• 제목/요약/키워드: Phase 1 Clinical Trial

검색결과 107건 처리시간 0.029초

알코올성 간질환에 대한 한의학 연구 경향 분석 : 국내논문을 중심으로 (A Review of Domestic Research on Traditional Korean Medicine for Alcoholic Liver Disease)

  • 조나경;이유리;김경순;최홍식;김승모;백영두;문병권
    • 대한한방내과학회지
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    • 제40권3호
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    • pp.458-477
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    • 2019
  • Objectives: This study aimed to investigate the trend in the research on alcoholic liver disease (ALD) using Korean traditional medicine. Methods: This review was conducted using six electronic databases (NDSL, KMBASE, Koreantk, KISS, KISTI, and KoreaMed) with no restrictions in year. The search terms were "alcoholic liver disease", "alcoholic fatty liver", "alcoholic hepatitis", "alcoholic cirrhosis", "herbal medicine", "acupuncture" and "traditional medicine". The searched studies were analyzed according to the type of research. Results: After screening, 37 studies were selected among 552. The types of studies were as follows: 8 in vivo studies, 17 case reports, 7 case series, 1 assessment scale study, 1 randomized controlled trial, and 3 research reviews. The in vivo studies reported the efficacy and its mechanism in the animal phase of single or complex herbal medicine. In the clinical research, interventions such as herbal medicine and acupuncture were most commonly used for ALD treatment. Conclusions: We analyzed the trends in ALD treatment using Korean traditional medicine through this review. The results showed that Korean traditional medicine could be an effective method for ALD treatment. Conducting related in-depth studies, such as well-designed randomized controlled trial based on the results of experimental research, is necessary.

소아청소년정신과영역의 새로운 항우울제 (NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY)

