| Diabetes mellitus is threatens the human health and life common diseaseseriously, the disease incidence rate grows year by year, appears the DM capillariescomplication along with the course of an illness progress, and implicates whole bodyeach system. Diabetes may cause a series of eye complication, in which diabetesretina pathological change (diabetic retinopathy, DR) are its main also the seriouscapillaries pathological change. The TCM is very early on has the understanding tothis complication. The new century Chinese medicine ophthalmology teachingmaterial causes diabetes names take the retinal pathological change as main changeblinding as xiaoke eye disease. When 2 DM patient diagnosis namely has 15% tocontract DR, but 10 years course of an illness 55%, above 15 years 70% has DR,surpass in 20 years patient in the course of an illness, have blinding approximately5%-8% because of DR. Because the later period DR prognosis is not good,extremely DR easy to cause to lose one's sight. Because according to 2001 the crosssection investigation extrapolation, at present DR causes blind in our country to reachmore than 70,000 people at least, this sickness caused the patient ability to work, thequality of life serious drop, and brought the soaring medical expenditure, for thepatient, the family and the country brought the serious financial burden. At presentdoctor practicingWestern medicine regarding DR (xiaoke eye disease) treatment viewpoint: Theearly internal medicine department controls DM, the ophthalmology departmentregular observation, the multiplication earlier period and the period of growth needslaser treatment, the serious period of DR needs surgery. Still did not have one kind ofcurative effect ideal preventing and controlling medicine regarding early DR, theChinese medicine passes through the long-term clinical observation, demonstrated had the good curative effect to early DR, like in promoted the patient visionenhancement and the retinal hemorrhage, dropsy absorption, after also the majoritypatients passed through take the Chinese native medicine, whole body symptomimprovement, quality of life enhancement. But the curative effect determinationmethod not unified also the standard is fuzzy, does not have the quantification or theobjective standard, does not favor the Chinese medicine to move towards the world.Quality of life (QOL) can reflect objectively the superiority of western andChinese medicine treat DR, but the present research very were few, because thewestern medicine theory system and the cultural context was dissimilar about QOL orcurative effect appraisal certain scales, it did not reflect the Chinese medicinetreatment the characteristic and the superiority, at present do not have to be able inaddition to reflect an xiaoke eye disease the cooperation of Chinese and Westernmedicine characteristic scale, therefore developed the appropriate scale system toreflect as soon as possible Chinese and Western union the curative effect, usemacroscopic and microscopic union assessment method, manifested Chinese andWestern medicine treatment the superiority, will be able to impel the cooperation ofChinese and Western medicine enterprise development.This research under the Chinese medicine theory instruction the methodologywhich according to the international general scale, to develop the curative effectappraisal scale system of DR, enables it to meet the clinical need. It include PRO(Patient Reported Outcomes) content: Namely the subjective feeling (QOL) and theobjective feeling (look, hearing, ask) obtains. And carries on the clinical investigationon it's the reliability, the validity and Responsiveness .inspects Scale system in xiaokeeye disease for clinical curative effect in the clinical application value, and whetherobserve Chinese medicine -Zishenjiangpihuayufang treat DR to reflect sensitively thecondition the change, carries on the examination and critique to the system. Thecooperation of Chinese and Western medicine clinical research and the curative effectappraisal gets sick which for other ocular disease provides the mentality. Enable thecurative effect assessment method which the Chinese and western medicine treateyeground disease obtain the quantification, makes it have the feasibility, finally hasthe repeatability.The first part: Iiterature reviewThrough the doctor practicing western medicine clinical curative effect appraisalcharacteristic and the present situation, the Chinese medicine clinical curative effect appraisal characteristic and the present situation, the QOL present situation, QOL andthe Chinese medicine relations, diabetes and xiaoke eye disease of QOL researchprogresses, the ophthalmology QOL research progresses, xiaoke eye disease clinicalcurative effect appraisal research summary, realized to the Chinese medicine andeyeground disease