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Global Health, Science and Practice Jun 2016Despite years of family planning effort in Nigeria, the modern contraceptive prevalence (mCPR) has reached only 10%. Yet a few recent seminal, well-executed programs...
Despite years of family planning effort in Nigeria, the modern contraceptive prevalence (mCPR) has reached only 10%. Yet a few recent seminal, well-executed programs have been outstandingly successful providing long-acting reversible contraceptives (LARCs)—both in the public and private sector, and in the North and South. Remarkably, the LARCs they provided were . Accordingly, we advocate markedly increased support for: (1) private-sector approaches such as social franchising, particularly in the South, (2) mobile outreach, and (3) support to public clinical facilities, including expanding access through community health extension workers (CHEWs), particularly in the North. Success will require system support, quality, and concerted engagement from a variety of partners including the Government of Nigeria. Without significant progress in Nigeria, the global FP2020 goal appears unattainable. Fortunately, leading with LARCs along with wide choice of other methods provides a clear avenue for success.
Topics: Drug Implants; Family Planning Services; Female; Health Services Accessibility; Humans; Long-Acting Reversible Contraception; Male; Nigeria; Quality of Health Care; Sex Education
PubMed: 27353612
DOI: 10.9745/GHSP-D-16-00135 -
Journal of Pharmaceutical Sciences Feb 2018The aim of this study was to formulate a biodegradable implant capable of imparting local antitumor activity through the sustained release of the chemotherapeutic agent,...
The aim of this study was to formulate a biodegradable implant capable of imparting local antitumor activity through the sustained release of the chemotherapeutic agent, 5-fluorouracil (5-FU). Thus, injectable pellets (<1.2 mm diameter) made from poly(lactide co-glycolide) (PLGA) and loaded with 5-FU at varying drug:polymer ratios were fabricated using hot-melt extrusion and tested for their ability to provide sustained release of 5-FU in in vitro and in vivo settings. In addition, these formulations were compared against soluble 5-FU for their antitumor activity in vivo as well as for their toxicity. It was demonstrated that the release rate of 5-FU from PLGA pellets was directly related to the percentage of 5-FU in the pellets. PLGA pellets loaded with 50% w/w 5-FU exhibited comparable, and significantly enhanced, antitumor activity (as measured by tumor volumes and survival) in vivo in a thymoma and colon cancer model, respectively, when compared to an equivalent bolus dose (120 mg/kg) of soluble 5-FU. We concluded that 5-FU-loaded PLGA pellets were more effective and specifically less erythrotoxic than 5-FU bolus injections and therefore may prove to be of benefit as an intraoperative adjunct therapy for patients with cancers that are sensitive to 5-FU and who are undergoing tumor resection.
Topics: Animals; Antimetabolites, Antineoplastic; Colonic Neoplasms; Delayed-Action Preparations; Drug Carriers; Drug Delivery Systems; Drug Implants; Female; Fluorouracil; Lactic Acid; Mice; Mice, Inbred BALB C; Mice, Inbred C57BL; Particle Size; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Thymoma
PubMed: 29031952
DOI: 10.1016/j.xphs.2017.10.005 -
BMJ Case Reports May 2015Nexplanon (Schering-Plough Limited/Merck Sharp & Dohme Limited (MSD)) is a long active reversible contraceptive method that provides effective contraception for...
Nexplanon (Schering-Plough Limited/Merck Sharp & Dohme Limited (MSD)) is a long active reversible contraceptive method that provides effective contraception for 3 years. It consists of a single, flexible, rod-shaped implant, containing 68 mg etonogestrel. It is 4 cm long, consists of an ethylene vinyl acetate copolymer, a non-absorbable material, and also contains 15 mg of barium sulfate, which makes it visible by X-ray. We describe a case of a 39-year-old woman who experienced a local reaction to the barium sulfate in Nexplanon. She was given medical treatment, but only the removal of the implant resolved the symptoms. After removal there was gradual improvement and 72 h later the patient was asymptomatic. Allergic reaction to barium sulfate is extremely rare: until now, there have only been two cases associated with Nexplanon described in the literature.
Topics: Adult; Barium Sulfate; Contraceptive Agents, Female; Desogestrel; Device Removal; Drug Eruptions; Drug Implants; Female; Humans; Treatment Outcome
PubMed: 25953577
DOI: 10.1136/bcr-2014-206256 -
Scientific Reports Mar 2022In this retrospective, multicenter study, we determined the predictive value of imaging biomarkers in diabetic macular edema (DME) outcomes following dexamethasone (DEX)...
