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Background: Dietary fiber is strongly recommended as the basic treatment for functional constipation according to global guidelines. However, a complete evaluation standard for the laxative functional food remains to be improved in China. Aims: To evaluate the efficacy and safety of the laxative function of a compound fructose-oligosaccharide fiber granule, so as to provide evidence-based medical basis for the evaluation of laxative functional food. Methods: In a randomized, double-blind, parallel and controlled trial with placebo as control, 120 subjects with functional constipation were enrolled in 2 clinical research centers in Beijing, and randomly divided into experimental group and control group (60 cases in each group). Subjects in experimental group were given a compound fructose-oligosaccharide fiber granule dissolved in 50 mL water orally, 1 bag (9 g) per day for 2 weeks; while those in control group were given a placebo granule with the same appearance, specification and dosage as the experimental group. The bowel movement frequency per week, defecation status and stool consistency were recorded before and after the test, and the safety tests were completed. Results: After 2 weeks of treatment, the bowel movement frequency in experimental group increased by (1.63±1.57) times per week, the stool consistency assessed by Bristol stool form scale and the difficulty in defecation were also improved as compared with the baseline (all P<0.05). Furthermore, improvements in experimental group were superior to those in control group (all P<0.05). No allergic and other adverse events were reported during the test, and there were no significant changes in blood, urine, stool routine and blood biochemical indices before and after the test. Conclusions: The compound fructose-oligosaccharide fiber granule tested in this study is proved to have laxative effect and is safety for functional constipation. The testing program is scientific and of feasibility, and may provide a methodology basis for human oral administration trials of laxative functional food.
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OBJECTIVE To observe the preventive effect of and to study the immunomechanism of Fangan 1 prescription (traditional Chinese medicine prescription) on repetitive upper respiratory infection in aged people. METHODS Sixty five old patients with repetitive upper respiratory infection as study objects were divided randomly into treatment group and control group and their T lymphocyte subset was detected. RESULTS CD3 and CD4 were decreased in different degree among them, the difference was significant in comparison with the healthy aged (P
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Objective To evaluate the therapeutic effects and dose-effect relationships of different doses of the blood-cooling and blood flow-promoting drugs(凉血活血方) on radiation-induced lung injury of rat.Methods Seventy-two Wistar rats were randomly allocated into four groups: irradiation group(group A),small-dose group(group B,9 g?kg-1?d-1),middle-dose group(group C,18 g?kg-1?d-1) and high-dose group(group D,36 g?kg-1?d-1).All groups were repeatedly exposed to small dose of X-ray in the right hemi-thorax,and then the mice were sacrificed at different time points.The living animal features,the macro-changes of lung were observed,and pulmonary histopathological changes in all the groups were investigated,and the results of observation were compared.Results The symptoms of red patches around the nose and dry stool in groups C and D were less than those of groups A and B.After 26 weeks,lung coefficient in groups B,C and D was the same as that in group A,but right lung wet weights and lung coefficients at each time point in groups B,C and D were significantly lower than those in group A,and during 5th week,the right lung wet weights in groups C and D were obviously lower than the weight in group B(all P
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Objectives:To explore the possibility of using experimental animal models as a new means for studying the pathogenesis and symptomatologic development of radiation-induced lung injury,and provide theoretical and experimental evidences for early prevention and treatment with the traditional Chinese medicine.Methods:80 female Wistar rats were divided randomly into the model group and control group with 40 rats in each group respectively.The rats in model group were anesthetized and fixed,and a 2cm?3cm area of the right lungs received 6mV X-ray radiation at 3Gy?2/w and a maximal 10/5w.Eight rats randomly selected from each group were sacrificed at the end of weeks of 3,5,8,12 and 26.Diagnostic techniques of TCM were employed to analyze symptomatological and developmental characteristics of TCM in radiation-induced lung injury during exposure by dynamic examination and comparison of living rats,gross lung samples and tissue sections.Results: Signs and symptoms including redness around nose and eyes,yellowish secretion,tachypnea,dry stool,lethargy,sluggishness, inactiveness were observed in model group in early stage of radiation exposure,which consistent with dominant heat in the interior and primordial qi exhaustion syndrome.Swollen lungs,bright redness on surface and red bleeding patches were observed in early stage of radiation;microscopic examination showed interstitial tissues,and readily visible congestion,hemorrhage and edema of pulmonary interstitial tissues,consistent with damaged blood collaterals by heat and blood escaping circulation syndrome.In the later stage of radiation exposure,the lungs showed dark appearance,apparent purple petechia,hard texture and poor elasticity.Microscopic examination showed remote hemorrhage foci,pulmonary capillary stasis or closure,and focal fibrotic clumps,consistent with obstruction of collaterals by blood stasis syndrome.No abnormal changes were observed in the control group.Conclusions:Animal experiments can redeem the clinical inadequacy of traditional inspection,auscultation and olfaction,interrogation and feeling pulse and palpation diagnostic techniques,modern pathological methods can be utilized to study symptomatology of traditional Chinese medicine.Symptomatological and developmental characteristics of'heat toxin impairment in radiation-induced lung injury characterized by heat damaging pulmonary collateral syndrome in early stage and pulmonary collateral stagnation syndrome in the advanced stage'can be revealed at living organism,gross lung sample and microscopic pulmonary tissue levels,thus providing theoretical basis for early prevention and treatment of radiation-induced lung injury using'cooling blood to remove apthogenic heat'.