scholarly journals Comprehensive assessment of exposure to clozapine in association with side effects among patients with treatment-resistant schizophrenia: a population pharmacokinetic study

2021 ◽  
Vol 11 ◽  
pp. 204512532110161
Author(s):  
Nobuyuki Nomura ◽  
Kohei Kitagawa ◽  
Ryuhei So ◽  
Fuminari Misawa ◽  
Masafumi Kodama ◽  
...  

Background: There have been scarce data on the distribution of clozapine concentrations in comparison with the recommended range (350–600 ng/ml) or their relationship with side effects among patients with treatment-resistant schizophrenia. Furthermore, no studies have assessed the association between side effects and overall exposure to the drug by calculating the 24-h area-under-curve (AUC). Methods: In- and outpatients with schizophrenia or schizoaffective disorder (ICD-10) who were receiving a stable dose of clozapine for ⩾2 weeks were included. Side effects were assessed using the Glasgow antipsychotic side-effects scale for clozapine (GASS-C). Using two collected plasma samples, plasma clozapine and norclozapine concentrations at peak and trough and their 24-h AUC were estimated using population pharmacokinetic models. Results: A total of 108 patients completed the study (mean ± SD age, 43.0 ± 10.1 years; clozapine dose, 357.5 ± 136.9 mg/day); 33 patients (30.6%) showed estimated trough concentrations of clozapine within the recommended range (350–600 ng/ml) whereas the concentrations were higher and lower than this range among 37 (43.5%) and 28 (25.9%) patients (%), respectively. There were no significant correlations between estimated peak or trough concentrations or 24-h AUC of both clozapine or norclozapine, and GASS-C total or individual scores. No significant differences were found between GASS-C total or individual item scores between the patients with estimated trough concentrations of clozapine of >600 ng/ml and the other subjects. Conclusion: The results suggest that clozapine or norclozapine concentrations are not linked directly to the extent of side effects experienced in clozapine-treated patients with treatment-resistant schizophrenia while the cross-sectional study design limits the interpretation of any causal relationships. These findings indicate that side effects associated with clozapine may occur at any dose or concentration.

2016 ◽  
Vol 2 (1) ◽  
pp. 62-78
Author(s):  
. Hemraj ◽  
Raj Kumar ◽  
Sourabh Kosey ◽  
Amit Sharma ◽  
Nalini Negi

To determine the most common physical side effects experienced by local chemotherapy patients. Their perceptions of these side effects and informational needs from clinical pharmacists were also evaluated. This was a single center, observational cross-sectional study conducted at department of General Surgery, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab. A face to face interview was conducted. Information collected included chemotherapy related side effects after last chemotherapy experience, the most worrisome side effects, overlooked by healthcare professionals and the preferred method, amount and source of receiving related information. In this study, hundred patients were enrolled out of them 48 were male and 52 were female. When differential calculations was done, common side effects or adverse effects of chemotherapy in the patients of breast, lung cancer, Ovarian Cancer, Colon cancer, Prostate cancer, Lymphoma Cancer, Cervix cancer where there is much irregular medicine intake 57.4% may be due to common problem of joint pain reported by all the patients under study, with the consecutive problem of nausea and vomiting. The high prevalence of chemotherapy related side effects among local patients is a major concern and findings of their perceptions and informational needs may serve as a valuable guide for clinical pharmacists and physicians to help in side effect management. This study shows the common problems reported by the patients when they are suffering from cancer condition, according to their incidence perceptions as experienced by the patient, this will allow the physician and clinical pharmacist to effectively counsel and manage the common symptoms as reported prior to its occurrence in the patient, so that withdrawal can be checked.


