经前期综合征肝气逆证临床疗效评价参考标准建立

Establishment of Reference Standards about Clinical Treatment Effect on Premenstrual Syndrome with Liver-qi Invasion

目的从临床症状和生化指标两方面建立反映经前期综合征肝气逆证疗效评价参考标准。方法采用流行病学前瞻连续跟踪观察受试者3个月经周期,筛选疗效评价临床症状和生化灵敏指标,对经前平组和安慰剂组进行疗效观察。结果治疗后DRSP总分变化<50分无效,变化50～100分有效,变化100～150分显效;"医生评价表"总分变化<4分无效,变化4～8分有效,变化8～12分显效;"患者自评表"总分变化<5分无效,变化5～10分有效,变化10～15分显效。用药后对PMS肝气逆证患者血清生化指标变化有调整作用,可以作为经前平颗粒治疗PMS肝气逆证的疗效观测指标。结论从临床症状和生化指标两方面初步建立了经前期综合征肝气逆证疗效评价的参考标准。

Objective To establish reference standards about Clinical Treatment Effect on Premenstrual Syndrome with Liver-qi Invasion from clinical symptoms identification and biochemical markers detection. Methods Adopted epidemiological perspectives to observe subjects’ three menstrual cycles,screened the sensitive indexes of clinical symptoms and biochemical markers for efficacy evaluation,and observered treatment effect of Jingqianping group and placebo group. Results After treatment,the total change of DRSP less than 50 points is invalid,change 50-100 points is effective,Change 100-150 points is markedly effective;" doctor evaluation scale" total score change less than 4 points is invalid,change 4-8 points is effective,Change 8-12 points is markedly effective;" patient self-assessment scale" total score change less than 5 points is invalid,change 5-10 points is effective,Change 10-15 points is markedly effective. Serum biochemical markers can be used as a efficacy observation index for the treatment of PMS with Liver-qi Invasion by Jingqianping granule since they were regulated after administration in patients. Conclusion we have initially established reference standards about clinical treatment effect on Premenstrual Syndrome with Liver-qi Invasion from clinical symptoms identification and biochemical markers detection.