| Objectives1 Through data mining of the published literature on the effective treatment of perimenopausal sleep disorders in Chinese medicine,we initially derived the distribution of TCM syndromes and medication rules so as to provide the clinical ideas of treating this disease.2 Through the clinical study,we analyzed the Pittsburgh sleep quality index(PSQI)scores,TCM syndrome scores,modified Kupperman index(KI)scores,Insomnia severity index(ISI)scores before and after treatment and evaluated the clinical efficacy of Zishui Qinggan Lichong decoction in treating perimenopausal sleep disorder patients with kidney deficiency and liver depression in order to provide reference for clinical treatment of this disease.Methods1 The studies of TCM for perimenopausal sleep disorders from January 1,2000 to June 30,2022 were retrieved by computer from the China Knowledge Resources Database(CNKI),China Academic Journal Database(Wanfang Data)and Chinese Science and Technology Journal Database(Wipu.com),and the basic information of which was extracted to establish an Excel database,and the python 3.8 programming language was used to analyze the TCM syndromes,the Chinese medicine prescription information for frequency statistics,association rule analysis and visualization presentation and using SPSS Statistics 26.0 statistical software to complete the clustering analysis.2 Thirty-eight patients with perimenopausal sleep disorders identified as kidney deficiency and liver depression in the outpatient clinic of Professor Liu Yanfeng,Department of Gynecology,Dongzhimen Hospital,Beijing University of Traditional Chinese Medicine were collected from December 2021 to December 2022 and Zishui Qinggan Lichong decoction was given orally to them for 8 weeks,of which the composition includes:Radix Rehmanniae Preparata,Rhizoma Dioscoreae,Fructus Corni,Cortex Moutan Radicis,Poria,Radix Salviae Miltiorrhizae,Carapax Trionycis,Radix Paeoniae Alba,Fructus Gardeniae,Semen Ziziphi Spinosae,Radix Curcumae,Cortex Albiziae and Plumula Nelumbinis etal.Choosing the before-after study method and using 0 and 8 weeks as observation time points,patients’ PSQI scale scores,TCM evidence scale evaluation scores,modified KI scale scores,Chinese version of ISI scale and female hormone levels(E2,LH,FSH)were observed and recorded before and after treatment.A total of five aspects were used to evaluate the clinical efficacy of Zishui Qinggan Lichong decoction in the treatment of perimenopausal sleep disorders with kidney deficiency and liver depression,in terms of improving sleep quality,improving TCM symptoms,improving quality of life,reducing the degree of insomnia,and regulating hormone levels.Meanwhile,the occurrence of adverse events,if any,was recorded during the treatment to evaluate the safety of Zishui Qinggan Lichong decoction.Results1 Characteristics of TCM syndromes and medication rules in treatment of perimenopausal sleep disorders based on data mining(1)Totally 109 articles were included at last.TCM syndromes were reported in 109 articles,and TCM prescriptions were reported in 54 articles.(2)The high-frequency syndromes were Yin-deficiency and fire-hyperactivity syndrome,Renal deficiency and liver depression syndrome and Heart-kidney disharmony syndrome.All the three covered more than 10.00%of the total number of patients studied.(3)The high-frequency Chinese materia medica included Semen Ziziphi Spinosae,Radix Paeoniae Alba,Radix Angelicae Sinensis,Poria Cocos,Radix Polygoni Multiflori,Liquorice,most of which property belonged to cold and mild,most of which the flavor belonged to sweet and bitter,and most of which belonged to liver,heart,spleen and kidney meridians.(4)Totally 1 binomial correlations and 19 trinomial correlations were obtained by correlation rule analysis.(5)7 medicine combinations were obtained by cluster analysis including:Cl:Os Draconis,Concha Ostreae,Radix Paeoniae Alba,Radix Bupleuri;C2:Rhizoma Coptidis,Radix Scutellariae,Radix Rehmanniae Recens;C3:Fructus Corni,Rhizoma Dioscoreae,Radix Rehmanniae Preparata;C4:Caulis Polygoni Multiflori,Bulbus Lilii;C5:Radix Angelicae Sinensis,Fructus Ligustri Luci di;C 6:Radix Polygalae,Cortex AlbiziaeC7:Rhizoma Anemarrhenae,Rhizoma Ligustici Chuanxiong,Poria,Radix Glycyrrhizae,Semen Ziziphi Spinosae.(6)A core herb-group containing 20 herbs was obtained by complex network analysis.The efficacies of those medicine combinations were calming the nerves,heat-clearing and fire-purging,nourishing yin and kidney,calming heart and mind,nourishing yin and blood,nourishing blood and clearing heat.2 A study on the clinical efficacy of Zishui Qinggan Lichong decoction in the treatment of perimenopausal sleep disorder patients with kidney deficiency and liver depression.(1)A total of 38 patients were included in this study,with an age distribution of 40-56 years and a total of 81.58%with a bachelor’s degree or higher.(2)PSQI scores:9 patients(23.68%)were significantly effective after treatment;19 patients(50%)were effective;10 patients(26.31%)were ineffective;the total number of effective cases was 28,and the total effective rate was 73.68%.the total PSQI scores as well as the sleep-related factor scores decreased compared with those before treatment(P<0.01).(3)TCM symptom scores:after treatment,there were 3 patients with significant effect,accounting for 7.89%;21 patients with effective effect,accounting for 55.26%;14 patients with ineffective effect,accounting for 36.84%;the total number of effective cases was 28,and the total effective rate was 63.15%.The total score of TCM symptoms and the points of each symptom were lower than those before treatment,and the difference was statistically significant(P<0.05).(4)Modified KI score:the modified KI score was significantly lower than before treatment,and the difference was statistically significant(P<0.001).(5)ISI score:the ISI score was significantly lower after treatment than before treatment,and the difference was statistically significant(P<0.001).(6)Female hormone levels:E2,LH and FSH levels were not statistically significant before and after treatment(P>0.05).(7)Safety aspects:No adverse reactions such as nausea,diarrhea and skin pruritus were observed in patients during the treatment period.Conclusions1 Data mining showed that:the common TCM syndrome of perimenopausal sleep disorder was liver depression syndrome,and the main pathogenesis of which was closely related to the dysfunction of kidney,liver and heart,TCM treatment was mainly to calm the mind,as well as paying attention to nourishing Yin,clearing heat and tonifying liver and kidney,TCM was mainly to nourish yin and clear heat-based,using both tonify and discharge,and giving consideration to both truth and falsehood.2 The clinical study showed that:Zishui Qinggan Lichong decoction could effectively improve the sleep quality of patients,improve the TCM symptoms of kidney deficiency and liver depression,improve the quality of life and reduce the degree of insomnia,and no adverse reactions were found during the treatment,which proved the clinical efficacy and safety of Zishui Qinggan Lichong decoction. |
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