Author(s):  
Mohamed N. Al Arifi ◽  
Abdulrahman Alwhaibi

Objective: Fever alone can lead to rare serious complications in children, such as febrile seizures. The aim of this study is to assess the knowledge, beliefs, and behavior of parents toward fever and its management. Methods: A cross-sectional study using an online questionnaire was applied over a period of 3 months, from January to March 2018, to parents who were living in Saudi Arabia. The inclusion criteria were a parent who is a resident of Saudi Arabia, with at least one child aged 6 years or less, while incomplete questionnaires, having a child aged more than 6 years, or parents who were not living in Saudi Arabia were excluded. Results: A total of 656 parents completed the questionnaire. More than two-thirds of the subjects were female, the majority of whom were aged between 25–33 years old. The best-reported place to measure the temperature of children was the armpit (46%), followed by the ear (28%) and the mouth (10.7%). More than half of the parents considered their children feverish at a temperature of 38 °C. The majority of parents (79.7%) reported that the most serious side effects of fever were seizure, brain damage (39.3%), coma (29.9%), dehydration (29.7%), and death (25%). The most common method used to measure a child’s temperature was an electronic thermometer (62.3%). The most common antipyretic was paracetamol (84.5%). Conclusions: Our study demonstrates the good knowledge of parents in identifying a feverish temperature using the recommended route and tools for measuring body temperature.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1110.1-1111
Author(s):  
J. Qiao ◽  
S. X. Zhang ◽  
T. T. Zhang ◽  
J. Zhang ◽  
M. T. Qiu ◽  
...  

Background:Systemic sclerosis (scleroderma, SSc) is a rare complex connective tissue disease associated with high mortality and high morbidity1. Active SSc are typically treated with immunosuppressants, which may create a variety of severe side-effects, especially for long-term treatment2. As the pathogenesis of SSc is still a matter of debate, growing evidences have focused on the immune disorders3. However, the quantitative status of lymphocyte subsets in SSc patients are unclear and effects of immunomodulatory combination therapies (avoiding side-effects of conventional therapy) on the lymphocyte subsets are unknown.Objectives:To investigate the quantitative status of peripheral lymphocyte subpopulations and CD4+T subsets in SSc patients for the exploration of SSc pathogenesis and evaluate the effects of new immunomodulatory combination therapies on those cells.Methods:From July 2014 to December 2019, total 166 patients with SSc and 206 healthy controls (HCs) were enrolled in this study, in which, 79 follow-up patients received immunomodulatory drugs (IMiDs) such as low-dose interleukin-2, rapamycin, metformin, retinoic acid and coenzyme Q10. The absolute numbers of T, B, NK, CD4+T, CD8+T, Th1, Th2, Th17 and Tregs in peripheral blood of these subjects were detected by flow cytometry combined with standard absolute counting beads.Results:Patients with SSc had lower absolute counts of total T, NK, Th2, Th17 and Tregs as compared with those of HCs (P<0.05) (Figure 1). After immunomodulatory combination treatments, there were increases in a various of peripheral lymphocyte subsets such as T, B and CD8+T (P< 0.05). Moreover, the increased level of Tregs was much more dramatical than those of other lymphocyte subsets, resulting in the decrease ratios of Teffs/Tregs such as Th1/Tregs and Th2/Tregs and rebuilding immunologic equilibrium (Figure 2).Conclusion:This cross-sectional study clarified the abnormal status of lymphocyte subsets in SSc patients, suggesting lymphocyte subsets, especially Tregs, might be relevant and play a crucial role in the pathogenesis of SSc, thus providing a potential therapeutic target for SSc patients. Immunomodulatory combination therapies effectively increase the level of Tregs as well as other lymphocytes to some degree and maintain the immunologic equilibrium, which may help for SSc patients’ symptom remission.References:[1]Denton CP, Khanna D. Systemic sclerosis. Lancet 2017;390(10103):1685-99. doi: 10.1016/S0140-6736(17)30933-9 [published Online First: 2017/04/18][2]Winthrop KL, Weinblatt ME, Bathon J, et al. Unmet need in rheumatology: reports from the Targeted Therapies meeting 2019. Ann Rheum Dis 2020;79(1):88-93. doi: 10.1136/annrheumdis-2019-216151 [published Online First: 2019/10/31][3]Skaug B, Khanna D, Swindell WR, et al. Global skin gene expression analysis of early diffuse cutaneous systemic sclerosis shows a prominent innate and adaptive inflammatory profile. Ann Rheum Dis 2019 doi: 10.1136/annrheumdis-2019-215894 [published Online First: 2019/11/27]Acknowledgments :None.Disclosure of Interests:None declared


Author(s):  
Mohammad Hashem Hashempur ◽  
Seyed Hamdollah Mosavat ◽  
Mojtaba Heydari ◽  
Mesbah Shams

