1.HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.
Ping LI ; Ying WU ; Yan XIE ; Feng CHEN ; Shao qiang CHEN ; Yun Hao LI ; Qing Qing LU ; Jing LI ; Yong Wei LI ; Dong Xu PEI ; Ya Jun CHEN ; Hui CHEN ; Yan LI ; Wei WANG ; Hai WANG ; He Tao YU ; Zhu BA ; De CHENG ; Le Ping NING ; Chang Liang LUO ; Xiao Song QIN ; Jin ZHANG ; Ning WU ; Hui Jun XIE ; Jina Hua PAN ; Jian SHUI ; Jian WANG ; Jun Ping YANG ; Xing Hui LIU ; Feng Xia XU ; Lei YANG ; Li Yi HU ; Qun ZHANG ; Biao LI ; Qing Lin LIU ; Man ZHANG ; Shou Jun SHEN ; Min Min JIANG ; Yong WU ; Jin Wei HU ; Shuang Quan LIU ; Da Yong GU ; Xiao Bing XIE
Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy
;
Child
;
Humans
;
Female
;
Glycated Hemoglobin
;
Cohort Studies
;
Diabetes Mellitus/diagnosis*
;
Sensitivity and Specificity
;
ROC Curve
2.Efficacy and safety of endoscopic diaphragm incision in children with congenital duodenal diaphragm.
Pei Qun WU ; Pei Yu CHEN ; Lu REN ; Li Ya XIONG ; Hui Wen LI ; Si Tang GONG ; Qiang WU ; Cheng Wen CHAI ; Lan Lan GENG
Chinese Journal of Pediatrics 2023;61(7):614-619
Objective: To explore the efficacy and safety of endoscopic diaphragm incision in pediatric congenital duodenal diaphragm. Methods: Eight children with duodenal diaphragm treated by endoscopic diaphragm incision in the Department of Gastroenterology of Guangzhou Women and Children's Medical Center from October 2019 to May 2022 were enrolled in this study. Their clinical data including general conditions, clinical manifestations, laboratory and imaging examinations, endoscopic procedures and outcomes were retrospectively analyzed. Results: Among the 8 children, 4 were males and 4 females. The diagnosis was confirmed at the age of 6-20 months; the age of onset was 0-12 months and the course of disease was 6-18 months. The main clinical manifestations were recurrent non-biliary vomiting, abdominal distension and malnutrition. One case complicated with refractory hyponatremia was first diagnosed with atypical congenital adrenal hyperplasia in the endocrinology department. After treatment with hydrocortisone, the blood sodium returned to normal, but vomiting was recurrent. One patient underwent laparoscopic rhomboid duodenal anastomosis in another hospital but had recurred vomiting after the operation, who was diagnosed with double duodenal diaphragm under endoscope. No other malformations were found in all the 8 cases. The duodenal diaphragm was located in the descending part of the duodenum, and the duodenal papilla was located below the diaphragm in all the 8 cases. Three cases had the diaphragm dilated by balloon to explore the diaphragm opening range before diaphragm incision; the other 5 had diaphragm incision performed after probing the diaphragm opening with guide wire. All the 8 cases were successfully treated by endoscopic incision of duodenal diaphragm, with the operation time of 12-30 minutes. There were no complications such as intestinal perforation, active bleeding or duodenal papilla injury. At one month of follow-up, their weight increased by 0.4-1.5 kg, with an increase of 5%-20%. Within the postoperative follow-up period of 2-20 months, all the 8 children had duodenal obstruction relieved, without vomiting or abdominal distension, and all resumed normal feeding. Gastroscopy reviewed at 2-3 months after the operation in 3 cases found no deformation of the duodenal bulbar cavity, and the mucosa of the incision was smooth, with a duodenal diameter of 6-7 mm. Conclusion: Endoscopic diaphragm incision is safe, effective and less invasive in pediatric congenital duodenal diaphragm, with favorable clinical applicability.
Male
;
Child
;
Female
;
Humans
;
Infant
;
Infant, Newborn
;
Retrospective Studies
;
Thorax
;
Endoscopy
;
Physical Examination
;
Adrenal Hyperplasia, Congenital
3.A case of Allgrove syndrome with achalasia of cardia as its first clinical phenotype caused by a new mutation of AAAS gene.
