Mastalgia in infertility: search for additional possibilities of therapy

GYNECOLOGY ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. 354-363
Author(s):  
Ksenia V. Krasnopolskaya ◽  
Vera E. Balan ◽  
Irina Y. Ershova ◽  
Elena O. Skorik ◽  
Sergey E. Malygin ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Adverse Reactions ◽  
Study Cohort ◽  
Open Label ◽  
Pharmacological Agents ◽  
Infertile Women ◽  
Analgesic Effects ◽  
Drug Tolerability ◽  
Cohort Study Design ◽  
Homeopathic Drug

Aim. To assess the efficacy and safety of using the homeopathic drug Mastopol for the relief of mastalgia in women with infertility, including those associated with endometriosis, as well as to study the drug tolerability and adherence to the treatment, as well as to determine its antiproliferative and analgesic effects in patients of the study cohort. Study design: open-label, randomized, non-comparative, observational study. Material and methods. 79 infertile women with mastalgia (67 with cyclic mastalgia and 12 with acyclic mastalgia) were examined and treated with Mastopol. Mastopol was prescribed 1 tablet 3 times a day sublingually. The course of treatment was 8 weeks. The efficacy of mastalgia relief was assessed using a Visual Analogue Scale (VAS). Treatment outcomes were considered good if pain severity by the VAS decreased by 4 or more points from the baseline levels at the end of Mastopol treatment course. Results. One Mastopol treatment course provided good treatment outcomes in 76,2% of patients with cyclic mastalgia and in 33,3% of patients with acyclic mastalgia. There were no adverse reactions or complications in patients treated with Mastopol. Conclusions. Mastopol has established itself as a quite effective and safe drug in patients of the study cohort; if there is an insufficient effect, Mastopol can supplement traditional pharmacological agents recorded in the current clinical guidelines.

scholarly journals Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044696
Author(s):  
Nadine Ezard ◽  
Brendan Clifford ◽  
Adrian Dunlop ◽  
Raimondo Bruno ◽  
Andrew Carr ◽  
...  
Keyword(s):  
Adverse Events ◽  
Risk Behaviour ◽  
Phase 2 ◽  
Open Label ◽  
Dose Escalation Study ◽  
Stimulant Use ◽  
Treatment Services ◽  
Drug Tolerability ◽  
Methamphetamine Dependence ◽  
Icd 10

ObjectivesTo examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence.DesignA dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services.SettingThe study was conducted at two Australian stimulant use disorder treatment clinics.ParticipantsThere were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days.InterventionsDaily, supervised LDX of 100–250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100–250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250–100 mg). Participants were followed through to week 12.OutcomesPrimary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning.ResultsFourteen of 16 participants (87.5%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16–23) to 13 days (IQR: 11–17) over the 4-week escalation period (p=0.013).ConclusionsLDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence.Trial registration numberACTRN12615000391572.

scholarly journals Analgesic effects of ketamine infusion therapy in korean patients with neuropathic pain: A 2-week, open-label, uncontrolled study

2010 ◽  
Vol 71 (2) ◽  
pp. 93-104 ◽  
Author(s):  
Jin Gu Kang ◽  
Chul Joong Lee ◽  
Tae Hyeong Kim ◽  
Woo Seok Sim ◽  
Byung Seop Shin ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Infusion Therapy ◽  
Open Label ◽  
Ketamine Infusion ◽  
Uncontrolled Study ◽  
Korean Patients ◽  
Analgesic Effects

scholarly journals Incidence and risk factors of transfusion reactions in postpartum blood transfusions

2019 ◽  
Vol 3 (15) ◽  
pp. 2298-2306 ◽  
Author(s):  
Lars Thurn ◽  
Agneta Wikman ◽  
Magnus Westgren ◽  
Pelle G. Lindqvist
Keyword(s):  
Blood Transfusion ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Adverse Reactions ◽  
Study Cohort ◽  
Blood Transfusions ◽  
Birth Registry ◽  
High Resource ◽  
Increased Risk ◽  
Transfusion Reactions