and so on, cooperation of Chinese and Western medicine treatmentxiaoke eye disease curative effect appraisal urgent need enhancement methodologyresearch, applies including statistics the applied mathematics method carries on thequality synthetic evaluation, specially, needs to QOL index of correlation Chinesemedicine syndrome to increase the curative effect. In the appraisal system, we mustthrough, the science method to develop evaluation scale system in xiaoke eye diseasefor clinical curative effect.The Second part: The preliminary development of evaluation scalesystem in xiaoke eye disease for clinical curative effect.goal and principle:a) The scale carries on the design according to the health definition unionChinese medicine theory to xiaoke eye disease understanding and the clinicalcharacteristic.b) the scale's subjective part is suitable to the patient , the objective part issuitable for Doctor to fill in, uses 4 kind of criteria, and easy to figure out the score.c) evaluation scale system in xiaoke eye disease for clinical curative effect.(clause) should the representation good, the independence strong, the sensitivity behigh, should be the clinical xiaoke eye disease item sickness specificity target, issuitable for xiaoke eye disease item sickness patient.d) The scale must be brief, easy to understand and the implementation, isadvantageous for filling in and the tracing investigation.e) The scale should have good the reliability, the validity and responsiveness.The research plan:1. experts integrate the standard this research choice to have the rich diagnosisxiaoke eye disease experience Chinese medicine ophthalmology department expert toform the expert group.2. clause pond determination first refers to the overseas commonly used life ofquality scale like VAQ, VF-14, ADVS, SIPV and so on, and unifies our country'scultural characteristic and eyeground sickness patient's some special symptoms, according to the Chinese medicine healthy theoretical model, the nurse, the eyegroundsickness patient discusses proposes the clause pond.3. expert investigations and the scale form by the expert group according to us toformulate the scale guiding ideology and the goal, carries on the choices to the scalecontent and gives the comment. Through target screening, finally chose the attachedscale 1 ,the attached scale 2, the attached scale 3, the attached scale 4 together tocompose evaluation scale system in xiaoke eye disease for clinical curative effect.一,the davelopment of the QOL scale in xiaoke eye disease1. goalform a clause pond, including: Symptom and apparent work energy, bodilyfunction, social activity, stress disorder, whole body and partial feeling and so onaspect targets. And carries on screening to the clause, enables in the scale the clauseboth comprehensively to weigh xiaoke eye disease patient's survival quality, and candifferentiate xiaoke eye disease patient and the healthy crowd.2. methodsrespectively are 105 examples and 105 examples carry on the investigation withthe QOL scale in xiaoke eye disease item to patient and the health, and simultaneouslyuses method of correlates 5 kind of clauses screens the method to carry on the clauseto screen.3. result3.1 use separate degree law, retention clause A1～A7, B1～B3, C1～C3, D1～D6,E1～E4, E6～E10, E11.Considered manifests an xiaoke eye disease the whole bodyperformance and the Chinese medicine asked examines the content, the E5 clausegives the retention.3.2 use correlation method of correlates, according to representation andindependent principle, retention clause: A1, A2, A3a, A3b, A6, A7, B1～B3, C1～C3,D1～D6, E1～E3, E5～E11.3.3 basis factor analysis result, the retention clause is: A1～A7, B1～B3, C2～C3,D1～D5, E1～E11.3.4 basis distinction analytic method, various clauses all may differentiate, givesthe retention.3.5 acts according to Koruna Bach method of correlates, after removes A9, B4,C4, D2, E2, E3, E9 alpha the coefficient fill-out, to various aspects internal uniformtremendous influence, had not died these clauses, other clauses give the retention. 3.6 passes through the above five methods to carry on screening, some 4 timesthe clause which selects: A1～A7, B1～B3, C1～C3, D1～D6, E1～E8, E10, E11.Togetheris composed the QOL scale in xiaoke eye disease like attached scale 1 by theseselected clause to show.二,the shape of the QOL scale in xiaoke eye diseasethe QOL scale in xiaoke eye disease finally is composed by 30 clauses, includingfive aspects. 