| Rheumatoid arthritis(RA) in the Western medical point of view is a kind of autoimmune diseases,cause of which is uncertain.In the theory of traditional Chinese medicine(TCM),RA belongs to "Pa disease "which the essence of pathogenesis is "asthenia in origin and asthenia in superficiality." Spleen as "the foundation of acquired constitution" in TCM,its dysfunction would lead to insufficiency of vital energy and blood,and business or other non-Visceral dysfunction,with the result that upright debilitating,phlegm and blood stasis block,Damp toxin of endogeny et al. contemporary researches of TCM cue that spleen correlates the course of RA which should not be negligible.In the case of Phaseâ…¡clinical trial of Qing Feng Tong Capsule,the subjects are early or metaphase of RA patients.Most of them often mentioned initiatively symptoms of splenic asthenia when talking about pathogenetic conditions such as lassitude and decreased food appetite.Some of these symptoms changed at the end of the clinical.Since the spleen deficiency symptoms are not the index to be observed,preliminary data could not reflect the information about the correlation of spleen and the tested medicine.The phaseâ…¡clinical research of new drugs is exploratory study.The effectiveness of Compound preparation of TCM Characterized by multitarget,multistrata,multisystem.Researchers should insist on the basic principle and aim directly at the global impact,that is not only consistent with the characteristics of thinking in TCM,but also for further clinical trials or clinical medication provides valuable messages.Therorial research1 Introduction of etiopathogenisis and pathogenesis of RA in traditional Chinese medical theory.RA belongs to "Pa disease" in the traditional Chinese medical theory."Pa" means emphraxis that hints "inhibited movement of qi and blood,obstruction of channels and network vessels" which is the repletion pattern of clinical manifestation of RA,such as painful swollen joints.According to archaic records from aesculapian of successive dynasties,"repletion evil" is one of the main etiological factors in the course of RA.Meanwhile it is emphasized that "insufficiency of right qi" is another main etiological factors in the course of RA.The internal cause "insufficiency or depletion of fight qi" is the root while "the invasion or arising internally of evils" is the tip.Thus we should realize that "vacuity-repletion complex" is one of the most impotant characteristics of the pathogenesis of RA.Differentiation of symptoms and signs and treatment in RA should be discriminated which is the dominating factor.It can not overall comprehend the substance of etiopathogenisis and pathogenesis of RA when you separate vacuity-repletion apart.For example,the main symptoms of RA are mostly the signs of repletion pattern,but the cause of them could be vacuity or repletion.Join pain is the most common symptoms in RA.The key causes of join pain includes "emphraxis" and "lusterless".Either "external evil" such as "wind cold dampness "etal or "inner evil" as "phlegm stasis" etal would block the channel and network vessels,which causes "inhibited movement of qi and blood,obstruction of channels and network vessels" and join pain.On the other hand,the depauperate function of bowels and viscera descends as well as the insufficiency and depletion of qi and blood which induces organism dystrophy,both causes "inhibited movement of qi and blood,obstruction of channels and network vessels" and join pain.2 Introduction of spleen and spleen vacuity pattern in traditional Chinese medical theory.According to traditional Chinese medical theory,spleen is the root of later heaven.The concept of spleen in traditional Chinese medical theory is not identical to that of anatomical "spleen".In traditional Chinese medical theory,spleen is a systematical and functional concept.For example,the functional concept of "spleen governs movement and transformation" means that the physiologic function of traditional Chinese medical spleen includes moving and transforming essence of grain and water.Associating with the concept of "spleen governs the flesh and limbs", muscularity depends on the physiologic function of traditional Chinese medical spleen.The healthy of traditional Chinese medical spleen impact the function of limbs straightly.Ancient illustrious internist Li Dong Yuan proposed "internal injury of spleen, production of disease".He emphasized that the insufficient right qi mainly induced by internal injury of spleen,spleen vacuity pattern is a series of symptom complex that cues the weakness of the physiologic function of traditional Chinese medical spleen,which includes "fatigued spirit and lack of strength","reduced appetite", "heavy cumbersome limbs" and "distention in stomach duct and abdomen that likes pressure" etal.The internal etiological factor of RA is insufficient right qi which is the root of RA pathogenesis.The induction of the function of traditional Chinese medical