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.Bioinformatic analysis of TCGA database based on INPP4B gene expression in hepatocellular carcinoma and its experimental validation
Limei WEN ; Yali GUO ; Wenmei MA ; Taotao XUE ; Ruoyu GENG ; Chong MA ; Xinhong ZHANG ; Jianhua YANG
Journal of Jilin University(Medicine Edition) 2025;51(6):1618-1629
Objective:To discuss the expression and clinical significance of inositol polyphosphate-4-phosphatase type Ⅱ(INPP4B)gene in hepatocellular carcinoma(HCC)based on The Cancer Genome Atlas(TCGA)database and experimental verification with clinical samples.Methods:Based on data from 424 clinical samples in the TCGA database(including 374 HCC tissues and 50 paracarcinoma tissues),Kaplan-Meier method and Cox regression analysis were used to evaluate the relationship between INPP4B gene and the clinical characteristics and survival prognosis of the HCC patients.The correlations between INPP4B gene and the number of 24 types of immune cells,matrix,immune cell infiltration and tumor purity in tumor tissue,and the expression level of the high-frequency mutant gene tumor protein 53(TP53)in HCC were analyzed.The clinicopathological data and paraffin-embedded tissue sections of 60 HCC patients treated with surgical resection from December 2022 to December 2023 were collected.According to clinical diagnosis,they were divided into poorly differentiated group(HCC-L group),moderately differentiated group(HCC-M group)and well-differentiated group(HCC-H group),with 20 cases in each group;20 patients during the same period who underwent biopsy and were pathologically diagnosed as non-tumor were selected as normal group,and their clinicopathologic data and liver tissue paraffin sections were collected.HE staining was used to observe the pathomorphology of HCC tissue and normal liver tissue of the subjects in various groups;immunohistochemistry method was used to detect the expressions of Ki-67 and INPP4B proteins in the HCC tissue and normal liver tissue of the subjects in various groups.Results:The TCGA database analysis results showed that compared with normal tissue,the expression level of INPP4B mRNA in HCC tissue was significantly increased(P<0.01).Compared with INPP4B low expression group,the overall survival(OS)of the patients in INPP4B high expression group was significantly prolonged(P<0.05).The univariate Cox regression analysis results showed that tumor stage,pathological stage,tumor status and residual tumor had impacts on OS of the HCC patients(P<0.05).The univariate regression analysis results showed that the INPP4B prognostic risk model score ratio was HR=0.781,95%confidence interval(CI):0.552-1.105,P=0.168.The AUC value for the impact of INPP4B on OS of the HCC patients was 0.558,indicating that the INPP4B gene prognostic risk model had certain predictive value in survival prognosis.The INPP4B mRNA expression level was not correlated with TNM stage,stage,patient gender,age,race or body mass index(BMI)(P>0.05).In tumor tissue with high and low INPP4B expression,22 types of immune cells showed statistically significant differences(P<0.05);the INPP4B mRNA expression level was positively correlated with the number of 23 types of immune cells except T helper(Th)17 cells(r>0),among which all Th cells except natural killer(NK)CD56+cells were statistically significant(P<0.01);INPP4B was significantly correlated with matrix(r=0.475),immune cell infiltration(r=0.641)and tumor purity(r=0.599)in tumor tissue(P<0.01).INPP4B was correlated with TP53(r=0.287,P<0.01).The HE staining results showed that clear and complete lobular structure,neatly arranged cells and slight inflammatory cell infiltration were observed in liver tissue of the subjects in normal group;completely destroyed lobular structure,significant hepatocellular steatosis,massive inflammatory cell infiltration,and lesions such as ballooning degeneration and small cell hyperplasia in some cells were observed in HCC tissue of the patients in HCC-L,HCC-M and HCC-H groups,and the lower the HCC differentiation degree,the more severe the tissue destruction;The immunohistochemistry results showed that compared with normal group,the expression levels of Ki-67 protein in HCC tissue of the patients in HCC-L,HCC-M and HCC-H groups were significantly increased(P<0.01),and the lower the differentiation degree of the HCC patients,the higher the Ki-67 positive rate.Brownish-yellow granules evenly distributed in the cells and INPP4B protein was highly expressed in liver tissue of the subjects in normal group;compared with normal group,the expression levels of INPP4B protein in HCC tissue of the patients in HCC-L,HCC-M and HCC-H groups were significantly decreased(P<0.01),and the lower the differentiation degree of the HCC tissue,the lower the INPP4B positive rate.Conclusion:INPP4B is a protective factor for the prognosis of HCC patients;as a new tumor suppressor gene,INPP4B may become a potential target for new drug screening in HCC treatment.