In this retrospective, multicenter study, we determined the predictive value of imaging biomarkers in diabetic macular edema (DME) outcomes following dexamethasone (DEX) implant(s). Sixty-seven eyes of 47 patients' best-corrected visual acuity (BCVA) and central foveal thickness (CFT) on optical coherence tomography (OCT) before and after intravitreal DEX implants were evaluated. Baseline imaging biomarkers were graded using fundus photography and OCT, and the predictive value of biomarkers for significant treatment effects at six months was analyzed. Six months after 2.0 ± 0.8 (mean ± SD) DEX implants, 35 (52%) and 16 (24%) eyes had CFT reduction ≥ 10% from baseline and decreased to < 300 µm, respectively. BCVA improved ≥ 3 lines in 15 (22%) and remained stable in 38 (57%) eyes. At six months, eyes with severe intraretinal cyst (IRC), abundant hyperreflective dots (HRD), and moderate or severe hard exudate had a significantly higher chance of CFT reduction ≥ 10%. Eyes with abundant HRD at baseline and those underwent three DEX implants were more likely to achieve CFT < 300 µm. Eyes with DME and severe IRC, abundant HRD, or moderate-to-severe hard exudate at baseline were more likely to show a significant reduction in CFT six months after DEX implant.
Topics: Biomarkers; Dexamethasone; Diabetes Mellitus; Diabetic Retinopathy; Drug Implants; Glucocorticoids; Humans; Intravitreal Injections; Macular Edema; Retrospective Studies; Tomography, Optical Coherence; Treatment Outcome; Visual Acuity
PubMed: 35264625
DOI: 10.1038/s41598-022-07604-7 -
The Journal of Family Planning and... Jan 2016
Topics: Contraceptive Agents, Female; Device Removal; Drug Implants; Female; Humans; Intrauterine Devices, Medicated
PubMed: 26700454
DOI: 10.1136/jfprhc-2015-101306 -
Reproductive Health Jun 2020Higher than expected adolescent pregnancy high rates continue globally, with repeated unplanned pregnancy (UP) in this age group is a public health problem. In Brazil,...
BACKGROUND
Higher than expected adolescent pregnancy high rates continue globally, with repeated unplanned pregnancy (UP) in this age group is a public health problem. In Brazil, 16% of pregnancies occur in adolescents under 18 years old, with high maternal morbidity and mortality rates in this age group. Effective and safe contraception is required to reduce UP rates. The objective of our study is to evaluate acceptance of etonogestrel (ENG)-releasing subdermal contraceptive implant after childbirth, before discharge, as well as clinical performance up to one year after placement. Comparison between teenagers who opt for ENG-implant versus other contraceptive methods after childbirth will be also evaluated, specifically regarding UP, continuation and discontinuation rates and reasons, body composition, pelvic ultrasound characteristics and user satisfaction.
METHODS
A non-randomized open-label trial will be conducted with teenagers after childbirth and followed up to one year at the Women's Hospital, University of Campinas (UNICAMP), Campinas, Brazil. The study group will consist of patients who accepted to use ENG-implant and placed before discharge. The comparison group will include adolescents who choose to use other contraceptive methods at the first postpartum visit (42 ± 3 days after childbirth). All women will follow-up at 40-60 days postpartum, as well as, at 6 and 12 months post-enrollment. Patient satisfaction, contraceptive effectiveness, reasons of discontinuation, continuation rate and body composition will be evaluated. Transvaginal ultrasound and electric bio impedance tests will be performed at all follow-up appointments. A 5% significance level was assumed, as well as, a sampling error (absolute) for 10% prevalence. The sample size was calculated at n = 100, obtaining an estimate of 50 to 70 adolescents who would accept the method offered, according to the prevalence and sample error assumed.
DISCUSSION
Long-acting reversible contraceptive (LARC) methods include subdermal implants and intrauterine contraceptives, are considered first line contraception for teenagers. Immediate postpartum use is a safe option, which significantly reduces rates of repeated UP and all the undesirable consequences inherent to this process.
TRIAL REGISTRATION
This study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 92869018.5.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC): http://www.ensaiosclinicos.gov.br/rg/RBR-4z7bc6, (number 2.901.752).
