• 대한임상독성학회지
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• 제11권1호
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• pp.49-52
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• 2013

Fentanyl, a synthetic, highly selective opioid ${\mu}$-receptor agonist, is 50 to 100 times more potent than morphine. The low molecular weight, high potency, great transdermal permeation rate and lipid solubility of fentanyl make it very suitable for transdermal administration. Durogesic is a novel matrix transdermal system providing continuous systemic delivery of fentanyl. In recently, there are many reports that misused or overused fentanyl transdermal patches result in severe intoxication of fentanyl. We present a case of fentanyl toxicity with misused durogesic transdermal patch and discuss the safe and appropriate application of the patches. In conclusion, fentanyl patches should be used in opioid tolerant patients and prescribed at the lowest possible dose and titrated upward as needed. All patients and their caregivers should be educated safe application of fentanyl patches and advised to avoid exposing the patches application site to direct external heat sources, such as heating pads, or electric blankets, heat lamps, sauna, hot tubs, and others. In addition, concomittant medications that affect fentanyl's metabolism should be avoided.

• The Korean Journal of Pain
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• 제13권1호
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• pp.60-66
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• 2000

Background: For terminal cancer pain management, controlled-release oral morphine (morphine sulfate tablet, MST) is a simple and convenient regimen. Recently, fentanyl transdermal therapeutic system (F-TTS, transdermal fentanyl) has been developed and became one of the alternative ways of providing adequate pain relief. This open prospective study was designed to compare the analgesic efficacy and safety of MST and transdermal fentanyl in the management of terminal cancer pain. Methods: In this open comparative and randomized study, 64 terminal cancer patients received one treatment for 15 days, controlled-release oral morphine (MST group) or fentanyl transdermal therapeutic system (F-TTS group). Daily diaries about the vital sign, visual analogue scale (VAS) for pain, opioids requirement, co-anagesics, adjuvant drugs and adverse effects were completed with 24 patients in MST group, 18 patients in F-TTS group. Results: The majority of patients in both treatment groups were late-stage cancer and their distribution was not different in both groups. Daily opioids requirement was 126.4 mg in MST uced in F-TTS group (P<0.05). The incidence of nausea, vomiting and constipation was lower in F-TTS group (P<0.05). Patients satisfaction was similar, but F-TTS patient group favored continous use of same treatment compared with MST group after the study was finished. Conclusions: Transdermal fentanyl seems to be safe and similar analgesic effect to controlled-release oral morphine for the control of the terminal cancer patients. However, transdermal fentanyl provides a simpler and more convenient especially in respect to constipation, nausea & vomiting. To determine the exact analgesic effect, cost-effectiveness and complications, controlled trials should be followed.

• Journal of Pharmaceutical Investigation
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• 제38권4호
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• pp.223-228
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• 2008

The purpose of this study was to investigate the feasibility of developing transdermal drug delivery system (TDDS) for fentanyl used for the management of chronic cancer pain. The effect of type of pressure sensitive adhesive on the permeation of fentanyl from polyisobutylene (PIB), silicone and acrylic adhesive was evaluated. Due to the good adhesive force and relatively steady flux for 3 days, both acrylic and PIB adhesives were chosen for further study. The permeation rate of fentanyl was the highest from acrylic adhesive with hydroxyl functional group. Permeation rate increased linearly as the concentration of fentanyl in acrylic adhesive was increased from 2.5% to 10%. In case of PIB adhesive, crystals of fentanyl were developed above 5% drug load. $Crovol^{(R)}$ A40, $Crovol^{(R)}$ PK40 and Plurol $oleique^{(R)}$ provided higher flux of fentanyl.

• Tuberculosis and Respiratory Diseases
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• 제62권2호
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• pp.140-143
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• 2007

심한 암통증을 호소하는 폐암 환자에서 고용량 펜타닐 첩포($600{\mu}g/hr$)를 이용하여 통증의 완화를 경험하였기에 이를 문헌고찰과 함께 보고하는 바이다.

• The Korean Journal of Pain
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• 제12권2호
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• pp.211-216
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• 1999

Background: Transdermal fentanyl patch (TDFP) is a simple, noninvasive analgesic with continuous effect. The aim of this study was to evaluate the postoperative analgesic effect of TDFP. Methods: Sixty healthy patients undergoing cesarean section were divided into 3 groups. Postoperative pain was controlled with different methods; Group I: application of TDFP-$25{\mu}g/hr$, Group II: intramuscular injection of ketoprofen; Group III: continuous epidural block. Pain scores (numerical rating scale, NRS), number of patients who needed additive ketoprofen injections and side effects were recorded at 8, 20, 32, 44 hours postoperatively. Results: There was no significanant difference in pain score between Group I and Group II. The numbers of patients who need additive ketoprofen injections were lower in group I than group II. Pruritis (25%), nausea/vomiting (10%), leg numbness (40%) was experienced in group III, but not in Group I & II. Conclusions: TDFP-$25{\mu}g/hr$ for postoperative pain control is simpler and more convinient than intramuscular injection of analgesics.

• 한국임상약학회지
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• 제28권2호
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• pp.81-87
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• 2018

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

• Tuberculosis and Respiratory Diseases
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• 제68권5호
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• pp.286-289
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• 2010

A 55-year old woman with advanced stage non-small cell lung cancer was admitted to hospital for the management of severe chest pain, which measured 7 out of 10 on a numerical rating scale (NRS). Despite palliative radiation and the application of multiple epidural blocks, she continued to experience severe cancer pain. We gradually increased the dose of transdermal fentanyl patches from $500{\mu}g/hr$ to $3,650{\mu}g/hr$, for 3 months without any significant side effects. Concomitantly, adjuvant therapy with antidepressants and anticonvulsants were added, decreasing the patient's pain to NRS 3~4 down from 7. After being transferred to a hospice clinic, her chest pain was well-controlled below NRS 4 by means of strong opioid medications, including the highest dose of transdermal fentanyl $4,050{\mu}g/hr$ for more than 16 months.

