Intake Regimen Research Articles

A CLINICAL STUDY TO ASSESS THE EFFICACY OF KASYAPOKTA SHATAPUSHPA REGIMEN IN ARTAV –VYAPAT W.S.R. TO ANOVULATORY CYCLES.

Hormonal imbalance, PCOD, menstrual irregularities and infertility are the leading problems affecting women’s health in today’s times. Allopathic medicines and treatments have their limitations and are very expensive, too. Hence, this study aims to find a safe and cost-effective alternative to Ayurveda. In Ayurved Samhitas, Kashyapa has given a collection of symptoms, which consist of menstrual irregularities like amenorrhea, menorrhagia, repeated abortions, weak progeny and infertility under the heading Artav-vyapad . The treatment modality of Artav vyapad is described in Kashyap samhita under Shatavari –Shatapushpa Adhyaya page no. 181. The Phalashruti of Shatapushpa is impressive and includes all the previously mentioned disorders. A well-specified regimen of oral intake of Shatpushpa Churna and Panchakarma like Snehan, Nasya and Basti with Shatapushpa oil is described. This study evaluates the potential use of Shatpushpa and establishes a cost-effective treatment for it. A clinical trial was carried out under the MUHS - LTRG project on 36 patients aged between 20- and 40-years having complaints of irregular menstruation with Anovulatory cycles.

Formation of treatment regimens in newly diagnosed patients before the diagnosis of pulmonary tuberculosis verification

Abstract. One of the basic principles of treatment of tuberculosis patients is the appointment of treatment taking into account the drug resistance of Mycobacterium tuberculosis (MBT). However, during treatment, it may be necessary to change the intake regimen when new data on drug resistance become available. The search for ways to choose the optimal treatment method seems relevant.Aim: To analyze the prescribed regimens and the reason for their correction in newly identified patients before verifying the diagnosis of tuberculosis.Material and Methods. The following methods were used to detect MBT: luminescent microscopy, molecular genetic methods and seeding on liquid and solid media. Tests for drug sensitivity were conducted in parallel. The study group consisted of patients with established bacterial excretion (n = 79), whose diagnosis was confirmed by cultural methods. A retrospective method was used in the analysis.Results. At the beginning of treatment with bacterioscopy and polymerase chain reaction methods MBT was detected in 65/79 (82.2%) cases, the remaining 14 cases were detected only by culture methods. Forced change of the therapy regimen during treatment after receiving the results was in 25/79 (31.6%) cases, of which 1/25 (4%) with isoniazid resistance, 7/25 (28%) with multidrug-resistant tuberculosis, 17/25 (68%) with the pre-extensive drug resistance regimen. The latter was prescribed only after receiving results of tests for drug sensitivity on liquid and solid media after 1–3 months. The multidrug-resistant tuberculosis treatment regimen decreased after receiving data on resistance to fluoroquinolones in accordance with the seeding data, but the largest number of patients still remained on this regimen – 41/79 (51.9%). Among these patients a change in chemotherapy regimen from multidrug-resistant tuberculosis to pre-extensive drug resistance during the intensive phase of treatment occurred in 17/25 (68%).Conclusion. When prescribing a regimen, it is recommended to assess the risk of changing the regimen and, if there are predictors, apply a chemotherapy regimen before treatment.

Vitamin D Intoxication in Children: A Case Report

Vitamin D is a crucial hormone in phosphocalcium homeostasis. Although vitamin D intoxication is rare, its complications can be dramatic, affecting both the short-term vital prognosis and long-term renal function. We report here a case of hypercalcemia due to vitamin D intoxication, with the aim of analyzing the factors that contribute to vitamin D intoxication, assessing the consequences of this intoxication on the child's health, and proposing recommendations for appropriate management. The patient was a 6-year-old child with a history of common nutritional rickets for which he had been receiving vitamin D supplementation. The patient was admitted to the pediatric emergency department of Children's Hospital in Rabat for incoercible vomiting and acute dehydration. Biological assessment showed severe hypercalcemia at 150mg/l, hypercalciuria at 192 mg /24 hours. The serum level of 25(OH) vitamin D was greater than 154 ng/ml. The diagnosis retained was as hypercalcemia due to vitamin D intoxication, confirmed by an in-depth interview with the parents, who found a over administration of the recommended dose. The evolution was marked by chronic kidney disease due to nephrocalcinosis (creatinine clearance according to the SCHWARTZ formula 17 ml/min). Heterogeneity of the expression forms of vitamin D dosages and intake regimens leads to confusion and increases the risk of misuse, as in the case of our patient, where a misreading of the medical prescription led to the intentional ingestion of toxic doses, hence the need for close and adequate medical supervision and awareness of vitamin D supplement use among healthcare professionals and parents.

