| Ankylosing spondylitis(AS) is a systematic inflammatory disease affecting spine column and articulatio sacroiliaca,commonly seen in young male patients.Most patients take the disease in delitescence.Early pathological changes are metastatic and upward lumbar and back pain with lower back pain most commonly seen.The other symptoms include fatigue and debility, emaciation and short breath,anemia,with a minority of patients accompanied by lower fever,early morning stiffness,difficulty in turning body over at night,difficulty in getting up and moving,etc.Keeping a posture for a long time causes obvious symptoms,which may easily ignored and classified as lumbar muscle strain.AS develops slowly and may extend to 10 to 20 years.It develops quickly at the late stage.Lump back and abnormity and arthrokleisis may form in a very short time.AS is classified as arthromyodynia in Chinese Medicine.Renalarthralgia, rheumatism involving bone,obstinate arthralgia,severe and migratory arthralgia and lumbar pain recorded in Chinese Medicine classic works are much similar to AS in modern medicine,which provides important guidance for the research of AS etiological factors,pathogenesis and treatment.The pathogenesis of AS is not definite now and there' s no radically curative drugs. Recently,Chinese Medicine treatment of AS is given more attention and in-depth researches are undertaken as it achieves good curative efficacy and little toxic and side effects.We believe AS is the result of interaction between the intrinsic factors and exopathic factors.The intrinsic factors include congenital deficiency, postnatal poor maintenance,liver and kidney deficiency,DU Meridian poor maintenance,disorder of yin,yang,qi and blood,healthy energy instability, however,kidney deficiency is the key factor.The exopathic factors include evasion of cold,dampness and heat evils,stagnation of qi and blood and disadvantage of bones and muscles,so tendon spasm,paralysis,weakness and disuse are caused.The initial disease part is mostly lumbosacral area with 100%of patients accompanied with sacroiliitis.Chapter 17 of Su Wen notes clearly that lumbar stores the kidney.Lumbar not only is where the substantial kidney lies,but also has foot-taiyin,foot-taiyang,Du Meridians and Belt Channel around,which directly or indirectly connect with and belong to kidney. General Collection for Holy Relief says lumbar is the key part of body and flexion,stretching,bending over and looking up all depend on lumbar. Therefore arthralgia spasm caused by kidney deficiency and kidney affected by long-time arthralgia spasm are all diseases of lumbar.Sacral region is below the lumbar which is called articulation sacroiliaca region in modern medicine.Qian Yi's Key to Therapeutics of Children's Disease in Song dynasty says clearly that sacral region and ear both belong to kidney and kidney has two belongings,one near sacral end,the other near brain and spine which explains clearly the close relationship between sacral region and kidney. Arthralgia spasm of lumbar and sacral region is the typical feature that differentiates AS from other arthromyodynia.This decides the controlling position of kidney in the etiology and pathogenesis of AS.Golden Chamber Kidney Qi Pill originates from Golden Chamber written by Zhang Zhongjing at the end of East Han Dynasty which is the representative prescription for warming and invigorating Kidney-yang and also the earliest prescription for invigorating kidney.In the prescription,there' s decanta in invigoration, and decanta doesn't hurt yin.Decanta and invigoration complement each other and cure both the root and syndromes of diseases.As a formula coordinating yin and yang,it reinforces the insufficiency and decanta the surplus.This formula takes into consideration the basic physiological features that kidney holds genuine yin and yang and is the viscera attributed to water and fire and is consistent with the pathogenesis of AS which is the deficiency of kidney-essence.At present,researches on treatment of AS with Golden Chamber Kidney Qi Pill mainly focus on clinical and experimental researches.Clinical researches mainly adopt simple observations on drugs' clinical efficacy,most of which lack of clear and recognized diagnosis criteria and efficacy criteria credibility.Experimental researches mainly adopt animal model or human cell vitro researches which have certain distance away from the clinical practice and can' t fully prove the efficacy of Golden Chamber Kidney Qi Pill in AS treatment.Concerning these problems,we designed research plans,chose strict selection criteria and internationally recognized efficacy judgment criteria. The purpose of this research is to fully prove the efficacy of Golden Chamber Kidney Qi Pill in AS treatment and provide evidence for Chinese Medicine treatment of AS.1.MethodsStrictly choose 48 AS patients consistent with the internationally recognized diagnostic,inclusion and exclusion criteria.Take Golden Chamber Kidney Qi Pill orally for 6 months.Grade on BASDAI,BASFI,general back pain, night back pain,patients' general evaluation of the disease and general efficacy according to internationally