scholarly journals Incidence of Neurological Complications Secondary to Intrathecal Chemotherapy Used As Either Prophylaxis or Treatment of Leptomeningeal Carcinomatosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5973-5973 ◽  
Author(s):  
Diana M Byrnes ◽  
Christopher R Dermarkarian ◽  
Ryan Kahn ◽  
Deukwoo Kwon ◽  
Fernando Vargas ◽  
...  
Keyword(s):  
Back Pain ◽  
Adverse Events ◽  
Side Effect ◽  
Cranial Nerve ◽  
Neurological Complications ◽  
Intrathecal Chemotherapy ◽  
Drug Combinations ◽  
Chemotherapy Treatment ◽  
Chemotherapy Administration ◽  
Significant Difference

Abstract Purpose: To examine the incidence and frequency of neurological complications secondary to intrathecal chemotherapy. Introduction: Intrathecal (IT) chemotherapeutic agents have a narrow therapeutic index and high potential for toxicity. Though severe side effects are considered rare, consequences of IT chemotherapy administration can be catastrophic. The most common neurotoxic side effect is chemical arachnoiditis, manifesting typically as headache and/or fever, but more severe symptoms have also been reported including paraplegia, cranial nerve palsies, and seizures. The true incidence of neurological complications is not well quantified, and many cases of toxicity may go unrecognized or unreported. Here we detail neurologic complications of IT chemotherapy in adult patients over a two-year time period at our institution. Patients and Methods: Sixty-three patients received IT chemotherapy between January 2014 and December 2015 at Jackson Memorial Hospital and were included in this analysis. We cataloged all neurological complications within four days of IT chemotherapy. We defined minor neurological complications as headache, backache, nuchal rigidity, fever, nausea, or vomiting. Major neurological complications were defined as paresthesia, cranial nerve palsy, paralysis, or asthenia. For each administration of IT chemotherapy we recorded the type and dose of chemotherapy, and results of associated CSF cytology and flow cytometry. Results: Of the 63 patients who received IT chemotherapy treatment, 44 (70%) were male. 20 (32%) patients identified as non-Hispanic, 41 (65%) identified as Hispanic, and 2 (3%) identified as Haitian. The average age at time of treatment was 47.87 years (median: 49, range 22-72). 14 (22%) of patients were HIV positive. At time of IT chemotherapy treatment, 18 (29%) patients had known malignancy present in the CNS. Of the 208 recorded administrations of IT chemotherapy, 197 (95%) included methotrexate and 122 (59%) included cytarabine. The incidence of major neurologic adverse events for all patients receiving IT chemotherapy was 6.8%. The rate of major events was 9.2% for methotrexate with or without hydrocortisone, 9.1% for cytarabine with or without hydrocortisone, and 5.4% for methotrexate and cytarabine combined with or without hydrocortisone. There was no statistically significant difference in rate of major events when the three drug combinations were compared (p=0.562). The rate of minor neurologic events was 38.3% for all cases of patients receiving IT chemotherapy, 42.4% for methotrexate with or without hydrocortisone, 36.4% for cytarabine with or without hydrocortisone, and 35.5% for methotrexate and cytarabine combined with or without hydrocortisone. There was no statistically significant difference in rate of minor events when comparing the three different drug combinations (p=0.604). The adverse events encountered most frequently were headache (15.9%), nausea (13.6%), vomiting (9.6%), back pain (5.8%), and fever (5.8%). The most frequent major adverse events were asthenia (4.3%) and paresthesia (3.8%). Discussion and Conclusion: More than one third of all IT chemotherapy administration events resulted in at least one minor side effect, with roughly 7% resulting in at least one major effect. Headache, nausea, vomiting, back pain, and fever were the most common events encountered-all of which are common sequelae of chemical arachnoiditis. In the cases of major neurologic events we considered potential contamination of the IT methotrexate. Though never confirmed at our institution, Zeng et. al. (J Clin Oncol, 2011) investigated the development of paraplegia amongst patients who received IT methotrexate, discovering trace amounts of vincristine that contaminated intrathecal drugs produced by a manufacturing plant in China causing a large outbreak of severe neurological damage. Murata et al. (J Med Case Rep, 2015) reported a case of demyelination secondary to myelopathy attributed to an IT methotrexate dose. Outbreaks of severe adverse reactions to IT chemotherapy, especially when temporally related, should prompt suspicion of potential chemotherapy contamination. It is important for clinicians to be aware of the adverse events described in this study and consider them seriously when treating patients with IT chemotherapy. * Byrnes D, Dermarkarian C, and Kahn R contributed equally to this work Disclosures No relevant conflicts of interest to declare.

