Need For Additional Medication Research Articles

Different diseases, different needs: Patient preferences for gene therapy in lysosomal storage disorders, a probabilistic threshold technique survey

BackgroundGene therapy is currently in development for several monogenetic diseases including lysosomal storage disorders. Limited evidence is available on patient preferences for gene therapy in this population. In this study, we compare gene therapy-related risk tolerance between people affected by three lysosomal storage diseases currently faced with different therapeutic options and prognoses.MethodsA survey including the probabilistic threshold technique was developed in which respondents were asked to choose between gene therapy and the current standard of care. The attributes included to establish participants’ risk tolerance were previously identified in focus groups of affected people or their representatives, namely: risk of mild side effects, severe side effects, the need for additional medication, and the likelihood of long-term effectiveness. The survey was distributed among people receiving outpatient care for type 1 Gaucher disease (good prognosis with current treatment options), Fabry disease (varying prognosis with current treatment options, XY-genotype on average more severely affected than XX), and parents representing people with severe forms of mucopolysaccharidosis type III A/B (poor prognosis, no disease-specific therapy available).ResultsA total of 85 surveys were completed (15 Gaucher disease respondents, 62 Fabry disease respondents (17 self-identifying male), eight parents of ten people with mucopolysaccharidosis type III). Disease groups with higher disease severity trended towards higher risk tolerance: Gaucher disease respondents were most cautious and predominantly preferred the current standard of care as opposed to MPS III representatives who were more risk tolerant. Respondents with Fabry disease were most heterogeneous in their risk tolerance, with male participants being more risk tolerant than female participants. Long-term effectiveness was the attribute in which respondents tolerated the least risk.ConclusionsPeople affected by a lysosomal storage disease associated with a poorer prognosis and less effective current treatment options trended towards more risk tolerance when choosing between gene therapy and the current standard of care. This study shows the importance of involvement of patient preferences before and during the development process of new treatment modalities such as gene therapy for rare diseases, to ensure that innovative therapies align with the wishes and needs of people affected by these diseases.

Comparative Analysis of Epidural Dexamethasone and Epidural Morphine (EM) for Postoperative Pain Control After Total Abdominal Hysterectomy: A Randomized Clinical Trial

Background: Epidural anesthesia is commonly utilized for pain management following lower abdominal surgeries; however, the search for an optimal analgesic additive continues. Objectives: This study aimed to compare the efficacy of epidural dexamethasone versus epidural morphine (EM) in managing postoperative pain after total abdominal hysterectomy. Methods: This randomized controlled trial enrolled patients undergoing total abdominal hysterectomy (TBAH) and assigned them to two groups: Group D (Dexamethasone), which received epidural dexamethasone (8 mg) with bupivacaine, and Group M (Morphine), which received epidural morphine (10 mg) with bupivacaine. Marcaine (bupivacaine) 0.25% was used in both groups. Baseline characteristics, surgical outcomes, physiological parameters, pain management, adverse effects, and blood sugar levels were analyzed and compared between the groups. Results: The groups exhibited similar initial characteristics and surgical outcomes. Vital signs, including heart rate (HR), mean arterial pressure, respiratory rate, and oxygen saturation, remained consistent before and after surgery. The Dexamethasone group (Group D) demonstrated superior pain control compared to the Morphine group (Group M). Patients in Group D required pain medication for a significantly shorter duration (24 hours vs. 36 hours, P < 0.05), representing a 50% reduction in medication duration. Additionally, Group D patients required fewer rescue analgesics (1.2 doses vs. 2.1 doses, P < 0.05), indicating a 43% decrease in the need for additional medication. The time to a visual analog scale (VAS) score exceeding 4 was significantly longer in Group D, indicating less intense pain for an extended period. Although no significant differences were observed in common postoperative side effects, Group D exhibited a lower incidence of these effects, albeit not statistically significant. Furthermore, Group D showed a significantly lower incidence of hyperglycemia at the 8th hour post-surgery compared to Group M (P < 0.05), suggesting a potential benefit of epidural dexamethasone in mitigating hyperglycemia risk. Conclusions: Epidural dexamethasone appears to offer superior analgesic efficacy compared to epidural morphine in postoperative pain management after total abdominal hysterectomy. The findings suggest that Group D (Dexamethasone) experienced improved pain management, reduced medication requirements, and a lower incidence of hyperglycemia. Further research with larger cohorts and extended follow-up is warranted to validate these findings and guide clinical practice.

24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial.

