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The Journal of Maternal-fetal &... May 2022Episiotomy is associated with an increased risk of postpartum pain, bleeding, and dyspareunia. The hypothesis of this trial was that in women with singleton pregnancy,... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Episiotomy is associated with an increased risk of postpartum pain, bleeding, and dyspareunia. The hypothesis of this trial was that in women with singleton pregnancy, and spontaneous labor at term, use of calendula ointment would reduce pain after episiotomy.
METHODS
This was a single-center parallel group randomized trial of women with singleton pregnancies and spontaneous labor at term who were randomized to either use of calendula ointment (i.e. intervention group) or standard care (i.e. control group) after episiotomy. Eligible women were those with singleton gestations in spontaneous labor and vertex presentation at term. Women with premature rupture of membranes were excluded from the study. Women in the intervention group were recommended use of calendula ointment 4 h after the episiotomy and then every 8 h for 10 days. The primary outcome was the pain level. Pain level was self-reported and recorded using the verbal rating scale (VRS). The effect of the calendula ointment was quantified as mean difference (MD) with 95% confidence interval (CI).
RESULTS
During the study, 100 women agreed to take part in the study, underwent randomization, and were enrolled in this trial. Of the 100 randomized women, 50 were randomized to the calendula ointment group, and 50 to the control group. No women were excluded after randomization or lost to follow up.Women who received calendula ointment after episiotomy compared to standard care had a significantly lower pain level starting from day two and during all the follow-up. Calendula ointment also improve wound healing in terms of redness and edema.
CONCLUSIONS
Use of calendula ointment significantly reduce pain after episiotomy.
Topics: Calendula; Episiotomy; Female; Humans; Ointments; Pain; Pain Measurement; Perineum; Pregnancy
PubMed: 32460565
DOI: 10.1080/14767058.2020.1770219 -
Vaccine May 2023The American Academy of Pediatrics recommends birth doses of vitamin K, erythromycin ointment, and the hepatitis B vaccine, but the relationship between birth medication...
BACKGROUND
The American Academy of Pediatrics recommends birth doses of vitamin K, erythromycin ointment, and the hepatitis B vaccine, but the relationship between birth medication administration and childhood immunization compliance is understudied. The objective of this study is to evaluate rates of newborn medication administration, and risk factors for refusal in military beneficiaries and determine the relationship between medication refusal and under-immunization at 15 months.
METHODS
A retrospective chart review was completed for all term and late preterm infants born at Brooke Army Medical Center, San Antonio, TX, from January 1, 2016, to December 31, 2019. The electronic medical record was queried for birth medication administration, maternal age, active-duty status, rank, and birth order. Childhood immunization records were extracted for all patients who continued care at our facility. A patient was considered completely immunized if they had received at least 22 vaccines by 15 months: three doses of the hepatitis B vaccine [Pediarix], two doses of the rotavirus vaccine [Rotarix], four doses of the DTAP vaccine [Pediarix and Acel-Immune], three doses of Haemophilus influenza B vaccine [Pedvaxhib], four doses of pneumococcal [Prevnar 13], three doses of IPV [Pediarix], one dose of measles, mumps, and rubella [MMR], one dose of varicella [Varivax] and one dose of hepatitis A vaccine [Harvix].
RESULTS
Seven thousand one hundred and forty infants were included; 99.3% received vitamin K, 98.8% received erythromycin ointment, and 93.8% received the hepatitis B vaccine. Refusal of the erythromycin ointment and hepatitis B vaccine was associated with older maternal age and higher birth order. Childhood immunization records were available for 607 infants; 7.2% (n = 44) were under-immunized by 15 months, with no infants being non-immunized. Refusal of the hepatitis B vaccine (RR: 2.9 (CI 1.16-7.31)) only at birth was associated with a higher risk of being under-immunized.
CONCLUSIONS
Refusal of the hepatitis B vaccine in the nursery is associated with a risk of being under-immunized in childhood. Obstetric and pediatric providers should be aware of this association for appropriate family counseling.
Topics: Humans; Child; Infant, Newborn; United States; Hepatitis B Vaccines; Retrospective Studies; Military Personnel; Ointments; Infant, Premature; Immunization; Vaccination; Medication Adherence; Vitamin K; Immunization Schedule; Haemophilus Vaccines; Vaccines, Combined; Measles-Mumps-Rubella Vaccine
PubMed: 37005102
DOI: 10.1016/j.vaccine.2023.03.052 -
International Journal of Molecular... Oct 2023The administration of therapeutic drugs through dermal routes, such as creams and ointments, has emerged as an increasingly popular alternative to traditional delivery...
