| ObjectiveTo clarify the necessity of multidimensional assessment of Traditional Chinese Medicine (TCM) clinical efficacy evaluation, and initiallyestablish analysis method of multidimensional assessment ofTCM curative effect. We studied randomized controlled trial in which TCM intervention in diabetic retinopathy (DR) during whole course, we verify multidimensional assessment method of TCM clinical curative effect, and to explore the possibility of multidimensional assessment method of TCM clinical curative effect.Methods1.We summarized the current evaluation methods of TCM clinical curative effect and proposed the necessity to build analysis method of multidimensional assessment of TCM curative effect.2.This essay introduced themethod of modern statistics and explained how to establish the paper expounds how to build a multi-dimensional evaluation analysis method of TCM curative effect.3.Document Research:We analyze clinical trials literature about curative effect valuation standards and evaluation indicators of TCM or combine traditional Chinese and western medicine treating DR over the past 15 years, and summarizes the current The clinical curative effect analysis method of TCM treating DR.4.Demonstration research on multidimensional evaluation of curative effect analysis method:use TCM treating DR (qi and yin deficiency, liver and kidney deficiency and channels stasis) as an example, through phase Ⅱ and phase Ⅲ clinical trials of applying doxium as a positive control, and placebo-controlled clinical studies conducted after marketed, compared with traditional curative effect analysis method, to validate the possibility of multidimensional assessment analysis method of TCM curative effect.Results1.39 articles about TCM or combine traditional Chinese and western medicine treating DR were included, through literature quality Jadad score,38 articles are found of low quality (less than 4 points).Though there is curative effect valuation standard for Clinical Guideline of New Drugs for Treating DR in book Clinical Guideline of New Drugs for Traditional Chinese Medicine (2002), only 17.14% articles mentioned using this effect valuation standard, the rest used self-compile standards or refer to other effect valuation standards. Evaluation standards used in these articles include physicochemical indexes, TCM syndrome or symptom indexes, quality of life indicators, end events and so on, conducted the evaluation mainly through main outcome indicators, combined with other single indicators.2.EWe determine the curative effects evaluation dimension including biological indicators dimension, living quality dimension, TCM syndrome dimension and main outcome measure dimension in total 4 dimensions, and detailed indicators in each dimension, using entropy method determine weight of each index, computing comprehensive evaluation of each dimension, to compare advantages and disadvantages of intervention methods. The main disease curative effect evaluation index show no statistical significance in research study phase Ⅱ using Qiming granules for 3 month treating main disease, Qiming granules equivalent Doxium. The biological indicators dimension, living quality dimension and TCM syndrome dimension of Qiming granules are 1.03,1.15,1.17, while for the Doxium are 0.97,0.89,0.83, showing that under the equivalent curative effect, Qiming granules is better in this three dimensions. The main disease curative effect evaluation index show statistical significance in research study phase Ⅲ using Qiming granules for 3 month, Qiming granules are better than Doxium. In the study treating for 6 months show no statistical significance, Qiming granules are equivalent with Doxium. The treatment for 3 months is different from the phase Ⅱ results, considering that the sample size is enlarged. At the stage Qiming granules used for 3 month, the biological indicators dimension, living quality dimension and TCM syndrome dimension of Qiming granules are 1.27,1.17,0.93, while for the Doxium are 0.91,1.02,0.77, Qiming granules used for 6 month this three dimensions are 1.06,0.91, 1.17, and for Doxium are 0.80,0.90,1.11. Whether 3 months or 6 months, Qiming granules is better in three dimensions including biological indicators dimension, living quality dimension and TCM syndrome dimension, agrees well with phase Ⅱ results. Comparing the treatment time, except for TCM syndrome dimension,6 months treatment time shows Qiming granules are better than 3 months in biological indicators dimension, living quality dimension. From the point view of risk-benefit assessments, it’s not showing the longer the treatment time is, the better. The post-marketing clinical research compared Qiming granules with placebo and end points events are used as main outcome indicators, taking the most concern events in clinic as final indicator can reveal the real clinical efficacy of a drug. There is no significant statistical difference when treatment time last for 6 months. Qiming granules used for 6 month, the main outcome measure dimension, biological indicators dimension, living quality dimension, TCM syndrome dimension are 1.00,1.12,1.19,1.26, and the control group are 0.51,0.88, 0.82,0.76. Qiming granules are better than placebo in each dimension indicators, and 3 month treatment time and 6 months treatment time results are in consistence of phase III results.Conclusions1.Given the nature of treatments by Chinese medicine and to comprehensively evaluate the effectiveness of TCM, curative effect analyzing of TCM clinical trials should be conducted from different dimensions.2.Current comprehensive assessment and mathematical statistics ways should be used to build multidimensional assessment analysis method of TCM curative effect. Though the validation of clinical randomized controlled trials, this curative effect evaluation method is available for curative effect evaluation of DR, which is feasible. |
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