Li Ya XIONG ; Pei Yu CHEN ; Jing XIE ; Lu REN ; Hong Li WANG ; Yang CHENG ; Pei Qun WU ; Hui Wen LI ; Si Tang GONG ; Lan Lan GENG
Chinese Journal of Pediatrics 2023;61(7):648-650
4.PK/PD model of Chuanxiong gel plaster in treatment of rheumatoid arthritis.
Wei-Ye ZHANG ; Xue-Qun ZHUO ; Wu-Long WEN ; Xiao LIANG ; Zhan XIAO ; Xin SUN ; Yu-Qiang ZHAO ; An-Qi LI ; Pei-Ran ZHAO ; Jing YANG ; Rui WANG
China Journal of Chinese Materia Medica 2023;48(23):6371-6377
In this experiment, the PK/PD fitting model of Chuanxiong(Chuanxiong Rhizoma) in the treatment of rheumatoid arthritis was established in the form of acupoint combined with external application gel paste. Firstly, the rheumatoid arthritis model was induced by ovalbumin, and the articular fluid of rabbits was extracted by microdialysis. The pharmacokinetic process of Chuanxiong in rabbit articular fluid was analyzed by UPLC-MS/MS, and the pharmacokinetic model was established. The pharmacodynamic effects of Chuanxiong on inflammatory factors IL-1β, TNF-α, and IL-6 were analyzed by enzyme-linked immunosorbent assay(ELISA). The pharmacodynamic model was established, and the PK/PD model was obtained by fitting the data of pharmacokinetics and pharmacodynamics. The results of pharmacokinetics showed that the concentration of ligustrolide A in the articular cavity by drug administration on classical acupoint Zusanli(ST 36) was higher than that by Yanglingquan(GB 34), which reflected the advantage of typical acupoint, while ligustrazine concentration was higher after administration through Yanglingquan than through Zusanli, which was different from the traditional acupoint theory. The results of pharmacodynamics showed that the drug had lag effect. The PK/PD model was constructed by fitting the data. When IL-1β was taken as the efficacy index, the PK/PD models of Chuanxiong in typical acupoint Zusanli group, atypical acupoint Yanglingquan group, and non-acupoint group were E=115.28C_e/(3 316.72+C_e), E=108.73C_e/(2 993.47+C_e), and E=101.34C_e/(3 028.51+C_e). When TNF-α was taken as the efficacy index, the PK/PD models of Chuanxiong in typical acupoint Zusanli group, atypical acupoint Yanglingquan group, and non-acupoint group were E=68.31C_e/(3 285.16+C_e), E=59.27C_e/(2 919.86+C_e), and E=53.61C_e/(2 862.87+C_e). When IL-6 was taken as the efficacy index, the PK/PD models of Chuanxiong in typical acupoint Zusanli group, atypical acupoint Yanglingquan group, and non-acupoint group were E=59.92C_e/(3 461.17+C_e), E=58.34C_e/(2 723.51+C_e), and E=49.17C_e/(2 862.76+C_e). The parameters showed that there were significant differences in E_(max), EC_(e50) and k_(eo). The analysis of data found that the PK/PD fitting effect of Zusanli, a typical acupoint, was the best, which proved that it was still the best site for drug administration. To sum up, it shows that there may be bidirectional selectivity between drugs and acupoints.
Animals
;
Rabbits
;
Tumor Necrosis Factor-alpha
;
Chromatography, Liquid
;
Interleukin-6
;
Tandem Mass Spectrometry
;
Acupuncture Points
;
Arthritis, Rheumatoid/drug therapy*
5.Analysis of solitary rectal ulcer syndrome in 7 children.
Li Ya XIONG ; Lan Lan GENG ; Pei Yu CHEN ; Lu REN ; Hui Wen LI ; Jing XIE ; Pei Qun WU ; Si Tang GONG
Chinese Journal of Pediatrics 2022;60(9):920-924
Objective: To analyze the clinical features, treatment and prognosis of solitary rectal ulcer syndrome (SRUS) in children. Methods: The clinical data of 7 children who were diagnosed with SRUS in Department of Gastroenterology in Guangzhou Women and Children' Medical Center from January 2019 to December 2021 were retrospectively analyzed. The clinical data including general demographics, clinical presentations, endoscopic and histologic features, treatment and outcome were extracted from hospital medical records. Results: The 7 patients were all males, and the age of onset was 6-12 years. The course before diagnosis was 2-36 months. The most common symptom was rectal bleeding (6 cases) and most common findings at initial colonoscopy were ulcer in 3 cases and protuberance in 4 cases, both located only in rectum. The intestinal histopathology of 5 cases showed characteristic fibromuscular obliteration of lamina propria. Five children were treated with mesalamine granules or suppositories, and 2 cases underwent local excision. The follow-up lasted for 5-24 months and found symptoms relieved in 5 cases, improved in 1 case, and no remission in 1 case. Colonoscopy after the treatment was performed in 5 children, among whom 2 cases achieved mucosal healing. Conclusions: SRUS in children is mainly presented with rectal bleeding, and has characteristic histological change of ulcer and protuberance in endoscopy. Pathology is crucial for diagnosis and differential diagnosis. Both the medical and surgical treatment are effective for SRUS.
