scholarly journals Enterococcus faecium SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics

2018 ◽  
Vol 9 (3) ◽  
pp. 375-388 ◽  
Author(s):  
W. Holzapfel ◽  
A. Arini ◽  
M. Aeschbacher ◽  
R. Coppolecchia ◽  
B. Pot
Keyword(s):  
Enterococcus Faecium ◽  
Safety Evaluation ◽  
Fermented Foods ◽  
Special Importance ◽  
Efficacy And Safety ◽  
Probiotic Strains ◽  
History Of ◽  
Extensive Information ◽  
Group 2 ◽  
Southern European Countries

As normal inhabitants of diverse ecosystems, including the human gastrointestinal tract, the enterococci, and especially the two species Enterococcus faecalis and Enterococcus faecium, can be considered ubiquitous with regard to our natural environment. E. faecium has gained special importance thanks to beneficial strains marketed as probiotics, and because of its beneficial role in traditional fermented foods such as artisanal cheeses in some Southern European countries. Yet, following reports on the increasing association of some enterococcal strains with nosocomial infections such as endocarditis and bacteraemia, it became evident that strains from clinical origin are frequently highly resistant to ‘last-defence-line’ antibiotics such as the glycopeptide derivatives. For this reason enterococci have been classified in risk group 2 in the European Directive 93/88. With this paper it is intended to clarify the uncertain situation around the safety of the species E. faecium, also with referring to intra-species heterogeneity. In fact, well established scientific and surveillance data support the safety of some probiotic E. faecium strains for both human and animal applications. As a model, summarising yet extensive information is provided on the efficacy and safety of E. faecium SF68®, a pharmaceutical probiotic with a long history of safe use. We propose the approach presented in this review as a model for the evaluation of safety of probiotic strains of this species.

Effect of capsule 'UB03' containing potential probiotic strains for the treatment of patients with irritable bowel syndrome

2011 ◽  
Vol 2 (3) ◽  
pp. 229-233 ◽  
Author(s):  
M. Ratna Sudha ◽  
P. Sawant
Keyword(s):  
Irritable Bowel Syndrome ◽  
Safety Evaluation ◽  
Abdominal Discomfort ◽  
Glutamic Pyruvic Transaminase ◽  
Efficacy And Safety ◽  
Serum Glutamic Pyruvic Transaminase ◽  
Rome Ii Criteria ◽  
Probiotic Strains ◽  
Irritable Bowel ◽  
To Receive

The objective of this research was to study the efficacy and safety of capsule 'UB03' to treat patients with Irritable Bowel Syndrome (IBS). Thirty patients with Rome II IBS were assigned to receive capsule 'UB03' (10 billion lyophilised bacteria and yeast/capsule produced by Unique Biotech Limited, India) twice daily for 90 days. Assessment of IBS was carried out according with Rome II criteria and their severity for 90 days of treatment with an interval of 30 days. Complete haemogram, serum glutamic pyruvic transaminase, serum creatinine were performed as a part of safety evaluation at the time of inclusion and after 90 days of treatment. There was significant improvement in frequency of defecation (23%), consistency of stool, abdominal discomfort, bloating and flatulence. However, there was no significant change in abdominal pain and mucus in stool. This trial demonstrates that the consumption of capsule 'UB03' containing potential probiotic strains is found to be effective and safe for the treatment of patients with IBS.

Treatment of varicose tributaries with sclerotherapy with polidocanol 0.5 % foam

VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker
Keyword(s):  
Scientific Evidence ◽  
Daily Practice ◽  
Severe Adverse Effect ◽  
Safe Procedure ◽  
Efficacy And Safety ◽  
Foam Sclerotherapy ◽  
History Of ◽  
One Year ◽  
Additional Therapy

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.

