Журнал клинических исследований

The world has been grappling with the COVID-19 pandemic for over two years, and the development of effective vaccines has been a crucial step towards controlling the spread of the virus. Among the many vaccines developed, a novel COVID-19 vaccine has emerged as a potential gamechanger in the fight against the virus. In this article, we delve into the findings from a Phase III clinical trial that evaluated the immunogenicity and safety of this groundbreaking vaccine. The Phase III clinical trial aimed to assess the effectiveness, immunogenicity, and safety profile of the novel COVID-19 vaccine in a large-scale population. The trial enrolled a diverse group of participants across different age groups, demographics and geographical locations to ensure a representative sample.

One of the most devastating challenges facing global health today is HIV/AIDS. However, significant advancements have been made in recent years, particularly in the areas of prompt treatment and early diagnosis. It is impossible to overstate the significance of these interventions, which have the ability to significantly alter HIV patients' prospects. The life-altering advantages of early diagnosis and timely treatment for HIV-positive patients are examined in this article, which sheds light on their impact on prognosis. It is impossible to overstate the transformative power of timely diagnosis and treatment on HIV-positive patients' prognoses. These interventions have the potential to end the transmission cycle, improve quality of life, and extend life expectancy.

Sepsis is still a serious medical condition that has a big impact on healthcare systems all over the world. When the body's response to an infection spirals out of control, leading to organ dysfunction, it is a life-threatening condition. In order to receive prompt and specialized care, patients with severe sepsis must be admitted to the Intensive Care Unit (ICU). In order to improve patient outcomes and optimize treatment strategies, it is essential to comprehend the clinical manifestations and outcomes of sepsis patients in the intensive care unit. It's a medical emergency that needs to be attended to right away. Everyone from young children to older adults can get sepsis. The immune system responds in an abnormally fast and irregular manner. The body experiences widespread inflammation as a result of this overactive immune response, which can damage organs and tissues. If not treated, the inflammation can cause organ failure, septic shock, and death. It can also disrupt normal organ function.

MDR-TB is a type of tuberculosis that is resistant to at least two of the most effective first-line anti-TB medications: rifampicin and isoniazid. It occurs when the TB-causing bacteria acquire mutations that render them drug-resistant. Because it is more challenging to treat and control than drug-susceptible TB, MDR-TB is a serious global health issue. Effective patient management, the introduction of appropriate treatment, and the prevention of further transmission all depend on a diagnosis of MDR-TB that is both prompt and accurate. To identify MDR-TB strains, various diagnostic methods have been developed and implemented over time. The various diagnostic methods used to detect MDR-TB are discussed in detail in this article, along with their advantages, disadvantages, and advancements.

Introduction: Malaria is a known major deadly global public health problem that causes morbidity and mortality in many countries, mostly in the African region. Evidence in Zambia shows it is amongst the top ten killer diseases, having a morbidity and mortality rate of 60/100 and 0.01/1000 respectively in pregnant women as recorded in 2013. The usage of IPTp is one of the recommended interventions by WHO to mitigate its impact in stable transmission zones such as Sub-Saharan African regions and also to ensure the best outcome for both the mother and her unborn child. Despite the availability of IPTp services offered in the health facilities, the uptake of IPTp is still very low.

Aim: This study aims to traverse the experiences of pregnant women regarding the utilization of intermittent preventive treatment of malaria in the Buchi township of Kitwe.

Methodology: The study will utilize an explorative qualitative design in which convenient sampling will be used to select participants to participate in the study. Data collection will be done through focus group discussions and in-depth interviews data collection will continue until the saturation point thematic content analysis will then be used to analyse the qualitative data.

Possible outcomes: This study aimed at identifying the factors influencing the utilization of IPTp Buchi area of Kitwe, improve the knowledge of IPTp treatment in women and with the health institutions, help them see where they are lacking in the sector of IPTp-SP thus help change or amplify their policies in regards to the above and also establish guidelines if none on the adoption of IPTp services and thereby increasing the health status of pregnant women and their unborn babies leading to reduced maternal morbidity and mortality rates.

