1.Prediction of gastric cancer T staging using oral contrast-enhanced ultrasonography combined with contrast-enhanced CT
Aiqing LU ; Fei QIU ; Xin DONG ; Xiaoyan LI ; Xiuyun SUN ; Xuefeng LI ; Zhaoxin JIN ; Xiankai WANG ; Yong ZHANG
Chinese Journal of Radiological Health 2025;34(3):368-372
Objective To explore the value of oral contrast-enhanced ultrasonography (OCEUS) combined with contrast-enhanced CT in predicting preoperative T staging in patients with gastric cancer. Methods A retrospective analysis was conducted on 80 patients with gastric cancer confirmed via endoscopic biopsy or postoperative pathology at the First People’s Hospital of Jining from January 2021 to November 2024. The cohort included 56 males and 24 females, aged 38-79 years, with a median age of 55.9 years. All patients underwent both OCEUS and contrast-enhanced CT within one week prior to surgery. T staging of gastric cancer was determined using OCEUS, contrast-enhanced CT, or their combination. The results were compared with pathological T staging, and statistical differences in accuracy were analyzed. Results Pathological T staging identified T1 in 9 cases, T2 in 16 cases, T3 in 42 cases, and T4 in 13 cases. OCEUS indicated T1 in 6 cases, T2 in 14 cases, T3 in 50 cases, and T4 in 10 cases, with an accuracy rate of 80.0%. Contrast-enhanced CT indicated T1 in 4 cases, T2 in 12 cases, T3 in 52 cases, and T4 in 12 cases, with an accuracy rate of 75.0%. The combination of OCEUS and contrast-enhanced CT indicated T1 in 6 cases, T2 in 15 cases, T3 in 47 cases, and T4 in 12 cases, with an accuracy rate of 87.5%. The combined approach demonstrated significantly higher accuracy in preoperative T staging compared to either method alone (P < 0.05). Conclusion The combination of OCEUS and contrast-enhanced CT improves the accuracy of preoperative T staging in gastric cancer patients, providing valuable support for their diagnosis and treatment.
2.Diagnostic efficacy of targeted biopsy plus ipsilateral hemiglandular systematic biopsy of the dominant lesion in prostate cancer
Yongsheng NIAN ; Yongbing CHENG ; Haifeng HUANG ; Shan PENG ; Jing LIANG ; Hongqian GUO ; Xuefeng QIU
Journal of Modern Urology 2025;30(7):593-598,602
Objective To investigate the diagnostic efficacy of targeted biopsy(TB)combined with ipsilateral hemiglandular systematic biopsy(SB)of the dominant lesion,so as to explore a novel reduced-core biopsy strategy.Methods A retrospective analysis was conducted on the clinical data of 299 patients treated in our hospital during Sep.1,2022,and Feb.28,2023,who had a Prostate Imaging Reporting and Data System(PI-RADS)score ≥3 and underwent combined TB and SB.The dominant lesion was defined as the lesion with the highest PI-RADS score on multi-parametric magnetic resonance imaging(mpMRI);in cases of identical scores,the largest was designated as the dominant.SB was categorized as ipsilateral(ipsi-SB)or contralateral(contra-SB)to the dominant lesion.The consistency in detecting clinically significant prostate cancer(csPCa)was compared between TB with ipsi-SB(TB+ipsi-SB),TB with contra-SB(TB+contra-SB),and TB with SB(TB+SB).Subgroup analyses were performed based on PI-RADS score,prostate-specific antigen(PSA)level,prostate volume(PV),and mpMRI lesion distribution to evaluate csPCa detection rates across different variables.Results TB+ipsi-SB demonstrated comparable detection rate to TB+SB(46.2%vs.46.8%).The K values for TB+ipsi-SB and TB+contra-SB relative to TB+SB were 0.987(95%CI:0.969-1.000,P<0.01)and 0.933(95%CI:0.892-0.974,P<0.01),respectively.Across all subgroups,TB+ipsi-SB showed the highest agreement with TB+SB.Notably,in subgroups with PI-RADS 3 and 5,PSA>0-20 ng/mL,PV<25 mL,bilateral or multiple mpMRI lesions,TB+ipsi-SB achieved complete concordance with TB+SB in csPCa detection[K=1.000(95%CI:1.000-1.000),P<0.01].Conclusion For patients with PI-RADS score ≥3,TB+ipsi-SB exhibits near-perfect consistency with TB+SB in csPCa detection while requiring fewer biopsy cores.TB+ipsi-SB represents a promising refinement of the TB+SB approach.