admitted ASAS20 criteria before the treatment,1 month after treatment,3 months after treatment and at the end of the treatment,so as to systematically and objectively evaluate the clinical efficacy of Golden Chamber Kidney Qi Pill on AS.2.Results2.1 Research shows patients' BASDAI grading is high before treatment and it drops gradually after treatment.1 month after treatment,the BASDAI grading improves at >20%compared with that before treatment and the difference is significant.The grading drops continuously after 3 months' treatment.The grading after 6 months' treatment is lower compared with that after 3 months' treatment,but the descending steps down gradually.About the last two items about morning stiffness in BASDAI grading,the VAS average change is consistent with BASDAI grading change.The grading 1 month after treatment has significant difference with that before treatment.The grading after 3 months' and 6 months' treatment gradually lessens and improves at 20%after treatment.2.2 Research shows patients' BASFI grading is high before treatment and it drops gradually after treatment.1 month after treatment,the BASFI grading improves at >20%compared with that before treatment and the difference is significant.The grading drops continuously after 3 months' treatment.The difference is significant comparing it with that before treatment.The grading after 6 months' treatment is lower compared with that after 3 months' treatment,but the descending steps down gradually.2.3 Research shows patients' general back pain and night back pain lessen after 1 month' s treatment.The difference is significant comparing them with those before treatment.The grading drops continuously after 3 months' and 6 months' treatment.At the end of the treatment,the general back pain and night back pain improve at 20%.2.4 Research shows patients' general evaluation of disease is high before treatment and it drops after 1 month' s treatment.The difference is significant.The grading drops continuously in the later period of treatment and at the end of the treatment,the grading drops > 20%.2.5 In the treatment with Golden Chamber Kidney Qi Pill,26 patients reached ASAS20 after 1 month' s treatment,32 patients after 6 months' treatment. Golden Chamber Kidney Qi Pill effectively lessens the AS patients' clinical symptoms in catabasis and can obviously improve the patients' BASDAI and BASFI grading,the general grading of diseases,the general back pain and night back pain grading.These reach ASAS20 criteria and have significant difference with those before treatment.3.Conclusion3.1 Golden Chamber Kidney Qi Pill Effectively Improves AS BASDAI GradingIn research,we find in the early stage and strong activity stage of AS, the BASDAI Grading is high.It occurs frequently in young people who are generally healthy but suddenly find lumbar and sacral pain.Sometimes it pains severely and sometimes it extends up to chest and neck and down to thigh and heel.Some even face limitation of activity and can' t take care of themselves. Some patients may be gloomy,agitated,upset and anxious.Some have dry mouth and tongue,dry stool,or fever with cold aversion,or low fever,thin and white lingual fur,thin and yellow lingual fur and frequent pulse tracings. We should emphasize eliminating pathogen,heat-clearing and detoxicating, promoting blood flow and eliminating bruise,eliminating dampness and turbidity.At the late stage and the weak activity stage of diseases,BASDAI grading is lower.The patients feel soft and feeble in lumbar and knee and it difficult to move.There' s false image of liver and kidney deficiency. It doesn' t mean that the disease is cured;however,it shows the pathogen qi is not the major contrary and asthenia qi deficiency gradually becomes the major contrary,so we need to lessen the intensity of pathogen elimination and reinforce the healthy qi.BASDAI evaluation includes fatigue,central and peripheral joint pain, morning stiffness and tendon pain and consists of 6 questions.The higher the score,the more active the disease.If the score is >4,it indicates the disease proceeds.Research shows the BASDAI average before treatment is about 4 and indicates the AS patients' diseases in this group don' t proceed actively. Some patients at the middle or late stages have comparatively still stage of diseases.In pathogenesis,it' s mainly healthy qi deficiency,so Golden Chamber Kidney Qi Pill is adopted.The 3-inviogration invigorates liver and kidney and the 3-decanta smoothes Du Meridian.After 1 month' s treatment, the BASDAI grading obviously drops.After 3 months,it continuously drops until the end of the research.It is much better compared with that before treatment. 