| Endometriosis (EMs) is a growth function of endometrial tissues and glands plants and grows in other parts of uterine cavity coated membrane and palace muscular. Its pathogenesis has not been clarified. The symptoms of dysmenorrhea and chronic pelvic pain caused by the disease have a serious impact on the normal work and life. The main treatment of this disease have the western medicine and traditional Chinese medicine (TCM). Now there is no satisfactory method to treat this disease. Therefore, It has a certain practical significance to explore the TCM traetment of this disease.This dissertation consists of two related parts, part one is the analysis of dysmenorrhea in the ancient literature. The second part is about the clinical study of TCM Yiqi Huayu Decoction in treating endometriosis dysmenorrhea.A. Bib Iiometric analysis componentObjective:A dictionary of TCM is used as the main searching target, scaning from the Eastern Han Dynasty, down to the Qing Dynasty for the prescription data about the treatment of dysmenorrhea. The thesis analyzes the ancient literature of TCM and the prescriptions and herbs treating dysmenorrheal recorded in them with the means of combining literature research and statistic analysis. The thesis recognizes the disease’s pathogen and pathogenesis, principle and method of treatment, the use of Chinese herbs and clinical thoughts.Methods:The retrieval words were established by literature retrieval. Medical records about dysmenorrhea were systematicly retrieved from’Chinese medical classics’.Then the related medical records were elaborately selected based on the inclusion criteria and exclusion criteria. The medical prescription information was put into the Health care data processing platform. Using data mining method, from the core theme, potential frequency analysis, association rule mining, clustering analysis of dysmenorrhea. According to the analysis results, combined with the theory of TCM.Result:Bibliometric analysis component:Through the analysis of 315 prescriptions, which involved 580 kinds of drugs. The TCM drugs range results show are as follows.1. Analysis from prescriptions about dysmenorrhea indicates that there is higher using proportion and frequency for Tonify deficiency drugs, dissipating blood stasis drugs, qi-regulating drugs interior-warming drugs. Chinese herb to tonify deficiency for the treatment of dysmenorrhea, promoting blood circulation to remove blood stasis drugs primarily. They thought the main pathogenesis is "pain due to stagnation of qi and blood" and "pain due to qi and blood fail to nourish "2. The characteristics of drug efficacy:High-frequency medicines of angelica, radix paeoniae alba, rhizoma ligustici wallichii, cinnamon, incense, liquorice, rhizoma corydalis, radix aucklandiae, rehmannia glutinosa, atractylodes, peach kernel, cortex moutan, ginseng, main licorice, twotooth achyranthes root, rhubarb, ginger, dried ginger, red flower. High frequency of drug use angelica, cinnamon, ginger, licorice root, ginseng to fill gas, cattail pollen promoting blood circulation to remove blood stasis and stop bleeding, dried tangerine or orange peel, magnolia bark to regulating qi.3. The characteristics of four properties and five tastes and channel tropism:Chinese herb is given priority to with Wen propertie, Ping properties, the use of hot drugs more than cold drugs. Chinese herb to the side, to return to the liver, spleen, stomach, lung, and kidney meridian.4. The result of factor analysis:the factor analysis shows that the three core angelica, radix paeoniae alba, rhizoma ligustici wallichii for drug use; Angelica sinensis and rhizoma chuanxiong, radix paeoniae alba, cinnamon, fragrance for dysmenorrhea five core drugs, drug compatibility between the inner relevance.5. Including four core theme analysis, the formulas is the main syndrome types including, blood deficiency and blood stasis, qi and blood stasis, blood stasis, qi haemorrheological nature two deficiency and blood stasis, blood stasis is the main pathologic basis of disease. Through cluster analysis, dysmenorrhea can include eight clustering.Conclusion:From ancient literature research, according to tonify deficiency and promoting blood circulation to remove blood stasis to treat the heart of the ancient treatment of dysmenorrhea. Blood stasis is one of the main factors of the disease. Pain has great effect on blood stasis. Tonifying qi and blood, promoting blood circulation to remove blood stasis pain for use as the core solution for the treatment of dysmenorrhea. The ancient period pain medication rules provide guidance for the endometriosis clinical study.B. Clinical research componentObjective:This study aims to observe the clinical efficacy and safety of Yiqi Huayu Decoction in treatment of patients with