scholarly journals Therapeutic Effect of Perioperative Mild Hypothermia on Postoperative Neurological Outcomes in Patients with Acute Stanford Type A Aortic Dissection

2020 ◽  
Vol 23 (6) ◽  
pp. E815-E820
Author(s):  
Run Fu ◽  
Lei Zou ◽  
Xiao-Chun Song ◽  
Xiao Shen ◽  
Fu-Hua Huang ◽  
...  
Keyword(s):  
Aortic Dissection ◽  
Conventional Therapy ◽  
Mild Hypothermia ◽  
Therapy Group ◽  
Neurological Dysfunction ◽  
Tissue Oxygen Saturation ◽  
Neurological Outcomes ◽  
Postoperative Time ◽  
Postoperative Serum ◽  
Conventional Therapy Group

Background: Postoperative patients of acute Stanford type A aortic dissection (AAAD) often experience complications consisting of nervous system injury. Mild hypothermia therapy has been proven to provide the therapeutic effect of cerebral protection. We aimed to investigate the therapeutic effects of perioperative mild hypothermia on postoperative neurological outcomes in patients with AAAD. Methods: A prospective randomized controlled study was conducted on adult patients undergoing aortic dissection surgery between February 2017 and December 2017. Patients in the treatment group underwent mild hypothermia (34° to 35°C) immediately after surgery, and in the conventional therapy group, patients were rewarmed to normal body temperature (36° to 37°C). Postoperative time to regain consciousness, postoperative serum neuron-specific enolase (NSE) and S-100β levels, cerebral tissue oxygen saturation, presence of delirium or permanent neurological dysfunction, intensive care unit (ICU) and hospital stay duration, and 28-day mortality were compared. Results: We enrolled 55 patients who underwent AAAD surgery and were randomly allocated into to 2 groups, 27 patients in the treatment group and 28 patients in the conventional therapy group. Compared with the conventional therapy group, postoperative time to regain consciousness was much shorter for patients in the mild hypothermia group (12.65 hours, interquartile range [IQR] 8.28 to 23.82, versus 25.80 hours, IQR 14.00 to 59.80; P = .02), and the rate of regaining consciousness in 24 hours after surgery was much higher (74.07% versus 46.42%; P = .037). At the same time, the ICU stay of patients in the mild hypothermia therapy group was significantly shorter than that in the conventional therapy group (5.53 ± 3.13 versus 9.35 ± 8.76 days; P = .038). Cerebral tissue oxygen saturation, incidence of delirium or permanent neurological dysfunction, duration of hospital stay, and 28-day mortality showed no statistical difference. Postoperative serum NSE and S-100β levels increased compared with preoperative baseline values in both groups (P < .05), and the serum NSE levels of patients in the mild hypothermia therapy was significantly lower than the conventional therapy group 1 hour (P = .049) and 6 hours (P = .04) after surgery. There was no difference in the chest drainage volume or shivering between the 2 groups 24 hours after surgery. Conclusions: Perioperative mild hypothermia therapy is able to significantly reduce brain cell injury and shorten the postoperative time to regain consciousness, thus improving the neurological prognosis of patients with AAAD.

scholarly journals Early Administration of Tolvaptan Can Improve Survival in Patients with Cirrhotic Ascites

2021 ◽  
Vol 10 (2) ◽  
pp. 294
Author(s):  
Atsushi Hosui ◽  
Takafumi Tanimoto ◽  
Toru Okahara ◽  
Munehiro Ashida ◽  
Kohsaku Ohnishi ◽  
...  
Keyword(s):  
Conventional Therapy ◽  
Low Dose ◽  
Therapy Group ◽  
Survival Rates ◽  
Refractory Ascites ◽  
High Dose ◽  
Term Survival ◽  
Conventional Therapy Group ◽  
One Year ◽  
The One

