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Objective@#To evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets (Combizym®) in the treatment of postprandial distress syndrome (PDS) in the elderly, compared with gastrointestinal motility drugs.@*Methods@#A prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry (ChiCTR-IPR-16008185). The elderly patients with PDS were randomly divided into three groups, including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks; Combizym® group with Combizym tablets 244 mg 3 times per day for 2 weeks; combined treatment group with both drugs and same doses for 2 weeks. The modified Nepean dyspepsia index (NDSI) score, discomfort intensity score and PDS score were calculated on patients before treatment, at the end of first and second week of treatment, as well as 4 weeks after treatment finished, respectively. Adverse effects were evaluated.@*Results@#A total of 323 patients from 16 tertiary hospitals in China were enrolled in this study. Among them, 105 patients were in Mosapride group, 109 in Combizym® group and 109 in combined treatment group. There were 148 males (45.8%) and 175 females (54.2%) with median age 71.4±9.0 years (60-100 years). Baseline characteristics of three groups were comparable. After treatment, the NDSI scores in three groups all decreased significantly (P<0.001), while they were similar between groups (P>0.05). The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment (P<0.001), especially in the combined treatment group. Compared with Mosapride group, the scores in Combizym® group decreased significantly after one or two weeks [discomfort intensity score: after one week, 4.0(2.5, 8.0) vs. 6.0(3.0, 10.0); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 6.0); all P<0.05. PDS score: after one week, 6.0(3.0, 9.0) vs. 7.0(3.5, 10.5); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 7.0); all P<0.05]. The efficacy rate in all patients after first week of treatment was over 15.0%. The efficacy rates after two weeks were 55.2%, 68.8% and 73.4% in Mosapride group, Combizym® group and combined treatment group, respectively. After two week treatment, the efficacy rates in Combizym® group (P=0.041) and combined group (P=0.006) were higher than that of Mosapride group. The recurrence rate of Mosapride group was 9.5%, which was significantly higher than that of Combizym® group (1.8%, P<0.05) and combined treatment group (1.8%, P<0.05). There were no serious adverse effects in the three groups.@*Conclusions@#The efficacy of Oryz-Aspergillus enzyme and pancreatin tablets is comparable with that of Mosapride in elderly PDS patients, with fewer adverse effects and low recurrence rate. Combination regimen indicates better efficacy than that of Oryz-Aspergillus enzyme and pancreatin tablets or Mosapride alone.
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Objective:To evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets (Combizym ?) in the treatment of postprandial distress syndrome (PDS) in the elderly, compared with gastrointestinal motility drugs. Methods:A prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry (ChiCTR-IPR-16008185). The elderly patients with PDS were randomly divided into three groups, including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks; Combizym ? group with Combizym tablets 244 mg 3 times per day for 2 weeks; combined treatment group with both drugs and same doses for 2 weeks. The modified Nepean dyspepsia index (NDSI) score, discomfort intensity score and PDS score were calculated on patients before treatment, at the end of first and second week of treatment, as well as 4 weeks after treatment finished, respectively. Adverse effects were evaluated. Results:A total of 323 patients from 16 tertiary hospitals in China were enrolled in this study. Among them, 105 patients were in Mosapride group, 109 in Combizym ? group and 109 in combined treatment group. There were 148 males (45.8%) and 175 females (54.2%) with median age 71.4±9.0 years (60-100 years). Baseline characteristics of three groups were comparable. After treatment, the NDSI scores in three groups all decreased significantly ( P<0.001), while they were similar between groups ( P>0.05). The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment ( P<0.001), especially in the combined treatment group. Compared with Mosapride group, the scores in Combizym ? group decreased significantly after one or two weeks [discomfort intensity score: after one week, 4.0(2.5, 8.0) vs. 6.0(3.0, 10.0); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 6.0); all P<0.05. PDS score: after one week, 6.0(3.0, 9.0) vs. 7.0(3.5, 10.5); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 7.0); all P<0.05]. The efficacy rate in all patients after first week of treatment was over 15.0%. The efficacy rates after two weeks were 55.2%, 68.8% and 73.4% in Mosapride group, Combizym ? group and combined treatment group, respectively. After two week treatment, the efficacy rates in Combizym ? group ( P=0.041) and combined group ( P=0.006) were higher than that of Mosapride group. The recurrence rate of Mosapride group was 9.5%, which was significantly higher than that of Combizym ? group (1.8%, P<0.05) and combined treatment group (1.8%, P<0.05). There were no serious adverse effects in the three groups. Conclusions:The efficacy of Oryz-Aspergillus enzyme and pancreatin tablets is comparable with that of Mosapride in elderly PDS patients, with fewer adverse effects and low recurrence rate. Combination regimen indicates better efficacy than that of Oryz-Aspergillus enzyme and pancreatin tablets or Mosapride alone.
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Objective To investigate the inhibitory effect of melatonin on TGF-β1-stimulated HSC-T6 cells and its underling mechanism.Methods The HSC-T6 cells were divided into five groups:control group,model group and three experimental groups.After being cultured for 24 h,they were replaced with FBS-free medium and treated with transforming growth factor-β1 (TGF-β1,5 ng/ml) excepted the control group,and melatonin was added immediately with different concentrations (1 nmol/L,1 μmol/L,0.1 mmol/L) in three experimental groups.After drugs incubation for 48 h,MTT assay was performed to assess the cell proliferation,immunocytochemistry were used to assess the expression levels of Smad2/3,p-Smad2/3.Results Melatonin could significantly inhibited cells proliferation simulating with TGF-β1 (P ＜ 0.05).The expression of Smad2/3 and p-Smad2/3 in TGF-β1-treated group were dramatically elevated compared to the control group(P ＜ 0.01).After being added with different concentrations of melatonin,the expression of Smad2/3 and p-Smad2/3 were strongly attenuated compared with the model group (P ＜ 0.05).Conclusion Melatonin significantly mitigates HSCs'activation,which might be related to TGF-β1/Smad signaling pathway.
