Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SARS-CoV-2 infection. This international, multicentre, prospective cohort study included patients undergoing elective or emergency surgery during October 2020. Surgical patients with pre-operative SARS-CoV-2 infection were compared with those without previous SARS-CoV-2 infection. The primary outcome measure was 30-day postoperative mortality. Logistic regression models were used to calculate adjusted 30-day mortality rates stratified by time from diagnosis of SARS-CoV-2 infection to surgery. Among 140,231 patients (116 countries), 3127 patients (2.2%) had a pre-operative SARS-CoV-2 diagnosis. Adjusted 30-day mortality in patients without SARS-CoV-2 infection was 1.5% (95%CI 1.4-1.5). In patients with a pre-operative SARS-CoV-2 diagnosis, mortality was increased in patients having surgery within 0-2 weeks, 3-4 weeks and 5-6 weeks of the diagnosis (odds ratio (95%CI) 4.1 (3.3-4.8), 3.9 (2.6-5.1) and 3.6 (2.0-5.2), respectively). Surgery performed ≥ 7 weeks after SARS-CoV-2 diagnosis was associated with a similar mortality risk to baseline (odds ratio (95%CI) 1.5 (0.9-2.1)). After a ≥ 7 week delay in undertaking surgery following SARS-CoV-2 infection, patients with ongoing symptoms had a higher mortality than patients whose symptoms had resolved or who had been asymptomatic (6.0% (95%CI 3.2-8.7) vs. 2.4% (95%CI 1.4-3.4) vs. 1.3% (95%CI 0.6-2.0), respectively). Where possible, surgery should be delayed for at least 7 weeks following SARS-CoV-2 infection. Patients with ongoing symptoms ≥ 7 weeks from diagnosis may benefit from further delay.
SARS-CoV-2 has been associated with an increased rate of venous thromboembolism in critically ill patients. Since surgical patients are already at higher risk of venous thromboembolism than general populations, this study aimed to determine if patients with peri-operative or prior SARS-CoV-2 were at further increased risk of venous thromboembolism. We conducted a planned sub-study and analysis from an international, multicentre, prospective cohort study of elective and emergency patients undergoing surgery during October 2020. Patients from all surgical specialties were included. The primary outcome measure was venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1-6 weeks before surgery); previous (≥7 weeks before surgery); or none. Information on prophylaxis regimens or pre-operative anti-coagulation for baseline comorbidities was not available. Postoperative venous thromboembolism rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2. After adjustment for confounding factors, patients with peri-operative (adjusted odds ratio 1.5 (95%CI 1.1-2.0)) and recent SARS-CoV-2 (1.9 (95%CI 1.2-3.3)) remained at higher risk of venous thromboembolism, with a borderline finding in previous SARS-CoV-2 (1.7 (95%CI 0.9-3.0)). Overall, venous thromboembolism was independently associated with 30-day mortality ). In patients with SARS-CoV-2, mortality without venous thromboembolism was 7.4% (319/4342) and with venous thromboembolism was 40.8% (31/76). Patients undergoing surgery with peri-operative or recent SARS-CoV-2 appear to be at increased risk of postoperative venous thromboembolism compared with patients with no history of SARS-CoV-2 infection. Optimal venous thromboembolism prophylaxis and treatment are unknown in this cohort of patients, and these data should be interpreted accordingly.
IntroductIonNon Hodgkin lymphomas (NHLs) are the most commonly occurring hematologic malignancies in the United States. They represent 4% to 5% of all new cancer cases. There is 65,540 men and women (35,380 men and 30,160 women) ARM I "cisplatin 75mg/m2 on day 1, dexamethasone 40 mg on days 1-4, and gemcitabine 1000mg/m2 on days 1 and 8, given every 21 days" and ARM II, Patients received "cisplatin 75mg/m2 IV over 24 hours on day 1, dexamethasone as in arm A, and cytarabine 2gm/m2 IV over 3 hours every 12 hours on day 2, given every 21 days". A total of 330 chemotherapy cycles were administered, with a mean of 5.4 cycles per patient (range 2-6). results: Among the sixty two eligible patients treated, there were three early deaths, including one patient in group A and two patient in group B. Four patients in group A and three patients in group B had disease progression during treatment. The overall response rate was 65% (29% CR rate, 38% PR rate) in arm A and 67.6% (32.2% CR rate, 35.4% PR rate) in arm B. The median disease free survival time was 10 months, 9 months (95% CI, 6.078 to 11.922 months), the median Progression free survival time was 4 months (95% CI, 2.108 to 5.892 months), 4 months (95% CI, 3.028 to 4.972 months), the median overall survival time was 20 months (95% CI, 14.377 to 25.623 months), 21 months (95% CI, 9.352 to 32.648 months) for arm A& B, respectively. Hematologic toxicities were comparable between the two arms with greater number of patients developed grade III, IV neutropenia in arm B. The most common grade III or IV hematological toxicities were neutropenia and thrombocytopenia, neutopenia was 62.9% in group A and 70% in group B, febrile neutopenia was significantly higher in group B (53.8%) compared to (22.2%) in group A. Grade III or IV thrombocytopenia was observed in 29.7% among both groups. Other hematological toxicities are comparable in both groups. Stomatitis and infection were higher in arm B. Stomatitis was 36%, 69.2%, Infection was 24%, 42.3% for arm A& B, respectively. conclusion: The study revealed no significant differences between GDP and DHAP as regarding response rate, OS, DFS and PFS in treatment of relapsed or refractory DLBCL. Toxicity was higher in DHAP group.
