月后,腰部疼痛继续减轻,与治疗前相比,差异有显著意义,治疗结束时,腰部疼痛明显减轻,统计学比较有显著性差异。在治疗一个月后,患者的腰部压痛症状有所改善,但与治疗前相比,差异没有显著意义;两个月后,腰部压痛继续减轻,与治疗前相比,差异有显著意义,治疗结束时,腰部压痛明显减轻,统计学比较有显著性差异。
3、结果显示,治疗一个月时,生理功能(PF)、生理角色限制(RP)、躯体疼痛(BP)、总体健康(GH)、活力(VT)、社会功能(SF)、情感角色限制(RE)、心理健康(MH)均有所改善,但无统计学差异;治疗两个月时,患者的PF、BP、GH、SF明显改善,与治疗前相比,有显著性差异;治疗3个月时,患者的PF、BP、GH、SF继续改善,与治疗前相比,有显著性差异。但患者的RP、VT、RE、MH虽也有一定改善,但仍无统计学差异。
结论:
1、提示独活寄生汤颗粒治疗2个月可以出现明显疗效。
腰椎骨关节炎归属中医“痹证”、“腰痛”范畴,祖国医学认为“腰为肾之府”,“肾立骨”,按照经络循行的部位,腰椎属督脉循行的部分,足太阳膀胱经循行于腰两侧,与足少阴肾经相互表里。因此,肾气、督脉、膀胱经气的充盛维系着腰部的正常活动功能。人到中年,肾气渐亏,腠理空虚,风寒湿邪乘虚而入,血脉凝滞不通,痹阻督脉,“不通则痛”。独活寄生汤取自千金要方,本方补肝肾,祛风湿,标本兼治。该方以熟地、牛膝、杜仲、桑寄生补益肝肾,当归、川芎、芍药、党参、茯苓、甘草以益气血,独活、秦艽、防风、细辛、桂枝以除风寒湿邪,针对腰椎骨关节炎的病因病机,故治疗后,患者及医生对包括腰部疼痛、伴随症状、日常活动及工作的总体评价均明显改善,由于腰椎骨关节炎的形成是一个长期的过程,前来求诊的患者都有较长的病程,经过各种治疗不理想,。肾虚之本逐渐严重,邪易祛,正难扶,所以,治疗不是一个短期的过程,
2、独活寄生汤颗粒治疗一个月明显缓解腰痛,治疗二个月缓解腰部压痛及腰部运动障碍。
和腰部压痛、腰部活动障碍相比,独活寄生汤对腰部疼痛起效较快,治疗一个月后腰痛就有明显好转,统计学有差异,而腰部压痛和腰部活动障碍要平均两个月左右才见到有统计学差异的疗效。除患者病程长,肾虚日渐显著,正气难补益之外,还可能与药物剂型有关,“汤者荡也”,用汤剂可更快荡涤邪气,“丸者缓也”,“散者散也”,独活寄生汤颗粒相当与丸散剂,药效发挥慢,但对于病位深在骨与关节的疾病,非荡涤可治,需缓缓扶正补虚收功,治疗是一个长期的过程,但由于治疗时间长,天天煎煮汤剂不甚方便,尤其在生活节奏加快的当今社会,更难坚持,所以长期应用颗粒剂比较现实。
3、独活寄生汤颗粒可以改善患者生存质量。
治疗后,患者的生理功能改善,这与症状缓解,活动能力改善有关;躯体疼痛明显减轻,这与临床观察方面一致:总体健康明显改善,由于腰部是人体主要负重和活动部位,腰部疼痛的好转,活动障碍的改善可明显提高患者的总体健康;社会功能改善,由于疼痛不适的好转,活动能力的提高,活动范围的增加,故可改善患者的社会功能,从事家务及日常工作的能力提高,对改善患者的生存质量非常有益。但研究显示,对患者的生理角色限制、活力、情感角色限制、心理健康改善没有统计学差异,提示,虽然治疗3个月后,临床症状明显好转,但由于疾病只能控制,不能痊愈,还是或多或少影响到患者的生理和心理健康。是否继续治疗,能继续改善患者的生存质量,值得进一步研究。
以上研究结果充分显示了独活寄生汤颗粒治疗肾虚型腰椎骨关节炎疗效确切,能明显改善患者的临床症状,改善患者的生存质量。本研究为中医药治疗骨关节退行性疾病的临床疗效提供了一定的依据。
Lumbar osteoarthritis refers to the osteoarthritis which takes place in the lumbar vertebras.It refers to the osteoarthritis caused by the narrowed and degenerative lumbar intervertebral ligament,the degeneration and hyperplasy of the vertebra body margin and the degeneration of the I-B minor joints and refers to a series of symptoms caused by them.Its main clinical symptoms are the chronic continuous or interrupted lower back pain.The Western Medicine therapy mainly adopts non-steroidal anti-inflammatory drug(NSAID) which inhibits the epoxidase' blocking the arachidonic acid metabolism and inhibits prostaglandin synthesis,so as to inhibit inflammation and pain and improve the clinical symptoms.At the same time,however,it can weaken the physiological protection of prostaglandin,cause serious impairment to stomach duodenum and kidney and damage the cartilage,especially among the aged population among whom lumbar osteoarthritis has high occurrence.At present safe and efficient medicine or therapies are not available.
