Low-Volume Polyethylene Glycol with Ascorbic Acid for Colonoscopy Preparation in Elderly Patients: A Randomized Multicenter Study.

BACKGROUND: Minimal data exist regarding the use of low-volume purgatives for elderly (≥65 years) patients. We aimed to investigate the bowel-cleansing efficacy and patient tolerability of split-dose 2 liters (L)-polyethylene glycol with ascorbic acid (2L-PEGA) in elderly outpatients undergoing colonoscopy. METHODS: Patients who underwent morning colonoscopies were randomly assigned to one of 3 arms: single-dose 4L-PEG on the day before colonoscopy; split-dose 4L-PEG; or split-dose 2L-PEGA. The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale (BBPS). RESULTS: Of 230 patients enrolled, 198 were analyzed. The proportion of adequate bowel preparations in split-dose 2L-PEGA was higher than that in single-dose 4L-PEG (92.1 vs. 75.0%, p = 0.009) and similar to split-dose 4L-PEG. The mean BBPS scores for global and right colon preparation in the split-dose 2L-PEGA were comparable to split-dose 4L-PEG but higher than those in the single-dose 4L-PEG. The proportion of patients who ingested the entire volume of solution in 2L-PEGA was higher than that in single-dose 4L-PEG (96.8 vs. 80.9%, p = 0.011). Patients receiving 2L-PEGA expressed more willingness to repeat the same preparation than other groups. The rate of adverse events did not differ among the 3 groups. CONCLUSIONS: Split-dose 2L-PEGA was an effective, safe, and comfortable method for colonoscopy preparation in elderly outpatients.

Peri-tumor administration of 5-fluorouracil sol-gel using a hollow microneedle for treatment of gastric cancer.

The aim of this study was to investigate the effectiveness of treating gastric cancer by injecting a pluronic F-127 sol-gel formulation of 5-fluorouracil (5-FU) into normal tissue surrounding the tumor using a hollow microneedle. The MTS tetrazolium assay was performed to assess the cytotoxicity of 5-FU after application to gastric cancer cells at different concentrations for 1, 5 and 10 h. Gastric cancer cells were inoculated subcutaneously into 30 male nude mice (CrjBALB/c-nu/nu mice, male); the inoculated mouse were divided into three groups. One group received no treatment, whereas the two other groups received free 5-FU gel (40 mg/kg) and 5-FU gel (40 mg/kg) for 4 days, respectively. Mean tumor volume, apoptotic index (TUNEL) and proliferative index (Ki 67) were evaluated in all groups. Cell viability was 77.3% when 1.22 g of free 5-FU was administered, whereas cell viability was 37.4% and 43.5% when 0.122 g of free 5-FU was administered per hour for 10 h and 0.244 g of free 5-FU was administered for 5 h (p < .01). The 5-FU sol-gel induced apoptosis and significantly inhibited cell proliferation compared to the free 5-FU (p < .01). In addition, xenografted tumor growth was significantly suppressed by administration of the 5-FU sol-gel formulation to inoculated mice (p < .01), and 71% (5/7) of xenografted tumors disappeared after 4 weeks. In conclusion, peri-tumor injection of a 5-FU sol-gel formulation into normal tissue surrounding the tumor mass using a hollow microneedle is an effective method for treating gastric cancer.

Randomized controlled trial of sodium phosphate tablets vs polyethylene glycol solution for colonoscopy bowel cleansing.

AIM: To compare efficacy, patient compliance, acceptability, satisfaction, safety, and adenoma detection rate of sodium phosphate tablets (NaP, CLICOLON(TM)) to a standard 4 L polyethylene glycol (PEG) solution for bowel cleansing for adults undergoing colonoscopy. METHODS: In this multicenter, randomized, prospective, investigator-blind study, the relatively young (19-60 years) healthy outpatients without comorbidity were randomly assigned to one of two arms. All colonoscopy were scheduled in the morning. The NaP group was asked to take 4 tablets, 5 times the evening before and 4 tablets, 3 times early on the morning of the colonoscopy. The PEG group was asked to ingest 2 L of solution the evening before and 2 L early in the morning of the procedure. Adequacy of bowel preparation was scored using the Boston bowel preparation scale. RESULTS: No significant differences were observed between the NaP group (n = 158) and PEG group (n = 162) in bowel cleansing quality (adequate preparation 93.0% vs 92.6%, P = 0.877), patient compliance (P = 0.228), overall adverse events (63.3% vs 69.1%, P = 0.269), or adenoma detection rate (34.8% vs 35.2%, P = 0.944). Patient acceptability, satisfaction, and patient rating of taste were higher in the NaP group than in the PEG group (P < 0.001). CONCLUSION: NaP tablets, compared with PEG solution, produced equivalent colon cleansing, did not cause more side effects, and had better patient acceptability and satisfaction in the relatively young (age < 60 years) healthy individuals without comorbidity. An oral tablet formulation could make bowel preparation less burdensome, resulting in greater patient participation in screening programs.

[Efficacy of bisacodyl given as part of a polyethylene glycol-based bowel preparation prior to colonoscopy in hospitalized patients: a prospective ramdomized trial].

