Presence Of Bleeding Research Articles

Periodontal and peri-implant microbiota in patients with healthy and inflamed periodontal and peri-implant tissues.

To compare the prevalence and levels of six bacterial pathogens within the subgingival/submucosal microbiota at teeth versus implants with various clinical conditions. Twenty-two Chinese were included. Four subgingival/submucosal sites were selected for microbiological sampling within each subject, that is, (1) healthy peri-implant tissues; (2) peri-implantitis [PPD ≥ 5mm, presence of bleeding on probing (BOP) and confirmed radiographic bone loss]; (3) healthy gingiva; and (4) periodontitis (PPD ≥4mm). Subgingival/submucosal plaque was sampled using paper points. Quantitative real-time polymerase chain reaction (q-PCR) was used to quantify six pathogens, including Porphyromonas gingivalis (P.g.), Treponema denticola (T.d.), Aggregatibacter actinomycetemcomitans (A.a.), Fusobacterium nucleatum (F.n.), Prevotella intermedia (P.i.), and Staphylococcus aureus (S.a.). Counts were log10-transformed. The most commonly detected species were S. a. and F. n., while A. a. and. P.i. had the lowest detection frequency. The detection frequencies of diseased tooth or implant sites for each of the six target species were either equal to or higher than the respective frequencies at the corresponding healthy sites. There were no statistically significant differences for any of the species or clinical sites (P>0.05, Cochran's Q test). No statistically significant differences in the bacterial loads were found among the four clinical sites; with the exception of F.nucleatum. This was more abundant in periodontitis sites (P=0.023, Friedman's 2-way anova). Both periodontal and peri-implant sites, irrespective of their health status, were revealed to harbor S.aureus cells. The log10-transformed loads of S.aureus were approximately 3.5 within each of the clinical sites (P=0.232). This was the highest of the six species analyzed. Within the same subjects, putative periodontal pathogens were common to both periodontal and peri-implant sites irrespective of health status. The prevalence and levels of P.gingivalis and F.nucleatum were significantly associated with periodontitis, but not with peri-implantitis. A.actinomycetemcomitans was associated with both disease conditions, periodontitis and peri-implantitis, but not with either gingival or mucosal health.

Colonic perforation following endoscopy revealed by plain radiography.

A 77-year-aged male patient without a remarkable medical history underwent colonoscopy because of chronic constipation and colon cancer family history. Colonoscopy failed at the 50 cm from the anal verge by the presence of bleeding from the proximal site of the colon. While retracting endoscope adipose tissue of retroperitoneum appeared. The lumen of the colon was collapsed (blue arrow) and immediately procedure was terminated (Fig. 1A). Patient did not complain of abdominal pain. The conventional X-ray of the abdomen and the chest was obtained. The abdominal X-ray revealed retroperitoneal and subdiaphragmatic free air. Chest X-ray (Fig. 1B) revealed bilateral subdiaphragmatic free air (yellow arrows). Patient was referred to Osmangazi University Hospital General Surgery Department and primary repair of a sigmoid colonic perforation was successfully performed. Postoperative course was uneventful and he was discharged 10 days later. A carefully observation while retracting endoscope can be useful to diagnose a potential injury of colon. Conventional X-ray is a simple and fast diagnostic method for gastrointestinal perforations [1]. Patients over 75 years of age have a higher risk of perforation during colonoscopy [2]. Immediate diagnosis gave a chance of a primary closure of perforation and refrain from peritonitis. Earlier a primary closure of perforation has a low rate of leakage rate [3]. Figure 1: (A) Colonoscopic image of perforation (B) Convential X-ray revealed bilateral subdiaphragmatic free air.

