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Research and Practical Medicine Journal

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Vol 2, No 1 (2015)
View or download the full issue PDF (Russian)
https://doi.org/10.17709/2409-2231-2015-1

Original Articles. Pharmacy. Russian products

8-12 3965
Abstract

Objective. Evaluation of pharmacokinetics, pharmacodynamics, safety and efficacy of rituximab biosimilar (Acellbia,  BIOCAD, Russia) used as  monotherapy in patients with indolent B-cell non-Hodgkin’s lymphoma in comparison with the parameters of innovator rituximab – MabThera.

Materials and methods. 92 patients (aged 18 years and older with diagnosed CD20-positive follicular non-Hodgkin’s lymphoma, stage II-IV by Ann Arbor, 1-2 histologic grade, or marginal zone lymphoma) were enrolled into the study. Patients were randomised in 1:1 ratio to receive 375 mg/sq.m of Acellbia or MabThera on days 1, 8, 15 and 22.

Results. Overall response rate in both arms was equivalent: 39.52% in BCD-020 arm and 36.57% of patients in RTX arm (p=0.8250). Within the first week after a single infusion of Acellbia or MabThera, the level of  CD19 and CD20-positive cells rapidly decreased to almost undetectable values without any obvious recovery by the end of observation (upon intergroup comparison p>0.05 at all specified time points). 90% CI for the geometric mean of a Acellbia/MabThera  AUC0-t ratio fell within standard bioequivalence range 80-125% (80.1-118.2% for the ratio of AUC0-168 after a single dose). Within the whole study period  the frequency of AEs, including severe AEs (grade 3-4), associated with the use of monotherapy, were equal in both arms without any significant differences.

 Conclusions. Acellbia is non-inferior to MabThera in terms of efficacy, pharmacokinetics, pharmacodynamics and immunogenicity. Acellbia was well tolerated, with the safety profile comparable with MabThera’s parameters.

Original Articles. Оncology

13-20 1492
Abstract

Objective. Background 99mTc-technephyt hepatobiliary scintigraphy (HBS) and 13C-methacetin breath test were used as a quantitative methods to evaluate liver function. The aim of this study was to compare future remnant liver function assessed by 99mTc-technephyt dynamic hepatobiliary scintigraphy with results of methacetin breath test in the prediction of liver failure after major liver resection.

 Materials and methods. Methacetin breath test and 99mTc-technephyt hepatobiliary scintigraphy were performed prior to major resection in 53 high-risk patients, including 48 patients with hepatic metastases from colorectal cancer and 5 patients with hepatocellular carcinoma . Liver function determined with HBS was compared with methacetin breath test by unified scale.

Results.  A strong positive association (r = 0.706) was found between 13C-methacetin breath test determined with 99mTc-technephyt hepatobiliary scintigraphy

Conclusions.  Preoperative 99mTc-technephyt hepatobiliary scintigraphy with 13C-methacetin breath test are a valuable techniques to estimate the risk of postoperative liver failure.They offers a unique combination of functional liver uptake and excretion with the ability to assess the preoperative liver function reserve and to estimate the remnant liver function preoperatively . This combination might significantly improve preoperative evaluation and postoperative outcomes in liver surgery.

Original Articles. Surgery

21-26 3676
Abstract

Objective. To evaluate the effect of vaginal operations to eliminate pelvic prolapse using polypropylene implants on quality of life and sexual function of patients.

Materials and methods. The study included 93 women with genital prolapse II - IV stage, underwent extraperitoneal colpopexy polypropylene implant. The patients were divided into two groups according to the method of vaginal ligation of colpopexy: in group 1 (n = 50) included patients who underwent the surgery perforated polypropylene implant "Cineplex" (LINTEX, Russia) according to the developed method (patent RF № 2538796); 2 (n = 43) group included patients who had an operation using standard kits with polypropylene mesh (ProliftTM, Prolift™ + M, ProsimaTM ETHICON Women's Health & Urology" Johnson & Johnson Company, USA). The quality of social and sexual life was assessed using the questionnaire to calculate the index of sexual function in women (Female Sexual Function Index (FSFI)) and non-specific questionnaire of quality of life SF-36 preoperatively and 6 months after.

