| ObjectiveThis clinical controlled study takes clinical epidemiological methods, clinical research methods and statistical analysis methods, observes the clinical effect of applying Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy to treat non-inflammatory fluor disease with the purpose of discussing the difference in the clinical effect of the therapy mentioned above and pure Wan Dai Tang Therapy and pure Chinese Herbal Medicine Washout Therapy, so as to provide basis for the clinical treatment.Methods90 patients of non-inflammatory fluor disease are chosen who meet the case selection criteria and who were treated in Geng De clinic in Taipei, Taiwan from September 2008 to February 2010. With randomized controlled methods, the author classifies them into three groups at the rate of 1:1:1, namely Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy Group, Wan Dai Tang Group and Pure Chinese Herbal Medicine Washout Group.7 days make 1 treatment course and 1-3 treatment courses are determined based on disease severity. Before and after treatment, evaluate the Chinese Medicine clinical symptoms and body signs and examine safety.Establish a database with software EPIDATA 3.1 and analyze with software SPSS 15.0. Measurement material is processed by x±S and numeration data is expressed by constituent ratio (%). The interclass comparison of measurement data adopts F test (for heterogeneity of variance, adopt Kruskal-Wallis H rank sum test). The interclass multiple comparisons take q test (Newman-Keuls test). The self circa comparison takes pair t test or Wilcoxon pair rank sum test. The classified material is processed withχ2 test. The interclass comparison of ranked material is processed with Kruskal-Wallis H rank sum test. The statistical graphs are made with software Graph Pad Prism 4.03.ResultThe research collects 90 qualified subjects at the age of 19-50 with 30 in each group. The average ages of the three groups are 35.18,36.75 and 37.61 respectively, the average pregnancy times are 2.08,1.96 and 1.57 and the average birth times are 1.21,0.96 and 1.07.In the comparability analysis of patients'baseline features, there's no statistical significance in the difference of three groups'age, cervix condition, pregnancy times, birth times and the total pre-treatment scores of Chinese Medicine syndromes which indicates there's comparability of the baseline material of the groups.Curative Effect of Major Research IndexesCurative Effect of Chinese Medicine SyndromeAfter treatment, the Chinese Medicine syndromes'scores of the three groups decrease. The Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy Group has more noticeable effect and the difference has statistical significance (P<0.05) compared with the other two groups. The Wan Dai Tang Therapy Group has medium effect and Chinese Herbal Medicine Washout Group has poor effect. The Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy Group has 30 cases among whom 21 were cured,6 were of excellence, 3 were effective and 0 was ineffective with the total effective power of 100%, the curative ratio of 70.0%, the curative and effective ratio of 90.0%; the Wan Dai Tang Therapy Group has 30 cases among whom 13 were cured,6 were of excellence,7 were effective and 4 were ineffective with the total effective power of 73.3%, the curative ratio of 43.3%, the curative and effective ratio of 63.3%; the Chinese Herbal Medicine Washout Therapy Group has 30 cases among whom 2 were cured,5 were of excellence,9 were effective and 14 were ineffective with the total effective power of 53.3%, the curative ratio of 6.7%, the curative and effective ratio of 23.3%. The difference in the groups'curative effect and total effective power has statistical significance (P<0.01) which indicates the Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy has more noticeable curative effect than the Pure Wan Dai Tang Therapy and Pure Chinese Medicine Washout Therapy in improving the Chinese Medicine syndromes of non-inflammatory fluor disease.Index of Major Symptoms of Chinese Medicine SyndromesImprovement has been found in the major and secondary symptoms of Chinese Medicine syndromes in the three groups after treatment. The Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy has noticeable effect to treat patients'pruritus vulvae and improve the color, quality and volume of leucorrhea. Its curative effect of major symptoms of Chinese Medicine syndromes, the excellence rate and the total effective power are superior to the other two groups and the difference has statistical significance (P<0.05). Pure Wan Dai Tang Therapy has better effect than pure Chinese Medicine Washout Therapy in improving patients'color, quality and volume of leucorrhea and the difference has statistical significance (P<0.05). In improving the pruritus vulvae, the difference has no statistical significance (P>0.05) between the two groups. It proves that the Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy has noticeable curative effect in improving the major symptoms of Chinese Medicine syndromes of non-inflammatory fluor patients. Wan Dai Tang Group has better effect than the pure Chinese Medicine Washout Group in improving the color, quality and volume of leucorrhea of patients and the two groups have equivalent effect in treating pruritus vulvae.Examine safety during research. No abnormality is found in patients whose results of blood, urine and stool routine tests, liver and kidney function tests and electrocardiogram test are normal. It indicates the clinical safety of this therapy and has the value of clinical promotion and research.ConclusionThe Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy has significant difference compared with pure Wan Dai Tang Therapy and pure Chinese Herbal Medicine Therapy in the curative effect of Chinese Medicine syndromes, Chinese Medicine major symptoms and focal body signs (gynecological examinations). It has confirmed curative effect without toxic or side effects. Wan Dai Tang Therapy can reinforce spleen and discharge liver, solve dampness and stop leucorrhea, and reinforce the immunity. It can improve patients' fluor symptoms and Chinese Medicine syndromes and enhance their life qualities. To summarize, this research further evaluates the clinical curative effect and safety of the Added Wan Dai Tang Plus Chinese Herbal Medicine Washout Therapy in treating non-inflammatory fluor disease and provides adequate basis for its further promotion. |
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