Assessment of periodontal and opportunistic flora in patients with peri‐implantitis

To assess the presence of periodontal and opportunistic organisms in patients with peri-implantitis. Thirty-three partially edentulous subjects (22 women, 11 men), aged 32-90 years, who had one or more implants with peri-implantitis were included. Peri-implantitis was defined as: (i) the presence of bleeding on probing and/or suppuration and (ii) radiographic images showed marginal bone loss >1.8 mm after 1 year in function. Criteria for inclusion were: (i) partially edentulous patients having at least one implant diagnosed with peri-implantitis; (ii) no antibiotic therapy for 6 months prior to clinical examination. Following this definition, a total of 48 implants were diagnosed with peri-implantitis. Subgingival bacterial samples were obtained with sterile paper points from infected implants and selected teeth of each individual. Periodontopathogens (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia and Treponema denticola) were detected by multiplex PCR targeting 16S rDNA. Samples were placed in reduced transport medium and cultured for opportunistic pathogens (Staphylococcus aureus, enteric bacteria, Pseudomonas and yeasts). Twenty-two patients yielded positive results for P. gingivalis, 25 for T. forsythia, eight for P. intermedia and 13 for T. denticola. None of the patients yielded a positive result for A. actinomycetemcomitans. Non-periodontal species were found in five patients (15% of total). P. aeruginosa was found in four (12%) patients, and C. albicans (3%) and S. aureus in one patient (3%) each. In two cases of peri-implantitis, none of the periodontal or opportunistic microorganisms studied were detected in either implant or tooth samples. When results of the periodontopathic bacteria from the implant and tooth samples of the same patient were compared, 18 patients (54%) showed the same results for both samples and 15 (45%) patients different results. The implant surface may be colonized with pathogens different from periodontal bacteria. Opportunistic pathogens such as P. aeruginosa, S. aureus and C. albicans may be associated with implant failure.

Clipping versus coiling for intracranial aneurysms

Background and purposeThe aim of this study was to compare results of clipping and coiling for aneurysms of the anterior circle of Willis. Previous studies have not identified a clear superiority of one method over the other. Material and methodsThe study group included 165 consecutive patients. The assessment took into account the risk of death, neurological status according to the scale of the GOS and mRS, the incidence of early complications and quality of life measured by own surveys and questionnaire EORTC QLQ-C30 v. 3.0. ResultsMean follow-up was more than four years. Early and late results of treatment after embolization and clipping for all patients did not differ. Evaluation of patients with bleeding aneurysms demonstrated better outcomes after embolization, however statistical significance was observed only in terms of symptomatic scale score of QLQ-C30 questionnaire (p=0.02). For patients with non-bleeding aneurysms better outcomes were obtained after clipping, but statistical significance was found only in the early results: more excellent results in GOS score at discharge (p<0.03) and fewer complications during hospitalization (p=0.02). ConclusionsResults of treatment after clipping and coiling do not differ in total for all patients, but differ depending on the presence of bleeding. Patients with bleeding aneurysms achieve better outcomes after coiling, and patients with non-bleeding aneurysms achieve better outcomes after clipping.

Bleeding Following Rattlesnake Envenomation in Patients With Preenvenomation Use of Antiplatelet or Anticoagulant Medications

Rattlesnake envenomations commonly produce coagulopathy and thrombocytopenia, yet clinically significant bleeding is uncommon. It is unknown if patients who use antiplatelet or anticoagulant medications prior to envenomation are at increased risk for bleeding after envenomation. This was a retrospective cohort study of patients age 14 years and older who were admitted to a single academic medical center for rattlesnake envenomation. Patients who reported use of antiplatelet or anticoagulant medications prior to envenomation were compared to patients not on those medications. Severity and timing of bleeding was compared between groups, as was a composite endpoint of major bleeding at any time, shock, readmission, or death. A total of 319 patients met inclusion criteria; 31 (9.7%) were documented to be taking antiplatelet or anticoagulant medications including aspirin, clopidogrel, and/or warfarin. Seventeen of the 319 patients developed bleeding associated with envenomation (major = 9; minor = 4; trivial = 4), with major bleeding occurring in five patients on antiplatelet or anticoagulant medications versus four patients not on antiplatelet or anticoagulant medications (p < 0.001). Seven of the 17 presented with early bleeding. This early bleeding occurred in three of 31 (9.7%) patients on antiplatelet or anticoagulant medications and four of 288 (1.4%) patients not on antiplatelet or anticoagulant medications (relative risk [RR] = 6.9; 95% confidence interval [CI] = 1.6 to 29.4; p = 0.022). Clinical outcome data were available for 300 of the 319 (94%) subjects following discharge. Late bleeding (bleeding after discharge from the index hospitalization) occurred in nine subjects, one of whom also had early bleeding (major = 2, minor = 3, trivial = 4). Three of these nine subjects with late bleeding were on antiplatelet or anticoagulant medications, compared with six not on antiplatelet or anticoagulant medications (p = 0.042). Both cases of late major bleeding occurred in patients on antiplatelet or anticoagulant medications. Therefore, among patients with follow-up data available, the overall rate of bleeding (early and late) was seven of 28 (25%) in patients taking antiplatelet or anticoagulant medications and 10 of 273 (3.7%) in patients not taking antiplatelet or anticoagulant medications (p < 0.001). The use of antiplatelet or anticoagulant medications was also associated with an increased risk of reaching the composite endpoint of major bleeding, shock, readmission, or death (6 of 31, or 19.4% vs. 14 of 288, or 4.9%; RR = 3.98; 95% CI = 1.65 to 9.62; p = 0.008). The risk of developing bleeding following rattlesnake envenomation is increased in patients who use antiplatelet or anticoagulant medications. This risk is greatest early after envenomation during the index hospitalization. However, risk of late, major bleeding appears also to be greatest in patients on antiplatelet or anticoagulant medications. Extra vigilance should be taken in patients on antiplatelet or anticoagulant medications and a careful risk/benefit analysis should be undertaken before continuing these medications in the weeks following the envenomation.

