| BackgroundPostoperative gastroparesis syndrome(PGS)is a functional disease with non-mech anical obstruction of the gastric outflow tract after postoperative gastrointestinal tumors,mainly manifested by gastrointestinal motility disorders,which are common after stomach,pancreaticoduodenum and other operations.According to statistics,the overall incidence of tumor PGS is 5%-10%,among which the incidence of PGS after subtotal gastrectomy is 8.5%and that after pancreatic surgery is 19%-57%.At present western medicine mainly refer to the American journal of gastroenterology treatment guidelines recommend the nutrition support,regulate water and electrolyte balance,etc.,although can improve symptom,but there is no evidence that patients can shorten recovery time,mean time to recovery still needs to be 4 to 6 weeks,as a result,rapid rehabilitation is the digestive system tumor surgery treatment of gastric paralysis of the main difficulties and challenges.In long-term clinical practice,traditional Chinese medicine has shown its unique advantages,especially the external treatment of traditional Chinese medicine.Our department has conducted more than ten years of clinical exploration and practice,and gradually screened out the simple,effective and inexpensive "gastricparalysis decoction for external application" acupoint application treatment.After more than five years of repeated clinical practice,We conducted a rigorous prospective,randomized,double-blind controlled trial in combination with the general surgery/abdominal surgery department of a major third-class A hospital in Beijing.Results showed that the effective rate in the treatment group was 77.8%(P<0.01),and the median recovery time was 8 days(P<0.01).Through long-term clinical practice and rigorous RCT study,the external application prescription of gastroparesis with the method of Wen Yang Qi has been proved to have a significant clinical effect on the "cold syndrome" of gastroparesis after the operation of digestive system tumor.But could recovery time be further reduced?According to the duration of postoperative gastric tube indwetting or intolerance to solid diet,the ISGPS classified PGS into three grades:A,B,and C(of which A was the lightest and had the shortest postoperative catheter insertion time),and stratified data from previous RCT studies showed thatMedian recovery times for grade A,B,and C patients were 3.00,6.78,and 8.29 days,respectively,suggesting that early intervention may further reduce recovery times.Therefore,we tried to make further progress on the basis of the above studies.On the one hand,we constructed a risk prediction model for postoperative gastroparesis of malignant tumors of the digestive system,and screened the high-risk population of PGS,on the other hand,on the digestive system malignant tumor patients with postoperative abdominal local differentiation"cold syndrome"early intervention,combined with PGS risk prediction model,and evaluate the curative effect of early intervention "gastric paralysis external party" advantage population characteristics and mining,this is to further shorten the digestive system cancer patients with postoperative gastric paralysis recovery time and saving the country limited medical resources has important signi ficance.Objectives1.A risk prediction model for postoperative gastroparesis with malignant tumors of the digestive system was established by combining Meta analysis and Logistic regression model.2.The risk prediction model of postoperative gastroparesis in patients with malignant tumor of the digestive system was verified and simplified by external validation method.3.Evaluate the efficacy of early intervention of "gastricparalysis decoction for external application",and screen the characteristics of the dominant population of "gastric paralysis decoction for external application".Methods1.Model researchThrough the formulation of retrieval strategies and inclusion and exclusion criteria,domestic and foreign literatures related to the risk factors of gastroparesis after surgery for digestive system tumors were retrieved and data were extracted.Meta-analysis was performed using Rev Man5.3 and Stata12.0 software.The combined risk degree of related influencing factors of gastroparesis after digestive system tumor operation calculated in the Meta analysis was incorporated into the Logistic regression model to establish the risk prediction model of gastroparesis after digestive system tumor operation.2.Clinical research:2.1 Model validation:External validation method was used to include the case data of gastrointestinal malignant tumor surgery in Department of Pancreatogastric Surgery and Colorectal Surgery,Cancer Hospital,Chinese Academy of Medical Sciences from January 01 to January 31,2019.01.31 as validation samples.The risk prediction model of gastroparesis after gastrointestinal tumor surgery was verified by combining