1.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.
2.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.
3.Characteristics and influencing factors of carotid ultrasound in 169 patients with human immunodeficiency virus/acquired immunodeficiency syndrome
Caihua MA ; Lei WANG ; Xue LIN ; Chunhui JIA ; Yanling LI ; Xiaojing SONG ; Yang HAN ; Zhifeng QIU ; Taisheng LI ; Wei LYU
Chinese Journal of Infectious Diseases 2021;39(3):145-151
Objective:To investigate the occurrence of carotid artery abnormalities in human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients and the related risk factors affecting the occurrence of carotid artery abnormalities.Methods:A total of 169 regular follow-up outpatients with HIV/AIDS from April 2003 to December 2019 in Peking Union Medical College Hospital, whose carotid artery ultrasound examination were performed from July 2015 to December 2019 were included. The patients were divided into young (≤44 years old), middle-aged and elderly (≥45 years old) according to their ages, and the physical examination data of the included patients were collected.The statistical methods were logistic regression analysis and single sample t test. Results:Among the 169 HIV/AIDS patients, 40(23.7%) had abnormal carotid artery and 129(76.3%) had no abnormal carotid artery. Middle-aged and elderly people (odds ratio ( OR)=3.85, 95%confidence interval (95% CI) 1.54-9.65, P<0.01), hypertension ( OR=6.24, 95% CI 1.95-20.00, P<0.01), hyperlipidemia ( OR=2.44, 95% CI 1.00-5.93, P<0.05), and elevated human leucocyte antigen (HLA)-DR + CD8 + /CD8 + ( OR=1.03, 95% CI 1.01-1.06, P<0.05) were the risk factors for carotid artery abnormality. The common carotid artery inner medium film thickness (IMT) of patients in HIV/AIDS group Ⅰ (20 to 30 years old), group Ⅱ (31 to 40 years old), group Ⅲ (41 to 50 years old) were (0.061 0±0.001 2), (0.062 9±0.001 4) and (0.065 6±0.002 6) cm, respectively, which were thicker than the control groups ((0.051±0.003), (0.056±0.004) and (0.063±0.002) cm, respectively). The differences were all statistically significant ( t=5.119, 4.775 and 1.739, respectively, all P<0.05). The common carotid artery IMT of patients in HIV/AIDS group A (30 to 44 years old) and group B (45 to 59 years old) were (0.062 6±0.001 1) and (0.072 3±0.003 4) cm, respectively, which were thicker than the control groups ((0.052±0.011) and (0.064±0.015) cm, respectively), the differences were both statistically significant ( t=9.520 and 3.012, respectively, both P<0.01). Conclusion:Younger HIV-positive people have a higher probability of abnormal carotid arteries and may be at greater risk of cardiovascular disease than HIV-negative people of the same age, suggesting that HIV-positive people, especially young people, should be examined early with ultrasound of the neck arteries to detect abnormalities and intervene as soon as possible.
4.Effect of thyroxine replacement therapy with residual subclinical hypothyroidism on the success rate of catheter ablation in elderly patients with atrial fibrillation
Yingwei CHEN ; Weihua GUO ; Xiaofei QIN ; Caihua SANG ; Deyong LONG ; Ronghui YU ; Zhanying HAN ; Chunguang QIU ; Jingzeng DONG ; Changsheng MA
Chinese Journal of Geriatrics 2017;36(7):735-738
Objective To investigate the effect of thyroxine replacement therapy with residual subclinical hypothyroidism on the success rate of catheter ablation in elderly patients with atrial fibrillation(AF).Methods Among the consecutive patients with AF who underwent a first AF ablation in our center between 2009 and 2012,we identified 56 patients(41 paroxysmal AF,15 persistent AF)with subclinical clinical hypothyroidism after receiving thyroid hormone replacement therapy as study group.The control group consisted of 56 patients with euthyroidism and no history of thyroid dysfunction.All patients underwent catheter ablation.Results At the end of follow up,37.5%(21/56)patients were AF free after the first procedure in the study group,in comparison to 64.3%(36/56)in control group(χ2=8.655,P=0.003).Last procedure was performed in 27 patients of study group and in 15 patients of control group.After the last performed ablation,62.5%(35/56)study group patients and 80.4%(45/56)controls group patients had no recurrence(χ2=4.653,P=0.031).The major complications rate did not differ between two groups(P=0.642).Conclusions Thyroid hormone replacement therapy with residual subclinical hypothyroidism reduces catheter ablation success rate in elderly patients with atrial fibrillation.
5.Clinical differential diagnosis value of detecting serum underglycosylated IgA1 in IgA nephropathy
Qiang QIU ; Caihua LIE ; Cuiming CAO ; Yuansheng XIE ; Xiangmei CHEN
Chinese Journal of Nephrology 2008;24(6):373-376
Objective To evaluate the clinical value of detecting serum underglycosylated IgA1 in diagnosis and differentiation of lgA nephropathy (IgAN). Methods Serum underglycosylated IgA1 was isolated by microspincolumn coupled with vicia villosa lectin (VVL) from 48 cases with IgAN and 43 cases with other primary glomemlonephritis. All the patients were diagnosed by renal biopsy. Sera from 20 healthy persons were used as control group. After isolation, the eluant with rich underglycosylated lgAl was detected by incubation with biotin- labeled horseradish peroxidase (HRP) and Helix aspersa (HAA, recognizing N-acetylgalactosamine specifically)in enzyme-linked immunosorbent assay (ELISA). The sensitivity and specificity of diagnosis and differentiation of IgAN with elevated serum underglycosylated IgA1 were analyzed. Results The level of serum underglycosylated IgA1 in IgAN patients [(83.7±41.0) U] was significantly higher than that in healthy control group [(52.6±22.9) U] and the patients with other primary glomerular diseases[(49.2±27.3) U] (all P<0.01). Twenty-two cases of non-IgA mesangial proliferative glomerulonephritis accounted for 51% of other primary glomerular disease, whose underglycosylated IgA1 level [(47.6±21.5 ) U] (all P<0.01 ) was significantly lower as compared to IgAN patients. Taking the renal biopsy diagnosis as golden diagnostic criteria, the ROC curve was performed. The area under the curve was 0.797 with a standard error 0.047 (P<0.01). The sensitivity as a diagnostic test was 72.9%, with specificity 72.1% and accuracy 72.5%. Conclusion Detection of serum underglycosylated lgAl level by mierospineolumn method and ELISA assay has certain clinical value in diagnosis and differentiation of IgAN.
6.Psychological Investigation and Treatment of Functional Dyspepsia
Jianweng WANG ; Caihua QIU ; Cilu ZHANG
Journal of Medical Research 2006;0(06):-
Objective To explore relationship between functional dyspepsia(FD)and psychological factors,and study the efficacy of prokinetics and antianxiety drugs,antidepressants.Methods Totally 220 FD patients were assessed with SAS,SDS,then compared the scales with norm,and 132 FD patients with abnormal SAS or/and SDS scores were randomly divided into mosapride,paroxetine,and mosapride plus paroxetine groups,each group have 44 cases and were treated for 8 weeks.Mosapride group were given mosapride 5mg,tid,po;Paroxetine were given 10mg,qm,po.Mosapride plus paroxetine group were given mosapride 5mg,tid,po plus paroxetine10mg,qm,po. Results The average scores of every scale were significantly higher than that of norms(P

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