Lumbar osteoarthritis belongs to the category of arthromyodynia and lumbago of Chinese Medicine which has discussed this disease for a long time in history.Internal Classics notes that waist houses the kidney;if the waist can' t move around,the kidney will be exhausted.Standards for Diagnosis and Treatment wind,dampness,coldness,heat,sudden sprain and contusion, stagnated blood,obscure complexion and phlegm are all signs;the root is kidney deficiency.These indicate the close relationship between lumbar osteoarthritis and kidney and kidney deficiency is the key cause.Modern Chinese Medicine considers that this disease is asthenia in origin and sthenia in superficiality.The asthenia indicates the liver and kidney deficiency, tendons and bones' loss of nutrition;the sthenia refers to cold dampness, blood stagnation,meridians and collaterals and blood vessels not smooth.The treatment principles should be to reinforce liver and kidney,strengthen tendons and bones,disperse wind,coldness and dampness,smooth the blood and activate the collaterals.
Angelicae Pubescentis and Loranthi Decoction comes from Valuable Prescriptions Worth A Thousand Gold which reinforces liver and kidney and disperse wind,coldness and dampness,and treat both signs and roots of diseases.It consists of prepared rhizome of rehmannia,achyranthis,eucommia bark and Chinese taxillus herb to reinforce liver and kidney,angelica, Szechwan lovage rhizome,paeonia,radix codonopsitis,hoelen and sweet root to replenish blood and qi and angelica tuhov,largeleaf gentian root, saposhnikoviae radix and asiasarum and ramulus cinnamoni to disperse wind, coldness and dampness evil factors.It' s the common prescription for the lumbar vertebra hyperosteogeny of the type of kidney deficiency.
The current clinical researches on lumbar osteoarthritis with Chinese Medicine mainly focus on the efficacy observation of certain prescription or drug.These lack of scientific research methods,unified diagnosis standard and efficacy standard.In efficacy evaluation,these mainly adopt the traditional indexes like morbidity rate,attack rate,remission rate and effective power,etc.These indexes can' t truly reflect the patients' comprehensive response to treatment nor comprehensively evaluate the intervention effect and finally can't meet the population's new requirements for health.The research results can't fully reflect the drug's efficacy and is not useful for the promotion of lumbar osteoarthritis treatment with Chinese Medicine.
Aim:based on the background mentioned above,we designed the trial plan of lumbar osteoarthritis treatment efficacy evaluation with Angelicae Pubescentis and Loranthi Decoction.By evaluating the patients' clinical symptom improvement and life quality improvement,we hope that accurate evaluation will be made on the lumbar osteoarthritis treatment efficacy evaluation with Angelicae Pubescentis and Loranthi Decoction.
Methods:Collect 53 lumbar osteoarthritis patients who meet the diagnosis, inclusion and exclusion criteria,give treatment with Angelicae Pubescentis and Loranthi Decoction granules for 3 months,and at the period of before treatment,1 month after treatment,2 months after treatment and at the end of the treatment respectively observe patients' evaluation on efficacy, doctors' evaluation on efficacy,patients' evaluation on lumbar pain,lumbar pressing pain and lumbar movement difficulties with Visual Analogue Scale; research on the effect of Angelicae Pubescentis and Loranthi Decoction granules on the patients' life quality.
Results:
1.After one month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the doctors' and patients' general evaluation on lumbar pain,accompanying symptoms,daily activities and work has improved;after 2 months,the general evaluation continuously improve and the difference has statistical significance compared with that 1 month after treatment;at the end of the treatment,the evaluation has obvious improvement compared with that before treatment and has statistical significant difference.
2.After one month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the patients' lumbar pain symptoms improve and the difference has statistical significance compared with that before treatment; after 2 months,the lumbar pain continuously improve and the difference has statistical significance compared with that before treatment;at the end of the treatment,the lumbar pain has obvious improvement and has statistical significant difference.
