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Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis
No full textCurrent methods for determination of impurities with different charge-to-volume ratio are limited especially in terms of sensitivity and precision. The main goal of this research was to establish a quantitative method for determination of impurities with charges differing from that of recombinant human granulocyte colony-stimulating factor (rhG-CSF, filgrastim) with superior precision and sensitivity compared to existing methods. A CZE method has been developed, optimized, and validated for a purity assessment of filgrastim in liquid pharmaceutical formulations. Optimal separation of filgrastim from the related impurities with different charges was achieved on a 50 μm id fused-silica capillary of a total length of 80.5 cm. A BGE that contains 100 mM phosphoric acid adjusted to pH 7.0 with triethanolamine was used. The applied voltage was 20 kV while the temperature was maintained at 25°C. UV detection was set to 200 nm. Method was validated in terms of selectivity/specificity, linearity, precision, LOD, LOQ, stability, and robustness. Linearity was observed in the concentration range of 6-600 μg/mL and the LOQ was determined to be 0.3% relative to the concentration of filgrastim of 0.6 mg/mL. Other validation parameters were also found to be acceptable; thus the method was successfully applied for a quantitative purity assessment of filgrastim in a finished drug product
"Blind" Interlaminar Epidural Steroid Injections in Lumbar Spinal Stenosis; Effective and safe Technique in Elderly Patients
No full textBackground and purpose: Blind interlaminar epidural steroid injection (BESI) is one of the treatment modalities for lumbar spinal stenosis (LSS). There are a growing number of elderly patients with LSS. The optimal timing and outcome of BESIs in this population are not well defined, which is the aim of this study.
Patients and methods: Thirty patients aged 67±1.5 yrs, with diagnosis of LSS and refractory painwere recruited during year 2010 and followed up for 12months. “Blind” epidural in corresponding interspace was performed with 18G Tuohy needle, using loss of resistance. The epidural mixture (10ml) consisted of 80 mg of triamcinolone acetonide and 40mg of lidocaine. Each patient received in total 3 BESIs every 3 weeks (BESI1, BESI2, BESI3). The pain was evaluated with visual analogue scale (VAS) before first BESI (VAS0) and after each treatment (VAS1, VAS2, VAS3). Subjective quality of performing the same physical activity (PA) was evaluated with simple 3-points scale (0 = no change, 1 = slight improvement, 2 = significant improvement).
Results: BESI resulted in significant reduction of VAS (VAS0 8.1±0.3, VAS1 5.8±0.2, VAS2 4.9±0.2, VAS3 4.4±0.3; F=87.57, P< 0.001) – all pair-wise comparisons were significantly different in post-hoc analysis (P<0.001), except VAS2 vs VAS3 having borderline significance (P=0.06). Subjective quality of physical activity significantly improved regarding baseline conditions (BESI1 PA score: 0=1/30,1=7/30, 2=22/30 patients; BESI2 PA score:0=1/30,1=5/30,2=24/30 patients; BESI 3 PA score: 0=4/30, 1=6/30, 2=20/30 patients; c2=3.7, p=0.45). The average duration of successful BESI treatmentwas 6.3±0.8months (range 1–12). There were no reported complications.