(1) Backgrounds and aim: Tolvaptan, a selective vasopressin type 2 receptor antagonist, was approved for ascites, and its short-term efficacy and safety have been confirmed. However, it is still unclear whether this novel drug may improve long-term survival rates in cirrhotic patients with ascites. (2) Patients and methods: A total of 206 patients who responded insufficiently to conventional diuretics and were hospitalized for refractory ascites for the first time were retrospectively enrolled in this study. Among them, the first 57 consecutive patients were treated with conventional diuretics (the conventional therapy group); the latter 149 consecutive patients were treated with tolvaptan in addition to the conventional therapy (the tolvaptan group). (3) Results: The exacerbation of renal function was significantly milder in the tolvaptan group than in the conventional therapy group. The prognostic factors for survival in the tolvaptan group were being male, having hyperbilirubinemia, having a high blood urea nitrogen (BUN), and receiving high-dose furosemide at the start of tolvaptan treatment. The one-year and three-year cumulative survival rates were 67.8 and 45.3%, respectively, in patients with low-dose furosemide (<40 mg/day) at the start of tolvaptan treatment. The prognosis was significantly better in the tolvaptan group with low-dose furosemide than in the conventional therapy group (p < 0.001). (4) Conclusion: Tolvaptan can improve survival in patients with cirrhotic ascites, especially when tolvaptan is started before high-dose furosemide administration.

scholarly journals Efficiency Evaluation of Neuroprotection for Therapeutic Hypothermia to Neonatal Hypoxic-Ischemic Encephalopathy

2021 ◽  
Vol 15 ◽  
Author(s):  
Bowen Weng ◽  
Chongbing Yan ◽  
Yihuan Chen ◽  
Xiaohui Gong ◽  
Cheng Cai
Keyword(s):  
Therapeutic Hypothermia ◽  
Conventional Therapy ◽  
Infant Development ◽  
Therapy Group ◽  
Hypoxic Ischemic Encephalopathy ◽  
Neuron Development ◽  
Significant Difference ◽  
Hypothermia Group ◽  
Conventional Therapy Group ◽  
Ischemic Encephalopathy

Background: To evaluate the safety and neurological outcomes of therapeutic hypothermia to neonatal hypoxic-ischemic encephalopathy (HIE).Materials and Methods: Medical records of 61 neonates with moderate to severe HIE were retrospectively enrolled and divided into a therapeutic hypothermia group (n = 36) and conventional therapy group (n = 25).Results: No significant difference in the incidence of severe adverse events was found between the two groups. Minimum and maximum voltages of amplitude-integrated electroencephalography (aEEG) recording results showed statistically significant differences in therapeutic hypothermia group after 72 h. The neonatal behavioral neurological assessment (NBNA) on the 28th day after birth and Bayley Scales of Infant Development, second edition (BSID II) scores at 18 months old were significant higher in the therapeutic hypothermia group than the conventional therapy group.Conclusion: Therapeutic hypothermia for neonates with moderate to severe HIE improved the development of the nervous system in 0–18-month-old infants and showed a predominant role in reducing death and major neuron development-associated disabilities.

Effect of ticagrelor monotherapy on mortality after percutaneous coronary intervention: a systematic review and meta-analysis of randomized trials including 26 143 patients

2020 ◽  
Author(s):  
Sung-Jin Hong ◽  
Chul-Min Ahn ◽  
Jung-Sun Kim ◽  
Byeong-Keuk Kim ◽  
Young-Guk Ko ◽  
...  
Keyword(s):  
Conventional Therapy ◽  
Randomized Trials ◽  
Therapy Group ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Short Term ◽  
Percutaneous Coronary ◽  
All Cause Mortality ◽  
Conventional Therapy Group ◽  
Type 3