spleen may be weaken by itself straightly or other fators indirectly.Anyway spleen vacuity pattern exists in RA certainly.It is used to be ignored by doctors and patients.For example,some RA patients do not realize the situation when they get low-grade or medium anaemia.Some patients feel dizziness which might be the sign of blood vacuity as the outcome of blood routine check is normal.Literature research1 The Contemporary research of traditional Chinese medicine about RA.At present,the researches of traditional Chinese medicine trend to depend on the pattern of western medicine like thought-mode,concept etal.These researches tried to use western concept and device to annotate the principles,methods,formulas and medicinals of traditional Chinese medicine.The way of these researches depart from the Chinese culture foundation of traditional Chinese medicine as well as the distinctness of holism and determination of treatment based in pathogenesis obtained throu-gh differentiation of symptoms and signs,which cause the catabolism of traditional Chinese medical theory.Among the total,the westernize manifest clinical research of traditional Chinese medicine induces that the consequence of these researches were unsatisfied mostly.For example,"pattern" is a qualitative variable which quantitative concept is default.Many contemporary research of traditional Chinese medicine about RA hint that logical thinking exists in the theory of differentiation of symptoms and signs.The theory of differentiation of symptoms and signs is scientific.It is not only a abstract and undefined process of diagnose and treatment but also a set of compact and systemic medical science hierarchy.The researches evocate the consider of contemporary research and development of traditional Chinese medicine.Some clinical research of traditional Chinese medicine indicate that subject sensation of patient to curative ensemble content-degree and existence-quality is more conclusively and more meaningful than single biological parameter.For example,researchers undertook the factor analysis of rational symptom to approach the relation of outcomes with immune-index.It also discussed the relation of RA symptoms with effect of Chinese and western medicine as well. The result displayed that the management of Chinese and western is coincidence to reflect the common-factors of arthrosis symptoms.Both of them could improve the symptoms.Otherwise Chinese medical treatment surpasses the western group on asthenia syndromes.Thus the dialectical of traditional Chinese medicine is not the type of abstract thinking as "black box" operation.The connection of Syndrome with disease and syndrome with symptom is systrmatical and regulary.They could be analyzed by microscopical gene.Combining disease,syndrome and symptom together is an important dependence to protocol design and election of therapeutic index in clinical research of traditional Chinese medicine.2 The contemporary researches of traditional Chinese medicine about splenasthenic syndrome.Recent years,utilizing western biomedical theory and experiment technique,the researchers reveal the substance of spleen as the mechanism of splenasthenic syndrome much deeper.The researches includes the relationship of splenasthenic syndrome with immune system,the relationship of splenasthenic syndrome with alimentary system and the relationship of splenasthenic syndrome with ceil signal transduction.Of the total,a few researches discussing the relationship of splenasthenic syndrome with immune system hint that the function of spleen relates closely to the homeostasis of immune system,which could be seen as the defensive contribution to exogenous evils from righteousness in traditional Chinese medical theory.Several studies indicates that immuneifaction theory substance could be identical to the doctrine of spleen of traditional Chinese medicine.For the theory of "spleen is the source of qi and blood formation",prosperous spleen induces sufficient qi and blood while the healthy atmosphere flourishing cueing the power of immune function.On the other hand,weakness of spleen induces insufficient of qi and blood as deficiency of vial QI that cues feeble immune function.For instance,some studis found that the functiong of immunologic system is weaken in model of spleen deficiency.The pathological changes such as immune organ analosis and functioning cell decreasing and connective tissue accrementition could be found in the model of spleen deficiency.The supplement formula to spleen could improve those pathological changes.It is obviously that the concept of traditional Chinese spleen is not the organ of spleen and possesses more extensive connotation.Nowadays the researches of traditional Chinese medicine about splenasthenic syndrome have been trending to disease-symptom combining gradually.No matter simple study of splenastherfic syndrome or the study of disease-symptom combining,all studies are beneficial to objectification and