3.Diagnostic efficacy of targeted biopsy plus ipsilateral hemiglandular systematic biopsy of the dominant lesion in prostate cancer
Yongsheng NIAN ; Yongbing CHENG ; Haifeng HUANG ; Shan PENG ; Jing LIANG ; Hongqian GUO ; Xuefeng QIU
Journal of Modern Urology 2025;30(7):593-598,602
Objective To investigate the diagnostic efficacy of targeted biopsy(TB)combined with ipsilateral hemiglandular systematic biopsy(SB)of the dominant lesion,so as to explore a novel reduced-core biopsy strategy.Methods A retrospective analysis was conducted on the clinical data of 299 patients treated in our hospital during Sep.1,2022,and Feb.28,2023,who had a Prostate Imaging Reporting and Data System(PI-RADS)score ≥3 and underwent combined TB and SB.The dominant lesion was defined as the lesion with the highest PI-RADS score on multi-parametric magnetic resonance imaging(mpMRI);in cases of identical scores,the largest was designated as the dominant.SB was categorized as ipsilateral(ipsi-SB)or contralateral(contra-SB)to the dominant lesion.The consistency in detecting clinically significant prostate cancer(csPCa)was compared between TB with ipsi-SB(TB+ipsi-SB),TB with contra-SB(TB+contra-SB),and TB with SB(TB+SB).Subgroup analyses were performed based on PI-RADS score,prostate-specific antigen(PSA)level,prostate volume(PV),and mpMRI lesion distribution to evaluate csPCa detection rates across different variables.Results TB+ipsi-SB demonstrated comparable detection rate to TB+SB(46.2%vs.46.8%).The K values for TB+ipsi-SB and TB+contra-SB relative to TB+SB were 0.987(95%CI:0.969-1.000,P<0.01)and 0.933(95%CI:0.892-0.974,P<0.01),respectively.Across all subgroups,TB+ipsi-SB showed the highest agreement with TB+SB.Notably,in subgroups with PI-RADS 3 and 5,PSA>0-20 ng/mL,PV<25 mL,bilateral or multiple mpMRI lesions,TB+ipsi-SB achieved complete concordance with TB+SB in csPCa detection[K=1.000(95%CI:1.000-1.000),P<0.01].Conclusion For patients with PI-RADS score ≥3,TB+ipsi-SB exhibits near-perfect consistency with TB+SB in csPCa detection while requiring fewer biopsy cores.TB+ipsi-SB represents a promising refinement of the TB+SB approach.
4.Effects of Abdominal Massage Combined with Electroacupuncture Point-through-point Method on the Circadian Clock Related Genes and Neurotransmitter Expressions of Insomnia Rats
Xuefeng ZHANG ; Sigan QIU ; Ziyue YAN ; Aikebaier GULAISAER ; Xusheng LU ; Lei GUO ; Junchang LIU ; Xingping ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(6):95-101
Objective To investigate the effects of abdominal massage combined with electroacupuncture point-through-point method on the expressions of circadian clock genes of Clock,BMAL1,PER1 and neurotransmitters contents of ACh and Glu in insomnia rats and its possible mechanism.Methods Totally 50 SD male rats were randomly divided into normal group,model group,abdominal massage group,electroacupuncture point-through-point group and combination group,with 10 rats in each group.Except for the normal group,an insomnia rat model was established by intraperitoneal injection of p-chlorophenylalanine.Abdominal massage group received abdominal massage;electroacupuncture point-through-point group was treated with flat acupuncture,"Baihui"through"Shenting","Sanyinjiao"through"Yinlingquan"(bilateral),"Shenmen"through"Neiguan"(bilateral),the electroacupuncture instrument dilatational wave,frequency of 1 Hz/20 Hz was connected;the combination group was treated with electroacupuncture through acupoints after abdominal massage;1 time/d for each treatment group,a total of 7 days.The normal group and model group were not