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温经养血膏治疗寒凝血瘀型子宫内膜异位症痛经的临床研究

Clinical Study on the Curative Effect of Wen Jing Yang Xue Ointment Recipe Treating Dysmenorrhea(the Type of Cold Coagulation and Blood Stasis) Caused by Endometriosis

作者: 专业:中医学(专业学位) 导师:梁雪芳 年度:2015 学位:硕士  院校: 广州中医药大学

Keywords

Endometriosis, The Type of Cold Coagulation and Blood Stasis, Danggui Sini, Ointment Recipe, Wen Jing Yang Xue Ointment Recipe

        目的:本课题通过观察子宫内膜异位症痛经患者VAS评分、痛经程度及中医证候的变化,评价温经养血膏治疗轻中度寒凝血瘀型内异症痛经的临床疗效及安全性,为慢病患者提供一种新机型,为新药开发提供依据。方法:按照西医及中医(寒凝血瘀型)的诊断标准,在我院门诊2012年1月~2015年1月期间选择符合纳入标准的年龄在18岁-50岁的106例患者分为三组:试验组为膏方组,以温经养血膏作为试验药物,由我院制剂室提供,于第一个月经周期第1天开始口服,每次15 m1,日3次,连服3个月经周期。对照组分别为孕三烯酮组、中药组,孕三烯酮组予孕三烯酮2.5mg口服,1周2次,中药组予当归四逆汤口服,均从第一个月经周期第1天开始,连服3个月经周期。治疗过程中,对VAS疗效、痛经程度疗效、中医证候疗效、体征、实验室检查及辅助检查结果和不良反应进行临床观察,评价药物的有效性和安全性。结果:(1)膏方组治疗后VAS评分为2.13±1.48,孕三烯酮组为0.58±1.50,中药组为2.94±1.82,经分析,孕三烯酮组和膏方组比较、孕三烯酮组和中药组比较,具有显著差异(P<0.01),孕三烯酮组VAS评分降低更为显著。膏方组和中药组比较,差异无统计学意义(P>0.05)。(2)膏方组治疗后痛经程度积分为4.53±2.55,孕三烯酮组为1-62±2.54,中药组为6.08+2.52,经分析,差异有统计学意义(P<0.05)。其中孕三烯酮组与膏方组、中药组比较,具有显著差异(P<0.01),提示孕三烯酮组能显著降低患者的痛经程度积分。膏方组较中药组更能降低患者的痛经程度积分。(3)膏方组治疗后中医证候积分为2.47±1.33,孕三烯酮组为3.54±1.70,中药组为3.24±1.73,经分析,膏方组与孕三烯酮组比较,差异有统计学意义(P<O.05)。中药组分别与膏方组、孕三烯酮组比较,差异无统计学意义(P>0.05)。(4)三组VAS疗效比较,膏方组总显效率90.00%,孕三烯酮组总显效率92.00%,中药组总显效率80.00%;三组痛经程度疗效比较,膏方组总有效率93.33%,孕三烯酮组总有效率92.31%,中药组总有效率86.00%;三组中医证候疗效比较,膏方组总有效率100.00%,孕三烯酮组总有效率96、15%,中药组总有效率90.00%,差异均有统计学意义(P<0.05)。(5)三组治疗后CA125水平、内异症囊肿大小、子宫大小比较,差异无统计学意义(P>0.05)。结论:温经养血膏能有效治疗寒凝血瘀型子宫内膜异位症,对改善中医证候疗效优于孕三烯酮,温经养血膏的痛经程度疗效和中医证候疗效的总有效率高于孕三烯酮,分别为93.33%、100%。孕三烯酮对改善患者VAS疗效明显优于温经养血膏和当归四逆汤,且VAS疗效的总显效率为92.3%,孕三烯酮对改善患者痛经程度疗效明显优于温经养血膏和当归四逆汤,温经养血膏又优于当归四逆汤。温经养血膏无明显不良反应,疗效安全,值得进一步研究和临床推广。
    ObjectivesThis paper observes the changes observed in the uterine Endometriosis Dysmenorrhea VAS score, pain degree and TCM syndrome, evaluates the clinical efficacy and safety of The Wen Jing Yang Xue ointment recipe in treating the mild to moderate Dysmenorrhea (the type of cold coagulation and blood stasis) caused by Endometriosis. It can provide a new method for patients with chronic disease, and provide the basis for new drug development.MethodsAccording to the diagnostic standard of Western medicine and Chinese medicine (the type of cold coagulation and blood stasis), we choosed the 106 outpatients, age at 18-50 years old and meet the inclusion criteria, during the January 2012-January 2015 in our hospital. We divided them into three groups:the experimental group is named ointment recipe group, treated with Wen Jing Yang Xue ointment recipe (provided by our hospital preparation room) and started to take ointment recipe from the first day of the first menstrual cycle,15 ml each time,3 times a day, and even last three menstrual cycles. The control group were the gestrinone group amd Chinese medicine group. The gestrinone group take gestrinone 2.5mg, twice a week. The Chinese medicine group take Danggui Sini Decoction. They starte from the first day of the first menstruation, and even last three menstrual cycles. In the course of treatment, we observes the VAS effect, dysmenorrhea effect and TCM syndromes effect sign, and of vas curative effect, the degree of dysmenorrhea effect, TCM syndromes, signs, laboratory examination and auxiliary examination results and adverse reactions of clinical observation, evaluate the effectiveness and safety of drug.Result(1)After the treatment, the degree of VAS score in the ointment recipe group is 2.13±1.48, the gestrinone group is 0.58±1.50, the Chinese medicine group is 2.94±1.82, according to the analysis, the gestrinone group comparing with ointment recipe group, the gestrinone group comparing with the Chinese medicine group, the difference is statistically significant (P<0.05). the gestrinone group reduce the degree of VAS score evidently. The the ointment recipe and the Chinese medicine group, the difference was not statistically significant (P>0.05).(2) After the treatment, the degree of dysmenorrhea score in the ointment recipe group is 4.53±2.55, the gestrinone group is 1.62±2.54, the Chinese medicine group is 6.08±2.52, according to the analysis, the difference is statistically significant (P<0.05).The gestrinone group compare with ointment recipe group and Chinese medicine group, with significant difference (P<0.01).That points out that gestrinone can reduce the dysmenorrhea score.(3) After the treatment, the degree of TCM syndrome in the ointment recipe group is 2.47±1.33, the gestrinone group is 3.54±1.70, the Chinese medicine group is 3.24±1.73, according to the analysis, the ointment recipe group and the Chinese medicine group, the difference is statistically significant (P <0.05). the Chinese medicine group and the ointment recipe group, the Chinese medicine group and the gestrinone group, the difference was not statistically significant (P>0.05).(4)The comparison of the VAS curative effect between three groups, the total effective rate of ointment recipe group was 90.00%, the gestrinone group’s was 92%, the Chinese medicine group’s was 80.00%. The comparison of the degree of dysmenorrhea effect between three groups, the total effective rate of ointment recipe group was 93.33%, the gestrinone group’s was 92.31%, the Chinese medicine group’s was 86.00%. The comparison of the degree of TCM syndrome curative effect between three groups, the total effective rate of ointment recipe group was 10.00%, the gestrinone group’s was 96.15%, the Chinese medicine group’s was 90.00%. the differences were statistically significant(P<0.05).(5)The comparison of the CA125 levels, endometriosis disease cyst size and uterine size between three groups, the difference was not statistically significant (P>0.05).ConclusionThe Wen Jing Yang Xue ointment recipe can treat Dysmenorrhea (the type of cold coagulation and blood stasis) caused by Endometriosis effectively. It is better than gestrinone in improving the TCM syndrome effect. The total effective rates of Wen Jing Yang Xue ointment recipe are better than gestrinone in the degree of dysmenorrhea degree effect (93.33%) and the TCM syndrome effect(100%). The.gestrinone in improving the VAS effect is better than Wen Jing Yang Xue ointment recipe and Danggui Sini Decoction Decoction. And the total effective rate of VAS effect is 92.3%. The gestrinone in improving the drgree of dysmenorrhea effect is better than Wen Jing Yang Xue ointment recipe and Danggui Sini Decoction Decoction obviously. While the Wen Jing Yang Xue ointment recipe is better than Danggui Sini Decoction Decoction. The Wen Jing Yang Xue ointment recipe, without obvious adverse reactions, is worthy of further study and clinical application.
        

