A Methodology Study Of Synthetical Evaluation On Clinical Curative Effect In Chinese Herbal Medicine (New Medicine)-The Clinical Curative Effect In CCHF With Shengmai Capsule Treatment Of Synthetical Evaluation

一. Study the backgroundChinese medicine inthe aspects of defending disease curing illness contain especially original advantage, the demonstration of these advantageses needs the clinical evaluation method of science, system urgently. Only have the adoption science, careful clinical trial design, take out the objective and dependable clinical curative effect proof, then can make Chinese medicine to get the more widespread approbation, establishing the applicable clinical demand in Chinese medicine, include its certificate the Hou and quantity of life evaluation in inside of comprehensive and clinical curative effect evaluation method, index sign of the system with standard, improving the best evidence to proof the clinical curative effect of the important hard disease, the fairly serious disease and subhealthy disease, all of these will push the Chinese medicine walk into the world medicine line.Make use of optionally a kind of or the variety synthetical evaluation method, passing the Number reason calculation and statistics, using the several many stereoscopic development index sign evaluate the Chinese herbal medicine (new medicine) that cure a certain disease certificate with safety and usefutness which should is a line of of valid, and should is a Chinese medicine (new Medicine) defend the disease and cure illness to get the world generally accepted, it is the necessary path that Chinese herbal medicine (new medicine) walk in modernization and internation.二. The methodology study 1. study the purposePass "Double—blind; randomized, placebo—controlled clinical trail on Chronic Congestive Heart Failure with Shengmai capsule treatment, which add to the base of normal treatment″, applying more kind of synthesizing evaluationses, study with inquiry in the ameliorative useness of Shengmai capsule to the heart function and Chronic Congestive Heart Failure patient; quantity of life and lower die ratio of illness; The first step establishes many index signs evaluation system meanwhile synthetize evaluates the Chronic Congestive Heart Failure with Shengmai capsule treatment; Passing this experiments to establish and investigate the keys and the technique norm about clinical curative effect in clinical trial in a set of Chinese herbal medicines(new medicine), learning the technique terrace for research and certain method in offering in evaluation in curative effects of the Chinese herbal medicine(new medicine).2. study the contentsPassing this experiments the research establishes the investigative and clinical curative effect in clinical trial in a set of Chinese herbal medicines (new medicine) synthesize evaluate the method with the technique norm. Provoting a good technique method for studying clinical curative effect in clinical trial in a set of Chinese herbal medicines (new medicine).At the saae time, borrowing this case for which Chinese herbal medicine (new medicine) establish the method of synthetical evaluation to offer the new way of thinking.3. study the hypothesis3.1 If the method of Chinese herbal medicine (new medicine) synthetical evaluation has more meaningful than the common method of single index sign medical science statistics of obvious examination curative effect judge?3.2 If we can establish the reasonable method to evaluate the Chinese herbal medicine(new medicine) with stable model and preface the clinical curative effect for its curative effect grade row?4. study the key problem of the solution4. 1 Establish many index signs evaluation system in clinical curative effect in CCHF with Shengmai capsule treatment of synthetical evaluation4.2 Study the solid viable methods to synthetical evaluate the clinical curative effect in CCHF with Shengmai capsule treatment. 4.3 Chose and establish the stable model which synthetical evaluation of Chinese herbal medicine (new medicine)clinlcal curative effect in CCHF With Shengmai capsule treatment.5. Double—blind, randomized, placebo—controlled clinical trail on Chronic Congestive Heart Failure with Shengmai capsule treatment (RCT)Result:5.1 The left room shoots the blood score EF value:EF value three hour point total to distribute the characteristic obeys positive the normal distributes, proceeding the independent sample t examination: diagnosing moment hour point an EF value variety of placebo group and treatment group have no to show the difference of obvious; 12 weeks with 24 week hour point, an EF value variety of placebo group and treatment group also have no to show the difference of obvious.Two EFs value makes the oneself to check against in front and back respectively again the——forms couples the sample t examination: The EF value of placebo group at diagnose hour point difference with experimenting 12 weeks, 24 weekses proceeding checking against, discovering its oneself in front and back has no to show the difference of obvious; (P＞0.05)The treatment group making same checking