UJR 2013, vol XXI, # 4
THE CONTENTS
2013, vol XXI, # 4, page 385
Pylypenko Mykola Ivanovych
Good clinical trials practice: some sources of bias
Purpose: To acquaint researchers with possible sources of hidden bias in planning and performing clinical trials that lead to errors in the results.
Materials and methods: The original experience gained from reviewing manuscripts of scientific papers, dissertation research projects and clinical research and ongoing review of current publications in professional Ukrainian and international journals, as well as review of some relevant publications.
Conclusion: Hidden sources of bias can occur at any stage of the planning and execution of research, which requires careful attention to the problem in order to prevent false results, if possible.
Key words: clinical trial, bias in trial, patients sample recruit, patients sample size, referent test.
2013, vol XXI, # 4, page 390
Kolomiytsev Vasyl Ivanovych, Palamarchuk Yuriy Oleksandrovych, Dovhan Yuriy Petrovych, Zhemela Volodymyr Gryhorovych
Comparative analysis of different methods of radiation diagnosis of choledocholithiasis
Objective: To perform a comparative analysis of different methods of radiation diagnosis of choledocholithiasis, i.e. transabdominal ultrasonography (TUS), helical computed tomography (CT), magnetic resonance (MR) and endoscopic retrograde cholangiography (ERC) to optimize the indications for their use, depending on the clinical situation.
Material and Methods: The study involved 1,703 patients with biliary problems caused by gallstones. Microcholedo-cholithiasis was detected in 628 (36.9 %) patients, the remaining 1075 (60.1 %) had stones in the common bile duct (CBD) measuring of 3-35 mm, which were removed endoscopically or surgically. USG and ERC were done in all patients, CT in 75, MR in 78 patients. Verification of the diagnosis was performed on the basis of the results of endoscopic intervention trans-papillary microscopy and bile microscopy. To evaluate and compare the diagnostic capabilities of the method generally accepted criteria were used.
Results: All non-invasive examination methods were highly effective in the diagnosis of cholecystolithiasis and common bile duct dilatation. Ultrasonography and routine CT appeared to be poorly informative in the diagnosis of choledocho-lithiasis (likelihood ratio 2.29 and 0.77, respectively), especially in small (< 6 mm) calculi in which the sensitivity was 49.7 and 43.5 %, and overall accuracy of the examination 69.7 and 42.7 % . More effective for the diagnosis were MR and ERC (likelihood ratio 4.83 and 4.3, respectively) at which the sensitivity of the diagnosis of small stones was 80.0 and 82.4 % , microliths measuring 1-3 mm 52. 6 and 55.5 % , with overall diagnostic accuracy 75.6 and 83.4 % .
Conclusion: Ultrasonography in the diagnosis of choledo-cholithiasis can only be a screening method, and CT without contrast of the biliary system is not superior to ultrasonography . When clinical and laboratory signs of choledocho-lithiasis are present and USG findings are questionable, it is advisable to perform MR before ERC.
Key words: choledocholithiasis, ultrasonography, computed tomography, magnetic resonance cholangiopancreatography, endoscopic retrograde cholangiography.
2013, vol XXI, # 4, page 400
Abdullayev Ryzvan Yahubovych, Gulchenko Yuriy Dmytrovych, Sybikhankulov Artur Khasbiyevych
The features of hemodynamics in the medial branch of the thoracic artery depending on the level of sex hormones in women with mastopathy at adenomyosis and uterine myoma
Objective: To investigate the hemodynamics in the medial branch of the thoracic artery in patients with mastopathy depending on the level of hormones in the blood at benign processes in the uterus by means of calculating Doppler blood flow investigation.
Material and Methods: The findings of hormonal and Doppler investigation of 134 women aged 21-45 with diffuse mastopathy with adenomyosis and uterine myoma as well as without them were compared. The level of lutropin (LH), follitropin (FSH), prolactin, progesterone, estradiol in the first and second phase of the menstrual cycle was determined. Blood flow parameters, i.e. peak systolic velocity (PSV), resistance index (RI) and pulsatility index (PI) were registered iln the medial branch of the thoracic artery.
Results: The highest concentration of prolactin, LH and FSH were recorded in women with combination of adenomyosis and uterine myoma. In the first phase of the menstrual cycle they were 659.0 ± 36.7 mlU/l; 27.34 ± 3.91 IU/l and 25.6 ± 4.7 IU/l, respectively. They also demonstrated the highest values of RI (0.67 ± 0.04) and PI (1.17 ± 0.06) in the first phase of the cycle.