scholarly journals COMPARISON OF EFFICACY AND SAFETY SILODOSIN 8 MG ONCE DAILY AND SILODOSIN 4 MG TWICE DAILY IN BPH PATIENTS WITH LUTS

2019 ◽  
Vol 26 (1) ◽  
Author(s):  
Ramzie Nendra Diansyah ◽  
Johan Renaldo ◽  
Wahjoe Djatisoesanto ◽  
Lukman Hakim
Keyword(s):  
Adverse Events ◽  
Side Effect ◽  
Similar Efficacy ◽  
Common Adverse Event ◽  
Common Side Effect ◽  
Urinary Flow ◽  
Once Daily ◽  
Significant Difference ◽  
Male Patients ◽  
Maximum Urinary Flow

Objective: This study was aimed to compare the efficacy and side effect of silodosin 8mg once daily and silodosin 4mg twice daily in BPH-LUTS patients after 4 and 12 weeks. Material & Methods: Single blind randomized controlled trials in 60 male patients aged ≥45 years with BPH-LUTS from July 2017 to October 2017 was divided into groups who received 8mg of silodosin once daily and those who received 4mg of silodosin twice daily. Efficacy and adverse events were evaluated after 4 and 12 weeks of treatment. Results:  There was no significant difference of mean age of the two groups was 67.93 ± 6.49 years and 69.07 ± 6.28 years respectively (p 0.49). Both doses of this drug decreased the International Prostate Symptom Score (IPSS) and significantly increased the maximum urinary flow (Qmax) (p<0.05) but there was no significant differences between the two groups (p>0.05). Ejaculation disorder was the most common side effect in all groups (6.7% and 5%) and there was no significant difference between the two groups (p>0.05). Conclusion: The administration of 8mg of once daily silodosin has similar efficacy as 4mg twice daily silodosin. There were no adverse events differences in the two groups. Ejaculation disorder is the most common adverse event of silodosin administration.

Medical resource utilization (MRU) and costs associated with paclitaxel poliglumex (PPX) compared to gemcitabine (Gem) or vinorelbine (Vin) in non-small cell lung cancer (NSCLC) patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18172-18172
Author(s):  
F. B. Oldham ◽  
K. P. Anastassopoulos ◽  
K. O'Byrne ◽  
M. S. Maxon ◽  
C. P. Schaefer
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Performance Status ◽  
Cost Savings ◽  
Phase Iii ◽  
Chemotherapy Administration ◽  
Outpatient Visits ◽  
Medical Resource Utilization ◽  
Significant Difference ◽  
Nsclc Patients

