• 제목/요약/키워드: Adverse events

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Effects of applying nerve blocks to prevent postherpetic neuralgia in patients with acute herpes zoster: a systematic review and meta-analysis

  • Kim, Hyun Jung;Ahn, Hyeong Sik;Lee, Jae Young;Choi, Seong Soo;Cheong, Yu Seon;Kwon, Koo;Yoon, Syn Hae;Leem, Jeong Gill
    • The Korean Journal of Pain
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    • 제30권1호
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    • pp.3-17
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    • 2017
  • Background: Postherpetic neuralgia (PHN) is a common and painful complication of acute herpes zoster. In some cases, it is refractory to medical treatment. Preventing its occurrence is an important issue. We hypothesized that applying nerve blocks during the acute phase of herpes zoster could reduce PHN incidence by attenuating central sensitization and minimizing nerve damage and the anti-inflammatory effects of local anesthetics and steroids. Methods: This systematic review and meta-analysis evaluates the efficacy of using nerve blocks to prevent PHN. We searched the MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov and KoreaMed databases without language restrictions on April, 30 2014. We included all randomized controlled trials performed within 3 weeks after the onset of herpes zoster in order to compare nerve blocks vs active placebo and standard therapy. Results: Nine trials were included in this systematic review and meta-analysis. Nerve blocks reduced the duration of herpes zoster-related pain and PHN incidence of at 3, 6, and 12 months after final intervention. Stellate ganglion block and single epidural injection did not achieve positive outcomes, but administering paravertebral blockage and continuous/repeated epidural blocks reduced PHN incidence at 3 months. None of the included trials reported clinically meaningful serious adverse events. Conclusions: Applying nerve blocks during the acute phase of the herpes zoster shortens the duration of zoster-related pain, and somatic blocks (including paravertebral and repeated/continuous epidural blocks) are recommended to prevent PHN. In future studies, consensus-based PHN definitions, clinical cutoff points that define successful treatment outcomes and standardized outcome-assessment tools will be needed.

만성 피로증후군과 특발성 만성 피로에 대한 침 치료 효과: 무작위 대조 예비 임상연구 (Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue: a Pilot Randomized Controlled Trial)

  • 김정은;강경원;김애란;김주희;김태훈;박효주;신미숙;이민희;이상훈;이승훈;정소영;정희정;홍권의;최선미
    • Journal of Acupuncture Research
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    • 제29권5호
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    • pp.109-118
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    • 2012
  • Objectives : The aim of this study was to evaluate the effectiveness and safety of acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : A randomized, controlled pilot trial was conducted. Twenty-four participants were randomized into one of the two groups: an acupuncture group(n=12) and wait-list group(n=12). The treatment group received 12 sessions of acupuncture over 4 weeks. Eight points($GV_{20}$; bilateral GB20, $BL_{11}$, $BL_{13}$, $BL_{15}$, $BL_{18}$, $BL_{20}$, and $BL_{23}$) were selected for needling. The control group did not receive acupuncture treatment during study period and follow-up were done in the $5^{th}$ and $9^{th}$ weeks after randomization in both groups. The primary outcome was fatigue severity scale(FSS) and the secondary outcomes included a short form of stress response inventory(SRI-short form), beck depression inventory(BDI), and insomnia severity index(ISI). Safety was assessed at every visit. Results : There were statistically significant differences in the between group values of FSS at $5^{th}$ weeks after randomization(p=0.0002), SRI-short form, BDI, and ISI at $5^{th}$, $9^{th}$ weeks after randomization(p<0.01). There were no adverse events. Conclusions : The results suggest that acupuncture is associated with benefits on the short-term outcomes in chronic fatigue syndrome and idiopathic chronic fatigue.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • 제23권6호
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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흉요추 압박 골절의 한의학적 치료에 대한 국내 임상 근거 : 체계적 문헌 고찰 (Korean Medicine for Thoracolumbar Compression Fracture in Korean Literature : a Systematic Review)

  • 배지민;김대훈;김재규;이병렬;양기영;김건형
    • Journal of Acupuncture Research
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    • 제32권4호
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    • pp.147-156
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    • 2015
  • Objectives : This study aims to evaluate the effectiveness and safety of Korean medicine for a thoracolumbar compression fracture. Methods : We searched six Korean databases (DBPIA, Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, National Digital Science Library, Research Information Sharing Service, KoreaMed) (up to June 2015) and the Journal of Korean Acupuncture and Moxibustion Society. Unpublished studies were also searched. Clinical research, other than case reports involving less than 10 patients, were eligible. The effectiveness and safety of Korean Medicine was analyzed. The 'Risk of Bias' was assessed using the 'Risk of Bias' assessment tool for non-randomized studies as well as the Cochrane Collaboration's 'Risk of Bias' tool. Results : We found 12 before-after studies (374 patients). There was no randomized trial. All studies combined at least three different types of Korean medicine treatments. The period of treatment varied between less a week and 154 days. All the included studies reported improvements in pain, functional disability related to lower back pain, global assessment, and benefits in the compression ratio of a fractured vertebrae and skin temperature measured by digital infrared thermal imaging in comparison with the baseline. However, all studies had a high risk of bias and three studies reported mild adverse events. Conclusions : There is no randomized trial for the role of Korean medicine for patients with a thoracolumbar compression fracture. The effectiveness and safety of Korean medicine for this population remains unclear. Findings in this review are seriously biased due to observational design and a high risk of bias included in the studies. Future high-quality randomized trials are warranted.