standardization of splenasthenic syndrome on clinical diagnosis as to revealing the patho-substance of splenasthenic syndrome.Furthermore the researches which could be stuied deeper by molecular biology would probide new theory and method on prebention and cure of clinic.The ease analysis of phaseâ…¡clinic trial of Qing Feng Tong capsule1 Synopsis of the phaseâ…¡clinical trial of Qing Feng Tong capsuleQing Feng Tong capsule is a kind of new Chinese traditional medicine(N0.6 category)used for RA treatment.It is composed of Caulis sinomenii,Allolobophora caliginosa trapezoides,Danshen root,Aceranthus sagittatus S.et Z.,Herba pyrolae,scorpion.It dispells the wind resolves dampness,warms channels,dispels coldness, invigorate the circulation of blood,and activates the channels.It is used to cure reactive RA which doctors of traditional Chinese medicine diagnose as wind dampness with stasis The phaseâ…¡clinical trail of Qingfengtong capsule preliminarily studies the curative effect and safety of Qing Feng Tong capsule for reactiveness RA.In this protocol the index of clinical observation of traditional Chinese medicine includes the main-sign as joint-ache,joint-swelling,limitation of joint-movement and morning stiffness.Secondary indexes include heavy cumbersome limbs,aversion to wind,hydrodipsia,night worsening of joint-ache or joint-twinge,joint-tenderness.2 Initial analysis about the syndrome-complex of stsplenic asthenia in this center.The protocol locates the subjects in wind-damp with stasis on differentiation of symptoms and signs of traditional Chinese medicine.Thus those subjects are prone to be early or intermediate stage.In these stages,sthenia syndrome is dominating. According to the traditional Chinese medical theory,insufficiency of right qi is the internal factor of etiopathogenisis and pathogenesis of RA.Even thought those subjects are early or metaphase patients of RA,they certainly have some signs of asthenia syndrome.However all subjects of this center,either invalidism or recent diacrisis,possess some signs of asthenia syndrome in diferent degrees.After preliminary data analysis,it could be found that of 60 subjects in this center,"fatigued spirit and lack of strength" is the most predominant simultaneous phenomenon.The follows are abdominal distention,anepithymia,.Alvo adstricto or loose stool occupy the smallest percentage.While the end of the clinical trial,some of them felt better on those simultaneous phenomenon.It should be point out that though the simultaneous phenomenon had not been listed in the protocol,the subjects mentioned them when they complainted which demonstrated those simultaneous phenomenon influent their daily life and work more or less.Compared with the present symptoms of RA such as joint-ache,joint-swelling,limitation of joint-motion and other suffering abarticular symptoms,the indisposition of splenic asthenia would nearly masked.Thus the symptoms of splenic asthenia used to be ignored in clinical diagnose and treatment.Adding the symptoms of splenic asthenia as indexes of clinical observation of traditional Chinese medicine to the protocol of the phaseâ…¡ clinical trail of Qingfengtong capsule,would offer valuable information to its sequent clinical researches and application.DiscussionThe clinical research of compound preparation of traditional Chinese medicine is one of the difficult points in clinical research of traditional Chinese medicine. Compared with orthodox medicinal broth,compound preparation possess two basic characteristics:fixity of component including fixity of composition and dose, communitilization of correspondence subject.Thus compound preparation of traditional Chinese medicine mainly consider the primary pathogenesis of disease (excluding macro-complex prescription) which could take accompanied symptoms and signs into account.However the principle of composing formula of compound preparation of traditional Chinese medicine still bases on the determination of treatment based in pathogenesis obtained throu-gh differentiation of symptoms and signs and the compatibility as principal,adjuvant,auxiliary and conductant ingredimts which all follows the theory of traditional Chinese medicine.It should be pointed out that the characteristic of the compound preparation of traditional Chinese medicine effect is comprehensive effect with multicomponent,multisystem and multi-target. How to personalize the distinctness of traditional Chinese medicine in new drug phaseâ…¡clinical studies should be pay great attention to as exploratory study, especially to the end-point indexed.For instance,adding the symptoms of splenic asthenia as indexes of clinical observation of traditional Chinese medicine to the protocol of the phaseâ…¡clinical trail of Qingfengtong capsule,not only could reveal the distinctness of traditional Chinese medicine,but also would offer valuable and meaningful information to its sequent clinical researches and clinical application.
|
PDF Full Text Request