18172 Background: NSCLC accounts for 80% of lung cancer cases and is commonly treated with taxanes. PPX is a phase III, biologically-enhanced, investigational, chemotherapeutic for treatment of NSCLC that links paclitaxel to a biodegradable polyglutamate polymer that potentially spares normal tissue exposure to chemotherapy toxicities. Methods: MRU data were collected as part of a multinational, randomized trial that compared PPX (n=191) to Gem or Vin (n=190) in chemotherapy-naïve advanced NSCLC patients with a performance status of 2. MRU and costs associated with chemotherapy administration and non-protocol-driven care were compared over the study period. Costs (2005 U.S. dollars) were assigned from a U.S. payer perspective. Results: Patient demographics were similar (p>0.05) between groups (mean age: 62 yrs, 72% male, 89% Caucasian). PPX had slightly longer median survival (220 vs. 198; p=0.686) with significantly fewer adverse events (all grades; 2.0 vs. 3.0; p=0.011) and significantly more chemotherapy cycles (3.4 vs. 3.9; p=0.007), per subject. Additionally, PPX had fewer outpatient visits (0.6 vs. 1.7; p<0.001), diagnostic tests (0.6 vs. 1.9; p<0.001), and days on non-chemotherapy medications (64.4 vs. 91.2; p<0.001), per subject. There was no significant difference in number of hospitalizations (0.04 in both groups; p=0.786), length of stay among those hospitalized (8.4 days PPX vs. 6.1 days Gem or Vin; p=0.301), or procedures (0.02 PPX vs. 0.04 Gem or Vin; p=0.238), per subject. Average costs per subject were significantly lower in PPX for outpatient visits ($34 vs. $78; p=0.014), non-chemotherapy medications ($717 vs. $911; p<0.001), and chemotherapy administration ($1,557 vs. $3,601; p<0.001) and similar for inpatient stays ($210 PPX vs. $244 Gen or Vin; p=0.794). Conclusions: This analysis suggests that, in addition to providing a clinical benefit of fewer adverse events, PPX results in reduced MRU and associated costs compared to Gem or Vin in treating NSCLC. These cost savings can be weighed against the cost of PPX and may provide a pharmacoeconomic advantage. Further research is warranted to confirm these results in routine clinical practice. [Table: see text]

scholarly journals Sciatic-obturator-femoral technique versus spinal anesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator: A randomized trial

2019 ◽  
Author(s):  
Hoda Shokri ◽  
Amr Kasem
Keyword(s):  
Back Pain ◽  
Adverse Events ◽  
Nerve Block ◽  
Spinal Anaesthesia ◽  
External Fixator ◽  
Tibial Fractures ◽  
Ilizarov External Fixator ◽  
Open Tibial Fractures ◽  
Significant Difference ◽  
Analgesic Dose

Abstract Background Peripheral nerve block is an ideal choice for lower limb surgery because of the peripheral site of the surgical procedure and the ability to block pain pathways at multiple levels. The aim of this study was to assess the efficacy and safety of SOFT block (sciatic-obturator-femoral nerve block technique) compared with spinal anaesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixatorMethods This study was conducted over 107 patients ASA I, II scheduled for fixation of open tibial fractures using Ilizarov external fixator. The patients were randomly allocated to receive either spinal anaesthesia or SOFT block. In spinal anaesthesia group, patients received spinal anaesthesia with hyperbaric bupivacaine 0.5% (7.5-10mg). In SOFT group, patients received SOFT block with bupivacaine 0.25%. Primary endpoint included the duration of analgesia. The secondary endpoints included patient satisfaction scores, time of first analgesic dose, visual analogue scale scores, incidence of adverse events as back pain, postural -puncture headache, vomiting, systemic toxicity from local anesthetic, parathesia observed within 48 hours of the block.Results The duration of soft block and time to first analgesic dose in SOFT group was significantly longer (p<0.001). The incidence of headache (p=0.028) and back pain (p=0.012) was significantly higher in spinal group. There was no significant difference between the study groups regarding satisfaction scores, the incidence of cardiovascular collapse, seizures and parathesia. Pain scores were significantly lower in SOFT group at 3,6,12 hours postoperative (p<0.001).Conclusion SOFT block is a feasible technique for control of postoperative pain with unremarkable adverse events compared with spinal anaesthesia, in patients undergoing fixation of tibial fractures using Ilizarov external fixator.