#2106 Higher daily protein intake can reduce the risk of infections in kidney transplant recipients during the early post-transplant period

Abstract Background and Aims Kidney transplantation (KT) is considered the most effective treatment for end-stage renal disease (ESRD), and it significantly contributes to enhancing the quality of life and extending the survival of patients with ESRD. After kidney transplantation, the early and heavy use of immunosuppressants and glucocorticoids can affect the recipients' immune status to varying degrees, increasing the risk of postoperative infections caused by a wide range of pathogens. Thus, the prevention and management of infectious diseases are major factors contributing to improved outcomes in kidney transplantation. Protein-energy wasting (PEW) is commonly observed in uremic patients, and it may persist even after they have undergone kidney transplantation (KT). And PEW is a significant factor in the progression of chronic kidney disease (CKD). Providing appropriate dietary guidance and intervention is essential for enhancing the immune status of recipients, promoting a positive nitrogen balance in the body, minimizing infections, and safeguarding graft function. This study aimed to investigate the relationship between daily protein intake (DPI) and postoperative infections at 3 months post-transplant, which may establish a foundation for the early postoperative protein intake regimen, reducing the incidence of postoperative infections, and improving the early prognosis of kidney transplantation. Method This is a retrospective observational study. 176 kidney transplant recipients (KTRs) who underwent kidney transplant in West China Hospital from December 2021 to June 2022 were included and followed up regularly. 24-hour urine urea data were collected at months 1 and 3 post-transplant to calculate their DPI. These KTRs were further divided into two groups according to the recommended DPI for KTRs by the 2021 Practice Guidelines for the Nutritional Management of Chronic Kidney Disease, namely high intake group (Group 1, with DPI ≥ 1.4 g/kg·d, n = 66) and low intake group (Group 2, with DPI < 1.4 g/kg·d, n = 110). Occurrence of hospitalization and postoperative infections within 3 months were recorded. Multiple logistic regression was utilized to analyze the association between DPI and early postoperative infections at 3 months post-transplant. Results Mean DPI levels at month 1 post-transplant were 1.58 ± 0.22 g/kg·d in Group 1 and 1.02 ± 0.31 g/kg·d in Group 2, respectively (P < 0.05), this huge difference in DPI between the two groups continued to month 3. There was no significant difference in age, gender, pre-transplant body mass index (BMI), dialysis type and time, donor type, or the ratio of delayed graft function (DGF) between the two groups. There was a statistically significant difference in the percentage of hospitalization between the two groups during the postoperative period of 3 months (P = 0.027). Pneumonia was the most common reason of hospitalization after transplantation, followed by urinary tract infection. The results of multiple logistic regression analysis showed that higher DPI in the early post-transplant period was a protective factor for infection after kidney transplantation. Conclusion In the early post-transplant period, consuming higher levels of dietary protein may reduce the risk of infections and complications, and help preserve the function of the transplanted kidney.

#2736 Higher daily protein intake can reduce the risk of infections in kidney transplant recipients during the early post-transplant period

