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1.
Am J Nephrol ; 55(2): 202-205, 2024.
Article in English | MEDLINE | ID: mdl-37579741

ABSTRACT

Recently, hyperosmolar hyponatremia following excessive off-label use of two exchanges of 2 L icodextrin daily during peritoneal dialysis (PD) was reported. We encountered a cluster of 3 cases of PD patients who developed hyperosmolar hyponatremia during on-label use of icodextrin. This appeared to be due to absorption of icodextrin since after stopping icodextrin, the serum sodium level and osmol gap returned to normal, while a rechallenge again resulted in hyperosmolar hyponatremia. We excluded higher than usual concentrations of specific fractions of dextrins in fresh icodextrin dialysis fluid (lot numbers of used batches were checked by manufacturer). We speculate that in our patients, either an exaggerated degradation of polysaccharide chains by α-amylase activity in dialysate, lymph, and interstitium and/or rapid hydrolysis of the absorbed larger degradation products in the circulation may have contributed to the hyperosmolality observed, with the concentration of oligosaccharides exceeding the capacity of intracellular enzymes (in particular maltase) to metabolize these products to glucose. Both hyponatremia and hyperosmolality are risk factors for poor outcomes in PD patients. Less conventional PD prescriptions such as off-label use of two exchanges of 2 L icodextrin might raise the risk of this threatening side effect. This brief report is intended to create awareness of a rare complication of on-label icodextrin use in a subset of PD patients and/or PD prescriptions.


Subject(s)
Hyponatremia , Peritoneal Dialysis , Water-Electrolyte Imbalance , Humans , Icodextrin/adverse effects , Hyponatremia/chemically induced , Hyponatremia/drug therapy , Glucans/adverse effects , Glucans/metabolism , Dialysis Solutions/adverse effects , Peritoneal Dialysis/adverse effects , Peritoneal Dialysis/methods , Glucose/adverse effects , Glucose/metabolism , Water-Electrolyte Imbalance/drug therapy
2.
Cell Biochem Funct ; 40(6): 578-588, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35788958

ABSTRACT

Several biological activities of the fungal exopolysaccharide (1 → 3)(1 → 6)-ß-d-glucan (botryosphaeran) have been described in the literature, but its effects on inflammation have not been evaluated. This study aimed to investigate the action of botryosphaeran on experimental mice models of carrageenan-induced acute pleurisy and acute paw edema, and complete Freund's adjuvant-induced persistent paw edema. All botryosphaeran doses tested (1.0, 2.5, 5.0, and 10.0 mg/kg birth weight [b.w.], orally administered) reduced leukocyte recruitment, nitric oxide (NO) levels, and protein extravasation in the pleural cavity. Botryosphaeran (5 mg/kg b.w.) did not diminish edema and mechanical hyperalgesia in the paw within 4 h; however, cold allodynia was alleviated within the first 2 h. In the persistent paw inflammation model, the effects of daily oral administration of botryosphaeran (5 mg/kg b.w.) were evaluated over 3 and 7 days. The fungal ß-glucan significantly reduced the levels of the cytokines, tumor necrosis factor(TNF)-α, interleukin (IL)-6), and IL-10, in the paw homogenates in both protocols, while paw edema and the levels of advanced oxidation protein products (AOPP) only diminished on Day 7. No effect in mechanical hyperalgesia was observed. Oral treatment for 3 or 7 days also decreased the plasma levels of NO, AOPP, TNF-α, and IL-10. On Day 7, the number of leukocytes in the blood was also reduced by this treatment. Importantly, botryosphaeran did not induce inflammation in mice when administered alone over 7 days. This study demonstrated the anti-inflammatory and antinociceptive potential of botryosphaeran in these experimental models, making this fungal ß-glucan a new possibility for complementary treating acute and chronic inflammation.


Subject(s)
Hyperalgesia , beta-Glucans , Administration, Oral , Advanced Oxidation Protein Products/metabolism , Animals , Edema/chemically induced , Edema/drug therapy , Edema/pathology , Glucans/adverse effects , Glucans/pharmacology , Glucans/therapeutic use , Hyperalgesia/chemically induced , Hyperalgesia/drug therapy , Inflammation/chemically induced , Inflammation/drug therapy , Interleukin-10 , Leukocytes/pathology , Mice , Nociception , beta-Glucans/adverse effects , beta-Glucans/pharmacology , beta-Glucans/therapeutic use
3.
Nutrients ; 13(7)2021 Jul 14.
Article in English | MEDLINE | ID: mdl-34371917