3.After one month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the patients' PF,RP,BP,GH,VT,ST,RE,MH improve and the difference has no statistical significance;after 2 months,the PF, BP,GS and SF obviously improve and the difference has statistical significance compared with that before treatment;after 3 months' treatment,the PF,BP, GS and SF has continuous improvement and has statistical significant difference compared with that before treatment,but the RP,VT,RE and MH still haven't statistical difference though has improvement at certain level.
Conclusion:
1.Obvious efficacy occurs after 2 months' treatmetn with Angelicae Pubescentis and Loranthi Decoction granules
Lumbar osteoarthritis belongs to the category of arthromyodynia and lumbar pain in Chinese Medicine which considers that waist houses the kidney and kidney supports bones.According to position of the meridians and collaterals' circulation,lumbar belongs to the circulation part of Du-meridian.Foot-taiyang Urinary Bladder Meridians move on both sides of lumbar and form the interior and exterior relationship with Kidney Meridian of Foot-shaoyin.Therefore,kidney qi,Du-meridian and Urinary Bladder Meridian qi maintain the normal function of waist.When people reach middle age,the kidney qi gradually loses,muscle and viscus are void,wind,cold and dampness evils enter,blood vessels stagnate,arthralgia spasm occurs to Du-meridian and pain is caused.Angelicae Pubescentis and Loranthi Decoction comes from Valuable Prescriptions Worth A Thousand Gold which reinforces liver and kidney and disperse wind,coldness and dampness,and treat both signs and roots of diseases.It consists of prepared rhizome of rehmannia,achyranthis, eucommia bark and Chinese taxillus herb to reinforce liver and kidney,angelica, Szechwan lovage rhizome,paeonia,radix codonopsitis,hoelen and sweet root to replenish blood and qi and angelica tuhov,largeleaf gentian root, saposhnikoviae radix and asiasarum and ramulus cinnamoni to disperse wind, coldness and dampness evil factors.This prescription takes into consideration of the etiology and pathogenesis of lumbar osteoarthritis,therefore after treatment,the doctors' and patients' general evaluation on lumbar pain, accompanying symptoms,daily activity and work improve remarkably.As the formation of lumbar osteoarthritis is a long time and patients coming for treatment generally have long disease course whose kidney deficiency is more serious and difficult to support the healthy qi and diminish the evil after unsatisfactory treatment,so the treatment will take a long time.
2.After 1 month' s treatment with Angelicae Pubescentis and Loranthi Decoction granules,the lumbar pain is obviously relieved and after 2 months the lumbar pain and lumbar movement difficulties are relieved
Compared with treatment of lumbar pressing pain and lumbar movement difficulties,Angelicae Pubescentis and Loranthi Decoction has quicker effect on lumbar pain.After 1 month' s treatment,the lumbar pain obviously improves and has statistical difference while the lumbar pressing pain and lumbar movement difficulties need two months on average to have the efficacy of statistical difference.It may have association with medication dosage form, besides the other factors like the disease course is long,the kidney deficiency is getting serious,the healthy qi is hard to reinforce,etc. Decoction can diminish evil qi more quickly.Angelicae Pubescentis and Loranthi Decoction granules are equivalent to pills and powder and the drug action is slow.However,to the disease deep at bones and joints,decoction must be used.The treatment takes long time,so making decoction is not convenient,especially in the quick-rhythm modern society,therefore granules are more practical.
3.Angelicae Pubescentis and Loranthi Decoction granules can improve patients' life quality
After treatment,the patients' physiological function improves with the release of symptoms and improvement of activity ability;body pain is obviously relieved which is consistent with clinical observation;the general health obviously improves,and the recovery of lumbar pain brings the improvement of activity difficulty as lumbar is the major weight loading and activity part; as the recovery of pain,the improvement of movement ability and the increase of movement range,the social function of patients improves;the ability of housework and daily work improvement is very helpful for the improvement of patients' life quality.However,the research shows that there' s no statistical difference in the improvement of RP,VT,RE and MH.It indicates that though after 3 months' treatment,the clinical symptoms obviously improve;patients' mental and physiological health is affected more or less as the disease can only be controlled but not cured.Whether the further treatment can improve the patients' life quality is worth of further research.
The research results above fully demonstrate the confirmed efficacy of Angelicae Pubescentis and Loranthi Decoction granules on the treatment of lumber vertebra arthritis which can significantly improve the patients' clinical symptoms and improve their life quality.This research provides evidence for the clinical efficacy of Chinese Medicine in the treatment of bone joint regressive diseases.
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