Assessment of dysgeusia and taste identification in patients undergoing chemotherapy for breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21668-e21668
Author(s):  
Sayaka Kuba ◽  
Rie Fujiyama ◽  
Kosho Yamanouchi ◽  
Chika Sakimura ◽  
Toshiko Hatachi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Oral Cavity ◽  
Side Effect ◽  
Cranial Nerve ◽  
Common Side Effect ◽  
Normal Range ◽  
Effective Prevention ◽  
Basic Taste ◽  
Significant Difference ◽  
Prevention And Treatment

e21668 Background: Dysgeusia is a common side effect of chemotherapy (CT) and often impacts negatively on QOL. This study analyzed the prevalence of gustatory test abnormalities in breast cancer (BC) patients undergoing CT. Methods: We enrolled 33 BC patients who were undergoing CT (26 adjuvant CT and 7 CT for advanced BC) and conducted 2 gustatory tests on CT day. In the test of sensitivity using the instillation method (IM), 4 basic taste stimuli (sweet, salty, sour, and bitter) at 5 concentrations were applied to the entire oral cavity. For the electrogustometry method (EM), we measured the amount of current for perception of metallic tastes, examining the front two thirds of the tongue (cranial nerve VII) and the back third of the tongue (cranial nerve IX). We compared awareness of dysgeusia with results of the 2 gustatory tests. Results: Median CT duration was 83 days (12–1,353). Fifteen (45%) patients had awareness of dysgeusia (Grade 1: 11, Grade 2: 4). IM revealed 8 (24%) patients with abnormalities, 7 in a single taste species and 1 in 3 taste species. EM revealed 20 (61%) patients withabnormalities, 7 in the cranial nerve VII and 20 in the cranial nerve IX innervation area. All patients with abnormalities in the cranial nerve VII innervation area also had abnormalities in the cranial nerve IX innervation area. Among 15 patients with awareness of dysgeusia, there were 5 (33%) IM abnormalities and 12 (80%) EM abnormalities (4 in the cranial nerve VII and 12 in the cranial nerve IX innervation area). Among 18 patients without awareness of dysgeusia, there were 3 (16%) IM abnormalities and 8 (44%) EM abnormalities (3 in the cranial nerve VII and 8 in the cranial nerve IX nerve innervation area). Patients with IM abnormalities had a higher frequency of abnormalities in the cranial nerve VII innervation area than the normal range (50% and 12%, respectively; p = 0.04); there was no significant difference in the cranial nerve IX innervation area. Conclusions: Nearly half of the patients reporteddysgeusia, but most of these could correctly identify the four basic tastes. Further studies to clarify the discrepancy between subjective and objective observations could lead to effective prevention and treatment of dysgeusia.

scholarly journals Safety Profile of Fostamatinib, an Oral Spleen Tyrosine Kinase Inhibitor: A Meta-Analysis of Randomized Controlled Trials

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4890-4890
Author(s):  
Apoorva Krishna Chandar ◽  
Omar Ali Alaber ◽  
Muhammad Zain Farooq ◽  
Basma Ali Dahash ◽  
Ankit Mangla
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Side Effect ◽  
Controlled Trials ◽  
Side Effect Profile ◽  
Bleeding Events ◽  
Randomized Controlled ◽  
Serious Infections ◽  
Significant Difference ◽  
Tract Infections

