活血化瘀、行气止痛法参白痛经颗粒治疗原发性痛经气滞血瘀型的临床研究-中医妇科专业论文.docxVIP

成都中医药大学硕士学位论文 成都中医药大学硕士学位论文 I I 中文摘要 研究目的：以安慰剂为对照，评价参白痛经颗粒治疗气滞血瘀型原发性痛 经的有效性和安全性。 研究方法：采用随机，双盲，安慰剂平行对照设计，2008 年 12 月—2009 年 6 月将成都中医药大学附属医院妇科门诊符合原发性痛经（气滞血瘀证）诊断 标准的 48 例患者，试验组 32 例，对照组 16 例，采用参白痛经颗粒，并以安慰 剂为对照药物治疗，疗程 2 月。观察两组治疗前后各症状记分及相关疗效指标和 安全性指标变化情况。 研究结果： 1.原发性痛经的疗效：试验组显愈率为 67.74%，总有效率为 83.87%，对照 组显愈率为 26.67%，总有效率为 40.00%,试验组对痛经的疗效优于对照组。 2.气滞血瘀证的疗效：试验组显愈率为 74.19%,总有效率为 83.87%，对照组 显愈率为 20.00%，总有效率为 46.67%，且试验组组间比较有统计学意义，试验 组对气滞血瘀证的疗效优于对照组。 3.疼痛程度的疗效：试验组显愈率为 80.69%,总有效率为 90.32%，对照组显 愈率为 26.67%，总有效率为 40.00%，试验组组间差异有统计学意义，试验组对 痛经疼痛程度的缓解优效于对照组。 4.各种中医症状的疗效：试验组对经血黯黑夹块、行经不畅、经前乳胀、胸 闷不舒等气滞血瘀症状,经行腹痛情况均有明显改善。试验组各单项症状治疗前 后差值比较，差异均有统计学意义。 5.安全性结果：本次试验过程中，未见明显不良反应和有临床意义的异常理 化检查指标，临床应用较安全。 结论：参白痛经颗粒能改善痛经的疼痛强度,能明显改善其经血黯黑夹块、 行经不畅、经前乳胀、胸闷不舒等症状。参白痛经颗粒对气滞血瘀所致的原发性 痛经疗效显著，同时具有较好的安全性。 关键词：活血化瘀、行气止痛法；原发性痛经；参白痛经颗粒；安慰剂； 临床观察 II II Objective： Abstract By comparing with the placebo, evaluate the effectiveness and safety of Shenbai dysmenorrhea particles in curing qi stagnation and blood stasis of primary dysmenorrhea. Methodology: Adopting controlled parallel group design of random, double blinding and placebo. From December 2008 to June 2009, 48 patients, 32 experimental groups,16 control groups that conform to the diagnostic standard of primary dysmenorrhea(qi stagnation and blood stasis ) in gynecology clinic of attached hospital of Chengdu University of Traditional Chinese Medicine were treated by adopting and control drug therapy with placebo, the course of treatment lasts 2 months. Observe the symptoms scores before and after treatment as well as the changes of the relevant endpoint and safety index. Results： Therapeutic effect on primary dysmenorrhea: The obvious curative rate in the experimental group was 67.74%; the total effective rate was 83.87%. The obvious curative rate in the control group was26.67% and the total effective rate was 40.00%. Experimental group than the control group the efficacy of dysmenorrhea. Therapeutic effect on QI STAGNATION AND BLOOD STASIS : The obvi