• 제목/요약/키워드: Clinical Guideline

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Single Dose Toxicity Test of 'Mahwangyounpae-tang' Extract in Male ICR Mouse (마황윤폐탕(麻黃潤肺湯) 추출물의 수컷 ICR 마우스에서 경구 단회투여 독성 평가)

  • Jung, Woo-Sik;Cho, Dong-Hee;Seo, Yeong-Ho;Park, Mee-Yeon;Choi, Hae-Yun;Kim, Jong-Dae;Jeon, Kwi-Ok
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.2
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    • pp.442-448
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    • 2006
  • To obtain the 50% lethal dose (LD50), approximated lethal dose (ALD) and approximated target organs of 'Mahwangyounpae-tang' for further study like repeat dose toxicity, genotoxicity and reproductive toxicity, single dose toxicity was tested in male ICR mouse according to KFDA Guideline 1999-61 [KFDA, 1999] at a dosage level of 2,000, 1,000, 500, 250 and $125\;mg/kg/10m{\ell}$. In this study, mortalities, clinical signs, body weight changes and body weight gains, gross findings and weight of principal organs were detected during and/or after 14 days of single dosing. After 2 or 3 days of dosing, 1 or 2 animals in 2,000 and 1,000 mg/kg-dosing groups were died. Excitation and leaping response were observed as test article-treatment related clinical signs. These abnormal signs were restricted to 2,000 and 1,000 mg/kg-dosing groups and they were recovered to normal within 4 days after dosing in case of survivors. A significant decrease of body weight were observed in some periods of observation in 2,000 and 1,000 mg/kg-dosing group from 1 days after dosing compared to those of vehicle control group. A significant decrease of body weight gains were observed in observation periods in 2,000 and 1,000 mg/kg-dosing group compared to those of vehicle control group. Hypertrophy of heart and decoloration of kidney were observed as test article-treatment related gross findings. These abnormal findings were restricted to 2,000 and 1,000 mg/kg-dosing groups. A significant increase of absolute and relative heart and kidney weight were demonstrated in 2,000 mg/kg-dosing groups. LD50 in this study was detected as 2,242.42 mg/kg. ALD in this study was detected as 1,000 mg/kg and the target organ was considered as the heart and kidney.

Changes in Renal Function by Nebulized Colistimethate Treatment (Colistimethate 분무요법 시행 환자에서 투여 전후 신기능의 변화)

  • Ahn, Hye Jin;Jung, Yoo Jin;Kim, Jae Song;Kim, Soo Hyun;Son, Eun Sun
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.2
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    • pp.92-98
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    • 2017
  • Background: Nebulized colistimethate is increasingly used, because there are problems such as renal dysfunction and low distribution within the lungs when colistimethate is administered intravenously. This study was designed to compare and analyze the changes in renal function by of nebulized colistimethate treatment for its safe administration. Methods: This study retrospectively reviewed the electronic medical records of adult patients above 19 years old, receiving only the nebulized colistimethate at least 4 days in Yonsei university health system from Nov 2014 to Aug 2015. Acute kidney injury (AKI) was determined by using the RIFLE criteria (Risk, Injury, Failure, Loss and End-stage renal disease) according to serum creatinine (SCr) levels before and after use of nebulized colistimethate. Results: 48 patients were included our study and their SCr increased significantly after nebulized colistimethate treatment ($SCr_0$ vs. $SCr_1$; $0.85{\pm}0.80$ vs. $1.00{\pm}0.82mg/dL$, n=48, p<0.001), but the changes were in normal range according to the standards at Yonsei university health $system^a$. Among 48 patients, 38 patients were in the non-AKI group (79.2%), and 10 patients developed AKI (20.8%). Within the AKI group, 2 patients were in the Injury group (20%) and the other 8 in the Risk group (80%). Conclusion: There was no significant difference in age, dosage and duration of treatment between AKI group and non-AKI group (p>0.05). The study has a significance in that it reviewed the safety of nebulized colistimethate only treatment to national patients, analyzing its nephrotoxicity. It has confirmed that nebulized colistimethate is a safer method than intravenous injection, and requires to establish a guideline for the use of nebulized colistimethate in further studies with broader patient groups. $^a$ : SCr Male 0.68-1.19 mg/dL, Female 0.49-0.91 mg/dL.