Introduction: Fostamatinib, a spleen tyrosine kinase (Syk) inhibitor has been studied in clinical trials of chronic immunologic conditions such as Rheumatoid Arthritis (RA), chronic immune thrombocytopenic purpura (ITP), IgA nephropathy and certain lymphomas. It has recently been granted FDA approval for the treatment of ITP. Fostamatinib inhibits the Syk pathway which is also involved in platelet activation through collagen receptor and the integrin αIIbβ3, which, in theory, would increases the risk of bleeding. Also, by inhibiting Syk, fostamatinib reduces macrophage phagocytosis and may render them ineffective against certain bacteria, hence increasing the risk of serious infections. We sought to examine the side effect profile of Fostamatinib in published and unpublished studies randomized controlled trials (RCT). Methods: A systematic search of scientific databases, major conference abstracts and clinical trial registries was performed. Only Phase 2 and Phase 3 RCTs with a placebo arm were included. For dosing of fostamatinib, we preferentially used the 100mg BID dosing as this is the dose approved by the FDA for ITP and is the dose determined through the large trials in patients with RA, which strikes a balance between benefits and harms. When the 100mg and 150mg dosing were combined (as in the ITP trials), we used data from that arm for the analysis. All major and minor harms specified in the trials were pooled using a random effects model and the risk ratio (RR) and confidence interval (CI) was determined using the Mantel-Haenszel method. An I2 value of less than ≤ 40% was considered minimal heterogeneity. Results: The search found 12 studies involving 1,444 cases and 1,188 controls. Of these, 9 studies examined the use of fostamatinib for RA whereas 2 studies were on ITP, and 1 study was on IgA nephropathy. Commonly encountered side effects of fostamatinib therapy were diarrhea, headache, nausea and hypertension. When compared to placebo, fostamatinib was associated with 19% higher risk of any adverse event (9 studies, RR = 1.19, CI = 1.07 - 1.33, I2 = 40%). Patients who received fostamatinib had a significantly higher risk of developing neutropenia (ANC < 1500/microL) when compared to placebo (8 studies, RR = 4.34, CI = 1.82 - 10.31, I2 = 30%). There was only 1 case of febrile neutropenia in one of the ITP trials. There were no significant differences between the fostamatinib and placebo groups with regard to upper respiratory tract infections (7 studies, RR = 1.43, CI = 0.61 - 3.36, I2 = 49%), urinary tract infections (4 studies, RR = 1.6, CI = 0.78 - 3.28, I2 = 0%) or serious infections (7 studies, RR = 1.18, CI = 0.42 - 3.30, I2 = 0%). However, when compared to placebo, there was a 2.23 times higher risk of developing diarrhea (10 studies, CI = 1.46 - 3.41, I2 = 45%) and hypertension (9 studies, CI = 1.61 - 3.09, I2 = 13%) in the fostamatinib group. Most patients had hypertension at baseline and few needed either medication initiation or adjustment in the fostamatinib cohorts. Fostamatinib also significantly increased liver enzyme (ALT > 3 ULN) when compared to placebo (9 studies, RR = 2.21, CI = 1.18 - 4.14, I2 = 0%). There were higher bleeding events in the fostamatinib group, but there was no significant difference between the treatment and placebo arms (4 studies, RR = 1.06, CI = 0.16 - 6.94, I2 = 45%). There were no significant differences between the treatment and control groups with regard to serious adverse events and mortality. Treatment discontinuation rates due to adverse events were not significantly different between groups. Conclusions: Fostamatinib tends to have a relatively benign side effect profile, with few serious side effects. In congruence of the theoretical higher bleeding risk with Syk inhibition, the bleeding events were slightly higher in fostamatinib group, however there was no statistically significant difference between the treatment and the placebo groups. Similarly, the incidence of neutropenia, though higher in the Fostamatinib group, was rarely associated with fever (1 event among all 12 trials). The incidence of serious infections did not differ significantly between groups. Gastrointestinal and cardiac side effects were transient and did not lead to significantly more treatment discontinuations when compared to placebo. Larger longitudinal studies are needed to better examine the long-term side effects associated with Fostamatinib. Table Disclosures No relevant conflicts of interest to declare.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals POS1280 SPINAL LOCATION OF TUBERCULOSIS: WHAT HAS CHANGED OVER THE LAST YEARS?

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 923.3-923
Author(s):  
S. Boussaid ◽  
M. Mrabet ◽  
S. Jemmali ◽  
H. Sahli ◽  
H. Ajlani ◽  
...  
Keyword(s):  
Neurological Complications ◽  
Developing Nations ◽  
Lumbar Pain ◽  
X Rays ◽  
Resonance Imaging ◽  
Vertebral Collapse ◽  
The Past ◽  
Significant Difference ◽  
Tuberculous Spondylodiscitis ◽  
Different Parts