Hereditary Heparin Cofactor II Deficiency and the Risk of Development of Thrombosis

1987 ◽  
Vol 57 (02) ◽  
pp. 196-200 ◽  
Author(s):  
R M Bertina ◽  
I K van der Linden ◽  
L Engesser ◽  
H P Muller ◽  
E J P Brommer
Keyword(s):  
Liver Disease ◽  
Venous Thrombosis ◽  
Healthy Volunteers ◽  
Mean Value ◽  
Age Group ◽  
Normal Range ◽  
Heparin Cofactor Ii ◽  
History Of ◽  
Group 2 ◽  
Hereditary Nature

SummaryHeparin cofactor II (HC II) levels were measured by electroimmunoassay in healthy volunteers, and patients with liver disease, DIC, proteinuria or a history of venous thrombosis. Analysis of the data in 107 healthy volunteers revealed that plasma HC II increases with age (at least between 20 and 50 years). HC II was found to be decreased in most patients with liver disease (mean value: 43%) and only in some patients with DIC. Elevated levels were found in patients with proteinuria (mean value 145%). In 277 patients with a history of unexplained venous thrombosis three patients were identified with a HC II below the lower limit of the normal range (60%). Family studies demonstrated hereditary HC II deficiency in two cases. Among the 9 heterozygotes for HC II deficiency only one patient had a well documented history of unexplained thrombosis. Therefore the question was raised whether heterozygotes for HC II deficiency can also be found among healthy volunteers. When defining a group of individuals suspected of HC II deficiency as those who have a 90% probability that their plasma HC II is below the 95% tolerance limits of the normal distribution in the relevant age group, 2 suspected HC II deficiencies were identified among the healthy volunteers. In one case the hereditary nature of the defect could be established.It is concluded that hereditary HC II deficiency is as prevalent among healthy volunteers as in patients with thrombotic disease. Further it is unlikely that heterozygosity for HC II deficiency in itself is a risk factor for the development of venous thrombosis.

Efficacy of intrauterine administration of autologous peripheral blood mononuclear cells prior to embryo transfer in patients with recurrent implantation failures in assisted reproductive technology programmes

GYNECOLOGY ◽  
2018 ◽  
Vol 20 (2) ◽  
pp. 28-33
Author(s):  
T S Amyan ◽  
S G Perminova ◽  
L V Krechetova ◽  
V V Vtorushina
Keyword(s):  
Embryo Transfer ◽  
Peripheral Blood Mononuclear Cells ◽  
Peripheral Blood ◽  
Mononuclear Cells ◽  
Peripheral Blood Mononuclear ◽  
Study Objective ◽  
Study Results ◽  
Blood Mononuclear Cells ◽  
History Of ◽  
Group 2

Study objective. To evaluate the efficacy of intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) prior to embryo transfer in patients with recurrent implantation failures in IVF program. Materials and methods. The study enrolled 129 patients with recurrent implantation failures in an IVF programme. Group 1 - 42 patients who had intrauterine administration of autologous PBMC activated with hCG (Pregnyl 500 IU). Group 2 - 42 patients who had intrauterine administration of autologous PBMC without hCG activation. Group 3 (placebo) - 45 patients who had intrauterine administration of saline. Study results. In the hCG-activated PBMC group, the rates of positive blood hCG tests, implantation, and clinical pregnancy were significantly higher than the respective rates in the non-activated PBMC group and in the placebo group, both in a stimulated cycle and in an FET cycle (р≤0.05). Conclusion. Intrauterine administration of autologous PBMC prior to embryo transfer in an IVF/ICSI programme increases the efficacy of IVF program in patients with a history of recurrent implantation failures.

scholarly journals Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S383-S384
Author(s):  
Peyman Goldeh ◽  
Peter Kim ◽  
Salaheddin Abouanaser ◽  
Eric Partlow ◽  
Patricia Beckett ◽  
...  
Keyword(s):  
Fecal Microbiota Transplantation ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
Fecal Microbiota ◽  
Efficacy And Safety ◽  
Open Label ◽  
Retention Enema ◽  
Recurrent Clostridium Difficile Infection ◽  
Laboratory Facility ◽  
History Of