A comparative clinical and quantitative evaluation of the efficacy of conventional and recent gingival retraction systems: An in vitro study

Aim: Gingival deflection techniques can be classified as mechanical, mechanochemical, surgical, or any combination. Comparative evaluations of gingival retraction systems are done rarely mainly because there is no consensus on the evaluation criteria. Therefore, this study aimed to evaluate the efficacy of three different gingival retraction systems, i.e., Magic Foam Cord, expasyl paste, and aluminium chloride-impregnated retraction cord. Materials and Methods: Following impressions, obtained casts were measured for gingival sulcus opening width under optical microscope (with imaging system software). The presence of bleeding after removal of material, ease of procedure, and patient's comfort were also evaluated. The data collected were tabulated and subjected to statistical analysis. Results and Conclusion: Evaluation of the clinical efficacy is relatively difficult because of the lack of appropriate measuring tool. In addition, choice of appropriate gingival retraction system is still a dilemma for the operator. Moreover, a particular clinical situation may indicate the specific technique.

Vitrectomía con técnica de viscodisección

ObjectiveTo evaluate de efficacy, advantages, disadvantages, indications and complications of the use of viscodissection techniques in vitrectomy. Material and methodsRetrospective analysis of a group of patients with vitreo-retinal diseases who underwent vitrectomy with the use of viscodissection to separate epiretinal anomalous tis-sue from the retinal surface with a follow up minimum of one year. Pre and post postoperative visual acuity, surgical complexity by a subjective scale, presence of bleeding during and after surgery, iatrogenic retinal breaks, and anatomical success were evaluated. ResultsSeventeen patients were included in our study, nine were male and eight female. the age ranged from three months to 75 years with a mean of 46.27 years. The preoperative diagno-sis was diabetic retinopathy with vitreous hemorrhage in five patients, diabetic retinopathy with tractional retinal detachment in five patients, proliferative vitreoretinopathy in patients, two patients with retinopathy of prematurity, one patient with a giant tear after blunt trauma with proliferative vitreoretinopathy and one patient with epiretinal membrane. in the majority of patients visual acuity improved or remained stable, just in one case with neovascular glau-coma visual acuity got worse. incidental retinotomies ocurred in seven patients, and hemor-rhage in two. At one year follow-up, 12 patients (70.58%) remained the retina attached, two patients (11.76%) had silicon oil and their retina attached and 3 patients had a retinal detach-ment. ConclusionVitrectomy with viscodissection techniques is a good option for the treatment of complicated cases of vitreoretinal pathology with good anatomical and visual results. the com-plication rate is similar to that reported with other techniques.