Introduction: Antiretroviral therapy has led to a rapid decrease in HIV related morbidity and mortality. However, most of the existing antiretroviral regimens have been established to cause adverse drug reactions, this problem is especially common in poor countries in which only cheap, and toxic drugs are available. Tenofovir Alafenamide+lamivudine+Dolutegravirs (TAFED) recently introduced in Zambia has little information concerning its associated adverse drug reactions. Hence, there is a need to assess the prevalence of adverse drug reactions due to this antiretroviral regimen. Generally, this study will assess the prevalence of adverse drug reactions and associated factors to antiretroviral therapy at Ndola teaching Hospital, Zambia. Inferences made from this study can be used to come up with better antiretroviral therapy with little or no adverse drug reactions in the future.

Methods: This was a hospital based retrospective cohort study and the target population was identified using a systematic random sampling technique in which the 13^th record was obtained. The data was collected from the files of HIV-positive patients to determine the prevalence of adverse drug reactions and associated factors to ART from January 2019 to January 2022. The data was analyzed using the Statistical Package for Social Sciences (SPSS) software version 26.

Results: A total of 356 files were reviewed and the prevalence of adverse drug reactions to antiretroviral therapy between January 2019 and January 2022 was approximately 62.1%. The common ADRS were general symptoms (43.4%), hypersensitivity reactions (27.6%), Peripheral neuropathy (11.8%), insomnia (8.1%), nephrotoxicity (5.9%), and anemia (3.2%). Among ART regimens only TLD (p-value <0.05) and TAFED (p-value<0.05) were associated with ADRS. Additionally, the time frame was also significantly associated with ADRS while age group and gender were not.

Conclusion: The prevalence of ADRS was calculated to be 62.1% and only ART regimens and time frames were significantly associated with ADRS. It was deduced that TAFED can cause adverse drug reactions; the common ones being general symptoms, hypersensitivity reactions, and respectively. Furthermore, those on TAFED had an approximately 2.6-fold increase in developing ADRS, while those on TLD had a 3.0-fold increase in developing ADRS.

Diabetes mellitus is a group of metabolic disorders that is characterized by prolonged hyperglycemia. It has become a serious public health problem that threatens the quality of life of an individual with diabetes mellitus and effective therapy relies massively on the compliance of the patient to the therapeutic plan. Statistics from international diabetes federation state that, about 463 million people are living with diabetes globally and about 2.2 million deaths are attributable to high blood glucose and associated complications. Adherence to diet recommendations among diabetic patients is very important for effective therapy as poor or inadequate adherence to diet among patients can be consequential as it leads to the exacerbation of the disease resulting in the development of avoidable complications. This study is aimed at determining the level of adherence to diet recommendations among diabetic patients and to find out if there are specific diet guidelines that have been outlined for them.

Methodology: A descriptive cross-sectional study was used. It targeted type 1 and type 2 diabetes patients of Kitwe teaching hospital and they were assessed by use of a standard questionnaire and a sample size of 217 participants was used. The criteria for selection were based on having been diagnosed with diabetes mellitus more than a year ago and above.

Results: Of a total population of 217 who met the inclusion criteria of which 35 (16.1%) were type 1 diabetes mellitus patients and 182 (83.9%) were type 2 diabetes mellitus patients. The study revealed that males were more adherent with satisfactory adherence of 27.19% and good adherence of 1.38% than the females with satisfactory of 25.35% and good adherence of 0.92%but despite the males recording a higher level of adherence than the females, it was not statistically significant. The study revealed that there was low consumption of fruits (1.8%) and foods rich in fiber (8.8%). According to the survey of the participants, inability to afford the cost of a healthy diet a busy schedule, availability of the healthy foods, old age and disease acceptance were the most cited reasons for poor dietary adherence. Findings indicate that involvement of health professionals in nutritional education was good with 94.47% and 5.53% not being able to state what has been recommended. Age, the type of diabetes, job occupation, duration of diabetes mellitus, knowledge on diet and diet recommended were statistically significant factors associated with adherence.

Conclusion: These results indicate that adherence to diet recommendation is satisfactory but not good even in copperbelt, Zambia. This calls for sensitization programs on the diet recommended for diabetes and its importance in the management of the disease. With hopes that it results into a more proactive approach toward diet recommended and an intentionality to adhere to it.