Topics: Adolescent; Brazil; Contraception; Contraceptive Agents, Female; Desogestrel; Drug Implants; Female; Humans; Postnatal Care; Postpartum Period; Pregnancy
PubMed: 32576199
DOI: 10.1186/s12978-020-00952-5 -
Eye (London, England) Feb 2023We aimed to compare visual and anatomical outcome in vitrectomized and non-vitrectomized eyes treated with dexamethasone (DEX) implant due to diabetic macular oedema...
OBJECTIVE
We aimed to compare visual and anatomical outcome in vitrectomized and non-vitrectomized eyes treated with dexamethasone (DEX) implant due to diabetic macular oedema (DMO).
DESIGN
Multicenter, retrospective, interventional study.
PARTICIPANTS
236 eyes from 234 patients with DMO with or without previous vitrectomy performed with follow-up of 12 months.
METHODS
Records were reviewed for cases of DMO treated with DEX implant in vitrectomized and not vitrectomized eyes. Best corrected visual acuity (BCVA), central subfoveal thickness (CST), and intraocular pressure (IOP) were recorded at baseline and 12 months after treatment with DEX implants. Correlations between vitreous status and visual and anatomical outcome, as well as safety profile were analysed.
MAIN OUTCOME MEASURES
BCVA and CST over follow-up period.
SECONDARY OUTCOMES
cataract rate formation, intraocular pressure increase, number of implants needed.
RESULTS
The non-vitrectomized group included 130 eyes (55.1%), the vitrectomized group included 106 eyes (44.9%). The groups were well balanced for age and gender (p = 0.540, and p = 0.053, respectively). Both groups showed statistically significant improvement in BCVA and CST (for all groups: p < 0.001). There was no significant difference between the groups in terms of change in vision (p = 0.89) and anatomy (p = 0.65). The mean number of DEX implants given during follow-up was 3.5 in both groups, and there was no significant difference between the groups (p = 0.81).
CONCLUSION
We demonstrated similar anatomical and functional efficacy of DEX implant in non-vitrectomized and vitrectomized eyes. Its efficacy was not influenced by full vitrectomy for diabetic retinopathy complications. Safety profile was well balanced between groups.
Topics: Humans; Macular Edema; Glucocorticoids; Diabetic Retinopathy; Dexamethasone; Retrospective Studies; Drug Implants; Intravitreal Injections; Treatment Outcome
PubMed: 35043004
DOI: 10.1038/s41433-022-01931-9 -
The Journal of Family Planning and... Oct 2009
Topics: Contraceptive Agents, Female; Device Removal; Drug Implants; Female; Humans; Ultrasonography
PubMed: 19849930
DOI: 10.1783/147118909789587286 -
Journal of Controlled Release :... Oct 2016Orthopaedic implants have been the subject of intense research in recent years, with academics, clinicians and industrialists seeking to broaden our understanding of... (Review)
Review
Orthopaedic implants have been the subject of intense research in recent years, with academics, clinicians and industrialists seeking to broaden our understanding of their function and potential consequences within the human body. Current research is focussed on ways to improve the integration of an orthopaedic device within the body, whether it be to encourage better osseointegration, combat possible infection or stem the foreign body response. A key emerging strategy is the controlled delivery of therapeutics from the device, which may take the form of, for example, antibiotics, analgesics, anti-inflammatories or growth factors. However, the optimal device design that gives rise to the desired controlled release has yet to be defined. There are many examples in the literature of experimental approaches which attempt to tackle this issue. However, the necessity of having to conduct multiple experiments to test different scenarios is a major drawback of this approach. So enter stage left: mathematical modelling. Using a mathematical modelling approach can provide much more than experiments in isolation. For instance, a mathematical model can help identify key drug release mechanisms and uncover the rate limiting processes; allow for the estimation of values of the parameters controlling the system; quantify the effect of the interaction with the biological environment; and aid with the design of optimisation strategies for controlled drug release. In this paper we review current experimental approaches and some relevant mathematical models and suggest the future direction of such approaches in this field.
Topics: Animals; Delayed-Action Preparations; Drug Design; Drug Implants; Humans; Models, Theoretical; Orthopedic Procedures; Prostheses and Implants
PubMed: 27521893
DOI: 10.1016/j.jconrel.2016.08.009 -
Drugs Nov 2021To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
METHODS
This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).
RESULTS
Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2-7.4, 6.5-7.8, and 6.1-6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group.
CONCLUSIONS
The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. CLINICALTRIALS.
GOV IDENTIFIER
NCT02250651.
Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Dose-Response Relationship, Drug; Double-Blind Method; Drug Implants; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Timolol; Young Adult
PubMed: 34724172
DOI: 10.1007/s40265-021-01624-9