Objective:To systematically analyze the basic information,research contents and related problems in the design of literature in the research field of traditional Chinese medicine(TCM) for irritable bowel syndrome,as w...Objective:To systematically analyze the basic information,research contents and related problems in the design of literature in the research field of traditional Chinese medicine(TCM) for irritable bowel syndrome,as well as to provide reliable evidence for improving clinical efficacy of IBS.Methods:Clinical observational literatures on the treatment of irritable bowel syndrome by TCM in 2009-2019 were searched in following Chinese databases:Chinese National Knowledge Infrastructure(CNKI),Wan Fang Database,China Science and Technology Journal Database(VIP).After selection,included studies were categorized by items as publication time,author regional distribution,treatment of TCM and control group,etc..Then we analyzed and evaluated the clinical effects of TCM treatment of irritable bowel syndrome.Results:1.Of the 986 literatures retrieved,318 met the inclusion criteria,and the number of relative literatures increased year by year.2.There were 224 literatures related to syndrome differentiation,in which 20 types of TCM syndromes were involved.The top three were the syndrome of disharmony between liver and spleen,deficiency of spleen Yang and kidney Yang and deficiency of spleen with damp retention,accounting for 53.12%、15.17% and 8.48%.3.There were 90 literatures on non-dialectical medication,among which Self-made Prescriptions(自拟方) were the most commonly used,accounting for 34.44%.4.There were 39.13% of the control group using antispasmodic.Among the antispasmodic,57.58% was Pinaverium bromide.5.Only 57 literatures were related to the recurrence rate,among which 54 showed a statistically significant difference between the two groups(P<0.05).6.There were 142 literatures involved in the observation of adverse reactions of patients,and the adverse reactions mainly included dryness in the mouth,constipation,abdominal pain,diarrhea,nausea,etc..7.After the evaluation of the quality of the included literature,it was found that among the types of randomized controlled trials(RCTs),5 was class Ⅰ,27 were class Ⅱ,and 273 were class Ⅲ;In non-randomized controlled trials,13 were all class Ⅲ.Conclusion:The number of literatures on TCM treatment for irritable bowel syndrome was increasing year by year,showing that more and more attention had been paid to the clinical application and research of TCM by clinical workers and researchers.While In the clinical research of TCM treatment of irritable bowel syndrome,there were some deficiencies,such as non-standard TCM syndrome type,the main subjects of this study were irritable bowel syndrome-D and the international scale for evaluation of irritable bowel syndrome was not used in most of the experiments.Therefore,it is an urgent need for more high-quality clinical research in attempts to provide enough and reliable evidence to guide the medical care.展开更多
Objective： To evaluate the efficacy and safety of Chinese medicine （CM） decoction Chang＇an I Recipe （肠安 Ⅰ号方） in the treatment of irritable bowel syndrome with diarrhea （IBS-D）. Method： A multicenter, ran...Objective： To evaluate the efficacy and safety of Chinese medicine （CM） decoction Chang＇an I Recipe （肠安 Ⅰ号方） in the treatment of irritable bowel syndrome with diarrhea （IBS-D）. Method： A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang＇an I Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score （IBS-SSS） and the differences in adequate relief （AR） responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life （IBS-QOL） and Hospital Anxiety and Depression （HAD） scales. The safety indices included adverse events and related laboratory tests. Results： A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set （FAS）, 191 were included in the per protocol set （PPS）. In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval （CI） for difference in the effective rates between the two groups of 14.4%-40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively （95% CI 16.6%-43.4%）. The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group （FAS： 59.6% vs. 35.5%; PPS： 62.8% vs. 38.1%）. As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups （P〉0.05）. Both anxiety and depression scales of HAD were not significantly different between the two groups （P〉0.05）. No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion： Chang＇an I Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. （No,ChiCTR-TRC-09000328）展开更多