intervened.HE staining was used to observe the pathological changes of neurons in hypothalamic tissue,the expression of Clock,BMAL1 and PER1 mRNA were detected by RT-qPCR,the expressions of Clock,BMAL1 and PER1 in hypothalamic tissue were detected by immunohistochemical staining,the expression of Clock,BMAL1 and PER1 protein in hypothalamic tissue were detected by Western blot,the contents of ACh and Glu in serum were detected by ELISA.Results Compared with the normal group,the model group rats had a longer sleep latency,shorter sleep duration,severe damage to the cellular structure of the hypothalamic tissue,and a vacuolar like change,with a decrease in the number of neuronal cells,the expressions of Clock and BMAL1 mRNA and protein in hypothalamic tissue increased,while the expressions of PER1 mRNA and protein decreased;the contents of serum ACh and Glu increased,with statistical significance(P<0.05).Compared with the model group,the abdominal massage group,electroacupuncture point-through-point group,and combination group could all shorten the sleep latency,prolong sleep duration,and improve the morphology of hypothalamic neurons,reduce the expressions of Clock and BMAL1 mRNA and protein in hypothalamic tissue,up-regulate the expressions of PER1 mRNA and protein,and reduce the contents of serum ACh and Glu,with statistical significance(P<0.05),the combination group showed the most obvious effects(P<0.05).Conclusion Abdominal massage combined with electroacupuncture point-through-point method can improve insomnia.Its mechanism may be related to the regulation of circadian clock genes Clock,BMAL1,PER1 mRNA and protein expression,as well as neurotransmitter content.
5.Analysis on NSFC Project Funding and Hotspots of Acupoints and Meridians from 1991 to 2022
Xuefeng ZHANG ; Sigan QIU ; Xusheng LU ; Gulaisaer AIKEBAIER ; Yakufu YASEN ; Junchang LIU
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(10):61-66
Objective To explore the funding situation and hot research directions of NSFC(National Natural Science Foundation of China)projects in the discipline of acupoints and meridians from 1991 to 2022;To provide reference for this discipline to apply for the NSFC.Methods National Natural Science Foundation of China was login in to query website.The acupoints and meridians discipline project from 1991 to 2022 were retrieved.The project leader,project name,supporting unit,province,funding category,funding amount,keywords and other information were extracted.The data were input to Excel 2023 to establish a database,and descriptive analysis of project funding situation was performed.Target keywords were extracted,and the word table was classified and uploaded to the micro-word cloud online to draw the word cloud map to analyze the research hotspots.Results From 1991 to 2022,the number of projects funded by the NSFC for acupoints and meridians was 173.The funding category was mainly general projects,and the supporting units were mainly TCM colleges and universities and scientific research institutions.The main research directions were meridian essence,acupoint-viscera/body related effects and mechanism of action,and the signal molecules and related pathways were the entry points.Conclusion From 1991 to 2022,the NSFC-funded acupoints and meridians disciplines are mainly based on general projects,mainly concentrated in scientific research institutions and TCM colleges and universities,with uneven regional distribution.The essence of meridians and collaterals,acupoints-viscera/body-related effects and mechanisms(mechanisms)are the key research directions.