Child
;
Colonoscopy
;
Female
;
Gastrointestinal Hemorrhage/therapy*
;
Humans
;
Male
;
Rectal Diseases/therapy*
;
Rectum/surgery*
;
Retrospective Studies
;
Ulcer/therapy*
6.Application effect of intelligent education model in the health management of the smokers with high-risk of chronic obstructive pulmonary disease
Hui JIN ; Xiaona LI ; Pei QIN ; Qun ZHANG
Chinese Journal of Health Management 2022;16(4):241-245
Objective:To explore the application effect of the intelligent interactive health education model in the health management of the smokers with high-risk of chronic obstructive pulmonary disease (COPD).Methods:From September 2019 to January 2020, 72 smokers with high-risk of COPD were recruited from Health Management Center, the First Affiliated Hospital of Nanjing Medical Universit y. The subjects were randomly divided into traditional group (35 cases) and intelligent group (37 cases) according to the intervention model. The traditional group used the method of mailing health education materials, while the intelligent group sent health education materials with the help of mobile intelligent platform for interactive feedback and intervention. After 12 weeks of intervention, the subjects′ nicotine dependence, international physical activity, population satisfaction, time consumption for follow-up and other indicators were compared. Results:After the intervention, the score of nicotine dependence in the intelligent group was lower than that in the traditional group [(1.86±1.48) vs (3.77±1.66), P<0.05], the number of smoking cessation cases was more than that in the traditional group (11 vs 1, P<0.05), the number of cases with significant improvement in the score of international physical strength scale was significantly improved than that in the traditional group (15 vs 0, P<0.01), and the satisfaction was higher than that in the traditional group (97.30% vs 42.85%, P<0.01), and the time consumption was less than that in the traditional group [(18.03±2.96) vs (25.14±2.64) min, P<0.01]. Conclusion:The intelligent interactive health education model can improve the health education effect of the smokers with high risk of developing COPD, and improve the health behavior of the population.
7.Effect of Trans-PRK combined with 0.02% MMC on corneal density in patients with moderate myopia
Tian-Xu PEI ; Lin JIN ; Chun-Jing YU ; Ya-Nan MU ; Chun-Xiao YAN ; Ji-Liang NING ; Ruo-Yu CHEN ; Ze-Qun XING ; Si-Yu SUN ; Li-Jun ZHANG
International Eye Science 2022;22(8):1345-1351
AIM: To evaluate the effect of 0.02% mitomycin-C(MMC)on the corneal density after transepithelial photorefractive keratectomy(Trans-PRK). METHODS: Retrospective case analysis. Selected 28 patients with 56 eyes in moderate myopia who underwent Trans-PRK surgery from January 2021 to June 2021 in our hospital. They were divided into MMC group in 28 eyes with a combination of 0.02% MMC 20s during the surgery and the control group in 28 eyes was not use MMC during the surgery. The Pentacam anterior segment analyzer was used to measured the corneal density in different diameter ranges and different thickness layers before and after surgery at 14d, and after surgery at 1 and 3mo.RESULTS: The total corneal density value of MMC group was 16.60(15.70,17.10 )before the surgery, after the surgery at 14d was 16.63(15.90,17.50 ), at 1mo was 16.57(15.10,16.70 ), at 3mo was 16.04(14.60,16.60 ). The total corneal density value of control group was 16.30(15.50,17.30 )before the surgery, after the surgery at 14d was 16.20(15.20,17.10 ), at 1mo was 16.08(14.90,16.40 )and at 3mo was 15.60(14.60,16.40 ). In the zone of 0-2mm diameter was centered on the corneal vertex, the corneal density of the two groups at 14d after the surgery was higher than those before surgery(P<0.001 ). In the zone of 2-6mm diameter, the corneal density of the two groups at 1mo and 3mo after surgery was higher than those before the surgery(P<0.001). In the zone of 6-10mm, the corneal density of the two groups at 14d, 1 and 3mo after surgery was higher than those before the surgery(P<0.001). In the layer of anterior 120 μm, the corneal density of the two groups at 1mo and 3mo after the surgery was decreased than that before surgery(P<0.01). In the middle layer, the corneal density of the two groups at 1mo after the surgery was decreased than those before surgery(P<0.01).CONCLUSION:The use of 0.02% MMC during the operation can reduce the corneal density and increase the corneal light transmittance in the early postoperative period. The occurrence and prognosis of haze can be effectively quantified by observing the changes of corneal optical density in different ranges in different time periods after operation.
