| Purpose:Currently, the morbidity of chloasma is showing a younger-age trend, and the predisposing factors are complicated. Genetic factors, endocrine disorders and ultraviolet irradiation are all inducements for pigmentation,therefore, the morbidity of chloasma has become an increasingly worsen issue.Up till now, no specific treatment against chloasma has been found.Although the laser therapy has significant effect,the prognosis is poor and is easy to relapse.Relatively speaking, the traditional Chinese medicine works slowly, yet fewer side effects and long-term efficacy have given it therapeutic advantages and made it the main method for treatment of chloasma at present. Thispaperstudies the formulation ingredients of flora and fauna compound products made of Chinese herbal medicine and red deer fetus, and analyzes theresultsof oral administration trialsto evaluatethe rationality andthe therapeutic effectof the formulation.Method:On the basis ofthe dialectical traditional Chinese medicine therapy,taking into account the main pathogenic reasons of chloasma--liver-kidney yin deficiency,qistagnationand blood stasis, as well as liver and qi stagnation, and in the light ofdrug matching principle of traditional Chinese medicine,this flora and fauna compound products is designed in accordance with the guidelines of relieving liver for smooth qi, reinforcing kidney, activating blood and removing turbidity, as well as tuning up Chong and Ren, and is made according to the high altitude regional characteristics of Tianzhu, Gansu province.120 subjects met the inclusion criteria for the study of chloasma are selected and are divided into trial group and control group (60 cases each) randomly to conduct oral administration trial.The chloasma removing effect and the function of mental health improvement are evaluated through observing the changes on area (calculated by measuring with specified scale-plate the length and width of chloasma before and after the oral administration) and color (recorded by comparing the shades of chloasma with criteria from Practical Standard Color Card) ofchloasma, as well as the improvement offatigue,irritability,and insomniasymptoms of subjects from both trial group and control group.Results:1. Raw materials for final formulation of the flora and fauna compound products are:red deer fetus, safflower, aloe, angelica dahurica, rehmannia root, lycopene and flaxseed oil.2.Results of oral administration show that the size of chloasma in the trial group subjects are reduced by an average of 9.42±14.15cm2 (P<0.01), with a declining percentage of 15.08%. The color of chloasma becomes lighter, with an average dropping of 0.39±0.38 degrees (P<0.01) on color card.32 cases are proved effective; the total effective rate is 64.00%, with a significant difference on self-matching comparison. By contrast, the size of chloasma in the blank control group subjects are reduced by an average of 0.74±2.69cm2 (P<0.001), with a declining percentage of 1.48%. The color of chloasma becomes lighter, with an average dropping of 0.07±0.23 degrees (P<0.01) on color card.6 cases are proved effective; the total effective rate is 12.00%. The comparison results of the two groups and the index differences are statistically significant.3. Results of oral administration trial show that,in trial group, the effective rate of fatigue improvement is 35.71%, the effective rate of irritability improvementis 28.95%, and the effective rate of insomniasymptoms improvement is 40.63%. Compared to the controlgroup,the conditions of fatigue, irritability and insomniasymptoms are all improved in the trial group,and the differencesarestatistically significant.Conclusion:Effect evaluation results on oral administration of the flora and fauna compound products made of red deer fetus, safflower, aloe, angelica dahurica, rehmannia root, lycopene and flaxseed oilshow significant improvementon removingof chloasma and fatigue, irritability, as well as insomniasymptoms, which prove the rationality and effectiveness of the formulation, recognizing the formulation as a valid products for removing of chloasma. |
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