Abstract Postpartum hemorrhages with blood transfusions are increasing in many high-resource countries. Currently, up to 3% of all women receive blood transfusion postpartum. Most blood transfusions are safe and, in many cases, are lifesaving, but there are significant concerns about adverse reactions. Pregnancy is associated with higher levels of leukocyte antibodies and has a modulating effect on the immune system. Our objective was to investigate whether blood transfusions postpartum are accompanied by an increased risk for transfusion reactions (TRs) compared with transfusions given to nonpregnant women. We included all women who gave birth in Stockholm County, Sweden between 1990 and 2011. Data from the Swedish National Birth Registry were linked to the Stockholm Transfusion Database and included information on blood components administered and whether a TR occurred in women who received blood transfusions postpartum. Background controls were nonpregnant women who received blood transfusions during the study period. The study cohort consisted of 517 854 women. Of these, 12 183 (2.4%) received a blood transfusion. We identified 96 events involving a TR postpartum, giving a prevalence of 79 per 10 000 compared with 40 per 10 000 among nonpregnant women (odds ratio, 2.0; 95% confidence interval, 1.6-2.5). Preeclampsia was the single most important risk factor for TRs (odds ratio, 2.1; 95% confidence interval, 1.7-2.6). We conclude that special care should be taken when women with preeclampsia are considered for blood transfusion postpartum, because our findings indicate that pregnancy is associated with an increased risk for TRs.

scholarly journals The FLUENT study design: investigating immune cell subset and neurofilament changes in patients with relapsing multiple sclerosis treated with fingolimod

2019 ◽  
Vol 5 (1) ◽  
pp. 205521731881924 ◽  
Author(s):  
Jeffrey A Cohen ◽  
Amit Bar-Or ◽  
Bruce A C Cree ◽  
Yang Mao-Draayer ◽  
May H Han ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Immune System ◽  
Immune Cell ◽  
Cell Subset ◽  
Adaptive Immune System ◽  
Study Cohort ◽  
Open Label ◽  
Receptor Modulator ◽  
Circulating Lymphocytes ◽  
B Cell Subsets

Background Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of patients with relapsing forms of multiple sclerosis (RMS). Fingolimod sequesters lymphocytes within lymphoid tissue thereby reducing the counts of circulating lymphocytes. However, fingolimod’s effects on the innate and adaptive components of the immune system are incompletely understood. Objective The FLUENT study will investigate temporal changes in circulating immune cell subsets in patients with RMS treated with fingolimod. Secondary objectives include examining the association between anti-John Cunningham virus (JCV) antibody status/index and phenotypic changes in innate and T and B cell subsets in patients on fingolimod therapy, and the association between serum neurofilament levels and clinical outcomes. Methods FLUENT is a prospective, multicenter, two-cohort, nonrandomized, open-label Phase IV study. Cohort 1 will include fingolimod-naïve patients and Cohort 2 will include patients who have received fingolimod 0.5 mg/day continuously for ≥2 years. Changes in the cellular components of the innate and adaptive immune system will be characterized over 12 months. Results The study is ongoing. Conclusion FLUENT may provide evidence for the use of immunologic profiling in predicting efficacy and risk of infection in patients with RMS treated with fingolimod.

Long-term safety, tolerability, and efficacy of OROS® hydromorphone in patients with chronic pain

2018 ◽  
Vol 5 (2) ◽  
pp. 97 ◽  
Author(s):  
Mark Wallace, MD ◽  
Dwight E. Moulin, MD ◽  
Richard L. Rauck, MD ◽  
Sarita Khanna, PhD ◽  
Iulia Cristina Tudor, PhD ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Plasma Concentrations ◽  
Brief Pain Inventory ◽  
The United States ◽  
Short Term ◽  
Open Label ◽  
Safety And Efficacy ◽  
Analgesic Effects ◽  
N 93

Objective: To assess the safety and efficacy of long-term repeated dosing of OROS® hydromorphone in chronic pain patients.Design: This multicenter, open-label extension trial enrolled patients from three short-term OROS® hydromorphone trials.Setting: Fifty-six centers in the United States and Canada.Patients: Adults with chronic cancer pain or chronic nonmalignant pain who were receiving stable doses of OROS® hydromorphone (≥8 mg/day). Three hundred and eighty-eight patients were enrolled, 106 patients completed at least 12 months of therapy.Interventions: OROS® hydromorphone (individualized doses) was administered once daily.Main outcome measures: Safety and efficacy (Brief Pain Inventory and patient and investigator global evaluations) were assessed at monthly visits.Results: The median duration of extended OROS® hydromorphone therapy was 274 days. The median daily dose of study medication was 32.0 mg at extension-study baseline, 40.0 mg at month 3, and 48.0 mg at months 6, 9, and 12, respectively. The most frequently reported adverse events were nausea (n = 93, 24.0 percent) and constipation (n = 75, 19.3 percent). The analgesic effects of OROS® hydromorphone, assessed using the Brief Pain Inventory, were maintained throughout the extension. At 12 months, 72.4 percent of patients and 75.9 percent of investigators rated overall treatment as good, very good, or excellent.Conclusions: Once-daily OROS® hydromorphone is an osmotically driven, controlled-release preparation that may be particularly well suited to long-term use, because it provides consistent plasma concentrations and sustained around-the-clock analgesia. In this study, the benefits of OROS® hydromorphone attained in short-term studies were maintained in the long-term when daily administration was continued.