Background:Tuberculosis (TB) is no longer a disease limited to developing nations and is still a major cause of significant morbidity and mortality worldwide. It can affect the different parts of the spine.Objectives:The aim of this study was to determine the preferred spinal location of TB.Methods:We conduct a retrospective and descriptive study in a single rheumatology department. Data were collected from observations of patients hospitalized in the past 20 years (2000-2020) who have been diagnosed with tuberculous spondylodiscitis (TS).Results:Fifty-two patients were included (37F/15M). Their mean age was 55.21 years ± 17.79 [19-91]. TS was more frequently unifocal (75%) than multifocal (25%). Lumbar spine involvement was the most common (57.7%) and more frequent in women (63.3%) but with no statistically significant difference (p = 0.2). Other localizations were described such as: dorso-lumbar (21.2%), dorsal (15.4%), lumbosacral (3.8%) and cervical (1.9%). Lumbar pain was present in 34 patients (65.4%) and 29 patients (55.8%) suffered from segmental lumbar stiffness. Imaging was contributive by showing the vertebral location using standard X-rays, computed tomography and magnetic resonance imaging. Disc pinch, erosion of vertebral plateaus and vertebral collapse were the major signs (82.7%, 65.4% and 67.3%, respectively).Conclusion:TS is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. Spinal involvement is often unifocal and mostly diagnosed with lumbar pain or stiffness. Multifocal forms, touching several parts of the spine, however remain rare. Our findings remain consistent with those of the literature.Disclosure of Interests:None declared

scholarly journals Comparison of Long-Term Outcomes of the Lamellar and Penetrating Keratoplasty Approaches in Patients with Keratoconus

2021 ◽  
Vol 10 (11) ◽  
pp. 2421
Author(s):  
Dominika Janiszewska-Bil ◽  
Barbara Czarnota-Nowakowska ◽  
Katarzyna Krysik ◽  
Anita Lyssek-Boroń ◽  
Dariusz Dobrowolski ◽  
...  
Keyword(s):  
Endothelial Cell ◽  
Adverse Events ◽  
Penetrating Keratoplasty ◽  
Corneal Thickness ◽  
Cell Loss ◽  
Lamellar Keratoplasty ◽  
Deep Anterior Lamellar Keratoplasty ◽  
Endothelial Cell Loss ◽  
Anterior Lamellar Keratoplasty ◽  
Significant Difference

We compared the visual and refractive outcomes, intraocular pressure (IOP), endothelial cell loss (ECL), and adverse events in keratoconus patients after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PK) with the best corrected visual acuity (BCVA) below 0.3 (logMAR 0.52). This is a prospective, comparative cohort study of 90 eyes (90 patients) with a clinical diagnosis of keratoconus. Patients underwent a complete eye examination before the surgical approach, 6 and 12 months postoperatively that consisted of BCVA, refractive astigmatism (AS), central corneal thickness (CCT), IOP, and ECL. Secondary outcomes were adverse events related to the surgical procedure. With lower ECL and less adverse events, DALK was revealed to be beneficial over PK with similar visual outcomes. Results: There was no significant difference between the BCVA in the DALK and PK groups (at 6 months: 0.49 ± 0.17 vs. 0.48 ± 0.17; p = 0.48; at 12 months: 0.54 ± 0.17 vs. 0.52 ± 0.14; p = 0.41). The mean value of AS was significantly lower after the PK procedure when compared to DALK, after both 6 and 12 months of follow up (p < 0.001). The CCT in the DALK group was significantly lower when compared to the PK group (at 6 months: 452.1 ± 89.1 µm vs. 528.9 ± 69.9 µm, p < 0.0001; at 12 months: 451.6 ± 83.5 µm vs. 525.5 ± 37.1 µm). The endothelial cell loss at 12 months after surgery was significantly lower after DALK when compared to PK (p < 0.0001). DALK transplantation should be considered as an alternative procedure in the surgical treatment of keratoconus.

scholarly journals Microelimination of hepatitis C in patients with chronic hemolytic anemias: a single-center experience

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Walaa M. Hashem ◽  
Manal Hamdy El-Sayed ◽  
Ossama A. Ahmed ◽  
Hany M. Dabbous ◽  
Mohamed Kamal Shaker ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Adverse Events ◽  
Hcv Rna ◽  
Special Population ◽  
Hepatic Decompensation ◽  
Delivery Of Care ◽  
Need For Treatment ◽  
Single Center Experience ◽  
Significant Difference