6.Evaluation of the diagnostic value of targeted biopsy of secondary lesion in the systematic biopsy combined with targeted biopsy for clinically significant prostate cancer
Yongbing CHENG ; Haifeng HUANG ; Shan PENG ; Danyan LI ; Xuefeng QIU ; Hongqian GUO ; Weidong GAN
Chinese Journal of Urology 2024;45(6):420-423
Objective:To evaluate the diagnostic value of targeted biopsy of secondary lesion (SL) in systematic biopsy (SB) combined targeted biopsy for clinically significant prostate cancer (CsPCa).Methods:A retrospective analysis was conducted on the data of patients who underwent systematic biopsy combined target biopsy at Nanjing Drum Tower Hospital from January 2021 to February 2023, and they had at least two Prostate Imaging-Reporting and Data System (PI-RADS) score ≥3 lesions on prostate magnetic resonance imaging. The study included patients with a median age of 70 (65, 76) years old, median prostate specific antigen (PSA) was 9.1 (5.96, 13.62) ng/ml, median prostate volume was 39.1 (29.27, 53.25) ml, and median PSAD was 0.2 (0.15, 0.38) ng/ml 2.The index lesion (IL) was defined as the one with the highest PI-RADS score and SL was defined as the one with the second-highest PI-RADS score. If the two lesions had the same PI-RADS score, the one with larger maximum diameter was IL and the other one was SL. The median maximum diameter of IL and SL were 1.3 (1.06, 1.66) cm and 0.9 (0.69, 1.20) cm, respectively. The median maximum diameter ratio of IL and SL was 1.48 (1.10, 1.91), and the median maximum diameter difference of IL and SL was 0.9 (0.20, 1.89) cm. The IL in peripheral zone was found in 238 patients (62.63%) and SL in peripheral zone was found in 255 patients (67.10%). There were 204 patients (53.68%) having both IL and SL on the same side of prostate. According to the combination of PI-RADS scores of IL and SL, patients were categorized into various groups: 96 patients (25.26%) with IL3 and SL3, 79 (20.78%) with IL4 and SL3, 98 (25.78%) with IL4 and SL4, 21 (5.52%) with IL5 and SL3, 76 (20.0%) with IL5 and SL4, and 10 (2.63%) with IL5 and SL5. Targeted biopsy was performed on at least two of the most significant lesions. Comparison was performed in the detection rate of CsPCa between SB+ IL+ SL and SB+ IL (SL was omitted). To explore the factors influencing the detection rate of CsPCa, a multivariate logistic regression analysis was used. Results:The detection rate of CsPCa in this study was 78.95% (300/380) based on SB+ IL+ SL. After omitting SL target biopsy, the detection rate of CsPCa was 78.16% (297/380, P>0.05) under the condition of SB+ IL. No significant differences were noted between the two groups. The multivariate logistic regression analysis showed that PSA ( OR=1.11, 95% CI 1.05-1.20, P<0.01), prostate volume ( OR=0.98, 95% CI 0.96-0.99, P<0.01), SL maximum diameter ( OR=0.19, 95% CI 0.08-0.50, P<0.01), ratio of IL and SL maximum diameter ( OR=0.34, 95% CI 0.16-0.68, P<0.01), difference of IL and SL maximum diameter ( OR=1.50, 95% CI 1.10-2.29, P<0.05), and PI-RADS score group of IL and SL (IL3 vs. SL3 as the reference, IL4 vs. SL3 OR=4.79, 95% CI 2.21-10.91, P<0.01, IL4 vs. SL4 OR=23.11 95% CI 8.09-85.28, P<0.01, IL5 vs. SL3/4/5 OR=15.28 95% CI 5.21-48.55, P<0.01) were the influencing factors for detection rate of CsPCa. Conclusions:For patients with at least two PI-RADS score≥3 lesions on prostate magnetic resonance imaging, omitting SL can almost maintain the same detection efficacy.
7.Pathological characteristics of false-positive lesions of prostate cancer on 68Ga-PSMA-11 PET/CT
Renjie LI ; Yao FU ; Shan PENG ; Fengjiao YANG ; Feng WANG ; Hongqian GUO ; Xuefeng QIU
Journal of Modern Urology 2024;29(11):988-992
[Objective] To investigate the pathological characteristics of false-positive lesions of prostate cancer on 68Ga-PSMA-11 PET/CT based on the pathology of whole mount specimens, in order to more accurately assess the degree of malignancy within the prostate tissue and avoid overdiagnosis and unnecessary treatment. [Methods] A total of 77 patients who underwent 68Ga-PSMA-11 PET/CT before radical prostatectomy in Nanjing Drum Tower Hospital during Jan.2018 and Dec.2022 were retrospectively analyzed.The pathology of whole mount specimens was detected.Two nuclear physicians examined all imaging plates without knowing the pathological results.Two pathological physicians completed all pathological diagnosis without knowing the imaging results.The pathological characteristics of false-positive lesions were determined by matching 68Ga-PSMA-11 PET/CT and pathological specimens.To analyze the pathological features of false-positive lesions, true-negative lesions were randomly delineated and defined.The pathological features of false-positive and true-negative lesions were analyzed and compared using Fisher exact test. [Results] After the imaging and pathological sections were matched, 21(16.3%) false-positive lesions were identified.The pathological characteristics of the 21 false-positive lesions were as follows: 16 (76.2%) simple atrophy with cyst formation, 3(14.3%) prostatic nodular hyperplasia, and 2(9.5%) inflammation.The pathological characteristics of 21 true-negative lesions were: 13(61.9%) normal glands, 5(23.8%) prostatic nodular hyperplasia and 3(14.3%) simple atrophy with cyst formation.Fisher exact test showed that the proportion of simple atrophy with cyst formation in the pathological features of false-positive lesions and true-negative lesions was statistically significant (76.2% vs.14.3%, P<0.001). [Conclusion] Simple atrophy with cyst formation may be a characteristic pathological type of the false-positive lesions of prostate cancer on 68Ga-PSMA-11 PET/CT.