Tratamento minimamente invasivo do adenoma hepático em situações especiais

ABSTRACTHepatocellular adenoma is a rare benign tumor that was increasingly diagnosed in the 1980s and 1990s. This increase has been attributed to the widespread use of oral hormonal contraceptives and the broader availability and advances of radiological tests. We report two cases of patients with large hepatic adenomas who were subjected to minimally invasive treatment using arterial embolization. One case underwent elective embolization due to the presence of multiple adenomas and recent bleeding in one of the nodules. The second case was a victim of blunt abdominal trauma with rupture of a hepatic adenoma and clinical signs of hemodynamic shock secondary to intra-abdominal hemorrhage, which required urgent treatment. The development of minimally invasive locoregional treatments, such as arterial embolization, introduced novel approaches for the treatment of individuals with hepatic adenoma. The mortality rate of emergency resection of ruptured hepatic adenomas varies from 5 to 10%, but this rate decreases to 1% when resection is elective. Arterial embolization of hepatic adenomas in the presence of bleeding is a subject of debate. This observation suggests a role for transarterial embolization in the treatment of ruptured and non-ruptured adenomas, which might reduce the indication for surgery in selected cases and decrease morbidity and mortality. Magnetic resonance imaging showed a reduction of the embolized lesions and significant avascular component 30 days after treatment in the two cases in this report. No novel lesions were observed, and a reduction in the embolized lesions was demonstrated upon radiological assessment at a 12-month follow-up examination.

Princicles of Solute Kinetics during Therapeutic Apheresis

Therapeutic apheresis (TA) is an extracorporeal depuration technique that, by separating plasma from blood cells, can remove pathogenic substances of high molecular weight (MW) such as auto-antibodies, immunocomplexes, light chains, etc. Solute kinetics in TA are based on the same pharmaco-kinetic principles used in hemodialysis (HD) patients, the main difference being the higher MW of the solutes of interest in AT. Since most high MW solutes have a prevalent intra-vascular distribution and/or are almost exclusively removed from the plasma volume (PV), during TA one can use the single-pool model derived Kt/V for prescribing the “AT dose”: the prescription of removing 1.2–1.4 times the patient's PV actually means a Kt/V of 1.2–1.4 for a solute whose V coincides with PV. However, for a more general modeling in TA, particularly between sessions, a multi-compartment model is required. By using a bi-compartmental model, Hanafusa has recently performed a series of computer simulations in order to analyze the impact of the various parameters on the solute kinetics in AT. In short, the main results of the above simulations are the following: the MW of the substance can help select the most suitable TA technique (the plasma exchange allowing the wider MW spectrum); a lower distribution volume allows for a more efficient removal; both the inter-compartment diffusion velocity and the half life (which is inversely related to the production rate) have an impact on the frequency of the treatment. Hanafusa also noted that the disease severity as well as the presence of bleeding or infection can impact not only on the dose but also on the selection of the AT modality and replacement fluids.

Social determinants of health and periodontal disease in Brazilian adults: a cross-sectional study.

BackgroundRecently, increasing importance has been placed on the social determinants of health and disease. The present study aimed to determine the prevalence of periodontal disease in Brazilian adults and identify possible relationships with social determinants.MethodsA cross-sectional study was performed using a sample of 743 adults (aged 35–49 years) living in an urban area of a large city in southeastern Brazil. The condition of the periodontium was assessed using the Community Periodontal Index (CPI) according to the diagnostic criteria established by the World Health Organization (WHO). The variables related to social determinants were collected using a structured questionnaire. A descriptive analysis of all study variables was performed. Multiple correspondence analysis was subsequently performed to identify relationships between periodontal disease and the social determinants of health.ResultsThe periodontal exams showed that 36.5% of adults had a healthy periodontium, 2.0% had gingival bleeding, 47.1% had calculus and 9.5% had periodontal pockets of 4–5 mm. Periodontal pockets of 6 mm or more were the worst periodontal condition found (affecting only 2.1% of the participants). The correspondence analysis enabled us to form three groups with different profiles. The first group was distinguished by the presence of bleeding (gingivitis) or a healthy periodontium. The members of this group were typically aged 35 to 39 years and had 9–12 years or more than 12 years of education. The second group consisted of subjects with calculus and periodontal pockets of 4–5 mm. The members of this group were typically white men aged 40–44 years with incomes greater than $ 300.00. The third group was distinguished by the presence of periodontal pockets of 6 mm or more. The members of this group were typically adult females, black and mixed individuals who had 8 years or less of schooling, individuals with incomes ≤ $ 300.00 and widowers.ConclusionThe results suggest that periodontal health is worse in the group for which the social indicators are worse. Therefore, the social determinants of health also affect the severity of periodontal disease in adults Brazilian society.

