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Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia
Lynn R Webster, Margarita Nunez, Marvin D Tark, Edwin D Dunteman, Biao Lu, Jeffrey K Tobias, Geertrui F Vanhove
BMC Anesthesiology , 2011, DOI: 10.1186/1471-2253-11-25
Abstract: Twenty-four patients with PHN were pretreated with lidocaine 2.5%/prilocaine 2.5% cream for 60 minutes before receiving a single 60-minute application of NGX-4010. Tolerability was assessed by measuring patch application duration, the proportion of patients completing over 90% of the intended treatment duration, application site-related pain using the Numeric Pain Rating Scale (NPRS), and analgesic medication use to relieve such pain. Safety was assessed by monitoring adverse events (AEs) and dermal irritation using dermal assessment scores.The mean treatment duration of NGX-4010 was 60.2 minutes and all patients completed over 90% of the intended patch application duration. Pain during application was transient. A maximum mean change in NPRS score of +3.0 was observed at 55 minutes post-patch application; pain scores gradually declined to near pre-anesthetic levels (+0.71) within 85 minutes of patch removal. Half of the patients received analgesic medication on the day of treatment; by Day 7, no patients required medication. The most common AEs were application site-related pain, erythema, edema, and pruritus. All patients experienced mild dermal irritation 5 minutes after patch removal, which subsequently decreased; at Day 7, no irritation was evident. The maximum recorded dermal assessment score was 2.NGX-4010 was well tolerated following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with PHN. The tolerability of the patch application appeared comparable with that seen in other studies that used 4% lidocaine cream as the pretreatment anesthetic. This study is registered at http://www.clinicaltrials.gov webcite as number NCT00916942.Neuropathic pain is pain arising as a direct consequence of a lesion or disease affecting the somatosensory system [1]. Post-herpetic neuralgia (PHN) is a common type of neuropathic pain occurring as a complication of reactivation of the varicella zoster virus (shingles). PHN is caused by damage to the small-diamet
Applying collateral disease theory to treat chronic dermal ulcer
Hua-fa QUE
Zhong Xi Yi Jie He Xue Bao , 2008,
Abstract: Collateral disease theory has been applied to investigate the pathogenesis of chronic dermal ulcer in traditional Chinese medicine. It is suggested that deficiency of vital qi is the pathological basis of chronic dermal ulcer with collaterals stagnation as the major pathological factor, and collaterals impairment by toxin evil is the main pathological change. The important principle in treatment of chronic dermal ulcer is established as strengthening the body resistance, dredging collaterals and removing toxins, and this enriched the theory of wound healing in traditional Chinese medicine, and has practical value.
Posterior repair with perforated porcine dermal graft
Taylor, G. Bernard;Moore, Robert D.;Miklos, John R.;Mattox, T. Fleming;
International braz j urol , 2008, DOI: 10.1590/S1677-55382008000100012
Abstract: objective: to compare postoperative vaginal incision separation and healing in patients undergoing posterior repair with perforated porcine dermal grafts with those that received grafts without perforations. secondarily, the tensile properties of the perforated and non-perforated grafts were measured and compared. materials and methods: this was a non-randomized retrospective cohort analysis of women with stage ii or greater rectoceles who underwent posterior repair with perforated and non-perforated porcine dermal grafts (pelvicoltm cr bard covington, ga usa). the incidence of postoperative vaginal incision separation (dehiscence) was compared. a secondary analysis to assess graft tensile strength, suture pull out strength, and flexibility after perforation was performed using standard test method tm 0133 and astm bending and resistance protocols. results: seventeen percent of patients (21/127) who received grafts without perforations developed vaginal incision dehiscence compared to 7% (5/71) of patients who received perforated grafts (p = 0.078). four patients with vaginal incision dehiscence with non-perforated grafts required surgical revision to facilitate healing. neither tensile strength or suture pull out strength were significantly different between perforated and non-perforated grafts (p = 0.81, p = 0.29, respectively). there was no difference in the flexibility of the two grafts (p = 0.20). conclusion: perforated porcine dermal grafts retain their tensile properties and are associated with fewer vaginal incision dehiscences.
Biocompatibility of acellular dermal matrix graft evaluated in culture of murine macrophages
Vendramini, Ana Paula;Melo, Rafaela Fernanda;Marcantonio, Rosemary Adriana Chiérici;Carlos, Iracilda Zepone;
Journal of Applied Oral Science , 2006, DOI: 10.1590/S1678-77572006000200001
Abstract: the acellular dermal matrix allograft has been used as an alternative to autogenous palatal mucosal graft. the aim of this study was the evaluation of the biocompatibility of an acellular dermal matrix (alloderm?) in culture of macrophages. for hydrogen peroxidase determination we used the method of pick & kesari, and the griess method for nitric oxide determination,. statistical analysis showed no significant difference (p < 0,05) in the release of nitric oxide and hydrogen peroxide by the macrophages exposed to acellular dermal matrix and the negative control. the results suggest that acellular dermal matrix did not activate the cell inflammatory response.