Objective To investigate the mechanism of Tojapride,a Chinese herbal formula extract,on strengthening the barrier function of esophageal epithelium in rats with reflux esophagitis(RE).Methods Ten out of 85 SD rats wer...Objective To investigate the mechanism of Tojapride,a Chinese herbal formula extract,on strengthening the barrier function of esophageal epithelium in rats with reflux esophagitis(RE).Methods Ten out of 85 SD rats were randomly selected as the sham group(n10),and 75 rats were developed a reflux esophagitis model(RE)by the esophageal and duodenal side-to-side anastomosis.Fifty successful modeling rats were divided into different medicated groups through a random number table including the model,low-,medium-,and high-dose of Tojapride as well as omeprazole groups(n10).Three doses of Tojapride[5.73,11.46,22.92 g/(kg•d)]and omeprazole[4.17 mg/(kg•d)]were administrated intragastrically twice daily for 3 weeks.And the rats in the sham and model groups were administered 10 mL/kg distilled water.Gastric fluid was collected and the supernatant was kept to measure for volume,pH value and acidity.Esophageal tissues were isolated to monitor the morphological changes through hematoxylin-eosin(HE)staining,and esophageal epithelial ultrastructure was observed by transmission electron microscopy.The expressions of nuclear factor kappa-light-chain-enhancer of activated B cells p65(NF-KBp65),κB kinase beta(IKKß),occludin,and zonula occludens-1(ZO-1)in the esophageal tissues were measured by immunohistochemistry and Western blot,respectively.Results The gastric pH value in the model group was significantly lower than the sham group(P<0.05).Compared with the model group,gastric pH value in the omeprazole and medium-dose of Tojapride groups were significantly higher(P<0.05).A large area of ulceration was found on the esophageal mucosa from the model rats,while varying degrees of congestion and partially visible erosion was observed in the remaining groups.Remarkable increase in cell gap width and decrease in desmosome count was seen in RE rats and the effect was reversed by Tojapride treatment.Compared with the sham group,the IKKßlevels were significantly higher in the model group(P<0.05).However,the IKKßlevels were down-regulated after treatment by all doses of Tojapride(P<0.01 or P<0.05).The occluding and ZO-1 levels decreased in the model group compared with the sham group(Ps0.01 or Ps0.05),while both indices were significantly up-regulated in the Tojapride-treated groups(P<0.01 or P<0.05).Conclusions Tojapride could improve the pathological conditions of esophageal epithelium in RE rats.The underlying mechanisms may involve in down-regulating the IKKßexpression and elevating ZO-1 and occludin expression,thereby alleviating the inflammation of the esophagus and strengthening the barrier function of the esophageal epithelium.展开更多
基金National Science and Technology Major Project(Major new drug de-velopment,NO.40883770)National Natural Science Foundation of China(NO.81774303)。
文摘Objective:To systematically analyze the basic information,research contents and related problems in the design of literature in the research field of traditional Chinese medicine(TCM) for irritable bowel syndrome,as well as to provide reliable evidence for improving clinical efficacy of IBS.Methods:Clinical observational literatures on the treatment of irritable bowel syndrome by TCM in 2009-2019 were searched in following Chinese databases:Chinese National Knowledge Infrastructure(CNKI),Wan Fang Database,China Science and Technology Journal Database(VIP).After selection,included studies were categorized by items as publication time,author regional distribution,treatment of TCM and control group,etc..Then we analyzed and evaluated the clinical effects of TCM treatment of irritable bowel syndrome.Results:1.Of the 986 literatures retrieved,318 met the inclusion criteria,and the number of relative literatures increased year by year.2.There were 224 literatures related to syndrome differentiation,in which 20 types of TCM syndromes were involved.The top three were the syndrome of disharmony between liver and spleen,deficiency of spleen Yang and kidney Yang and deficiency of spleen with damp retention,accounting for 53.12%、15.17% and 8.48%.3.There were 90 literatures on non-dialectical medication,among which Self-made Prescriptions(自拟方) were the most commonly used,accounting for 34.44%.4.There were 39.13% of the control group using antispasmodic.Among the antispasmodic,57.58% was Pinaverium bromide.5.Only 57 literatures were related to the recurrence rate,among which 54 showed a statistically significant difference between the two groups(P<0.05).6.There were 142 literatures involved in the observation of adverse reactions of patients,and the adverse reactions mainly included dryness in the mouth,constipation,abdominal pain,diarrhea,nausea,etc..7.After the evaluation of the quality of the included literature,it was found that among the types of randomized controlled trials(RCTs),5 was class Ⅰ,27 were class Ⅱ,and 273 were class Ⅲ;In non-randomized controlled trials,13 were all class Ⅲ.Conclusion:The number of literatures on TCM treatment for irritable bowel syndrome was increasing year by year,showing that more and more attention had been paid to the clinical application and research of TCM by clinical workers and researchers.While In the clinical research of TCM treatment of irritable bowel syndrome,there were some deficiencies,such as non-standard TCM syndrome type,the main subjects of this study were irritable bowel syndrome-D and the international scale for evaluation of irritable bowel syndrome was not used in most of the experiments.Therefore,it is an urgent need for more high-quality clinical research in attempts to provide enough and reliable evidence to guide the medical care.
