Objective: Aimed directly at the problem that the diagnostic criteria of premenstrual syndrome is vacant in the country at present, to set up the domestic diagnostic criteria of premenstrual syndrome initially; Aimed at the status quo that the subtypes of premenstrual syndrome can not be discriminated each other,to establish the differentiation of symptoms and signs standard for liver-qi invasion of PMS; Aimed at the problem that the measurement means for quantization diagnosis and curative effect evaluation of liver-qi invasion of PMS is vancant,to manufacture the "symptoms severity doctor evaluation scale for liver-qi invasion of PMS"; Aimed at the problem that there is no diagnosis and curative effect standard of liver-qi invasion of PMS,to construct the reference standard of diagnosis and curative effect evaluation for the liver-qi invasion of PMS.Method: Translate and introduce the diagnosis standard of PMS recommended by The American College of Obstetrics and Gynecology(ACOG);to inspect the application of above standard by epidemiologic survey,and amend the items; finally set up the diagnosis standard of PMS .To set up the symptoms and signs differentiation standard for the liver-qi invasion of PMS by EFA and CFA according to the data from"symptoms information gain list of the liver-qi invasion of PMS for doctor";to set up the scale "symptom severity doctor evaluation scale for liver-qi invasion of PMS"according to the symptoms and signs differentiation standard;to analysis the scale's stability and interior concordance degree of the scale by re-test reliability and Chronbach's a and split-half reliability coefficient; to analysis the scale's structure validity by CFA; to analysis the scale's discrimination validity by curative effect evaluation research of "jingqianping granule" that is designed by the principle of random, double blind, contrast and multicentre; according to the scale's data distribution,and integrating the clinic experience, to construct the reference standard of diagnosis and curative effect evaluation for the liver-qi invasion of PMS.Result: The diagnosis standard of PMS recommended by ACOG is suitable to the domestic patients too;The most important symptom is "irritable and Felt angry"in the liver-qi invasion of PMS,Principle pathogenesis is that hyperactivity of liver-qi dispersion leads to invasion of liver-qi,premenstrual "liver-blood redundance"is the foundation to induce disease and syndrome, "dropsy" and "stagnation of phlegm" are the secondary pathogenesis;The scale"symptoms severity doctor evaluation scale for liver-qi invasion of PMS",its reliability and validity meet the scale qualification; "jingqianping granule"and placebo have good therapeutic efficacy to the patient with liver-qi invasion of PMS,and "jingqianping granule"is better than placebo.All items can be used as indexes of curative effect evaluation.The research establishes the diagnosis and curative effect evaluation initial criteria.Conclusion: Firstly,introduce the diagnostic criterion of PMS recommemded by ACOG and carry out the application research, set up the diagnostic criterion of PMS, provide the important reference for domestic PMS research in the domain of TCM and western medicine; The differentiation of symptoms and signs standard and symptom-complex analysis provide the important theory guidance for the therapy of liver-qi invasion of PMS; and first time, carry out the the diagnosis and curative effect evaluation criteria research of liver-qi invasion of PMS, set up the stable and effective evaluation method for disease and syndrome,provide the important evaluation instrument for liver of TCM research. The initial establishment of the diagnosis and curative effect evaluation criterion of PMS and PMS liver-qi invasion provides the important foundation for profession criterion's establishment.
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