Small intestinal submucosa for patch grafting after plaque incision in the treatment of Peyronie's disease
W. Lee, Eugene;Shindel, Alan W.;Brandes, Steven B.;
International braz j urol , 2008, DOI: 10.1590/S1677-55382008000200009
Abstract: objective: report the results using porcine small intestinal submucosa (sis) as a graft material in the surgical management of peyronie's disease (pd). materials and methods: we performed a retrospective chart review of men with pd who underwent surgical correction of the curvature by plaque “h” incision and patch grafting with 4-ply sis (cook, bloomington, in) by a single surgeon at our institution. degree and direction of curvature, sexual function, and co-morbidities were assessed pre- and postoperatively. results: thirteen patients were identified. mean age was 57 ± 8, range 42-70 years. median follow-up was 14 months, range 3-89 months. at presentation, all reported penile curvature. also reported were difficulty with vaginal penetration (determined by question number 2 of the sexual encounter profile questionnaire - sep2), palpable plaque, hourglass deformity, difficulty with firmness, and difficulty with sustaining erection (determined by sep3) in77%, 69%, 77%, 62%, and 46% of patients, respectively. mean and median degrees of curvature of the primary deformity were 71 and 67.5 degrees, respectively. three patients had secondary curves of less than 30 degrees in a different direction. mean and median plaque size were 3.5 and 2.7 cm2, respectively. seven patients had one graft and six patients had two grafts placed with a mean size of 15 ± 0 cm2. conclusions: for the patient with pd, sis grafting can achieve a functionally straight erection with durable results yet with relatively high rates of erectile dysfunction. sis is a viable graft material for use in the surgical treatment of pd.
Large defect of abdominal wall repair by dermal and sinthetic graft  [PDF]
Stojiljkovi? Danilo M.,Vi?nji? Milan M.,Trenki? Srbobran,Ran?i? Zoran S.
Acta Chirurgica Iugoslavica , 2003, DOI: 10.2298/aci0302019s
Abstract: Large defects of abdominal wall (greater than 8 cm in diameter) related to different cause, are still difficult problem of modern surgery. The best results in order to obtain safe and permanent anatomical and functional abdominal wall integrity are reached by autogenous dermal and synthetic grafts. Controversies concerning quality of these procedures are still presents. Our work is based on two equal experimental groups of 20 Vister rats each, with large artificial abdominal wall defects: one treated with autogenous dermal graft, another with synthetic Mersilene mesh graft. The animals from both groups were sacrificed in previous planned time intervals (3rd, 7th, 14th and 48th days). Afterwards detailed microscopic and gross examination of abdominal wall reparation and quality of reconstructed abdominal wall defects had been performed. According to our results both methods are easy to be performed and safety surgical procedures. Overestimated usage of synthetic grafts should be diminished because of advantages of autologous dermal graft - availability, substitution of firmly fibrosis tissue and endurance against infection.
Acellular dermal graft for repair of abdominal wall defects in rabbits  [cached]
A.K. Gangwar,A.K. Sharma,Naveen Kumar,N. Kumar
Journal of the South African Veterinary Association , 2012, DOI: 10.4102/jsava.v77i2.349
Abstract: Sixteen clinically healthy New Zealand white rabbits of either sex were divided into 2 equal groups (I and II) of 8 animals each. Under thiopental sodium (2.5 %) anaesthesia a 2 — 3 cm full-thickness abdominal wall defect in the mid-ventral abdominal wall was created and repaired with an acellular dermal graft (ADG) in all the animals of group I (test group). In animals of group II (control group) a full-thickness linear midline abdominal muscular wall incision was made and repaired with a continuous suture pattern using 2-0 nylon.
Cutaneous Chronic Graft-Versus-Host Disease Does Not Have the Abnormal Endothelial Phenotype or Vascular Rarefaction Characteristic of Systemic Sclerosis
Jo Nadine Fleming,Howard M. Shulman,Richard A. Nash,Pamela Y. Johnson,Thomas N. Wight,Allen Gown,Stephen M. Schwartz
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0006203
Abstract: The clinical and histologic appearance of fibrosis in cutaneous lesions in chronic graft-versus -host disease (c-GVHD) resembles the appearance of fibrosis in scleroderma (SSc). Recent studies identified distinctive structural changes in the superficial dermal microvasculature and matrix of SSc skin. We compared the dermal microvasculature in human c-GVHD to SSc to determine if c-GVHD is a suitable model for SSc.