Abstract Background Fecal microbiota transplantation (FMT) has shown to be effective for recurrent Clostridium difficile infection (rCDI). However, significant laboratory costs for donor screening and a lack of suitable donors and laboratory facility have restricted the availability of the treatment. In order to expand access to FMT, we have investigated the efficacy of lyophilized FMT, comparing it to the published historical efficacy of frozen FMT in preventing further episodes of CDI in patients with a history of rCDI. This study was designed to be open-labeled to expedite and minimize costs associated with conducting a two-armed randomized controlled trial, given that the efficacy of frozen FMT is known to be 85%. Additionally, using lyophilized FMT offers two major advantages: 1) its prolonged shelf life reduces cost because fewer donors need to be screened; and 2) it can be transported without freezing. Methods This is an open-labeled, prospective study involving 50 patients with a history of 2 or more rCDI who have failed at least 1 course of tapered vancomycin therapy. Eligible patients received 2 lyophilized FMT via retention enema within 8 days of each treatment and were followed for 13 weeks post last FMT to determine efficacy and safety of FMT. Results The efficacy of lyophilized FMTs in preventing further episodes of CDI in patients with rCDI was 80%. The adverse events associated with lyophilized FMT were similar to frozen FMT. Conclusion Lyophilized FMT in treating rCDI showed similar efficacy and safety to frozen FMT. Lyophilized FMT appears to be promising in preventing further episode of CDI and increasing accessibility for patients with rCDI. Disclosures All authors: No reported disclosures.

scholarly journals Nanomedicine Reformulation of Chloroquine and Hydroxychloroquine

Molecules ◽  
2020 ◽  
Vol 26 (1) ◽  
pp. 175
Author(s):  
David M. Stevens ◽  
Rachael M. Crist ◽  
Stephan T. Stern
Keyword(s):  
Safety Evaluation ◽  
Therapeutic Index ◽  
Short Term ◽  
Tissue Concentrations ◽  
History Of ◽  
History Of Use ◽  
Novel Applications ◽  
Therapeutic Doses ◽  
Extensive Clinical Experience ◽  
Higher Doses

The chloroquine family of antimalarials has a long history of use, spanning many decades. Despite this extensive clinical experience, novel applications, including use in autoimmune disorders, infectious disease, and cancer, have only recently been identified. While short term use of chloroquine or hydroxychloroquine is safe at traditional therapeutic doses in patients without predisposing conditions, administration of higher doses and for longer durations are associated with toxicity, including retinotoxicity. Additional liabilities of these medications include pharmacokinetic profiles that require extended dosing to achieve therapeutic tissue concentrations. To improve chloroquine therapy, researchers have turned toward nanomedicine reformulation of chloroquine and hydroxychloroquine to increase exposure of target tissues relative to off-target tissues, thereby improving the therapeutic index. This review highlights these reformulation efforts to date, identifying issues in experimental designs leading to ambiguity regarding the nanoformulation improvements and lack of thorough pharmacokinetics and safety evaluation. Gaps in our current understanding of these formulations, as well as recommendations for future formulation efforts, are presented.

scholarly journals Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaping Wang ◽  
Bin Liu ◽  
Xiuqiong Fu ◽  
Tiejun Tong ◽  
Zhiling Yu
Keyword(s):  
Relapse Rate ◽  
Large Scale ◽  
Primary Outcome ◽  
Response Rate ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
History Of ◽  
Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

Myeloid neoplasms in the setting of chronic lymphocytic leukaemia/chronic lymphocytic leukaemia-like disease: a clinicopathological study of 66 cases comparing cases with prior history of treatment to those without

2021 ◽  
pp. jclinpath-2020-207334
Author(s):  
Catherine Luedke ◽  
Yue Zhao ◽  
Jenna McCracken ◽  
Jake Maule ◽  
Lian-He Yang ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukaemia ◽  
Lymphocytic Leukaemia ◽  
The Other ◽  
Prior History ◽  
Myeloid Neoplasm ◽  
Myeloid Neoplasms ◽  
History Of ◽  
Cytogenetic Profile ◽  
Group 2 ◽  
Group 1