Abstract Background Despite growing demand for medicinal plants, there is little data about their use by patients with dyslipidemia. We aimed to determine the prevalence, pattern, and associated factors for the use of medicinal plants among patients with dyslipidemia. Methods A 17-item semi-structured questionnaire was filled out by 195 patients with dyslipidemia in a cross-sectional study carried out in two academic endocrinology clinics in Shiraz, Iran. The questionnaire comprised of three main domains of demographic data (6 questions), clinical data (2 of them), and data related to the use of medicinal plants (totally 9 questions). Results A total of 77.4% of patients took medicinal plants. The most common medicinal herbs used by dyslipidemic patients were Zataria multiflora, Cinnamomum zeylanicum, and Zingiber officinale. Duration of dyslipidemia was significantly longer in herbal users than non-herbal users (p=0.04). Patients believing that concomitant use of conventional drugs and herbal preparations had synergic positive effects in addition to those persuaded that herbal preparations possessed less side effects, were significantly more likely to use medicinal plants (p=0.008 and 0.005, respectively). Additionally, most of the medicinal herb users (87.4%) changed neither the pattern nor the dosage of their medications all during herbal preparations use. Conclusions This study demonstrated a high prevalence of medicinal plants’ use among patients with dyslipidemia, which was associated with the duration of dyslipidemia, patients’ viewpoints about herbal preparations’ synergic positive effects, and their fewer side effects.


Author(s):  
Susmita Bhattacharya ◽  
Amit Kyal ◽  
Payel Mondal ◽  
Partha Mukhopadhyay ◽  
Mrinalini Chowdhury ◽  
...  

Background: Most of the couples suffering from infertility report it to be the most stressful and depressing period of their life, more so if it is a primary infertility. Studies regarding the prevalence and role of infertility-specific stress especially in eastern part of India is very limited. The objective of the present study was to estimate the prevalence of infertility-specific stress and its role in marital adjustment in women diagnosed with infertility.Methods: It was a cross-sectional study done on 80 married couple diagnosed with infertility (both primary and secondary) over 1 year from July 2016 to June,2017. Dyadic Adjustment Scale (DAS), "semi-structured questionnaire" compiled by the authors and "ICD-10 Classification of Mental and Behavioral Disorders (Clinical Descriptions and Diagnostic Guidelines)" were used for the evaluation. The analysis was done using SPSS (version 16) and Chi-square test.Results: Around 86% infertile women and 21% infertile men were found to suffer from mental stress. Infertility related stress were more in patients with primary infertility than in secondary one. Women mostly (56.5%) coped with stress by self-blaming whereas men (58.2%) by blaming the partner.Conclusions: Mental stress was significantly associated with infertility. In fact, maladjustment in marital relation caused by the stress adversely affected the conjugal life and thus also the fertility. Proper counselling of both partners might be helpful to solve this problem.


2021 ◽  
Vol 3 (2) ◽  
pp. 105-108
Author(s):  
Jamshid Ayatollahi ◽  
◽  
Abolhasan Halvani ◽  
Mohammadhesam Gharaei Khezri ◽  
Hossein Shahcheraghi ◽  
...  

Introduction: Tuberculosis infection caused by Mycobacterium tuberculosis is one of the most common infectious diseases, especially in countries such as Iran. The course of treatment and the number of drugs used vary depending on the severity of the disease and the parts of the body involved. The resistant tuberculosis to treatment has increased in recent years. Thus, this study was conducted to investigate the frequency distribution of response to treatment of patients with tuberculosis in Sirjan, Iran. Methods: This descriptive cross-sectional study investigated all patients with tuberculosis in Sirjan city who had referred to health centers during the years 2011-2019. The data collection tool was a pre-prepared checklist that included information on age, sex, sputum smear results, sputum culture results, diabetes, patients' nationality, drug side effects, and response to treatment. Finally, data was entered into SPSS version 22, and analyzed. Results: In this study, the overall response rate was 83% and the mortality rate was 10%. Between the frequency distribution of response to treatment in terms of gender, age, sputum smear results, sputum culture results, patients' nationality and diabetes was not statistically significant difference. Also, no statistically significant difference was found between the frequency distribution of pulmonary TB treatment response in terms of drug allergy, drug hepatitis and other drug side effects. Conclusion: According to results, can be concluded that none of the variables: age, sex, smear and culture result, and history of diabetes have no an effect on response to treatment and mortality of tuberculosis.


2021 ◽  
Vol 13 (4) ◽  
pp. 888-901
Author(s):  
Nishat Jahan ◽  
Fahad Imtiaz Rahman ◽  
Poushali Saha ◽  
Sadia Afruz Ether ◽  
ASM Roknuzzaman ◽  
...  