To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion. We conducted a prospective randomized controlled trial. Participants were allocated to receive mifepristone either 24 hours or 12 hours before misoprostol administration. The primary outcome was the time from the first misoprostol administration to abortion (induction time). Secondary outcomes included the time from mifepristone to abortion (total abortion time); fetal expulsion percentages at 12, 24, and 48 hours after the first misoprostol dose; side effects proportion; and pain and satisfaction scores. A sample size of 40 per group (N=80) was planned to compare the 24- and 12-hour regimens. Eighty patients were enrolled between July 2020 and June 2023, with 40 patients per group. Baseline characteristics were comparable between groups. Median induction time was 9.5 hours (95% CI, 10.3-17.8 hours) and 12.5 hours (95% CI, 13.5-20.2 hours) in the 24- and 12-hour interval arms, respectively ( P =.028). Median total abortion time was 33.0 hours (95% CI, 34.2-41.9 hours) and 24.5 hours (95% CI, 25.7-32.4 hours) in the 24- and 12-hour interval groups, respectively ( P <.001). At 12 hours from misoprostol administration, 25 patients (62.5%) in the 24-hour arm and 18 patients (45.0%) in the 12-hour arm completed abortion ( P =.178). At 24 hours from misoprostol administration, 36 patients (90.0%) in the 24-hour arm and 30 patients (75.0%) in the 12-hour arm had complete abortion ( P =.139). The need for additional medication or surgical treatment for uterine evacuation, pain scores, side effects, and satisfaction levels were not different between groups. A 24-hour mifepristone-to-misoprostol regimen for medication abortion in the second trimester provides a median 3-hour shorter induction time compared with the 12-hour interval. However, the median total abortion time was 8.5-hours longer in the 24-hour interval regimen. These findings can aid in shared decision making before medication abortion in the second trimester. ClinicalTrials.gov, NCT04160221.

Intravitreal bevacizumab improves trabeculectomy survival at 12 months: the bevacizumab in trabeculectomy study—a randomised clinical trial

AimsTo evaluate the effect of an intraoperative dose of intravitreal bevacizumab (Avastin) on surgical success following trabeculectomy with mitomycin-C (MMC) over 12 months.MethodsA single centre, parallel, double-blinded randomised, placebo-controlled trial...

Rapid tranquilization in a psychiatric emergency room: A naturalistic cohort study in 12 h

The purpose of this study was to conduct a naturalistic assessment of the efficacy of four distinct fast tranquilization techniques (intramuscular haloperidol, midazolam, haloperidol plus promethazine, or haloperidol plus midazolam) over a period of 12 h. The sample included 1603 people who were psychiatric emergency room patients at Hospital Geral de Palmas in Brazil between January 2018 and June 2022. The primary outcome was the number and proportion of patients who achieved the ideal response of the rapid tranquilization concept: tranquil without sedation in all assessments (measure by BARS scale), without restraint, without additional medication and without side effects. The secondary outcomes were mild agitation, tranquil or asleep over 12 h, the need for additional medication, use of physical restraints, and side effects. Among all patients, the proportion of rapid tranquilization over 12 h was 14.1% besides (32.9% for haloperidol, 29.2% for midazolam, 4.1% for haloperidol plus promethazine, and 5.4% for haloperidol plus midazolam) there is response some time in 97%. Logistic regression assessed the rapid tranquilization concept with to haloperidol as parameter: midazolam Exp(B) = 0.718 (95% CI 0.362–1.421), p = 0.341, had no difference; haloperidol plus promethazine Exp(B) = 0.011 (95% CI 0.004–0.026), p < 0.001] and haloperidol plus midazolam Exp(B) = 0.019 (95% CI 0.07–0.050) p < 0.001] had higher chance to fail. Secondary outcomes are described in manuscript. Data suggest that the use of monotherapy should be encouraged, and the use of associations does not produce better results to reach rapid tranquilization over 12 h.

Treatment of Congenital Hypotransferrinemia Patients with Human Apotransferrin Resolves Anemia and Reduces Iron Accumulation