Metastatic Colorectal Cancer Treatment and Survival: the Experience of Major Public Hospitals in South Australia Over Three Decades

  • Roder, David;Karapetis, Christos S;Wattchow, David;Moore, James;Singhal, Nimit;Joshi, Rohit;Keefe, Dorothy;Fusco, Kellie;Buranyi-Trevarton, Dianne;Sharplin, Greg;Price, Timothy J
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5923-5931
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    • 2015
  • Background: Registry data from four major public hospitals indicate trends over three decades from 1980 to 2010 in treatment and survival from colorectal cancer with distant metastases at diagnosis (TNM stage IV). Materials and Methods: Kaplan-Meier product-limit estimates and Cox proportional hazards models for investigating disease-specific survival and multiple logistic regression analyses for indicating first-round treatment trends. Results: Two-year survivals increased from 10% for 1980-84 to 35% for 2005-10 diagnoses. Corresponding increases in five-year survivals were from 3% to 16%. Time-to-event risk of colorectal cancer death approximately halved (hazards ratio: 0.48 (0.40, 0.59) after adjusting for demographic factors, tumour differentiation, and primary sub-site. Survivals were not found to differ by place of residence, suggesting reasonable equity in service provision. About 74% of cases were treated surgically and this proportion increased over time. Proportions having systemic therapy and/or radiotherapy increased from 12% in 1980-84 to 61% for 2005-10. Radiotherapy was more common for rectal than colonic cases (39% vs 7% in 2005-10). Of the cases diagnosed in 2005-10 when less than 70 years of age, the percentage having radiotherapy and/or systemic therapy was 79% for colorectal, 74% for colon and 86% for rectum (&RS)) cancers. Corresponding proportions having: systemic therapies were 75%, 71% and 81% respectively; radiotherapy were 24%, 10% and 46% respectively; and surgery were 75%, 78% and 71% respectively. Based on survey data on uptake of offered therapies, it is likely that of these younger cases, 85% would have been offered systemic treatment and among rectum (&RS) cases, about 63% would have been offered radiotherapy. Conclusions: Pronounced increases in survivals from metastatic colorectal cancer have occurred, in keeping with improved systemic therapies and surgical interventions. Use of radiotherapy and/or systemic therapy has increased markedly and patterns of change accord with clinical guideline recommendations.

A Web-based Survey for Assessment of Korean Medical Treatment Clinical Practice Patterns for Neck Pain and Cervical Intervertebral Disc Displacement (경항통 및 경추 추간판 탈출증의 한의진료 임상현황조사를 위한 웹기반 설문조사)

  • Suh, Chang Yong;Lee, Yoon Jae;Kim, Me-riong;Bae, Young Hyeon;Kim, Ho Sun;Kim, No Hyeon;Yang, Kyu Jin;Lee, Gi Bum;Ha, In Hyuk
    • Journal of Acupuncture Research
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    • v.33 no.4
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    • pp.65-72
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    • 2016
  • Objectives : While neck pain is highly prevalent in Korea, studies examining its Korean medical treatment are currently lacking. The aim of this study was to assess current Korean medical treatment practice patterns for neck pain. Methods : A preliminary questionnaire was developed to investigate current practice patterns of neck pain and cervical intervertebral disc displacement (IDD) treatment, and underwent further revision through external review. The final questionnaire was distributed as a web-based survey to 18,289 potential respondents by email. Results : The response rate was 3.34 %. Most participants replied that they received multiple Korean medicine interventions for neck pain treatment consisting of such methods as acupuncture, wet cupping, interferential current therapy and electroacupuncture. A total of 378 respondents acknowledged that diagnostic testing was needed for neck pain treatment. The most commonly used Korean Standard Classification of Diseases (KCD) principal diagnosis code for neck pain was M542, and for cervical IDD was M501. Conclusion : This survey study helps determine current practice patterns of neck pain, and recognizes the need for use of diagnostic devices in neck pain treatment. These results are further anticipated to provide basic data for clinical practice guidelines (CPGs) and future studies using Korean National Health Insurance and Health Insurance Review & Assessment Service data.

A Web-based Survey for Assessment of Korean Medical Treatment Clinical Practice Patterns for Temporomandibular Disorders (턱관절 질환의 한의진료 임상현황조사를 위한 웹기반 설문조사)

  • Kim, Chang-Eun;Do, Ho-Jeong;Song, Hyun-Seop;Shin, Jae-Kwon;Lee, Won-Jun;Kim, Jong-Ho;Lee, Keun-Jae;Yoon, Young-Suk;Kim, No-Hyeon;Suh, Chang-Yong;Lee, Yoon-Jae;Kim, Mi-Riong;Cho, Jae-Heung;Kwon, Mi-Jung;Ha, In-Hyuk
    • Journal of Korean Medicine Rehabilitation
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    • v.28 no.1
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    • pp.73-84
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    • 2018
  • Objectives While Temporomandibular disorders (TMD) is highly prevalent in Korea, studies examining its Korean medical treatment are currently lacking. The aim of this study was to assess current Korean medical treatment practice patterns for TMD. Methods A preliminary questionnaire was developed to investigate current practice patterns of TMD treatment and underwent further revision through external review. The final questionnaire was distributed as a web-based survey to 18,289 potential respondents by email. Results The response rate was 2.23%. Most participants replied that they received multiple Korean medicine interventions for TMD treatment consisting of such methods as acupuncture, chuna manipulation, electroacupuncture. The percentage of treatment services among uncovered services, which need to be covered by national health insurance was high in the order of pharmacopuncture, chuna manipulation, and herbal medicine. The most commonly used diagnostic examination tools for TMD was Physical examination and next was Imaging diagnosis. The frequency of TMD treatment was the highest at 2~3 times per week (76%) and the period was from 4 to 12 weeks (63%). Conclusions This survey study helps determine current practice patterns of TMD, and recognizes the need for use of diagnostic devices in TMD treatment. These results are further anticipated to provide basic data for clinical practice guide lines (CPGs).

