티로파 정(염산티로프라미드 100 mg) 에 대한 안티모딕정의 생물학적 동등성

곽손혁,구선회,린팜두안,강종성,황성주 충남대학교 약학대학 의약품개발연구소 2000 藥學論文集 Vol.16 No.-

Bioequivalence of two tiropramide tablets, test drug (Antimodic® tablet: Chong Kun Dang Pharm. Co.) and reference drug (Tiropa® tablet: Dae Woong Pharm. Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 100 mg as tiropramide hydrochloride in a 2×2 crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 10 hr and the plasma concentration of tiropramide HCl was determined by a GC/MS method. AUC_0-10hr (area under the plasma concentration-time curve from time zero to 10 hr), C_max (maximum plasma drug concentration) and T_max (time to reach C_max) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in AUC_(0-10hr), C_max and T_max between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 0.043, 6.430 and 8.929% for AUC_(0-10hr), C_max and T_max, respectively). The powers (1-β) for AUC_(0-10hr) and C_max were over 0.9. Minimal detectable differences (Δ) at α=0.05, 1-β=0.8 were less than 20% (i.e. 15.71 and 12.53% for AUC_(0-10hr) and C_max, respectively). The 90% confidence intervals (δ) for these parameters were also within ±20% (i.e. -9.15≤δ≤9.24 and -0.90≤δ≤13.77 for AUC_(0-10hr) and C_max, respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of tiropramide were bioequivalent.

프레팔시드정(시사프리드 5 mg)에 대한 시사컨시드정의 생물학적 동등성

곽손혁,구선회,황성주 충남대학교 약학대학 의약품개발연구소 2000 藥學論文集 Vol.16 No.-

Bioequivalence of two cisapride tablets, test drug (Cisaconsid® tablet: Hankook Nelson Pharm Co.) and reference drug (Prepulsid® tablet. Yansen Pharm. Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 10 mg as cisapride in a 2×2 crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 36 hr and the plasma concentration of cisapride was determined by a HPLC method. AUC_(0-36hr) (area under the plasma concentration-time curve from time zero to 36 hr), C_max (maximum plasma drug concentration) and T_max (time to reach C_max) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in AUC_(0-36hr), C_max and T_max between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 2.23, 7.99 and 3.81% for AUC_(0-36hr), C_max and T_max., respectively). The powers (1-β) for AUC_(0-36hr), C_max and T_max were over 0.9. Minimal detectable differences (Δ) at α=0.10, 1-β=0.8 were less than 20% (i.e. 16.34, 13.81 and 17.99% for AUC_(0-36hr), C_max and T_max, respectively). The 90% confidence intervals (δ) for these parameters were also within ±20% (i.e. -13.21≤δ≤8.75, -17.27≤δ≤1.28 and -l5.93≤δ≤8.24% for AUC_(0-36hr), C_max and T_max, respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of cisapride were bioequivalent.

모티리움 엠정(말레인산돔페리돈 12.72 mg)에 대한 한미 돔페리돈정의 생물학적 동등성

곽손혁,우종수,황성주 충남대학교 약학대학 의약품개발연구소 2002 藥學論文集 Vol.17 No.-

Bioequivalence of two domperidone maleate tablets, test drug (Hanmi Domperidone^ⓡ tablet: Hanmi Pharmaceutical Co.) and reference drug (Motilium-M^ⓡ tablet: Jassen Korea Pharm. Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 20㎎ as domperidone in a 2×2 crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 48hr and the plasma concentration of domperidone was determined by a HPLC method. AUC_0-48hr (area under the plasma concentration-time curve from time zero to 48hr), C_max (maximum plasma drug concentration) and T_max, (time to reach C_max) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in AUC_0-48hr, C_max and T_max between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 1.047, -0.416 and 9.347% for AUC_0-10hr, C_max and T_max, respectively). The powers (1-β) for AUC_0-48hr, C_max and T_max were over 0.99. Minimal detectable differences (Δ) at α=0.05, 1-β=0.8 were less than 20% (i.e. 11.15, 10.21 and 18.13% for AUC_0-10hr, C_max and T_max respectively). The 95% Confidence intervals (δ) for these parameters were also within ±20% (i.e. -5.49≤δ≤7.58, -6.39≤δ≤5.57 and -1.28≤δ≤19.95 for AUC_0-10hr, C_max and T_max, respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of domperidone maleate were bioequivalent.