The administration of therapeutic drugs through dermal routes, such as creams and ointments, has emerged as an increasingly popular alternative to traditional delivery methods, such as tablets and injections. In the context of drug development, it is crucial to identify the optimal doses and delivery routes that ensure successful outcomes. Physiologically based pharmacokinetic (PBPK) models have been proposed to simulate drug delivery and optimize drug formulations, but the calibration of these models is challenging due to the multitude of variables involved and limited experimental data. One significant research gap that this article addresses is the need for more efficient and accurate methods for calibrating PBPK models for dermal drug delivery. This manuscript presents a novel approach and an integrated dermal drug delivery model to address this gap that leverages virtual in vitro release (IVRT) and permeation (IVPT) testing data to optimize mechanistic models. The proposed approach was demonstrated through a study involving Desoximetasone cream and ointment formulations, where the release kinetics and permeation profiles of Desoximetasone were determined experimentally, and a computational model was created to simulate the results. The experimental studies showed that, even though the cumulative permeation of Desoximetasone at the end of the permeation study was comparable, there was a significant difference seen in the lag time in the permeation of Desoximetasone between the cream and ointment. Additionally, there was a significant difference seen in the amount of Desoximetasone permeated through human cadaver skin at early time points when the cream and ointment were compared. The computational model was optimized and validated, suggesting that this approach has the potential to bridge the existing research gap by improving the accuracy and efficiency of drug development processes. The model results show a good fit between the experimental data and model predictions. During the model optimization process, it became evident that there was variability in both the permeability and the partition coefficient within the stratum corneum. This variability had a significant and noteworthy influence on the overall performance of the model, especially when it came to its capacity to differentiate between cream and ointment formulations. Leveraging virtual models significantly aids the comprehension of drug release and permeation, mitigating the demanding data requirements. The use of virtual IVRT and IVPT data can accelerate the calibration of PBPK models, streamline the selection of the appropriate doses, and optimize drug delivery. Moreover, this novel approach could potentially reduce the time and resources involved in drug development, thus making it more cost-effective and efficient.
Topics: Humans; Ointments; Desoximetasone; Skin; Skin Absorption; Computer Simulation; Administration, Cutaneous
PubMed: 37894801
DOI: 10.3390/ijms242015118 -
Biomedicine & Pharmacotherapy =... Jun 2022The phytochemical analysis of the investigated Immortelle essential oil revealed the presence of monoterpenes and sesquiterpenes as major components that might be...
The phytochemical analysis of the investigated Immortelle essential oil revealed the presence of monoterpenes and sesquiterpenes as major components that might be efficient as a wound healing potential agent. The present study aimed to develop an ointment based on the Immortelle essential oil and investigate its wound healing effects on excision wounds in diabetic rats. The topical formulated Immortelle ointment was subjected to pharmaco-technical characterization. Thirty-two diabetic rats with the induced excision wound were used to evaluate in vivo wound healing effects of ointment. The animals were randomly divided into four groups untreated or topically treated with either a 1% silver sulfadiazine, the ointment base, or Immortelle ointment. The response to the treatment was assessed by macroscopic, biochemical and histopathological analysis. The ointment, compatible with the skin remained stable for 6 months. Topical application of the Immortelle ointment showed the highest wound contraction with the highest content of hydroxyproline in comparison to the all examined groups. The Immortelle ointment showed significant wound contraction from day 7 to day 21 as compared to other groups. On the day 21, there was an average of 99.32% wound contraction in the Immortelle group, whereas the mean wound contraction in the negative control and ointment base group was 71.36% and 81.26% respectively. The histopathological results validated the potential wound healing effect of Immortelle ointment with evident post-excision scar maturation and increased collagen fibers density. Our findings revealed that the Immortelle ointment approach might serve as a promising and innovative tool for wound healing.
Topics: Animals; Diabetes Mellitus, Experimental; Oils, Volatile; Ointment Bases; Ointments; Rats; Skin; Wound Healing
PubMed: 35429742
DOI: 10.1016/j.biopha.2022.112941 -
The Annals of Pharmacotherapy Apr 2022Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new... (Review)
Review
OBJECTIVE
Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new topical treatment for AKs, recently approved by the Food and Drug Administration.
DATA SOURCES
The PubMed database was searched for articles published from 1960 to March 31, 2021, using the keywords and .
DATA EXTRACTION
Phase 2 and phase 3 clinical trials were reviewed.