Evaluation on Toxicity of Habitual dose of Extract of Rheum Palmatum through Single Blinded Pilot Study (단일맹검시험을 통한 대황(大黃) 상용량(常用量)의 독성작용 평가)

  • Kwon, Hyork;Chi, Gyoo-Yong;Eom, Hyun-Sup
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.24 no.3
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    • pp.390-400
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    • 2010
  • This study is aimed to test physiological and hematological actions of Rheum palmatum through clinical pilot study optimized for usual oriental medicine prescription. Thirty-one cases were finally collected and the sample extract 100 $m{\ell}$ of Rheum palmatum (ERP) was administered two times in a day during 3 days and checked with blood CBC test, urinalysis, liver function test, abdominal X-ray as well as general diagnostic process of oriental medicine; pattern identification, assessment of shapes and constitution. The total toxic effective rate of ERP was 9.68% in 3 cases of the whole in case of consistent uneasy state in the subjective symptomatic assessment and aggravation of blood and urine examination. The relevant diagnostic factors were so-eum constitution and essence type subject, carapaces species, lung type in the aspect of Jisan shape theory. On the other hand, the positive effective rate of ERP was 29.03% manifesting improvement of vital signs or present illness and no abnormal changes of blood chemistry and urinalysis and simple abdomen radiology. The relevant diagnostic factors were tae-eum constitution, energy type subject, aves species, heart and liver type in Jisan's shape theory. And the other cases were manifesting no specific change through the administration of ERP. The ratio of the numbers of decrease and increase was 44:5 in the tenderness and hardness of abdominal palpation. But if the pattern identification doesn't comply with the aim of rhubarb application despite of constipation and abdominal pain, the tendeness and biochemical report was shown in abnormal change. The mean number of diarrhea by ERP was $16.77{\pm}6.95$ during 3 days after administration, and the frequent areas of abdominal pain were lower>middle>upper in order, and it meant the target site of ERP too. Besides, the toxic reaction against ERP was expressed highly in case of decrease in blood cell count and hemoglobin, hematocrit having blood deficiency syndrome. Likewise, the toxicity of ERP was influenced by pattern identification manifesting present disease condition and diagnostic factors of four constitutions, Jisan's shape theory collaterally. In conclusion, evaluation of herbal toxicity in order for using as a clinical guideline, various diagnostic pattern information and shape features like the above should be studied together with other pharmacologic toxicology test for the future.

Comparison of high molecular coating type dentine hypersensitivity desensitizers (고분자 기반 코팅형 상아질 지각 과민 처치제의 효과에 대한 비교 연구)

  • Roh, Young-Hoon;Lee, Joo-Yeon;Park, Hyun-Jung;Choi, Cha-Nam;Park, Yoon-Jeong;Koo, Ki-Tae;Kim, Tae-Il;Seol, Yang-Jo;Lee, Yong-Moo;Ku, Young;Rhyu, In-Chul;Chung, Chong-Pyoung
    • The Journal of the Korean dental association
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    • v.46 no.11
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    • pp.683-688
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    • 2008
  • Purpose : The aim of this study was to evaluate the clinical efficacy of two commercially available desensitizing agents over 3 weeks on patients with dentin hypersensitivity. Materials and Methods : An oxalate-based solution, Sensblok (NIBEC Inc. Seoul, Korea) & Superseal (Pheonix Inc. Michigan, USA), and a distilled water placebo were compared in a clinical setting. Seven volunteers exhibiting three or more teeth that were sensitive to tactile & air were enrolled in the study (35 teeth total). A visual analog scale (VAS) was used for recording each patient s level of sensitivity to tactile & air stimuli. A Florida probe was rubbed across the exposed dentin three times with a constant pressure 20 grams to measure the tactile stimulus. The air stimulus was generated by dental unit air syringe for 1-second blast from 1/2 inch distance. The desensitizing agents were applied according manufacture s guideline. VAS scores were recorded at baseline, 1 minute after treatment, at 1 week, 2weeks, 3weeks. VAS score were analyzed using a repeated measures ANOVA ( =0.05). Results : The Sensblok, Superseal, and distilled water placebo all decreased dentin sensitivity. A statistically significant difference existed between Sensblok and placebo when tactile stimulus was applied (P<0.05), but no significant difference was found among other desensitizing agents and tactile and air stimuli.