전신성 홍반성 루푸스에서 F-18 FDG PET상 기저핵 포도당대사 증가 소견을 보이는 무도병 1예 : Evidence for Bilateral Putaminal Hypermetabolism on F-18 FDG PET

서욱장,정선미,고수진,이창근,김재승,임주혁,유빈,문희범 대한핵의학회 2003 핵의학 분자영상 Vol.37 No.5

Purpose: We describe a 54-year-old woman with systemic lupus erythematosus (SLE) who suddenly presented with chorea and had positive antiphospholipid antibodies. F-18 FDG PET showed abnormally increased glucose metabolism in bilateral putamen and primary motor cotex. Tc-99m ECD SPECt also showed abnormally increased regional cerebral blood flow in bilateral putamen. She was treated with corticosteroid and aspirin after which the symptoms improved. Four months later, follow up F-18 FDG PET showed improvement with resolution of hypermetabolism in bilateral putamen. This case suggests that striatal hypermetabolism is associated with chorea in SLE.

GO-27 : Prediction of lymph node metastasis in patients with apparent early endometrial cancer

( Joo Hyuk Son ),( Su Hyun Kim ),( Suk Joon Chang ),( Tae Wook Kong ),( Jiheum Paek ),( Hee Sug Ryu ) 대한산부인과학회 2014 대한산부인과학회 학술대회 Vol.100 No.-

목적: The purpose of this study was to the investigate the incidence of lymph node metastasis in patients who were presumed to have endometrial cancer confined to the uterine corpus without enxtrauterine involvement and to evaluate preoperative clinicopathological factors predicting lymph node metastasis. 방법: We identified 142 consecutive patients with endometrial cancer between January 2000 and February 2013. All patents demonstrated endometrioid adenocarcinoma with grade 1 or 2 on preoperative endometrial biopsy. Preoperative magnetic resonance imaging (MRI)showed that tumors were confined to the uterine corpus with superficial myometrial invasion(less than 50%) and there was no any evidence of extrauterine metastasis. All patients had complete staging procedures ? total hysterectomy, adnexectomy, peritoneal cytology, bilateral pelvic lymphadenectomy, and para-aortic lymphadenectomy- and were surgically staged according to the 2009 FIGO staging system. Clinical and pathologic data were obtained from medical records and statistically analyzed. 결과: Of 142 patients, 127 patients (89.4%) presented with stage 1A, 8 (5.6%) had stage IB, 3 (2.1%) had stage II, and 4 (2.8%) had stage III diseases. Three patients (2.1%) had lymph node metastasis ? 2 IIIC1 and 1 IIIC2 diseases. Preoperative tumor grade was upgraded in 8 patients (5.6%) and 27 patients (19%) presumed to have no or superficial myometrial invasion on preoperative MRI postoperatively showed deep myometrial invasion. Age, preoperative tumor grade, and myometrial invasion less than 50% on preoperative MRI were not associated with lymph node metastasis. High preoperative serum CA-125 level (>35 IU/mL) was a statistically significant factor predicting lymph node metastasis on univariate and and multivariate analyses. Lymph node metastasis was only found in patients with preoperative grade 2 tumors or high serum CA-125 level. 결론: Preoparative tumor grade and serum CA-125 level can predict lymph node metastasis in apparent early endometrial cancer patients who had endometriod histology, grade 1- 2 tumor, and superficial myometrial invasion on preoperative on preoperative MRI. Keywords Tumor grade, CA-125, Lymph node metastasis, Early endometrial cancer

Perinatal outcomes in fetal growth restriction according to types of hypertensive disorders in pregnancy

( Joo Hyuk Son ),( Joo Hyung Lee ),( Ji Yoon Cheong ),( Haeng Soo Kim ),( Jeong In Yang ) 대한산부인과학회 2015 대한산부인과학회 학술대회 Vol.101 No.-

GO-26 : Cutoff value of pre- and post-cone HR-HPV load predicting residual/recurrent disease after conization in high-grade intraepithelial neoplasia and microinvasive