ABSTRACT

Diabetes mellitus is a chronic condition characterized by increased blood glucose levels from dysfunctional carbohydrate metabolism. Dietary intervention can help to prevent and manage the disease. Food hydrocolloids have been shown to have favorable properties in relation to glycaemic regulation. However, the use of food hydrocolloids of bacterial origin to modulate glucose responses is much less explored than other types of hydrocolloids. We, therefore, carried out the first review examining the impact of intake of food hydrocolloids of bacterial origin (as a direct supplement or incorporated into foods) on glycemic response in humans. Fourteen studies met the inclusion criteria. They used either xanthan gum, pullulan, or dextran as interventions. There was a wide variation in the amount of hydrocolloid supplementation provided and methods of preparation. Postprandial blood glucose responses were reduced in half of the studies, particularly at higher intake levels and longer chain hydrocolloids. When xanthan gum was added to the cooking process of muffins and rice, a significant reduction in postprandial blood glucose was observed. The use of these hydrocolloids is potentially effective though more research is needed in this area.


Subject(s)
Bacteria/chemistry , Blood Glucose/drug effects , Dextrans/therapeutic use , Diabetes Mellitus, Type 2/drug therapy , Glucans/therapeutic use , Glycemic Control , Hypoglycemic Agents/therapeutic use , Polysaccharides, Bacterial/therapeutic use , Adolescent , Adult , Aged , Biomarkers/blood , Blood Glucose/metabolism , Colloids , Dextrans/adverse effects , Dextrans/isolation & purification , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnosis , Female , Glucans/adverse effects , Glucans/isolation & purification , Glycemic Control/adverse effects , Humans , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/isolation & purification , Male , Middle Aged , Polysaccharides, Bacterial/adverse effects , Polysaccharides, Bacterial/isolation & purification , Treatment Outcome , Young Adult
4.
Nutrients ; 10(7)2018 Jul 19.
Article in English | MEDLINE | ID: mdl-30029461

ABSTRACT

Chronic constipation (CC) remains a common gastrointestinal (GI) disorder that conveys a substantial healthcare burden. Expert guidelines recommend increasing fiber intake, yet the clinical evidence to support this needs strengthening for specific fibers. The aim was to evaluate changes in intestinal transit time and GI symptoms in CC patients who consumed polydextrose. In a randomized, double-blind, placebo-controlled trial, 128 adults with CC received 8 g or 12 g polydextrose, or placebo, daily for 4 weeks. Transit time, as primary outcome, was assessed by radiopaque marker distribution after 2-weeks intervention. Bowel habits, GI symptoms and quality of life (QOL) were assessed by questionnaire, including the Patient-Assessment of Constipation (PAC) Symptoms (SYM), and PAC-QOL. Following 2-weeks intervention, no reduction was seen in transit time in any group and following 2- or 4-weeks intervention, no improvements were seen in stool frequency or consistency in any group. After 2-weeks intervention with 8 g/day polydextrose an improvement was seen in the PAC-SYM rectal score (p = 0.041). After 4-weeks intervention both rectal (p = 0.049) and stool (p = 0.029) scores improved while improvement in the QOL satisfaction score did not reach significance (p = 0.071). Overall, the results suggest that 2-weeks consumption of 8 or 12 g/day polydextrose does not significantly improve physiological measures of gut function in CC adults. Longer term consumption may improve clinical measures, but further studies will be required to substantiate this.


Subject(s)
Constipation/therapy , Dietary Fiber/therapeutic use , Dietary Supplements , Gastrointestinal Transit , Glucans/therapeutic use , Intestines/physiopathology , Abdominal Pain/etiology , Abdominal Pain/prevention & control , Adult , Aged , Constipation/physiopathology , Dietary Fiber/administration & dosage , Dietary Fiber/adverse effects , Double-Blind Method , Female , Glucans/administration & dosage , Glucans/adverse effects , Humans , Intention to Treat Analysis , Male , Middle Aged , Patient Dropouts , Quality of Life , Self Report , Severity of Illness Index , Young Adult
5.
Hum Vaccin Immunother ; 14(9): 2189-2193, 2018.
Article in English | MEDLINE | ID: mdl-29624474

ABSTRACT

The mucosal surfaces of the respiratory and gastrointestinal tracts are continuously exposed to countless beneficial and pathologic antigens. These mucosal surfaces are thus equipped with an immune system that is unique from those elsewhere in the body; this unique system provides the first line of immune surveillance and defense against pathogen invasion. The sophisticated immune induction machinery in the aero-digestive tract involves mucosa-associated lymphoid tissues, including nasopharyngeal- and gut-associated lymphoid tissues, for the generation of antigen-specific humoral and cellular immune responses. Consequently, nasal or oral immunization with an appropriate vaccine delivery vehicle prompts the induction of protective immunity in both the mucosal and systemic compartments, leading to a double layer of protection against pathogens. To harness the benefits of mucosal vaccines, various mucosal antigen delivery vehicles are under development, and a cationic cholesteryl-group-bearing pullulan nanogel (cCHP nanogel) has emerged as a potent nasal vaccine delivery system for the induction of protective immunity against respiratory infections.