Pharmacologic interventions for reversing the effects of oral anticoagulants

To describe the pharmacologic agents and strategies used for urgent reversal of warfarin and the target-specific oral anticoagulants dabigatran, rivaroxaban, and apixaban. To reverse the anticoagulant effects of warfarin in patients who are bleeding or need surgery, exogenous vitamin K (phytonadione) may be used in combination with another, shorter-acting intervention, such as fresh frozen plasma (FFP), prothrombin complex concentrate (PCC), recombinant factor VIIa, or activated PCC (aPCC). Three-factor PCC contains factors II, IX, and X in an inactivated form, and four-factor PCC also includes factor VII in an inactivated form. No four-factor PCC products are available in the United States, but aPCC, which contains the same four factors with factor VII provided in an activated form, is available. The intervention depends on the International Normalized Ratio, presence of bleeding, and need for and timing of surgery. Research suggests that clotting factor concentrates are more effective than FFP alone for warfarin reversal. These products also may be useful for reversing the effects of target-specific oral anticoagulants, but limited efficacy and safety data are available to support their use. The risks and benefits associated with these products need to be weighed before their use for reversal of dabigatran, rivaroxaban, or apixaban. Additional clinical data are needed to clearly define the role of concentrated clotting factor products in reversal and to determine the optimal clotting factor concentrate product and dose for urgent reversal of oral anticoagulation. Phytonadione and clotting factor concentrates appear to have a role for reversal of warfarin, and limited evidence suggests that clotting factor concentrates could have a role in reversal of target-specific oral anticoagulants in an emergency situation.

Periodontal self‐care: evidence‐based support

The focus of this review on periodontal self-care will be based primarily on the results of systematic reviews and meta-analyses. Based on the evidence gleaned from systematic reviews, it is notable that most authors of these reviews commented on the relatively small number of trials that could pass the quality-assessment inclusion in the systematic review. Interproximal devices, namely interproximal brushes, are more effective for reducing interproximal plaque and gingivitis than are flossing or brushing alone. Some added benefit may be attributed to the use of rotational oscillation powered toothbrushes over manual toothbrushes. Recommendations by the dentist and dental hygienist to add one or more chemotherapeutic agents to the typical oral hygiene regimen has been shown, in systematic reviews and meta-analyses, to reduce the level of plaque and gingival inflammation in patients. Oral irrigation does not seem to reduce visible plaque but does tend to reduce inflammation, determined by the presence of bleeding on probing, the gingival index score and probing depth measurements. To date, high-quality evidence is either lacking or weak in some areas regarding the efficacy of self-care and periodontal disease. Low educational attainment, smoking and socio-economic status are related to adverse periodontal health outcomes. Variation in self-esteem, self-confidence and perfectionism are associated with oral health status and oral health behaviors. Better understanding of the psychological factors associated with oral hygiene would be of benefit in further developing strategies to help patients improve their oral hygiene in addition to helping professionals design better programs on prevention and education.

The subgingival microbiome in health and periodontitis and its relationship with community biomass and inflammation.

The goals of this study were to better understand the ecology of oral subgingival communities in health and periodontitis and elucidate the relationship between inflammation and the subgingival microbiome. Accordingly, we used 454-pyrosequencing of 16S rRNA gene libraries and quantitative PCR to characterize the subgingival microbiome of 22 subjects with chronic periodontitis. Each subject was sampled at two sites with similar periodontal destruction but differing in the presence of bleeding, a clinical indicator of increased inflammation. Communities in periodontitis were also compared with those from 10 healthy individuals. In periodontitis, presence of bleeding was not associated with different α-diversity or with a distinct microbiome, however, bleeding sites showed higher total bacterial load. In contrast, communities in health and periodontitis largely differed, with higher diversity and biomass in periodontitis. Shifts in community structure from health to periodontitis resembled ecological succession, with emergence of newly dominant taxa in periodontitis without replacement of primary health-associated species. That is, periodontitis communities had higher proportions of Spirochetes, Synergistetes, Firmicutes and Chloroflexi, among other taxa, while the proportions of Actinobacteria, particularly Actinomyces, were higher in health. Total Actinomyces load, however, remained constant from health to periodontitis. Moreover, an association existed between biomass and community structure in periodontitis, with the proportion of specific taxa correlating with bacterial load. Our study provides a global-scale framework for the ecological events in subgingival communities that underline the development of periodontitis. The association, in periodontitis, between inflammation, community biomass and community structure and their role in disease progression warrant further investigation.