ROC curve and MED Calc.The model is simplified by assigning the influence factors in the model.2.2 Evaluation of the efficacy of early intervention with "external prescription for gastroparesis":The historical control study method was adopted.Patients undergoing digestive system tumor surgery in Department of Pancreatic and Gastric Surgery,Cancer Hospital,Chinese Academy of Medical Sciences from October 01,2020.to January 31,2021.01.31 and with local abdominal syndrome differentiation of "cold syndrome"were included as the treatment group.On the first day after surgery,they were given"gastricparalysis decoction for external application" intervention in advance.Patients undergoing digestive system tumor surgery in the same period(2019.10.1?2020.1.31)of the previous year,with the same surgeon,the same disease type and the same surgical plan,and with local abdominal syndrome differentiation of "cold syndrome",were in cluded as the blank control group to compare the incidence of PGS.Combined with the PGS risk prediction scoring system,To evaluate the efficacy of early intervention of"gastricparalysis decoction for external application",and to summarize the characteristics of the dominant population of "gastricparalysis decoction for external application".Results1.Meta analysis and model construction1.1 In this study,a total of 3,480 literatures related to the influencing factors of gastroparesis after the operation of digestive system malignancies were retrieved and obtained through other means.Finally,82 literatures were included,including 78 case-control studies and 4 cohort studies,involving 48,342 patients with postoperative digestivesy stem malignancies,of which 4.397 cases were confirmed with gastroparesis.1.2 After the risk factors of OR?1 were excluded,a total of 29 influencing factors were included.The preliminary model was as follows:Logit(P)=-2.31+1.2×age?67 years+0.97×obesity+0.89×weight loss+0.51×history of alcohol consumption+0.62×Hp infection+1.34×preoperative gastric outflow tract obstruction+0.86×history of diabetes+0.83×history of abdominal surgery+1.45×preoperative hyperglycemia+0.41×preoperative anemia+0.83×preoperative hypoproteinemia+0.77×emergency operation+1.02×non-BI reconstruction+0.99×?3 hours of operation+0.48×3.5hours+0.54×bleeding?1000mL-1.83×D0-2 lymph node dissection+1.45×combined organ resection+1.23×cervical anastomosis+1.25×anastomotic leakage+1.37×abdominal infection?1.21 ×pancreatic fistula+1.22×postoperative hyperglycemia+0.81×postoperative anemia+0.55×postoperative self-controlled analgesia pump+1.07×postoperative adverse eating process+1.16×perioperative hyperglycemia+0.62×perioperative hypoproteinemia+1.4×mental factors.2.Clinical research2.1 Verification and simplification of the risk prediction model for gastroparesis after surgery for malignant tumors of the digestive system2.1.1 Using external validation method,a total of 1031 sample cases of digestive system malignant tumor surgery were finally included in Department of Pancreatogastric Surgery and Colorectal Surgery,Cancer Hospital,Chinese Academy of Medical Sciences,including 110 cases of gastroparesis group and 921 cases of control group.The results showed that:The AUC and 95%CI of the model prediction results and the actual incidence were 0.709(0.657?0.761)and 0.708(0.651?0.765),respectively.The difference test results were Z=0.028,P=0.977.It is suggested that the prediction efficiency of the risk predictionmodel established in this study is close to that of the actual incidence,and there is no statistical difference.2.1.2 Eleven single influencing factors,including preoperative hyperglycemia,preoperative hypoproteinemia,?3.5 hours of operation,combined organ resection,anastomotic 1eakage,abdominal infection,postoperative hyperglycemia,use of postoperative analgesia pump,perioperative hyperglycemia,perioperative hypoproteinemia,and mental factors,have diagnostic value for the risk prediction of PGSs.But the measured efficiency is less than the comprehensive PGS risk prediction model.2.1.3 By assigning values to each influencing factor in the model,the simplified risk prediction model of postoperative gastroparesis in patients with malignant tumor of the digestive system is:score=12×age?67years+10×obesity+9×weight loss+5×history of alcohol consumption+6×Hp infection+13×preoperative gastric drain tract obstruction+9×history of diabetes+8×history of abdominal surgery+15×preoperative hyperglycemia+4×preoperative anemia+8×preoperative hypoproteinemia+8×emergency surgery+10lO×non-Bi reconstruction?10×intraoperative? 