The maximum increase in progesterone (3.18 times), PSV (by 36.6 %), lsignificant reduction of RI (from 0.62 to 0.52; p <0.05) and minimal change in PI (0.83 and 0.81) were observed in women with uterine myoma. The lowest values of estradiol (0.53 ± 0.04 and 0.39 ± 0.03 nmol/l), PSV, RI, PI were detected in women with mastopathy without pathology of the uterus. The value of PSV, RI and PI was significantly lower (p <0.05) than in the group of women with myoma and adenomyosis.
Conclusion: The greatest increase in prolactin, LH and FSH occurs at cpmbinationof adenomyosis and uterine myoma. The level of LH and FSH in both phases of the menstrual cycle does not change significantly. The increase in these hormones increases vascular resistance index, especially PI, which remains increased in the second phase of the cycle, as opposed to RI. Adequate increase in progesterone level in the second phase of the cycle, which occurs ain myoma, causes the greatest increase in PSV and RI normalization in the medial branch of the thoracic artery. The highest level of estradiol in both phases of the cycle is observed in patients with adenomyosis of the uterus. They also demonbstrate significant reduction of RI and PI in the second phase of the menstrual cycle compared with the first group.
Key words: Doppler ultrasound, breast, hormonal status, mastopathy, uterine myoma and adenomyosis.
2013, vol XXI, # 4, page 405
Sokolovska Maryna Vyacheslavivna, Govorukha Tetyana Mykhaylivna, Yefremova Nataliya Anatoliyivna, Synyushkina Larysa Mykolayivna, Yudko Oleksandr Oleksandrovych, Pleshkov Maksym Dmytrovych
The experience of chemoradiation treatment for stage I-II laryngeal cancer
Objective: To determine of the efficacy of chemoradiation treatment of stage I-II laryngeal cancer (LC) and compare the results with those at radiotherapy separately.
Material and Methods: The experience of radiotherapy of 63 patients with stage I-II LC at radiology department of Kyiv City Clinical Cancer Center in 2008-2012 is presented. The patients were administered radiotherapy on gamma-therapy units and a linear accelerator using Ftorafur and without it.
Results: It was shown that radiotherapy of patients with stage I-II LC using Ftorafur 2.8 times reduced mortality compared with radiation therapy separately. It was also found that irradiation with a linear accelerator allowed delivery of the dose required for complete eradication of the tumor, which in turn increased the quality assurance and efficacy of radiation therapy.
Conclusion: The use of Ftorafur with radiotherapy increases the life expectancy of patients with stage I-II LC regardless of the technique of irradiation. It is important that this simple method of chemoradiation treatment can be used in almost all radiology departments of oncology treatment facilities.
Key words: larynx, cancer, radiation therapy, chemoradiation therapy, Ftorafur, gamma-therapy unit, linear accelerator.
2013, vol XXI, # 4, page 409
Seheda Tetyana Valeriyivna
Synergism of the effect of ionizing radiation and anticancer drugs on the content of ceramide in Guerin's carcinoma
Objective: To study the effects of combined action of ionizing radiation and chemotherapy on the amount of apoptosis inductors, i.e. ceramide in Guerin’s carcinoma.
Material and Methods: Wistar rats weighing 160-180 g with subcutaneously inoculated Guerin’s adenocarcinoma were used as an experimental model. Irradiation of the tumor zone was performed with RUM x- ray unit and linear accelerator 600 Clinac C (high-energy photon radiation ) at standard conditions, with 24-hour intervals between fractions, absorbed dose of 5 Gy per fraction, total of 10 Gy . Antitumor drugs were administered intraperitoneally 24 hours before the first session of irradiation: Taxotere (Rohr Pulenok Rorer) - 8 mg/kg, cisp-latin (Ebeve) 6.0 mg/kg, etoposide (Ebeve) in a dose of 8 mg/kg. Decapitation was performed 24 hours after the last irradiation session. Lipid extraction was performed by the method of Folch. Lipids were developed in iodine vapor and compared with cera-mide standards (Sigma). The findings were expressed as nmol/ mg of protein. The protein content in the test samples was determined according to Lowry. Statistical analysis was performed using statistical software for PC, Biostat and Statistica, using parametric and nonparametric methods for small samples.