AimsMyeloid neoplasms occur in the setting of chronic lymphocytic leukaemia (CLL)/CLL-like disease. The underlying pathogenesis has not been elucidated.MethodsRetrospectively analysed 66 cases of myeloid neoplasms in patients with CLL/CLL-like disease.ResultsOf these, 33 patients (group 1) had received treatment for CLL/CLL-like disease, while the other 33 patients (group 2) had either concurrent diagnoses or untreated CLL/CLL-like disease before identifying myeloid neoplasms. The two categories had distinct features in clinical presentation, spectrum of myeloid neoplasm, morphology, cytogenetic profile and clinical outcome. Compared with group 2, group 1 demonstrated a younger age at the diagnosis of myeloid neoplasm (median, 65 vs 71 years), a higher fraction of myelodysplastic syndrome (64% vs 36%; OR: 3.1; p<0.05), a higher rate of adverse unbalanced cytogenetic abnormalities, including complex changes, −5/5q- and/or −7/7q- (83% vs 28%; OR: 13.1; p<0.001) and a shorter overall survival (median, 12 vs 44 months; p<0.05).ConclusionsMyeloid neoplasm in the setting of CLL/CLL-like disease can be divided into two categories, one with prior treatment for CLL/CLL-like disease and the other without. CLL-type treatment may accelerate myeloid leukaemogenesis. The risk is estimated to be 13-fold higher in patients with treatment than those without. The causative agent could be attributed to fludarabine in combination with alkylators, based on the latency of myeloid leukaemogenesis and the cytogenetic profile.

scholarly journals The Association of Pre-Existing Left Atrial Fibrosis with Clinical Variables in Patients Referred for Catheter Ablation of Atrial Fibrillation

2014 ◽  
Vol 8s1 ◽  
pp. CMC.S15036 ◽  
Author(s):  
Jane Dewire ◽  
Irfan M. Khurram ◽  
Farhad Pashakhanloo ◽  
David Spragg ◽  
Joseph E. Marine ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Left Atrial ◽  
Af Ablation ◽  
Group 4 ◽  
Significant Difference ◽  
History Of ◽  
Group 2 ◽  
Magnetic Resonance Imaging Mri ◽  
Left Atrial Fibrosis

Introduction Atrial fibrillation (AF) recurrence after ablation is associated with left atrial (LA) fibrosis on late gadolinium enhanced (LGE) magnetic resonance imaging (MRI). We sought to determine pre-ablation, clinical characteristics that associate with the extent of LA fibrosis in patients undergoing catheter ablation for AF. Methods and Results Consecutive patients presenting for catheter ablation of AF were enrolled and underwent LGE-MRI prior to initial AF ablation. The extent of fibrosis as a percentage of total LA myocardium was calculated in all patients prior to ablation. The cohort was divided into quartiles based on the percentage of fibrosis. Of 60 patients enrolled in the cohort, 13 had <5% fibrosis (Group 1), 15 had 5-7% fibrosis (Group 2), 17 had 8-13% fibrosis (Group 3), and 15 had 14-36% fibrosis (Group 4). The extent of LA fibrosis was positively associated with time in continuous AF, and the presence of persistent or longstanding persistent AF. However, no statistically significant difference was observed in the presence of comorbid conditions, age, BMI, LA volume, or family history of AF among the four groups. After adjusting for diabetes and hypertension in a multivariable linear regression model, paroxysmal AF remained independently and negatively associated with the extent of fibrosis (-4.0 ± 1.8, P = 0.034). Conclusion The extent of LA fibrosis in patients undergoing AF ablation is associated with AF type and time in continuous AF. Our results suggest that the presence and duration of AF are primary determinants of increased atrial LGE.

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