Purpose: Gemcitabine plus cisplatin (GC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic bilharzial urothelial carcinoma. Patients and Methods: Patients with with locally advanced or metastatic bilharzial urothelial carcinoma (no prior systemic chemotherapy) were randomized to GC (gemcitabine 1,000 mg/m 2 days 1, 8, 15, cisplatin 70 mg/m 2 day 2) or standard MVAC every 28 days for a maximum of six cycles (Methotrexate = 30 mg/m 2 on days 1, 15 and 22, Vinblastine = 3 mg/m 2 on days 2, 15 and 22,Doxorubicin = 30 mg/m 2 on day 2 and Cisplatin = 70 mg/m 2 on day 2 (1-2 h infusion). Results: forty-one patients were randomized, twenty-one to the GC arm and twenty to the MVAC arm. Overall survival was similar(13 months) on both arms. Time to progressive disease was 7 months with GC group and 6 months with MVAC group and response rate (GC, 47.6% vs MVAC 45%). Significant prognostic factors correlating with better overall survival were Karnofsky performance status ≥ 70, TNM staging (Mo vs.M1) and the absence of visceral metastasis. Hematologic toxicities were significantly higher with GC therapy. More GC patients, compared with MVAC patients had grade 3/4 anemia (28.5% vs 15%) and thrombocytopenia (47.6% vs 25%). More MVAC patients, compared with GC patients had grade 3/4 neutropenia (80% vs 67.6% P = 0.001), grade 3/4 mucositis (20% v 9.5%) and alopecia (25% v 14.3%) Conclusion: GC provides a similar survival advantage to MVAC with a better tolerability. These results strengthen the role of GC as a standard of care in patients with locally advanced or metastatic bilharzial-related urothelial carcinoma.
Background According to the WHO there are 185 million people infected with HCV in the world.Egypt has the highest prevalence of hepatitis C virus (HCV) in the world reaching 13% equating to an estimated 12 million Egyptians . HCV is one of the main causes of liver cirrhosis and hepatocellular carcinoma.HCV can develop kidney disease because of extrahepatic manifestations of HCV or as a disease process independent of the HCV infection.In addition, hemodialysis has been a risk factor for acquiring HCV infection. The prevalence of HCV infection is high in patients with ESRD, on hemodialysis ranges from 6% to 60% in different parts of the world. Several studies show that patients on hemodialysis have an increased overall mortality risk if they have chronic HCV when compared with those on dialysis who do not have HCV. Antiviral treatment in CKD patients can be complicated because many of the agents used for anti-HCV therapy can accumulate to toxic levels in the setting of renal impairment. Treatment of HCV compensated cirrhosis with the new DAA therapy Qurevo “ombitasvir/paritaprevir/ritonavir” with ribavirin in ESRD was approved in many countries. Aim of the study To evaluate the efficacy and safety of Qurevo/Ribavirin regimen in ESRD Egyptian patients who are infected with hepatitis C virus (HCV) . Patients and Methods A prospective cohort study evaluated the outcome of 12-week ombitasvir (NS5A inhibitor)/paritaprevir (NS3/4A protease inhibitor)/ritonavir with ribavirin combination therapy for 50 ESRD patients with HCV at the hepatic virology clinic at Ain Shams University hospital over a period of 15 months (from December 2016 to February 2018). The primary endpoint was sustained virologic response 12 weeks after therapy (SVR12). Results 50 ESRD patients with a mean age of 51.4 years, range from 23-77 years were enrolled.The SVR12 rate was 96% (48/50); 2 patients had virologic failure. As regards adverse events, the most frequent was fatigue/asthenia in 44 patients (88%) and worsening anemia (Hb dropped to < 10 g/dl) in 42 patients (84%). GIT upset occurred in 10 patients (20%), sleep disorders in 8 patients (16%), decreased appetite in 8 patients (16%),respiratory distress in 6 patients (12%), headache, dizziness in 6 patients(12%). Muscle spasms in 4 patients (8%). Itching(pruritis) occurred in 3 patients(6%).2 patients (4%) were non-responders to treatment and another 2 (4%) were relapsers.Death occurred in 4 patients (8%) due to myocardial infarction, pulmonary edema, severe hypotension on hemodialysis sessions, shock due to blood loss in retroperitoneal hematoma following peritoneal dialysis. Hepatic decompensation, hypersenisitivity (angioedema), teratogenicity and drug interactions did not occur in any patient (0%).Other events occurred in 11 patients (22%). They were parenchymal liver changes in ultrasound at the end of therapy after being normal before therapy (in 3 patients), thrombocytopenia, increased alkaline phosphatase, hiccough, deterioration of hypertension, urinary tract infection, lower limb cellulitis, vaginal bleeding, chest infection(in 1 patient each). SVR12 was achieved in 100% of patients who had to stop or modify ribavirin dose;this means that Ribavirin absence didn’t affect the sustained viral response in these patients. Conclusion Our results confirm the efficacy of Qurevo “ombitasvir/paritaprevir/ritonavir” with Ribavirin combination therapy in ESRD patients with HCV infection, with anemia as the most frequent adverse event.
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