Subject(s)
Drug Carriers/administration & dosage , Glucans/administration & dosage , Polyethylene Glycols/administration & dosage , Polyethyleneimine/administration & dosage , Respiratory Tract Infections/prevention & control , Vaccines/administration & dosage , Administration, Intranasal , Drug Carriers/adverse effects , Glucans/adverse effects , Humans , Nanogels , Polyethylene Glycols/adverse effects , Polyethyleneimine/adverse effects , Vaccines/adverse effects
6.
J Immunother Cancer ; 6(1): 16, 2018 02 27.
Article in English | MEDLINE | ID: mdl-29486797

ABSTRACT

BACKGROUND: BTH1677, a beta-glucan pathogen-associated molecular pattern molecule, drives an anti-cancer immune response in combination with oncology antibody therapies. This phase II study explored the efficacy, pharmacokinetics (PK), and safety of BTH1677 combined with bevacizumab/carboplatin/paclitaxel in patients with untreated advanced non-small cell lung cancer (NSCLC). METHODS: Patients were randomized to the BTH1677 arm (N = 61; intravenous [IV] BTH1677, 4 mg/kg, weekly; IV bevacizumab, 15 mg/kg, once each 3-week cycle [Q3W]; IV carboplatin, 6 mg/mL/min Calvert formula area-under-the-curve, Q3W; and IV paclitaxel, 200 mg/m2, Q3W) or Control arm (N = 31; bevacizumab/carboplatin/paclitaxel as above). Carboplatin/paclitaxel was discontinued after 4-6 cycles and patients who responded or remained stable received maintenance therapy with BTH1677/bevacizumab (BTH1677 arm) or bevacizumab (Control arm). Efficacy assessments, based on blinded central radiology review, included objective response rate (ORR; primary endpoint), disease control rate, duration of objective response, and progression-free survival. Overall survival and adverse events (AEs) were also assessed. RESULTS: ORR was higher in the BTH1677 vs Control arm but the difference between groups was not statistically significant (60.4% vs 43.5%; P = .2096). All other clinical endpoints also favored the BTH1677 arm but none statistically differed between arms. PK was consistent with previous studies. Although a higher incidence of Grade 3/4 AEs occurred in the BTH1677 vs Control arm (93.2% vs 66.7%), no unexpected AEs were observed. Serious AEs and discontinuations due to AEs were lower in the BTH1677 vs Control arm. CONCLUSIONS: Improvements in tumor assessments and survival were observed with BTH1677/bevacizumab/carboplatin/paclitaxel compared with control treatment in patients with advanced NSCLC. TRIAL REGISTRATION: ClinicalTrials.gov registration ID: NCT00874107 . Registered 2 April 2009. First participant was enrolled on 29 September 2009.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Bevacizumab/administration & dosage , Carboplatin/administration & dosage , Carcinoma, Non-Small-Cell Lung/drug therapy , Glucans/administration & dosage , Lung Neoplasms/drug therapy , Paclitaxel/administration & dosage , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics , Bevacizumab/adverse effects , Carboplatin/adverse effects , Female , Glucans/adverse effects , Glucans/pharmacokinetics , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Paclitaxel/adverse effects , Treatment Outcome
8.
Transplant Proc ; 50(1): 160-164, 2018.
Article in English | MEDLINE | ID: mdl-29407302