endometrisis, comparing with the Western medicine Tablets. Take notes with the patients’ The degree of visual analog scales of dysmenorrhea, the degree of dysmenorrhea rating scale, menstrual period, TCM syndrome scores before and after treatment. The changes of CA125 between two groups were also compared before and after treatment.Methods:The prospective randomized controlled study is used in this study. Patients meeting the standard of diagnostic criteria and inclusion criteria were included in the Department of Gynecology of Guangdong Province Traditional Chinese Medical Hospital during December 2014 to March 2016. Sixty eligible subjects were divided into two groups:treatment group and control group. The treatment group was treated with Yiqi Huayu Decoction, the control group received oral contraceptive pills for cycle therapy. The treatment period was 3 menstrual cycles, the observation time was 1 weeks before treatment and 1 weeks after the end of treatment, the curative effect and safety index were observed. Take observation of the recovery of menstrual cycle, menstrual period of all patients. The vasual analogue scale (VAS), the degree of dysmenorrhea rating scale, CA125, also fill in the TCM Syndrome Scale. Then monitor the safety indicators, liver and kidney function and record adverse drug reactions to evaluate the clinical efficacy and safety of Yiqi Huayu Decoction in treatment of patients with endometriosis dysmenorrhea. Establish the database and analysis the data by SPSS17.0 software package.Result:1. The baseline before treatment:Before treatment, all index, as the age, gravidity, parity, menstrual disorder, vaginal hemorrhage time, TCM syndrome score, CA125, between the treatment group and the control group, has no no statistical significance (P>0.05). The baseline between two groups is comparable.2. Comparison of dysmenorrhea of VAS and dysmenorrhea TCM score before and after treatment:treatment group after treatment period pain VAS is 3.17 ±0.96, control group is 3.28 ± 1.12. Two groups after the treatment period VAS and the dysmenorrhea symptom scores are lower than before the treatment, and the difference is statistically significant (p<0.05). It shows that treatment group and control group all can alleviate of patients with endometriosis dysmenorrhea. Two groups of VAS and the dysmenorrhea symptom decreased scores difference is no statistically significant (P>0.05).3. Comparison of TCM syndromes before and after treatment:Compared between the two groups, the total score of TCM syndrome and secondary symptoms scores in the treatment group is lower than the control group, and the difference is statistically significant (P<0.05). Compared within group, after treatment, the total score of TCM syndrome and secondary symptoms scores in both the treatment group and the control group are lower than before treatment, and the difference is statistically significant (P<0.05). It indicates that Chinese medicine decoction has better curative effect than that of Western medicine Progesterone Tablets in improving the symptoms related with qi.4. In the two groups after treatment CA125 level, there was no statistically significant difference (P>0.05), and may be associated with the small sample size.5. Comparison of the curative effect of regulating dysmenorrhea before and after treatment:Results of two independent sample rank test show that VAS curative effect comparison of the two groups, treatment group total effective rate 96.7%, control group total effective rate 95%. On dysmenorrhea symptom scores, treatment group total effective rate is 96.7%, control group total effective rate is 85%, the comparison of two independent sample rank and inspection comparison, difference also no statistical difference (P>0.05).Treatment group and control group of equivalent in terms of improvement of endometriosis dysmenorrhea. On TCM syndrome score, treatment group total effective rate 96.7%and control group total effective rate 85%. Treatment group to improve TCM syndrome integral than control group, the difference was statistically significant (P>0.05).Conclusion:Yiqi Huayu Decoction can effectively improve menstrual disorders of the patients with anovulatory abnormal uterine bleeding, including hemostasis, adjusting the menstrual cycle, reducing bleeding duration and bleeding amount, which has a considerable effect with the western medicine groups. In the two groups before and after treatment, their safety index is not abnormal, and there is not any obvious adverse drug reaction happened in the two groups. This study shows that the Chinese medicine decoction has a good clinical efficacy and safety in treating endometriosis dysmenorrhea, and it is worth of clinical popularization and application. |
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