ABSTRACT
Objective The incidence of gastrointestinal symptoms in diabetes is higher than that of non-diabetes.Thus,the aim of the present study was to observe the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets in the treatment of constipation in patients with type 2 diabetes mellitus.Methods This is a multicenter,randomized,double-blind,placebo-controlled,parallel group-comparison clinical research.The subjects were randomly divided into study group and control group according to 1 ∶ 1 ratio by computer generated random number method.The subjects were either treated with bifidobacterium tetragenous viable bacteria tablets (study group) or placebo (control group) for eight weeks,and they were followed up for four weeks without changing foundation therapy for diabetes.The primary outcome was the change of complete spontaneous bowel movements (CSBMs).Results A total of 234 subjects (the study group:116 cases;the control group:118 cases) from 7 centers were included in the present study.The baseline characteristics were comparable between the two groups.In the study group,the CSBMs at 0,2,4,8 and 12 weeks were 0.0(0.0,1.0),1.0(0.5,2.0),2.0(1.0,3.0),3.0(2.0,3.5),2.0(1.0,3.0) times per week,respectively,while the CSBMs of the control group at each corresponding weeks were 0.0(0.0,1.0),1.0(0.0,1.5),1.0(0.0,1.5),1.0(0.0,2.0),1.0(0.0,1.5)times per week,respectively.There is significant difference in CSBMs between the two groups (P＜0.05).Moreover,after 12 weeks treatment,the CSBMs over spontaneous bowel movements (SBMs) ratio in the study group was higher than that in the control group [0.53 (0.40,0.67) vs 0.33 (0.00,0.50),P=0.048],indicating a more complete evacuation sensation in the study group.More subjects in the study group (66.38％) reached Bristol stool classification of normal criteria than those in the control group (48.31％,P=0.005).There were significantly improvement of bowel function index in the study group [study group 42.7 (33.3,56.7),control group 60.6 (51.7,75.7),P＜0.000 1].Furthermore,the symptoms of constipation was improved,and the satisfaction for the treatment was high in the study group.There were no significant differences of the safety indicators between the two groups.Conclusions Bifidobacterium tetragenous viable bacteria tablets can be used in patients with type 2 diabetes mellitus and constipation.Compared with placebo,it improves constipation and has no obvious adverse effects.
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Objective To compare the differences in setup error ( SE) assessment and correction between three-dimensional cone-beam computed tomography ( 3DCBCT ) and four-dimensional CBCT ( 4 DCBCT ) in breast irradiation patients during free breathing after breast-conserving surgery . Methods Twenty patients with breast cancer after breast-conserving surgery were recruited for external beam breast irradiation and 4DCBCT and 3DCBCT simulation. The target volumes were delineated. Volumetric modulated arc therapy plans were designed using the MONACO v510 treatment planning system. 3DCBCT and 4DCBCT images were collected alternately five times each before breast irradiation. The CT images were matched, and the interfraction SEs were acquired. After online setup correction, the residual errors were calculated, and the SEs, systematic errors, and random errors were compared. The paired t test was used for comparison between groups. Results The SEs acquired by 4DCBCT were significantly larger than those acquired by 3DCBCT in three directions ( P=0035, 0018, 0040 ) . After online setup correction, the random errors based on 3DCBCT were significantly smaller than those based on 4DCBCT in left-right and anterior-posterior ( AP ) directions ( 0.5± 039 mm vs. 0.7± 030 mm, P=0005;0.9± 109 mm vs. 1.2± 048 mm, P=0000) , and the residual errors based on 3DCBCT were also significantly smaller than those based on 4DCBCT in AP direction (0.2±033 mm vs. 0.6±063 mm, P=0000). The setup margins based on 4DCBCT was significantly larger than those based on 3DCBCT in AP direction both before and after online setup correction (P=0002). Conclusions Compared with 3DCBCT, 4DCBCT has more advantages in monitoring the SEs in three directions. Both 3DCBCT and 4DCBCT have similar efficacy in random error correction. The satisfying position repeatability and minimized target volume margins will be achieved by online setup correction.
ABSTRACT
Objective To compare the differences in setup error ( SE) assessment and correction between three-dimensional cone-beam computed tomography ( 3DCBCT ) and four-dimensional CBCT ( 4 DCBCT ) in breast irradiation patients during free breathing after breast-conserving surgery . Methods Twenty patients with breast cancer after breast-conserving surgery were recruited for external beam breast irradiation and 4DCBCT and 3DCBCT simulation. The target volumes were delineated. Volumetric modulated arc therapy plans were designed using the MONACO v510 treatment planning system. 3DCBCT and 4DCBCT images were collected alternately five times each before breast irradiation. The CT images were matched, and the interfraction SEs were acquired. After online setup correction, the residual errors were calculated, and the SEs, systematic errors, and random errors were compared. The paired t test was used for comparison between groups. Results The SEs acquired by 4DCBCT were significantly larger than those acquired by 3DCBCT in three directions ( P=0035, 0018, 0040 ) . After online setup correction, the random errors based on 3DCBCT were significantly smaller than those based on 4DCBCT in left-right and anterior-posterior ( AP ) directions ( 0.5± 039 mm vs. 0.7± 030 mm, P=0005;0.9± 109 mm vs. 1.2± 048 mm, P=0000) , and the residual errors based on 3DCBCT were also significantly smaller than those based on 4DCBCT in AP direction (0.2±033 mm vs. 0.6±063 mm, P=0000). The setup margins based on 4DCBCT was significantly larger than those based on 3DCBCT in AP direction both before and after online setup correction (P=0002). Conclusions Compared with 3DCBCT, 4DCBCT has more advantages in monitoring the SEs in three directions. Both 3DCBCT and 4DCBCT have similar efficacy in random error correction. The satisfying position repeatability and minimized target volume margins will be achieved by online setup correction.