Abstract Background and Aims Kidney transplantation (KT) is considered the most effective treatment for end-stage renal disease (ESRD), and it significantly contributes to enhancing the quality of life and extending the survival of patients with ESRD. After kidney transplantation, the early and heavy use of immunosuppressants and glucocorticoids can affect the recipients' immune status to varying degrees, increasing the risk of postoperative infections caused by a wide range of pathogens. Thus, the prevention and management of infectious diseases are major factors contributing to improved outcomes in kidney transplantation. Protein-energy wasting (PEW) is commonly observed in uremic patients, and it may persist even after they have undergone kidney transplantation (KT). And PEW is a significant factor in the progression of chronic kidney disease (CKD). Providing appropriate dietary guidance and intervention is essential for enhancing the immune status of recipients, promoting a positive nitrogen balance in the body, minimizing infections, and safeguarding graft function. This study aimed to investigate the relationship between daily protein intake (DPI) and postoperative infections at 3 months post-transplant, which may establish a foundation for the early postoperative protein intake regimen, reducing the incidence of postoperative infections, and improving the early prognosis of kidney transplantation. Method This is a retrospective observational study. 176 kidney transplant recipients (KTRs) who underwent kidney transplant in West China Hospital from December 2021 to June 2022 were included and followed up regularly. 24-hour urine urea data were collected at month 3 post-transplant to calculate their DPI. These KTRs were further divided into two groups according to the recommended DPI for KTRs by the 2021 Practice Guidelines for the Nutritional Management of Chronic Kidney Disease, namely high intake group (Group 1, with DPI ≥ 1.4 g/kg·d, n = 66) and low intake group (Group 2, with DPI < 1.4 g/kg·d, n = 110). Occurrence of postoperative infections events within 3 months were recorded. Multiple logistic regression was utilized to analyze the association between DPI and early postoperative infections at 3 months post-transplant. Results Mean DPI levels at month 3 post-transplant were 1.75 ± 0.56 g/kg·d in Group 1 and 0.98 ± 0.24 g/kg·d in Group 2, respectively. There was no significant difference in age, gender, pre-transplant body mass index (BMI), dialysis type and time, donor type, or the ratio of delayed graft function (DGF) between the two groups. There was a statistically significant difference in the percentage of hospitalization for infections between the two groups during the postoperative period of 3 months (P = 0.027). Pneumonia was the most common reason of rehospitalization after transplantation, followed by urinary tract infection. The results of multiple logistic regression analysis showed that higher DPI in the early post-transplant period was a protective factor for infection after kidney transplantation. Conclusion In the early post-transplant period, consuming higher levels of dietary protein can reduce the risk of infections and complications, and help preserve the function of the transplanted kidney.

Preoperative free access to water compared to fasting for planned cesarean under spinal anesthesia: a randomized controlled trial

BACKGROUNDContemporary guidance for preoperative feeding allows solids up to six hours and clear fluid up to two hours before anesthesia. Clinical trial evidence to support this approach for cesarean section is lacking. Many medical practitioners continue to follow conservative policies of no intake from midnight to the time of surgery, especially in pregnant women. OBJECTIVETo evaluate the pragmatic approach of permitting free access to water to the point when the operating theater call to dispatch the woman compared to fasting from midnight in preoperative oral intake restriction for planned cesarean under spinal anesthesia on perioperative vomiting and maternal satisfaction. STUDY DESIGNA randomized controlled trial was conducted in the Obstetric Unit, Universiti Malaya Medical Center from October 2020 to May 2022. 504 participants scheduled for planned cesarean delivery were randomized: 252 each to preoperative free water access until the call to dispatch to the operating theater or fasting from midnight. The primary outcomes were perioperative vomiting and maternal satisfaction. Analyses were performed using t-test, Mann-Whitney U and Chi-Square test as appropriate. RESULTSVomiting at up to six hours after completion of cesarean delivery were 9/252 (3.6%) vs. 24/252 (9.5%) RR 0.38 95% CI 0.18-0.79 p=0.007 and maternal satisfaction score (0-10 VNRS) median [interquartile range] 9 [8-10] vs. 5 [3-7] p<0.001 for preoperative free access to water and fasting respectively. Assessed before dispatch to the operating theater, thirst was reported by 69/252 (27.4%) vs. 134/252 (53.2%) RR 0.52 95% 0.41-0.65 p<0.001, capillary glucose level (mmol/l) mean ± standard deviation 4.8 ± 0.7 vs. 4.9 ± 0.8 p=0.048, and preoperative intravenous fluid hydration commenced in 49/252 (19.4%) vs. 76/252 (30.2%) RR 0.65 95% 0.47-0.88 p=0.005 for free access to water and fasting respectively. In the operating theater, ketone was detected in the catheterized urine in 38/252 (15.1%) vs. 78/252 (31.0%) RR 0.49 (5% CI 0.25-0.59 p<0.001 and the number of doses of vasopressors needed to correct hypotension were 2.3 ± 1.7 vs. 2.7 ± 2.2 p=0.009 for free access to water and fasting respectively. Recommendation of allocated preoperative oral intake regimen rates to a friend were 240/252 (95.2%) vs. 100/252 (39.7%) RR 2.40 95% CI 2.06-2.80 p<0.001 in favor of free access to water. Other assessed maternal and neonatal outcomes were not different. CONCLUSIONFree access to water compared to fasting in planned cesarean delivery reduced perioperative vomiting and was strongly favored by women. A number of pre and intraoperative secondary outcomes were also improved. However, post cesarean recovery and neonatal outcomes were not different.