Introduction: Sickle cell disease is a genetic autosomal recessive disease that causes considerable morbidity and mortality and affects millions of people globally. The WHO has advocated for SCD awareness, however, studies on the impact of these awareness programmes through knowledge, attitudes and practices assessment among caregivers has rarely been studied. Zambia lacks resources to support the increasing incidences of the disease, hence the need to find innovative ways to prevent complications of SCD, one of them being educating care givers on home based prevention of sickle cell crises. The objective of this research was to evaluate the knowledge, attitude and practices of caregivers of children with SCD towards SCD at Kitwe teaching hospital in Kitwe, Zambia.

Methodology: A cross sectional study was conducted on caregivers of children with SCD at Kitwe teaching hospital in Kitwe with a targeted sample size of 227 participants. Non probability sampling techniques was employed while self-administered questionnaires and interviews were used to collect data. Data was analyzed using SPSS version 22.0.

Results: A total of 192 (84.58%) respondents were included in the final analysis. Majority (65.6%) of the participants had good knowledge, 83.3% had a positive attitude towards prevention of sickle cell crises while 84.4% engaged in good practices to reduce frequency of SCC. Factors that influenced the level of knowledge included age, level of education, monthly income and social cultural practices as these were statistically significant (p<0.05).

Conclusion: The study reviewed that respondents had good knowledge about SCD and prevention of SCC. Majority had positive attitudes and good practices towards prevention of SCC. However, some caregivers are still lacking in knowledge, attitudes and practice towards SCD.

Risky health behaviour can be described as action or deliberate inaction by an individual that affect his or her own health or the health of others. The prevalence of risky health behaviours remains high in Lusaka, Zambia and globally. These behaviours are most likely to cause unwanted health related states. The selected risky health behaviours in this study include: Risky sexual behaviour that lead to unintended pregnancies or STIs, harmful alcohol and other drugs usage, behaviours that lead to violence and unintended injuries, unhealthy dietary behaviours and physical inactivity. In this study, the prevalence of risky heath behaviours and their determinants will be determined.

Methods: A cross-sectional survey was conducted in Lusaka province, Zambia to collect data from a sample of 422 Lusaka residents using a structured questionnaire. Descriptive statistics were used to analyse the data. Cross tabs using a Chi-square and expressed with p-value for statistical significances was done to determine the association.

Results: The prevalence of risky dietary behaviours, physical inactivity, harmful use of alcohol and other drugs, risky sexual behaviour, and behaviour leading to unintentional injuries and violence were 100%, 56.5%, 40.2%, 78.7%, and 77.1%, respectively. Gender was found to be the only significant determinant of harmful use of alcohol and other drugs and behaviour leading to unintentional injuries and violence. No significant associations were found between the other risky behaviours and age, income, or education level.

Conclusion: The study highlights the high prevalence of risky health behaviours in Lusaka province, Zambia, and the need for targeted interventions and policies to reduce the risk of these behaviours. The findings also suggest that gender based cultural norms and expectations may play a role in shaping harmful use of alcohol and other drugs and behaviour leading to unintentional injuries and violence.

Introduction: Stillbirth is a profound experience affecting millions of families worldwide every year. It is the most frequently reported adverse pregnancy outcome worldwide, which imposes significant psychological and economic consequences to mothers and affected families. The World Health Organization reports that there are nearly 2 million stillbirths every year. A lot of resources are dedicated to this area of research. Researchers worldwide are working hard to untangle the mystery surrounding the high prevalence of stillbirths. Majority of the causes and risk factors remain unknown, although some of them are preventable, the rate of stillbirths is very alarming. There is limited evidence on the pooled prevalence and associated factors of stillbirth in Zambia hence the need for this study.

Objective: To determine the prevalence of stillbirth and its associated risk factors at Kitwe teaching hospital in 2021.

Study design: Retrospective study.

Study area: Kitwe teaching hospital.

Method: This was a cross sectional retrospective study that included the use of a data extraction form to obtain secondary data from birth registry and maternal hospital records. The study took duration of 12 weeks. Data was entered and analyzed using the Statistical Package for Social Science (SPSS). Records of women of reproductive ages between 15 years and 50 years old who had stillbirths from January 2021 to December 2021 and delivered at KTH were randomly selected.