Introduction Congenital hypotransferrinemia is a very rare inherited and life-threatening disorder (MIM#209300) characterized by systemic iron overload and anemia. The deficiency of serum transferrin leads to inadequate iron supply to erythroid bone marrow, resulting in microcytic hypochromic anemia. This triggers hepcidin downregulation, causing increased iron absorption and production of non-transferrin bound iron (NTBI), leading to iron overload in various organs and tissues. Currently, there is no targeted therapy for this disease. Method In an open-label phase II/III study, four children (age 0-7 years) and one adult (20 years) with congenital hypotransferrinaemia were treated with purified plasma-fractionated human apotransferrin for nearly 10 years. All patients received an initial intravenous dose of 75 mg/kg every 8 weeks for 6 months, followed by 75 mg/kg every 4 weeks for additional 6 months, and in the subsequent years apotransferrin was administered every 4 weeks but the dose was adjusted to 75-150 mg/kg based on clinical judgement of physician according to patient condition. Prior to the start of the study two patients already received replacement therapy, i.e., human apotransferrin or plasma. Serum transferrin and serum iron were determined before every infusion. Primary objective was to investigate the effect of apotransferrin treatment on anemia and iron overload. Hemoglobin, hematocrit, and erythrocytes as markers of anemia were measured every 8 weeks. Iron overload was monitored by measuring serum ferritin every 8 weeks and yearly iron quantification in liver and heart through MRI. Labile Plasma Iron (LPI) was measured before and after infusion (starting after 2 years of treatment). The need for additional treatment for anemia or iron overload was defined as a secondary outcome. Safety and clinical tolerance were evaluated by adverse event surveillance and laboratory measurements. Results Baseline serum transferrin levels were significantly below the normal range in all patients (&amp;lt;10-189 mg/L; normal range: 1800-3500 mg/L). Treatment with human apotransferrin increased serum transferrin and serum iron levels in all patients. Fifteen minutes after the first infusion, transferrin levels ranged from 1340-2415 mg/L, but declined to values just above baseline before the next infusion (dosing interval 8 weeks). During the study period serum transferrin concentrations were affected by dose adjustments; however, trough levels of transferrin remained below the normal range throughout the study (range 200-800 mg/L). Despite subnormal trough levels, apotransferrin infusion led to rapid increase of hemoglobin (Figure 1), hematocrit, and erythrocyte levels up to normal values. The two patients who were already treated before the study, showed normal levels at baseline that were maintained. In all patients hematologic parameters remained stable throughout the study. Ferritin levels were elevated at baseline and decreased to normal ranges in 1.2 to 7.3 years, with a maximum decrease ranging from 82% to 97% of baseline. MRI examinations revealed liver iron overload at baseline which normalized in all patients after apotransferrin treatment, in most cases after 3 to 4 years (Figure 2). No myocardial iron overload was observed at baseline and during the follow-up. Pre-infusion LPI was found in all five patients, however in three patients the values were undetectable on most occasions. Immediately after infusion with apotransferrin, in none of the patients LPI was present anymore. Throughout the study no additional use of plasma/blood products or iron chelators was needed. Apotransferrin infusions were well tolerated. No serious adverse events were reported. No loss of clinical response to treatment was detected over time. Conclusion Treatment with human apotransferrin in patients with congenital hypotransferrinemia demonstrated good long-term clinical efficacy. Apotransferrin infusions increased hematopoiesis, reduced iron overload in organs, and eliminated the need for additional medication. The therapy was well-tolerated and showed good clinical safety. Human apotransferrin holds promise as the mainstay treatment option for congenital hypotransferrinemia.

Therapeutic Options for Migraines in the Microsurgical Patient: A Scoping Review.

There exists an increasing array of treatments proposed to prevent, alleviate, and abort symptoms of a migraine; however, for patients who undergo reconstructive microsurgery, caution must be taken to preserve vascular integrity. This study is the first-to-date scoping review of vascular and bleeding risk of current migraine therapies, with the purpose of identifying potential therapeutic agents for postoperative migraine management appropriate for microsurgical patients. Currently available migraine therapeutics were compiled from the UpToDate software system and the American Academy of Family Physicians. A PubMed literature review was performed for each therapeutic's effect on bleeding or vascular involvement. Data were compiled into tables of abortive, symptom-controlling and prophylactic, and nonpharmacologic treatments. Expert microsurgeons reviewed the data to provide recommendations for optimized patient care. Triptans and other ergot derivatives demonstrated strong evidence of vasoconstriction and were greatly advised against for immediate postmicrosurgical use. Novel pharmaceutical therapies such as lasmiditan and calcitonin gene-related peptide antagonists have no literature indicating potential for vasoconstriction or hematoma and remain an investigational option for abortive medical treatment. For symptom control, acetaminophen appears the safest option, with clinical judgment and further research needed for use of nonsteroidal antiinflammatory drugs. Alternative treatment techniques may include migraine prophylaxis with botulinum toxin injection or nutraceutical treatment by means of magnesium supplementation or coenzyme Q10 administration, minimizing the need for additional medication in the postoperative setting. Patients undergoing reconstructive microsurgery have a unique medical profile limiting the therapeutic options available to treat migraines. This review provides preliminary evidence to be considered as a guide for prescribing therapeutics for migraine in the postoperative setting.

Does rapid discharge after breast cancer surgery have an impact on wound healing and complications? COVID-19 pandemic experience.

The COVID-19 pandemic has challenged the health systems worldwide. Because of high volume of COVID-19 patients, all hospitals in our region were re-configured as COVID-19 centres and elective surgery procedures were cancelled. Our clinic was the only active centre in the region and grave increase in our patient volume urged our clinic to modify our discharge protocol. This retrospective study included all breast cancer patients underwent mastectomy and/or axillary dissection, in the Breast Surgery Clinic of Kocaeli State Hospital, a regional pandemic hospital, between December 2020 and January 2021. Patients were mostly discharged the day of surgery with drains because of congestion, while some of the patients had traditional stay, when beds were available. The patients were evaluated postoperatively (the first 30 days) in terms of wound complications, Clavien-Dindo classification grade, satisfaction, presence of pain and nausea, and treatment costs during the follow-up period of the study. Outcomes were compared between early discharged patients and patients who had traditional long stay. Compared with long-stay patients, in the early discharged group, postoperative wound complications was significantly lower (P < .01) with significant cost savings. There were no significant changes in variables such as surgery type, ASA class, satisfaction, need for additional medication and Clavien-Dindo between the groups. Adaptation to an early discharge protocol for breast cancer surgeries may be an efficient way of practicing surgery in a pandemic. Early discharge with drains may be beneficial for patients.