Abstract Aims Optimal timing and strategy of antiplatelet monotherapy after dual-antiplatelet therapy (DAPT) consisting of aspirin and P2Y12 inhibitor for patients who underwent percutaneous coronary intervention (PCI) is still being debated. The aim of this study was to evaluate the effect of ticagrelor monotherapy after short-term DAPT after PCI on mortality. Methods and results A systematic review and meta-analysis was performed using PubMed to search for ticagrelor monotherapy after short-term DAPT comparing conventional DAPT in patients who underwent PCI. Three randomized trials encompassing 26 143 patients [ticagrelor monotherapy after 1–3 months of DAPT (n = 13 062) vs. conventional therapy (n = 13 081)] were included. The efficacy endpoint of all-cause mortality was significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group [risk ratio (RR) = 0.80, 95% confidence interval (CI) 0.65–0.98; P = 0.03; I2 = 0%; number needed to treat for benefit (NNTB) = 320]. The safety endpoint of Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was also significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group (RR = 0.67, 95% CI 0.49–0.92; P = 0.01; I2 = 65%; NNTB = 156). There were no significant differences in ischaemic stroke, acute myocardial infarction, and stent thrombosis. The favourable effects of the ticagrelor monotherapy vs. the conventional therapy on all-cause mortality and BARC type 3 or 5 bleeding were consistent in the subset of patients presenting acute coronary syndromes (n = 15 157). Conclusion Ticagrelor monotherapy after short-term DAPT of 1–3 months was associated with decreased all-cause mortality and BARC type 3 or 5 bleeding not offset by increase of cardiac death, ischaemic stroke, acute myocardial infarction, and stent thrombosis.

scholarly journals Application Effect Evaluation of Telmisartan combined with Spironolactone after Catheter Ablation of Patients with Paroxysmal Atrial Fibrillation

2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Rongcheng Zhao ◽  
Jia Han ◽  
Lei Zhao
Keyword(s):  
Atrial Fibrillation ◽  
Treatment Group ◽  
Catheter Ablation ◽  
Paroxysmal Atrial Fibrillation ◽  
Conventional Therapy ◽  
Therapy Group ◽  
Combined Treatment ◽  
Time To Recurrence ◽  
Conventional Therapy Group ◽  
Hs Crp

Objective: To evaluate the application effect of telmisartan combined with spironolactone after catheter ablation of patients with paroxysmal atrial fibrillation. Methods: 80 cases of patients with paroxysmal atrial fibrillation who received radiofrequency catheter ablation treatment from March 2013 to March 2016 in our hospital were randomly selected, these patients were divided into two groups according to the treatment methods, namely, the telmisartan with Spironolactone treatment group (combined treatment group, n=40) and the conventional therapy group (n=40). The hs-CRP, NT-proBNP, LAD and recurrence of the two groups were analyzed. Results: The hs-CRP, NT-proBNP levels after 3 months of the combined treatment group were significantly lower (P<0.05), the recurrence rate 10.0% (4/40) was significantly lower than the conventional therapy group 27.5% (11/40) (P<0.05), the time to recurrence was significantly longer than the conventional therapy group (P<0.05). Conclusion: The application effects of telmisartan combined with spironolactone after catheter ablation in the treatment of patients with paroxysmal atrial fibrillation are better than conventional therapy.

Furosemide Dose Changes Associated with Furosemide/Tolvaptan Combination Therapy in Patients with Cirrhosis

2019 ◽  
Vol 38 (1) ◽  
pp. 38-45 ◽  
Author(s):  
Haruki Uojima ◽  
Hisashi Hidaka ◽  
Yoshiaki Tanaka ◽  
Naohisa Wada ◽  
Kousuke Kubota ◽  
...  
Keyword(s):  
Renal Function ◽  
Combination Therapy ◽  
Conventional Therapy ◽  
Therapy Group ◽  
Randomized Study ◽  
Diuretic Therapy ◽  
Combination Therapy Group ◽  
Open Label ◽  
Conventional Therapy Group ◽  
Dose Reductions