4.Expert consensus on quality assurance for SPECT and SPECT/CT equipment with CZT detectors
China Medical Equipment 2025;22(6):1-6
The quality assurance(QA)of cadmium zinc telluride(CZT)detector-based Single Photon Emission Computed Tomography(SPECT)and Single Photon Emission Computed Tomography/X-ray Computed Tomography(SPECT/CT)systems is critical to the quality and safety of diagnosis and treatment for patients.Currently,there are no dedicated standards or guidelines for QA of specifically tailored for CZT detector equipment within the industry,resulting in uncertainties regarding their performance and operational safety.To address this gap,the Nuclear Medical Equipment and Technology Committee of China Association of Medical Equipment has convened a panel of experts to formulate a consensus on the QA for CZT detector-based SPECT and SPECT/CT equipment.This expert consensus aims to define the scope,protocols,and performance standards for QA about CZT detector-based SPECT and SPECT/CT equipment,so as to ensure that the equipment can reach to the performance indicators designed by the original factory in clinical application,and reach to the safe and reliable operation of equipment,and can meet requirements of clinical diagnosis.
5.Expert consensus on quality assurance for SPECT and SPECT/CT equipment with CZT detectors
China Medical Equipment 2025;22(6):1-6
The quality assurance(QA)of cadmium zinc telluride(CZT)detector-based Single Photon Emission Computed Tomography(SPECT)and Single Photon Emission Computed Tomography/X-ray Computed Tomography(SPECT/CT)systems is critical to the quality and safety of diagnosis and treatment for patients.Currently,there are no dedicated standards or guidelines for QA of specifically tailored for CZT detector equipment within the industry,resulting in uncertainties regarding their performance and operational safety.To address this gap,the Nuclear Medical Equipment and Technology Committee of China Association of Medical Equipment has convened a panel of experts to formulate a consensus on the QA for CZT detector-based SPECT and SPECT/CT equipment.This expert consensus aims to define the scope,protocols,and performance standards for QA about CZT detector-based SPECT and SPECT/CT equipment,so as to ensure that the equipment can reach to the performance indicators designed by the original factory in clinical application,and reach to the safe and reliable operation of equipment,and can meet requirements of clinical diagnosis.
6.Study on impact of source distance changes on the intrinsic spatial resolution and linearity of single photon emission computed tomography equipment
Hao HONG ; Jianhua GENG ; Zhiwen CHEN ; Xuesong SU ; Xuejuan WANG ; Jing LI
Chinese Journal of Radiological Medicine and Protection 2024;44(12):1049-1055
Objective:To study the impact of changes in distance from the point source to the detector lead grid phantom surface on the intrinsic spatial resolution and linearity of single photon emission computed tomography equipment (SPECT), and to provide references for exploring quality control performance testing method.Methods:The intrinsic spatial resolution and linearity indexes of the dual detectors of the two SPECT machines(model 1, 2) were examined using the parallel slit lead grid phantom method, respectively, at five different positions of the vertical distance from the point source to the surface of the lead grid phantom, namely, 150, 170, 190, 210 and 230 cm.Results:After completion of image acquisition about the two SPECT machines with dual detectors at the five positions, the software-based calculated intrinsic spatial resolution and linearity in x and y direction fluctuated both within a very small range: effective field of view half-width half-maximum 3.310-3.902 mm, central field of view half-width half-maximum 3.274-3.910 mm, UFOV differential linearity (0.059-0.180 mm), FUOV absolute linearity (0.171-0.628 mm), CFOV differential linearity (0.046-0.165 mm), CFOV absolute linearity (0.115-0.534 mm). The intrinsic spatial resolution was slightly poor at a source distance of 150 cm. The UFOV FWHM detection value of two machines was (3.80±0.07)mm, with a range of 3.695-3.902 mm. The CFOV FWHM detection value was (3.73±0.11) mm, with a range of 3.572-3.910 mm. However, no statistically significant difference was found in inherent spatial resolution between model 1 and model 2 ( P>0.05). Under the WS 523-2019, the intrinsic spatial resolution and linearity of two machines with dual detectors were both qualified. The comparison of inherent spatial linearity between model 1 and model 2 showed that model 1 was inferior to model 2, with statistically significant difference ( t=15.09, P<0.001). Conclusions:There was no variation in intrinsic spatial resolution and linearity with the source distance when the vertical distance from the point source to the surface of the detector lead grid phantom was changed (150 to 230 cm). When intrinsic spatial resolution and linearity testing were performed on SPECT, it is necessary to ensure that the vertical distance from the point source to the detector is greater than 150 cm and recommended to be at least 170 cm.