Conclusions: Blind interlaminar epidural steroid injections (in total 3 injections every 3 weeks) resulted in significant reduction of pain and improvement of physical activity in elderly patients with LSS. It could be regarded as effective and safe procedure in this population
Utjecaj alergije i kolonizacije bakterijama na kvalitetu života pacijenta s nosnom polipozom
No full textAllergies and bacterial colonization are frequently found in patients with chronic rhinosinuitis with nasal polyposis (CRSwNP). The aim of this study was to identify patients with allergy and present microorganisms in ethmoid sinus among the patients with refractory CRSwNP undergoing surgical treatment at the University Hospital Centre Osijek, and to compare their life quality, defined by SNOT-20 analysis (sinonasal outcome test) to the rest of patients, and a con- trol group consisting of patients undergoing septoplasty but free of allergy and/or CRS. An additional aim was to iden- tify specific types and strains of microorganisms (bacteria and fungi) found in these patients, in order to compare them to other reports, and to revise the empirical antimicrobial therapy. In this paper we demonstrate a high incidence of bacte- rial colonization (83.3%) among CRSwNP patients. As in previous studies, gram positive aerobes were the most fre- quently isolated bacteria and all of them were covered by specific antibiotics given before the specimen collection. Allergy was found in only 20% of these patients, who presented with a reduced quality of life when compared to the control group and CRSwNP without allergy. Significantly more frequent dominant symptoms in these patients were cough, frustration and irritation. In the line with this finding is the objective assessment by endoscopy (Malm score) that showed more prominent nasal polyposis in allergy patients.Alergije i kolonizacija bakterijama se često pojavljuju kod bolesnika sa kroničnim rinosinuitisom i nosnom polipozom (CRSwNP). Cilj ove studije je bio identificirati pacijente koje boluju od alergije i/ili imaju patogene mikroorganizme u etmoidnom sinusu među pacijentima sa refraktornim CRSwNP, koji se podvrgavaju funkcionalnoj endoskopskoj sinusnoj kirurgiji u Kliničkom bolničkom centru Osijek. Uspoređivala se njihova kvaliteta života (definirana sa SNOT-20 analizom) sa ostalim pacijentima te sa kontrolnom skupinom koju su činili pacijenti podvrgnuti rekonstrukciji nosne pregrade, a koji nisu imali alergiju niti su bolovali od kroničnog rinosinuitisa. Drugi cilj ove studije je bio identifikacija specifične vrste i sojeva mikroorganizama (bakterija i gljivica) koje se nalaze u ovih pacijenata kako bi se usporedile sa učestalostima u drugim populacijama te preispitala učinkovitost empirijske antimikrobne terapije. U ovom članku prikazujemo visoku incidenciju bakterijske kolonizacije (83,3%) među pacijentima sa nosnom polipozom. Sukladno prijašnjim istraživanjima, gram pozitivni aerobi su bili najčešće izolirane bakterije i sve su bile pokrivene specifičnim antibioticima, ordiniranim prije skupljanja uzoraka. Alergija je bila prisutna u 20% CRSwNP pacijenata te je kod njih nađena značajno smanjena kvaliteta života u usporedbi sa kontrolnom grupom i grupom nosne polipoze bez alergije. Značajno učestaliji dominantni simptomi u ovih pacijenta su bili kašalj, frustracija i iritacija. Sukladno ovim rezultatima je i objektivni endoskopski nalaz po Malmu koji pokazuje značajno naglašeniju nosnu polipozu u pacijenata sa alergijom
Kikuchi-fujimoto bolest: prvi zabilježeni slučaj u Hrvatskoj
No full textKikuchi-Fujimoto disease (KFD) is an extremely rare disease known to have a worldwide distribution with higher prevalence among Japanese and other Asiatic individuals. KFD presents as benign and self-limited disorder, characterized by regional cervical lymphadenopathy with tenderness, usually accompanied with mild to high fever and night sweats. Less frequent symptoms include weight loss, nausea, vomiting and sore throat. Final diagnosis can only be determined on the basis of typical morphological changes in the lymph node, therefore lymph node biopsy is crucial for proving the diagnosis. Here we present a 16-year-old, native Croatian, aucasian girl with KFD, as a first case of KFD reported in Croatia. We suggest that this disease should be considered as a possible cause of fever of the unknown origin followed by lymphadenopathy.Kikuchi-Fujimoto bolesti (KFB) je izuzetno rijetka bolest, koja se pojavljuje u cijelom svijetu s većom