DATA SYNTHESIS
In phase 2 clinical trials, 43% of patients treated with tirbanibulin experienced complete clearance by day 57 (43% [95% CI = 32, 54]). Across two phase 3 clinical trials (pooled data), complete (100%) clearance occurred in 49% of patients in tirbanibulin groups and in only 9% of the vehicle groups (difference, 41% points; 95% CI = 35 to 47; < 0.001). Although no comparative studies are available, tirbanibulin is applied for a shorter duration (5 days) compared with diclofenac 3% gel, fluorouracil 5% cream, and imiquimod 3.75% cream. Adverse events were mild and included pruritus, application site pain, and local skin reactions. Systemic adverse events such as necrosis and angioedema, observed with other AK treatments such as fluorouracil and imiquimod, were not observed with tirbanibulin, thus giving tirbanibulin a favorable safety profile.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Tirbanibulin effectively reduces AK burden and recurrence and has a favorable safety profile with mild adverse events. In comparison, imiquimod, 5-flourouracil, and diclofenac can result in necrosis, angioedema, and arthralgias.
CONCLUSION
With a favorable safety profile and short regimen, tirbanibulin is an efficacious treatment for clinicians to utilize in their treatment toolbox when treating AKs on the face and scalp.
Topics: Acetamides; Humans; Keratosis, Actinic; Morpholines; Ointments; Pyridines; Treatment Outcome; United States
PubMed: 34301153
DOI: 10.1177/10600280211031329 -
Immunotherapy Sep 2023Atopic dermatitis (AD, also called atopic eczema) is a skin disease that that can affect a person for a long time and causes red or flaky skin that can be itchy and... (Review)
Review
WHAT IS THIS SUMMARY ABOUT?
Atopic dermatitis (AD, also called atopic eczema) is a skin disease that that can affect a person for a long time and causes red or flaky skin that can be itchy and uncomfortable. Healthcare providers can prescribe medicated creams and ointments to reduce the visible signs and symptoms of AD, but these treatments are not always enough to keep it under control. A new medicine called abrocitinib is taken every day as a tablet. Abrocitinib works by slowing a part of the body's defense mechanism, called immune response, that is not functioning properly in AD. The clinical study described in this plain language summary, called JADE DARE, investigated how well and how safely 26 weeks of treatment with abrocitinib worked in adults with AD compared to an injected medicine, called dupilumab, that is also approved for AD.
WHAT WERE THE RESULTS?
The study showed that abrocitinib was more effective than dupilumab in providing itch relief after 2 weeks. In addition, people who were taking abrocitinib for 4 and 16 weeks experienced greater improvement in the visible skin signs of AD than people who were taking dupilumab. The number of people who had health complaints while taking abrocitinib was similar to the number of people who had health complaints while taking dupilumab. Most of these complaints were minor.
WHAT DO THE RESULTS MEAN?
Abrocitinib was more effective than dupilumab in quickly improving the signs and symptoms of moderate or severe AD in people who did not show improvement with prescribed medications like creams or ointments. NCT04345367 (ClinicalTrials.gov).
Topics: Adult; Humans; Dermatitis, Atopic; Ointments; Severity of Illness Index; Treatment Outcome; Clinical Studies as Topic
PubMed: 37254941
DOI: 10.2217/imt-2022-0306 -
European Archives of Paediatric... Apr 2022Oral Lichen Planus (OLP) is a chronic autoimmune mucocutaneous condition, the exact etiology of which is still unknown. It is known to occur chiefly in adults and has a... (Review)
Review
BACKGROUND
Oral Lichen Planus (OLP) is a chronic autoimmune mucocutaneous condition, the exact etiology of which is still unknown. It is known to occur chiefly in adults and has a reported prevalence of 0.5-2% in general population and < 2-3% of total in pediatric population. OLP is considered as Oral Potentially Malignant Disorder with a malignant transformation rate of 1-2% in adults. Its occurrence in children is a rare finding with few cases reported in the literature. As a result, it gets misdiagnosed by the general practitioner and hence, there is a need to consider OLP in differential diagnosis of white lesions of oral cavity even in children. Therefore, in this paper, we present six cases of childhood OLP along with their management and follow-up.
CASE SERIES
We present here six patients aged between 11 and 13 years who presented either as incidental finding or as symptomatic lesions and were diagnosed with OLP. Symptomatic patients were treated with topical steroid ointment and both the symptomatic and asymptomatic patients were followed-up. We have also presented literature review of childhood OLP reported in PubMed, Medline and google scholar from 1980 till December 2020.