8.Progress in research of economic evaluation of COVID-19 vaccination strategies.
Jing Yu ZHAO ; Pei En HAN ; Ya Qun FU ; Li YANG ; Tao REN ; Si Yan ZHAN ; Li Ming LI
Chinese Journal of Epidemiology 2022;43(4):460-465
Objective: To understand the research progresses of economic evaluation of COVID-19 vaccination strategies both at home and abroad, and provide reference for the economic evaluation of COVID-19 vaccination strategies using real word data in China. Methods: Literature retrieval was conducted for related papers published from January, 2020 to December, 2021 in Chinese and English databases, including the economic evaluation of COVID-19 vaccination, and the results of the related literatures were narratively integrated. Results: A total of 16 English literatures (including 3 reviews) were included, and it was found that the COVID-19 vaccination was cost-effective or cost-saving regardless of the vaccine types, while the cost-effectiveness in different population and under different vaccination dose strategies varied due to vaccine efficacy, vaccine price, duration of natural immunity, duration of vaccination campaign, vaccine supply, and vaccination pace. Conclusions: China lacks suitable evidences of economic evaluation of COVID-19 vaccination strategies based on real-world data in the context of long-term epidemic. Therefore, further researches of suitable strategies of booster COVID-19 vaccination are needed.
COVID-19/prevention & control*
;
COVID-19 Vaccines
;
China/epidemiology*
;
Cost-Benefit Analysis
;
Humans
;
Vaccination
9.Effects of lifestyle changes on body weight and metabolic parameters during the early stage of COVID-19 epidemic and regular epidemic prevention period in physical examination population
Xin ZHAO ; Wen GUO ; Pei QIN ; Xiuru LIANG ; Wenfang ZHU ; Xiaona LI ; Qingqing DIAO ; Nianzhen XU ; Qun ZHANG
Chinese Journal of Health Management 2022;16(11):751-757
Objective:To analyze the influence of lifestyle changes on body weight and metabolic parameters during the early stage of corona virus disease 2019 (COVID-19) epidemic and regular epidemic prevention period in physical examination population.Methods:A total of 801 subjects from Nanjing enterprises and institutions who underwent physical examination in the Department of Health Promotion Center, the First Affiliated Hospital of Nanjing Medical University in May of 2019 to 2021 were included in this study. The basic information and data of body mass index, fasting blood glucose, total cholesterol, low density lipoprotein cholesterol (LDL-C), triglyceride and uric acid were collected. Information about dietary and exercise habits was obtained through pre-examination questionnaires. The data of 2019 was set as baseline data, data of 2020 represented information during the early stage of COVID-19 epidemic and data of 2021 represented information in regular epidemic prevention period. The subjects were divided into underweight group, normal weight group, overweight group, and obese group according to the body mass index at baseline. The Friedman test was applied to compare changes in body mass index and metabolic parameters across the population. Chi-square test was used to compare changes in dietary and exercise habits. Multivariate logistic regression analysis was adopted to explore the influencing factors of body mass index changes.Results:During the early stage of COVID-19 epidemic, the proportion of weight gain was the highest in the underweight group (42.9%), the proportion of weight loss was the highest in the overweight group (24.2%), and the obese group has the most stable body weight (70.6%) ( P=0.004). Men ( OR=0.56, 95% CI: 0.36-0.87) were less likely to gain weight than women ( P=0.010). There was no significant differences in weight change among all groups in the regular epidemic prevention period ( P=0.380). During the early stage of COVID-19 epidemic, the levels of fasting blood glucose, total cholesterol and LDL-C were significantly lower than those of baseline [4.98 (4.66, 5.42) vs 5.23 (4.91, 5.66) mmol/L, 4.98 (4.36, 5.67) vs 5.11 (4.54, 5.77) mmol/L, 2.90 (2.45, 3.33) vs 3.23 (2.77, 3.74) mmol/L], and the uric acid level was higher [333.0 (275.5, 