퇴행성 슬관절염에 대한 맞춤형 침 치료 효과 검증 무작위 대조군 임상연구(RCT) (ISRCTN 40706107) (Individualized Acupuncture versus Standardized Acupuncture in Symptomatic Treatment of Osteoarthritis of the Knee-a Randomized Controlled Trial (ISRCTN 40706107))

  • 변혁;김선웅;안지현;김용석;서정철;최선미;박지은;;;;이승덕
    • Journal of Acupuncture Research
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    • 제24권4호
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    • pp.183-195
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    • 2007
  • Objectives : To determine whether individualized acupuncture (IA) provides greater pain relief and improved function compared with standardized acupuncture (SA) in patients with osteoarthritis of the knee. Methods: Design is a randomized single blind controlled trial with two intervention arms (IA vs SA) of 6 weeks' duration and 3 months follow up. An orthopedist diagnosed 50 patients' symptoms as knee osteoarthritis. Interventions were applied by 2 residents studying the acupuncture and moxibustion specially in Dongguk University International Hospital. Primary outcome measure is pain as measured by visual analogue scale (VAS). Secondary measures of pain and disability include WOMAC, SF-36, LFI and KHAQ. Results : The 50 participants were well matched for age, sex, bad side, VAS, WOMAC, SF-36, LFI and KHAQ scores at the baseline. 3 participants dropped out. There have not been any adverse events in both groups. Participants in both groups experienced great improvement in all measures except SF-36at 3 and 6 weeks. At 18 weeks, the IA group experienced significantly greater improvement than the SA group in VAS but not in WOMAC, SF-36, LFI and KHAQ. Conclusions : Manipulation of IA seems to provide pain relief longer for osteoarthritis of the knee when compared with SA.

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Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • 제37권2호
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

비스테로이드소염제로 인한 궤양 합병증 예방을 위한 비스테로이드소염제 사용 현황 및 적절성 평가 (Evaluation of NSAID Usage and Appropriateness for Prevention of NSAID-Related Ulcer Complications)

  • 조정원;이은숙;신완균
    • 한국임상약학회지
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    • 제22권3호
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    • pp.211-219
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    • 2012
  • Nonsteroidal antiinflammatory drugs (NSAIDs) are used in the treatment of extensive diseases related to various symptoms; inflammation, pain and fever. NSAIDs work by blocking prostaglandin synthesis, but adverse drug events (ADEs) have been increasing dramatically such as gastrointestinal bleeding, perforation and stenosis, a kind of serious ADEs. Therefore, NSAID-related ulcer complication guidelines have been announced containing various risk factors and symptoms. Thus, this study aims to evaluate of NSAID usage and appropriateness for prevention of NSAID-related ulcer complication based on American journal of gastroenterology (AJG) guideline 2009. Further, the study suggests Korean guideline for prevention of NSAID-related ulcer compared to AJG guideline. For this study, data was collected through electronic medical record (EMR) at Seoul national university of Bundang hospital. The primary end point was a composite of NSAID-related ulcer risk factor, types of NSAIDs, co-prescribed NSAID ulcer prevention drugs and NSAID-related ulcer after taking NSAID. The risk factors include over 65 years, high dose NSAID, previous ulcer history and taking drugs (e.g. aspirin, anticoagulant and steroid) causing ulcer. If a patient has 3 or 4 factors, that patient was classified high risk group. And if 1 or 2 factors that patient was classified moderate risk group. The patient who has no risk factor was in low risk group. I studied 8,120 patients who received NSAID from 1 January 2009 to 31 December 2009. High risk group was 16(0.2%), moderate risk group was 4,364(53.7%), and low risk group was 3,740(46.1%). The results show that high risk group should be prescribed COX-2 inhibitors with ulcer prevention drugs, and moderate or low risk group need traditional NSAIDs with ulcer prevention drugs. This may be different with 2009 AJG guideline because AJG guideline suggested taking COX-2 inhibitor alone in moderate group or taking traditional NSAID alone in low risk group could get higher ulcer complication. The results indicated that choosing preventive drug is important in case that how many risk factors the patients have. The proper drugs would be helpful for safe and effective NSAID usage in each patient group.