Medication safety with oral antitumour therapeutics in paediatrics (youngAMBORA): A mixed-methods approach towards a tailored care program.

Oral antitumour therapeutics (OAT) are increasingly used due to improvements in outcomes and their convenient application. However, complex intake regimens pose several challenges. The randomised AMBORA trial (Medication Safety With Oral Antitumour Drugs) demonstrated highly positive outcomes of a clinical pharmacological/pharmaceutical care program for adults treated with numerous OAT, but comparable concepts in paediatrics are lacking so far. We used a parallel mixed-methods approach to develop a tailored pharmacological/pharmaceutical care program for OAT in paediatrics (youngAMBORA). We combined a quantitative analysis of tumour entities and used OAT in a paediatric cancer centre with a qualitative survey for patients, caregivers, and healthcare professionals to identify particular demands and educational needs (e.g., application problems, side effects). Leukaemia (77/315) and antimetabolites (95/151) were the most frequently observed entity and OAT, respectively. Of 22 surveyed patients, 81.8% wanted to be involved in oral medication education. Compared to caregivers, significantly more healthcare professionals graded the three most common application problems to be challenging ('Smell/taste': 32/36 vs. 23/42, p = 0.001; 'Refusal of intake': 31/36 vs. 16/42, p<0.001; 'Swallowing problems': 28/36 vs. 21/42, p = 0.011). We identified nine relevant side effects, of which two ('Skin dryness', 'Taste changes') were not included in 15 previously published core side effects of the Common Terminology Criteria of Adverse Events (CTCAE) item library. Based on the present findings, the tailored youngAMBORA care program will include: 1) counselling sessions for classic and targeted OAT, 2) child-friendly support with drug application, and 3) systematic evaluation of 17 relevant side effects from patients' and caregivers' points of view including age-appropriate information material.

Социальные практики питания старшеклассников

The paper presents the results of an assessment of the social nutrition practices of high school students. The study involved 256 girls and boys aged 15–17 years – students of general education institutions in the city of Lipetsk. The study included: studying the state of the body's supply of nutrients and energy (nutritional status); assessing the risk of developing eating disorders and types of eating disorders; determination of actual food consumption. The data obtained indicate a high prevalence of eating disorders among schoolchildren of the overeating type. It was found that 40,2 % of schoolchildren of both sexes have risky eating behavior. It is shown that the externalized type of eating behavior is more common among high school students, and the restrictive and emotiogenic types are less common. Violations of food consumption by schoolchildren have been re-vealed, which manifest themselves in non-compliance with the food intake regimen, monotonous diet, exces-sive consumption of sugar, confectionery, fatty food, fast food.

The Importance of Iron Supplementation in Pregnant Women

Iron supplementation is an important treatment for pregnant people with iron deficiency anemia. For this reason, we designed and created an evidence-based infographic with accessible fonts, pictograms, and language. This tool serves as a framework for the potential of visual communication tools in the context of improving medication and treatment adherence. Various sources were utilized to derive information on a suggested iron intake regimen; however, we encourage individuals to consult with their primary care providers in order to establish the ideal regimen for them, adjusted to unique individual factors.

Effect of Potassium Supplementation on Endothelial Function: A Systematic Review and Meta-Analysis of Intervention Studies.

(1) Background: Endothelial dysfunction is an early predictor of cardiovascular diseases. Although a large body of evidence shows an inverse association between potassium intake and cardiovascular risk, the studies on endothelial function provided contrasting results. Thus, we carried out a systematic review and a meta-analysis of the available intervention studies of the potassium supplementation on endothelial function. (2) Methods: A systematic search of the online databases available (up to December 2022) was conducted including the intervention trials that reported flow-mediated dilation (FMD) changes-a non-invasive method of assessing endothelial function-after two different potassium intake regimens. For each study, the mean difference (MD) and 95% confidence intervals were pooled using a random effect model. (3) Results: Five studies met the pre-defined inclusion criteria and provided eight cohorts with 332 participants. In the pooled analysis, potassium supplementation was associated with a significant increase in FMD (MD: 0.74%), with a higher effect for a urinary potassium excretion higher than 90 mmol/day. There was a moderate heterogeneity among studies (I2 = 59%), explained by the different amount of potassium supplementation. (4) Conclusions: The results of our meta-analysis indicate that dietary potassium supplement improves endothelial function. This effect is directly associated with the amount of potassium supplement. The findings support the campaigns in favour of an increase in dietary potassium intake to reduce cardiovascular risk.