1. The (A) apparent work can the aspect be composed (question by 8clauses 1～7), 2. The (B) body function is composed (question by 3 clauses 8～10), 3.The (C) social activity aspect is composed (question by 3 targets 11～13), 4. The (D)stress disorder and diabetes itself aspect is composed (question by 6 clauses 14～19), 5.The (E) subjective symptom and the Chinese medicine clinical manifestation aspect iscomposed (question by 10 clauses 19～21), these clause score and total scale totalscore correlation, its correlation coefficient 0.6191(P=0.000).According to diabetesand xiaoke eye disease Chinese medicine clinical manifestation and the Chinesemedicine asked examines the characteristic, selects can reflect an xiaoke eye diseasethe Chinese medicine characteristic clause for exampte: Question 20～29.Theseclauses enable this scale to have certain innovation, was formerly other scales doesnot have. Above the synthesis, this scale both reflects xiaoke eye disease in theapparent work to be able fully, the bodily function, the social activity aspect, the stressdisorder aspect survival quality, and can the specificity reflection diabetes clinicalmanifestation and xiaoke eye disease Chinese medicine characteristic. Is the Chinesemedicine ophthalmology department first appearance specificity survival qualityscaler, has the innovation, has provided the new method for the Chinese medicineophthalmology department survival quality and the Clinical curative effect appraisalresearch.三,the examination and critiques of the QOL scale in xiaoke eyedisease1. goalto exam the QOL scale in xiaoke eye disease and so on it's validity, Reliability,degree of reaction carries on the examination and critique.2. methods30 xiaoke eye disease patient is after first time fills in the QOL scale in xiaokeeye disease r, fills in a time the QOL scale in xiaoke eye disease by this patient in 24hours; Other 30 examples are fill in a time it before the Chinese medicine treatment,treats for 3 months after the Chinese medicine once more to fill in a time it. 3. result and appraise(1) this research application criterion correlation validity, its correlationcoefficient is 0.7421(P=0.000).The result showed that, this may reflect to a certainextent the patient survives the quality situation.(2) we 30 example patients in 24 hours, two survey identical scale score, carryon the correlation analysis, its correlation coefficient is 0.7803(P=0.000).This resultshowed this table stability is good. this scale variance ratio is 0.0531, indicated thescale the confidence level is good.(3) we based on treat the before and after 3 month-long survival quality score to30 example xiaoke eye disease patient Chinese medicine to carry on the T-test (t=6.92,P=0.000), the effect size statistics (effect size statistic, ES)=the Chinese medicinetreats the before and after survival quality before the average increment/Chinesemedicine treatment to QOL score standard deviation This research ES is 1.402.Theresult indicated this scale has had the reflection clinical change ability.四,the conelusion1. this research basis Chinese medicine theory as well as xiaoke eye diseasespecificity and the reflection Chinese medicine clinical characteristic, first forms aclause pond, and uses 5 clause screening method to screen xiaoke eye disease QOLscale the item, finally forms xiaoke eye disease survival QOL scale which likeattached scale 1 shows, enable this scale to have the scientific nature and the Chinesemedicine characteristic, can reflect an xiaoke eye disease the comprehensive survivalquality condition, has certain innovation and the specificity.2. through carries on xiaoke eye disease QOL scale, the validity, the degree ofreaction inspection, obtains this scale to conform to the specification which thesurvival quality scale validity, the reliablity, the degree of reaction and easy to analyze,may test in the clinical research.3. bases compose a comprehensive cooperation of Chinese and Western medicinecurative effect appraisal system the mentality, this xiaoke eye disease curative effectappraisal scale system is constitutes by two parts: Subjective part: Xiaoke eye diseaseQOL scale (attached scale 1), Chinese medicine state of health scale (attached scale 2),objective part: Xiaoke eye disease clinical observation table (attached scale 3), xiaokeeye disease eyeground inspects the scale objectively (attached scale 4), altogether fourtable constitution entire clinical curative effect appraisal system.Manifests theChinese medicine and the doctor practicing western medicine unifies, macroscopicand microscopic unifies, overall and partial unifies, the body and mind condition andthe survival quality unify, have the innovation. The third part: evaluation scale system in "xiaoke" eye disease forclinical curative effect. preliminary clinical practice1. goalappraisal xiaoke eye disease curative effect appraisal scale in the clinicalapplication value, whether observe this scale sensitive reflection tozishenjianpihuayufang treatment xiaoke eye disease the condition change andobjective evaluation its curative effect.2. methods2.1 take zishenjianpihuayufang, the date 3 times, each time 4 pieces; the treatmenttime is 3 months. Conforms to the