Kompanse Böbrek Yetmezlikli Hastalarda Koroner Bypass Morbiditesini Azaltan bir Teknik; Peroperatif Ultrafiltrasyon

INTRODUCTION: Preoperative renal dysfunction is one of the most important risk factors affecting postoperative morbidity and mortality in patients undergoing cardiac surgery. While patients with end-stage renal disease and dialysis-dependent constitute 1-3% of the renal failure spectrum, it should not be forgotten that coronary revascularization surgery is performed at a rate of 2-5% in the remaining asymptomatic majority. However, an optimal perioperative strategy has not been developed for this group of patients who have not yet undergone hemodialysis. In our study, conventional ultrafiltration was applied with a modified peroperative heart-lung machine and it was aimed to decrease mortality and morbidity. METHOD: 6303 patients who underwent coronary bypass surgery with the cardiopulmonary bypass technique between 2004 and 2011 at Başkent University Adana Hospitals were examined, and 99 patients with a preoperative serum creatinine level higher than 1.5 mg/dl were included in this retrospective study. 99 patients were divided into two groups as UF performed (35) and not performed (64); They were evaluated in terms of drainage amounts, length of hospital stay, early/late mortality and morbidity, and newly developing dialysis needs. RESULTS: There was no significant difference between the groups in terms of post-operative hemodialysis need, length of hospital stay and major complications. However; Peroperative ultrafiltration in obese, diabetic, recent MI, COPD and congestive heart failure patients; postoperatively less inotrope (P=0.0001), less diuretic requirement (P=0.0001), less colloidal fluid replacement (p=0.009), and relatively fewer minor complications. DISCUSSION AND CONCLUSION: Ultrafiltration to be applied during cardiopulmonary bypass in order to create a more balanced intravascular volume in patients with compensated renal failure, to reduce the need for volume expander fluid used for this purpose, to remove inflammation mediators that occur during cardiopulmonary bypass, and therefore to protect renal functions without the need for additional medication, especially COPD. We recommend it in the diabetic and obese patient group.

Safety and effectiveness of benzodiazepines and antipsychotics for agitation in older adults in the emergency department

PurposeTo examine the safety and effectiveness of benzodiazepines (BZD) as compared to antipsychotics for the management of acute agitation in older adults in the emergency department (ED). Basic proceduresRetrospective observational cohort study of 21 EDs across four states in the US, including adults ≥60 years old who received either BZD or antipsychotics for acute agitation in the ED and subsequently were admitted to the hospital. Safety was measured as presence of adverse events: respiratory depression, cardiovascular effects, extrapyramidal side effects, or a fall during hospitalization. Effectiveness was measured as indicators of treatment failure: need for additional medication, one-to-one observation, or physical restraints following initial medication administration. Proportions and odds ratios with 95% confidence intervals (CI) were calculated. Univariable and multivariable logistic regression were used to assess the association between potential risk factors and for efficacy and safety endpoints. Main findingsA total of 684 patients were included (63.9% received a BZD and 36.1% an antipsychotic). There was no difference in the incidence of adverse events between groups (20.6% vs 14.6%, difference 6.0%, 95% CI -0.2% to 11.8%), but there was a higher intubation rate in the BZD group (2.7% vs 0.4%, difference 2.3%). There were more treatment failures in the antipsychotic group for the composite primary efficacy endpoint (94.3% vs 87.6%, difference 6.7%, 95% CI 2.5% to 10.9%). This appears to have been driven by the need for 1:1 observation; sensitivity analysis excluding 1:1 observation in the composite outcome demonstrated no significant difference with a failure rate of 38.5% in the antipsychotic group and 35.2% in the benzodiazepine group. Principal conclusionsOverall there are high rates of treatment failure among agitated older adults receiving pharmacological treatment for agitation in the emergency department. The optimal selection of pharmacological treatment for agitation in older adults should be made considering patient-specific factors that could increase the risk of adverse effects or treatment failure.

