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Objective To investigate the efficacy of different adding times,treatment courses and doses of bifidobacterium and lactobacillus triple live bacteria in Helicobacter pylori (Hp) eradication.Methods A total of 280 patients Hp-infected were enrolled and randomly assigned to five groups.Group A received lansoprazole 30 mg,clarithromycin 500 mg and amoxicillin 1,000 mg bid for 14 days;group B received bifidobacterium and lactobacillus triple live bacteria 2,000 mg tid for 14 days followed by regimen of group A for another 14 days;group C1 received regimen of group A with addition of bifidobacterium and lactobacillus triple live bacteria 2,000 mg bid for 14 days;group C2:regimen of group A with addition of bifidobacterium and lactobacillus triple livc bacteria 2,000 mg tid for 14 days;and group D received regimen of group C2 followed by bifidobacterium and lactobacillus triple live bacteria 2,000 mg tid for another 14 days.4 weeks after end of treatment,Hp eradication was assessed by 13C-urea breath test.Adverse effects during the courses of treatment were recorded.Results A total of 252 (90.0％) patients completed the treatment.The completion rate in group A,B,C1,C2,and D were 78.6％ (44/56),92.9％ (52/56),87.5％ (49/56),96.4％ (54/56),and 94.6％ (53/56) respectively;the completion rate was significantly higher in group B,C2 and D than in group A (P ＜ 0.05),but there were no differences among groups B,C2 and D (P ＞ 0.05).According to intention-to-trcat (ITT) analysis,the eradication rate was 62.5％,80.4％,69.6％,85.7％,and 87.5％ in groups A,B,C1,C2,and D respectively.The eradication rate in groups B,C2 and D was significantly higher than that in group A (x2 =4.375,P =0.036;x2 =7.864,P =0.005;x2 =9.333,P =0.002),and the eradication rate was higher in group C2 than in group C1 (x2 =4.171,P =0.041),but there were no differences among groups B,C2 and D (P ＞0.05).As for per-protocol (PP) analysis,the eradication rate was 79.5％,86.5％,79.6％,88.9％ and 92.5％ in groups A,B,C1,C2,and D respectively,but no significant statistical differences were found among the five groups (P ＞ 0.05).Adverse effects included nausea,bloating,taste distortion,anorexia and constipation.The rate of adverse effects in groups A,B,C1,C2 and D was 67.9％ (38/56),26.8％ (15/56),35.7％ (20/56),21.4％ (12/56),and 17.9％ (10/56) respectively.The incidence rate was significantly lower in groups B,C2 and D than in group A (P ＜ 0.05),but no significant statistical differences were found among groups B,C2,and D (P ＞ 0.05).Conclusions The triple therapy combined with bifidobacterium and lactobacillus triple live bacteria can obviously decrease the adverse effects and improve patient compliance,thereby increasing the rate of Hp eradication.14-day therapy with probiotics is the best regimen.
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Therapeutic monoclonal antibodies become the major product class within the biopharmaceutical market. Protein A as the first capture step is still dominant in current platforms for purification of monoclonal antibodies. In this study, we developed a new antibody harvest process that incorporates acidic treatment of cell harvest, demonstrating high process yield, improved clearance of host cell associated contaminants, like non-histone host cell protein, histone, DNA and heteroaggregates. Host protein contamination was reduced about 10-fold compared to protein A loaded with harvest clarified by centrifugation and microfiltration. Turbidity increase of eluted IgG upon pH neutralization was nearly eliminated. Residual levels of impurities in the protein A eluate were achieved that potentially meet requirements of drug substance and thus alleviate the burden for further impurities removal in subsequent chromatography steps. The mechanism of host cell associated contaminants removal during acidic treatment was also explored. After a polishing step by Capto adhere, host cell protein was reduced to less than 5 ppm, DNA less than 1 ppb, histone to undetectable level, heteroaggregates less than 0.01% with total IgG recovery around 87%. This efficient process can be easily integrated into current IgG purification platforms, and may overcome downstream processing challenges.
Subject(s)
Antibodies, Monoclonal , Biotechnology , Chromatography, Affinity , DNA , Histones , Hydrogen-Ion Concentration , Immunoglobulin G , Staphylococcal Protein A , ChemistryABSTRACT
This article was aimed to investigate the effect of theXin-Jiang-Tang(XJT) Granules on activity of hepatic glycometabolic key enzymes and liver function in streptozotocin (STZ)-induced type 2 diabetes mellitus (T2DM) rats. Fifty male SD rats were randomly divided into the normal control group with 8 rats fed with normal diet, and other rats in the model group fed with high-fat diet for 4 weeks. And then, STZ (40 mg·kg-1) was peritoneally injected once to induce T2DM rat model. The model rats were randomly divided into the T2DM model group, metformin (0.15 g·kg-1) group, and high-dose (12.64 g·kg-1) and low-dose (6.32 g·kg-1) XJT Granules group. The intragastric administration was given once a day for 8 weeks. After 8-week intervention, fasting blood glucose (FBG), fasting serum insulin (FINS), glycosylated hemoglobin (HbA1c), hepatic glycogen, serum ALT, AST, ALP,γ-GT and the activity of HK, PFK, PK, and G6PDH were detected. The results showed that comparing with the model group, XJT Granules group can obvious reduce FBG, FINS, HOME-IR, HbA1c and liver function indexes such as ALT, AST, ALP,γ-GT levels (P < 0.05,P < 0.01), increase the content of hepatic glycogen (P < 0.01), and the activity of HK, PFK, PK and G6PDH (P < 0.05,P < 0.01). It was conclude that XJT Granules can remarkably regulate glycometabolism of diabetic model rats and the regulatory mechanism may be associated with the increasing of HK, PFK, PK and G6PDH activity, promoting the synthesis of hepatic glycogen, improving liver function, downregulating FINS level, improving insulin resistance and eventually decreasing the level of FBG and HbA1c of T2DM rats.
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Objective To evaluate narrow band imaging (NBI) assisted argon plasma coagulation (APC) in treatment of Barrett's esophagus (BE). Methods Suspected BE lesion was observed under white light, NBI and magnification, biopsies were taken at the site with characteristic pit pattern and capillary architecture of BE. A total of 86 patients with pathologically confirmed BE were randomly divided into NBI group (n= 42) to receive APC under NBI, or control group (n= 44) to receive APC under whit light. For APC procedure, the probe was inserted through biopsy channel to reach 1 cm beyond the endoscope tip, and was located 1-2 cm from the lesion to assure safe use. All patients were followed up with endoscopy and biopsy at 3 and 6 months after APC, respectively. Results There was no significant difference between 2 groups in effective rate of BE mucosal eradication at 3 and 6 months after APC procedure (P > 0.05). Conclusion NBI assisted APC is safe and effective in eradication of BE epithelium, in reducing procedure time and in relieving of functional gastrointestinal symptoms related with BE.