Results. In patients prior to surgical intervention compared with the general population indicators of quality of life statistically significantly reduced for all scales. Physical health component (PHC) reduced by 57.8% in the 1st group and 59.5 per cent in the 2nd group, and psychological health (PsCH) by 42% and 43.5% respectively groups compared with the general population indicators. In the postoperative period, significant improvement in the quality of life in the 2 treatment groups compared with preoperative observed in all parameters. In group 1 noted that PHC restored by 32%, and PsCH 40.7%; in the 2nd group - PHC improved by 26.1% and PsCH of 29.4% (Fig. 2). Comparative analysis of the quality of life of patients after surgery compared groups showed that in group 1 was able to significantly (p<0.05) improve social functioning and mental health patients in comparison with group 2.
The total score of the index of sexual function after surgery was significantly increased in the 1st group from 15.8 ± 5.3 to 25.2 ± 4,2; in the 2nd group - from 15.5 ± 5 to 21.4 ± 6. Intergroup statistical analysis of the index of female sexual function after surgical treatment of pelvic prolapse showed significant improvement (p<0.05) in the 1st group for all indicators (desire, arousal, lubrication, orgasm, satisfaction and total score), in addition to the indicator dyspareunia, in comparison with patients of the 2nd group.

Conclusions. The pelvic organ prolapse in women significantly affects their quality of life and becomes the cause of sexual disorders. Vaginal reconstruction of pelvic prolapse using polypropylene implants in sexually active women leads to better sexual function by eliminating the loss of the walls of the vagina and urinary incontinence. However, the peculiarities of surgical intervention are responsible for the reduced orgasmic function and appearance of dyspareunia. In patients after vaginal ligation of colpopexy using perforated polypropylene implant according to the developed method was significantly improved sexual function in all indicators of the FSFI questionnaire in comparison with the patients operated using a standard set with polypropylene implant for the correction of pelvic prolapse.

Review

27-35 4887
Abstract

The unilocular echinococcosis (hydatid disease)is the severe chronic parasitic disease, helminthiasis caused by the larval stage of the tapeworm Echinococcus granulosus, characterized by the development of parasitic cysts in the liver, rarely in the lungs and in other organs and tissues. The etiology of the disease, characterized by the pathogen and its development cycle, final and intermediate hosts, structure and morphology of the hydatid cyst. They describe the geographic distribution of helminth infections, pathogenesis, immunity, clinical picture, echinococcosis of the liver (asymptomatic, uncomplicated stage and stage of complications), echinococcosis of the lungs (the initial stage and the stage of developed clinical picture), other bodies. Clinical observation of unilocular echinococcosis in a 10 year old girl and a 9 year old boy. Diagnosis includes epidemiological, anamnestic and clinical data, changes in laboratory parameters, instrumental methods, diagnostic methods, immunodiagnostics, parasitological diagnosis. The surgery remains the main method of treatment. They described pharmacological therapy with albendazole in combination with a surgical method and as an involuntary self-treatment. A detailed clinical examination of patients after treatment, epidemiology of helminth infections and the major modern preventive measures.

36-41 3091
Abstract

The problem of cervical cancer (CC) for many decades continues to be the center of attention leading foreign and domestic oncologists. Malignant cervical tumors occupy the leading position among malignant neoplasms of reproductive system in women, second only to breast cancer, despite having far more effective screening compared with this disease. On predictive expert estimates (taking into account population growth and the expected increase in life expectancy) by 2020 in developing countries, the rising incidence and prevalence of cervical cancer is 40%, while in developed countries - 11%. If we do not perform timely interventions for prevention and treatment of cervical cancer, after 2050 cervical cancer every year in the world will become sick 1 million women. In the last decade inRussiathere has been a gradual increase in the incidence of cervical cancer: average annual growth rate of 2.21%, General 25,18%. Cervical cancer is one of nosological forms that meet all the requirements of population-based screening. The current Russian normative documents do not give clear answers to questions concerning the age of onset of cervical cancer screening and the time interval between tests, no clear program organized cytological screening of cervical cancer.