P335 Impact of cancer therapy on the course of Inflammatory Bowel Disease (ONCOEII study of GETECCU)

Abstract Background Cancer in inflammatory bowel disease (IBD) patients is increasing mainly due to the aging of patients. There are few data regarding the effect of different types of cancer treatments in IBD disease outcome. The aim of the study was to evaluate the impact of cancer treatments on the course of IBD patients. Methods An observational, multicenter, retrospective cohort study was conducted. We identified IBD patients diagnosed for an extraintestinal malignancy and who received any of the following cancer treatment types: chemotherapy, hormonal therapy, targeted therapy or immunotherapy. Patients who simultaneously received more than one different type of cancer treatment were excluded. Primary outcome was to evaluate the risk of IBD relapse for each type of cancer treatment. IBD relapse was defined as the need for additional medication, hospitalization or surgery related to IBD. Secondary outcomes were to describe the IBD treatment modifications after cancer diagnosis and to identify predictive factors for IBD relapse. IBD relapse was defined as the need for additional medication, hospitalization or surgery related to IBD. Predictive factors for IBD relapse were identified using multivariate Cox proportional hazard analysis. Results A total of 180 patients from 26 centers were included. Median age at cancer diagnosis was 57.5 years (IQR 46.8-67), 52.2% were female and 51.1% had Crohn’s disease. 36.1% and 20.6% were receiving immunomodulators and biologic drugs at the moment of cancer diagnosis respectively. IBD was in remission in most of the patients (85%). The most frequent malignancies were breast, prostate and hematological (33.9%, 12.2% and 12.2% respectively). IBD treatment was discontinued in 40.6% of patients at cancer diagnosis (77.1% of patients receiving thiopurines and 79.2% of those receiving anti-TNF drugs). 33% of patients experienced IBD relapse after cancer treatment initiation, at a median time of 7.6 months. IBD relapse was treated more frequently with steroids, vedolizumab and anti-TNF (56%, 15.2% and 13.6% respectively). In multivariate Cox-regression analysis, older age (HR=0.98; 95% CI [0.96-0.99]) and chemotherapy (HR=0.57; 95% CI [0.34-0.96]) were associated with a lower risk of IBD relapse, and active IBD at baseline (HR=2.9; 95% CI [1.67-5.07] was associated with a higher risk. Kaplan-Meier survival curves for time to IBD relapse are shown in Figures 1 and 2. Conclusion One out of three patients experienced IBD relapse after cancer treatment initiation. IBD drugs were discontinued in almost half of the cohort, specially thiopurines and anti-TNF drugs. Older age and chemotherapy were associated with a lower risk of IBD relapse, and active IBD at baseline with a higher risk.

Prophylactic effect of rectal and sublingual misoprostol on postpartum hemorrhage in mothers with preeclampsia following cesarean section surgery; a double-blind randomized controlled trial

BackgroundPostpartum hemorrhage is one of the three major causes of maternal morbidity and mortality, so delay in the diagnosis and proper management of postpartum hemorrhage is of great importance. The present study aimed to determine the prophylactic effect of misoprostol on postpartum hemorrhage in patients with preeclampsia. MethodsThis was a double-blind randomized controlled clinical trial performed on 128 pregnant women with preeclampsia undergoing cesarean section in Kamali hospital in Karaj. After cesarean delivery, immediately after clamping the umbilicus, the first group was administered 400 μg of rectal misoprostol and the second group was given 400 μg of sublingual misoprostol. The third group (control) was given 30 units of oxytocin during surgery and within 12 h after surgery, respectively. Hemoglobin and hematocrit were measured 24 h later. The estimated bleeding rate by the physician, the need for additional medication to control bleeding, and the amounts of hemoglobin and hematocrit in the first 24 h were compared in the three groups. Finally, the obtained information was entered into SPSS version 21 and analyzed using statistical tests. ResultsThe mean hemoglobin and hematocrit levels 6 and 12 h after cesarean section were significantly lower in the oxytocin group than in the sublingual and rectal misoprostol groups (Hemoglobin level (mg/dl) for oxytocin group 10.39 ± 0.73 and 9.53 ± 1.09 vs. sublingual misoprostol 11.05 ± 0.71 and 10.39 ± 0.84 vs. rectal misoprostol 10.92 ± 0.85 and 10 ± 1.01; hematocrit level for Hemoglobin level (%) for oxytocin group 31.27 ± 2.29 and 28.64 ± 2.93 vs. sublingual misoprostol 33.09 ± 2.20 and 31.05 ± 2.37 vs. rectal misoprostol 32.54 ± 2.7 and 29.92 ± 2.86) (p < 0.005). The mean estimation of visual bleeding in the oxytocin group was higher than the other three groups, followed by the rectal and the sublingual groups, respectively. However, there was no significant difference between the three groups regarding visual bleeding. There was no significant difference in hemoglobin and hematocrit between the two groups of sublingual and rectal misoprostol before and 6 and 12 h after the surgery (P > 0.05). ConclusionIt seems that sublingual or rectal misoprostol administration along with oxytocin is associated with a reduction in postpartum cesarean section bleeding compared to oxytocin administration alone.