3.2 Golden Chamber Kidney Qi Pill Obviously Lowers the BASFI Grading of AS PatientsBASFI is short for Bath AS Function Index and used to evaluate the comprehensive function of AS patients.The higher the score,the poorer the function.In clinical trials,it' s a sensitivity index to evaluate the medical treatment on patients' function improvement.The basic pathogen of AS is kidney deficiency and DU Meridian stagnation. Liver and kidney are from the same origin.Liver governs tendons and kidney governs bones.If there' s liver and kidney deficiency,the tendons and bones are deficient and have difficulty in moving.Research shows after one month' s treatment,the patients' BASFI obviously drops and shows the function improves obviously.The function of neck,lumbar,coax and knee function improves,so the grading drops.With treatment,the liver and kidney deficiency is gradually reinforced,the tendon and bone' s function gradually recovers, so the patients' daily activity improves and the grading drops until the end of the research.In research,we find most patients are in eatabasis,so severe lumbar and sacral joint pain is not obvious,but the limitation of function is comparatively obvious.For the disease course is long and the inflammation of tendon ligament attachment point causes the limitation of spinal column function,so medical treatment takes a long time.After 1 month' s treatment, the function improves.After 3 months,the improvement is obvious.BASFI drops slowlier compared with BASDAI.The difference is significant 3 months after treatment compared with that before treatment;however the BASDAI difference is significant after just 1 month' s treatment.We also find the basic principle for AS treatment is 30%of medicine and 70%of exercise.For AS is a chronic life-long disease,it develops delitescently and destroys spinal column joints and ligament.It starts with stiffening and inflammation.Inflammation destroys tissues with heat,after which the new granulation grows with flexible joints and ligaments,causing it to lose moving ability and difficult to recover.If the joints and ligament often moves,the granulation can' t grow together with them.After the inflammation,the joints can still move.Exercise can add strength and is the best way to keep joints from stiffness.3.3 Golden Chamber Kidney Qi Pill Obviously Improves the General Back Pain and Night Back Pain Grading of AS PatientsThe First Chapter of Su Wen says when a girl is 7 years old,the kidney qi is sufficient and teeth changes.At 14,kidney-essence for promoting reproductive function begins to take effect,Ren Meridian is smooth and Taichong Channel is sufficient.Regular menstrual cycle comes,so she can give birth.At 21,she has adequate kidney-qi,so the wisdom tooth grows and the body matures.At 28,she has strong tendon and bones,her hair grows to the extreme,and is very healthy.At 35,Yangming Meridian declines,the face turns yellowish and hair begins to drop.At 42,three yang meridians all decline, the face is all yellowish and hair turns white.At 49,the Ren Meridian is deficient,the Taichong Channel declines,the kidney-essence for reproductive ability exhausts and menostasis comes,so body wanes and she can' t give birth. When a boy is 8 years old,the kidney qi is sufficient,the hair grows and teeth changes.At 16,kidney-essence for promoting reproductive function begins to take effect,the kidney-qi is sufficient and spermatic ejaculation takes place.Children may be born if female and male have sexual intercourse. At 24,he has adequate kidney-qi and strong tendon and bones,so the wisdom tooth grows and the body matures.At 32,he has strongest tendon and bones as well as muscles.At 40,the kidney-qi declines,the hair drops and the teeth wither.At 48,the yang-qi declines,the face is all yellowish and hair turns white.At 56,the liver-qi is deficient,the tendons can' t move and the kidney-essence for reproductive ability exhausts,the essence is little, the kidney declines and the body wanes completely.At 64,the teeth all drop. The kidney governs water and stores the essence of five viscera and six Fu-organs.So if the five viscera are sufficient,the essence can be decanta. Now the five viscera all wanes,the tendons and bones are lazy and feeble, the reproductivity is gone.This paragraph stresses the function of kidney-qi in human growth and reproduction.It' s both the suscitation power and the material basis.The growth of teeth,bone and hair is the physiological effect of kidney-essence(kidney-yin and kidney-yang) and also reflects the sufficiency and deficiency of kidney-essence.It synthesizes a series of viewpoints,like the tissue connects with the kidney being bone from Chapter 10 of Su Wen,kidney governs the bones from Chapter 23 of Su Wen,kidney grows marrow from Chapter 5 of Su Wen and marrow fills the bones from Chapter 81 of Su Wen.Kidney stores essence,governs the growth of marrow and the sufficiency and deficiency of kidney-essence concerns the bones' growth and strength.Sufficient kidney-essence brings full marrow and strong tendons and muscles.If not,the marrow becomes hollow and weak.Therefore this is very important in clinical significance of AS.Golden Chamber Kidney Qi Pill consists of adhesive rhemannia dried root 8 liang,batatatis and cornel 4 liang each,cortex moutan,hoelen and water plantation tuber 3 liang,ramulus cinnamomi and prepared commonot 1 liang each. Yin-increasing and yang-increasing medicine are both used in the formula,the kidney-qi and kidney-essence grow together,so the kidney reinforcement is enough.Therefore after treatment with Golden Chamber Kidney Qi Pill,the patient' s