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Objective To explore the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets (BTVBT) in blood glucose control in patients with type 2 diabetes mellitus (T2DM).Methods This study was a randomized, double-blind, placebo parallel comparison, multicentre clinical research.The subjects were T2DM patients who were using anti-hyperglycemic drugs.They were randomly divided into observation group and control group according to 1∶1 ratio.The subjects accepted the therapy of BTVBT or placebo by oral administration (3 tablets, tid) for eight weeks, followed up for 4 weeks, during which the basic treatment maintained unchanged.The primary outcomes: the changes of glycosylate hemoglobin A1c (HbA1c) from baseline.Results Totally 234 subjects (116 cases in observation group and 118 cases in control group) from 7 centers were included in the study.The baseline characteristics were comparable between these two groups.The HbA1c was (8.00±1.08)％ and (7.99±1.03)％ in observation group and control group, respectively, at baseline, and was (7.28±1.28)％ and (7.36±1.02)％ after 12 weeks of treatment [(-0.66±1.38)％ vs.(-0.64±1.14)％,P=0.914 5].The secondary outcomes were as follows: the fasting blood glucose (FBG) in the observation group were (7.91±1.87)mmol/L and (8.05±2.33)mmol/L at baseline and after 12 weeks of treatment;while in the control group, the FBG were (8.51±1.68)mmol/L and (8.00±2.02)mmol/L, and comparisons between two groups showed no significant change (P>0.05).The glycated albumin in the observation group and control group were (21.38±5.74)％ and (21.93±6.51)％ at baseline;after 4 weeks of treatment, they were (20.08±6.05)％ and (20.58±7.30)％ (the changes from baseline in these two groups were (-1.19±4.37)％ and (-1.20±5.08)％];after 8 weeks of treatment, they were (19.07±5.56)％ and (20.83±8.74)％ [the changes from baseline were (-2.09±4.51)％ and (-0.98±6.85)％];after 12 weeks of treatment, they were (19.03±5.19)％ and (19.36±6.14)％ [the changes from baseline were (-2.18±4.60)％ and (-2.47±5.20)％], there were no significant differences between two groups (P>0.05).The subgroup analysis showed that in those patients with the characteristics including body mass index (BMI)≥25 kg/m2 at baseline, the duration of diabetes mellitus longer than 8 years, fasting blood glucose less than 8 mmol/L and using insulin at baseline, the changes of HbA1c from baseline to the end of 12 weeks therapy in the observation group were more than in the control group.There were no significant differences between the two groups in terms of safety profiles, including the vital signs and laboratory findings (blood cell counts, liver function, and kidney function, all P>0.05).Conclusion Administration of BTVBT in T2DM patients for 12 weeks does not remarkably improve the HbA1c.
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Objective To analyze the stability and accuracy of the equipment for three-dimensional ultrasound-based image-guided radiation therapy (3DUS-IGRT) in daily practice, and to provide a basis for clinical application of radiotherapy for soft tissue tumors.Methods A specific calibration phantom was used for continuous calibration and quality control of the 3DUS-IGRT equipment in a year.The method for daily quality control of ultrasound-guided equipment was explored, and its stability and accuracy were monitored.Results The phantom position errors in both Sim and Guide stations of the 3DUS-IGRT equipment were within 1 mm.Conclusions The 3DUS-IGRT equipment has a stable performance with the support of a complete set of stringent and accurate calibration and quality control, which provides a new image-guided method for precise radiotherapy for soft tissue tumors.
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Objective To investigate the therapeutic efficacy of endoscopic sphincterotomy (EST) for treatment of choledocholithiasis. Methods The clinical data of 326 patients receiving EST from July 1990 to January 2009 were retrospectively analyzed. Long-term follow-up was performed in 195 of the 326 patients. Results The common bile duct stones were removed in 301 cases (92. 33%).The occurring rate of complications after EST was 6.13% (20/326). Of the 20 patients, 10 had pancreatitis (3.07%), 7 hemorrhage (2. 14%), 4 cholangitis (1. 220%) and 1 duodenal perforation (0.09%). Only 1 patient died. The follow-up showed that 20 patients had reflux cholangitis and 18 recurrence of common bile duct stones. Conclusion Therapeutic endoscopy is safe and effective for treatment of choledocholithiasis.