Background: Few data have demonstrated that the combination therapy comprising a natriuretic drug and an aquaretic drug has improved renal function compared with the conventional diuretic therapy of only a natriuretic drug in patients with cirrhosis. Objective: This study aimed to assess the influence to the renal function by furosemide dose reductions after administration of tolvaptan in cirrhotic ascites patients. Methods: A 2-center, open-label, randomized study with a 24-week treatment period was conducted in Japan. Patients who met the study’s criteria were randomized to a conventional therapy group or a combination therapy group in a 1:1 ratio. The combination therapy group received tolvaptan and reduced furosemide doses compared with those received before the study enrollment. The conventional therapy group continued with the original dosage regimens. We assessed the change in estimated glomerular filtration rate (eGFR) from baseline through the duration of the study in the 2 groups. Results: Twenty-nine patients were randomized to receive either the combination therapy group (n = 14) or the conventional therapy group (n= 15). The change in the furosemide dose from baseline was –35.2 ± 10.1 mg in the combination therapy group. After 24 weeks of treatment, significantly greater improvement in eGFR was observed in the combination therapy group (2.4 ± 0.4 mL/min 1.73 m2) compared with those in the conventional therapy group (–5.1 ± 1.2 mL/min 1.73 m2; p = 0.013). Conclusion: A combination therapy of tolvaptan and furosemide enabled furosemide dose reductions. Systematic reductions of the furosemide doses can lead to the improvement of renal function.

scholarly journals IMMUNOLOGICAL ASSESSMENT OF THE STRESS RESPONSE IN PATIENTS WITH INFLAMMATORY POSTPROTHETIC COMPLICATIONS

2021 ◽  
Vol 11 (2) ◽  
pp. 93-97
Author(s):  
Yuliya Makedonova ◽  
Dmitry Mikhalchenko ◽  
Oksana Kurkina ◽  
Olga Afanasyeva ◽  
Sergej Veremeenko ◽  
...  
Keyword(s):  
Stress Response ◽  
Conventional Therapy ◽  
Therapy Group ◽  
Transcranial Electrical Stimulation ◽  
Ozone Therapy ◽  
Dental Implantation ◽  
Psychoemotional State ◽  
Conventional Therapy Group ◽  
Pain Symptoms ◽  
Prosthetic Complications

Post-prosthetic complications during dental implantation are accompanied by pain symptoms leading to disorders of the psychoemotional state. All this influences the behavior of patients. In addition, psychoemotional stress is often a factor of provocation and persistence of the complications. The presence of a stress state in the identified pathology, as well as the influence of various therapies on the treatment of post-prosthetic complications, is reflected in the dynamics of changes in the concentrations of both catecholamines (epinephrine, norepinephrine) and glucocorticoids (cortisol) — hormones of the medulla and the adrenal cortex. The aim: to conduct an immunological analysis of the stress response in patients with postprosthetic complications during dental implantation. Materials and methods: The study was performed in 120 patients with post-prosthetic complications during dental implantation before and during treatment: Group I (control) — 30 patients treated with the conventional therapy; group II — 30 patients treated with ozone therapy in addition to the conventional therapy; group III — 30 patients treated with transcranial electrical stimulation in addition to the conventional therapy; Group IV — 30 patients treated with a combination of conventional therapy, ozone therapy and transcranial electrical stimulation. The concentration of epinephrine, norepinephrine, cortisol, alkaline phosphatase, and the Garkavi index were evaluated. Results: The change in these indicators after the treatment indicates the normalization of the level of the studied enzymes — markers of bone homeostasis, which is confirmed by an improvement in the clinical picture in the oral cavity. Conclusion: changes in immunological parameters objectively reflect the psychoemotional state of patients. The nature of changes in the hormonal stress response to the treatment of post-prosthetic complications indicates the effectiveness of the therapeutic regimens used, and, as a result, a decrease in both pain symptoms and psychoemotional stress.

