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산모(産母)의 B형 간염(肝炎) Virus 보유(保有)가 신생아(新生兒) 건강(健康)에 미치는 영향(影響)
박정한,윤성도,김창윤,이성관,Park, Jung-Han,Yoon, Sung-Do,Kim, Chang-Youn,Lee, Sung-Kwan 대한예방의학회 1984 예방의학회지 Vol.17 No.1
산모(産母)의 B형 간염(肝炎) virus감염에 관련되는 위험요소와 HBsAg 보유(保有)가 신생아의 건강에 미치는 영향을 알아보기 위하여 개명대학교 동산의료원 산부인과에서 1982연(年) 2월(月) 1일(日)부터 동년(同年) 5월(月) 30일(日) 사이에 분만한 729명의 산모(産母)를 대상으로 혈청 HBsAg과 anti-HBs를 조사하였다. 산모(産母)의 HBsAg 양성율은 729명중 43명으로 5.9%, anti-HBs는 246명으로 33.7%의 양성율을 보여 전체적인 B형 간염(肝炎) 감염율은 39.6%였다. HBsAg 양성인 산모(産母) 43명과 음성 산모(産母) 210명을 무작위로 뽑아 면접 조사하여 비교한 결과 침술력이 HBsAg 보유(保有)와 유의한 상관관계를 보여 (p<0.005) 침술을 통해 B형 간염(肝炎)이 상당히 전파되었을 가능성을 보였다. 또한 HBsAg 양성 산모(産母)가 음성 산모(産母)에 비해 생활수준이 일반적으로 낮아 B형 간염(肝炎) 감염에 환경적 요소가 관여한다는 설(設)과 일치하는 결과를 보였다. HBsAg 양성 산모(産母)에서 태어난 신생아 43명의 제대혈액에서는 한명도 HBsAg 양성 발견이 없었다. 43명의 신생아중 생후 3개월까지 추적 가능하였던 35명중 한명이, 그리고 6개월까지 추적 가능했던 32명중 한명이 HBsAg 양성 발현을 보였는데 이는 동일아(同一兒)였다. 대조군으로 본 조사에 응했던 HBsAg 음성 산모(産母)에서 태어난 신생아 20명을 3개월, 6개월 2차에 걸쳐 추적 검사한 결과 한명의 HBsAg 양성 발현을 볼 수 없어 한국을 비롯한 동남아의 B형 간염(肝炎)은 주산기(周産期) 감염이 주전파경로(主傳播經路)라는 설(說)과는 일치하지 않았다. 조산아 출산율은 HBsAg 양성 산모(産母)(27.9%)가 음성 산모(産母)(11.7%)에 비하여 현저하게 높았다(p<0.05). 저체중아 출산율은 HBsAg 양성 산모(産母)가 23.3%로 HBsAg 음성 산모(産母)의 14.1%보다 높았으나 통계적 유의 수준에는 미달하였다(p=0.16). 조기파막의 빈도는 HBsAg 양성 산모(産母)(25.5%)가 음성 산모(産母)(11.1%)에 비하여 유의하게 높았다(p<0.05). HBsAg 양성. 산모(産母)와 음성 산모(産母) 사이에 사산(死産)과 선친성 기형아 출산율에는 유의한 차이를 볼 수 없었다. HBsAg 양성 산모(産母)가 음성 산모(産母)보다 높은 조기파막의 빈도와 조산아 출산율은 HBsAg 보유(保有) 그 자체에 기인하는 것인지 아니면 HBsAg 보유(保有) 산모(産母)의 낮은 생활수준에 기인한 것인지는 연구대상자 수가 적어 규명할 수 없었다. To study the risk factors associated with maternal HBsAg carrier and the effects of maternal HBs antigenemia on the neonatal health, sera of 729 pergnant women admitted to the Keimyung University Hospital for delivery during the period of February 1-May 30. 1982 were tested for HBsAg by RPHA method and for anti-HBs by PHA method. Among them 43 women (5.9%) had HBsAg and 246 women (33.7%) had anti-HBs giving an infection rate of 39.6%. The interview data for 43 HBsAg positive mothers and randomly selected 210 HBsAg negative mothers showed a statistically significant association between acupuncture history and HBsAg positive rate (p<0.005) which suggest that acupuncture might have contributed significantly to the propagation of viral hepatitis in Korea. The living standard of HBsAg positive mothers was generally lower than that of HBsAg negative mothers which supports the hypothesis that environmental factors are associated with viral hepatitis B infection. None of the 43 neonates born to HBsAg positive mothers had HBsAg in their cord blood. Three months after birth, 35 out of 43 infants were retested and only one infant became HBsAg positive. At six months of age, 32 out of 35 infants were retested and none of them were HBsAg positive except the same infant who was positive at three months. Among 20 control infants of HBsAg negative mothers, all of them were HBsAg negative at three and six months follow-up. These findings are not consistent with the supposition that perinatal infection is a main route of viral hepatitis B