• Title/Summary/Keyword: Adverse events

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The Effect of Cheonmagudeung-eum for Hypertension: A Systematic Review and Meta-analysis (고혈압에 대한 천마구등음의 효과 : 체계적 문헌고찰과 메타분석)

  • Kang, Ki-wan;Kang, Ja-yeon;Jeong, Min-jeong;Kim, Hong-jun;Sun, Seung-ho;Jang, In-soo
    • The Journal of Internal Korean Medicine
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    • v.39 no.1
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    • pp.22-43
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    • 2018
  • Objective: The purpose of this study is to investigate the effect of Cheonmagudeung-eum (CGE) for essential hypertension by systematic review and meta-analysis. Methods: The period of literature search was until October 30, 2016, and 14 electronic databases were utilized as search engines. The evaluation for the risk of bias (RoB) was conducted by using the Cochrane Risk of Bias Tool. The meta-analysis was performed by synthesizing outcome data, including total effective rate (TER), systolic blood pressure (SBP), diastolic blood pressure (DBP), and the incidence of adverse events. Result: There were a total of 64 RCTs using CGE on adult essential hypertension. In the RoB evaluation, most of the items were unclear, and the qualities of studies were rated low. The concurrent treatment of CGE and antihypertensive drug (AHD) showed a significant hypotensive effect since the risk ratio (RR) of TER was 1.17 times (95% CI 1.14, 1.20, p<0.01) higher than that of AHD alone. In addition, the mean difference (MD) appeared low as 8.73 mm/Hg in SBP (95% CI -11.36, -6.09, p<0.01) and 5.81 mm/Hg in DBP (95% CI -7.50, -4.12, p<0.01). Conclusion: Through this study, it was identified that the combined treatment of CGE and AHD on hypertension would be more effective than that of AHD treatment alone. However, due to the low quality of the selected original articles, the significance of this conclusion is somewhat limited, and we hope that this would be complemented through more rigorous RCTs in the future.

A Case Report of Gaegyeolseogyeong-tang Treatment of a Female Patient with a Tension Type Headache (개결서경탕(開結舒經湯)을 투여한 긴장형 두통 여성 환자 치험례 1례)

  • Lee, Yu-ra;Oh, Ju-hyun;Kong, Geon-sik;Song, Jin-young;Park, Jin-hun;Kim, So-won;Kang, Man-ho;Lee, Hyung-chul;Eom, Gook-hyun;Song, Woo-sub;Lim, Su-yeon
    • The Journal of Internal Korean Medicine
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    • v.41 no.5
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    • pp.705-716
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    • 2020
  • Objective: Tension Type Headache is the most common primary headache, and the prevalence is highest among people in their thirties. The 2009 domestic headache epidemiological survey indicated a prevalence rate of 30.8% per year. The patients often complain of feeling "as if they are tightening their head or wearing a band." No other symptoms, such as nausea and vomiting, accompany the headache, and the physical and neurological findings are normal. Korean medicine treatment of tension type headache is mainly with acupuncture, not herbal medicine. In the present study, a patient with tension type headache was admitted to the Korean medicine hospital for treatment. We report on the patient's progress and the effects of the herbal treatment. Methods: The patient was treated with Gaegyeolseogyeong-tang, acupuncture, herbal acupuncture therapy, and physical therapy. We used the Korean Headache Impact Test-6 and Numeric Rating Scale to assess changes in tension type headache symptoms. Results: The patient was diagnosed with Qi-stagnation syndrome (氣滯證) and Ganyangsanghang-headache (肝陽上亢頭痛). The patient was hospitalized for 42 days and showed recovery from the tension type headache without any adverse events. Conclusion: Patients with tension type headache could be treated with Korean medicine.

