1.Multicenter,randomized,superiority,parallel-controlled clinical study of compound azinomide enteric-coated tablets in the treatment of dyspepsia after laparoscopic cholecystectomy
Jialu CHEN ; Yue TANG ; Delong QIN ; Zonglong LI ; Peng GONG ; Hong ZHU ; Jianhua LIU ; Junjing ZHANG ; Zhimin GENG ; Yubin ZHANG ; Xinjian XU ; Zhaohui TANG
Chinese Journal of General Surgery 2025;34(2):298-309
Background and Aims:Laparoscopic cholecystectomy(LC)is a common surgical method for the treatment of gallbladder diseases.However,some patients experience symptoms such as dyspepsia after surgery,which can affect their quality of life.Compound azinomide enteric-coated tablets,a novel drug,may improve dyspeptic symptoms after LC.This study was conducted to explore the clinical efficacy of compound azinomide enteric-coated tablets in treating post-LC dyspepsia symptoms through a multicenter clinical trial.Methods:A multicenter,superior efficacy,open-label,parallel-controlled design was used.Patients with postoperative dyspepsia were enrolled in 7 centers between January 2023 and May 2024.Patients were randomly assigned to either the observation or control groups using a random number table.The observation group received compound azinomide enteric-coated tablets,while the control group was treated with a combination of oryzae pancreatin tablets and ursodeoxycholic acid tablets.Both groups were treated for 4 weeks.The primary endpoints included gastrointestinal symptom scores and quality of life scores assessed before and at 14 and 28 d after treatment.Additionally,the incidence of adverse reactions and cost-effectiveness ratio(CER)were compared between the groups.Results:A total of 303 patients were included,with 150 in the observation group and 153 in the control group.Baseline characteristics were balanced between the groups before treatment(all P>0.05).After treatment,the observation group showed significantly higher effective rates at 14 d and 28 d than the control group(44.7%vs.29.4%;98.0%vs.73.9%,both P<0.05).The observation group also had significantly lower symptom scores and quality of life scores at both 14 and 28 d,with a significantly higher improvement rate in symptom scores compared to the control group(all P<0.05).Further analysis of the improvement rate and treatment efficacy for individual symptoms revealed that,except for the 14-d improvement in abdominal pain/discomfort,the observation group showed better improvement in all other symptoms at 14 d and in all symptoms at 28 d compared to the control group(all P<0.05).No adverse reactions were observed in either group.The CER for the observation group was 283.78 yuan/efficacy rate at 14 d and 128.57 yuan/efficacy rate at 28 d,while the control group's CER was 729.93 yuan/efficacy rate at 14 d and 290.22 yuan/efficacy rate at 28 d.Conclusion:Compound azinomide enteric-coated tablets demonstrated good clinical efficacy in treating dyspepsia symptoms after LC with excellent safety and high cost-effectiveness.Despite some limitations,the results provide a new treatment option for dyspepsia after LC.Larger-scale randomized controlled trials are needed to validate this study's conclusions further.
2.Multicenter,randomized,superiority,parallel-controlled clinical study of compound azinomide enteric-coated tablets in the treatment of dyspepsia after laparoscopic cholecystectomy
Jialu CHEN ; Yue TANG ; Delong QIN ; Zonglong LI ; Peng GONG ; Hong ZHU ; Jianhua LIU ; Junjing ZHANG ; Zhimin GENG ; Yubin ZHANG ; Xinjian XU ; Zhaohui TANG
Chinese Journal of General Surgery 2025;34(2):298-309
Background and Aims:Laparoscopic cholecystectomy(LC)is a common surgical method for the treatment of gallbladder diseases.However,some patients experience symptoms such as dyspepsia after surgery,which can affect their quality of life.Compound azinomide enteric-coated tablets,a novel drug,may improve dyspeptic symptoms after LC.This study was conducted to explore the clinical efficacy of compound azinomide enteric-coated tablets in treating post-LC dyspepsia symptoms through a multicenter clinical trial.Methods:A multicenter,superior efficacy,open-label,parallel-controlled design was used.Patients with postoperative dyspepsia were enrolled in 7 centers between January 2023 and May 2024.Patients were randomly assigned to either the observation or control groups using a random number table.The observation group received compound azinomide enteric-coated tablets,while the control group was treated with a combination of oryzae pancreatin tablets and ursodeoxycholic acid tablets.Both groups were treated for 4 weeks.The primary endpoints included gastrointestinal symptom scores and quality of life scores assessed before and at 14 and 28 d after treatment.Additionally,the incidence of adverse reactions and cost-effectiveness ratio(CER)were compared between the groups.Results:A total of 303 patients were included,with 150 in the observation group and 153 in the control group.Baseline characteristics were balanced between the groups before treatment(all P>0.05).After treatment,the observation group showed significantly higher effective rates at 14 d and 28 d than the control group(44.7%vs.29.4%;98.0%vs.73.9%,both P<0.05).The observation group also had significantly lower symptom scores and quality of life scores at both 14 and 28 d,with a significantly higher improvement rate in symptom scores compared to the control group(all P<0.05).Further analysis of the improvement rate and treatment efficacy for individual symptoms revealed that,except for the 14-d improvement in abdominal pain/discomfort,the observation group showed better improvement in all other symptoms at 14 d and in all symptoms at 28 d compared to the control group(all P<0.05).No adverse reactions were observed in either group.The CER for the observation group was 283.78 yuan/efficacy rate at 14 d and 128.57 yuan/efficacy rate at 28 d,while the control group's CER was 729.93 yuan/efficacy rate at 14 d and 290.22 yuan/efficacy rate at 28 d.Conclusion:Compound azinomide enteric-coated tablets demonstrated good clinical efficacy in treating dyspepsia symptoms after LC with excellent safety and high cost-effectiveness.Despite some limitations,the results provide a new treatment option for dyspepsia after LC.Larger-scale randomized controlled trials are needed to validate this study's conclusions further.