  • 이수정
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • 제14권1호
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    • pp.12-25
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    • 2003
  • 새로운 항우울제가 다량 개발되어 임상에 도입되면서 항우울제의 약리 작용에 대한 이해도 넓어졌다. 그에 따라 얻어진 새로운 정보와 이론을 소아청소년기 우울증 치료에 반영할 필요가 있다. 소아청소년기 최신지견에 따라 합리적인 우울증 치료 지침 마련을 위하여 고려하여야 할 주요 사항들과 새로운 항우울제의 특징들을 살펴보고자 하였다. 전자문헌 데이터베이스 검색 도구를 사용하여'new', 'antidepressant', 'children'의 검색어로 얻어진 97개 고찰 문헌 가운데 특히 치료 지침과 새로운 항우울제의 정신약리작용에 관한 것을 선별하여 중점적으로 고찰하였다. 아울러 새로운 항우울제 각 약물에 대한 치료 효과에 대한 문헌을 추가로 선택 참고하였다. 또 약물상호 작용과 안전성에 관하여 미국 식품보건국과 보건후생부의 공식사이트에서 제공되는 문헌을 참고하였다. 1) 우울 장애의 임상 경과, 치료 기간, 및 치료 효과는 성인기 치료 지침에서 제시된 바를 채택한 경우가 많았다. 2) 소아청소년기 우울증에 대한 항우울제의 효과에 대한 연구 결과는 TCA가 효과와 부작용에서 SSRI보다 뒤져서 소아청소년 우울장애의 일차 치료제로 권장 된다. 3) 새로운 항우울제는 아직 소아청소년에게 치료 경험과 임상 연구 결과가 부족하다. 4) SSRI와 새로운 항우울제들은 두 개 이상을 병용할 때 약동학적 및 약력학적인 상호작용이 있을 수 있다. 5) 소아청소년기 항우울제의 임상적 효과가 성인기와 다른 것은 발달적 측면에서 설명할 수 있겠으나 직접적인 증거가 좀더 쌓일 필요가 있다. 소아청소년기 우울증의 약물 치료 지침은 임상 연구 소견과 임상적 경험을 종합하여 세울 수 있다. 그러나 약물 치료 지침은 임상가가 합리적인 판단을 내릴 수 있도록 하는 참고 자료이며 그 목적을 다하기 위하여 새로운 연구 결과가 있을 때 마다 새로 개정 되어야 할 것이다. 중 외톨이-왕따에 해당되는 청소년의 어머니는 비외톨이 청소년의 어머니보다 자녀들의 사고 문제 및 우울/불안 등의 정서적 문제를 더 높게 평가하였다. 그러나, 자녀들에 대한 양육 태도에 대해서는 차이를 두지 않는 것으로 보인다. 향후 보다 많은 환자들을 대상으로 한 추가 연구가 필요할 것이다. 강압적인 양육행동을 변화시키기 위해서는 주의력결핍과잉행동장애 아동 부모의 양육 스트레스, 아동에 대한 역기능적 사고 및 양육 효능감을 다루어야 할 뿐 아니라, 부모의 우울감을 치료 시 고려해야 할 것이다.순차처리항목과 계산능력에서 유의하게 높았고(p<.05), KEDI-WISC를 이용한 평가에서는 ADHD- HI형은 대상수가 소수여서 비교할 수 없었으며, ADHD-C형과 ADHD-Ⅰ형 사이에 유의한 차이는 보이지 않았다. CPT, WCST, SST를 이용한 신경심리학적 실행기능의 비교에서 아형간 계량적인 차이는 있었으나 통계적으로 유의한 차이는 보이지 않았다. 결 론:결론적으로 ADHD 세 아형은 임상적으로 뚜렷한 차이를 보였지만, 실행기능상 유의한 차이를 발견할 수 없었다. 향후 보다 잘 고안 된 연구와 발달중인 아동에 적절한 신경심리 평가 도구의 개발을 통해 결과를 보완해야 할 것으로 사료된다.었으나, 주의력에서는 전두엽의 실행능력(executive function)과 관련되는 검사들에서 산소흡입이 특이한 효과를 보여준다는 것이 확인되었고, 기억능력에서는 단기기억능력 평가에서 산소흡입군이 대조군보다 유의한 효과를 보여주는 것으로 평가되었다. 이러한 연구결과는 산소흡입이 전두엽과 관련된 수행능력, 작동기억능력 향상에 도움이 될 가능성이 있음을 시사하는 결과라고 생각된다.증 1명(5%)이었다. 모든 대상 아동이 주 진단 이외의 2∼6개 이상의 다양한 공존진단을 보였다. 공존진단에는 주의력결핍-과잉운동장애, 우울병, 경계선지능 및 정신지체, 학습장애,

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21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전 (Advances in Radiation Oncology in New Millennium in Korea)

  • 허승재;박찬일
    • Radiation Oncology Journal
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    • 제18권3호
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    • pp.167-176
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    • 2000
  • 최근의 방사선치료는 치료의 질을 향상시켜서 치료 후의 삶의 질을 높이는 것을 목표로 하고 있다. 국내에서도 방사선치료 환자와 치료 시설의 빠른 증가로 방사선종양학 분야는 많은 발전이 되고 있으며, 치료기술 또한 3-dimensional conformal radiotherapy의 보편화, liuac based stereotactlc radiosurgery의 활발한 적용과 luteuslty modulated radiation tferapy (IMRT)의 도입 준비 등 고난도의 치료 기술도입이 시도되고 있다. 저자는 최근 20년간 한국에서의 방사선 종양학의 발전을 조망하고 최근 발전되는 4차원적 방사선치료, IMRT의 현황, blologlcai conformailty치료의 개념, 항암제와 방사선치료의 병용에 대하여 살펴보고 최근 정보기술 혁명에 따른 인터넷과 방사선종양학 분야의 정보관리 시스템의 중요성 및 원격진료의 세계적 현황 등에 대해서 알아보고, 21 세기 한국에서의 방사선치료의 질을 올리기 위한 방법들을 제시하였다. 이들은 1) OA (qualify assurance) 향상, 2) 공동 프로토콜에 의한 3상 임상 연구의 필요성, 3) 특정 암에 대한 통일된 치료 프로토콜 또는 가 이드라인, 4) 전국적인 방사선종양학 관련 자료의 광역 data base구축과 중요 암에 대한 patterns of care study 등 시행의 필요성이다