HIV pre-exposure prophylaxis during the SARS-CoV-2 pandemic: Results from a prospective observational study in Germany.

AimsSince 2017, HIV pre-exposure prophylaxis (PrEP) care has been provided through an intersectoral collaboration at WIR (Walk-in-Ruhr, Center for Sexual Health and Medicine, Bochum, Germany). The aim of this study was to establish possible impact of COVID-restrictions on the sexual behavior of PrEP users in North Rhine-Westphalia.MethodsThe current PrEP study collected data of individuals using PrEP, their sexual behavior and sexually transmitted infections (STIs) before (each quarter of year 2018) and during the COVID-19 pandemic (each quarter of year 2020).ResultsDuring the first lockdown in Germany from mid-March until May 2020, PrEP-care appointments at WIR were postponed or canceled. Almost a third of PrEP users had discontinued their PrEP intake in the 2nd quarter of 2020 due to alteration of their sexual behavior. The number of sexual partners decreased from a median of 14 partners in the previous 6 months in 1st quarter of 2020, to 7 partners in 4th quarter of 2020. Despite such a significant reduction in partner number during the pandemic in comparison to the pre-pandemic period, a steady rate of STIs was observed among PrEP users in 2020.ConclusionThe SARS-CoV-2-pandemic has impacted PrEP-using MSM in North Rhine-Westphalia with respect to their PrEP intake regimen and sexual behavior in 2020. Our study revealed a steady rate of STI among PrEP users even during the pandemic, thus highlighting the importance of ensuring appropriate HIV/STI prevention services in times of crisis.

Анестезіологічне забезпечення у хворих на епілепсію

Епілепсія є однією із найбільш частих неврологічних хвороб і зустрічається майже в 1 % світової популяції. Хворі на епілепсію потребують анестезіологічного забезпечення при планових чи екстрених оперативних втручаннях, інвазивних діагностичних процедурах, пологах, стоматологічній допомозі тощо. Анестезія в пацієнтів з епілепсією має свої особливості з огляду на можливість розвитку нападів під час знеболювання та хірургічного втручання. Важливим є передопераційне ведення: з’ясування етіології, типу та частоти судомних нападів, факторів, що провокують напад, режиму прийому протиепілептичних препаратів. Основні протиепілептичні препарати можуть взаємодіяти з іншими ліками, у тому числі з анестетиками, знижувати їх ефективність або, навпаки, викликати збільшення їх концентрації в крові й токсичні побічні дії. Загальні анестетики (інгаляційні та внутрішньовенні) мають різний вплив на епілептичні процеси в головному мозку. Деякі з них можуть провокувати епілептичні напади залежно від їх дози. Застосування одних анестетиків може бути рекомендоване в пацієнтів з епілепсією, а інших — протипоказане. Важливо не пропустити під час анестезії розвитку епілептичного нападу, що може бути замаскований унаслідок застосування міорелаксантів. Регіонарна анестезія в більшості випадків є безпечнішою за загальну анестезію. У післяопераційному періоді слід відновити прийом протиепілептичних препаратів так швидко, як це можливо. У разі розвитку епілептичних нападів у періопераційному періоді важливо їх вчасно діагностувати й купірувати.

Порівняльна характеристика лікувальних методів усунення гемоконцентрації у хворих із судинними захворюваннями головного мозку