Results: It was shown that combined action of ionizing radiation and chemotherapy increased the content of pro-apoptotic lipid, ceramide in Guerin’s carcinoma: 5.6 times at the action of x-rays and Taxotere, 4.2 times with cisplatin and 7.5 times with etoposide vs. the controls. The action of high-energy photon radiation and chemotherapy increased this 6.3, 4.9, and 7.5 times, respectively when compared to the controls. Radiobiological effects of ionizing radiation and chemotherapy on ceramide amount were identified.
Conclusion: Synergic effects of exposure to ionizing radiation of different energy range and chemotherapy on the level of ceramide in Guerin’s carcinoma were determined, their quantitative assessment was done.
Key words: Guerin carcinoma, ionizing radiation, Taxotere, cisplatin, etoposide, synergism.
2013, vol XXI, # 4, page 414
Zakharchenko Tamara Fedorivna, Zamotayeva Halyna Anatoliyivna, Gulevatyy Serhiy Vasylovych
Comparative determination of radiosensitivity to iodine -131 NK-cell function in patients with thyroid cancer according to age and the presence of distant metastases
Objective: To determine the effects of radioiodine therapy (RIT) on the cytotoxic activity of NK- cells in patients with differentiated thyroid cancer DTC), depending on the age and the presence of distant metastases.
Materials and methods: Activity of NK-cells was investigated in patients operated for DTC. Considering the age, 3 comparable group of patients were formed. Group 1 consisting of children and adolescents included 24 patients aged 13-18, mean age 16.0 ± 0.3 years, group 2 included 42 young adults aged 19-39 (27,9 ± 0,8). Group 3 included- 37 patients aged 40 - 71 (53,0 ± 1,4). Dependence of the NK-cells function on the presence of distant metastases was studied in patients aged 1939 years, who were divided into 2 groups: 26 - without distant metastases (the average number of RIT courses 1,3 ± 0,2) and 23 patients with distant metastasis (the average number of RIT courses - 6,7 ± 0,6). The study was conducted the day before administering Na131I and 6 days after RIT. NK-cell activity was determined by cytotoxic method. The indicator was assessed by spectrophotometry.
Results: Determining the activity of NK- cells in different age groups revealed the lowest rates in patients with DTC of older age - both before and after the course of RIT. The degree of reduction of NK-cell activity in patients with DTC 6 days after RIT, compared with baseline, was the highest in the group of children and adolescents. In young patients with distant metastases of DTC NK-cell activity before and after the course of RIT was lower than in younger patients without distant metastases.
Conclusions: A significant reduction in activity of NK-cells 6 days after RIT in children and adolescents as well as older patients with DTC indicates the radiosensitivity of the functional capacity of these cells. The result of the radioiodine activity on NK-cells is dependent on the age of patients and the presence of distant metastases. To determine the time of restoration of disturbed indicator it is useful to determine the activity of NK-cells in dynamics.
Key words: differentiated thyroid cancer, radioiodine therapy, metastatic disease, the age of patients, activity of NK-cells.
2013, vol XXI, # 4, page 420
Yakymova Tamara Petrivna, Vasylyev Leonid Yakovych
Clinical and morphological characteristics of polyneoplasia combined with breast cancer
Objective: To investigate the questions of prevention, timely diagnosis and determine the causes and signs of breast cancer (BC) associated with polyneoplasia with the purpose of for timely treatment.
Material and Methods: Clinical and morphological, laboratory and radiation methods were used in 26 patients with T2N0M0 - T2N1M0 BC who received combined treatment associated with polyneoplasia.
Results: It was determined that the majority of second tumors associated with BC at polyneoplasia were hormone-dependent or hormone-active ones. These included breast cancer (50%), ovarian cancer (26.92%), and uterine body cancer (11.59%).
The main etiopathogenetic factors of polyneoplasia development associated BC were radiation therapy, polychemotherapy and hormonal disorders, gastrointestinal and liver diseases, especially Botkin’s disease.
Conclusion: The most frequent (88.46%) second hormone-dependent tumor developing as a part of multiple primary malignancies after solitary BC is cancer of the second breast (50.00%), ovarian cancer (26.92%) and uterine body cancer (11.53%).
Key words: primary multiple malignant tumors, breast cancer, metachronic tumors, secondary tumors, ovarian cancer, endometrial cancer.