3. Predictive value of prostate biopsy results based on predictive model established by the PI-RADS version 2
Jinyang LUO ; Jiaxin ZHENG ; Zonglong CAI ; Xiongbo YAO ; Jiaxin CHEN ; Jiecheng ZHANG ; Rui WAN ; Guishuang LIANG ; Jinchun XING ; Xuan ZHUANG
Chinese Journal of Urology 2019;40(9):673-679
Objective:
To explore a predictive nomogram for the result of prostate biopsy based on Prostate Imaging Reporting and Data System version 2(PI-RADS v2)combined with prostate specific antigen (PSA) and its related parameters, and to assess its ability to diagnose prostate cancer by internal validation.
Methods:
We retrospectively analyzed the clinical data of 509 patients who underwent transrectal prostate biopsy guided by ultrasound during the period from January 2014 to December 2018 in the Department of Urology, First Affiliated Hospital of Xiamen University. In 509 cases, the mean age was (68.1±7.2) years. The mean prostate volume(PV) was (55.8±30.7) ml. The mean tPSA value was (19.86±18.94) ng/ml. The mean value of fPSA was (2.63±3.60) ng/ml and the mean f/tPSA was 0.14±0.08. The mean PSAD was (0.46±0.52) ng/ml2. Based on the PI-RADS v2, score 1 point have 37 cases, score 2 point have 131 cases, score 3 point have 152 cases, score 4 point have 102 cases, score 5 point have 87 cases. Of these patients, we randomly selected 80% (407 cases) as development group, and the other 20% (102 cases) as validation group. Univariate and multivariate logistic regression analysis of the development group was performed to identify the independent influence factors that can predict prostate cancer (PCa), thereby establishing a predictive model for the result of prostate biopsy. In the development group, validation group and tPSA was between 4.1-20.0 ng/ml, the model was evaluated by analyzing the receiver operating characteristic (ROC) curve, calibration curve and decision curve, and compared to PSA, fPSA, f/tPSA, PSAD, PI-RADS v2.
Results:
Among the 509 patients enrolled in the study, the detection rate of PCa was 43.0% (219/509). In the development group, the logistic regression analysis demonstrated that patient age (
4.Biosafety evaluation of collagen-based bone repairing material.
Zonglong WANG ; Chunhong ZHANG ; Lei XIE
Journal of Biomedical Engineering 2013;30(1):105-109
To evaluate the biological safety of collagen-based bone repairing material, we implanted the sample or reference substance into rats, and observed relative signs, including the specific inspection targets in animals, blood examination, analysis of immune organ, the pathological examination of organs and tissues, NK cell killing activity assay, lymphocyte group analysis, serum IL-1, IL-6, TNF-alpha detection, detection of immune globulin. Meanwhile, we set control group, sham group, and immunosuppression group. The final results showed that there was no abnormal mental state before and after the experiment. Compared with the control group, the tested group indicated no significant difference in blood test, immune organ analysis, the pathological examination of organs and tissues, NK cell killing activity assay, lymphocyte subset analysis serum IL-1, IL-6, TNF-alphadetection, and detection of immune globulin. Collagen-based bone repairing material produced a slight and transient stimulation on the rats, but created no significant inflammatory responses.
Absorbable Implants
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Animals
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Bone Matrix
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physiology
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transplantation
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Bone Regeneration
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Bone Substitutes
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Collagen
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chemistry
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Implants, Experimental
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Materials Testing
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Prostheses and Implants
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Rats
5.Dynamic Observation of Biliary Tract after Surgery Via T-Tube Cholangiography in 170 Cases
Fanglong YIN ; Junyi TANG ; Zonglong ZHANG ; Jian ZHANG ; Longzhuang TIAN
Chinese Journal of Bases and Clinics in General Surgery 2003;0(05):-
Objective To gain accurate imaging i nformation of biliary tract after surgery. Methods The biliary tract of 170 cases after s urgery had been observed dynamically from different directions for longer time. The results of data on biliary tract change were stored in disc, or picture. Results Of 170 cases, 120 cases were cured with out any abnormal change on cholangiography, and then the T-tube was removed. Of another 50 cases, 30 cases revealed remnant stone on cholangiography, 9 cases s howed inflammatory stricture of biliary tract, 4 cases displayed common bile duc t tumor, and 7 cases had false filling-defect. Then, the results were further c onfirmed by sonography, CT, choledochoscopy, and operation. Conclusion The dynamic observation of biliary tract by T-tube cholangiography after surgery is usual way that is handy, pract ical, painless, and economic.

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