Актуальність. Розведення крові (гемодилюцію) давно застосовують у практичній медицині у вигляді водного навантаження (посилене пиття) і парентерального введення водно-електролітних і плазмозамінних розчинів. Гемодилюція покращує реологічні властивості крові таким чином, що приплив кисню та поживних речовин до мозку покращується, і нейрони, яким загрожувала смерть, можуть вижити. Гемодилюція може бути досягнута кровопусканням (видалення крові), введенням розчинів у вигляді інфузій чи шляхом комбінації обох методів. Розчини, які використовуються при гемодилюції, можуть бути сольовими та колоїдними. Колоїдні розчини, які складаються з більшості нерозчинних молекул і призначення яких — збереження інтраваскулярної рідини, є більш ефективним засобом гемодилюції. В багатьох країнах гемодилюція використовується в клінічному лікуванні пацієнтів із 70-х років ХХ століття. Матеріали та методи. Проведено ретроспективний аналіз найбільш ефективного методу усунення гемоконцентрації у хворих на цереброваскулярні захворювання та іншу патологію, що лікувалися в ангіоневрологічному відділенні клініки нейрохірургії та неврології Військово-медичного клінічного центру Західного регіону з січня по червень 2018 року. Результати. Обстежено 212 хворих віком від 20 до 80 років. Середній вік пацієнтів становив 50 років. Чоловіків було 164 (73 %), жінок — 48 (23 %). Гемоконцентрація спостерігалася у 32 (15 %) пацієнтів. Порушення реологічних властивостей крові мало місце у 28 (17 %) чоловіків і 7 (14 %) жінок. При ішемічному інсульті (ІІ) порушення реологічних властивостей крові спостерігалось у 10 (24 %) пацієнтів, із наслідками перенесеного ІІ у 12 (24 %) пацієнтів, при дисциркуляторній енцефалопатії (ДЕ) у 8 (8 %) пацієнтів, аномалії Кімерлі — в 1 (20 %) пацієнта, вегетосудинній дистонії (ВСД) на фоні гострого періоду закритої черепно-мозкової травми (ЗЧМТ), струсу головного мозку — 1 (3 %) пацієнта. Питний режим був ефективний у 3 пацієнтів при ДЕ, ВСД на фоні гострого періоду ЗЧМТ, струсу головного мозку та аномалії Кімерлі. Позитивний ефект гіперволемічної гемодилюції (ГГ) спостерігався у 17 пацієнтів, ізоволемічної гемодилюції (ІГ) у 12 пацієнтів при гострому перебігу ІІ, наслідках перенесеного ІІ та ДЕ. При посиленому питному режимі, ГГ та ІГ рівень показників гемоглобіну та гематокриту нормалізовувався; показники протромбіну в середньому знижувалися на 10 одиниць. Рівень фібриногену, електролітного обміну, тромбоцитів при посиленому питному режимі суттєво не змінювався. Концентрація тромбоцитів при ГГ та ІГ незначно підвищувалася. Побічних реакцій не спостерігалося. Висновки. Порушення реологічних властивостей крові з тенденцією до гемоконцентрації найбільш характерне для пацієнтів віком 40–50 років чоловічої статі при ІІ та наслідках перенесеного ІІ. Найменш ефективний метод розрідження крові — питний режим, більш ефективний — ГГ. Питний режим недостатньо ефективний при ІІ та перенесених його наслідках. При даній патології показана ГГ чи ІГ. При неефективності ГГ доцільно застосовувати ІГ, для досягнення ефективності достатньо одного сеансу. Дані методи лікування є безпечними.

Quiral Inversion of Ibuprofen after an Oral Administration Under Complete Fasting and Fed Conditions in Caucasian Healthy Subjects

Background: The aim was to determine the effect of feeding on chiral inversion of Ibuprofen isomers. Method: Six healthy volunteers participated in a two-treatment crossover study where a single dose of Ibuprofen racemate was given. One stage consisted in an 8-hour interval of fasting, while in the other, the drug was administered with a solution of saccharose and a standard food intake regimen was implemented.

Transfusion of Sickle Cell Anemia Patients in Quebec: Challenges and Opportunities

Background: The Black population is the largest visible minority in Québec, comprising approximately 250,000 people (3%). But their needs per capita in red blood cells transfusions are much higher relative to the whole population for comparable age groups. The reason is the incidence of sickle cell anemia patients necessitating regular transfusions, especially those under an erythrapheresis exchange protocol. An extensive program to sensitize the Black community regarding the importance of blood donation was launched in 2010, yet we are still far from attaining the goals set in terms of units collected within the Black community. This leads to an ongoing significant burden especially on Rh negative Caucasian blood donors. Challenges to overcome are deferral for higher prevalence of Hb level below 12.5g/100ml (26%) among black women along with iron depletion <11μg/L (19%) among those who qualify for this Hb criteria.Design and methods: Health Canada has accepted a lower Hb criteria for black women of 11.5g/100ml coupled with a program of ferritin monitoring and iron replacement. Since launching the program in August 2015, 553 black women have registered to participate. The % of women with ferritin level <11μg/L is 35% for those between 11.5 and 12.5g Hb vs 19% for those above 12.5gm. An increase of 33% in blood donations has resulted from this unique measure and an improvement in ferritin levels has been observed among compliant women who take ≥75% of the prescribed pills.Future directions: Ina recent Issue of Transfusion, M.Goldman also reported that 20% of Canadian female donors are iron depleted despite meeting the qualification criteria of 12.5gm Hb/100ml. These observations, similar across ethnic origins, are now challenging the blood community about possible negative impacts on both donors and recipients. Consequently, we are planning to accumulate more data through our current program aimed at black female donors, and determine the feasibility and effectiveness of extending an iron replacement protocol to all female donors of childbearing age. We are namely planning to step up efforts to enhance iron intake regimen compliance to a more beneficial level. DisclosuresNo relevant conflicts of interest to declare.