Assessment of the effect of adding furosemide to antihypertensive treatment on postpartum hypertension in women with preeclampsia; a randomized clinical trial

Introduction: One of the probable mechanisms of hypertension that may occur in women with preeclampsia after delivery is returning of interstitial and extravascular fluid into the bloodstream. Objectives: The present study aimed to investigate the effect of furosemide to control postpartum hypertension in women with preeclampsia. Patients and Methods: This randomized clinical trial was conducted on 116 patients with preeclampsia with a blood pressure (BP) of more than 150/100 mm Hg in the first 24 hours after delivery. Patients were randomly divided into two groups of nifedipine (taking 10 mg tablets every 8 hours) and nifedipine plus furosemide (nifedipine plus 20 mg furosemide tablet once daily). Patients were monitored until the fifth day after delivery. After the first 48 hours, patients with a BP lower than 150/100 mm Hg were discharged from the hospital and the treatment continued at home. Results: Systolic BP (SBP), diastolic BP (DBP), and mean arterial pressure (MAP) were significantly reduced in all patients and in each group on the first to fifth days after delivery. On the second day, DBP in the nifedipine group was significantly lower (P=0.005). On the third to fifth days, SBP in the nifedipine plus furosemide group was significantly lower (P&lt;0.05), while DBP did not change (P&gt;0.05). On the third and fourth days, MAP was significantly lower in the nifedipine plus furosemide group (P&lt;0.05), however it was not significantly different on the fifth day (P=0.383). The need for additional medication to control BP was higher in the nifedipine group than in the nifedipine plus furosemide group. BP became normal (less than 120/80 mmHg) in 74 patients (68%) within five days after delivery; which was more popular in the nifedipine plus furosemide group (P&lt;0.001). Conclusion: The findings of the present study showed that inclusion of furosemide in nifedipine regimen was associated with a further reduction in SBP and MAP. Furosemide also reduced the need for additional medication to control BP and increased the frequency and speed of reaching toward normal BP. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20191031045289N2; https://irct.ir/trial/49806, ethical code; IR.SBMU.MSP. REC.1399.067).

Nifedipine for primary dysmenorrhoea.

Dysmenorrhoea (period pain) is a common condition with a substantial impact on the well-being and productivity of women. Primary dysmenorrhoea is defined as recurrent, cramping pelvic pain that occurs with periods, in the presence of a normal uterus, ovaries and fallopian tubes. It is thought to be caused by uterine contractions (cramps) associated with a high level of production of local chemicals such as prostaglandins. The muscle of the uterus (the myometrium) responds to these high levels of prostaglandins by contracting forcefully, causing low oxygen levels and consequently pain. Nifedipine is a calcium channel blocker in widespread clinical use for preterm labour due to its ability to inhibit uterine contractions in that setting. This review addresses whether this effect of nifedipine also helps with relief of the uterine contractions during menstruation OBJECTIVES: To assess the effectiveness and safety of nifedipine for primary dysmenorrhoea. We searched for all published and unpublished randomised controlled trials (RCTs) of nifedipine for dysmenorrhoea, without language restriction and in consultation with the Cochrane Gynaecology and Fertility Group (CGF) Information Specialist. The following databases were searched to 25 November 2021: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL. Also searched were the international trial registers: ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, the Web of Science, OpenGrey, LILACS database, PubMed and Google Scholar. We checked the reference lists of relevant articles. We included RCTs comparing nifedipine with placebo for the treatment of primary dysmenorrhoea. The primary outcomes to be assessed were pain, and health-related quality of life. Secondary outcomes were adverse effects, satisfaction, and need for additional medication. The two review authors independently assessed the included trials. There were insufficient data to allow meaningful meta-analysis. The evidence assessed was of very low quality overall. We examined three small RCTs, with a total of 106 participants. Data for analysis could be extracted from only two of these trials (with a total of 66 participants); two trials were published in the 1980s, and the third in 1993. Nifedipine may be effective for "any pain relief" compared to placebo in women with primary dysmenorrhoea (odds ratio (OR) 9.04, 95% confidence interval (CI) 2.61 to 31.31; 2 studies, 66 participants; very low-quality evidence). The evidence suggests that if the rate of pain relief using placebo is 40%, the rate using nifedipine would be between 64% and 95%. For the outcome of "good" or "excellent" pain relief, nifedipine may be more effective than placebo; the confidence interval was very wide (OR 43.78, 95% CI 5.34 to 259.01; 2 studies, 66 participants; very low-quality evidence). We are uncertain if the use of nifedipine was associated with less requirement for additional analgesia use than placebo (OR 0.54, 95% CI 0.07 to 4.20, 1 study, 42 participants; very low-quality evidence). Participants indicated that they would choose to use nifedipine over their previous analgesic if the option was available. There were similar levels of adverseeffects and menstruation-related symptoms in the placebo and intervention groups (OR 0.94, 95% CI 0.08 to 10.90; 1 study, 24 participants; very low-quality evidence); if the chance of adverseeffects with placebo is 80%, the rate using nifedipine would be between 24% and 98%. There were no results regarding formal assessment of health-related quality of life. The evidence is insufficient to confirm whether nifedipine is a possible medical treatment for primary dysmenorrhoea. The trials included in this review had very low numbers and were of low quality. Notably, there was a large imbalance in numbers randomised between placebo and treatment groups in one of the two trials with data available for analysis. While there was no evidence of a difference noted in adverse effects between groups, more data from larger participant numbers are needed for this outcome. Larger, more well-conducted trials are required to elucidate the potential role of nifedipine in the treatment of this common condition, as it could be a useful addition to the therapeutic options available if shown to be well tolerated and effective. The safety of nifedipine in women of reproductive age is well established from trials of its use in preterm labour, and clinicians are accustomed to off-label use for this indication. The drug is inexpensive and readily available. Other options for relief of primary dysmenorrhoea are not suitable for all women; NSAIDs and the oral contraceptive pill (OCP) are contraindicated for some women, and the OCP is not suitable for women who are trying to conceive. In addition, the trials examined suggest there may be a participant preference for nifedipine.