Soluble Recombinant Thrombomodulin Ameliorates Hematological Malignancy-Induced Disseminated Intravascular Coagulation More Promptly Than Conventional Anticoagulant Therapy Without Causing Severe Hemorrhagic Events

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2381-2381
Author(s):  
Naoki Kurita ◽  
Masanori Seki ◽  
Yasuhisa Yokoyama ◽  
Mamiko Sakata-Yanagimoto ◽  
Naoshi Obara ◽  
...  
Keyword(s):  
Anticoagulant Therapy ◽  
Conventional Therapy ◽  
Hematological Malignancies ◽  
Hematological Malignancy ◽  
Therapy Group ◽  
Treated Group ◽  
Bleeding Tendency ◽  
Hemorrhagic Events ◽  
Conventional Therapy Group ◽  
Recombinant Thrombomodulin

Abstract Background Disseminated intravascular coagulation (DIC) is a lethal complication in patients with hematological malignancies. Although standard therapy against DIC remains to be established, soluble recombinant thrombomodulin (rTM), which serves as a receptor for thrombin, has been developed and its effectiveness for DIC was reported (Saito et al, J Thromb Haemost 2006). However, there is not enough evidence of rTM on DIC associated with hematological malignancy. Therefore we retrospectively compared outcome of hematological malignancy-related DIC treated with rTM or other conventional anticoagulant therapies. Patients and Methods One hundred and sixty-five consecutive DIC episodes in 146 patients with hematological malignancies (AML except for APL, 49; APL, 21; ALL, 19; NHL, 31; myeloma, 11; CML, 7; other; 8) hospitalized between January 2004 and May 2013 in University of Tsukuba Hospital were retrospectively analyzed. Diagnosis of DIC was based on DIC score of Japanese Ministry of Health and Labor Welfare criteria (Kobayashi et al, Bibl Haematol 1983). DIC was induced by hematological malignancy itself (h-DIC) or severe infection secondary to hematological malignancy (i-DIC) in 108 and 57 episodes, respectively. In 73 episodes, 380 units/kg/day of rTM was administered intravenously from the onset of DIC for median of 6 (range, 2-22) days. Other DIC episodes were treated with conventional anticoagulant therapy (low molecular weight heparin, 65; gabexate mesilate, 17; other anticoagulant, 10). Every anticoagulant therapy was accompanied by treatment for DIC-causing disease. We compared recovery time from DIC (the day when DIC score was decreased to 5 or less), overall survival, and severe hemorrhagic events related to the treatment, between rTM- and conventional anticoagulant-treated groups. Results Fifty-three DIC episodes were accompanied by bleeding tendency at the onset. In h-DIC, recovery from DIC was significantly more prompt in rTM-treated group, with the recovery rates of 55% (95% CI: 40 - 68) in the rTM-treated group and 33% (95% CI: 21 - 45) in the conventional therapy group at day 7 after the therapy initiation (P = 0.03, Fig.1). On day 14, the recovery from h-DIC was seen in 72% (95% CI: 56 - 83) and 60% (95% CI: 47 - 71) with the rTM and conventional therapies, respectively (P = 0.2). By contrast, recovery from i-DIC was significantly worse than that from h-DIC, and was not influenced by anticoagulant therapies. Recovery rates from i-DIC at day 14 were 27% (95% CI: 12 - 45) in the rTM-treated group and 36% (95% CI: 19 - 52) in the conventional therapy group (P = 0.6). Day 60 overall survival rates in h-DIC were 82% (95% CI: 66 - 91) and 79% (95% CI: 65 - 88) in the rTM-treated and conventional therapy groups. In i-DIC, on the other hand, 33% (95% CI: 16 - 52) and 33% (95% CI: 18 - 50) survived with the rTM and conventional therapies, respectively (Fig.2). Severe hemorrhagic events that led to discontinuation of anticoagulant therapy was significantly less in the rTM-treated group (3%; 95% CI, 0.3 - 9) compared with that in the conventional therapy group (12%; 95% CI: 6 - 20; P = 0.04). Discussion and Conclusion The recovery from h-DIC treated with rTM was more prompt compared to that with conventional anticoagulant therapy. Although the conventional anticoagulant therapy has fostered bleeding tendency, bleeding tendency was reduced after rTM administration in most of the DIC episodes. We emphasize that rTM can be an effective anti-DIC agent without causing adverse hemorrhagic event even in DIC cases with preexisting bleeding tendency. However, the outcome was still significantly worse in i-DIC secondary to hematological malignancies even after introduction of rTM. Further development of anticoagulant therapy is required for the control of i-DIC. Disclosures: Chiba: Asahi Kasei Pharma: Research Funding.