Results: Out of 384 total births, 17 stillbirths (4.4%) were observed. The SBR was calculated to be 44.16/1000 births. Out of the total number of stillbirths, 14 (82%) were macerated and 3 (18%) were fresh. Stillbirths were more common unregiste red women compared to registered women, that is 11 (65% and 6 (35%) respectively. A majority of the stillbirths, that is 9 (53% were found in women from the rural population. caesarean sections were 4 (24%) and vaginal deliveries 13 (76%) among stillbirths in this study. The majority of stillbirths 7 (41%) were seen in women above the age of 35. The prevalence of low birth weight (<2500 g) including 2500-4000 and >4000 was 8 (47%), 5 (29%) and 4 (24%) respectively. The proportion of preterm stillbirths was 7 (41%) and it was highest among stillbirths in the study population. The proportion of preterm delivery, hypertensive disorders of pregnancy, abruption and congenital malformations with stillbirth was estimated to be 7 (41%), 5 (29%), 4 (24%) and 4 (24%) and they were statistically significant (P<0.05). Though FGR, fetal distress and DM in pregnancy are potential risk factors for stillbirth, they were not significantly associated with stillbirth in this study.

Conclusion: Stillbirth remains a major public health problem in the country. The prevalence of stillbirth at KTH was found to be high compared to national and regional figures. These findings highlight the weak healthcare system of the country. There’s need to regularize uniform protocols for intranatal care in both urban and rural settings for a better neonatal outcome.

Introduction: Higher education is seen as an important aspect for an individual, as it is imperative for getting good jobs, success and opportunities for better living. Academic performance of any student is a result of interactions of various factors, which could have an effect on a student’s academic performance either positively or negatively. This research is a correlational study taking the quantitative approach that examines the association of various factors at play that would have an effect on student’s academic performance.

Aim: The aim of the study was to find associations between the factors being studied which are stress, quality of sleep, time management, lifestyle and their effect on an individual’s academic performance.

Methodology: The study was carried out at the Copperbelt university school of medicine, amongst those that have completed at least an academic year. A self-administered questionnaire was given to a total of 270 participants. The data was coded and analyzed with SPSS software.

Results: Out of 270 questionnaires given, a total of 262 were collected giving a response rate of 96.3%. 44.3% where in their 2^nd year and 55.7% in 3^rd year. Dominant programme of study was MBChB 67.6% and BDS 32.4%. Academic performance was measured using cGPA which was categorized as excellent with a frequency of 27.5%, average 53.8% and poor 18.7% according to GPA calculated. The study revealed significant associations between levels of stress and academic performance, time management as well as quality of sleep as the p-value<0.001. Lifestyle which was subdivided into exercise, healthy diet and substance use had p-values of 0.006, 0.003 and 0.002 respectively, all indicating a significant association with academic performance as p-values were less than 0.05.

Conclusion: The study has given an insight on factors that affect student performance as all the factors investigated in this paper being stress, time management, quality of sleep and lifestyle were associated with student performance. It is recommended that time management and stress management as well as copping programs for university students be implemented, awareness of proper sleep hygiene be done amongst medical students and have authorities establish clubs, promote sports by having them frequently and during such, talks on healthy diets can be done as all this could contribute to success in academic achievement.

An estimated 3,000 women in Zambia suffered from obstetric fistula. Suggestions are that more women could be suffering from the same condition but do not report it due to fear of stigmatization. Incidences of obstetric fistula in Zambia may indicate that most pregnant women do not access the much-needed maternal health services, especially at the time of delivery. Therefore, determining the prevalence and understanding the factors that lead to obstetric fistula is vital for developing primary preventive interventions. This study determined the prevalence and factors associated with obstetric fistula among women admitted at Kitwe Teaching Hospital for obstetric related conditions between 2021-2022.

Methodology: This study was a cross-section and used data from Kitwe Teaching Hospital patient records from 2021-2022 on women who gave birth at the hospital and those who gave birth from other hospitals and clinics and later developed obstetric complications that were referred to be managed at Kitwe teaching hospital. Physical interviews on the challenges women face by living with obstetrics fistula was done on the patients available at the institution during the data collection period. The study consisted of 950 women admitted at this hospital for obstetric related conditions. In compiling and analyzing the data collected, SPSS v 26.0 was used. Results were summarized in frequency distribution and cross tabulation tables and pie charts.

