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（原发性痛经的中西医治疗进展）
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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。
Objective:
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:
A. 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.
B. Therapeutic effect on QI STAGNATION AND BLOOD STASIS:The obvious curative rate in the experimental group was74.19%; the total effective rate was83.87%. The obvious curative rate in the control group was20.00% and the total effective rate was 46.67%. Between the two groups of the experimental group was statistically significant, the experimental group on the efficacy of qi stagnation card than the control group.
C. Therapeutic effect on pain severity:The obvious curative rate in the experimental group was80.69%, the total effective rate was90.32%. The obvious curative rate in the control group was26.67% and the total effective rate was 40.00%. Group differences of the experimental group were statistically significant. Experimental group dysmenorrhea pain relief superior efficiency of the control group.
D. Therapeutic effect on various tem symptoms:The experimental group provide obvious improvements for QI STAGNATION AND BLOOD STASIS symptoms such as the black menstrual blood, unclear menstruation, breast distention before menstruation, chesttightness as well as dysmenorrhea. Group differences of the experimental group were statistically significant. there is have statistical significance of the differences between the two.
E.Safety Result:In the process of the experiment, neither observed adverse effect nor any unusual physiochemical index of any clinical significance was yet seen and it is much safer in clinical applications.
Conclusion:
Shenbai dysmenorrhea particles can improvePain intensity of dysmenorrhea and obvious improve the symptoms like the black menstrual blood, unclear menstruation, breast distention before menstruation, chesttightnes. Shenbai dysmenorrhea particles have significant effect on primary dysmenorrhea due to qi stagnation and blood stasis and meanwhile with better safety.
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。
Objective:
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:
A. 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.
B. Therapeutic effect on QI STAGNATION AND BLOOD STASIS:The obvious curative rate in the experimental group was74.19%; the total effective rate was83.87%. The obvious curative rate in the control group was20.00% and the total effective rate was 46.67%. Between the two groups of the experimental group was statistically significant, the experimental group on the efficacy of qi stagnation card than the control group.
C. Therapeutic effect on pain severity:The obvious curative rate in the experimental group was80.69%, the total effective rate was90.32%. The obvious curative rate in the control group was26.67% and the total effective rate was 40.00%. Group differences of the experimental group were statistically significant. Experimental group dysmenorrhea pain relief superior efficiency of the control group.
D. Therapeutic effect on various tem symptoms:The experimental group provide obvious improvements for QI STAGNATION AND BLOOD STASIS symptoms such as the black menstrual blood, unclear menstruation, breast distention before menstruation, chesttightness as well as dysmenorrhea. Group differences of the experimental group were statistically significant. there is have statistical significance of the differences between the two.
E.Safety Result:In the process of the experiment, neither observed adverse effect nor any unusual physiochemical index of any clinical significance was yet seen and it is much safer in clinical applications.
Conclusion:
Shenbai dysmenorrhea particles can improvePain intensity of dysmenorrhea and obvious improve the symptoms like the black menstrual blood, unclear menstruation, breast distention before menstruation, chesttightnes. Shenbai dysmenorrhea particles have significant effect on primary dysmenorrhea due to qi stagnation and blood stasis and meanwhile with better safety.
引文
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