Value of FGFR2 expression for advanced gastric cancer patients receiving pazopanib plus CapeOX (capecitabine and oxaliplatin).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 65-65
Author(s):  
Seung Kim ◽  
Young-Woong Won ◽  
Jung Hoon Kim ◽  
Joon Ho Park
Keyword(s):  
Gastric Cancer ◽  
Treatment Outcomes ◽  
Advanced Gastric Cancer ◽  
Complete Response ◽  
Open Label ◽  
Prognostic Analysis ◽  
Tumor Tissues ◽  
Significant Difference ◽  
Open Label Phase ◽  
Gastric Cancer Patients

65 Background: The aim of this study was to use immunohistochemistry (IHC) to determine the effect of FGFR2 and VEGFR2 expression on treatment outcomes for patients with metastatic or recurrent advanced gastric cancer (AGC) receiving a combination of pazopanib with CapeOx (capecitabine and oxaliplatin). Methods: We conducted a single-arm, open-label phase II study to determine the efficacy and toxicity of the combination of pazopanib with CapeOx in 66 patients with metastatic or recurrent AGC (ClinicalTrials.gov NCT01130805). IHC analysis of FGFR2 and VEGFR2 was possible in 54 patients (81.8%). Results: Among 54 patients, the median age was 51.5 years (range, 23–72 years). Most patients were men (59.3%). Seven patients (13.5%) had tumor tissues that expressed FGFR2 by IHC. No patients had tumors that expressed VEGFR2. Among 7 patients with tumors with FGFR2 expression, 6 achieved partial response (PR) with a 85.7% response rate and one patient with stable disease. Among 47 patients with tumors without FGFR2 expression, one had complete response and 27 had PR (59.5%). A significant difference in PFS was seen between patients who were positive and negative for FGFR2 using IHC (8.5 vs. 5.6 months, p = 0.050). By prognostic analysis for PFS, only FGFR2 status by IHC (positive vs. negative) had significant prognostic value for predicting PFS. Conclusions: FGFR2 expression by IHC might be a useful biomarker for predicting treatment outcomes of patients with metastatic or recurrent AGC treated with a combination of pazopanib and CapeOx.

scholarly journals Collaborative Care Management Associated With Improved Depression Outcomes in Patients With Personality Disorders, Compared to Usual Primary Care

2018 ◽  
Vol 9 ◽  
pp. 215013271877326 ◽  
Author(s):  
Jeremy J. Solberg ◽  
Mark E. Deyo-Svendsen ◽  
Kelsey R. Nylander ◽  
Elliot J. Bruhl ◽  
Dagoberto Heredia ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Clinical Outcomes ◽  
Collaborative Care ◽  
Care Management ◽  
Term Treatment ◽  
Study Cohort ◽  
Long Term Treatment ◽  
Patient Health ◽  
Short And Long Term

Background: The use of a collaborative care management (CCM) model can dramatically improve short- and long-term treatment outcomes for patients with major depressive disorder (MDD). Patients with comorbid personality disorder (PD) may experience poorer treatment outcomes for MDD. Our study seeks to examine the differences in MDD treatment outcomes for patients with comorbid PD when using a CCM approach rather than usual care (UC). Methods: In our retrospective cohort study, we reviewed the records of 9614 adult patients enrolled in our depression registry with the clinical diagnosis MDD and the diagnosis of PD (Yes/No). Clinical outcomes for depression were measured with Patient Health Questionnaire–9 (PHQ-9) scores at 6 months. Results: In our study cohort, 59.4% of patients (7.1% of which had comorbid PD) were treated with CCM, as compared with 40.6% (6.8% with PD) treated with UC. We found that the presence of a PD adversely affected clinical outcomes of remission within both groups, however, at 6 months patients with PD had significantly lower MDD remission rates when treated with UC as compared with those treated with CCM (11.5% vs 25.2%, P = .002). Patients with PD in the UC group were also noted to have an increased rate of persistent depressive symptoms (PHQ-9 score ≥10) at 6 months as compared with those in the CCM group (67.7% vs 51.7%, P = .004). Conclusions: In patients with comorbid MDD and PD, clinical outcomes at 6 months were significantly improved when treated with CCM compared with UC. This finding is encouraging and supports the idea that CCM is an effective model for caring for patients with behavioral concerns, and it may be of even greater benefit for those patients being treated for comorbid behavioral health conditions.