Skin permeability and pharmacokinetics of diclofenac epolamine administered by dermal patch in Yorkshire-Landrace pigs  [cached]
Tse S,Powell KD,MacLennan SJ,Moorman AR
Journal of Pain Research , 2012,
Abstract: Susanna Tse,1 Kendall D Powell,2 Stephen MacLennan,3 Allan R Moorman,4 Craig Paterson,5 Rosonald R Bell11Pfizer Inc, Groton, CT, USA; 2Tandem Labs, Durham, NC, USA; 3BioCryst Pharmaceuticals Inc, Durham, NC, USA; 4Alta Vetta Pharmaceutical Consulting LLC, Durham, NC, USA; 5Salix Pharmaceuticals Inc, Raleigh, NC, USAPurpose: This study compared the pharmacokinetic profile, and systemic and local absorption of diclofenac, following dermal patch application and oral administration in Yorkshire- Landrace pigs.Patients and methods: Twelve anesthetized, female, Yorkshire-Landrace pigs were randomized to receive either the dermal patch (FLECTOR patch, 10 × 14 cm; Alpharma Pharmaceuticals, a subsidiary of Pfizer Inc, New York, NY) or 50 mg oral diclofenac (Voltaren ; Novartis, East Hanover, NJ). Tissue (skin area of 2 × 2 cm and underlying muscles approximately 2–3 cm in depth) and blood (10 mL) samples were collected at timed intervals up to 11.5 hours after initial patch application or oral administration. The concentrations of diclofenac in plasma, skin, and muscle samples were analyzed using validated ultra performance liquid chromatography tandem mass spectrometric methods.Results: Peak systemic exposure of diclofenac was very low by dermal application compared with oral administration (maximum concentration [Cmax] values of 3.5 vs 9640 ng/mL, respectively). Absorption of diclofenac into underlying muscles beneath the dermal patch was sustained, and followed apparently zero-order kinetics, with the skin serving as a depot with elevated concentrations of diclofenac. Concentrations of diclofenac in muscles beneath the patch application site were similar to corresponding tissues after oral administration (Cmax values of 879 and 1160 ng/mL, respectively). In contrast to the wide tissue distribution of diclofenac after oral administration, dermal patch application resulted in high concentrations of diclofenac only on the treated skin and immediate tissue underneath the patch. Low concentrations of diclofenac were observed in the skin and muscles collected from untreated areas contralateral to the site of dermal patch application.Conclusion: Dermal patch application resulted in low systemic absorption and high tissue penetration of diclofenac compared with oral administration.Keywords: NSAIDs, systemic absorption, topical patch, tissue distribution
Skin permeability and pharmacokinetics of diclofenac epolamine administered by dermal patch in Yorkshire-Landrace pigs
Tse S, Powell KD, MacLennan SJ, Moorman AR, Paterson C, Bell RR
Journal of Pain Research , 2012, DOI: http://dx.doi.org/10.2147/JPR.S35450
Abstract: in permeability and pharmacokinetics of diclofenac epolamine administered by dermal patch in Yorkshire-Landrace pigs Original Research (886) Total Article Views Authors: Tse S, Powell KD, MacLennan SJ, Moorman AR, Paterson C, Bell RR Published Date October 2012 Volume 2012:5 Pages 401 - 408 DOI: http://dx.doi.org/10.2147/JPR.S35450 Received: 28 June 2012 Accepted: 28 July 2012 Published: 23 October 2012 Susanna Tse,1 Kendall D Powell,2 Stephen MacLennan,3 Allan R Moorman,4 Craig Paterson,5 Rosonald R Bell1 1Pfizer Inc, Groton, CT, USA; 2Tandem Labs, Durham, NC, USA; 3BioCryst Pharmaceuticals Inc, Durham, NC, USA; 4Alta Vetta Pharmaceutical Consulting LLC, Durham, NC, USA; 5Salix Pharmaceuticals Inc, Raleigh, NC, USA Purpose: This study compared the pharmacokinetic profile, and systemic and local absorption of diclofenac, following dermal patch application and oral administration in Yorkshire- Landrace pigs. Patients and methods: Twelve anesthetized, female, Yorkshire-Landrace pigs were randomized to receive either the dermal patch (FLECTOR patch, 10 × 14 cm; Alpharma Pharmaceuticals, a subsidiary of Pfizer Inc, New York, NY) or 50 mg oral diclofenac (Voltaren ; Novartis, East Hanover, NJ). Tissue (skin area of 2 × 2 cm and underlying muscles approximately 2–3 cm in depth) and blood (10 mL) samples were collected at timed intervals up to 11.5 hours after initial patch application or oral administration. The concentrations of diclofenac in plasma, skin, and muscle samples were analyzed using validated ultra performance liquid chromatography tandem mass spectrometric methods. Results: Peak systemic exposure of diclofenac was very low by dermal application compared with oral administration (maximum concentration [Cmax] values of 3.5 vs 9640 ng/mL, respectively). Absorption of diclofenac into underlying muscles beneath the dermal patch was sustained, and followed apparently zero-order kinetics, with the skin serving as a depot with elevated concentrations of diclofenac. Concentrations of diclofenac in muscles beneath the patch application site were similar to corresponding tissues after oral administration (Cmax values of 879 and 1160 ng/mL, respectively). In contrast to the wide tissue distribution of diclofenac after oral administration, dermal patch application resulted in high concentrations of diclofenac only on the treated skin and immediate tissue underneath the patch. Low concentrations of diclofenac were observed in the skin and muscles collected from untreated areas contralateral to the site of dermal patch application. Conclusion: Dermal patch application resulted in low systemic absorption and high tissue penetration of diclofenac compared with oral administration.
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