42-48 1614
Abstract

Prostate cancer remains an actual problem in daily practice of oncourology because of the ongoing high incidence of this pathology. The main method of treatment in patients with metastatic PC is palliative hormonal therapy. In case of disease progression and development of castration-refractory prostate cancer it is possible to provide the second line chemotherapy or hormonal therapy, as well as to treat with drugs aimed at inhibiting the so-called ligand-independent pathway of activation of androgenous receptors. The article presents an overview of the results of a recent study that evaluated the efficacy of inhibitors of insulin-like growth factor, the analogue of somatostatin - octreotide - depot.

Clinical Case Reports

49-54 1391
Abstract

Renal cell carcinoma (RCC) is one of the most urgent problems of modern urology, due to the steady increase in the incidence of this disease worldwide. Horseshoe kidney is a rare observation, the frequency of detection of this disease in the population is 2.8% of all malformations. RCC horseshoe kidney are rare, less than 2% of all cases of horseshoe kidney. Surgical treatment remains the golden standard of therapy of patients with RCC. The article presents a clinical case of resection of horseshoe kidney in a patient with RCC.

55-60 1407
Abstract

The principal marker of neuroendocrine differentiation (NED) is chromogranin A (HGA). The purpose of this work is to determine the role of NED in diseases of the prostate gland by the level of HGA.

Materials and methods. The study included 304 men with various diseases of the prostate: BPH - 20; chronic prostatitis (CP) - 22; BPH and prostatic low-grade intraepithelial neoplasia (BPH+LDPIN) - 50; BPH and high degree PIN (BPH+HGPIN) - 32; localized prostate cancer (LPC) - 80; locally advanced PCA (LAPC) - 21; CRPC - 51. The last group United in patients LPC, LAPC and metastatic prostate cancer. All these groups of patients were performed blood sampling fasting with further definition of the level of HGA in serum by enzyme immunoassay. The reference values of HGA for this method are ranged from 0 to 3 nmol/L.

Results. During the analyzing of the results of the study they revealed a general trend of increasing of mean values of HGA of serum with the growth stage of prostate cancer, with a maximum of patients with CRPC. According to the analysis they revealed no significant correlation between age and HGA (r = 0,05) among all study groups. They noted the persistent correlation (r = 0,32; p <0,001) between HGA and PSA levels among all studied groups of patients. They traced some relationship between the amount of points Gleason and HGA (r = 0,19; p <0,05) in cases of LPC, LAPC and CRPC. Defining the relationship between HGA and stage of prostate cancer (LPC, LAPC and CRPC), we also found a correlation (r = 0,31, p <0,005) among these groups of patients.

Conclusions. HGA is a high interest for the early detection CRPC. Also with the help of HGA it seem to be quite promising to discover the most aggressive forms of prostate cancer. Definition of NED-tumor may be necessary for the analysis of a comprehensive approach to prostate cancer treatment selection.

61-64 1508
Abstract

The article presents a clinical case of successful conservative treatment of acute prosthesis infection described in falloprosthetics a. In terms of the ineffectiveness of glycopeptides and carbapenems inflammatory process was docked with the help of new antibacterial agents "Tigecyclin" belonging to the class of glycylcyclines, structurally similar to tetracycline.

The article is supplemented with a short analysis of the current data on antimicrobial resistance the most likely causative agents of infectious-inflammatory complications after Falloprosthesis. The possibility of applying tigecycline in urological practice is observed.

Health Organization

65-68 1260
Abstract

The article deals with the problem of education of doctors in order to form their competence in the field of forensic medicine, necessary in case to carry out further the procedural role of a specialist in the field of forensic medicine or a forensic medical expert. The differences in the systems of their education, as well as distinction between the systems of training of forensic medical experts and forensic experts in other fields of knowledge are shown.

69-71 1277
Abstract

The article presents the approximate calculations of working time of physician to work with the patient and documentation. On the base of these calculations they outline the possible ways to optimize the work of the medical staff.

72-75 1854
Abstract
The paper presents the analysis of the statistical data on the Russian Federation, showing how often controversy and conflicts due to improper medical care occurs in medical practice, as well as what are the ways to resolve them.
77-82 1451
Abstract

Objective. Improving health outcomes in prostate cancer by developing optimal approaches to early detection, staging and treatment of disease.