温经养血膏治疗寒凝血瘀型子宫内膜异位症痛经的临床研究

摘要3-5
ABSTRACT5-7
引言10-12
第一章 研究背景12-29
    第一节 祖国医学对内异症的认识12-19
        一、内异症的中医病因病机研究12-15
        二、中医治疗进展15-19
    第二节 内异症的现代医学相关研究19-25
        一、病因及发病机制19-20
        二、西医学治疗方法及局限性20-25
    第三节 治疗厥阴肝经寒证代表方当归四逆汤的研究及进展25-27
        一、治疗厥阴肝经寒证代表方当归四逆汤方解25
        二、以厥阴肝经寒证统领妇科经行痛症25-26
        三、当归四逆汤治疗内异症痛经的研究进展26-27
    第四节 膏方在妇科领域的应用现状27-29
        一、膏方的拟定与特点27-28
        二、基于厥阴肝寒证研制温经养血膏治疗经行痛症前景广阔28-29
第二章 资料与方法29-44
    第一节 研究对象29-30
        一、病例来源29
        二、西医诊断标准29
        三、寒凝血瘀型痛经的中医辨证标准29
        四、疾病严重程度分级标准29
        五、纳入标准29-30
        六、排除标准30
        七、剔除或脱落标准30
    第二节 实施方法30-33
        一、分组方法30
        二、治疗方法30-31
        三、观测指标与观察时点31-32
        四、疗效评定标准32-33
        五、撤出和中止试验的标准33
        六、不良事件的记录方式33
    第三节 数据管理及统计方法33
    第四节 质量控制33-34
    第五节 技术路线34-35
    第六节 结果分析35-38
        一、基线资料35
        二、主要疗效指标分析35-37
        三、次要疗效指标分析37-38
    第七节 不良反应38
    第八节 脱落病例记录38
    第九节 结论38
    第十节 讨论38-44
结语44-45
参考文献45-53
附录53-56
致谢56
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