In response to the raging COVID-19 pandemic, Bangladesh started its vaccine administration in early 2021; however, due to the rapid development and launch of the vaccines in the market, many people had concerns regarding the safety of these vaccines. The purpose of this study was to evaluate the side effects that were experienced by the Bangladeshi residents after receiving the first dose of the Oxford-AstraZeneca’s Covishield vaccine (ChAdOx1nCoV-19). The study was conducted using both online and printed questionnaires and the data were analysed using SPSS. The results included the responses of 474 vaccine recipients from March–April 2021. Pain at the site of injection, fever, myalgia, fatigue and headache were the most commonly reported symptoms, and the overall side effects were found to be significantly more prevalent in the younger population (p ≤ 0.05). These findings were consistent with the results indicated by the clinical trial of ChAdOx1nCoV-19. Logistic regression analysis further revealed that compared to people aged 70 years or above, the incidence of reported side effects was significantly higher in people aged 18–30 years (odds ratio (OR) = 8.56), 31–40 years, (OR = 5.05), 41–50 years (OR = 4.08), 51–60 years (OR = 3.77) and 61–70 years (OR = 3.67). In addition, a significantly higher percentage of female participants suffered from post-vaccination side effects compared to males (OR = 1.51). It was concluded that the Covishield vaccine was well-tolerated among people of different age groups. Nevertheless, further long-term follow-up study with a larger sample size is warranted to establish the long-term safety of the COVID-19 vaccine.


Author(s):  
Basmah Mohammed Alazmi ◽  
Shaikha Sulayyem Alsharari ◽  
Razan motawkel ◽  
Sara Alzahrani ◽  
Anhar Alfateel ◽  
...  

Background: Nowadays there are a lot of women using contraceptive oral combined pills for birth control and as we know VTE is one of the complications when it used for a long time, and here in this study our aim is to assess the awareness and knowledge of females who live in Saudi Arabia about COCP and its complications like VTE. A cross-sectional observational study based on a questionnaire conducted among females who live in Saudi Arabia. Data collection was done by using online survey which contains questions about the age, education and contraception. Methods: An observational cross-sectional study carried out during December 2020 in Saudi Arabia. We minimize our target population through inclusion criteria: 1- Female 2- Live in Saudi Arabia 3- Agree to participate. Sample size was 454 participants calculated by using survey system website through sample size calculator with Confidence Level 95% and margin of error 5%. Result: A total of 454 patients completed the survey questionnaire. The results showed that the vast majority of the study participants aged 20 years or more. Moreover, more than 90% of the study participants were Saudi females. The average body weight is around 95 kg and height 164.2 cm. The results also indicated that two-third of the study participants attained university education level compared to 16.1% obtained secondary education. Additionally, 36.6% of the study participants worked as a housewife, 18.1% working in health field. Moreover, 40% of the respondents reside in the western regions, 34% live in eastern regions compared to the lowest percentage in South region 3.3%. Conclusion: In summary, this study revealed that the internet was the main source of knowledge. Health care providers should perform their intended role in improving the female’s awareness regarding family planning. The criteria for preferable contraceptive method are that it has few or no side effects, also it depends on how much effective and convenient it is. Educational programs may be warranted to minimize the fear of side effects and to enhance the general knowledge about contraception.


Author(s):  
Yoan Chou ◽  
Dharmady Agus ◽  
Dwi Jani Juliawati

Background: Medical education is full of burden and pressure, so that medical students are prone to get depressive disorder and anxiety disorder. These have been proven by several researches conducted in the faculties of medicine from abroad as well as in Indonesia. Medical students, either preclinical or clinical, need to face many obstacles, but clinical students have more demands than preclinical students and they are directly responsible for patient safety. The more demands of the clinical students made them prone to have more depressive and anxiety disorder.Method: This research was conducted as a cross-sectional study on 200 students on Atma Jaya Medicine Faculty by choosing 100 pre-clinical and clinical students with simple random sampling. Data were collected with structured interviews by using MINI ICD-10 instrument to determine the depressive and anxiety disorder.Results: There were significant differences between the proportion of depressive disorder and anxiety disorder among preclinical and clinical students in FKUAJ 2015 (p = 0.044 and p = 0.048). The proportion of depressive disorder and anxiety disorder in clinical students are higher than preclinical students (29% vs. 17% and 38% vs. 25%).Conclusions: Clinical students are more prone to get depressive disorder 1,99 times and anxiety disorder 1,84 times than preclinical students FKUAJ year 2015 


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