against, although the value of EF at threely hour point also has no to show the difference of obvious (P＞0.05), its all count the all over and above placebo group all counts, explaining at Shengmai capsule under medical treatment, has the exaltation.5.2 NYHA heart function ratingsPlacebo group and treatment group in front and back and Non—parameter examination——Wilcoxon examination: Two treatments in front and back the heart function ratings checks against to have no to show the difference of obvious (P＞0.05).The heart function ratings oneself checks against the—Wilcoxon sign order in front and back with the examination: Two hearts function ratings experiments in front and back the oneself checks against the result gets, two heart for experimenting in front and backs function ratings all contain variety, reporting to show the difference of obvious. (P＜0.05)5.3 Important affairs occurrence ratio and die ratio of illnessImportant affairs occurrence ratio placebo group is: 7.7%, the treatment group is 8.2%; Die of illness ratio placebo group as: 4.8%, treatment group is: 3.1%; The bad affairs takes place ratio placebo group as 3.8%, treatment group is 1.5%. Two Chis—Square(X²) examination all has no to show the difference of obvious. (P＞0.05)Because the current sample of this experiment research is 265 cases obvious lower than the need samples 360 cases estimated, so the whole data is shortage to deal the examination result and proceed to show the obvious examination analytic, naturely, as above the result can't represent the curative effect final outcome of whole clinical trial, but the actual analytic result has explain this circumstance.The final outcome of the traditional curative effect evaluation is bases on interrupting hour point do of show the obvious examination result, this examination need the sample in certain quantity foundation top to deal with various examinations term match then can realize, at the same time a history for making use of data information measures is limited, the result do not keep the view, But the cinical curative effect synthesize evaluation is restrict that a continuous dynamic evaluation process, not summit to sample how much, with stability and reasonable model in science to proceed many factors, many the degree of dimensions to synthesize adjudicate with the complicated system, synthesized to make use of well in its evaluation process the history data information measures, reducing the informationn measures of throw to lose, guarantee the evaluation final outcome comprehensive, and judge the effect result keep the view therefore. Matching the information more many will be more true, the common ground that dependability and accuracy of evaluation will be more high.6. The clinical curative effect in CCHF with Shengmai capsule treatment of synthetical evaluationEvaluation purpose: The clinical curative effect in CCHF with Shengmai capsule treatment of synthetical evaluation from many degree measure, many factors.Evaluate the object: Shengmai capsule6.1 AHPShengmai capsule treatment group synthesize to evaluate index number as 1.3051, the obvious over and above placebo group synthesizes to evaluate the index number 0.8787, Shengmai capsule function is positive, at the same time its synthetical evaluation index number higher than the placebo group's. Among them, the EF value to record to divide with the Chinese medicine symptom of synthesize the index number obvious exceed the placebo matched control synthesize the index number.6.2 Set up the TOPSIS ideal order the model synthesizes to evaluate the methodCombination the index sign system that Delphi method expert's grade point establish, according to return a primitive data matrix after turning, make "Double—blind, randomized, placebo—controlled clinical trail on Chronic Congestive Heart Failure with Shengmai capsule treatment" justice in the project which negative solution and positive ideal solution constitution as a space, needing evaluation treatment group and the placebo group are each to see as space a little bit and some, so acquire point which is the positive ideal solution or the negative ideal solution of distance D_i⁺ with D_i^- (the in common use 0 surname distance means), from a project of which near to the degree C_i value, according to size in C_i to evaluate each from project which good and bad, row preface the result expresses to treatment group of the clinical curative effect is obvious better than placebo group, and treatment group near to degree C_i value is 0.9534 has very near to 1, elucidation Shengmai capsule treatment the CHF nears to very much the justice the ideal project. Have a conclusion for the treatment group project nears to the more better than placebo group project.On the comprehension a clinical curative effect for saying, establishing Chinese herbal medicine(new medicine) belongs to more index synthetical evaluation is more meaningful than a present and in common use medical science to statistics which show the obvious examination curative effect judge the method; We can establish the reasonable method to evaluate the Chinese herbal medicine(new medicine) with stable model and preface the clinical curative effect for its curative effect grade row.