Regulation of HbA1c of uncontrolled diabetic type II obese and normal weight patients by oral hygiene performance (Comparative study)

The association between periodontal diseases incidence and development and the metabolic diseases as Diabetes Mellitus and Obesity are recently have attract great deal of researchers attention and investigation. The periodontal health proved to reduce the systemic inflammatory reactions and positively improve the glycemic control of diabetes Type2 patients. The aim of the study was to investigate the influence of oral hygiene control on the glycemic control of obese and normal weight moderately controlled Diabetic Type 2 patients, in addition to study the association of obesity with the gingival inflammation. Materials and Methods: Cross sectional study of three months duration. Included 30 moderately controlled diabetic type2 patients who attend the Specialist Center for Endocrine and Diabetes diseases Baghdad Al-Russafa administration / Iraqi Ministry of Health, were grouped into two groups, G1 of normal weight diabetics, and G2 obese diabetics according to their BMI level, the oral hygiene status measured by their PLI,GI,BBOP,PDI,CAL was conducted at each of the five visits of three weeks interval between each till the end of three months duration of the study and the level of their glycemic control measured by HbA1c level was conducted at the first and the fifth visit of the research duration , BMI was measured at the first and the fifth visit also. Paired t-test, ANOVA, Qui-square and Pearson correlation statistical analysis was used to investigate the significance of the improved glycemic control after oral hygiene control (OHC) of both G1 and G2. Results: periodontal parameters of both G1 and G2 were significantly improved after OHC with a significant reduction in HbA1c level of both normal weight and obese patients. Conclusion: The Oral Hygiene Control (OHC) is sufficient to improve reduction in Diabetes control level with or without overweight.OHC home care and professional measures could improve the gain in periodontal health in normal weight diabetics and overweight diabetics Obesity has an association with the presence of bleeding on probing as an indicator of the gingival inflammation in diabetic Type2 patients.

Human protein C concentrate in a patient with meningitis and bleeding as a complication of treatment with recombinant activated protein C

Some case reports suggest that protein C zymogen supplementation may improve the outcome of patients with congenital or acquired protein C deficiency, such as sepsis-induced purpura fulminans. We describe the case report of a patient suffering from meningitis who developed a bleeding complication after recombinant human activated protein C administration and was successfully treated without any further bleeding complication with protein C concentrate. Protein C concentrate can be considered in adult patients with meningitis, even if at risk or in the presence of bleeding.

Stapled hemorrhoidopexy – Initial experience from a general surgery center

BackgroundStapled hemorrhoidopexy is gaining popularity as a relatively painless alternative to conventional excisional hemorrhoidectomy. The initial experience from a service hospital is presented along with review of literature. Methods40 cases were managed by stapled hemorrhoidopexy (SH) over a period of two and half years. The primary outcome measures assessed were the analgesic requirement in the post-operative period and the time taken to resume Activities of Daily Living (ADL). Additional outcome measures studied were; presence of bleeding per rectum, prolapse of mass per rectum, incontinence to flatus/stool, post-operative urinary retention, requirement of a repeat procedure, presence of post-operative anal stenosis, and residual external haemorrhoids at 1 week, 1, 3 and 6 months and 1 year after surgery. Results40 patients with grade II, III and IV hemorrhoids underwent SH under spinal anesthesia. In the first 24 h 17 patients required a single dose of Injection Diclofenac Sodium while 19 patients required two doses and 4 patients had to be given three doses. 14 patients (35%) achieved Katz Index of Independence in Activities of Daily Living score of 6 on the first post-operative day and another 17 (42.5%) on the second post-operative day. By the fourth post-operative day all patients had achieved a score of 6. One patient had a rectal perforation as a complication of the procedure and another required a second procedure for excision of thrombosed external hemorrhoids. ConclusionStapled hemorrhoidopexy is associated with less post-operative pain and early resumption of ADL. Although the procedure appears simple to perform, it can be associated with serious complications and still cannot be considered the standard of care for the operative treatment of internal hemorrhoids.