učestalošću među japanskom i drugim azijskim populacijama. KFB je dobročudni, samo-ograničavajući poremećaj kojeg karakterizira regionalna cervikalna limfadenopatija, najčešće uz blagu vrućicu i noćno znojenje. Manje česti simptomi su gubitak težine, mučnina, povraćanje i bolovi u grlu. Konačna dijagnoza se određuje na temelju tipičnih morfoloških promjena u zahvaćenom limfnom čvoru, stoga je biopsija limfnog čvora presudna za potvrdu dijagnoze. Ovdje predstavljamo šesnaestogodišnju djevojčicu, autohtonu hrvaticu, bijele rase s dokazanom KFB, kao prvi zabilježeni slučaj KFB-i u Hrvatskoj. Također, ovdje čelimo istaknuti da KFB treba razmotriti kao mogući uzrok vrućice nepoznatog porijekla praćene limfadenopatijom
Infekcija mokraćnog sustava u novorođenčadi: rizični čimbenici, prepoznavanje i sprječavanje posljedica
No full textThe aim of the study is identification of urinary tract infections (UTI) and urinary tract anomalies (UTA) already in the perinatal period. The authors attempted to prevent serious consequences of the above conditions in the examined children. Family history data, certain conditions in pregnancy and appertaining symptoms in children were elaborated to specify selective distinctive criteria for children at risk. Newborns (1200) were selected for potential existence of a UTI. All the examined newborns underwent a urinalysis. Those with significant bacteriuria were taken urine specimens, C-reactive protein (RVP), Complete Blood Count (CBC) and bilirubin. The newborns with a UTI and a suspected UTA were sent to ultrasound examination, direct radio nuclide cystography and Tc99m MAG3 dynamic scanning. The frequency of a UTI in the perinatal period amounted to 4.5%. A UTA was found in 29.6% of the examinees. The infection was more likely to appear among newborns with a UTA in their families, a UTI, pre-eclampsia and a febrile infection in mother, intrauterine growth retardation, premature rupture of membranes (RVP), umbilical cord strangulation, jaundice, cyanosis, breathing difficulties, seizures and asphyxia.Cilj ove studije je prepoznavanje novorođenčadi s prirođenim manama mokraćnog sustava radi sprječavanja posljedica tih mana. Prepoznavanje je vršeno putem otkrivanja novorođenčadi s infekcijom mokraćnog sustava u perinatalnom razdoblju. Nastojali smo pronaći osobitosti u anamnezi majke te odrediti karakteristike trudno}e i simptome kod novorođenčadi pomoću kojih bi izdvojili onu djecu kod koje su infekcija i mana mokraćnog sustava vjerojatnije. U istraživanje smo uključili 1200 novorođenčadi. Svima smo uzeli urinokulturu. Ako im je dijagnosticirana značajna bakteriurija, ispitali smo im nativni urin, C-reaktivni protein, kompletnu krvnu sliku i ukupni bilirubin. Novorođenčad s infekcijom mokraćnog sustava podvrgnuta je ultrazvučnom pregledu, direktnoj radionuklidnoj cistografiji i Tc99m MAG3 dinamičkoj scintigrafiji. Učestalost infekcije mokraćnog sustava u perinatalnom razdoblju iznosila je 4,5%. Manu mokraćnog sustava imalo je 29,6% novorođenčadi s infekcijom. U pogledu perinatalnog razdoblja, takva novorođenčad češće pati od žutice (nejasne), periferne cijanoze, problema s disanjem, konvulzije i asfiksije. Osobitosti u anamnezi i trudno}i majki koje su rodile djecu s manama mokraćnog sustava su sljedeće: mane mokraćnog sustava u užoj obitelji, pre-eklampsija ili febrilna infekcija majke pred porod, intrauterina hipotrofija ploda, prerano prsnuće plodovih ovoja te pupkovina omotana oko vrata ili tijela djeteta
First Guidelines of Croatian Interest Group in Diagnosing and Treating Lower back and Radicular pain Using Minimally Invasive Diagnostic and Therapeutic Procedures
No full textKrižobolja i lumboishijalgija su značajni javnozdravstveni problemi. Troškovi operacijskog liječenja iznimno su visoki, a radno sposobni ljudi s ovim bolestima često izostaju s posla. Kroničnu križobolju najčešće uzrokuju degenerativne promjene intervertebralnog diska, malih zglobova i sakroilijakalnog zgloba, dok lumboishijalgiju najčešće uzrokuje hernijacija intervertebralnog diska. Svaka minimalno invazivna dijagnostička procedura bolesnika predodređuje za specifični minimalno invazivni terapijski zahvat. Kod bolova u slabinskoj kralježnici uzrokovanih degenerativnim promjenama intervertebralnog diska, bolesniku se preporuča biakuplastika. Ukoliko je križobolja uzrokovana degenerativnim promjenama malih zglobova ili sakroilijakalnog zgloba, tada se primjenjuju procedure radiofrekventne neuroablacije. U slučajevima kada su akutna