8.A clinical prediction model based on 68Ga-PSMA-11 PET/CT and mpMRI parameters to determine the diagnostic accuracy of targeted biopsy alone in prostate cancer population
Chaoli AN ; Xuefeng QIU ; Feng WANG ; Yao FU ; Xiaozhi ZHAO ; Hongqian GUO
Journal of Modern Urology 2024;29(3):212-218
【Objective】 To develop a clinical prediction model based on 68Ga-prostate-specific membrane antigen-11 (68Ga-PSMA-11), positron emission tomography/computed tomography (PET/CT) and multiparametric magnetic resonance imaging (mpMRI) parameters to stratify prostate cancer patients undergoing targeted biopsy, so as to avoid unnecessary systematic biopsy. 【Methods】 A total of 96 clinically significant prostate cancer (csPCa) patients who underwent 68Ga-PSMA-11 PET/CT and mpMRI prior to prostate targeted biopsy with systematic biopsy during Jan.2020 and Feb.2023 in Nanjing Drum Tower Hospital were retrospectively analyzed.By univariate and multivariate logistic regression analyses, maximum standard uptake value (SUVmax) in 68Ga-PSMA-11 PET/CT and minimum apparent diffusion coefficien (ADCmin) in mpMRI, as well as clinical parameters were evaluated to identify the independent predictors correlative with the effective diagnosis of targeted biopsy, and a clinical prediction model was constructed. 【Results】 Multivariate logistic regression analysis showed that SUVmax (OR=0.878, 95%CI: 0.804-0.959, P=0.004) and ADCmin (OR=1.005, 95%CI:1.001-1.010, P=0.027) were independent predictors of the effective diagnosis of targeted biopsy alone.The sensitivity, specificity, accuracy and area under the receiver operator characteristic curve (AUC) of the model were 0.80, 0.80, 0.83 and 0.84, respectively. 【Conclusion】 The clinical prediction model based on 68Ga-PSMA-11 PET/CT and mpMRI parameters is helpful to improve the effective diagnosis of targeted biopsy alone, and has practical value to stratify patients with csPCa so as to safely avoid systematic biopsy and effectively balance the benefits and risks.
9.Efficacy and safety of Shugan Jieyu capsule combined with mosapride in the treatment of functional dyspepsia: a multicenter, randomized, double-blind, placebo-controlled trial
Ping XU ; Biyu WU ; Bin ZHAO ; Weiwu SHI ; Xuefeng ZHANG ; Shujun LIU ; Lina MENG ; Caihua WANG ; Rongyuan QIU ; Jie WU ; Xuanping XIA ; Xiujuan YAN ; Shengliang CHEN
Chinese Journal of Digestion 2024;44(10):671-678
Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.
10.Efficacy and safety of Shugan Jieyu capsule combined with mosapride in the treatment of functional dyspepsia: a multicenter, randomized, double-blind, placebo-controlled trial
Ping XU ; Biyu WU ; Bin ZHAO ; Weiwu SHI ; Xuefeng ZHANG ; Shujun LIU ; Lina MENG ; Caihua WANG ; Rongyuan QIU ; Jie WU ; Xuanping XIA ; Xiujuan YAN ; Shengliang CHEN
Chinese Journal of Digestion 2024;44(10):671-678
Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.

Result Analysis
Print
Save
E-mail