Abstract Background Patients with chronic hemolytic anemias (CHA) are at a high risk for transfusion-transmitted infections. Various studies in Egypt have shown a prevalence of hepatitis C virus (HCV) infection in 24–37% of those patients. Elimination of hepatitis C virus (HCV) in patients with CHA would prevent early progression of liver disease. In this study, we aimed to assess the efficacy, safety, and tolerability of sofosbuvir (SOF) and daclatasvir (DAC) in the special population of HCV-infected patients with CHA. In this prospective study, 21 consenting hepatitis C patients were recruited and treated using ribavirin-free SOF/DAC regimen for either 12 or 24 weeks according to categorization of patients into easy or hard-to-treat in accordance with the national protocols. Sustained virological response was assessed by RT-PCR for HCV-RNA at 12 weeks post-treatment (SVR12). Any treatment-related adverse events were noted. Results All patients were adherent to treatment with no discontinuation of therapy. SVR12 was achieved in 19 out of 21 patients (90.5%). There was a significant improvement in levels of ALT (p<0.009) after completion of therapy. On the other hand, the hemoglobin, total bilirubin, and ferritin levels showed a non-significant difference (p<0.501, p<0.542, and p<0.339, respectively). Moderate adverse events were observed in 2 out of 21 patients (9.5%), including sickling crisis and hepatic decompensation. Conclusion The results of this study substantiate the favorable efficacy, safety, and tolerability of ribavirin-free direct-acting antivirals (DAAs) in the special population of HCV-infected patients with CHA. Micro-elimination of HCV in special patient populations allows for pragmatic delivery of care to patients with co-morbid conditions who are in most need for treatment and allows for achievement of global elimination of HCV worldwide.

scholarly journals Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Ni Zeng ◽  
Xin-Yuan Chen ◽  
Zhi-Peng Yan ◽  
Jie-Ting Li ◽  
Tao Liao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Meta Analysis ◽  
Placebo Treatment ◽  
Cartilage Volume ◽  
Cartilage Thickness ◽  
Random Effects Models ◽  
Structural Progression ◽  
Significant Difference ◽  
Mean Differences

Abstract Objective To perform a meta-analysis comparing the structural progression and clinical symptom outcomes as well as adverse events experienced from intra-articular injections of sprifermin compared to a placebo treatment for patients with knee osteoarthritis (KOA). Method We systematically searched the literature for studies that compared long-term outcomes between sprifermin and placebo injections for KOA treatment. Meta-analysis was performed with RevMan5.3 using an inverse variance approach with fixed or random effects models. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results Eight studies were included. Overall, there was significantly less improvement of WOMAC total scores in patients receiving sprifermin, compared with the placebo (mean difference (MD) = 3.23, 95% CI 0.76–5.69; I2 = 0%; P = 0.01). Further, sprifermin injection patients gained more, and lost less, cartilage thickness and volume in total femorotibial joint (cartilage thickness: standardized mean differences (SMD) = 0.55, 95% CI 0.26–0.84; I2 = 78%; P = 0.0002; cartilage volume: SMD = 0.39, 95% CI 0.20–0.58; I2 = 49%; P < 0.0001). Changes in the cartilage surface morphology of the medial tibio-femoral joint (MD = −0.30, 95% CI −0.44 to −0.16; I2 = 0%; P < 0.0001) and patello-femoral joint (MD = −0.22; 95% CI −0.37 to −0.07; I2 = 0%; P = 0.004) showed a significant difference between the sprifermin and placebo injections. Moreover, there were no significant differences between sprifermin and the placebo in the risk of treatment-emergent adverse events (OR = 1.05; 95% CI 0.52–2.14; I2 = 48%; P = 0.89). Conclusion The data from the included studies provide strong evidence to determine the effect of intra-articular sprifermin on joint structure in individuals with KOA and show no specific adverse effects. Nevertheless, intra-articular sprifermin did not likely have any positive effect on symptom alleviation.

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