| Colorectal cancer is a common malignant tumor of the digestive system in China,and its incidence and mortality rates are at the forefront of malignant tumors.For patients with colorectal cancer,recurrence and metastasis is the main cause of death,so the prevention and treatment of tumor recurrence and metastasis is the focus and difficulty of clinical work.Traditional Chinese medicine(TCM)has a clear effect on both the short-term efficacy and long-term survival of colorectal cancer,so this study mainly investigated the influence of TCM on postoperative recurrence and metastasis of colorectal cancer from three parts.First,the relevant literature on the prevention of postoperative recurrence and metastasis of colorectal cancer by TCM was summarized,and the characteristics of the drugs were sorted out.Secondly,a TCM prescription data mining was conducted to collect the relevant medical records of patients with stage Ⅱ-Ⅲ colorectal cancer after surgery by Professor Wu Yu,the medication rules of Professor Wu Yu in the prevention of recurrence and metastasis of colorectal cancer were summarized,and the formulation principle of Jianpi Huatan granules was explained.Finally,a multi-center randomized controlled trial was conducted to select patients with high-risk stage Ⅱ and stage Ⅲ colorectal cancer after postoperative chemotherapy,and the effect of Jianpi Huatan granules on recurrence,metastasis and patients’ quality of life was observed.Clinical study Ⅰ:TCM medication rules in the prevention of postoperative colorectal cancer recurrence and metastasis based on literature analysisObjective:To analyze the medication rules of TCM in the prevention of postoperative recurrence and metastasis of colorectal cancer,and to summarize the drug characteristics.Methods:Literature on the prevention of postoperative recurrence and metastasis of colorectal cancer by TCM from the establishment of the database to January 2023 was retrieved and sorted from CNKI,Wanfang and VIP databases.Based on the inclusion and exclusion criteria,relevant TCM prescriptions were screened,and the frequency,four qi and five tastes,meridian tropism and treatment methods of TCM involved were statistically analyzed.Results:A total of 24 articles were included,and 28 TCM compounds were finally analyzed.The prescriptions included 104 Chinese medicines,and the total frequency of use was 305 times.The top five Chinese medicines in terms of frequency of use were Fuling(Poria Cocos),Baizhu(Atractylodes Macrocephala Koidz),Gancao(Licorice),Dangshen(Codonopsis Radix)and Huangqi(Astragalus Membranaceus).In terms of four qi and five tastes,warm and sweet medicines were the most commonly used with 34.62%and 38.59%respectively.In terms of meridian tropism distribution,spleen(25.65%)ranked first,followed by lung(18.17%),stomach(15.56%),liver(11.05%)and kidney(10.10%).The efficacy of TCM was mainly focused on restoring vital energy and clearing heat,of which tonifying Qi and heat-clearing and detoxifying were the most important.The drugs with a frequency of more than 15%can be divided into the six treatment methods of invigorating the spleen,dissipating dampness,regulating Qi,detoxifying,eliminating phlegm and clearing heat,of which invigorating the spleen was the main treatment method.The association between Baizhu(Atractylodes Macrocephala Koidz)and Fuling(Poria Cocos)was the strongest in the association network,and there was a high degree of support between Chinese herbs for invigorating spleen(Fuling(Poria Cocos),Dangshen(Codonopsis Radix),Baizhu(Atractylodes Macrocephala Koidz),Huangqi(Astragalus Membranaceus),Shanyao(Chinese Yam))and other Chinese herbs.Through cluster analysis,five drug combinations were obtained,which were mainly divided into invigorating spleen and tonifying Qi based on Sijunzi decoction and Shanyao(Chinese Yam),and detoxifying,eliminating phlegm and clearing heat based on Baihuasheshecao(Oldenlandia Diffusa),Banzhilian(Sculellaria Barbata),Yiyiren(Coix Seed),Banxia(Pinellia Rhizome)and Huanglian(Coptidis Rhizoma).Conclusion:In the clinical application of TCM for the prevention of postoperative recurrence and metastasis of colorectal cancer,the medication rule of invigorating spleen as the common treatment,combined with detoxification,dissipating dampness,regulating Qi and activating blood has been formed.And Fuling(Poria Cocos),Baizhu(Atractylodes Macrocephala Koidz),Dangshen(Codonopsis Radix)and Huangqi(Astragalus Membranaceus)are commonly used in Chinese medicine to invigorate the spleen.Clinical study II:Analysis on medication rules to prevent