kidney-essence is nourished;the lumbar and back pain lessens obviously and improves at 20%.3.4 Golden Chamber Kidney Qi Pill Obviously Improves Patients' General Evaluation of DiseasesSpinal column pain and activity limitation severely affects the life quality of patients.In this research,most patients are in AS catabasis,but the lumbar and back pain and limitation as well as the treatment prospect are not definite and clear,so the general evaluation of disease is high.After one month' s treatment with Golden Chamber Kidney Qi Pill,because of lessening pain and limitation of activity,the patients' life quality improves; therefore the grading improves significantly compared with that before treatment.With treatment going on,the grading further drops and reaches 20% improvement standard.3.5 Golden Chamber Kidney-qi Pill Treatment of AS Reaches ASAS 20 Criteria As a chronic disease,AS demands long-term and short-term evaluation.One year or above is long term,and within 1 year is short term.ASAS team suggested originally that AS efficacy evaluation needs to be given from 7 decks, including disease controlling the anti-rheumatism drugs' long-term efficacy. After study,ASAS team believe it only needs 4 decks,namely the physical therapy,symptomatic relief anti-rheumatism drugs,disease controlling anti-rheumatism treatment and daily clinical record.The definition is:(1) disease controlling anti-rheumatism treatment changes AS disease course from 2 aspects,namely lessening inflammatory reaction to maintain and improve joint function and preventing or obviously lessens the occurrence rate of joint structure progressive injury which takes at least 1 year(2) symptomatic relief anti-rheumatism drugs must be able to improve AS symptoms and clinical features of inflammation(3) the purpose of daily clinical record is to keep the consistent clinical record and to strengthen the intensity of clinical record research(4) there' s no specific regulation about physical therapyIn 1997,ASAS team firstly selected 110 variables possibly related to AS efficacy evaluation from literature.According to the definition above,36 experts made preliminary selection and chose 51 variables.Experts were divided into 4 groups and vote.As a result in disease controlling the anti-rheumatism drugs,the physical function,pain,spinal column movement and peripheral joint and bone attachment point get 4 scores,spinal column' s radiological changes and patients' comprehensive grading get 3 scores,the coax joint radiological changes,spinal column stiffness,fatigue and acute phase reactant get 2 scores,the doctors' comprehensive evaluation,social and economical result,life quality,drug safety and skeleton outward appearance get 1 score.In symptomatic relief anti-rheumatism drug evaluation, pain,physical function,spinal column stiffness and movement get 4 scores, patients' comprehensive grading get 3 scores,peripheral joint and bone attachment and the doctors' comprehensive evaluation get 1 score.Therefore, that meeting' s result believed that disease controlling anti-rheumatism drug evaluation must include 6 contents:physical function,spinal column stiffness and movement and patients' comprehensive evaluation.10 factors are decided according to the research.In recent years,ASAS experts work on the specific ways to evaluate each factor.The preliminarily decided evaluation ways include:(1) physical function:adopts BASFI and Dougados Function Index and either is suitable to choose(2) pain:adopts VAS of 100 mm to evaluate night pain caused by AS and pain caused by AS(including day and night) in recent week(3) spinal column movement:including thorax movement,Schober test and pillow-wall distance(4) spinal column stiffness:the early morning stiffness time of spinal column in the recent week(5) patients' general evaluation: VAS of 100mm evaluation in recent week(6) peripheral joint and bone attachment point:count swollen joints from 44 peripheral joints;no suitable ways are found for the evaluation of bone attachment joints.(7) acute phase reactant: though acute phase reactant include blood sedimentation rate and C-reaction protein are frequently used clinically,the ASAS team believes,after discussion,that blood sedimentation rate applies in clinic more extensively than C-reaction protein,so blood sedimentation rate is finally decided as the acute phase reactant(8) spinal column radiological change:it needs the pieces of abdominal vertebra at A-P and lateral position and cervical vertebra and pelvis pieces at lateral position;whether to adopt Bath' s AS Radiological Index or Stoke' s AS Spinal Column INTGR is not decided.(9) coxa joint photograph:pelvis piece may include coax joint,but coax joint evaluation method needs to be decided(10) fatigue.ASAS further simplifies the observation index and proposes ASAS 20 and ASAS 40 criteria recognized by international rheumatism study field.In this research,ASAS 20 criteria is adopted.It is found that Golden Chamber Kidney Qi Pill' s treatment of AS can reach ASAS 20 relief standard and it proves the efficacy of Golden Chamber Kidney Qi Pill.
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