Sublingual Sufentanil in Pain Management After Pulmonary Resection: A Randomized Prospective Study

BackgroundSuccessful postoperative pain management after major lung resection surgery is mostly achieved through intravenous administration of analgesic drugs. This study explored the use of sublingual sufentanil cartridges (Zalviso) as a noninvasive alternative to postoperative analgesia. MethodsFrom July 2019 to April 2020, patients who underwent major thoracoscopic lung resection surgery were randomly allocated to receive either intravenous pain management, or patient-controlled analgesia by the Zalviso system. Pain assessment scores were collected for a 72-hour time window, and requests for additional medication due to insufficient pain control were recorded. ResultsOf the 80 patients enlisted, 40 were assigned to the Zalviso group and 40 to the control group. The groups were not statistically different from each other. The difference in the mean pain scores reported was statistically significant in the first 24 hours in favor of the Zalviso group (P = .046), and the need for additional pain medication was significantly higher in the control group (P = .004). ConclusionsPatient-controlled analgesia using sublingual sufentanil cartridges can provide effective pain relief for patients undergoing video-assisted thoracic surgery and can reduce the need for additional medication, offering a noninvasive alternative to traditional intravenous therapy.

Risk Factor for Additional Intravenous Medication during Transforaminal Full-endoscopic Lumbar Discectomy under Local Anesthesia.

Transforaminal full-endoscopic lumbar discectomy (TELD) can be performed under local anesthesia. However, there have been no reports on risk factors for a change in vital signs or the need for additional medications to maintain adequate analgesia during this procedure. The purpose of this study was to identify risk factors for additional intravenous medication during TELD under local anesthesia. The following factors were retrospectively evaluated in 113 consecutive patients who underwent TELD under local anesthesia at our institution: demographic characteristics, radiological features at the intervertebral disc level, distance between the superior articular process and the exiting nerve root, height of the intervertebral disc, height of the bulging disc, height of the intervertebral foramen, and distance from the insertion site to the spinous process on magnetic resonance imaging (MRI) and computed tomography (CT) scans of the lumbar spine. Logistic regression analysis was performed to determine factors associated with the need for additional drugs. In all, 23 cases (20.4%) required additional intraoperative medications because of hypertension, hypotension, bradycardia, or pain. Logistic regression analysis revealed that age (partial regression coefficient 0.05, p = 0.02) and bulging disc height (partial regression coefficient −0.7, p = 0.003) influenced the need for additional drugs. There were significant associations of need for additional intravenous medication with older age (>62 years) and a smaller bulging disc height (<8.2 mm). Patients with these factors require close monitoring for changes in vital signs or increasing pain when performing TELD under local anesthesia and may need additional intravenous medication.

Description of a Comprehensive Medication Management service in an adult intensive care unit

Objective: To describe the results of a Comprehensive Medication Management (CMM) service offered to patients of an adult intensive care unit. Methods: A descriptive cross-sectional study of the results of the CMM service (April 2017 to November 2018). All the patients followed up in the CMM service were included in the sample of this study. The service was integrally based on the Pharmaceutical Care Practice and, therefore, used the Pharmacotherapy Workup (PW) method. the drug therapy Problems (DTP) were quantified and classified according to the PW method. The main medications involved in the DTP were also described, as well as the acceptance of the interventions by the multidisciplinary care team members and patients. Results: 146 patients were followed up during the study period, and 512 DTP were identified. Of these DTP, most were related to medication safety (37.7%) and to indication (37.5%). The main causes were high dose (23.0%, with emphasis on dose adjustments in cases of kidney injury), need for additional medication (18.9%, inclusion of medication for electrolytic, glycemic, and prophylactic control), and unnecessary medication (18.6%, emphasis on de-prescription of antibiotics that were not indicated). Most of the problems (23.6%) were related to the therapeutic class of systemic anti-infective agent. Of the total DTP detected, 81.6% were resolved. A total of 451 interventions were implemented, of which 92.9% (n=419) were with physicians. The majority of the interventions with physicians were accepted (n=344, 82.1%). Conclusion: A high number of drug therapy problems have been detected and resolved by the CMM pharmacist, with emphasis on safety problems. The high acceptability of the interventions reinforces the need for the service applied to the critical patient.