recurrence and metastasis of postoperative patients with colorectal cancer in Professor Wu YuObjective:To analyze the medication rules of Professor Wu Yu in the treatment of postoperative patients with stage Ⅱ and Ⅲ colorectal cancer,and to summarize the medication experience of Professor Wu Yu in the prevention of postoperative recurrence and metastasis of colorectal cancer.Methods:The medical records of postoperative patients with stage Ⅱ-Ⅲ colorectal cancer who visited the outpatient department of Professor Wu Yu,Xiyuan Hospital,China Academy of Chinese Medical Sciences from January 2019 to December 2022 were collected.The clinical data and TCM prescription information were sorted out,and the frequency,four qi and five tastes,meridian tropism and efficacy of the used TCM were statistically analyzed,and the association rule analysis and cluster analysis were performed by IBM SPSS Modeler 18.0 and IBM SPSS 25.Results:A total of 189 initial medical records were included,including 72 patients(38.10%)with stage Ⅱ,117 patients(61.90%)with stage Ⅲ,91 patients(48.15%)with colon cancer,98 patients(51.85%)with rectal cancer.The analysis of the TCM prescriptions showed that 93 Chinese medicines were involved in 189 prescriptions,with a total frequency of 3017 times.Taizishen(Pseudostellariae Radix),Gancao(Licorice),Huangqi(Astragalus Membranaceus),Banxia(Pinellia Rhizome)and Chenpi(Pericarpium Citri Reticulatae)were used more frequently.The herbs used were mostly warm(37.52%)and flat(32.52%)in nature,sweet(42.80%),bitter(28.54%)and pungent(19.38%)in taste.In terms of meridian,the distribution of spleen(23.57%),lung(20.18%)and stomach(14.74%)were the top three,followed by kidney(13.67%)and liver(11.83%),and the pericardium meridian was the least used.The distribution of effects was mainly for restoring vital energy,clearing heat and regulating Qi and tonifying Qi and heat-clearing and detoxification were the main parts.Taizishen(Pseudostellariae Radix),Huangqi(Astragalus Membranaceus),Baizhu(Atractylodes Macrocephala Koidz)and Baihuasheshecao(Oldenlandia Diffusa),Banzhilian(Sculellaria Barbata)were commonly used Chinese medicines.Huangqi(Astragalus Membranaceus)and Banxia(Pinellia Rhizome)had the strongest connection in the association rule network,and the association rules with the highest support were Banxia(Pinellia Rhizome)-Huangqi(Astragalus Membranaceus)and Banxia(Pinellia Rhizome),Huangqi(Astragalus Membranaceus)-Chenpi(Pericarpium Citri Reticulatae).The association rules between Huangqi(Astragalus Membranaceus),Banxia(Pinellia Rhizome)and Chenpi(Pericarpium Citri Reticulatae)had strong support.Five combinations were obtained by cluster analysis,involving the aspects of invigorating spleen,tonifying kidney,detoxification,dissipating phlegm and regulating Qi.In terms of treatment,13 drugs with a frequency of>50%can be divided into 7 treatments,including dispelling phlegm and dampness,tonifying kidney and nourishing Yin,invigorating spleen and tonifying Qi,detoxifying,activating the blood,promoting digestion and regulating Qi.Among them,invigorating kidney and spleen and dispelling phlegm and dampness were the representative treatments for strengthening body resistance to eliminate pathogenic factors,and dispelling phlegm and dampness was the most commonly used treatment.Conclusion:In the prevention of recurrence and metastasis of colorectal cancer after surgery,Professor Wu Yu mainly used drugs to strengthen the spleen and kidney,and also to dispel phlegm and dampness.In clinical practice,Taizishen(Pseudostellariae Radix),Huangqi(Astragalus Membranaceus),Nvzhenzi(Fructus Ligustri Lucidi),Huangjing(Polygonati Rhizoma),Banxia(Pinellia Rhizome)and Chenpi(Pericarpium Citri Reticulatae)were commonly used.At the same time,combined with the common pathological factors of colorectal cancer and the physiological functions of the large intestine,Professor Wu Yu attached great importance to the application of detoxifying and regulating Qi,and the drugs were mainly found in Baihuasheshecao(Oldenlandia Diffusa),Banzhilian(Sculellaria Barbata),Tufuling(Smilax Glabra Roxb)and Muxiang(Aucklandiae Radix),etc.Clinical study Ⅲ:Efficacy evaluation and risk factors analysis of Jianpi Huatan granules for preventing postoperative recurrence and metastasis of colorectal cancer Objective:To observe the clinical effect of Jianpi Huatan granules on the prevention of postoperative recurrence and metastasis of colorectal cancer.Methods:This was a multicenter,randomized,double-blind,controlled clinical trial.A total of 350 postoperative patients with high-risk