ABSTRACT

OBJECTIVE: Encapsulating peritoneal sclerosis (EPS) is a serious complication for patients with chronic kidney disease (CKD) who were treated with long-term peritoneal dialysis (PD). The risk of EPS was increased after kidney transplantation. In our study we evaluated risk factors for EPS patients after kidney transplantation who were treated before with PD. MATERIALS AND METHODS: In our study, between January 2008 and August 2015, 47 PD patients (12 had EPS) who underwent kidney transplantation were analyzed. Age, gender, time of PD treatment, human leukocyte antigen (HLA) matching, cold ischemia time, kidney function (serum urea, creatinine, etc), comorbidities, immunosuppressive therapy, clinical features, and outcomes of PD patients were retrospectively evaluated in both groups. RESULTS: Mean age was 42 (range, 25-60) years in EPS patients, versus 43 (range, 22-77) years without EPS (P = .798). Distribution of gender was similar in both groups (P = .154). The C-reactive protein levels (P < .001), number of patients with peritonitis (P = .001), length of time on PD (P < .001), and serum ferritin levels (P = .020) were higher in EPS patients. The immunosuppressive therapy was changed; tamoxifen and steroids were used after diagnosis in EPS patients. HLA matching was higher in the non-EPS group (P = .006). EPS was more often seen in patients who were treated with continuous ambulatory peritoneal dialysis (CAPD; 75%; P = .036). EPS was more often detected in cadaveric transplant recipients (83.3%; P = .024). High peritoneal transmittance rate was more identified in EPS (+) patients (P = .001). EPS was more often seen in patients who were treated with icodextrin-based regimens in PD before transplantation (91.7%; P = .037). The length of time on PD and high ferritin levels increased EPS 1.08 and 1.01, respectively (P = .036 and .049, respectively), in multivariate analysis. CONCLUSION: The length of time on PD, type of PD, PD regimens with icodextrin, episodes of peritonitis, and peritoneal transmittance in patients with CKD affect the development of EPS after transplantation.


Subject(s)
Kidney Transplantation/adverse effects , Peritoneal Dialysis/adverse effects , Peritoneal Fibrosis/etiology , Postoperative Complications/etiology , Adult , Cold Ischemia/adverse effects , Creatinine/blood , Dialysis Solutions/adverse effects , Female , Glucans/adverse effects , Glucose/adverse effects , Humans , Icodextrin , Immunosuppression Therapy/adverse effects , Male , Middle Aged , Multivariate Analysis , Peritoneum/physiopathology , Peritonitis/complications , Preoperative Period , Renal Insufficiency, Chronic/complications , Retrospective Studies , Risk Factors
9.
Nephrol Ther ; 14(4): 201-206, 2018 Jun.
Article in French | MEDLINE | ID: mdl-29291942

ABSTRACT

Icodextrin is a glucose polymer derived from starch that is used as an osmotic agent in peritoneal dialysis. Its high molecular weight limits blood absorption and is useful for long dwell since there is few osmotic gradient dispersal. Its benefits are numerous: ltrafiltration optimization and better salt and water control especially in anuric patients with a high peritoneal permeability and also in case of infectious peritonitis, glucose sparing with less metabolic complications and a better preservation of peritoneal membrane, better biocompatibility. However it should not be forgotten that icodextrin has also side effects that must be known: allergies, cases of aseptic peritonitis, overintense water and salt depletion, lymphatic absorption of icodextrin and its metabolites (including maltose) with a risk of false capillary glucose rate estimation and a moderate increase in plasma osmolality. That is why it is not recommended now to use more than one daily icodextrin dwell. Nevertheless, several dialysis units use icodextrin in more than one daily dwell, especially in patients with an important ultrafiltration loss or in those in whom glucose sparing is essential. It seems to profit them with no more side effects. A large multicenter trial is in progress to test the efficacy and safety of icodextrin dwell twice a day in elder incident patients in peritoneal dialysis (DIDo). Moreover, icodextrin is also used combined with glucose in a long dwell (bimodal ultrafiltration) with encouraging results in terms of ultrafiltration and glucose sparing.


Subject(s)
Dialysis Solutions/chemistry , Glucans/administration & dosage , Glucose/administration & dosage , Peritoneal Dialysis/methods , Dialysis Solutions/adverse effects , Glucans/adverse effects , Glucose/adverse effects , Humans , Icodextrin
10.
Expert Rev Gastroenterol Hepatol ; 12(1): 83-90, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28946778

ABSTRACT

INTRODUCTION: The intestinal barrier controls the absorption of nutrients and water whilst helping to prevent the entry of toxins and pathogenic micro-organisms from the lumen into the tissues. Deficiencies in the barrier are associated with various gastrointestinal and extra digestive disorders. Areas covered: This review provides an overview of the relationship between increased intestinal permeability and disease, and considers the role of mucosal protectants (mucoprotectants) in restoring normal intestinal barrier function, with a particular focus on diarrheal disorders. Expert commentary: Impairment of the intestinal barrier characterizes a variety of diseases, and there is ongoing interest in the development of pharmacological approaches targeting the reduction of intestinal permeability. These include corticosteroids, aminosalicylates and anti-tumor necrosis factor-α (TNF-α), which act by reducing inflammation; probiotics, which modulate the production of mucin and epithelial tight junction proteins; and mucoprotectants, which form a protective film over the epithelium. Recently, preclinical and clinical data highlight, the ability of new mucoprotectants, such as gelatin tannate and xyloglucan, to protect the intestinal mucosa and to exert anti-diarrheal effects. In the future the ability of these substances to enhance the intestinal barrier may extend their use in the management of a variety of gastro-intestinal diseases associated with 'leaky gut'.