scholarly journals Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nirmal Ghati ◽  
Ambuj Roy ◽  
Sushma Bhatnagar ◽  
Sumit Bhati ◽  
Sudha Bhushan ◽  
...  
Keyword(s):  
Sample Size ◽  
Clinical Improvement ◽  
Conventional Therapy ◽  
Therapy Group ◽  
Sample Size Calculation ◽  
Open Label ◽  
Once Daily ◽  
Participant Recruitment ◽  
Full Protocol ◽  
Conventional Therapy Group

Abstract Objectives To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients will also be evaluated. Trial design This is a single-centre, prospective, four-arm parallel design, open-label, randomized control trial. Participants The study will be conducted at National Cancer Institute (NCI), Jhajjar, Haryana, which is a part of All India Institute of Medical Sciences (AIIMS), New Delhi, and has been converted into a dedicated COVID-19 management centre since the outbreak of the pandemic. All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial. Written informed consent will be taken for all recruited patients. Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. Patients refusing to give written consent and taking drugs that are known to have a significant drug interaction with statin or aspirin [including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine] will also be excluded from the trial. Intervention and comparator In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. Atorvastatin will be prescribed as 40 mg oral tablets once daily for ten days or until discharge, whichever is earlier. The dose of aspirin will be 75 mg once daily for ten days or until discharge, whichever is earlier. All other therapies will be administered according to the institute’s COVID-19 treatment protocol and the treating physician’s clinical judgment. Main outcomes All study participants will be prospectively followed up for ten days or until hospital discharge, whichever is longer for outcomes. The primary outcome will be clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality). The secondary outcomes will be change in serum inflammatory markers (C-reactive protein and Interleukin-6), Troponin I, and creatine phosphokinase (CPK) from time zero to 5th day of study enrolment or 7th day after symptom onset, whichever is later. Other clinical outcomes that will be assessed include progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality. Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding will also be examined in the trial to assess the safety of the interventions. Randomisation The study will use a four-arm parallel-group design. A computer-generated permuted block randomization with mixed block size will be used to randomize the participants in a 1:1:1:1 ratio to group A (atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy). Blinding (masking) The study will be an open-label trial. Numbers to be randomised (sample size) As there is no existing study that has evaluated the role of aspirin and atorvastatin in COVID-19 patients, formal sample size calculation has not been done. Patients satisfying the inclusion and exclusion criteria will be recruited during six months of study period. Once the first 200 patients are included in each arm (i.e., total 800 patients), the final sample size calculation will be done on the basis of the interim analysis of the collected data. Trial Status The institutional ethical committee has approved the study protocol (Protocol version 3.0 [June 2020]). Participant recruitment starting date: 28th July 2020 Participant recruitment ending date: 27th January 2021 Trial duration: 6 months Trial registration The trial has been prospectively registered in Clinical Trial Registry – India (ICMR- NIMS): Reference no. CTRI/2020/07/026791 (registered on 25 July 2020)]. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Five-year Safety Data From OPUS, a European Observational Safety Registry for Adults With Ulcerative Colitis Treated With Originator Infliximab [Remicade®] or Conventional Therapy

2019 ◽  
Vol 13 (9) ◽  
pp. 1148-1157 ◽  
Author(s):  
Julián Panés ◽  
James O Lindsay ◽  
Niels Teich ◽  
Stefan Lindgren ◽  
Jean-Frédéric Colombel ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Conventional Therapy ◽  
Therapy Group ◽  
Severe Disease ◽  
Safety Data ◽  
Autoimmune Disorder ◽  
Available N ◽  
Mayo Score ◽  
Serious Infection ◽  
Conventional Therapy Group