križobolja i lumboishijalgija uzrokovane stenozom spinalnog kanala, a bolesnici nemaju klaudikacije, istima se preporučuju epiduralne steroidne injekcije. Bolesnici s kroničnom lumboishijalgijom liječe se s nekom od metoda nukleoplastike ili im se može preporučiti perkutana radiofrekventna neuromodulacija. Svrha je ovih procedura, primjenom dugodjelujućih glukokortikoida i kratkodjelujućeg lokalnog anestetika, te primjenom radiofrekventne struje, bolesnika na duže vrijeme osloboditi bolova te mu poboljšati kvalitetu života.Low back and radicular pain recently became a major public health problem. Medical expenses in general, and surgical procedures associated with overall care for the lower back pain are high and growing. Furthermore, these two chronic pain conditions are also leading causes for missed workdays. Degenerative changes of the intervertebral disc, facet joints, sacroiliac joint or disc herniation as described during imaging diagnostics may or may not be the cause of patients’ lower back pain. Diagnostic blocks often precede further interventions in order to confirm or dispute a source of the lower back pain. Chronic lower back pain caused by painful intervertebral disc should be treated using biacuplasty. If the pain of the lumbar spine is caused by facet joints or sacroiliac joint, patient can be offered neuroablative procedures using radiofrequency. In cases where the low back and radicular pain are caused by the central and foraminal spinal stenosis patients are advised epidural steroid injections, unless claudications are present. Patients suffering from the chronic radicular pain may be treated with various nucleoplasty procedures or they may be offered percutaneous radiofrequent neuromodulation. The purpose of above advised procedures is to relieve patients’ pain, allow optimal physical therapy, and improved functional capacity, consequently providing better quality of lif
The use of an Ultrasound-guided Popliteal Block for Hallux Valgus Surgery in a Patient with Myasthenia Gravis
No full textMyasthenia gravis (MG) is an autoimmune disease which affects neuromuscular transmission, causing muscle fatigue and weakness(1).The myasthenic patients are always a challenge to the anesthesiologist, because they demonstrate various responses to the neuromuscular blocking agents. The post-operative risk of respiratory failure has always been a matter of concern (2, 3). We report a successful use of the ultrasound guided popliteal block for elective foot surgery in a 46-year
old woman with MG, showing that this regional anesthesia technique, by avoiding the use of neuromuscular blocking agents, provided safe care for this patient
Lumbar Facet Joint Injections and Medial Branch Blocks
No full textLumbar zygapophyseal joints have been considered a significant source of chronic low back. The zygapophyseal (facet) joints are true synovial joints, which connect adjancet vertebrae posteriorly. The medial branch of the posterior primary ramus is responsible for joint sensation.
Symptoms of facet arthropathy include: hip and buttock pain,cramping lower extremity pain, usually not lower than the knee, low back stiffness, especially in the morning, pain commonly aggravated by prolonged sitting or stending. Signs of lumbar facet arthropathy are: paraspinal tenderness, worse over the affected joint, pain with movements that stresses the joints, i.e., hyperextension, lateral rotation and side bending, hip, buttock, or back pain on straight leg raising, absence of signs of nerve root irritation. Lumbar facet joint injection are performed for theurapeutic and diagnostic reason. Most studies have found that facet injection provide temporary pain relief. The current recommendations suggest the primary role of facet injection (intra-articular or medial branch block) to be diagnostic. These procedures may facilitate the diagnostic of facet syndrome and help predict if patient would benefit from more permanent measures, such as facet rhizotomy
Polimorfizam interleukina-6 i rizik od karcinoma prostate u populaciji istočne Hrvatske