3 hours+5×3.5 h+5 ×bleeding?1000ML-18×D0-21ymphnode dissection+15×combined organ resection+12×cervical anastomosis+13×anastomotic leakage+14×abdominal infection+12×pancreatic fistula+12×postoperative hyperglycemia+8×postoperative anemia+6×postoperative self-controlled analgesia pump+11×postoperative adverse feeding+12×perioperative hyperglycemia+6×perioperative hypoproteinemia+14×mental factors.The simplified PGS risk prediction score model AUC and 95%CI were 0.710(0.658,0.762),and the ROC diagnostic cut-off point was>51 points.According to this node,the risk of PGS in postoperative patients with digestive system tumors was divided into high risk and low risk.2.1.4 The AUC and 95%CI of the simplified PGS risk prediction model were 0.710(0.658,0.762),and the diagnostic cut-off point of ROC curve was 51 points.According to this diagnostic cut-off point,the risk of patients with postoperative PGS could be divided into high risk(model score>51 points)and low risk(model score ?51 points).2.1.5 The risk prediction model of gastroparesis after surgery for digestive system tumors was used to score 1031 validation samples to compare the outcome of gastroparesis.The results showed that:746 patients in the low-risk group had the incidence of gastroparesis(6.43%);The incidence of gastroparesis was 21.75%in the high-risk group.2.2 Combined with the risk prediction model of postoperative gastroparesis for malignant tumors of the digestive system,the efficacy evaluation of early intervention of"gastricparalysis decoction for external application" and the characteristics analysis of the dominant population were evaluated2.2.1 General InformationA total of 152 patients were collected in the intervention group,including 5 cases of gastroparesis in the high-risk group(50 cases)and 1 case of gastroparesis in the low-risk group(102 cases).In terms of age,there are differences between the general population and high-risk groups.In terms of gender,there was no statistical difference in the overall population,high risk population and low risk population.A total of 152 cases were collected in the control group,including 14 cases of gastroparesis in the high-risk group(50 cases)and 6 cases in the low-risk group(102 cases).There was no statistical difference in gender distribution and age among the overall population,high-risk population and low-risk population.There was no significant difference in age,gender and risk score between the two groups,and the data of the two groups were comparable.2.2.2 Efficacy of interventionThe incidence of gastroparesis in the whole population,high risk group and low risk group in the intervention group decreased compared with the control group(overall population:intervention group:3.95%(6/152),control group:13.16%(20/152);High-risk population:intervention group 10%(5/50),control group:28%(14/50);Low-risk population:0.98%(1/102)in the intervention group and 5.88(6/102)in the control group.The incidence of gastroparesis in the whole population and the high-risk group was statistically different(P=0.004 for the whole population,P=0.022 for the high-risk group and P=0.053 for the low-risk group).2.2.3 Intervention of "gastricparalysis decoction for external application" for postoperative local syndrome differentiation of malignant tumors of the digestive system belongs to the characteristics of people with "cold syndrome"The characteristics of the advantages of "gastricparalysis decoction for external application" were as follows:(1)Overall population:<67 years old,no postoperative abdominal infection and undisturbed mental adjustment;(2)High-risk population:No post operative abdominal infection.Conclusions1.The risk prediction model of postoperative gastroparesis for malignant tumors of the digestive system was established by combining Meta analysis and Logistic regression.The verification results showed that the model had good prediction efficiency,and the further simplified risk prediction scoring system enhanced the convenience of use.2.It is recommended to use the risk prediction model of postoperative gastropare sis for patients undergoing surgery for digestive system malignant tumors to score post operative gastroparesis risk.For patients whose score result is>51,it is suggested that they are at high risk of postoperative gastroparesis,and it is recommended to start in tervention as soon as possible.3.For the digestive system malignant tumor,abdominal postoperative local syndrome differentiation is a "cold syndrome" and the digestive system cancer postoperative gastric paralysis risk prediction model assessment for patients with high-risk groups,to"gastricparalysis decoction for external application" early intervention to a certain exte nt,reduce the incidence of postoperative gastric paralysis,preliminary suggest the necessity and rationality of early intervention,deserves further research.4.Age<67 years old,no postoperative abdominal infection,and mental patency are the dominant population characteristic variables of "gastricparalysis decoction for external application" in the treatment of patients with"cold syndrome" of gastroparesis after the operation of digestive system tumor in this study. |
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