CONCLUSION
OLP is unusual in children and is often left untreated due to low awareness among the patients. Can be often misdiagnosed and should be considered in differential diagnosis of any white lesion of oral cavity. Any such lesions must be correctly diagnosed in time to institute appropriate management and follow-up.
Topics: Adolescent; Adult; Cell Transformation, Neoplastic; Child; Humans; Lichen Planus, Oral; Mouth Neoplasms; Ointments
PubMed: 35094367
DOI: 10.1007/s40368-021-00690-7 -
PM & R : the Journal of Injury,... Dec 2023Autonomic dysreflexia (AD) is a frequent complication of spinal cord injury (SCI), though current clinical practice patterns for medication management of this condition...
BACKGROUND
Autonomic dysreflexia (AD) is a frequent complication of spinal cord injury (SCI), though current clinical practice patterns for medication management of this condition are unknown. Correspondingly, it is unclear if national differences in practice patterns exist.
OBJECTIVE
To determine trends in current pharmacologic management of AD throughout the Americas.
DESIGN
International survey of current physician practice patterns.
SETTING
Academic medical center.
PARTICIPANTS
Sixty physicians managing patients with SCI and prescribing medications to manage AD.
INTERVENTIONS
Not applicable.
MAIN OUTCOME MEASURES
Presence of a formal pharmacologic AD management protocol, first- and second-line medications, patient characteristics influencing pharmacologic management.
RESULTS
The majority of physicians (69%) had a formal AD management protocol for inpatient care, with nitroglycerin ointment (82%) being the most common first-line medication. Strong national differences existed regarding the use of nitroglycerin ointment, with 98% of U.S.-based physicians using this as first-line medication and 0% of physicians in Canada or Latin America using this due to recent lack of medication availability. Only 67% of physicians had a preferred second-line medication, with preferences split between hydralazine (48%) and nifedipine (28%). A systolic blood pressure threshold for pharmacologic management was used by 56% of physicians, wheres 26% considered neurological level of injury in decisions to use medications for AD. Heart rate was used by only 5% of physicians in their decision to manage AD with medications.
CONCLUSIONS
As of 2023, U.S.-based physicians caring for individuals with SCI largely have formal inpatient protocols in place for medication management of AD, with nearly all relying on nitroglycerin ointment as their first-line medication. In areas outside of the United States where nitroglycerin ointment is unavailable, pharmacologic practice patterns significantly differ.
Topics: Humans; Autonomic Dysreflexia; Nitroglycerin; Ointments; Spinal Cord Injuries; Blood Pressure
PubMed: 37545115
DOI: 10.1002/pmrj.13051 -
Journal of Natural Medicines Jan 2023Chemotherapy-induced oral mucositis (COM) is a common adverse effect of cancer chemotherapy. Several clinical studies reported that repetitive use of mouthwashes...
Chemotherapy-induced oral mucositis (COM) is a common adverse effect of cancer chemotherapy. Several clinical studies reported that repetitive use of mouthwashes containing 2.5-6.25% Hangeshashinto (HST), a Kampo formula, relieves COM, but the effect is insufficient. To solve this problem, we produced an oral ointment of 12% HST extract (considered quantitatively equivalent to 20% commercially available HST), which will increase the local concentrations of its active ingredients and prolong the contact time with COM. In this study, we evaluated the pharmaceutical properties (spreadability and stability) of HST oral ointment. In addition, its safety (oral mucosal irritation) and therapeutic effects on 5-fluorouracil-induced oral mucositis were evaluated in male Syrian hamsters. The HST ointment showed good spreadability and stability for more than 8 weeks at 4 °C. In the oral mucosal irritation test, topical application of HST ointment (0.2 g) three times per day for 14 days had no adverse effect on the oral mucosa of hamsters. In hamsters treated with 5-fluorouracil (60 mg/kg) twice, COM was induced by a submucosal injection of 5% acetic acid into the cheek pouch. When HST ointment (50 µg) was topically applied to the mucositis area once per day for 12 days, the area and macroscopic score of mucositis were significantly decreased, and the depth of the wound tended to be reduced compared with the lactose ointment-treated control animals. These findings suggest that HST oral ointment shows good properties in spreadability, stability, and safety, and elicits a therapeutic effect in an animal model of COM.
Topics: Cricetinae; Animals; Male; Mesocricetus; Fluorouracil; Mucositis; Ointments; Stomatitis
PubMed: 36002763
DOI: 10.1007/s11418-022-01645-y -
Liver Transplantation : Official... Dec 2020
Topics: Bile; Humans; Liver Diseases; Liver Transplantation; Microbiota; Ointments
PubMed: 33010103
DOI: 10.1002/lt.25908