Initial clinical outcomes of proton beam radiotherapy for hepatocellular carcinoma

  • Yu, Jeong Il;Yoo, Gyu Sang;Cho, Sungkoo;Jung, Sang Hoon;Han, Youngyih;Park, Seyjoon;Lee, Boram;Kang, Wonseok;Sinn, Dong Hyun;Paik, Yong-Han;Gwak, Geum-Youn;Choi, Moon Seok;Lee, Joon Hyeok;Koh, Kwang Cheol;Paik, Seung Woon;Park, Hee Chul
    • Radiation Oncology Journal
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    • v.36 no.1
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    • pp.25-34
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    • 2018
  • Purpose: This study aimed to evaluate the initial outcomes of proton beam therapy (PBT) for hepatocellular carcinoma (HCC) in terms of tumor response and safety. Materials and Methods: HCC patients who were not indicated for standard curative local modalities and who were treated with PBT at Samsung Medical Center from January 2016 to February 2017 were enrolled. Toxicity was scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Tumor response was evaluated using modified Response Evaluation Criteria in Solid Tumors (mRECIST). Results: A total of 101 HCC patients treated with PBT were included. Patients were treated with an equivalent dose of $62-92GyE_{10}$. Liver function status was not significantly affected after PBT. Greater than 80% of patients had Child-Pugh class A and albumin-bilirubin (ALBI) grade 1 up to 3-months after PBT. Of 78 patients followed for three months after PBT, infield complete and partial responses were achieved in 54 (69.2%) and 14 (17.9%) patients, respectively. Conclusion: PBT treatment of HCC patients showed a favorable infield complete response rate of 69.2% with acceptable acute toxicity. An additional follow-up study of these patients will be conducted.

Review of Clinical Studies on Oriental Medicine Treatment for Obesity in the Korean Literature (비만의 한방 치료에 대한 국내 임상 논문 고찰)

  • Moon, Su-Jeong;Kong, Jae-Cheol;Kwon, Young-Dal;Song, Yong-Sun;Han, A-Lum;Kwon, Young-Mi;Lee, Su-Kyung
    • Korean Journal of Oriental Medicine
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    • v.16 no.3
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    • pp.85-93
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    • 2010
  • The aim of this review is to investigate clinical studies on oriental medicine treatment for obesity in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Electric searches were performed with NDSL, National assembly library, RISS4U, DBPIA, KISS, KMBASE, KoreaMed, Korean traditional knowledge portal and Oasis. Also, 21 major journals associated with oriental medicine in Korea were searched manually. Eighty three studies were included and analyzed in terms of study design, subjects, interventions, results and evaluation of safety. The numbers of controlled, non-controlled and case studies are respectively 26(31%), 43(52%) and 14(17%). Studies using sample size less than 30 accounts for 49% and studies using subjects diagnosed as obese or overweight by specific criteria were 35(42%). Studies which used more than 2 interventions or co-interventions were 76%. Clinical studies which used single herbal medicine were few and clinically studied single herbal medicine were limited to ephedra. More than half of 83 studies were studied for 8 weeks and less. 12% of 69 studies(except case studies) were not statistically analyzed and studies which evaluated safety of intervention were 22(27%) and reported adverse events were 9(11%). To improve the quality of clinical studies on oriental medicine treatment for obesity, studies need to use restricted number of interventions and subjects need to specifically diagnosed as overweight or obese. In addition, various kinds of single herbs need to be clinically studied based on experimental studies and herbalogy.

Use of Information Component (IC) and Relative Risk (RR) for Signal Detection of Drug Interactions of Clopidogrel : Data-mining Study Using Health Insurance Review & Assessment Service (HIRA) Claims Database (정보 성분과 상대위험도를 이용한 clopidogrel의 약물상호작용 시그널 검색 : 건강보험데이터베이스를 대상으로 한 데이터마이닝 연구)