transmission in south-east Asia including Korea. HBsAg positive mothers had significantly higher rate of premature delivery (27.9%) than HBsAg negative mothers (11.7%) (p<0.05). Also, the low birthweight incidence rate was higher among HBsAg positive mothers (23.3%) than negative mothers (14.1%) but this was not statistically significant (P=0.16). The premature rupture of membrane was more frequent among HBsAg positive mothers (25.5%) than negative mothers (11.1%) (p<0.05). There were no significant differences in the stillbirth rate and incidence of congenital anomalies between HBsAg positive and negative groups. It was not clarified in this study due to small sample size whether higher incidence of premature delivery and premature rupture of membranes among HBsAg positive mothers was due to HBs antigenemia per so or their lower living standard than HBsAg negative mothers.
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권지윤,윤성도,조동현,길영식,김수경,Kwon, Gee-Youn,Yoon, Sung-Do,Cho, Dong-Hyun,Gil, Young-Sig,Kim, Soo-Kyung 대한임상약리학회 2003 Translational and Clinical Pharmacology Vol.11 No.2
Background: This study was conducted to evaluate the bioavailability of Fluconazole formulation in healthy Korean volunteers. Furthermore, the bioequivalence of $Flukan^{\circledR}$ capsule, a fluconazole preparation from Korea United Pharm, Inc., was determined. Methods: The study employed a randomized, two-way crossover Latin square design with a two-week washout period. The test product was $Flukan^{\circledR}$ capsule (Korea United Pharm Inc., South Korea) and the reference was $Diflucan^{\circledR}$ capsule (Pfizer Inc.). The two products were administered in 150 mg single oral doses into 26 healthy Korean volunteers. Serial blood samples were collected for a period of 120 hours. Plasma fluconazole concentrations of the two brands were measured by HPLC using UV detector, and the pharmacokinetic parameters including $AUC_t,\;C_{max},\;T_{max}$, and half-life were determined from plasma concentrations of both formulations. Results: Both formulations were well tolerated in 26 volunteers. Mean $AUC_t,\;C_{max}$ of $Flukan^{\circledR}$ capsule were 1.068 $(90%\;confidence\;interval:\;1.0057{\leq\delta\leq}1.1349)$ and 1.017 $(90%\;confidence\;interval:\;0.9633{\leq\delta\leq}1.0749)$ compared to those of $Diflucan^{\circledR}$ capsule. Mean half-life of $Flukan^{\circledR}$ capsule was $30.41{\pm}5.44$ and that of $Diflucan^{\circledR}$ capsule was $30.74{\pm}5.86$ hr. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were above 90%. The pharmacokinetic parameters $(AUC_t,\;C_{max},\;T_{ max})$ were analyzed statistically with K-BE test 2002 (KFDA). Conclusion : No significant differences between two formulations were observed in terms of $AUC_t\;and\;C_{max}$, the main pharmacokinetic parameters used for bioequivalence evaluation. The results satisfied the bioequivalence criteria of KFDA guidelines, and $Flukan^{\circledR}$ capsule was determined to be bioequivalent to $Diflucan^{\circledR}$ capsule.
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