| Objective: In this study,based on Professor Mao Dewen ’s clinical medical records of patients with primary liver cancer(PLC)after operation,the regularity of prescription medication was analyzed from multiple perspectives using data mining technology,and the clinical efficacy of the core prescription of high-frequency TCM syndrome types was verified through randomized controlled studies in order to provide a reference and reference for TCM treatment after PLC.Methods: This study is divided into two parts: medical record data mining and clinical efficacy observation.Part I: Collect the complete medical records of patients with PLC after interventional therapy in the outpatient department of Professor Mao Dewen from October 2018 to October 2021,apply Microsoft Office Excel 2019,SPSS Modeler 18.0,SPSS Statistics 21.0,Cytoscape 3.9.1 and other software for multi-level data mining and visualization processing,analyze the prescription medication rules of Professor Mao after interventional therapy for PLC,and obtain the core prescription of high-frequency TCM syndrome types and their corresponding treatment according to the analysis results.Part Ⅱ: The core prescription of high-frequency TCM syndrome established by data mining analysis was verified for clinical efficacy.Sixty patients with high-frequency TCM syndrome types who met the diagnosis of "primary liver cancer after interventional therapy" from November 2021 to December 2021 were randomly divided into control group and treatment group,with 30 cases in each group.The control group was given basic western medicine treatment,and the treatment group was given high-frequency TCM syndrome core prescription on the basis of the control group.The course of treatment was 3 months and the follow-up was 9 months.The changes of TCM syndrome,quality of life,serological indexes(liver function and alphafetoprotein)and progression-free survival before and after treatment were observed and recorded,and SPSS Statistics 21.0 was used for statistical analysis.Results:(1)In this study,262 complete medical records of patients with PLC after interventional therapy were collected from Professor Mao Deven ’s outpatient department,and the number of visits was 971.The age range of the included patients was 25-88 years,and the age of onset was the highest in middle-aged and elderly people(41-70 years),totaling 193 people,accounting for 73.66% of the total number.The sex distribution was predominantly male,with a male to female ratio of approximately 3:1.(2)Among 262 effective prescriptions,205 herbs were used in total,and the total frequency of use was 4086 times.The top 10 high-frequency herbs in the frequency of drug use were Radix Astragali,Radix Glycyrrhizae,Pericarpium Citri Reticulatae,Rhizoma Corydalis,Radix Ophiopogonis,Radix Bupleuri,Rhizoma Atractylodis Macrocephalae,Fructus Aurantii Immaturus The maximum dose used in high-frequency traditional Chinese medicine is 50g(Astragalus membranaceus)and the minimum dose used is 5g(Glycyrrhiza uralensis,Bupleurum chinense,Rehmannia glutinosa).The therapeutic drugs were mainly cold and warm drugs,followed by flat drugs;the medicinal taste was mainly sweet,bitter and pungent drugs;the drugs were attributed to both spleen,liver,lung,stomach,heart and kidney meridians;the efficacy of traditional Chinese medicine was mainly tonic drugs,followed by heat-clearing drugs.The TCM syndrome types of the patients involved liver and kidney yin deficiency syndrome(37.02%),liver and gallbladder damp-heat syndrome(27.48%),liver heat and blood stasis syndrome(17.18%),liver depression and spleen deficiency syndrome(14.12%),and spleen deficiency and dampness syndrome(4.20%),of which liver and kidney yin deficiency syndrome was the high-frequency TCM syndrome type of this study.(3)There were 97 cases of liver-kidney yin deficiency syndrome in TCM,156 different herbs were used,and the total frequency of use was 1621 times.The high-frequency herbs of this syndrome included Ophiopogon japonicus,Astragalus membranaceus,Rehmannia glutinosa,Achyranthes bidentata,Bai Ziren,Gorgon aurantium,Cornus officinalis,Gentian,Yam,Scrophularia sinensis,Rhodiola rosea The ranking of support,confidence and improvement in the results of comprehensive prescription association rule analysis yielded the core drug pairs and hornworts: Ophiopogon japonicus–Bai Zi Ren,Ophiopogon japonicus–Cornus officinalis,Cornus officinalis–Yam,Citrus aurantium–Cornus officinalis–Ophiopogon japonicus,Ophiopogon japonicus–Astragalus membranaceus–Ophiopogon japonicus,Cornus officinalis–Astragalus membranaceus The complex network relationship of traditional Chinese medicines further constructed showed that 11 herbs including Ophiopogon japonicus,Astragalus membranaceus,Rehmannia glutinosa,Achyranthes bidentata,Gorgon aurantium,Cornus officinalis,Bai Zi Ren,Gentian,Scrophularia sinensis,Yam and Rhodiola rosea were the drugs that Professor Mao used the most frequently,closely related,and most compatible drugs in clinical treatment.Based on the cluster analysis results,two effective drug combinations were obtained,C1 formula drugs included gentian,yam,gorgon fruit,cornus officinalis,scrophularia,cypress seed kernel,rhodiola rosea,ophiopogon japonicus,astragalus,rehmannia glutinosa,and Achyranthes bidentata;C4 formula drugs included angelica sinensis and wolfberry fruit.Combined with the above analysis results and the guidance of the tutor,it is established that the core formula of liver-kidney yin deficiency syndrome is Huishen Suxing Decoction,and the composition and dose are: Ophiopogon japonicus 15 g,Astragalus membranaceus 30 g,Yam 30 g,Achyranthes bidentata15 g,Gorgon aurantium 30 g,Scrophularia 15 g,Rehmannia glutinosa 10 g,Bai Zi Ren 30 g,Gentian 5g,Cornus officinalis 15 g,Hongjingtian 15 g.