Abstract Background and Aims The Observational Postmarketing Ulcerative colitis Study [OPUS] was conducted to obtain the first long-term [5 years] safety data assessing treatment with originator infliximab versus conventional therapies in patients with ulcerative colitis [UC] in real-world clinical practice. Methods The OPUS registry was a prospective, non-randomised, observational study that measured adverse events in nine prespecified categories of interest in UC patients whose treatment with either originator infliximab or conventional therapy [defined as initiation or dose-increase of corticosteroids and/or immunosuppressants] was determined by their treating physician. Results Data for 2239 patients were available: N = 1180 enrolled to conventional therapy [including N = 296 who switched to originator infliximab during follow-up] and N = 1059 enrolled to originator infliximab. Patients in the originator infliximab group, compared with the conventional therapy group, had more severe disease at baseline, based on partial Mayo score [PMS]: 46.0% of patients in the originator infliximab group had severe disease (PMS of 7–9 [out of 9]), compared with 30.5% in the conventional therapy group. In adjusted time-to-event analyses, enrolment into the originator infliximab group was associated with a higher risk of serious infection (hazard ratio = 1.98 [95% confidence interval: 1.34, 2.91; p <0.001]) compared with enrolment into the conventional therapy group. No notable risk differences between groups were identified for haematological disorder, autoimmune disorder, malignancy/lymphoproliferative disorder, hepatobiliary disorder or fatality. Conclusions UC patients treated with infliximab had higher risk for serious infection, compared with conventional therapies. No new safety concerns were observed with originator infliximab in the OPUS registry. [ClinicalTrials.gov: NCT00705484.]

Treatment of hard-to-heal leg ulcers with hyaluronic acid, sodium alginate and negative pressure wound therapy

2020 ◽  
Vol 29 (7) ◽  
pp. 419-423
Author(s):  
Omer Arda Cetinkaya ◽  
Suleyman Utku Celik ◽  
Can Yahya Boztug ◽  
Hakan Uncu
Keyword(s):  
Hyaluronic Acid ◽  
Lower Extremity ◽  
Negative Pressure ◽  
Conventional Therapy ◽  
Negative Pressure Wound Therapy ◽  
Therapy Group ◽  
Complete Healing ◽  
Leg Ulcers ◽  
Wound Therapy ◽  
Conventional Therapy Group

Objective: Hard-to-heal lower extremity ulcer is a common healthcare problem and can lead to a poor quality of life (QoL). Despite the advances in wound care, conventional therapies, such as necrotic tissue debridement, cleansing, treatment of infection and local treatment with dressing application are still considered the standard of care in patients with hard-to-heal leg ulcers. However, managing hard-to-heal ulcers that do not respond well to these methods has led to new treatment strategies. In this study, the effects of hyaluronic acid (HA) and sodium alginate (SA), combined with negative pressure wound therapy (NPWT), in patients with hard-to-heal leg ulcers are evaluated. Method: Patients with hard-to-heal lower extremity ulcers were treated with HA-SA combined with NPWT (HA-SA-NWPT, n=11), or conventional therapy (n=14), between June 2014 and September 2015. Demographics, comorbidities, time to complete healing and change in wound area were recorded and compared. Results: A total of 25 patients took part. Complete healing was achieved in 63.6% (n=7) of the patients in the HA-SA with NPWT group, compared with 14.3% (n=2) of the patients in the conventional therapy group (p=0.017). The mean decrease in wound size was significantly higher in the HA-SA-NPWT group than in the conventional therapy group (73.8% versus 34.8%, respectively, p=0.029). Despite a shorter healing period in the HA-SA-NPWT group than in the conventional group, no statistically significant difference was found between groups for time to complete healing (37 days versus 55 days, respectively). Conclusion: These results demonstrate that the combination of HA-SA-NPWT is a promising treatment for decreasing the healing time and increasing the success rate by their synergistic effect on wound healing in hard-to-heal lower extremity ulcers. However, further studies with a larger number of patients are needed to confirm the results.

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