• 한국임상약학회지
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• 제6권2호
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• pp.24-27
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• 1996

In order to determine whether there was a clinically sufficient amount of drug remaining in used fentanyl patches, quantitative analysis of two different types of patches, each containing 2.5 mg (n=36) and 5 mg (n=20) was performed. After being used for approximately 72 hours by patients with cancer, each patch was put in the plastic bag and stored at $4^{\circ}C$ until analysis. Fentanyl remaining in patches was extracted with 50 ml methanol, diluted with water, and counted twice in a $\gamma-Counter$ (expressed as CPM). Patches that originally contained 2.5 mg and 5 mg of fentanyl were shown to have $0.48{\sim}1.86\;mg\;(mean:\;1.03\;mg,\;41.16\%)\;and\;0.37{\sim}3.95\;mg\;(mean:\;2.37\;mg,\;47.33\%)$ after use, respectively. A wide interpatient variability was observed in the rate of fentanyl release from patches although the application period was standardized to 72 hours. Since a significant amount of drug remained in the discarded patches, it is highly recommended that patients dispose used ones under supervision to prevent abuse or misuse of the narcotic drug.

• Radiation Oncology Journal
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• 제24권4호
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• pp.263-271
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• 2006

목 적: 방사선치료로 인해 발생하는 점막염, 식도염 등의 통증과 암성 통증을 가진 환자에 대한 듀로제식의 통증 완화 및 일상생활 개선 효과를 알아보고자 하였다. 대상 및 방법: 다기관 전향적 4상 임상시험으로 방사선치료로 인한 통증을 호소하거나(A군) 암성통증으로 방사선치료를 시행 받고 있는 환자(B군) 중에 진통제를 복용 중임에도 숫자등급평가(Numeric rating scale, NRS)가 4 이상 이거나 진통제 복용 없이 NRS가 6 이상인 환자를 대상으로 듀로제식 25 ug/hr을 처방한 후에 1주일과 2주일 후에 통증횟수와 강도변화, 통증이 일상생활에 미치는 영향평가, 피험자와 임상의 만족도 평가, 그리고 이상반응 평가를 시행하였다. 결 과: 2005년 3월 28일부터 6월 15일까지 26개 기관에서 총 312명의 피험자를 등록하였고 그 중 249명이 임상시험을 완료하였는데 A군은 185명, B군은 64명이였다. 평균 연령은 60세였고, 남자가 189명, 여자가 60명이였다. 2주 후 가장 심한 통증의 강도 변화를 보면 A군에서 6.9에서 3.9로 B군에서는 7.1에서 3.9로 통계적으로 유의하게(p=0.003) 감소하였고 일상생활의 미치는 영향을 보기 위한 수면방해 정도와 일상적인 일의 저하 그리고 삶의 질의 저하는 투여 2주 후에 모두 호전되었다. 연하통증의 변화는 A군에서만 유의하게 투여 후 호전되었으며 피험자의 만족도는 매우 만족이 A에서 47%, B군에서 41%로 좋았고 만족 이유는 진통효과 우수, 전반적 만족, 편리성 순이었다. 임상의 만족도는 매우만족이 50% 정도로 좋았다. 이상반응은 A군에서 40% B군에서 34%로 총 38%에서 나타났고 오심이 30%로 가장 많았고 소양증 16%, 어지러움 14%, 변비 10% 순이었다. 중대한 이상반응은 없었다. 결 론: 듀로제식의 통증완화 효과 일상생활 개선효과는 우수하였고 피험자와 임상의의 만족도도 좋았고 중대한 이상반응도 없었다.

• The Korean Journal of Pain
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• 제22권2호
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• pp.130-134
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• 2009

Background: The advances in surgical technology, anesthesia and perioperative care have made it possible to perform laparoscopic cholecystectomy on an outpatient basis. This study was conducted to assess the analgesic effect and the adverse events of different dosing methods when using transdermal fentanyl patches (TDFPs) after laparoscopic cholecystectomy. Methods: Sixty patients who were to undergo laparoscopic cholecystectomy under general anesthesia were divided into two groups. Group 1: 2 TDFPs that released $12{\mu}g/h$ were applied after the induction of anesthesia and these 2 patches were removed after 24 hours. Group 2: 2 TDFPs that released $12{\mu}g/h$ were applied after the induction of anesthesia and one patch was removed after 7 hours and the other patch was removed after 24 hours. The intensity of the postoperative pain was assessed by using a visual analogue scale (VAS) and assessing the adverse events, including dizziness, pruritus and nausea/vomiting, were recorded for 48 hours postoperatively. Results: The VAS score of postoperative pain was not significantly different between the two groups at all times. The incidence of dizziness in groups I and II was 10 and 3, respectively, and the incidence of nausea/vomiting in group I and II was 4 and 0, respectively. The incidences of dizziness and nausea/vomiting in group II were significantly lower than those of group I (P<0.05). Conclusions: A dosing method that removes half of the TDFPs ($24{\mu}g/h$) after 7 hours of application caused a lower incidence of dizziness and nausea/vomiting without any significant difference of postoperative analgesic efficacy, as compared to leaving on both the TDFPs (24$\mu$g/h) for 24 hours after laparoscopic cholecystectomy.