A novel sustained-release cysteamine bitartrate formulation for the treatment of cystinosis: Pharmacokinetics and safety in healthy male volunteers.

The strict intake regimen of cysteamine bitartrate formulations, associated with side effects, is a concern for the treatment compliance in cystinosis therapy. Therefore, there is a need for a cysteamine formulation with an improved pharmacokinetic profile. This study investigated the pharmacokinetics, safety and tolerability of a new sustained‐release cysteamine dosage form, PO‐001, in healthy volunteers. This was a randomized, investigator‐blinded, three‐way cross‐over study to compare single doses (600 mg) of PO‐001 with Cystagon® (immediate‐release) and Procysbi® (delayed‐release). Collected blood samples were analyzed for plasma cysteamine concentrations and pharmacokinetic parameters were estimated by noncompartmental analysis. In addition, plasma cysteamine concentrations were analyzed using a population pharmacokinetic approach using NONMEM®. Pharmacokinetics showed clear sustained‐release characteristics of PO‐001 over time with a lower C max and longer T max compared to Cystagon® and Procysbi®. All treatment‐emergent adverse events were of mild severity, with the exception of two subjects who reported moderate severity gastrointestinal problems including vomiting and diarrhea, which were related to Cystagon® intake. Population PK simulations showed a favourable PK profile based on C max and C trough concentrations at steady state. In conclusion, a single dose of 600 mg PO‐001 was well tolerated with no findings of clinical concern. This new cysteamine bitartrate formulation showed pharmacokinetics of a sustained‐release formulation, which may be beneficial for the treatment of cystinosis patients. This study supports advancing this type of sustained‐release formulation into a subsequent study to confirm reduced dosing frequency with efficient control of white blood cells (WBCs) cystine levels. Netherlands Trial Registry (NTR) (NL67638.056.18).

Deprescribing and Optimal Selection of Proton Pump Inhibitors (Contributions of the 26th United Russian Gastroenterology Week)

Aim. Presentation of the Forum “Deprescribing and optimal selection of proton pump inhibitors” held in Moscow on 29 September 2020 during the 26th United Russian Gastroenterology Week.Key points. The Forum was aimed at discussing issues associated with improving the proton pump inhibitor (PPIs) therapy in treatment and prevention of acid-related diseases and upper gastrointestinal tract (GIT) disorders induced by non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet medications. Deprescribing is considered to be an effective strategy of a motivated reduction of the PPI dosage, duration of therapy and the patient’s transfer from a regular to on-demand intake regimen. The choice of PPI may condition an optimal therapy for acid-related diseases.Conclusion. PPIs prevail in therapies for acid-related diseases and NSAID-induced upper GIT lesions. PPI deprescribing should be a strategy of choice if medically indicated. A non-enzymatic metabolism, high acid suppression, stable antisecretory effect from day 1 of therapy and cytoprotective action justify the application of rabeprazole (Pariet®) for optimising therapies for acid-related diseases and implementing the deprescribing strategy.

