Safety and effectiveness of a drug-loaded haemostatic sponge in chronic rhinosinusitis: a randomized, controlled, double-blind study.

Some cases of chronic rhinosinusitis (CRS) require surgical treatment and postoperative nasal packing, but bleeding and adhesion are common complications after nasal surgery. Biodegradable drug-loaded implants hold great therapeutic options for the treatment of CRS, but little data are available regarding the safety and efficacy of a novel drug-loaded haemostatic sponge (DLHS) in the sinus. The aim of this study was to investigate the safety and efficacy of DLHS in the sinus. We conducted a prospective, randomized, controlled, double-blind clinical trial. In this clinical trial, 49 patients were enrolled and randomly divided into 2 groups: group A (n = 25) had the DLHS containing 1 mg budesonide and 0.67 mg sodium hyaluronate placed into the sinus, and group B (n = 24) had the Nasopore placed after ESS. Endoscopic follow-up was performed for 12 weeks, and the findings were classified using the discharge, inflammation, polyps/oedema (DIP) endoscopic appearance scores. All patients completed questionnaires to evaluate their sinonasal symptoms by using the sinonasal outcome test-22 (SNOT-22) Chinese version and visual analogue scale (VAS). Serum cortisol concentration in group A was measured prior to surgery and at days 1, 3, 7, and 14 after nasal surgery. Comparing group A and group B, at 2 weeks, no significant differences were observed in either objective or subjective parameters. The mean value of VAS for rhinorrhoea and DIP for oedema and the mean value of nasal adhesion were significantly lower in Group A than in Group B at 6 and 12 weeks, but a significant difference did not occur in SNOT-22 and VAS for dysosmia between the two groups at 6 and 12 weeks. The mean serum cortisol concentrations in group A at the follow-up were within normal limits without remarkable fluctuations. This study demonstrates the safety and efficacy of a novel biodegradable DLHS with the possibility of being used in CRS patients, and this sponge may reduce inflammation and minimize adhesions via controlled local drug delivery without measurable systemic exposure.

ILUVIEN® technology in the treatment of center-involving diabetic macular edema: a review of the literature.

Diabetic macular edema (DME) is one of the major causes of blindness, caused primarily by hyperglycemia and results from multiple pathological processes mostly secondary to increased levels of VEGF and other inflammatory cytokines. DME management includes control of systemic risk factors together with laser photocoagulation, frequent intraocular injections of anti-VEGF agents and steroids implants. Recent adoption of novel alternative drug delivery options has led to the development of sustained release ocular implants with longer duration of action with less injection frequency. This article will review the pharmacology and clinical data in terms of efficacy, safety and benefits of the sustained release steroid implants in treatment of DME with special emphasis on the fluocinolone acetonide ILUVIEN® implant.

Clinical Observation of Acetic Acid Goserelin Sustained-release Implants in the Treatment of Ovary Endo-metrium Cyst Recurrence after Surgery / 中国药房

OBJECTIVE:To investigate therapeutic efficacy and safety of Acetic acid goserelin sustained-release implants (AGRI) in the treatment of ovary endometrium cyst (OEC) recurrence after laparoscopic enuleation of ovarian cyst. METHODS:Totally of 60 patients with OEC recurrence after laparoscopic enuleation of ovarian cyst in Zhangjiagang First People's Hospital dur-ing Jan. 2013-Jan. 2015 were divided into control group and observation group according to random number table,with 30 cases in each group. Both groups were given Mifepristone tablets orally 25 mg,qd. Control group was given Gestrinone capsules orally 2.5 mg,twice a week. Observation group was given AGRI subcutaneously 3.6 mg,once a month. Both groups were treated for consec-utive 6 months. Clinical efficacies of 2 groups were observed as well as the levels of serum follicle stimulating hormone(FSH),lu-teinizing hormone(LH)and estradiol(E2),VAS scores of dysmenorrheal and chronic pelvic pain before treatment,3,6 months af-ter treatment. The occurrence of ADR and the prognosis of 12-month follow-up were observed in 2 groups. RESULTS:Total re-sponse rate of observation group was 86.67%,which was significantly higher than 70.00%of control group,with statistical signifi-cance(P0.05);after 6 months of treatment,the levels of FSH,LH and E2 in 2 groups were decreased significantly,and the observation group was significantly lower than the control group,with statistical significance(P0.05). The recovery rate of men-struation in observation group was 86.67%,the rate of dominant follicle formation was 60.00% and pregnancy rate was 53.33%, which were significantly higher than 46.67%,46.67% and 33.33% of control group,with statistical significance(P<0.05). CON-CLUSIONS:AGRI shows significant therapeutic efficacy for OEC recurrence after laparoscopic enuleation of ovarian cyst,can ef-fectively relieve dysmenorrhea and chronic pelvic pain,increase the rate of pregnancy. There is still recurrent cases after drug with-drawal. The incidence of ADR is high,but the symptoms are mild.

Granuloma induced by sustained-release fluorouracil implants misdiagnosed as a hepatic tumor: A case report.

Sustained-release fluorouracil (FU) implants have been extensively used in peritoneal interstitial chemotherapy, and during surgery for gastrointestinal tumors, breast cancer and hepatic tumors. Currently, studies regarding the complications associated with sustained-release FU implants are rare. The present study describes the case of a 61-year-old male who presented with a space-occupying lesion of the left lobe of the liver six months after undergoing a radical total gastrectomy. Thus, laparoscopic exploration was performed to remove the tumor. Postoperative histological examination demonstrated that the lesion in the left lobe comprised of necrotic tissue with granulation tissue hyperplasia. Based on the surgical and postoperative histological findings, the mass was proposed to be due to a high concentration of local sustained-release FU implants. Furthermore, the drug was partially surrounded and had been insufficiently metabolized over a long time period, which was proposed to have caused necrosis, proliferation and fibrillation, and induced granuloma. In conclusion, local high concentrations of sustained-release FU implants may be associated with granuloma and this finding may enable improved management of sustained-release FU implants during surgery.

Clinical trials on corticosteroids for diabetic macular edema.

Diabetic macular edema (DME) is a common cause of visual impairment in diabetic patients. It is caused by an increase in the permeability of the perifoveal capillaries and a disruption of the blood retinal-barrier. The pathogenesis of DME is multifactorial. Several therapeutic modalities have been proposed for the treatment of DME. Corticosteroid treatments have emerged as an alternative therapy for persistent DME or refractory to conventional laser photocoagulation and other modalities, due to anti-inflammatory, anti-vascular endothelial growth factor and anti-proliferative effects. Many studies have demonstrated the beneficial therapeutic effect of corticosteroids with improvement to both retinal thickness and visual acuity in short-term on the treatment of DME. Peribulbar and intravitreal injections have been used to deliver steroids for DME with frequent injections due to the chronic and recurrent nature of the disease. Steroid-related side effects include elevated intraocular pressure, cataract, and injection related complications such as endophthalmitis, vitreous hemorrhage, and retinal detachment particularly with intravitreal steroid injections. In order to reduce the risks, complications and frequent dosing of intravitreal steroids, intravitreal implants have been developed recently to provide sustained release of corticosteroids and reduce repeated intravitreal injections for the management of DME.