diagnosis standard, integrates the standard thexiaoke eye disease patient altogether 159 examples, divides into five groups accordingto the Chinese medicine syndrome.2.2 observation projects and target: After xiaoke eye disease QOL scale observation(before treatment, treatment fills out a form after patient in time 20 minutes tocomplete, the Chinese medicine state of health scale respectively) (before treatment,treatment fills out a form respectively by patient one time, in 20 minutes completes),xiaoke eye disease clinical observation table (around treatment fills out a formrespectively by doctor one time), the vision, the eyeground inspection, FFA. Theobservation point in time for treats the 0,3rd month.2.3 patients to own curative effect appraisal, altogether divide into 3 kinds: Obviouschange for the better (appearance), change for the better (effective), invalid orworsening.2.4 this curative effect appraisal scale system judgment standard basis integrationjudgment curative effect. Evaluation basis: Around treatment attached scale 1,attached scale 2, attached scale 4 total integrals. A. shows results B. effective C.invalid or the worsening.2.5 statistics analysis all data indicated with the mean value±standard deviation that,in the group around compares uses the T-test, between the multi-group mean valuegroup compares with the variance analysis, the classified material uses the chi-squaretest, the rank material uses the Ridit examination, the rank material correlationanalysis is connected with spersman examines. Carries on statistics processing withthe SPSS13.0 software, P＜0.05 for has the significance difference or the connection.3. results3.1 use to zishenjianpihuayufang to treat for 3 months to reveal the efficiency are31.44%, the patient from comments reveals the efficiency is 35.84%, both coincidence rate is 87.72%; Effectiveness is 42.27%, the patient from commentseffectiveness is 45.91%, both coincidence rate is 93.15%; The inefficiency is 25.78%,the patient from comments the inefficiency is 18.24%, both coincidence rate is70.73%.3.2 treats for 3 months, the yinxuzaore group, was mad between qiyinlianxu group oftwo groups compares the non-significance difference (P＞0.05), but with thepishenlianxu group of, the xuexingyuzhi group and the tanyuzhuzhi group to comparehas the significance difference (P＜0.05).3.3 yinxuzaore group ,qiyinlianxu group, pishenlianxu group, xuexingyuzhi groupand in zishenjianpihuayufang treatment QOL to have the obvious change (P＜0.05)around, but the tanyuzhuzhi group to treat survives the quality change not not in a bigway (P＞0.05), but the survival quality total integral has the drop.3.4 yinxuzaore group ,qiyinlianxu group, pishenlianxu group, xuexingyuzhi group ofthe Chinese medicine state of health has the obvious change around the treatment (P＜0.05),Chinese medicine state of health all varying degree improvement; Around buttanyuzhuzhi group to treat the Chinese medicine state of health not to have theobvious change (P＞0.05).3.5 yinxuzaore group ,qiyinlianxu group, pishenlianxu group, xuexingyuzhi group ofthe vision has the distinct enhancement around the treatment (P＜0.05), but thetanyuzhuzhi group (P＞0.05) to treat the vision to improve not obviously.3.6 xiaoke eye disease patient in zishenjianpihuayufang treatment, the eyegroundbleeds and the yellow spot dropsy has the varying degree improvement (P＜0.05),butcapillaries lump, and around retina blood capillary non-irrigation area treatment notdistinct improvement (P＞0.05)4. conclusions4.1 press the curative effect to appraise the scale the evaluation criteria, compares thepatient to own curative effect appraisal result and the use xiaoke eye disease curativeeffect appraisal scale system curative effect appraisal result, the proof xiaoke eyedisease curative effect appraisal scale system is objective regarding the Chinesemedicine treatment xiaoke eye disease curative effect appraisal.4.2 through xiaoke eye disease curative effect appraisal scale system analysis,zishenjianpihuayufang to bleed and the yellow spot dropsy to the eyeground has thevarying degree improvement, but to the capillaries lump, the retina blood capillarynon-irrigation area improves not obviously, zishenjianpihuayufang not to beinconsistent to xiaoke eye disease various curative effect. 4.3 through xiaoke eye disease curative effect appraisal scale system analysis,observes zishenjianpihuayufang only then to enhance the vision, the improvementapparent work energy, simultaneously may improve xiaoke eye disease patient'ssurvival quality ,the scale system can appraises the clinical curative effect from thesurvival quality and the Chinese medicine symptom improvement aspect, this is thewestern medicine curative effect appraisal system does not have; it have theinnovation.
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