Efficacy and Safety of Eltrombopag for the Treatment of Thrombocytopenia of Low and Intermediate-1 IPSS Risk Myelodysplastic Syndromes: Interim Analysis of a Prospective, Randomized, Single-Blind, Placebo-Controlled Trial (EQoL-MDS)

AbstractAbstract 923 Introduction:The increased risk of bleeding in myelodysplastic syndromes (MDS) is due to low platelet (PLT) counts and abnormalities of PLT morphology and function. Severe thrombocytopenia occurs in about 10% of low and Int-1 International Prognostic Scoring System (IPSS) risk MDS patients in whom PLT transfusions are indicated mainly in the presence of bleeding. Short therapeutic effect and the development of refractoriness to PLT transfusions motivate research in novel treatments. Eltrombopag is an oral, non peptide, non-competitive agonist of the thrombopoetin-receptor (TPOR) which interacts selectively with the TPOR transmembrane domain to initiate TPO signaling. Eltrombopag is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura. Its potential in increasing PLT count in lower risk MDS has not been evaluated. Study Design and Methods:We present preliminary results of a Phase II, multicentre, prospective, placebo-controlled, single blind study to evaluate the safety and efficacy of eltrombopag in low and intermediate-1 risk adult MDS patients with PLT count <30 Gi/L. Patients are included if: ECOG performance status < 4; ineligible for or relapsed or refractory to other treatments; and naive to TPO-R agonists. Secondary endpoints include differences in: changes in quality of life (QoL) scores by EORTC QLQ-C30 and QOL-E v. 3 questionnaires, frequency of PLT transfusions, incidence and severity of bleeding, and overall and leukemia-free survival. Eltrombopag or placebo (2:1 ratio) is administered to 69 patients at a 50 mg daily initial dose with 50 mg increases every 2 weeks to a target PLT count of 100 Gi/L. Dose interruptions or reductions are required for PLT >200 Gi/L or adverse events. PLT response is defined as Response (R) if: 1) baseline > 20 Gi/L: absence of bleeding and absolute increase in PLT ≥ 30 Gi/L/mm3; 2) baseline < 20 Gi/L: PLT <20 Gi/L and increase by at least 100%, not due to PLT transfusion; and Complete Response (CR) if PLT count ≥ 100 Gi/L and absence of bleeding. Bone marrow (BM) aspirate smears, cytogenetics and peripheral blood (PB) smears are performed throughout the study and blinded centralized morphology review is performed. Results:Seventeen patients (10 on active drug – Arm A) of mean age 64, SD 12, years are randomized and 2 are in screening at the time of the present report. Baseline mean PLT count was 14, SD 8, Gi/L. Three cases had significant bleeding (2 in Arm A, and 1 in Arm B) and 2 patients in each arm required PLT transfusions during screening. After a mean follow up of 6 months, 5 cases on the eltrombopag arm have obtained a CR (1 at day 8, 3 at day 15 with 50 mg dosing, and 1 at day 54 with 100 mg dosing) and one case is in R at 8 weeks follow-up; amongst non-responders, two have reached a 300 mg dose, the remaining are ongoing at a 100 and 150 mg dose, respectively. In Arm B, there was one case with an unstable R. In Arm A, PLT count increased by mean 68 SD 76 Gi/L (p=0.010) after 4 weeks and 114 SD 110 Gi/L (p=0.021) after 8 weeks, versus no significant change in Arm B. Furthermore, after 2 months, no bleeding occurred in Arm A (N=9) versus 3 cases with bleeding in Arm B (N=6). In fact, no PLT transfusions were required in Arm A, while 3 patients were transfused at 2 months in Arm B. At baseline, patients presented poor QoL scores. Overall, of the 9 patients in arm A reaching a 3-month follow-up, there were significant improvements in functional QoL, from baseline median score 33 (IQR 22–67) to 78 (IQR 31–92, p=0.047) and treatment-related scores from median 51 (IQR 35–66) to 74 (IQR 35–82, p=0.029). Grade III-IV adverse events (worsening of pre-existing arthritis; acute febrile enteritis) occurred in only 2 patients in Arm A, all unrelated to eltrombopag. Progressions have not been observed in Arm A, versus 1 progression in Arm B. No deaths have occurred at the time of the present analysis. Conclusions:Preliminary results suggest safety of eltrombopag in terms of drug-related adverse events and disease progression in MDS patients with low and Intermediate-1 risk IPSS and thrombocytopenia. In such patients, eltrombopag treatment is effective in raising PLT counts and in reducing the risk of bleeding and is associated with significant improvements in QoL. Disclosures:Off Label Use: Eltrombopag is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) .