stage Ⅱ and Ⅲ colorectal cancer were enrolled from 8 sub-centers and randomly divided into the treatment and control groups,with 175 patients in each group.The treatment group received Jianpi Huatan granules and the control group received placebo granules.The recurrence and metastasis of the two groups and the changes in FACT-C scale,TCM symptom grading scale,ESAS scale and ECOG scale were observed.Results:1 Clinical Characteristics350 patients(175 in the treatment group and 175 in the control group)were enrolled between December 2018 and November 2021.By 27 January 2023,256 patients had completed two years of follow-up,and 219 patients(109 in the treatment group and 110 in the control group)were included in the analysis.In the control group,there were 64 men and 46 women,with a mean age of(58.24±11.03)years,54 rectal cancer cases,56 colon cancer cases,35 high-risk stage Ⅱ cases,and 75 stage Ⅲ cases.In the treatment group,there were 64 men and 45 women,with a mean age of(58.87±9.57)years,55 rectal cancer cases,54 colon cancer cases,34 high-risk stage Ⅱcases and 75 stage Ⅲ cases.2 Follow-up and recurrence and metastasisThe median follow-up time of both groups was 30(24-37)months,the median time to recurrence and metastasis was 9(5.75,13)months in the control group and 7(5,11)months in the treatment group,with no statistical difference between the two groups(P>0.05).There were 30(27.27%)cases of recurrence and metastasis in the control group and 26(23.85%)cases in the treatment group.There was no statistical difference between the two groups(P>0.05).Survival analysis showed no significant difference in disease-free survival(DFS)between the treatment and control groups(HR=0.886,95%CI:0.524-1.495,P=0.647).Subgroup analysis showed that patients with ECOG 0 had higher DFS after taking Jianpi Huatan granules(HR=0.301,95%CI:0.125-0.725,P=0.013).3 Risk factors for recurrence and metastasis of colorectal cancerMultivariate Cox regression analysis showed that TNM stage Ⅲ(HR=2.128,95%CI:1.081-4.191,P=0.029),ECOG=1(HR=1.820,95%CI:1.003-3.303,P=0.049),Qi-deficiency(HR=2.085,95%CI:1.020-4.264,P=0.044)and tumor location(HR=0.564,95%CI:0.324-0.981,P=0.043)were all independent factors influencing colorectal cancer recurrence and metastasis.4 Effect of Jianpi Huatan granules on the FACT-C scale in colorectal cancer patientsThe between-group comparison showed that after 3 treatment sessions,the treatment group[24(18.50-28)]had higher additional concerns scores than the control group[21.50(15-28)](P=0.043).The within-group comparison showed that both the treatment and control groups were better off than before treatment in the physical well-being field(P=0.001,P=0.004).5 Effect of Jianpi Huatan granules on the TCM symptom grading scale in colorectal cancer patientsThe overall efficacy rate was 48,62%(53/109)in the treatment group and 42.73%(47/110)in the control group,and there was no statistical difference in clinical efficacy between the two groups(P>0.05).The between-group comparison showed that the abdominal distension score[0(0-0)vs 0(0-1),P=0.010]and the total score[1(0-4)vs 2(0-4),P=0.047]were better in the treatment group than in the control group after 3 treatment sessions.The within-group comparison showed that the treatment groups improved in abdominal distension[0(0-0)vs 0(0-1),P=0.006],loss of appetite[0(0-0)vs 0(0-1),P=0.002],shortness of breath[0(0-0)vs 0(0-1),P=0.004],and total score[1(0-4)vs 3(1-6),P=0.000].6 Effect of Jianpi Huatan granules on the ESAS scale in colorectal cancer patientsThe between-group comparison showed that after 3 treatment sessions,sleep in the treatment group[0(0-2)]was better than in the control group[1(0-2.25)](P=0.041).The within-group comparison showed that in the treatment group,fatigue[0(0-1)vs 1(0-3),P=0.001],sleepiness[0(0-1)vs 0(0-2),P=0.004],appetite[0(0-1)vs 1(0-2),P=0.006],sleep[0(0-2)vs 1(0-3),P=0.004]were better than before treatment,and fatigue in the control group was also improved after treatment[1(0-3)vs 0(0-2),P=0.013].7 Effect of Jianpi Huatan granules on the ECOG scale in colorectal cancer patients After 3 treatment sessions,the ECOG scores of the two groups were still mainly 0 and 1 points,with no significant statistical difference(P>0.05).Conclusion:Jianpi Huatan granules can improve the quality of life of patients with colorectal cancer after surgery,and has a tendency to reduce the recurrence and metastasis of high-risk stage Ⅱ and Ⅲ colorectal cancer.However,longer follow-up is needed to detect complete outcome outcomes. |
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