7.Study on exposure levels and protection of the thyroids,eye lenses and hands of technologists in SPECT/CT room of hospital
Zuowei ZOU ; Xuesong SU ; Jianhua GENG
China Medical Equipment 2024;21(11):25-29
Objective:To study exposure doses and radiation levels of thyroids,eye lenses and hands of technologists who worked in the single-photon emission computed tomography/computed tomography(SPECT/CT)room,so as to provide a reference for assessing radiation hazards and radiation protection of technologists in SPECT/CT machine room.Methods:During February 2019 and October 2020,2 technologists each of two SPECT/CT machine rooms of the department of nuclear medicine of Cancer Hospital,Chinese Academy of Medical Sciences were selected,and the optically stimulated luminescence(OSL)dosimeters were used to monitor the exposure doses of four technologists in the SPECT/CT room in 7 quarters.The total amount that they put positions of patients were 20 682 patients.The technologist routinely wore lead aprons(0.5 mmPb)and lead collars(0.5 mmPb)during clinical work.OSL dosimeters were placed on the thyroids,the locations nearby the eyes and hands of each technologist.Each one of 4 technologists wore a set of dosimeters(included three sets for the thyroid,the locations nearby the eye and hand).The monitoring period that technologists wore OSL dosimeters was 21 months.The personal dose equivalent[Hp(10)]of thyroid at 10 mm depth,the personal dose equivalent[Hp(3)]of the location nearby eyes at 3 mm depth,and the personal dose equivalent[Hp(0.07)]of hands at 0.07 mm were monitored as quarter.The exposure doses of the thyroids,eye lens and hands of 4 technologists in SPECT/CT machine room were assessed on the basis of these results of measurements.All four technologists also underwent dose monitor of routine external radiation.Results:The average number of each technologist who put position was approximately 2 955 patients.Among of the four technologists,the exposure doses of thyroid,eye lens and hand of only one technologist were highest,which were respectively 0.129,0.071 and 0.151 mSv,while they were far below the constraint values(5,5 and 125mSv/a)of dose for radiation workers.Conclusion:The four technologists of the SPECT/CT room directly contact with patients who have been injected with radiopharmaceuticals during they put the positions of patients.But,the exposure doses of their thyroid,eye lenses and hands are far below the constraint value of dose for radiation workers.The reasonable use of personal protective equipment as requirement can effectively safeguard against radiation exposure during technologist put position of patient.
8.Performance evaluation of PET/CT based on silicon photomultiplier and photomultiplier tube under clinical imaging conditions
Xuesong SU ; Jianhua GENG ; Yibin WANG ; Xuejuan WANG ; Rong ZHENG ; Jing LI
Chinese Journal of Radiological Medicine and Protection 2024;44(5):428-435
Objective:To investigate the spatial resolution and image quality of positron emission tomography and X-ray computed tomography (PET/CT) based on the next-generation silicon photomultiplier (SiPM) and the conventional photomultiplier tube (PMT) and to explore the effects of different PET photoelectric transducers (PMT and SiPM) and the Q. Clear algorithm on the spatial resolution, quantitative accuracy, and image quality of PET/CT.Methods:GE Discovery Elite PET/CT (PMT PET/CT) and GE Discovery Meaningful Insights (MI) PET/CT (SiPM PET/CT) were employed to scan the elliptical resolution phantom and NEMA NU2-2018 image quality phantom. Using the OSEM+ PSF+ TOF (VPFX-S) algorithm, image reconstruction was performed based on raw data of both phantoms. For the MI-acquired phantom data, additional reconstructions were conducted using the Q. Clear algorithm, with β values ranging from 150 to 550 and an increment of 100. For the elliptical resolution phantom, the radial, tangential, and axial full-width at half-maximum (FWHM) values of five line sources in three slices were calculated and averaged. For the image quality phantom, the recovery coefficient (RC), contrast recovery coefficient (CRC), contrast-to-noise ratio (CNR), percentage of background variability (PBV), background coefficient of variability (BCV) of the spheres, as well as the residual error (RE) of lung inserts at different image slices, were calculated.Results:Compared to Elite, MI (VPFX-S) showed decreases in the radial, tangential, and axial FWHM of 4.25%-13.58%, 7.00%-13.22%, and 6.02%-36.14%, respectively; no significant difference in RCmax for the spheres; increases in spheres′ CRC and CNR of 10.17%-38.89% and 38.31%-94.95%, respectively, and decreases in spheres′ PBV and BCV of 26.20%-33.82% and 31.29%-35.97%, respectively. When compared to MI (VPFX-S), MI (Q.Clear) showed decreases in the radial, tangential, and axial FWHM of 6.49%-45.02%, 7.80%-35.60%, and 13.31%-36.80%, respectively; an increase in spheres′ CNR of 38.31%-94.95%; decreases in spheres′ PBV and BCV of 26.20%-33.82% and 6.64%-10.31%, respectively, and no significant difference in spheres′ RC. With an increase in the β value, the CNR, RE, and FWHM in radial, tangential, and axial directions derived from MI (Q.Clear) increased, while RC, CRC, PBV, and BCV decreased. Conclusions:Under image reconstruction using VPFX-S, the next-generation SiPM PET/CT exhibits elevated spatial resolution, hot lesion contrast, detectability, and background noise compared to the PMT PET/CT. Compared to OSEM, the Q. Clear algorithm improves spatial resolution, quantitative accuracy, and image quality, with such improvement related to the β value. The β value affects the outcomes of the Q. Clear algorithm, especially the maximum quantitative value of small lesions. This is particularly important for improving clinical diagnostic capabilities.