수술후 급성 동통에 대한 Tramadol/Acetaminophen과 Codeine/Acetaminophen/Ibuprofen의 효과 발현시점과 진통효과의 비교 (COMPARISON OF TRAMADOL/ACETAMINOPHEN AND CODEINE/ACETAMINOPHEN/IBUPROFEN IN ONSET OF ANALGESIA AND ANALGESIC EFFICACY FOR POSTOPERATIVE ACUTE PAIN)

  • 정영수;김동기;김문기;김형준;차인호;한무영;이의웅
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제30권2호
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    • pp.143-149
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    • 2004
  • Background: Some clinical trials have reported that a new analgesic combination of tramadol and acetaminophen provides good efficacy in various pain models. For the more clinical uses of this agent, comparisons about the onset of analgesia and analgesic efficacy in the acute state of pain with the other drugs known as strong analgesics were needed. Purpose: The goal of this study was to compare the times to onset of analgesia and the other analgesic efficacy of 75 mg tramadol/650 mg acetaminophen and 20 mg codeine/500 mg acetaminophen/400 mg ibuprofen in the treatment of acute pain after oral surgery. Patients and Methods: Using a randomized, single-dose, parallel-group, single-center, and active-controlled test design, this clinical study compared the times to onset of analgesia using a two-stopwatch technique and the other analgesic efficacy of the single-dose tramadol/acetaminophen and codeine/acetaminophen/ibuprofen. These were assessed in 128 healthy subjects with pain from oral surgical procedures involving extraction of one or more impacted third molars requiring bone removal. From the time of pain development, the times to onset of perceptible and meaningful pain relief, pain intensity, pain relief, an overall assessment, and adverse events of the study medications were recorded for 6 hours. Results: The demographic distribution and baseline pain data in the two groups were statistically similar. The median times to onset of perceptible pain relief were 21.0 and 24.4 minutes in the tramadol/acetaminophen and codeine/acetaminophen/ibuprofen groups respectively and those to onset of meaningful pain relief were 56.4 and 57.3 minutes, which were statistically similar. The other efficacy variables such as mean total pain relief (TOTPAR) and the sum of pain intensity differences (SPID) were also similar in the early period after pain development and drug dosing. The safety of tramadol/acetaminophen was well tolerated and very comparable to that of codeine/acetaminophen/ibuprofen. Conclusions: In this acute dental pain model, the onset of analgesia and analgesic efficacy of tramadol/acetaminophen was comparable to that of codeine/acetaminophen/ibuprofen. These results showed that tramadol/acetaminophen was recommendable for fast and effective treatment in the management of postoperative acute pain.

Feasibility and Effects of a Postoperative Recovery Exercise Program Developed Specifically for Gastric Cancer Patients (PREP-GC) Undergoing Minimally Invasive Gastrectomy

  • Cho, In;Son, Younsun;Song, Sejong;Bae, Yoon Jung;Kim, Youn Nam;Kim, Hyoung-Il;Lee, Dae Taek;Hyung, Woo Jin
    • Journal of Gastric Cancer
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    • 제18권2호
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    • pp.118-133
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    • 2018
  • Purpose: Exercise intervention after surgery has been found to improve physical fitness and quality of life (QOL). The purpose of this study was to investigate the feasibility and effects of a postoperative recovery exercise program developed specifically for gastric cancer patients (PREP-GC) undergoing minimally invasive gastrectomy. Materials and Methods: Twenty-four patients treated surgically for early gastric cancer were enrolled in the PREP-GC. The exercise program comprised sessions of In-hospital Exercise (1 week), Home Exercise (1 week), and Fitness Improvement Exercise (8 weeks). Adherence and compliance to PREP-GC were evaluated. In addition, body composition, physical fitness, and QOL were assessed during the preoperative period, after the postoperative recovery (2 weeks after surgery), and upon completing the PREP-GC (10 weeks after surgery). Results: Of the 24 enrolled patients, 20 completed the study without any adverse events related to the PREP-GC. Adherence and compliance rates to the Fitness Improvement Exercise were 79.4% and 99.4%, respectively. Upon completing the PREP-GC, patients also exhibited restored cardiopulmonary function and muscular strength, with improved muscular endurance and flexibility (P<0.05). Compared to those in the preoperative period, no differences were found in symptom scale scores measured using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Quality of Life Questionnaire-Stomach Cancer-Specific Module (QLQ-STO22); however, higher scores for global health status and emotional functioning were observed after completing the PREP-GC (P<0.05). Conclusions: In gastric cancer patients undergoing minimally invasive gastrectomy, PREP-GC was found to be feasible and safe, with high adherence and compliance. Although randomized studies evaluating the benefits of exercise intervention during postoperative recovery are needed, surgeons should encourage patients to participate in systematic exercise intervention programs in the early postoperative period (Registered at the ClinicalTrials.gov, NCT01751880).

Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE)

  • Lee, Kwan-Ho;Lee, Kye-Young;Jeon, Young-June;Jung, Maan-Hong;Son, Choonhee;Lee, Min-Ki;Ryu, Jeong-Seon;Yang, Sei-Hoon;Lee, Jae-Cheol;Kim, Young-Chul;Kim, Sun-Young
    • Tuberculosis and Respiratory Diseases
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    • 제73권6호
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    • pp.303-311
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    • 2012
  • Background: This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC). Methods: In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor (EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker. These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics of modified intent-to-treat population. Results: A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004). In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence interval, 3.9~8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%). Conclusion: Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.