397.0) vs 311.0 (257.5, 368.0) μmol/L] (all P<0.001). In regular epidemic prevention period, the levels of body mass index, fasting blood glucose, total cholesterol and LDL-C were significantly higher than those in the early stage of the epidemic [24.0 (21.9, 26.3) vs 23.8 (21.7, 26.1) kg/m 2, 5.18 (4.85, 5.62) vs 4.98 (4.66, 5.42) mmol/L, 5.12 (4.42, 5.76) vs 4.98 (4.36, 5.67) mmol/L, 3.06 (2.59, 3.57) vs 2.90 (2.45, 3.33) mmol/L], while the uric acid was significantly lower [319.0 (265.0, 377.0) vs 333.0 (275.5, 397.0) μmol/L] (all P<0.001). During the early stage of the epidemic, the reduction proportion of unhealthy diet in the home group was significantly higher than that in the outing group (19.5% vs 11.4%), and the increment proportion of exercise in the outing group was significantly higher than that in the home group (5.1% vs 1.6%) (both P<0.05). In regular epidemic prevention period, the increase rate of unhealthy diet in the home group was significantly higher than that in the outing group (26.8% vs 13.0%) ( P<0.001), and there was no significant difference in exercise between the two groups ( P=0.325). During the early stage of COVID-19 epidemic and in the regular epidemic prevention period, unhealthy diet>3 times per week ( OR=3.85, 3.01, 95% CI: 1.74-8.51, 1.41-6.39) was positively correlated with weight gain, and regular exercise ( OR=4.35, 2.61, 95% CI: 2.05-9.23, 1.15-5.91) was positively correlated with weight loss (all P<0.05). Conclusions:During the early stage of COVID-19 epidemic and in the regular epidemic prevention period, the lifestyle in the physical examination population has an impact on body weight and metabolic indicators. In the early stage of the epidemic, unhealthy diet and exercise decreased, and metabolic indicators such as blood glucose and lipids decreased. People with low body weight tend to gain weight. In the regular epidemic prevention period, the subjects′ exercise increased but unhealthy diet also increased, and blood glucose, lipid and body weight elevated significantly.
10.Neoadjuvant chemoradiotherapy combined with surgery versus direct surgery in the treatment of Siewert type II and III adenocarcinomas of the esophagogastric junction: long-term prognostic analysis of a prospective randomized controlled trial.
Yuan TIAN ; Qiang WANG ; Jun WANG ; Xue Ying QIAO ; Jun ZHANG ; Ye Cheng LIN ; Yong LI ; Li Qiao FAN ; Pei Gang YANG ; Qun ZHAO
Chinese Journal of Gastrointestinal Surgery 2021;24(2):128-137
Objective: To investigate the effectiveness, safety, and prognosis of neoadjuvant chemoradiotherapy (nCRT) for Siewert type II and III adenocarcinomas of the esophagogastric junction (AEG). Methods: This study is a prospective randomized controlled clinical study (NCT01962246). AEG patients who were treated at the Third Department of Surgery of the Fourth Hospital of Hebei Medical University from February 2012 to June 2016 were included. All of the enrolled patients were diagnosed with type II or III locally advanced AEG gastric cancer (T2-4N0-3M0 or T1N1-3M0) by gastroscopy and CT before operation; the longitudinal axis of the lesion was ≤ 8 cm; no anti-tumor treatment was previously given and no contraindications of chemotherapy and surgery were found. Case exclusion criteria: serious diseases accompanied by liver and kidney, cardiovascular system and other vital organs; allergy to capecitabine or oxaliplatin drugs or excipients; receiving any form of chemotherapy or other research drugs; pregnant or lactating women; patients with diseases resulting in difficulty to take capecitabine or with concurrent tumors. Based on sample size estimation, a total of 150 AEG patients were enrolled. Using the random number table method, the enrolled patients were divided into the nCRT group and the direct operation group with 75 cases in each group. The nCRT group received XELOX chemotherapy (capecitabine+ oxaliplatin) before surgery and concurrent radiotherapy (45 Gy, 25 times, 1.8 Gy/d, 5 times/week). Clinical efficacy of the nCRT group was evaluated by the solid tumor efficacy evaluation standard (RECIST1.1) and the tumor volume reduction rate was measured on CT. After completing the preoperative examination in