Real-time viewing of video capsule endoscopy for on-going mid GI bleeding.

RAPID Access Real-Time (RT) has the ability to provide an endoscopist with the presence of bleeding and its location for cases with on-going mid GI bleeding. However, to date, the clinical benefits of this device remain unknown as studies on it have not yet been published. We present a case of recurrent GI bleeding where video capsule endoscopy (VCE) with real time viewing helped them decide on the route of double-balloon enteroscopy (DBE). Since the bleeding image of RT had not been obtained over 150 minutes after passing the pylorus, the patient underwent retrograde DBE. In the middle of the ileum, active bleeding from Dieulafoy's lesion was found and we treated it successfully. It was suggested the effectiveness of VCE in reference to the determination of RT for on-going mid GI bleeding.

Simple Clinical and Laboratory Predictors of Chikungunya versus Dengue Infections in Adults

BackgroundDengue and chikungunya are co-circulating vector-borne diseases with substantial overlap in clinical presentations. It is important to differentiate between them during first presentation as their management, especially for dengue hemorrhagic fever (DHF), is different. This study compares their clinical presentation in Singapore adults to derive predictors to assist doctors in diagnostic decision-making.MethodsWe compared 117 patients with chikungunya infection diagnosed with reverse transcription-polymerase chain reaction (RT-PCR) with 917 dengue RT-PCR-positive adult patients (including 55 with DHF). We compared dengue fever (DF), DHF, and chikungunya infections by evaluating clinical characteristics of dengue and chikungunya; developing classification tools via multivariate logistic regression models and classification trees of disease etiology using clinical and laboratory factors; and assessing the time course of several clinical variables.FindingsAt first presentation to hospital, significantly more chikungunya patients had myalgia or arthralgia, and fewer had a sore throat, cough (for DF), nausea, vomiting, diarrhea, abdominal pain, anorexia or tachycardia than DF or DHF patients. From the decision trees, platelets <118×109/L was the only distinguishing feature for DF versus chikungunya with an overall correct classification of 89%. For DHF versus chikungunya using platelets <100×109/L and the presence of bleeding, the overall correct classification was 98%. The time course analysis supported platelet count as the key distinguishing variable.InterpretationThere is substantial overlap in clinical presentation between dengue and chikungunya infections, but simple clinical and laboratory variables can predict these infections at presentation for appropriate management.

Exit strategies following percutaneous nephrolithotomy (PCNL): a comparison of surgical outcomes in the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study

PurposeTo compare the characteristics and outcomes of exit strategies following percutaneous nephrolithotomy (PCNL) using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database.Materials and methodsTwo matched data sets were prepared in order to compare stent only versus NT only and TTL versus NT only. Patients were matched on the exit strategy using the following variables: case volume of the center where they underwent PCNL, stone burden, the presence of staghorn stone, size of sheath used at percutaneous access, the presence of bleeding during surgery, and treatment success status. For categorical variables, percentages were calculated and differences between the four groups were tested by the chi-square test.ResultsThe only significant difference reported between the matched pairs was between NT and stent only groups. NT only PCNL was associated with significantly longer operating times (p = 0.029) and longer hospital stay (p < 0.001) than stent only PCNL.ConclusionsPatients who undergo PCNL with less invasive exit strategy involving a stent only have shorter hospital stay than those who have postoperative NT. The intraoperative course is the primary driver of complications in PCNL and not necessarily the exit strategy.