9.Effect of adductor canal block and single sciatic nerve block combined with analgesic drugs on pain after total knee arthroplasty
Haoyang GENG ; Wenping LIU ; Guorui WANG ; Bin LIU ; Wei WANG ; Zhanqiao MA ; Jianhua WANG
Chinese Journal of Tissue Engineering Research 2024;28(24):3833-3838
BACKGROUND:Total knee arthroplasty is an effective treatment for late-stage osteoarthritis,but postoperative pain and joint function recovery are the main challenges.Nerve block and mixed drug injection are two common pain relief methods,but the effect of their combined use is still unclear. OBJECTIVE:To investigate the effects of ultrasound-guided continuous adductor canal block+single sciatic nerve block+"cocktail"mixed drug analgesia on postoperative pain relief and joint function recovery in total knee arthroplasty. METHODS:120 patients with osteoarthritis admitted to Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine from January to May 2022 were randomly divided into two groups(n=60).The observation group received ultrasound-guided continuous adductor canal block+single sciatic nerve block+"cocktail"mixed drug analgesia.The control group received ultrasound-guided continuous adductor canal block+single sciatic nerve block.The differences in visual analog scale score,hospital for special surgery score,pain mediators,expression levels of inflammatory factors,the occurrence of adverse reactions,and postoperative barehanded muscle strength test were compared between the two groups. RESULTS AND CONCLUSION:(1)The visual analog scale scores at rest and exercise were lower in the observation group than those in the control group at 6,8,12,24,48,and 72 hours postoperatively(P<0.05).(2)Hospital for special surgery scores at 1 and 3 months postoperatively were significantly higher in the observation group than those in the control group(P<0.05).(3)In terms of pain mediators and inflammatory factors,the expression levels were significantly lower in the observation group than those in the control group(P<0.05).(4)There was no statistically significant difference in terms of adverse effects and postoperative barehanded muscle strength examination between the two groups(P>0.05).(5)In total knee arthroplasty,ultrasound-guided continuous adductor canal block and single sciatic nerve block,together with a"cocktail"mixed drug analgesia injected into the joint cavity,can provide excellent analgesia,facilitate the recovery of joint function,and relieve postoperative pain and inflammation with a high degree of safety.
10.Impact of 177Lu-DOTATATE therapy on radiation exposure of ward healthcare staff and accompanying persons
Xuesong SU ; Jinming ZHANG ; Jianhua GENG ; Yingmao CHEN ; Gaofeng LI ; Xuejuan WANG
Chinese Journal of Radiological Health 2024;33(5):510-516
Objective To investigate air radioactivity contamination, surface contamination, ambient dose equivalent rates, and radiation doses to individuals in the treatment room during 177Lu-DOTATATE therapy. Methods A ward for 177Lu-DOTATATE therapy was selected in the nuclear medicine department of a general hospital. Air and surface radioactivity samples were collected before and after therapy for four patients. Ambient dose equivalent rates were measured around the four patients following the initiation of 177Lu-DOTATATE therapy. Measurements were taken at distances of 0.1, 0.3, 0.5, and 1−4 m (with 0.5 m intervals) from the right lateral midsection of the patient’s torso. The measurement time points included 5, 15, and 30 min after initiation of administration, as well as 0−4 h (with 1 h intervals), 24 h, and 48 h post-administration. Radiation exposure doses for personnel at different distances from the patients were calculated for each time interval. Results The results of radioactive aerosol detection for all four patients during and after the administration of 177Lu-DOTATATE were similar to those before administration. Surface contamination was not detected at the measurement locations except for patient number 2. The ambient dose equivalent rates increased with increasing injection dose during the administration. However, the ambient dose equivalent rates decreased significantly within one hour after administration. At the end of the administration, the average ambient dose equivalent rate at a distance of one meter for the four patients was 42.931 μSv/h. From the start of administration to four hours post-administration, personnel maintaining a distance of one meter from the patient received a total radiation dose of 167.64 μSv. Conclusion Air radioactivity contamination does not occur during 177Lu-DOTATATE therapy. However, measures should be taken before the commencement of therapy to address potential surface contamination. Both accompanying persons and healthcare staff receive radiation doses below the stipulated dose constraints throughout the treatment process. Therefore, it is necessary to implement appropriate measures to minimize the radiation exposure of healthcare staff.

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