(4)A total of 59 cases were completed in the clinical observation,including 30 cases in the control group;29 cases in the treatment group,and 1case of dropout.No adverse reactions occurred during the treatment and followup.In the treatment group,there were 22 males and 8 females with a mean age of 50.77 ± 5.82 years,12 CNLC stage IIa,12 stage IIb,and 6 stage IIIA.In the control group,there were 23 males and 7 females with a mean age of 49.93 ±6.82 years,14 CNLC stage IIa,11 stage IIb,and 5 stage IIIA.There were no statistically significant differences in baseline data such as gender,age,and tumor stage before treatment between the two groups(P > 0.05),indicating that the two groups were comparable.The results of randomized controlled study showed:(1)The total score of TCM syndrome: the total effective rate was 86.21% in the treatment group and 63.33% in the control group,and the difference was statistically significant(P < 0.05);the median score of TCM syndrome before and after treatment in the treatment group was 28 and 8 points,respectively,and the median score of TCM syndrome before and after treatment in the control group was 30 and 10 points,respectively,and the TCM syndromes of the two groups after treatment were significantly improved compared with before(P < 0.05),and the comparison between the groups after treatment showed that the improvement of TCM syndromes in the treatment group was more significant than that in the control group(P < 0.05),indicating that this prescription could significantly improve the TCM syndromes of patients with liver-kidney yin deficiency syndrome,and had a better effect than western medicine alone.(2)KPS score:The median KPS score of the treatment group before and after treatment was70 and 80 points,respectively,and the median KPS score of the control group before and after treatment was 70 and 70 points,respectively.After treatment,the KPS score of the treatment group was significantly higher than before(P <0.05),while there was no significant difference in the KPS score of the control group before and after treatment(P > 0.05),and the comparison between the groups after treatment showed that the improvement of the treatment group was more significant than that of the control group(P < 0.05),suggesting that in improving the quality of life,the advantages of combined treatment of traditional Chinese and western medicine were more obvious than those of western medicine alone.(3)Serological indicators: After treatment,the liver function indicators and AFP levels of the two groups were significantly decreased(P < 0.05),and the improvement degree of the treatment group was significantly better than that of the control group(P < 0.05),indicating that this prescription can reduce the liver function damage of patients after liver cancer surgery and reduce the AFP level of tumor markers.(4)Progression-free survival: The PFS of the treatment group and the control group were 10.53 ±2.20 months and 9.16 ± 2.86 months,respectively,and the treatment group was significantly better than the control group in prolonging the progressionfree survival of patients(P < 0.05),suggesting that this prescription helps to maintain a longer tumor-bearing survival.Conclusions:(1)Based on data mining analysis,Professor Mao Dewen treated patients with primary liver cancer after operation with medicinal properties mostly cold,warm,flat,sweet,bitter,pungent taste,traditional Chinese medicine meridians taking into account the five viscera meridians,drug efficacy to supplement yin deficiency,supplement qi deficiency as the first.The main treatment ideas are as follows: "deficiency of vital energy" is the root of the occurrence of the disease,liver-kidney yin deficiency is the specific embodiment of "deficiency of vital energy",the treatment is mainly to nourish liver-kidney yin and support vital qi,the treatment attaches importance to tonifying liver-yin,softening liver-yin,in order to warm up without injuring body yin,nourishing without hindering qi,and can also take the qi of each viscera back into the kidney,used to nourish kidney-yin metaplasia essence,vital qi is sufficient then the tumor gradually subsides.(2)Professor Mao Dewen diagnosed the high-frequency TCM syndrome type of patients with primary liver cancer after operation as liver-kidney yin deficiency syndrome.Further excavation analysis established that the core formula of liver-kidney yin deficiency syndrome was Huishen Suxing Decoction.Drug composition and dose: Ophiopogon japonicus 15 g,Astragalus membranaceus 30 g,Yam 30 g,Achyranthes bidentata 15 g,Gorgon aurantium30 g,Scrophularia 15 g,Rehmannia glutinosa 10 g,Bai Zi Ren 30 g,Gentian 5g,Cornus officinalis 15 g,Hongjingtian 15 g.(3)Randomized controlled studies have found that Huishen Shuangsheng Decoction is more effective in improving the TCM syndrome of patients with liver-kidney yin deficiency syndrome,can effectively improve the quality of life,reduce liver function damage,reduce tumor marker AFP levels,prolong progression-free survival,clinical efficacy has certain advantages over western medicine alone. |