No full textRecent studies suggest that chronic inflammation is crucial in the development and progression of prostate cancer (CaP). Interleukin-6 (IL-6) is a proinflammatory cytokine that plays an important role in intraprostatic inflammation and thus carcinogenesis. The –174G>C polymorphism of IL-6 gene has been associated with high IL-6 producer pheno- type and an increased risk for CaP . The aim of this study was to evaluate the association between the mentioned IL-6 polymorphism and CaP risk, as well as to compare the genotype frequency between the different tumour grades of CaP , in population of Eastern Croatia. We analyzed the IL-6 polymorphism in 120 CaP patients and 120 controls with benign prostatic hyperplasia (BPH). CaP patients and BPH controls did not statistically differ in studied IL-6 polymorphism. Furthermore, high IL-6 producer genotypes (GG or GC) were more frequent in controls than in CaP group (86.7% vs 80.8%, respectively, p=0.147). Also, no statistically significant difference in IL-6 high and low producer genotype fre- quency was noticed between well, moderately and poorly differentiated tumours. Our results, taken together with other studies on the subject, suggest that IL-6 – 174 single nucleotide polymorphism (SNP) distribution may differ between various ethnic groups and that a single cytokine gene polymorphism has probably just a minor effect on CaP susceptibil- ity. Further studies should be performed to clarify the link between SNPs of different cytokines and the risk for CaP .Novija istraživanja navode kroničnu upalu kao ključni čimbenik u nastanku i progresiji karcinoma prostate (CaP). Interleukin-6 (IL-6) je proinflamatorni citokin koji ima važnu ulogu u upali prostate, a prema tome i u karcinogenezi. –147G>C polimorfizam IL-6 gena se povezuje s fenotipom visoke produkcije IL-6 i pove}anim rizikom za CaP. Cilj ovog istraživanja bio je ispitati povezanost između navedenog IL-6 polimorfizma i rizika za razvoj CaP, kao i usporediti frekvenciju genotipova između različitih stadija karcinoma prostate, u populaciji Istočne Hrvatske. Ispitali smo polimorfizam IL-6 u 120 pacijenata s CaP i 120 kontrolnih subjekata s benignom hiperplazijom prostate (BPH). Pacijenti s CaP se u ispitivanom polimorfizmu IL-6 nisu statistički razlikovali od kontrola s BPH. Štoviše, genotipovi visoke produkcije IL-6 (GG ili GC) bili su učestaliji u kontrolnoj grupi nego u grupi s CaP (86,7% naspram 80,8%, p=0,147). Osim toga, značajna razlika u raspodjeli genotipova visoke i niske produkcije nije nađena niti između dobro, srednje i slabo diferenciranih tumora. Naši rezultati, ako se uzmu u obzir i ostale studije o istoj temi, navode na zaključak da bi se raspodjela polimorfizma IL-6-174 mogla razlikovati među različitim etničkim skupinama i da polimorfizam jednog nukleotida gena za citokine vjerojatno ima samo manji utjecaj na podložnost razvoja CaP. Potrebna su daljnja istraživanja kako bi se pojasnila poveznica između polimorfizama gena različitih citokina i rizika za CaP
Association of Increased Body Mass Index with Chiari Malformation Type I and Syrinx Formation in Adults
No full textOBJECT: In this paper the authors describe an association between increased body mass index (BMI) and Chiari malformation Type I (CM-I) in adults, as well as its relationship to the development of syringomyelia.
METHODS: In the period between January 2004 and December 2011, the senior author reviewed the data for all CM-I patients with or without syringomyelia and neurological deficit. Analyzed factors included clinical status (headaches and neurological signs), radiological characteristics of syringomyelia (diameter and vertical extent of syrinx), BMI, and relationship of age to BMI, syrinx diameter, and vertical extent of syrinx.
RESULTS: Sixty consecutive adults had CM-I, 26 of whom also had syringomyelia. The mean BMI among all patients was 30.35 ± 7.65, which is Class I obesity (WHO), and was similar among patients with or without syringomyelia. Extension of the vertical syrinx was greater in overweight patients (p = 0.027) than in those with a normal body weight. Evidence of de novo syrinx formation was found in 2 patients who gained an average BMI of 10.8 points. After repeated decompression and no change in holocord syrinx width or vertical extent, a reduction in the syrinx was seen after BMI decreased 11.7 points in one individual. No correlation was found between patient age and BMI, age and vertical extension of the syrinx, and age and diameter of the syrinx.
CONCLUSIONS: An association between increased BMI and CM-I in adults was recognized. Gaining weight may influence the de novo creation of a syrinx in adults who previously had minimally symptomatic or asymptomatic CM-I, and reducing weight can improve a syrinx after unsuccessful surgical decompression. Therefore, a reduction in body weight should be recommended for all overweight and obese patients with CM-I