  • Kim, Jin-Hyung;Choi, Chung-Am;Oh, Jung-Mi;Son, Sung-Ho;Shin, Wan-Gyoon
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.2
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    • pp.90-99
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    • 2011
  • Health Insurance Review & Assessment Service (HIRA) claims database has a high potential to detect signals of new drug interactions. The aim of this study was to evaluate the usefulness of information component (IC) and relative risk (RR) as a tool for signal detection, and to analyze the possible drug interactions caused by clopidogrel using HIRA claims database. This study was performed in elderly patients over 65 years of age who administered clopidogrel from January 2005 to June 2006 in South Korea. Serious Adverse Events (SAEs) as drug interactions of clopidogrel were defined as any ambulatory hospitalization for ischemic diseases within comcomitant medication period of clopidogrel. Information Component (IC) and Relative Risk (RR) were calculated to compare the proportion of drug-SAE pairs in order to select drug specific SAEs. IC and RR signals of clopidogrel drug interaction were screened when IC's 95% confidence interval was greater than 0 and RR's 95% confidence interval was greater than 1 respectively. All detected signals were compared to references such as $Micromedex^{(R)}$ and 2010 Drug Interaction $Facts^{TM}$. Sensitivity, specificity, positive predicted value and negative predicted value were used to evaluate usefulness of this method. Among 13,252,930 cases of elderly patients who co-administered clopidogrel and other drugs, 47,485 cases were detected as SAE. Of these, one-hundred nine cases were detected by the IC-based data-mining approach and ninety one cases were detected by the RR-based data-mining approach. Total One-hundred sixty three unrecognized signals were detected by IC or RR. Twelve signals from IC-based data-mining (57.1%) were corresponded with drug interactions from references and eight signals from RR-based data-mining (38.1%) were corresponded with drug interactions from references. These signals include proton pump inhibitors, calcium channel blockers and HMG CoA reductase Inhibitors, which were known to affect CYP450 metabolism. Further studies using HIRA claims database are necessary to develop appropriate data-mining measure.

Eleven Year's Single Center Experience of Endovascular Treatment of Anterior Communicating Artery Aneurysms : Focused on Digital Subtraction Angiography Follow-Up Results

  • Hur, Chae Wook;Choi, Chang Hwa;Cha, Seung Heon;Lee, Tae Hong;Jeong, Hae Woong;Lee, Jae Il
    • Journal of Korean Neurosurgical Society
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    • v.58 no.3
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    • pp.184-191
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    • 2015
  • Objective : Anterior communicating artery (AcomA) aneurysms represent the most common intracranial aneurysms and challenging to treat due to complex vascularity. The purpose of this study was to report our experience of endovascular treatment of AcomA aneurysms. Methods : Between January 2003 and December 2013, we retrospectively reviewed the medical records of 134 AcomA aneurysm patients available more than 6 months conventional angiographic and clinical follow-up results. We focused on aneurismal or AcomA vascular characters, angiographic and clinical follow-up results, and retreatment. Results : The rate of ruptured cases was 75.4%, and the small (<10 mm) aneurysms were 96.3%. Based on the subtypes defined by dominance of A1, 79 patients (59%) had contralateral A1 hypoplasia or agenesis. The immediate post-procedural angiography confirmed complete occlusion in 75.4%, partial occlusion in 24.6%. Procedure related complications were observed in 25 (18.6%) patients. Most of the adverse events were asymptomatic. Follow-up conventional angiography at ${\geq}6$ months was performed in all patients (mean 16.3 months) and major recanalization was noted in 6.7% and regrowth in one case. The aneurysm size (p=0.016), and initial treatment results (p=0.00) were statistically significant risk factors related to aneurysm recurrence. An overall improvement in mRS was observed during the clinical follow-up period and no rebleeding episode occurred. Conclusion : This study demonstrated that endovascular treatment is an effective treatment modality for AcomA aneurysms with low morbidity. Patients should take long term clinical and angiographic follow-up in order to assess the recurrence and warrant retreatment, especially ruptured, large, and initially incomplete occluded aneurysms.

A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.29 no.1
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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A Mechanistic Study on the Early Stage-Events Involved in Low Temperature Stress in Clamydomonas reinhardtii (Clamydomonas reinhardtii의 냉해 초기과정에 관한 기작론적 연구)

  • Cho, Hyun-Soon;Kim, Chang-Sook;Jung, Jin
    • Applied Biological Chemistry
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    • v.37 no.6
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    • pp.433-440
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    • 1994
  • The exposure of Clamydomonas reinhardtii to low temperatures resulted in an accumulation of cellular pyruvate that dissipated when the chilled cells returned to ambient temperature. The dissipation of pyruvate accumulation was accompanied by an increase in the production level of superoxide radicals $(O_2^-)$ in cells. The formation of $O_2^-$ at an excessive level during the post-chilling period was apparently countered by a substantial activation of superoxide dismutase (SOD). All these results are similar to those observed previously in rice seedlings subjected to the cold-treatment, implicating that a common mechanism is probably underlying for the primary processes of chilling injury both in higher plants and in algae. It was also observed that the activation of Mn-containing SOD contributes the major share in the increase of SOD activity of whole algal cells. Because Mn-SOD is present only in mitochondria, the observation corroborates the concept that the $O_2^-$ scavenging enzyme would be induced to cope with the cold treatment-caused adverse situation in mitochondria where the toxic active oxygen is produced at rates far exceeding the normal rate.