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TOSC 법을 이용한 당알코올의 항산화 활성 평가 (Evaluation of Antioxidant Activity of Sugar Alcohols Using TOSC (Total Oxy-radical Scavenging Capacity) Assay)

  • 강건욱;곽상훈;윤세영;김상겸
    • Toxicological Research
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    • 제23권2호
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    • pp.143-150
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    • 2007
  • Although animal and epidemiological studies have suggested oxidative stress as an etiological factor in pathogenesis including cancer, inflammation, sepsis, fibrosis, cardiovascularlneurodegenerative diseases and aging-related disorders, conflicting results have been obtained in clinical trial with antioxidants. The reason for this discrepancy remains unknown but may be due, in part, to the lack of a validated assay system for evaluating antioxidant capacity. The antioxidant activity of a series of sugar alcohols against peroxyl radicals, hydroxyl radicals and peroxynitrites was determined by the total oxy-radical scavenging capacity (TOSC) assay and cell-based assay using H4IIE cells. Specific TOSC values calculated from the slope of the linear regression for erythritol, xylitol, sorbitol or mannitol against peroxyl radicals was $2.1{\pm}0.2,\;3.7{\pm}0.3,\;9.1{\pm}0.3$ or $8.7{\pm}1.1$ TOSC/mM, respectively. Specific TOSC values for erythritol, xylitol, sorbitol or mannitol against peroxynitrite was $1.9{\pm}0.3,\;3.9{\pm}0.4,\;7.8{\pm}0.7$ or $7.7{\pm}0.5$ TOSC/mM, respectively. These results suggest that oxy-radical scavenging capacity is dependent on the number of aliphatic hydroxyl group in sugar alcohols of monosaccharide. Tert-butylhydroperoxide (t-BHP)-induced cell toxicity determined by MTT assay was marginally attenuated by 10 mM erythritol, but completely inhibited by 10 mM xylitol, 2 mM sorbitol or 0.75 mM maltitol, a disaccharide alcohol. Oxidative stress markers, such as glutathione (GSH) and malondial-dehyde (MDA) levels, were measured in t-BHP-treated cells using HPLC equipped with a fluorescence detector and a reverse phase column. Erythritol did not change the levels of GSH and MDA in H411E cells treated with t-BHP. The t-BHP-induced changes in cellular GSH and MDA levels were ameliorated by 10 mM xylitol and completely blocked by 10 mM sorbitol and maltitol. These results indicate that sugar alcohols protect cells against oxidative stress via scavenging oxy-radical and suggest that TOSC assay in conjunction with cell-based assay is a valid method for evaluating antioxidant capacity of natural and synthetic chemicals.

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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Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
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    • 제36권1호
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    • pp.17-24
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    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

Nutrikinetic study of fermented soybean paste (Cheonggukjang) isoflavones according to the Sasang typology

  • Kim, Min Jung;Lee, Da-Hye;Ahn, Jiyun;Jang, Young-Jin;Ha, Tae-Youl;Do, Eunju;Jung, Chang Hwa
    • Nutrition Research and Practice
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    • 제14권2호
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    • pp.102-108
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    • 2020
  • BACKGROUND/OBJECTIVES: In Oriental medicine, certain foods may be beneficial or detrimental based on an individual's constitution; however, the scientific basis for this theory is insufficient. The purpose of this study was to investigate the effect of body constitution, based on the Sasang type of Korean traditional medical classification system, on the bioavailability of soy isoflavones of Cheonggukjang, a quick-fermented soybean paste. SUBJECTS/METHODS: A pilot study was conducted on 48 healthy Korean men to evaluate the bioavailability of isoflavone after ingestion of food based on constitution types classified by the Sasang typology. The participants were classified into the Taeeumin (TE; n = 15), Soyangin (SY; n = 15), and Soeumin (SE; n = 18) groups. Each participant ingested 50 g of Cheonggukjang per 60 kg body weight. Thereafter, blood was collected, and the soy isoflavone metabolites were analyzed by ultra-performance liquid chromatography/quadrupole time-of-flight mass spectrometry. Ntrikinetic analysis of individual isoflavone-derived metabolites was performed. RESULTS: Our nutrikinetic analysis identified 21 metabolites derived from isoflavones in the blood samples from 48 healthy Korean men (age range, 21-29 years). Significant differences were observed in the time to maximum concentration (Tmax) and elimination half-life (t1/2) for nine metabolites among the three groups. The Tmax and t1/2 of the nine metabolites were higher in the SE group than in the other groups. Moreover, the absorption rates, as determined by the area under the plasma-level curve (AUC) values of intact isoflavone, were 5.3 and 9.4 times higher in the TE group than in the SY and SE groups, respectively. Additionally, the highest AUC values for phase I and II metabolites were observed in the TE group. CONCLUSIONS: These findings indicate that isoflavone bioavailability, following Cheonggukjang insgestion, is high in individuals with the TE constitution, and relatively lower in those with the SE and SY constitutions.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • 대한치매학회지
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    • 제22권3호
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