Subject(s)
Demulcents/therapeutic use , Diarrhea/drug therapy , Gelatin/therapeutic use , Glucans/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Intestinal Absorption/drug effects , Intestinal Mucosa/drug effects , Tannins/therapeutic use , Xylans/therapeutic use , Demulcents/adverse effects , Diarrhea/diagnosis , Diarrhea/metabolism , Diarrhea/physiopathology , Gelatin/adverse effects , Glucans/adverse effects , Humans , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/metabolism , Inflammatory Bowel Diseases/physiopathology , Intestinal Mucosa/metabolism , Intestinal Mucosa/pathology , Intestinal Mucosa/physiopathology , Permeability , Tannins/adverse effects , Treatment Outcome , Xylans/adverse effects
11.
Nefrologia (Engl Ed) ; 38(1): 87-91, 2018.
Article in English, Spanish | MEDLINE | ID: mdl-28760437

ABSTRACT

Severe congestive heart failure (CHF) patients are prone to hyponatremia. Peritoneal dialysis (PD) is increasingly used for long-term management of refractory CHF patients. The glucose polymer icodextrin was proposed to be a good option for fluid removal in such patients. A small, although statistically significant reduction in serum sodium (∼2mmol/l) consistently observed in multiple trials, is considered as not clinically relevant. Here we reported five refractory CHF patients who demonstrated sodium drop by median of 8meq/l (range 5.4-8.3meq/l) after icodextrin was added to their program. It seems that icodextrin may contribute to clinically relevant hyponatremia if the hyponatremia is compounded by other factors. Patients with extremely severe congestive heart failure are susceptible to this complication.


Subject(s)
Glucans/adverse effects , Glucose/adverse effects , Heart Failure/blood , Hemodialysis Solutions/adverse effects , Hyponatremia/etiology , Peritoneal Dialysis/adverse effects , Aged , Aged, 80 and over , Cardio-Renal Syndrome/complications , Combined Modality Therapy , Disease Susceptibility , Fatal Outcome , Female , Furosemide/therapeutic use , Glucans/pharmacology , Glucose/pharmacology , Heart Failure/drug therapy , Heart Failure/therapy , Humans , Hypertension, Pulmonary/complications , Icodextrin , Male , Middle Aged , Nephrosclerosis , Prognosis
12.
Geriatr Gerontol Int ; 17(12): 2514-2519, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28675566

ABSTRACT

AIM: Glutamine has various beneficial functions in the gastrointestinal tract. The present study was designed to investigate the effect of two different glutamine supplements on bowel movement at the start of enteral feeding in elderly inpatients. METHODS: This was a double-blind, prospective, randomized comparison study. A total of 25 patients aged >75 years recovering from a critical illness in a non-intensive care unit and scheduled for tube feeding were recruited. Of them, 22 consenting patients were randomly assigned to two groups: glutamine-fiber-oligosaccharide treatment group (n = 11) and glutamine F treatment group (n = 11). They were given glutamine three times daily at a dosage of 9 g/day. Enteral nutrition was given at the same dosage to both groups for the duration of the study. The end-points were stool frequency, Bristol Scale Form Score, bowel function index (Bristol Scale Form Score × stool frequency), the percentage of patients with stool frequency over three per day and those with a BSFS of 6 or 7 in each group. RESULTS: There were no significant differences between the two groups in terms of patient characteristics before the study. All the end-points in the glutamine F group were significantly lower than those in the glutamine-fiber-oligosaccharide group. CONCLUSIONS: Compared with glutamine-fiber-oligosaccharide, glutamine F administration resulted in stool hardening and reduced stool frequency in elderly inpatients recovering from acute critical illness in non-intensive care units. The effects might be caused by the different additive components of glutamine supplements. Geriatr Gerontol Int 2017; 17: 2514-2519.