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Comparisons of Effects of Biman-tang according to Administration Period in Childhood Obesity (비만환아에서 복약기간에 따른 비만탕의 치료효과 비교연구)

  • Lim, Youngkwern;Min, Seorim;Kim, Heeman;Hur, Kwang-Wook;Lee, Hoon;Lee, Jinsoo;Kim, Hocheol;Park, Jae-Woo;Park, Hi-Joon
    • The Journal of Pediatrics of Korean Medicine
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    • v.27 no.4
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    • pp.57-67
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    • 2013
  • Objectives The purpose of this study is to investigate the safety and effect of Biman-tang (BMT) on two different administration periods in the treatment of childhood overweight and obesity. Methods In retrospective study, 39 overweight and obese ($85^{th}$ percentile ${\leq}$ Body Mass Index (BMI)) children were treated with BMT from January 2006 to April 2013 at Korean Medical Clinic in Suwon, Korea. The primary outcomes were the changes in BMI and Obesity Index (OI) from baseline to the treatment groups. Secondary outcomes included the changes in height, weight and safety of the medicine. Comparisons of BMI, OI, height and weight between the short-period (SP) treatment group and the long-period (LP) treatment group were done by using ANCOVA. Results The change of the mean of BMI ($-0.5{\pm}0.6kg/m^2$ vs $-1.4{\pm}0.8kg/m^2$, respectively; p=0.003) and OI ($-3.6{\pm}3.9%$ vs $-9.7{\pm}4.7%$, respectively; p<0.001) showed significant reduction both in SP (n=16) and LP treatment group (n=23). The mean height showed no significant difference in both groups. The mean weight of LP treatment group showed significant reduction compared to SP treatment group ($-0.2{\pm}1.3kg$ vs $-1.6{\pm}1.6kg$, respectively; p=0.006). Most of the children were compliant to the medication and no serious adverse events were found in two groups. Conclusions These findings emphasize that BMT is effective in the treatment of childhood obesity and it requires at least 45 days of treatment for the best result.

Retrospective analysis of the financial break-even point for intrathecal morphine pump use in Korea

  • Kim, Eun Kyoung;Shin, Ji Yeon;Castaneda, Anyela Marcela;Lee, Seung Jae;Yoon, Hyun Kyu;Kim, Yong Chul;Moon, Jee Youn
    • The Korean Journal of Pain
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    • v.30 no.4
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    • pp.272-280
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    • 2017
  • Background: The high cost of intrathecal morphine pump (ITMP) implantation may be the main obstacle to its use. Since July 2014, the Korean national health insurance (NHI) program began paying 50% of the ITMP implantation cost in select refractory chronic pain patients. The aims of this study were to investigate the financial break-even point and patients' satisfaction in patients with ITMP treatment after the initiation of the NHI reimbursement. Methods: We collected data retrospectively or via direct phone calls to patients who underwent ITMP implantation at a single university-based tertiary hospital between July 2014 and May 2016. Pain severity, changes in the morphine equivalent daily dosage (MEDD), any adverse events, and patients' satisfaction were determined. We calculated the financial break-even point of ITMP implantation via investigating the patient's actual medical costs and insurance information. Results: During the studied period, 23 patients received ITMP implantation, and 20 patients were included in our study. Scores on an 11-point numeric rating scale (NRS) for pain were significantly reduced compared to the baseline value (P < 0.001). The MEDD before ITMP implantation was 0.59 [IQR: 0.55-0.82]. The total MEDD increased steadily to 0.77 [IQR: 0.53-1.08] at 1 year, which was 126% of the baseline (P < 0.001). More than a half (60%) responded that the ITMP therapy was somewhat satisfying. The financial break-even point was 28 months for ITMP treatment after the NHI reimbursement policy. Conclusions: ITMP provided effective chronic pain management with improved satisfaction and reasonable financial break-even point of 28 months with 50% financial coverage by NHI program.