BACKGROUND/AIMS: Inpatient status can cause inadequate bowel preparation. The majority of previous studies regarding bowel preparation have focused on comparing the effects of different purgative regimens in outpatients. However, data on bowel preparation for inpatients are lacking. The aim of this study was to investigate whether bisacodyl plus polyethylene glycol (PEG) can improve bowel preparation in hospitalized patients. METHODS: A prospective, randomized and observer-blind study was performed. A total of 196 hospitalized patients undergoing colonoscopy were randomized to receive 4 L PEG (PEG only group) or 4 L PEG＋bisacodyl 10 mg (bisacodyl added group). The adequacy of bowel preparation was scored using the Ottawa bowel preparation scale. RESULTS: One hundred and eighty-three subjects completed the study; 96 in the bisacodyl added group and 87 in the PEG only group. There were no significant differences between the bisacodyl added group and the PEG only group with respect to the score of bowel cleansing (3.59±B1;2.81 vs. 3.82±B1;3.03, p=0.607), quality of bowel cleansing (adequate preparation 89.6% vs. 85.1%, p=0.380), and overall adverse events (66.7% vs. 52.9%, p=0.057). However, a larger proportion of patients in the PEG only group were able to ingest the entire solution as prescribed than in the bisacodyl added group (98.9% vs. 75.0%, p<0.001). CONCLUSIONS: In hospitalized patients, the quality of bowel preparation did not differ depending on whether bisacodyl is added or not. In addition, patient compliance based on consumption of cleansing agent was better in the PEG only group.

A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients.

BACKGROUND/AIMS: A dietary regimen consisting of a clear liquid diet (CLD) for at least 24 hours is recommended for colonoscopy preparation. However, this requirement results in problems in patient compliance with bowel preparation. The aim of this study was to evaluate the efficacy of a CLD compared with a regular diet (RD) for colonoscopy preparation using a polyethylene glycol (PEG) solution. METHODS: This was a multicenter, randomized, investigator-blind prospective study. A total of 801 healthy outpatients undergoing afternoon colonoscopy were randomized to either a CLD or RD in addition to a 4 L PEG regimen. RESULTS: The quality of bowel cleansing was not different between the CLD and RD groups in terms of the proportion with excellent or good preparation. In addition, no significant differences were observed between the two groups for polyp and adenoma detection rates and overall adverse events. Good compliance with bowel preparation was higher in the RD group than in the CLD group. CONCLUSIONS: A CLD for a full day prior to colonoscopy should not be mandatory for PEG-based bowel preparation. Dietary education concerning the avoidance of high-fiber foods for 3 days before colonoscopy is sufficient, at least for healthy outpatients.

Surface modification of pancreatic islets using heparin-DOPA conjugate and anti-CD154 mAb for the prolonged survival of intrahepatic transplanted islets in a xenograft model.

This study proposes a combination method of using 3,4-dihydorxy-l-phenylalanine (DOPA) conjugated heparin (heparin-DOPA) and a low dose of anti-CD154 monoclonal antibody (MR-1) treatment to improve the survival time of intrahepatic islet xenograft. To inhibit instant blood mediated inflammatory reactions, heparin-DOPA was directly grafted to the pancreatic islet surface. The surface coverage of heparin-DOPA, the viability and functionality of heparin-DOPA grafted islets were evaluated. In addition, the combined effect of grafted heparin-DOPA and a low dose of MR-1 (a T-cell targeting immunosuppressive drug) on the survival of islet was evaluated in a xenograft model. Both unmodified islets and heparin-DOPA grafted islets were completely rejected within 2 weeks after intraportal transplantation. However, when 0.1 mg/mouse of MR-1 was administered (at day 0, 2, 4, 6 of transplantation) to 11 mice that had heparin-DOPA grafted islets transplanted to, seven out of the recipients maintained normoglycemia over 60 days. Therefore, we propose that a developed combinatory immunoprotection protocol of surface modification of pancreatic islets using heparin-DOPA with a low dose of MR-1 can be effective in prolonging the survival rate of transplanted islets in a xenograft model.

Molecularly engineered islet cell clusters for diabetes mellitus treatment.

Pancreatic islet transplantation is a promising method for curing diabetes mellitus. We proposed in this study a molecularly engineered islet cell clusters (ICCs) that could overcome problems posed by islet transplantation circumstances and host's immune reactions. A gene containing highly releasable exendin-4, an insulinotropic protein, was delivered into single islet cells to enhance glucose sensitivity; thereafter, the cells were reaggregated into small size ICCs. Then the surface of ICCs was modified with biocompatible poly(ethylene glycol)-lipid (PEG) (C18) for preventing immune reactions. The regimen of ICCs with low doses of anti-CD154 mAb and tacrolimus could effectively maintain the normal glucose level in diabetic mice. This molecularly engineered PEG-Sp-Ex-4 ICC regimen prevented cell death in transplantation site, partly through improving the regulation of glucose metabolism and by preventing hypoxia- and immune response-induced apoptosis. Application of this remedy is also potentially far-reaching; one would be to help overcome islet supply shortage due to the limited availability of pancreas donors and reduce the immunosuppressant regimens to eliminate their adverse effects.