Subject(s)
Defecation/drug effects , Diarrhea/chemically induced , Enteral Nutrition/adverse effects , Glucans/adverse effects , Glutamine/therapeutic use , Oligosaccharides/adverse effects , Trisaccharides/adverse effects , Aged , Aged, 80 and over , Critical Illness , Double-Blind Method , Female , Galactans/therapeutic use , Glutamine/adverse effects , Humans , Male , Mannans/therapeutic use , Plant Gums/therapeutic use , Prospective Studies
13.
Invest New Drugs ; 35(3): 345-358, 2017 06.
Article in English | MEDLINE | ID: mdl-28303530

ABSTRACT

Introduction BTH1677, a 1,3-1,6 beta-glucan immunomodulator, stimulates a coordinated anti-cancer immune response in combination with anti-tumor antibody therapies. This phase II study explored the efficacy, pharmacokinetics (PK), and safety of BTH1677 combined with cetuximab/carboplatin/paclitaxel in untreated stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Methods Patients were randomized 2:1 to the BTH1677 arm (N=60; BTH1677, 4 mg/kg, weekly; cetuximab, initial dose 400 mg/m2 and subsequent doses 250 mg/m2, weekly; carboplatin, 6 mg/mL/min AUC (area-under-the-curve) by Calvert formula, once each 3-week cycle [Q3W]); and paclitaxel, 200 mg/m2, Q3W) or Control arm (N=30; cetuximab/carboplatin/paclitaxel as above). Carboplatin/paclitaxel was discontinued after 4-6 cycles; patients who responded or remained stable received maintenance therapy with BTH1677/cetuximab (BTH1677 arm) or cetuximab (Control arm). Investigator and blinded central radiology reviews were conducted. Efficacy assessments included objective response rate (ORR; primary endpoint), disease control rate, duration of objective response, time-to-progression and overall survival (OS); safety was assessed by adverse events (AEs). Potential biomarker analysis for BTH1677 response was also conducted. Results Compared to control treatment, the addition of BTH1677 numerically increased ORR by both investigator (47.8% vs 23.1%; p=0.0468) and central (36.6% vs 23.1%; p=0.2895) reviews. No other endpoints differed between arms. PK was consistent with previous studies. BTH1677 was well tolerated, with AEs expected of the backbone therapy predominating. Biomarker-positive patients displayed better ORR and OS than negative patients. Conclusions BTH1677 combined with cetuximab/carboplatin/paclitaxel was well tolerated and improved ORR as first-line treatment in patients with advanced NSCLC. Future patient selection by biomarker status may further improve efficacy ClinicalTrials.gov Identifier: NCT00874848.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Cetuximab/therapeutic use , Glucans/therapeutic use , Lung Neoplasms/drug therapy , Paclitaxel/therapeutic use , Adult , Aged , Antineoplastic Agents/adverse effects , Antineoplastic Agents/blood , Antineoplastic Agents/pharmacokinetics , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carboplatin/adverse effects , Carcinoma, Non-Small-Cell Lung/metabolism , Cetuximab/adverse effects , Female , Glucans/adverse effects , Glucans/blood , Glucans/pharmacokinetics , Humans , Kaplan-Meier Estimate , Lung Neoplasms/metabolism , Male , Middle Aged , Paclitaxel/adverse effects , Treatment Outcome
14.
Iran J Kidney Dis ; 11(1): 70-73, 2017 01.
Article in English | MEDLINE | ID: mdl-28174356

ABSTRACT

Psoriasis vulgaris is not frequently seen in patients with renal replacement therapy, especially in patients on peritoneal dialysis. Dialysis also has been reported to improve psoriatic skin lesions with a much higher response rate for peritoneal dialysis than haemodialysis. Conversely, we present a case of a man who developed psoriasis after 16 months of peritoneal dialysis. Discontinuation of icodextrin as a possible factor provoking systemic inflammation had no impact on the course of the disease. In this report, we review the existing studies and counsel caution against optimistic expectations of benefits from dialysis in patients with psoriasis.


Subject(s)
Emollients/administration & dosage , Glucans , Glucocorticoids/administration & dosage , Glucose , Hypertension/complications , Peritoneal Dialysis , Psoriasis , Renal Insufficiency, Chronic/therapy , Administration, Topical , Dialysis Solutions/adverse effects , Dialysis Solutions/therapeutic use , Glucans/adverse effects , Glucans/therapeutic use , Glucose/adverse effects , Glucose/therapeutic use , Humans , Icodextrin , Male , Middle Aged , Peritoneal Dialysis/adverse effects , Peritoneal Dialysis/methods , Psoriasis/diagnosis , Psoriasis/etiology , Psoriasis/physiopathology , Psoriasis/therapy , Renal Insufficiency, Chronic/etiology , Renal Insufficiency, Chronic/physiopathology , Treatment Outcome
15.
J Comp Eff Res ; 6(2): 137-144, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28114795

ABSTRACT

AIM: Comparing efficacy and safety of APT198K (xyloglucan plus heat-killed Lactobacillus reuteri SGL01 and Bifidobacterium brevis SGB01) versus a lactase dietary supplement as first-line treatment of infantile colic. METHODS: Randomized, multicenter, open-label, parallel group, active-controlled study, in 46 infants aged 3-16 weeks with infantile colic, receiving APT198K or a lactase dietary supplement for 10 days. RESULTS: Number and duration of crying episodes decreased significantly versus baseline in both groups. On day 8, the mean duration of crying per episode was significantly shorter in the APT198K group compared with the lactase group (9.14 ± 5.34 vs 13.22 ± 5.29 min; p = 0.014) and remained so up to day 11. CONCLUSION: APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted. Clinical trial registry: EudraCT number 2014-002860-334; https://eudract.ema.europa.eu .