Materials and methods. Urologic care for patients with prostate cancer in the Voronezh region is divided according to the conception of the Program "Urology" into 4 of standardized, integrated stages. The first stage are primary care physicians. The purpose of this stage is a screening questionnaire for men of Voronezh region between the ages of 45 to 74 years using a modified international questionnaire lower urinary tract symptoms (IPSS) and nomograms individual risk of prostate cancer (SWOP №1).            

In case of identification of risk groups for prostate cancer, patients were sent to the urologist at the place of residence, which is conducting special examinations (FRA, ultrasound of the kidneys, bladder, TRUS, UFW), forming a risk group for verification of diagnosis. Then the patient is directed to the second stage of inter-regional urology center (ITC), whose task in the diagnostic phase is to verify the diagnosis.    

In case of confirmation of the diagnosis by an urologist of ITC there was created the interactive consultation on the basis of remote Advisory portal Nethealth.ru together with leading research Institute of urology and regional urology center they identified the clinical significance of the disease and subsequent treatment strategy. In case of the detection of clinically significant prostate cancer patient is sent to the third stage - Regional or an optional fourth stage (center providing PMF) - the Federal urology center, where he is treated with highly specialized medical care and conducted quality control.   In case of detection of clinically insignificant PC assistance was provided at the level of ITC (active surveillance, watchful waiting, hormone therapy on the recommendations of the oncourologist of regional urology center).

Results. During the realisation of the Programme on the territory of theVoronezh region they deployed 7 Interdistrict (ITC) and 1 regional centre. The most difficult clinical cases were sent to the Federal urology center - research Institute of urology. They humiliated 140 experts from the region, with 80 of them they studied using remote sensing technology. For the realisation of the Program it was established an Advisory portal NetHealth.ru, which considered 498 clinical cases of prostate cancer, with 28 of specialists in various stages of the region took an active part in distance counseling.      

From 2009 to 2013 an improvement of a number of indicators was marked: increase in the absolute number of patients with newly diagnosed prostate cancer from 451 to 603 cases, a localized increase in the share stages with 60.3% to 71.2 %, a decrease of deaths within one year from the date of diagnosis for prostate cancer from 14.6% to 6.5% and deaths among all registered patients with prostate cancer from 10.4% to 5.5%, reducing the proportion of clinically insignificant PCA from 36.4 to 14.1%.

Conclusions. "PC module" of integrated phased standardized program "Urology" is a universal tool for solving the problems of improving the organization of medical care for prostate cancer, as well as the principles of operation can be used in other diseases of urology and other medical fields. Clinical and economic efficiency and the versatility of the basis for its recommendations as a priority in the organization of medical care at a cancer on the entire territory of the Russian Federation.

Translated Articles

84-94 8015
Abstract

Hypoxia is a critical hallmark of solid tumors and involves enhanced cell survival, angiogenesis, glycolytic metabolism, andmetastasis. Hyperbaric oxygen (HBO) treatment has for centuries been used to improve or cure disorders involving hypoxia and ischemia, by enhancing the amount of dissolved oxygen in the plasma and thereby increasing О2 delivery to the tissue. Studies on HBO and cancer have up to recently focused on whether enhanced oxygen acts as a cancer promoter or not. As oxygen is believed to be required for all the major processes of wound healing, one feared that the effects of HBO would be applicable to cancer tissue as well and promote cancer growth. Furthermore, one also feared that exposing patients who had been treated for cancer, to HBO, would lead to recurrence. Nevertheless, two systematic reviews on HBO and cancer have concluded that the use of HBO in patients with malignancies is considered safe. To supplement the previous reviews, we have summarized the work performed on HBO and cancer in the period 2004–2012. Based on the present as well as previous reviews, there is no evidence indicating that HBO neither acts as a stimulator of tumor growth nor as an enhancer of recurrence. On the other hand, there is evidence that implies that HBO might have tumor-inhibitory effects in certain cancer subtypes, and we thus strongly believe that we need to expand our knowledge on the effect and the mechanisms behind tumor oxygenation.



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ISSN 2410-1893 (Online)