슈크로오스디스테아레이트를 사용한 액정구조의 생성과 보습효과에 관한 연구 (A Study on the Moisturizing Effect and Preparation of Liquid Crystal Structures Using Sucrose Distearate Emulsifier)

  • 곽명헌;김인영;이환명;박주훈
    • 한국응용과학기술학회지
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    • 제33권1호
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    • pp.1-12
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    • 2016
  • 이 연구는 슈크로오스디스테아레이트(Sucro-DS)를 사용하여 친수형 O/W 에멀젼을 만들고, 이 에멀젼의 드로플렛(droplet)은 다중층의 구조를 가지는 액정생성에 관한 것이다. Sucro-DS의 물리화학적 특성을 알아보았고, 이를 이용한 유화성능에 대하여 연구하였다. 액정을 형성하기 위하여 3wt%의 Sucro-DS, 5wt%의 글리세린, 5wt%의 수쿠알란, 5wt%의 카프릭/카프릴릭트리글리세라이드, 3wt%의 세토스테아릴알코올, 1wt%의 글리세릴모노스테아레이트, 78wt%의 정제수의 혼합계에서 안정한 다중층의 라멜라구조가 형성됨을 알 수 있었다. 이를 응용하여 불안정한 활성물질을 봉입한 크림을 만드는 방법에 대하여 기술하였다. 또한, 이 기술을 이용한 크림의 보습효과에 대하여 연구하였다. 인체 임상시험을 통한 피부개선효과에 대하여 연구한 결과를 보고한다. Sucro-DS 를 사용하여 안정한 액정상을 생성하는 pH 범위는 5.2~7.5 에서 안정한 액정구조를 유지하고 있었다. 액정의 안정성이 우수한 농도는 3wt%의 베헤닐알코올을 함유할 경우의 경도는 13kg/mm,min 이었다. 동일 함량의 점도는 25,000mPas/min 이었다. 유화제의 영향에 대하여 실험한 결과, Sucro-DS 의 농도는 5wt%가 적합하였고, 안정한 액정의 입경분포는 4~6mm 이었다. 이를 현미경분석을 통하여 관찰하였고, 3 개월동안 액정변화의 안정성은 $4^{\circ}C$, $25^{\circ}C$, $45^{\circ}C$에서 안정함을 알 수 있었다. 임상시험으로, 바르기 전의 보습력은 $13.4{\pm}7%$ 이었다. 액정이 형성되지 않은 크림의 보습력은 $14.5{\pm}5%$로 바르기 전보다는 약 8.2% 보습력이 상승하였다. 반면, 액정크림의 경우 $19.2{\pm}7%$로, 도포 전보다는 43.3%보습력이 상승하였다. 응용분야로 Sucro-DS 유화제를 사용한 액정크림, 로션, 아이크림 등 다양한 제형개발이 가능하고, 화장품산업은 물론 의약품산업 및 제약산업에서 피부외용제의 유화기술로 폭넓게 응용이 가능할 것으로 기대한다.

A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • 제23권2호
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.