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Objective To investigate the protective effects of melatonin and possible mechanisms on rats with alco-holic fatty liver (AFL). Methods All rats were randomly divided into 4 groups: normal group (n = 10), model group (n = 12) and melatonin groups (10 mg / kg, 20 mg / kg; n = 10, respectively). The model of rats’ alcoholic fatty liver was induced by intragastric influsion of ethanol for 8 weeks. The melatonin groups’ rats received melato-nin by intraperitoneal injection after intragastric infusion of ethanol. Histopathological changes were evaluated by hematoxylin and eosin staining. The expressions of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were detected by immunohistochemical methods. The detection of aspartate aminotransferase (AST) levels and alanine transarninase (ALT) levels and the total bilirubin ( TBIL) levels in serum were provided by routine laboratory methods using an autoanalyzer. The levels of malondialdehyde ( MDA) and activities of glutathione peroxidase ( GPx) were measured by spectrophotometry. Results Compared with the normal group, the liver cells of the mod-el group showed obvious steatosis and significant swelling. However, less degree and less extensive of steatosis and swelling were observed in the melatonin groups. Compared with the normal group, the levels of ALT, AST and TBIL in serum and the levels of MDA in liver homogenates were significantly increased in the model group (P <0. 01), and the activities of GPx were distinctly decreased in the model group(P < 0. 01). But in the melatonin groups, the levels of ALT, AST and TBIL in serum and the levels of MDA in liver homogenates were decreased (P< 0. 01), and the activities of GPx were increased (P < 0. 01). Additionally, melatonin lessened the expression of TNF-α and IL-6 in liver obviously (P < 0. 01). Conclusion Melatonin may inhibit the development of alcoholic fatty liver and its possible mechanism is the ability to resist oxidative stress and lessen the expression of TNF-α and IL-6 and other relevant factors in liver.
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Objective To explore the risk factors of esophageal gastric varices in patients with primary biliary cirrhosis (PBC ) .Methods From January 2008 to November 2014 ,112 PBC patients underwent gastroscopy examination and among them 24 received liver biopsy .The correlation between esophageal gastric varices and histological stage ,age ,gender ,anti‐centromere antibodies (ACA) ,platelet (PLT ) , albumin (Alb ) , total bilirubin (TBil ) , alkaline phosphatase (ALP ) , γ‐glutamyl‐transferase (GGT ) ,aspartate‐aminotransferase (AST ) ,alanine‐aminotransferase (ALT ) ,prothrombin time (PT ) and Mayo score was analyzed .Logistic regression analysis was used to identify independent risk factors predicting esophageal gastric varices in PBC patients .Results Among 112 patients with PBC ,varices was found in 62 patients (51 pure esophageal varices ,nine esophageal gastric varices and two pure gastric varices) .Among 24 patients with liver biopsy ,15 had varices (two at early histological stage Ⅰ and Ⅱ , 13 at later histological stage Ⅲ and Ⅳ ) .The ACA positive rate ,PT ,TBil and Mayo score of patients with varices were higher than those of patients without varices ;while Alb ,GGT and PLT were lower than those of patients without varices , and the differences were statistically significant (all P < 0 .01) . Multivariate Logistic regression analysis revealed that positive ACA (odds ratio (OR) = 8 .759 ,95%cofidence interval (CI) :1 .308 to 58 .637) ,Mayo score over 4 .52 (OR = 8 .941 ,95% CI :1 .145 to 69 .809) ,PLT count less than 96 .5 × 109 /L (OR = 10 .410 ,95% CI :2 .344 to 46 .224) ,TBil level over 26 .62 μmol/L(OR = 14 .348 ,95% CI :2 .945 to 69 .913) were independent risk factors predicting varices . Conclusion ACA positive ,PLT count less than 96 .5 × 109 /L ,TBil level over 26 .62 μmol/L and Mayo score over 4 .52 can help to predict esophageal gastric varices in patients with PBC .
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Silymarin has been introduced fairly recently as a hepatoprotective agent. But its mechanisms of action still have not been well established. The aim of this study was to make alcoholic fatty liver model of rats in a short time and investigate silymarin's protective effects and possible mechanisms on alcoholic fatty liver for rats. The model of rat's alcoholic fatty liver was induced by intragastric infusion of ethanol and high-fat diet for six weeks. Histopathological changes were assessed by hematoxylin and eosin staining (HE). The activities of alanine transarninase (ALT) and aspartate aminotransferase (AST), the levels of total bilirubin (TBIL), total cholesterol (TC) and triglyceride (TG) in serum were detected with routine laboratory methods using an autoanalyzer. The activities of superoxide dismutase (SOD) and glutathione peroxidase (GPx) and the level of malondialdehyde (MDA) in liver homogenates were measured by spectrophotometry. The TG content in liver tissue was determined by spectrophotometry. The expression of nuclear factor-kappaB (NF-kappaB), intercellular adhesion molecule-1 (ICAM-1) and interleukin-6 (IL-6) in the liver were analyzed by immunohistochemistry. Silymarin effectively protected liver from alcohol-induced injury as evidenced by improving histological damage situation, reducing ALT and AST activities and TBIL level in serum, increasing SOD and GPx activities and decreasing MDA content in liver homogenates and reducing TG content in liver tissue. Additionally, silymarin markedly downregulated the expression of NF-kappaB p65, ICAM-1 and IL-6 in liver tissue. In conclusion, Silymarin could protect against the liver injury caused by ethanol administration. The effect may be related to alleviating lipid peroxidation and inhibiting the expression of NF-kappaB.