Subject(s)
Colic/drug therapy , Probiotics/administration & dosage , Abdominal Muscles/drug effects , Administration, Oral , Bifidobacterium breve , Crying , Drug Combinations , Female , Flatulence/drug therapy , Flushing/drug therapy , Glucans/administration & dosage , Glucans/adverse effects , Humans , Infant , Infant, Newborn , Limosilactobacillus reuteri , Male , Pilot Projects , Posture , Probiotics/adverse effects , Treatment Outcome , Xylans/administration & dosage , Xylans/adverse effects
16.
Clin Nephrol ; 86 (2016)(11): 283-286, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27616762

ABSTRACT

The 7.5% icodextrin solution is widely used for long-dwell in peritoneal dialysis (PD) regimens as an alternative osmotic agent to glucose. It has been defined as a biocompatible agent because of its iso-osmolarity and is generally safe and well tolerated. Icodextrin and its hydrolyzed metabolites are found in systemic circulation. In serum, icodextrin interferes with amylase determination causing a significantly decreased plasma amylase level making it unreliable for the diagnosis of acute pancreatitis. Lipase measurement provides an alternative and accurate method for diagnosing acute pancreatitis (AP) in patients using icodextrin. Icodextrin-induced acute pancreatitis is not well described. The literature appears limited to two case reports. We describe a case of a man with end-stage renal disease (ESRD) on PD who developed acute pancreatitis following icodextrin use. We also provide a novel possible mechanism for understanding how icodextrin causes AP.
.


Subject(s)
Dialysis Solutions/adverse effects , Glucans/adverse effects , Glucose/adverse effects , Pancreatitis/chemically induced , Peritoneal Dialysis , Humans , Icodextrin , Kidney Failure, Chronic/therapy , Male , Peritoneal Dialysis/methods
17.
Fertil Steril ; 106(5): 994-997.e1, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27624952

ABSTRACT

Despite use of meticulous surgical techniques, and regardless of surgical access via laparotomy or laparoscopy, postoperative adhesions develop in the vast majority of women undergoing abdominopelvic surgery. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. Application of antiadhesion adjuvants compliment the benefits of meticulous surgical techniques, providing an opportunity to further reduce postoperative adhesion development. Improved understanding of the pathophysiology of adhesion development and distinguishing variations in the molecular biologic mechanisms from adhesion-free peritoneal repair represent future opportunities to improve the reduction of postoperative adhesions. Optimization of the reduction of postoperative adhesions will likely require identification of unique, personalized approaches in each individual, representing interindividual variation in peritoneal repair processes.


Subject(s)
Cellulose, Oxidized/therapeutic use , Glucans/therapeutic use , Glucose/therapeutic use , Gynecologic Surgical Procedures/adverse effects , Hyaluronic Acid/therapeutic use , Postoperative Complications/prevention & control , Tissue Adhesions , Cellulose, Oxidized/adverse effects , Female , Glucans/adverse effects , Glucose/adverse effects , Humans , Hyaluronic Acid/adverse effects , Icodextrin , Oxidative Stress , Postoperative Complications/etiology , Postoperative Complications/metabolism , Postoperative Complications/physiopathology , Risk Assessment , Risk Factors , Treatment Outcome , Wound Healing
18.
Int J Food Sci Nutr ; 67(7): 844-56, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27346078

ABSTRACT

Two independent clinical studies were conducted to compare the gastrointestinal (GI) tolerability of corn starch fiber, a novel dietary fiber, at up to 50 g/day (single-dose study) or 90 g/day (multiple-serving study) with a negative control (no fiber) and a positive control (50 or 90 g polydextrose, for single- and multiple-serving studies, respectively) in generally healthy study volunteers. Flatulence and borborygmus were the primary symptoms reported at the higher doses of corn starch fiber and for the positive control interventions. Bowel movements were increased over 48 h with corn starch fiber at 90 g. Thresholds for mild GI effects were established at 30 g as a single dose and 60 g as multiple servings spread over the day. Other than moderate abdominal pain and mild increased appetite in one subject at 90-g corn starch fiber, no test article-related adverse events were reported.