the direct operation group, and 8-10 weeks after the end of nCRT in the nCRT group, surgery was performed. Laparoscopic exploration was initially performed. According to the Japanese "Regulations for the Treatment of Gastric Cancer", a transabdominal radical total gastrectomy combined with perigastric lymph node dissection was performed. The primary outcome was the 3-year overall survival (OS) and disease-free survival rate (DFS); the secondary outcomes were R0 resection rate, the toxicity of chemotherapy, and surgical complications. The follow-up ended on December 31, 2019. The postoperative recurrence, metastasis and survival time of the two groups were collected. Results: After excluding patients with incomplete clinical data, patients or family members requesting to withdraw informed consent, and those failing to follow the treatment plan, 63 cases in the nCRT group and 69 cases in the direct operation group were finally enrolled in the study. There were no statistically significant differences in baseline characteristics of the two groups (all P>0.05). Sixty-three patients in the nCRT group were evaluated by RECIST1.1 after treatment, the image based effective rate was 42.9% (27/63), and the stable disease rate was 98.4% (62/63); the tumor volume before and after nCRT measured on CT was (58.8±24.4) cm(3) and (46.6±25.7) cm(3), respectively, the effective rate of tumor volume reduction measured by CT was 47.6% (30/63). Incidences of neutrophilopenia [65.1% (41/63) vs. 40.6% (28/69), χ(2)=7.923, P=0.005], nausea [81.0% (51/63) vs. 56.5% (39/69), χ(2)=9.060, P=0.003] and fatigue [74.6% (47/63) vs. 42.0% (29/69), χ(2)=14.306, P=0.001] in the nCRT group were significantly higher than those in the direct surgery group. Radiation gastritis/esophagitis and radiation pneumonia were unique adverse reactions in the nCRT group, with incidences of 52.4% (33/63) and 15.9%(10/63), respectively. The classification of tumor regression of 63 patients in nCRT group presented as 11 cases of grade 0 (17.5%), 20 cases of grade 1 (31.7%), 28 cases of grade 2 (44.4%), and 5 cases of grade 3 (7.9%). Eleven (17.5%) patients achieved pathologic complete response. Sixty-one (96.8%) patients in the nCRT group underwent R0 resection, which was higher than 87.0% (60/69) in the direct surgery group (χ(2)=4.199, P=0.040). The mean number of harvested lymph nodes in the specimens in the nCRT group and the direct operation group was 27.6±12.4 and 26.8±14.6, respectively, and the difference was not statistically significant (t=-0.015, P=0.976). The pathological lymph node metastasis rate and lymph node ratio in the two groups were 44.4% (28/63) vs. 76.8% (53/69), and 4.0% (70/1 739) vs. 21.9% (404/1 847), respectively with statistically significant differences (χ(2)=14.552, P<0.001, and χ(2)=248.736, P<0.001, respectively). During a median follow-up of 52 (27-77) months, the 3-year DFS rate in the nCRT group and the direct surgery group was 52.4% and 39.1% (P=0.049), and the 3-year OS rate was 63.4% and 52.2% (P=0.019), respectively. According to whether the tumor volume reduction rate measured by CT was ≥ 12.5%, 63 patients in the nCRT group were divided into the effective group (n=30) and the ineffective group (n=33). The 3-year DFS rate of these two subgracps was 56.6% and 45.5%, respectively without significant difference (P=0.098). The 3-year OS rate was 73.3% and 51.5%,respectively with significant difference (P=0.038). The 3-year DFS rate of patients with the tumor regression grades 0, 1, 2 and 3 was 81.8%, 70.0%, 44.4%, and 20.0%, repectively (P=0.024); the 3-year OS rate was 81.8%, 75.0%, 48.1% and 40.0%, repectively (P=0.048). Conclusion: nCRT improves treatment efficacy of Siewert type II and III AEG patients, and the long-term prognosis is good.
Adenocarcinoma/therapy*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Capecitabine/administration & dosage*
;
Chemoradiotherapy, Adjuvant
;
Esophagogastric Junction/surgery*
;
Gastrectomy
;
Humans
;
Lymph Node Excision
;
Neoadjuvant Therapy
;
Neoplasm Staging
;
Oxaliplatin/administration & dosage*
;
Prognosis
;
Prospective Studies
;
Retrospective Studies
;
Stomach Neoplasms/therapy*

Result Analysis
Print
Save
E-mail