( Joo Hyuk Son ),( Seong Woo Kang ),( Tae Wook Kong ),( Jiheum Paek ),( Suk Joon Chang ),( Hee Sug Ryu ) 대한산부인과학회 2014 대한산부인과학회 학술대회 Vol.100 No.-

목적: The aim of this study was to analyze clinico-pathologic factors and the optimal cut-off value of high-risk human papillomavirus (HR-HPV) load for predicting high-grade residual/recurrent disease after the conization in cervical intraepithelial neoplasia (CIN 2-3), adenocarcinoma in situ (AIS), and microinvasive carcinoma of the uterine cervix (MICA). 방법: We retrospectively reviewed data from 701 patients with CIN 2-3, AIS, and MICA who underwent conization between September 2003 and June 2012. Receiver-operating characteristic curve analysis was used to find out the optimal cut-off value of HR-HPV load for predicting residual/ recurrent disease. Clinico-pathologic variables, including resection margin and HR-HPV load, were evaluated as possible predictors of residual/ recurrent disease. 결과: At a cut-off value of 1.16 RLU/CO for post-cone HR-HPV load, the sensitivity was 88.2% and the specificity was 98.3%. Multivariate analysis demonstrated that abnormal post- cone cytology (p=0.001, OR = 83.808, 95% CI = 6.688 ? 1050.232), positive endocervical margin (p<0.001, OR = 80.478, 95% CI = 7.421 ? 872.732), and positive post-cone HR HPV (p<0.001, OR = 79.660, 95% CI = 8.539 ? 743.129) were significantly associated with residual/recurrent disease. The post-cone HR-HPV positivity was observed more in the patients who showed positive endocervical margin than in the patients with positive ectocervical margin (32.6% vs. 5.3%, p=0.002). 결론: Positive post-cone HR-HPV was, not a high pre-cone HR-HPV load, a significant risk factor for predicting residual/recurrent disease. Patients with positive endocervical margin showed not only the post-cone HR-HPV positivity but also the residual/recurrent disease after the conization. Therefore, complete assessment of the endocervical margin status is necessary to determine residual/recurrent disease.

Clinicopathologic factors of ovarian clear cell carcinoma in a background of endometriosis: Clues for proper treatment and follow up intervals

( Joo-hyuk Son ),( Hana Cho ),( Joo-hyung Lee ),( Tae-wook Kong ),( Jiheum Paek ),( Yong-hee Lee ),( Hee-sug Ryu ),( Suk-joon Chang ) 대한산부인과학회 2016 대한산부인과학회 학술대회 Vol.102 No.-

목적: The aim of this study was to analyze clinicopathologic factors and oncologic outcomes in patients with ovarian clear cell carcinoma associated with endometriosis in order to provide clinical answers to follow up intervals and treatment strategy for endometriosis. 방법: We retrospectively reviewed clinicopathologic data of 50 patients with ovarian clear cell carcinoma between March of 2001 and March 2016. Clinicopathologic characteristics, treatment outcomes, and relations to endometriosis were analyzed. 결과: The most common initial symptom of clear cell carcinoma was palpable mass (32%) followed by incidental diagnosis during regular follow up of endometriosis without any symptom (22%). Compared to other symptomatic groups, asymptomatic patients diagnosed with clear cell carcinoma during regular gynecologic check up were more likely to have low recurrence rate (9.09% vs. 35.8%) and early FIGO stage I or II disease (81.8% vs 66.7%). Endometriosis was confirmed in 20% of cases before the diagnosis of clear cell carcinoma and 70% of all cases were diagnosed as endometriosis after complete staging surgery. The mean latent period from the diagnosis of endometriosis to that of clear cell carcinoma was 65.6 months. The existence of endometriosis was not related to the prognosis. 결론: Asymptomatic patients with clear cell carcinoma diagnosed during regular gynecologic examination were likely to have smaller tumor lesion size with better oncologic outcomes. More frequent gynecologic check up is needed to detect clear cell carcinoma associated with endometriosis. Early surgical treatment is required for this patient group.

