Analysis Of TCM Syndromes And Medication Rules Of Recurrent Spontaneous Abortion Based On Modern Literature And Development Of The Patient Reported Outcomes Scale

Objective: Based on "Recurrent spontaneous abortion-TCM syndrome-TCM formula",modern literature on recurrent spontaneous abortion(RSA)was excavated and sorted out.The Traditional Chinese Medicine Inheritance Support System(TCMISS)was used to analyze the TCM syndrome and medication rule of RSA,providing scientific basis for clinical treatment of RSA.The PRO scale of recurrent abortion with TCM characteristics was developed according to the international general method,which was patient-centered,to objectively evaluate the clinical efficacy of TCM in the treatment of RSA,and to preliminarily evaluate the scale.It provides a quantifiable,scientific and objective measuring tool for the clinical efficacy evaluation of recurrent abortion in Traditional Chinese medicine.Methods: 1.Literature research: By searching TCM clinical research literatures on RSA published from 2000 to 2020,standardized syndromes and prescription drugs involved in the literatures were recorded into the TCM inheritance auxiliary platform system,and a database was established for analysis using statistical methods integrated with the system.To obtain the common TCM syndromes,clinical symptoms and drug frequency,efficacy classification,sexual and taste meridian,association rules,core combinations,potential new prescriptions of RSA,and provide literature support for the development of PRO scale;2.Development and evaluation of RSA TCM PRO scale Follow international PRO scale production process,set up the team,clear the research object,establish a theoretical framework,through the analysis of the literature review,interviews,reference domestic and foreign relevant scale method of RSA patients related data collection,construction of RSA PRO scale item pool of traditional Chinese medicine,on a small scale test,to solve the problem of feedback will complement adjust item pool,Form the first draft of the scale.Use scale in the early clinical investigation,using discrete tendency method,factor analysis,entry inspection method,correlation coefficient method,Cronbach’s alpha coefficient of 5 kinds of statistical methods for item selection,delete part of item according to the results of the screening,draft form scale,and its feasibility,reliability and validity of scientific evaluation.Results: 1.RSA modern literature research finally included 102 articles in accordance with the standard,and a total of 21 TCM syndrome types were collected.The top 10 are: kidney deficiency and blood stasis syndrome(41.35%),spleen and kidney deficiency syndrome(26.45%),kidney deficiency syndrome(10.08%),spleen and kidney yang deficiency syndrome(6.52%),spleen and kidney deficiency with blood stasis syndrome(2.14%),kidney qi deficiency syndrome(1.94%),liver stagnation and kidney deficiency syndrome(1.80%),kidney deficiency and blood heat syndrome(1.68%),heart and kidney disharmony syndrome(1.35%),heat accumulation and blood stasis syndrome(1.33%).Compound syndrome is more common.After separation,17 single syndromes were obtained,the top three of which were kidney deficiency syndrome(45.34%),blood stasis syndrome(23.28%)and spleen deficiency syndrome(15.71%).The syndrome elements of disease position are mainly kidney,spleen and liver,while the syndrome elements of disease are mainly qi deficiency,blood stasis,yang deficiency.104 prescriptions of traditional Chinese medicine for the treatment of RSA were collected,including 89 traditional Chinese medicines.The frequency of the top 10 were: Mulberry parasite(91),dodder(91),Dipsacus(84),Atractylodes macrocephala(74),Ejiao(59),Glycyrrhiza uralensis(52),Codonopsis pilosula(52),Radix Paeoniae Alba(47),Eucommia ulmoides(47),Salvia miltiorrhiza(43).The four qi are mainly warm(41.37%)and flat(41.09%),and the five flavors are sweet(45.19%)and bitter(28.09%).The liver meridian(24.45%)accounts for the most,followed by the kidney meridian(20.86%)and the spleen meridian(20.35%).Using the traditional chinese medicine inheritance support system for statistical analysis,a total of 334 drug combinations with frequency > 20 were obtained,and 20 drug association combinations with confidence ≥ 0.9 were selected.such as Ejiao-mulberry parasite,Codonopsis pilosula-dodder,Ejiao-dodder-Dipsacus-mulberry parasite,etc.12 potential core combinations were obtained by entropy clustering analysis,and 6 potential new prescriptions were further obtained;2.Construction of TCM PRO scale for recurrent abortion: the nature of the scale was defined as a self-rating scale for RSA patients,which was suitable for clinical outcome and efficacy evaluation of RSA;The item pool of the scale was constructed from four dimensions of physiology,psychology,society and treatment.After the items were screened by five statistical methods,the PRO scale of TCM for recurrent abortion with 33 items was formed.In the reliability evaluation,the Cronbach’s α coefficient and Spearman-Brown coefficient of the total scale were 0.862 and 0.750,indicating good internal consistency of the scale.Factor analysis was adopted to extract10 common factors for structural validity evaluation,and the cumulative variance contribution rate was 63.531%,indicating that most of the total variance of all variables in the scale could be explained by the extracted common factors,and the internal structure was good.Conclusion:1.The common TCM syndromes of RSA are kidney deficiency and blood stasis syndrome and spleen and kidney deficiency syndrome;the common syndrome elements are kidney,liver and spleen,and the disease syndrome elements are qi deficiency,blood stasis and yang deficiency;the most commonly used traditional Chinese medicine for the treatment of RSA is deficiency medicine;the most common medicine is warm and flat,and the medicine taste is sweet and bitter;it mainly belongs to the meridians of liver,kidney and spleen;the drug association rules and core combinations are roughly consistent with the distribution of syndrome types.The potential new prescription obtained by cluster analysis has guiding significance for TCM syndrome differentiation and treatment of RSA;2.The scientific evaluation of RSA PRO scale of traditional Chinese medicine shows that it has good feasibility,reliability and validity,and can be used as a tool to evaluate the efficacy of traditional Chinese medicine in the treatment of RSA.