2013, vol XXI, # 4, page 427
Vasylyev Leonid Yakovych, Radzishevska Yevheniya Borysivna, Vikman Yan Eduardovych, Tarasova Oksana Mykolayivna, Nasonova Alla Mykolayivna, Ponomarov Ihor Mykolayovych, Shutov Serhiy Vladyslavovych, Sukhina Olena Mykolayivna
Possible aspects of special treatment influence on development of second tumors in cancer patients
Objective: To determine the possible aspects of the impact of specific treatment on the appearance of other tumors using the methods of statistical processing of electronic data of case histories of cancer patients treated in the clinic of S.P. Grigoriev Institute for Medical Radiology.
Material and Methods: A sample containing 322 formal case history with a detailed description of the treatment was analyzed. The sample was distributed into the following groups: ST - second tumor (study group - patients who had second tumors as a long-term effects of treatment); MT - metastatic tumor (positive control group - patients who had metastatic tumor as long-term effects), WC - without consequence - patients who had no adverse effects of treatment. Methods to find hidden knowledge and methods of nonparametric statistics with Statistica statistical environment and DataMining software were used. The study was conducted by comparison of groups of ST and MP, WC. The main directions of the search of differences between the groups were characteristics of surgery, radiation and chemotherapy.
Results: It was significantly determined that blood transfusion during surgery increased the risk of second tumors. In the absence of difference between the number of courses of radiation treatment, the group of patients with second tumors was characterized by higher focal dose to each area at a lower total number of such areas. In patients in this group if the first nosology was breast cancer, typical was irradiation of regional lymph nodes, but not post-operative field. The patients with second cancers had less long, but more toxic course of chemotherapy and were often treated with alkylating agents (especially complex compounds of platinum). The use of mitosis inhibitors (vinyl alkaloids) and absence of antibiotics in treatment regimens were characteristic.
Conclusion: The use of special techniques of processing follow-up data of cancer patients revealed the influence of some factors of surgical treatment, radiotherapy and chemotherapy on the appearance of secondary tumors in the future.
Key words: cancer, secondary tumors, radiation therapy, chemotherapy, surgical treatment, statistical analysis.
2013, vol XXI, # 4, page 435
Grushka Ganna Vasylivna
The diagnosis of thyroid cancer by metastases to the skeleton: a clinical case
Key words: bone metastases, radiation diagnosis, types of cancer, multimodality treatment.
2013, vol XXI, # 4, page 439
Okuntsev Dmytryy Vytalevych, Krutylyna Nyna Yvanovna
Peculiarities of pathogenesis, risk factors and possible prevention of late radiation damage to the heart in patients with breast cancer
The possibility of radiation damage to the heart at multimodality treatment of breast cancer was proven. Historical changes in the dose to the tumor and heart are presented along with the development and improvement of methods and means of exposure. Individual and pharmacological risk factors regarding their effect on the incidence and severity of radiation damage to the heart were assessed. Radiobiological mechanisms of radiation-induced cardiovascular diseases have been studied only partially due to the presence of various heart structures differing in their radiosensitivity and topographic heterogeneity. In addition, individual anatomical features can increase or decrease the risk of late radiation damage to the heart or cardiac death. The mechanisms of injury and radiobiological characteristics of radiation damage to the heart are presented in terms of dosimetric and biological parameters.
Key words: radiation-induced cardiovascular diseases, radiation therapy, breast cancer, dosimetry planning, radiobiological parameters.
2013, vol XXI, # 4, page 454
Okuntsev Dmytryy Vytalevych, Krutylyna Nyna Yvanovna
Mechanisms of radiation fibrosis development and possibility of treatment
Changing in regulation of normal regenerative processes in response to physical, chemical and biological effects of toxins results in violation of extracellular matrix synthesis with development of pathological fibrosis. The processes occurring after irradiation have much in common with the mechanisms of fibrotic diseases affecting the heart, skin, lungs, kidneys, gastrointestinal tract and liver. Among the factors triggering the mechanism of fibrosis, growth factor 1 (TGFb1), produced by a variety of mesenchymal and epithelial cells and stimulating transformation of fibroblasts and other types of cells into myofibroblasts, has been most extensively investigated. To initiate fibrosis, inflammation is necessary, but further secretion of TGFb1 is irrelevant for fibrogenesis control. This review features the role of inflammation as well as the origin and mechanisms of activation of myofibroblasts. The contribution of hypoxia and damage to the capillaries are considered in the context of radiotherapy. A closer cooperation between the scientists investigating fibrosis and radiation oncologists is promising for development and introduction of new therapeutic strategies for treatment and prevention of postradiation fibrosis.
Key words: radiation therapy, radiation damage, fibrosis, pathogenesis.
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