三. conclusionThe clinical curative effect in Chinese herbal medicine(new medicine) synthesizes evaluation that the method establishes at the first step1. Clear and definite evaluation object: A certain(some several kinds) or a certain(some several types). Chinese herbal medicine(new medicine)2. The purpose of the certain evaluation: The application is belonged to index(many index signs) more to synthesize each Chinese herbal medicine(new medicine) of evaluation at cure the clinical curative effect final outcome between a certain disease certificate or a type disease certificate3. Establishing the clinical curative effect synthetical evaluation of the index sign system3.1 A method—"Delphi" chose the index sign and settle the weight: Adoption" cultural reference data analysis optimization method" select index sign of the disease certificate by opposite examinations of the clinical curative effect evaluation, design the expert investigates form, combination" expert's experience chooses the method" chose the index sign and settles the weight, chose 15～50 experts is properly.3.2 Saaty' weight estimational method3.2.1 Establish a construction of level of structure, formation target tree diagram3.2.2 Adoption Saaty of 1—9 mark a method will evaluate the index sign proceeds to give a score3.2.3 Establish the index sign contrast than judge the optimization matrix3.2.4 Use method that Look like the solution to make the each index sign weight: W'_i=(a_i1a_a2…a_im)^1/m3.2. 5 Proceed the consistency examination: When judge the matrix rank the number the＜2, CI＜0.10; When judges the matrix rank the number the＞2, calculate the random consistency comparison CR, be with the random consistency comparison CR＜0.10, usually think that judge the matrix has the satisfied consistency, may have no the logic confusion, then pass various weights that calculation get weight is acceptable.3.2.6 Pass the" product method" compute the power of each time class index sign heavy, compute finally most the heavy vector in power in combination Ci of the bottom layer(project layer) index sign.4. Chose the synthetical evaluation model:4.1 Choice or set up the line add the weight synthesizes the method(the "addition" synthesizes the method) model: The calculation synthesizes the grade point index number GI=sum from i=1 to m CiPi, proceed to totally evaluate in clinical curative effect index sign of the Chinese herbal medicine(new medicine).4.2 The TOPSIS ideal point model: 4.2.1 Primitive data collections: Establish the n an evaluation object, m an evaluation index sign, get the primitive data matrix of a n×m4.2.2 Establish the primitive data matrix of the same trend turn. In common use method is a high and excellent index sign conversion method, the low and excellent index sign, in opposite number uses the count down worth method(1—x) conversion; Absolute number the low and excellent index sign uses the reciprocal method conversion.The count down method formula: X'_nm=1-X_nmX'_nm=1/X_nm4.2.3 Set up the return on turning the matrix Z after turned the primitive data same trend(the primitive data is a high and excellent index sign)(the primitive data is a low and excellent index sign)After return on turning the matrix Z that handles is:4.2.4 According to return on turning the matrix Z gets the superior vector and the inferior vector(namely the positive ideal sulotion and negative ideal solution)positive ideal sulotion: Z⁺= (z_i1⁺, z_i2⁺……z_im⁺)negative ideal solution: Z^-= (z_i1^-,z_i2^-……z_im^-)type inside, i=1,2……n; j=1, 2……m. Z_i⁺ mean the biggest value that evaluate the object with Z_i^- respectively with minimum Value.4.2.5 Compute each evaluation object value of the index sign which the distance D_i⁺ come from positive ideal solution and the distance D_i^- come from negative ideal solutiontype inside, the wj means the power of the index sign j weight. Wjfrom Delphi method expert sieving and settle the index sign power of the power income heavy through return on turning to obtain the coefficient weight.4. 2.6 Compute each evaluation object value of the index sign which the positive ideal sulotion and negative ideal solution in opposite near to degree C_i value C_i=D_i^-/(D_i⁺＋D_i^-)4.2.7 according to size in C_i to evaluate each from project which good and bad, row preface the result. The C_i takes the worth scope[0, 1]. C_i value more near to 1. express to evaluate the object to near to more the justice positive ideal solution.; Ci value more near to 0, express to evaluate the object more near to negative ideal solution.Main solution: Establish many index signs evaluation system in clinical curative effect in CCHF with Shengmai capsule treatment of synthetical evaluation: Study the solid viable methods to synthetical evaluate the clinical curative effect in CCHF with Shengmai capsule treatment: Chose and establish the stable model which synthetical evaluation of Chinese herbal medicine(new medicine)clinical curative effect in CCHF with Shengmai. capsule treatment.