Subject(s)
Dietary Fiber/administration & dosage , Gastrointestinal Tract/metabolism , Starch/administration & dosage , Abdominal Pain/diagnosis , Abdominal Pain/etiology , Adolescent , Adult , Appetite/drug effects , Body Mass Index , Cross-Over Studies , Defecation , Dietary Fiber/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Female , Flatulence/diagnosis , Flatulence/etiology , Gastrointestinal Diseases/diagnosis , Gastrointestinal Diseases/etiology , Glucans/administration & dosage , Glucans/adverse effects , Humans , Male , Middle Aged , Starch/adverse effects , Surveys and Questionnaires , Treatment Outcome , Young Adult
19.
Pediatr Nephrol ; 31(10): 1673-9, 2016 10.
Article in English | MEDLINE | ID: mdl-27178072

ABSTRACT

BACKGROUND: Icodextrin is a solution of glucose polymers developed to provide sustained ultrafiltration over an extended dwell. Our aim was to determine whether or not fill volume with icodextrin contributes to the ability to achieve ultrafiltration in children. METHODS: The charts of all children on chronic peritoneal dialysis between January 2000 and July 2014 were screened for the use of an icodextrin day dwell. Data were extracted from the electronic chart and the HomeChoice™ Pro card and corrected for body surface area (BSA). RESULTS: Fifty children had an icodextrin day dwell. A linear correlation was found between the daytime fill volume and net ultrafiltration (p < 0.001). More ultrafiltration was achieved with a fill volume above 550 ml/m(2) BSA (107 ± 75 ml/m(2) BSA) than with smaller fill volumes (-8 ± 99 ml; p = 0.004). Ultrafiltration was achieved in 88 % of children with a fill volume above 550 ml/m(2) BSA versus only 44 % of patients with a smaller fill volume (p = 0.001). Icodextrin was well tolerated. CONCLUSIONS: Our observations reveal that the larger the fill volume the higher the likelihood of achieving ultrafiltration with icodextrin and suggest that a minimum day dwell volume of 550 ml/m(2) BSA seems to facilitate ultrafiltration in children. To our knowledge this is the largest study addressing ultrafiltration with icodextrin in children.


Subject(s)
Dialysis Solutions/therapeutic use , Glucans/therapeutic use , Glucose/therapeutic use , Peritoneal Dialysis/methods , Ultrafiltration/methods , Adolescent , Body Surface Area , Child , Child, Preschool , Dialysis Solutions/adverse effects , Female , Glucans/adverse effects , Glucose/adverse effects , Humans , Icodextrin , Infant , Male , Renal Insufficiency, Chronic/therapy
20.
Medicine (Baltimore) ; 95(13): e2991, 2016 Mar.
Article in English | MEDLINE | ID: mdl-27043667

ABSTRACT

Although icodextrin solution has been highlighted in the fluid management compared to glucose-based solutions, proof of a beneficial effect of icodextrin solution on residual renal function (RRF) is lacking. We conducted a multicenter prospective randomized controlled open-label trial to investigate whether icodextrin solution can preserve RRF.One hundred patients with urine volume ≥750 mL/day from 8 centers in Korea were randomly assigned to receive 1 exchange of icodextrin solution for a ≥8 hour-dwell time and 2 exchanges of 1.5% glucose-based biocompatible neutral pH solution or 1 exchange of ≥2.5% and 2 exchanges of 1.5% glucose-based biocompatible solutions. Using mixed-effects general linear models, we analyzed changes in residual glomerular filtration rate (GFR) and daily urine volume at 1 year.Forty-nine patients were assigned to the icodextrin group and 51 to the glucose solution group. During follow-up, the slope of the decline in residual GFR was -0.170 mL/min/month/1.73 m² in the icodextrin group, while it was -0.155 mL/min/month/1.73 m² in the glucose solution group (95% confidence interval [CI], -0.06 to 0.10; P = 0.701). Daily urine volume decreased faster in the glucose solution group than in the icodextrin group (-31.02 vs -11.88 mL per month; 95% CI, -35.85 to -2.44; P = 0.025). Results were consistent when we analyzed using intention-to-treat and per protocol principles. There were no differences in fluid status, peritoneal ultrafiltration, and peritoneal transport between groups during follow-up.This study clearly showed that icodextrin solution preserves residual urine volume better than glucose solution.


Subject(s)
Glomerular Filtration Rate/drug effects , Glucans/therapeutic use , Glucose/therapeutic use , Kidney Failure, Chronic/therapy , Peritoneal Dialysis/methods , Adult , Aged , Female , Glucans/adverse effects , Glucose/adverse effects , Humans , Icodextrin , Male , Middle Aged , Prospective Studies , Republic of Korea
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