基金Supported by China International Sciences and Technology Cooperation Program(No.2007DFA30560)
文摘Objective： To evaluate the efficacy and safety of Chinese medicine （CM） decoction Chang＇an I Recipe （肠安 Ⅰ号方） in the treatment of irritable bowel syndrome with diarrhea （IBS-D）. Method： A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang＇an I Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score （IBS-SSS） and the differences in adequate relief （AR） responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life （IBS-QOL） and Hospital Anxiety and Depression （HAD） scales. The safety indices included adverse events and related laboratory tests. Results： A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set （FAS）, 191 were included in the per protocol set （PPS）. In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval （CI） for difference in the effective rates between the two groups of 14.4%-40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively （95% CI 16.6%-43.4%）. The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group （FAS： 59.6% vs. 35.5%; PPS： 62.8% vs. 38.1%）. As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups （P〉0.05）. Both anxiety and depression scales of HAD were not significantly different between the two groups （P〉0.05）. No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion： Chang＇an I Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. （No,ChiCTR-TRC-09000328）
基金Supported by Natural Science Foundation of China(No.81503560)“Ten Diseases and Ten Drugs”Program and the Cultivation Research of Biological Medicine and Life Science Innovation of Beijing Municipal Science and Technology Commission(No.Z141100002214012,Z161100000116046)。
文摘Objective To investigate the mechanism of Tojapride,a Chinese herbal formula extract,on strengthening the barrier function of esophageal epithelium in rats with reflux esophagitis(RE).Methods Ten out of 85 SD rats were randomly selected as the sham group(n10),and 75 rats were developed a reflux esophagitis model(RE)by the esophageal and duodenal side-to-side anastomosis.Fifty successful modeling rats were divided into different medicated groups through a random number table including the model,low-,medium-,and high-dose of Tojapride as well as omeprazole groups(n10).Three doses of Tojapride[5.73,11.46,22.92 g/(kg•d)]and omeprazole[4.17 mg/(kg•d)]were administrated intragastrically twice daily for 3 weeks.And the rats in the sham and model groups were administered 10 mL/kg distilled water.Gastric fluid was collected and the supernatant was kept to measure for volume,pH value and acidity.Esophageal tissues were isolated to monitor the morphological changes through hematoxylin-eosin(HE)staining,and esophageal epithelial ultrastructure was observed by transmission electron microscopy.The expressions of nuclear factor kappa-light-chain-enhancer of activated B cells p65(NF-KBp65),κB kinase beta(IKKß),occludin,and zonula occludens-1(ZO-1)in the esophageal tissues were measured by immunohistochemistry and Western blot,respectively.Results The gastric pH value in the model group was significantly lower than the sham group(P<0.05).Compared with the model group,gastric pH value in the omeprazole and medium-dose of Tojapride groups were significantly higher(P<0.05).A large area of ulceration was found on the esophageal mucosa from the model rats,while varying degrees of congestion and partially visible erosion was observed in the remaining groups.Remarkable increase in cell gap width and decrease in desmosome count was seen in RE rats and the effect was reversed by Tojapride treatment.Compared with the sham group,the IKKßlevels were significantly higher in the model group(P<0.05).However,the IKKßlevels were down-regulated after treatment by all doses of Tojapride(P<0.01 or P<0.05).The occluding and ZO-1 levels decreased in the model group compared with the sham group(Ps0.01 or Ps0.05),while both indices were significantly up-regulated in the Tojapride-treated groups(P<0.01 or P<0.05).Conclusions Tojapride could improve the pathological conditions of esophageal epithelium in RE rats.The underlying mechanisms may involve in down-regulating the IKKßexpression and elevating ZO-1 and occludin expression,thereby alleviating the inflammation of the esophagus and strengthening the barrier function of the esophageal epithelium.
