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AIM: To evaluate the clinical efficacy and safety of He-wei-zhi-xie (HWZX) capsules in diarrhea patients. METHODS: The clinical study was conducted in 35 clinical trials centers from October 2015 to December 2017 by multicenter, prospective, open and uncontrolled design methods. The primary efficacy endpoint is the effective rate of diarrhea, the secondary endpoints include recovery rate of diarrhea, recovery time of diarrhea, number of irregular stools and Leeds dyspepsia questionnaire. The pharmacodynamics model of time course was established by nonlinear mixed effect model, and the effect of covariates on pharmacodynamic parameters was investigated. The safety measures were the incidence of adverse events, adverse reactions and the laboratory test indicators. RESULTS: A total of 2 285 cases were included in full analysis set. The effective rate of diarrhea was 90.8%, and the diarrhea recovery rate was 77.3%. The median time of recovery was 3 days, and the Leeds score was reduced by 3.6 points. It is found that baseline has a significant effect on model parameter E
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Objective To study the expression of Akt and MAPK in the stomach and colon of slow transit constipation (STC) in rats, as well as the effect of exogenous glial cell line-derived neurotrophic factor (GDNF) on it. Methods Forty-four SD rats were divided into control group and model group randomly. The STC model group was established by gastric irrigation of rhubarb for 3.5 months. The control group was received normal saline. After model building, each group was equally divided into 2 subgroup randomly, administrated with exogenous GDNF and normal saline by vein injection for one week respectively. The expression of Akt and MAPK in stomach and colon was detected by immunohistochemistry.Results ( 1 ) The expression of Akt in the stomach tended to weaker in STC rats comparing with the normal rats ( P ＞ 0. 05 ), but it was stronger in STC plus GDNF group than in STC group ( P ＜ 0. 05 ). ( 2 ) The expression of Akt and MAPK in the colon was weaker in STC group than in the normal group ( all P ＜0. 05 ), and was stronger in STC plus GDNF group than in STC group ( all P ＜ 0. 05 ). ( 3 ) The expression of MAPK in the stomach in STC group was weaker than in normal group (P ＜ 0.05 ), and was stronger in STC plus GDNF group than in STC group (P ＜0.01 ). There was no significant difference among STC plus GDNF group, normal group and GDNF group (P ＞ 0. 05 ). Conclusions Long term consumption of rhubarb could induce STC by down-regulating the expression of Akt and MAPK in digestive tract. Exogenous GDNF may have a potential role on the etiology of STC.
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Objective To assess the efficacy and safety of esomeprazole in long-term or intermittent treatment of gastroesophageal reflux disease (GERD). Methods Twenty-eight patients with GERD who accepted esomeprazole 20 mg bid for 2 weeks were further divided into long-term treatment group and intermittent treatment group according to the protocol of therapy. Patients in long-term treatment group were received minimum dose that was needed to relief the symptoms for more than 6 months, whereas those in intermittent treatment group were received esomeprazole 20 mg qd until the symptoms completely disappeared, if symptoms relapsed the patients were treated again.The dosage, recurrence of symptoms and the side effects were compared between two groups. ResultsThirteen patients in long-term treatment group were treated for 7-44 months (20 mg daily in 7,twice daily in 5 and every other day in 1). While 15 patients in intermittent treatment group had a good relief of the symptoms. No adverse reactions was found in two groups. The follow-up study of 10-57 months in intermittent treatment group revcaled that the longer the treatment maintained,the longer the symptoms relieved (r=0. 447, P= 0. 008). Conclusion It is safe for esomeprazole in relieving symptoms of patients with GERD by long time or intermittent use.