Results: A total of 30 women out of 950 women admitted for obstetric related conditions had obstetric fistula representing a prevalence of 3.15%. The identified risk factors were young age at getting married and first pregnancy (50% below 18 years), low socio-economic status, and long distance to the health facilities and home deliveries, low level of education and short physical stature. Half of the women (50%) had not attended antenatal care and had only primary level of education. The study also identified discrimination, stigma and limitation of participation on social and religious life as challenges fistula women face due to living with this condition. Other challenges included psychological, sexual and economic problems.

Introduction: Pregnancy is considered a life-changing moment for almost every woman in her child bearing age. Nevertheless, it becomes challenging whenever complications commence be it physically, mentally or emotionally as they might pose a threat to the lives of both the mother and fetus. Hypertensive disorders are leading causes of maternal and fetal morbidity and mortality worldwide. Early detection and treatment is one of the ways that can help combat this fatal condition and in order to achieve this, the community must have adequate knowledge and skills concerning the condition and should also be provided with emergency care.

Objectives: The purpose of this study is to assess the knowledge levels of women as well as attitudes towards preeclampsia and eclampsia.

Method: This was a cross-sectional study on pregnant women of Kitwe. The target population was identified using a purposive sampling technique with a sample size of 143. Data was collected from the women themselves using structured questionnaires through face to face interviews. The questionnaires were made in such a way that even those who only understood the local language were able to benefit from the survey. Data analysis was done using IBM Statistical Package for Social Sciences (SPSS) version 26.

Results: During the study, 128 patients agreed to answer the questionnaire out of the calculated sample size of 143 giving a response rate of 89.5%. The study revealed that 77.3% of the participants have heard of the terms PE/E but only 5.5% knew what either term meant. In this study, 64 (50.0%) of the participants were moderately knowledgeable, 54 (42.2%) were poorly knowledgeable and only 10 (7.8%) had good knowledge regarding PE. With regards to attitude towards preeclampsia, 32 (25.0%) of the participants had good attitude while 31 (24.2%) had poor attitude towards pre-eclampsia and eclampsia. Most participants agreed that PE/E is a danger to their health (66%) and that regular ANC follow up (77%) can reduce the risk of having it.

Conclusion: This study reveals that participants do suffer from PE and have heard of the term from different sources like the community, friends and neighbors, their doctors etc. but only a small proportion know and understand what the term means and were able to describe it.

There is very poor knowledge regarding it and negative attitude by most pregnant women. Therefore, it is important that these women be made aware of the dangers of PE, as well as symptoms and how to prevent it.

Introduction: Glioblastoma (GBM) is characterized by recurrence (rGBM), resistance to chemotherapy and low life expectancy. The methyl grouping pathway plays a crucial role in macromolecule synthesis, gene expression control and maintenance of cellular redox balance. Under physiological conditions, the clearance pathways of homocysteine (Hcys) do not exist in the brain. This work aimed to determine circulating homocysteine levels according to the location of the tumor lesion (lobar or deep).

Material and methods: Hcys was dosed by enzymatic method in the serum of 61 patients at the time of inclusion in the Phase I/II study protocol (CONEP 9681 no: 25000.009627/2004-25). Medians were compared between the groups according to tumor location and statistical significance by effect size. Moreover, statistical significance by effect size between survival and homocysteine level and significance by effect size between survival and tumor location were calculated.

Results: Cohort included 65.6% men and 34.4% women (age 19-81 years). The mean value of Hcys was 63 times higher than the physiological maximum limit and 8 times higher than in severe hyperhomocysteinemia. Patients with tumor with deep localization had higher Hcys than rGB with lobar tumor. Patients with ≤ 585 μM survived longer than ≥ 585 μM. Patients with right hemisphere tumor localization survived longer than left hemisphere tumor localization.

Conclusions: The results confirm that Hcys may be an indicator of the highly proliferative characteristic and heterogeneity of the methyl group pathway in the different brain microenvironments in rGBM related to distinct microenvironments with marked metabolic demand.