scholarly journals A Prospective Evaluation of Adverse Reactions to Single-Dose Intravenous Antibiotic Prophylaxis During Outpatient Hand Surgery

Hand ◽  
2018 ◽  
Vol 15 (1) ◽  
pp. 41-44 ◽  
Author(s):  
Kristin Sandrowski ◽  
David Edelman ◽  
Michael Rivlin ◽  
Christopher Jones ◽  
Mark Wang ◽  
...  
Keyword(s):  
Adverse Reaction ◽  
Single Dose ◽  
Antibiotic Prophylaxis ◽  
Upper Extremity ◽  
Adverse Reactions ◽  
Prophylactic Antibiotic ◽  
Hand Surgery ◽  
Outpatient Setting ◽  
Study Cohort ◽  
Antibiotic Administration

Background: While it is established that routine prophylactic antibiotics are not needed for all hand surgery, some cases do require it. The purpose of this study was to determine the rate of adverse reactions resulting from prophylactic antibiotic administration on patients undergoing outpatient hand and upper extremity surgical procedures. We hypothesize that the rate of complications resulting from the use of antibiotic prophylaxis is smaller than that reported in the currently referenced literature. Methods: We prospectively evaluated 570 consecutive patients undergoing outpatient upper extremity surgery. Patients were excluded if they were on antibiotics prior to surgery, were discharged on antibiotics, or if they wished to be excluded. Nineteen patients were excluded, resulting in a study cohort of 551 patients. Patients were monitored perioperatively, 2 to 3 days postoperatively, during the first postoperative visit and 1 month postoperatively for adverse reactions. The type and timing of the adverse reaction was recorded. Results: Five hundred fifty-one patients were included for evaluation and 8 patients (1.5%) developed an adverse reaction to antibiotics. Five patients (0.9%) reported a rash and 3 patients (0.5%) reported diarrhea within 3 days of surgery. There were no anaphylactic reactions or complications necessitating hospital transfer or admission in the postoperative period. Conclusion: This study represents a prospective investigation designed to determine the rate of adverse reactions to single-dose antibiotics given during outpatient hand surgery. We conclude that the use of intravenous, single-dose prophylactic antibiotic is safe in the outpatient setting for cases that require it.

scholarly journals Profile, Outcomes, and Determinants of Unsuccessful Tuberculosis Treatment Outcomes among HIV-Infected Tuberculosis Patients in a Nigerian State

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Daniel Chukwunweolu Oshi ◽  
Sarah Nakalema Oshi ◽  
Isaac Alobu ◽  
Kingsley Nnanna Ukwaja
Keyword(s):  
Treatment Outcomes ◽  
Rural Areas ◽  
Multivariable Logistic Regression Analysis ◽  
Public Facility ◽  
Hiv Patients ◽  
Tuberculosis Patients ◽  
Treatment Services ◽  
Hiv Coinfection ◽  
Unsuccessful Treatment ◽  
Cohort Study Design

Background. Few studies have evaluated the rate of tuberculosis (TB)/human immunodeficiency virus (HIV) coinfection and the determinants of its treatment outcomes in Africa. We aimed to determine the predictors of unsuccessful treatment outcomes in HIV-infected tuberculosis patients in Nigeria.Methods. A retrospective cohort study design was used to assess adult TB/HIV patients who registered for TB treatment in two health facilities in Ebonyi State, Southeast Nigeria, between January 2011 and December 2012. Predictors of unsuccessful treatment outcomes were determined using multivariable logistic regression analysis.Results. Of 1668 TB patients, 342 (20.5%) were HIV coinfected. Of these, 195 (57%) had smear-negative pulmonary TB and 11 (3.2%) had extrapulmonary TB. Overall, 225 (65.8%) patients achieved successful outcomes, while 117 (34.2%) had unsuccessful outcomes. The unsuccessful treatment outcomes were due to “default” (9.9%), “death” (19%), “treatment failure” (1.5%), and “transferring out” (3.8%). Independent determinants for unsuccessful outcomes were receiving care at a public facility and noninitiation of antiretroviral therapy.Conclusion. There is need for the reevaluation of the quality of public sector treatment services provided for TB/HIV patients as well as further expansion of TB/HIV collaborative activities in rural areas, and interventions to reduce mortality and default rates among TB/HIV patients are urgently needed in Nigeria.

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