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Bioequivalence Test of Rebamipide 100 mg Tablets (레바미피드 100 mg 정제의 새울학적동등성)

  • Kim, Se-Mi;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.1
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    • pp.38-44
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    • 2008
  • Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.84$\sim$log 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

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Characteristics of Respiration and Phonation in Normal Health Elderly (정상 노년층의 호흡 및 발성 특성)

  • Woo, Mee-Ryung;Choi, Hong-Shik;Baek, Seung-Jae;Nam, Chung-Mo;Choi, Yae-Lin
    • Phonetics and Speech Sciences
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    • v.2 no.4
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    • pp.245-252
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    • 2010
  • Korea does not have a certain criteria on the respiratory ability and phonation of the normal aged, and also has no clear standard to examine the boundaries of geriatric diseases. This study analyzed the characteristics in respiration and phonation of the aged in normal healthy elderly from diverse angles with different variables. Thirty-three participants in total, seven males and eight females in the age group 55-64 participated in the study. Seven males and eleven females in the age group 65-74 were selected for the respiration and phonation experiments, and 10 different variables such as FVC, $FEV_1$, $FEV_1$/FVC, MPT, MFR, Psub, f0, jitter, shimmer and NHR were comparatively analyzed for each group of different age and gender. To see the difference in respiration and phonation by age and gender, the study conducted a two-way ANOVA. First, from the result of the analysis on respiratory ability, FVC of male appeared to be significantly greater than female. In both age groups of 55-64 and 65-74, male displayed greater FVC than female did. Second, as for $FEV_1$, $FEV_1$/FVC, the age group of 55-64 showed greater values than the values measured in the age group of 65-74. Third, MFR showed a significant difference by gender. In both age groups, male showed significantly higher MFR than female. Fourth, for different gender, a significant difference in MFR was observed. In both age groups of 55-64 and 65-74, male exhibited higher MFR than female. This study has a clinical implication in that it analyzed the criteria on respiration and phonation in normal healthy elderly according to gender and age. The normal aged showed a difference in their respiratory and phonatory functions by age and gender, it was closely related to the decline of pulmonary function due to the physical aging and the weak respiration coming from weakness of respiratory muscles. Also, the physical differences in height, weight, and the muscles in laryngeal and respiratory system between males and females had an influence on the performance. These results from this study might be a helpful guideline for the clinical criterion in the future.

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Evaluation of the Pharmacy Student Practice Programs in the Mono Community Pharmacy and Multiple Community Pharmacies (단일약국과 다약국 프로그램에서 수행한 지역약국 필수실무실습에 대한 평가)

  • Lee, Min Cheol;Cho, Min Hwi;Jung, Young Joon;Lee, Ji Young;Yoon, Hyonok
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.4
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    • pp.296-303
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    • 2014
  • Background: The first pharmacy student practice undergoing 6 year pharmacy school curriculum have begun in the hospital pharmacy, community pharmacy, pharmaceutical company and administrative office since 2013. Although most of practice sites have prepared the program of pharmacy student practice education for several years under guideline of Korean Association of Pharmacy Education, generally community pharmacies which start the pharmacy student practice education have difficulty in performing the desirable student practice program due to absent experience for it. So we reported the comparison of student practice programs between mono pharmacy and multiple pharmacies conducted by Gyeongsang National University College of Pharmacy to provide the future design information of the ideal pharmacy student practice in community pharmacy. Method: Students who practiced both multiple (multi) and mono pharmacy (mono) programs for each 5 weeks were participated the survey to evaluate the student practice programs. Results: The results of the survey on the student practice program reported that students were much more satisfied with the multiple pharmacies program than mono pharmacy program in both practical contents ($4.12{\pm}0.72$ : $3.27{\pm}1.28$; multi : mono) and satisfaction ($4.54{\pm}0.54$ : $3.54{\pm}1.3$; multi : mono) and they all gave the highest points ($5.00{\pm}0.00$) to multiple pharmacies program for recommendation because the multiple pharmacies program was significantly helpful for their experience to plan the future career. Conclusion: Mono and multiple pharmacy practice programs would be a great helpful for student's future career. However, the disadvantages of each program should be amended gradually for the unified and specialized program to be established the ideal community pharmacy student practice in Korea. The results will be affected the pharmacy practice program for students in community pharmacy and the other colleges of pharmacy to design the ideal community pharmacy practice program.