Optimizing Opioid Pain Medication Use After Vasectomy—A Prospective Study

To act as good stewards, urologists need to balance patient's pain requirements against the risk of narcotic abuse. We prospectively consented subjects who underwent vasectomies. Procedural technique was not standardized. All subjects received hydrooxycodone/acetaminophen 5-325 mg tablets and Ibuprofen 800 mg tablets. The subjects were then contacted by phone 1-3 weeks after their procedure with a follow-up questionnaire. Data collected included age, weight, number of pills used and pills remaining, number of days pain medication used, need for additional medication, pain treatment satisfaction, disposal knowledge, and complications. A total of 76 subjects completed the study. Overall, 88.3% rated excellent pain treatment satisfaction with score ⩾4 (scale 1-5). No opioid medication was used by 18.2% of subjects, 33.8% used 1-5 tablets, and 24.7% used all 15 tablets. At the end, 9 subjects (11.7%) reporting needing more pain medication. Using Pearson correlation, younger age was significantly related to number of pills used. (P <.001) In total, 648 additional narcotic tablets were prescribed. In terms of disposal, 20 (25.9%) subjects disposed of extra medication, 14 (24.7%) used all medication, and 50.6% did not dispose of medication. Proper disposal technique was known by 50 (64.9%) subjects. Opioid medication use after vasectomy is variable though correlated with age. Clinicians should weigh the need versus potential abuse to determine the amount of tablets they are comfortable prescribing. Counseling and documentation on proper use and disposal of opioid medication is strongly encouraged.

Primary baerveldt versus trabeculectomy study after 5years of follow-up.

PurposeAlthough the Baerveldt glaucoma implant (BGI) initially was reserved for refractory glaucoma, its role in the surgical management of glaucoma has shifted towards a primary treatment choice. We performed a randomized prospective study to compare BGI surgery and trabeculectomy (TE) in patients without previous ocular surgery.MethodsWe included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized to either a BGI or TE. Follow‐up visits were at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1, 2, 3, 4 and 5 years postoperatively. Primary outcomes were intraocular pressure (IOP) and failure rate. Secondary outcomes were medication, anterior chamber laser flare value and complications.ResultsAfter 5 years, an IOP of 12.7 ± 3.9 mmHg (mean ± SD) was achieved in the TE group and 12.9 ± 3.9 mmHg in the BGI group. We found no statistically significant difference in failure rate between the groups (p = 0.72). More BGI patients needed additional medication to control their IOP (85%; 1.9 ± 1.2 types of glaucoma medication) compared to the TE patients (57%; 0.5 ± 0.9 types of glaucoma medication). Diplopia was significantly more present in the BGI group than in the TE group (27% versus 4%; p < 0.001). The self‐limiting complication rate was similar in both groups.ConclusionsOur study demonstrates that, in the long term, the final IOP and failure rate are similar after TE and BGI surgery. However, the need for additional medication after BGI surgery is higher than after TE. Also, the increased risk of developing diplopia after BGI surgery must be taken into consideration.

Treatment of the opioid use disorder in the primary health care in The City of Zagreb

Abstract Issue/problem Management of patients with opioid use disorder commonly includes opioid agonist therapy as a part of an integrated treatment plan. These interventions are associated with proven benefits to the individual and society. Treatment choices in opioid use disorder pharmacotherapy should be based on the needs of the individual and characteristics of medications. Description of the problem The aim was to present the use of pharmacotherapy in the treatment of opioid use disorder in family medicine practice in Zagreb. We collected data from 30 family physician practices, on patients treated for opioid use disorder. We analyzed the epidemiological characteristics of the patient, the diagnosis according to ICD X rev., as well as the frequency of the medication use and the duration of the treatment. Results Data about 100 patients treated for opioid use disorder were obtained, (88% men and 12% women). The average age of the patients was 37.9 years. From all patients, 31% had dg. F.60, 22% had dg. F19, 15% had dg. F32, 3% had dg. F29. 19% of patients was HCV positive. 62%of patients were treated with buprenorphine and 38% with methadone. In 5% of patients buprenorphine was only medication in therapy. 53% of patients with buprenorphine use diazepam, 30% use buprenorphine with antidepressant, and 12% use diazepam and antidepressant with buprenorphine. All patients who are on methadone therapy are using some other medication in therapy. Methadone is commonly prescribed in combination with diazepam and antidepressant (55%). The following combination is methadone and diazepam (34%), a combination of methadone, antipsychotics and pregabalin (7%) and a combination of methadone, antidepressants and antipsychotics (4%). The average duration of treatment for opiate addicts is 11.9 years. Lessons Patients who use buprenorphine in the treatment of opioid use disorder have less need for additional medication in therapy than patients who use methadone. Key messages Patients who use buprenorphine in the treatment of opioid use disorder have less need for additional medication in therapy than patients who use methadone. Treatment choices in opioid use disorder pharmacotherapy should be based on the needs of the individual and characteristics of medications.