Concomitant lorazepam use and antidepressive efficacy of repetitive transcranial magnetic stimulation in a naturalistic setting

Background/objectives:Repetitive transcranial magnetic stimulation (rTMS) has been established as an effective therapeutic intervention for the treatment of depression. Preliminary data suggest that the efficacy of rTMS is reduced in patients taking benzodiazepines (BZD). Here, we use real-world data from a large sample to investigate the influence of lorazepam on the effectiveness of rTMS.MethodsFrom a retrospective cohort of clinically depressed patients that were treated with rTMS, we compared 176 patients not taking any BZD with 73 patients taking lorazepam with respect to changes in the Hamilton Depression Rating Scale (HRDS).ResultsBoth groups improved during rTMS according to HRDS scores, but the amelioration of symptoms was significantly less pronounced in patients taking lorazepam (18% vs. 38% responders in the non-lorazepam group). We could not see any association of intake regimen of lorazepam with response in rTMS.ConclusionOur observational study suggests that intake of lorazepam impedes the response to rTMS. The impact of lorazepam and other BZD on rTMS should receive more attention and be further investigated in prospective, hypothesis-based treatment studies to determine causal relationships between medication treatments and outcome. This could lead to specific recommendations for pharmacological treatment for depressed patients undergoing rTMS.

Effect of dietary salt restriction on central blood pressure: A systematic review and meta-analysis of the intervention studies.

Central blood pressure (cBP) is highly associated with cardiovascular risk. Although reduction of salt intake leads to lower peripheral blood pressure (BP), the studies on cBP provided inconsistent results. Therefore, we performed a systematic review and a meta-analysis of the available intervention trials of salt reduction on cBP values to reach definitive conclusions. A systematic search of the online databases available (up to December 2018) was conducted including the intervention trials that reported non-invasively assessed cBP changes after two different salt intake regimens. For each study, the mean difference and 95% confidence intervals were pooled using a random-effect model. Sensitivity, heterogeneity, publication bias, subgroup, and meta-regression analyses were performed. Fourteen studies met the pre-defined inclusion criteria and provided 17 cohorts with 457 participants with 1-13weeks of intervention time. In the pooled analysis, salt restriction was associated with a significant reduction in augmentation index (9.3%) as well as central systolic BP and central pulse pressure. There was a significant heterogeneity among studies (I2 =70%), but no evidence of publication bias. Peripheral BP changes seemed to partially interfere on the relationship between salt restriction and cBP. The results of this meta-analysis indicate that dietary salt restriction reduces cBP. This effect seems to be, at least in part, independent of the changes in peripheral BP.

The main results of clinical trials of the efficacy, safety and pharmacokinetics of the perspective anti-tuberculosis drug makozinone (PBTZ169)

The goal of phase I CT was to assess the safety, tolerability and pharmacokinetics (PK) of PBTZ169, 40 mg capsule, after single and multiple administration under fasting conditions in increasing doses in healthy volunteers. The goal of phase IIa CT was to study the efficacy (in terms of early bactericidal activity EBA), safety and PK of the drug PBTZ169, 80 mg capsules, in various doses, when used as monotherapy in patients with newly diagnosed respiratory tuberculosis with bacterial excretion and retained sensitivity to isoniazid and rifampicin. The purpose of phase Ib CT was to evaluate the safety, tolerability, PK of PBTZ169, 80 mg capsule, after single, double and multiple administration under fasting conditions in increasing doses, as well as the effect of food on its bioavailability in healthy volunteers. The data of 100 healthy volunteers and 15 patients with newly diagnosed pulmonary tuberculosis, who received the study medication PBTZ169, capsules 40 mg and 80 mg, in the dose range 40 mg 1280 mg of PBTZ169, obtained during phase I, IIa and Ib CTs were analyzed. During I phases CTs, safety, tolerability, and PK of the drug after a single and multiple administration under fasting condition and after meals at rising doses were evaluated. The safety assessment included evaluation of AE/SAE, vital signs, ECG results, and laboratory tests results in the safety population. In the course of phase IIa CT, in addition to safety, tolerance, and PK evaluation, the efficacy of the drug (in terms of EBA) using sputum culture on agar with CFU/ml counting (main method) and quantitative PCR method (auxiliary method) was evaluated. During all CTs, a high safety and tolerability profile was shown, the main PK parameters of the drug and the efficacy were described. PBTZ169 demonstrated linear PK in the dosage range up to 640 mg after single and multiple administration, a statistically significant of EBA of the drug after monotherapy at the dose of 640 mg/day was demonstrate, and it was concluded that the preferred regimen of the drug PBTZ169 intake is administration after meals. Good tolerability and a favorable safety profile of the drug in the studied doses range were demonstrate during all the CTs. One of the most promising and currently studied drugs-inhibitors of DprE1, a new target for the cell wall of mycobacteria, is PBTZ169 or macozinone, which is being develop by the Russian pharmaceutical company NEARMEDIC PLUS ltd.