GO-37 : Outcomes of cold knife conization according to the margin involvement in high-grade lesions and microinvasive squamous cell carcinoma of the uterine cervix

( Joo Hyuk Son ),( Tae Wook Kong ),( Ji Heum Paek ),( Hee Sug Ryu ),( Suk Joon Chang ) 대한산부인과학회 2012 대한산부인과학회 학술대회 Vol.99 No.-

To evaluate the long-term outcome of patients with cervical intraepithelial neoplasia (CIN 2-3), adenocarcinoma in situ (AIS), and microinvasive squamous cell carcinoma of the cervix (MICA) after cold knife conization (CKC). We retrospectively reviewed data from 355 patients (median age 40 years old, range 21-68) with CIN 2-3, AIS, and MICA treated by CKC at a single institution. Clinico-pathologic variables, including age, parity, severity of the disease in cone specimens, number of quadrant involved, ecto- and endo-cervical margin involvement, were evaluated as possible predictors of residual disease. Among the 355 patients, 26 (7.3%) had residual disease demonstrated by colposcopic-directed biopsy and subsequent loop electrosurgical excision procedure (LEEP) or hysterectomy. In 244 patients (68.7%) the specimen was assessed as complete excision, and in 111 patients (31.3%) the excision was turn out to be incomplete. There were no significant differences in age, parity, and follow-up period between patients in whom excision was incomplete and those in whom complete excision was achieved. The patients who demonstrated positive margin was related to more severe disease of CKC specimens (p<0.01), glandular involvement (p<0.01), number of involved quadrants (p<0.01), and residual disease (p<0.01). Of 244 patients, 238 (97.5%) were found to have been cured of disease in the negative margin group. The cure rate for incomplete excision at the ectocervical margin was 91.5%; incomplete excision at the endocervix was 76.7% and only 44.4% if excision was incomplete at both margins. In univariate analysis, severity of the disease in CKC specimens (20.4% [11/54] of patients with AIS and MICA vs. 5.0% [15/301] of patients with CIN 2-3, p<0.01) and positive resection margin (18.0% [20/111] vs. 2.5% [6/244], p<0.01) were significant risk factors for the residual disease. Multivariate analysis demonstrated that age (>50 years) (p<0.01), severity of the disease in CKC specimens (p<0.01), positive ecto- and endo-cervical resection margin (p<0.01) were significantly associated with higher risk of residual disease. CKC performed for CIN2-3, AIS, and MICA is likely to be curative when the lesion is completely excised. Most cases of incompletely excised CIN 2-3, AIS, and MICA would also be curative, even in the positive ectocervical margin. Age (>50 years), severity of the disease in CKC specimens, positive ecto- and endo-cervical resection margin could be a significant risk factor for developing residual disease after CKC.

Prediction of lymph node metastasis in patients with apparent early endometrial cancer

( Joo-hyuk Son ),( Taewook Kong ),( Suhyun Kim ),( Jiheum Paek ),( Sukjoon Chang ),( Eunju Lee ),( Heesug Ryu ) 대한산부인과학회 2015 Obstetrics & Gynecology Science Vol.58 No.5

The purpose of this study is to investigate the incidence of lymph node metastasis in early endometrial cancer patients and to evaluate preoperative clinicopathological factors predicting lymph node metastasis.We identified 142 patients with endometrial cancer between January 2000 and February 2013. All patients demonstrated endometrioid adenocarcinoma with grade 1 or 2 on preoperative endometrial biopsy. Preoperative magnetic resonance imaging showed that tumors were confined to the uterine corpus with superficial myometrial invasion (less than 50%), and there were no lymph nodes enlargements. All patients had complete staging procedures and were surgically staged according to the 2009 FIGO (International Federation of Gynecology and Obstetrics) staging system. Clinical and pathological data were obtained from medical records and statistically analyzed.Of the 142 patients, 127 patients (89.4%) presented with stage 1A, 8 (5.6%) with stage IB, 3 (2.1%) with stage II, and 4 (2.8%) with stage III disease. Three patients (2.1%) had lymph node metastasis­2 IIIC1 and 1 IIIC2 disease. Age, preoperative tumor grade, and myometrial invasion less than 50% on preoperative MRI were not associated with lymph node metastasis. A high preoperative serum CA-125 level (>35 IU/mL) was a statistically significant factor for predicting lymph node metastasis on univariate and multivariate analyses. Lymph node metastasis was only found in patients with preoperative grade 2 tumors or a high serum CA-125 level.Preoperative tumor grade and serum CA-125 level can predict lymph node metastasis in apparent early endometrial cancer patients.