• Title/Summary/Keyword: SAFE in Korea

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Mid-Term Results of Modified Hoffman Procedure for Rheumatoid Forefoot Deformity (류마티스 전족부 변형에 대한 변형 Hoffman 술식의 중기 결과)

  • Kim, Yoon-Chung;Choi, Hyun Chul;Lee, Hyo Jin;Ahn, Jae Hoon
    • Journal of the Korean Orthopaedic Association
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    • v.56 no.6
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    • pp.484-490
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    • 2021
  • Purpose: A rheumatoid forefoot deformity includes severe hallux valgus and claw toe of the four lateral toes. The authors intended to analyze the mid-term results of the modified Hoffman procedure for a rheumatoid forefoot deformity. Materials and Methods: Twenty-two feet of eighteen patients were followed up for more than two years after the modified Hoffman procedure. The mean age was 54.7 years, and the mean follow-up period was three years and four months. Clinically visual analogue scale (VAS) and American Orthopaedic Foot and Ankle Society (AOFAS) MP-IP score were analyzed preoperatively and postoperatively. The postoperative complications, the satisfaction of patients, and the presence of plantar callosity were also analyzed. Radiographically, the hallux valgus angle, the 1st intermetatarsal angle, the 1st interphalangeal angle, the 1st interphalangeal joint arthritic change after the operation, and the dorsiflexion angle and the time to union of the 1st metatarsophalangeal joint were analyzed. Results: Clinically, the VAS and AOFAS score were respectively improved from 7.1 points and 30.3 points preoperatively to 1.5 points and 83.1 points postoperatively (p<0.001). All patients were satisfied with the results. Plantar callosity disappeared in all cases. Radiographically, the mean hallux valgus angle, the 1st intermetatarsal angle, and the 1st interphalangeal angle changed from 52.8°, 13.3°, and 7.5° preoperatively to 16.2°, 8.7°, and 14.6° postoperatively (p<0.001). The mean dorsiflexion angle of the 1st metatarsophalangeal joint was 17.2° postoperatively. The mean time to radiographic union of the 1st metatarsophalangeal joint was 11.1 weeks. There were two cock-up deformities of the lesser toe, one wound problem, and two hallux interphalangeal joint arthritis as a complication. There were no cases of nonunion of the 1st metatarsophalangeal joint. Conclusion: The modified Hoffman procedure appears to be a safe and satisfactory procedure for a rheumatoid forefoot deformity.

Immunogenicity and Safety of a Combined Hepatitis B and Haemophilus influenzae Type b Conjugate(PRP-OMP) Vaccine(ComvaxTM; Merck & Co.) in Korean Infants (한국 영아에서 B형 간염과 PRP-OMP의 혼합백신(ComvaxTM; MSD사)의 면역원성 및 안전성)

  • Chung, Eun Hee;Ma, Sang Hyuck;Hong, Young Jin;Kim, Kyung Hyo;Kim, Jong-Hyun;Lee, Jin A;Lee, Hoan Jong
    • Pediatric Infection and Vaccine
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    • v.13 no.2
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    • pp.163-173
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    • 2006
  • Purpose : To reduce the number of injections necessary to vaccinate young infants, various combined vaccines have been developed. The $Comvax^{TM}$ manufactured by Merck & Co. is a combination of Hepatitis B and PRP-OMP conjugate Haemophilus influenzae Type b vaccine. The purpose of this study is to evaluate the immunogenicity and safety of $Comvax^{TM}$ in Korean infants. Methods : The infants who were vaccinated at 0 months of age with Hepatitis B vaccine, were recruited for this study after parental informed consent was obtained. The subjects were vaccinated with $Comvax^{TM}$ at 2 and 4 months of age. At each visit, infants were also immunized with DTaP, inactivated poliovirus vaccine, and pneumococcal vaccine when indicated. The serum anti-PRP and anti-HBs were measured at 2 months after the 1st dose(4 months age), and the 2nd dose(6 months age) by the ELISA and chemiluminescent microparticle immunoassay method, respectively. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Results : Among sixty-five healthy infants(35 male infants) enrolled in this study; fifty eight(32 male infants) completed the scheduled immunizations. The geometric mean titers (GMTs) of anti-PRP at 2 months after the 1st dose and the 2nd dose were 1.96 ${\mu}g/mL$ (95% CI; 1.38~2.78) and 10.02 ${\mu}g/mL$ (95% CI; 7.04~14.26), respectively. Anti-PRP ${\geq}1.0$ ${\mu}g/mL$, was obtained in 63.2%(95% CI; 53.75~72.65) after 1 dose, and 96.6%(95% CI; 93.05~100) after 2 doses. The GMTs of anti-HBs were 38.32 mIU/mL(95% CI; 22.42~65.51), and 101.17 mIU/mL(95% CI; 65.94~155.25) at 2 month after the 1st dose and 2nd dose of $Comvax^{TM}$, respectively. Anti-HBs ${\geq}10$ mIU/mL was observed in 73.7%(95% CI; 65.07~82.33) after 1 dose and 94.8%(95% CI; 90.45~99.15) after 2 doses. Most of the adverse reactions after vaccination were mild. Irritability, the most common systemic reaction, was observed in 24.8%, followed by drowsiness(19.2%), poor feeding(19.2%) and fever(7.2%). Among the local reactions tenderness was observed in 25.6%, redness(${\geq}5$ mm) in 19.2% and swelling(${\geq}5$ mm) in 4.8%. Conclusion : The $Comvax^{TM}$ vaccine was highly immunogenic for PRP and safe in Korean infants. Although the hepatitis B vaccine component was administered at 0, 2, 4 months, this study showed good immunogenicity against HBsAg.

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The Content and Risk Assessment of Heavy Metals in Herbal Pills (유통 환제의 유해 중금속 함량 및 위해도 평가)

  • Lee, Sung-Deuk;Lee, Young-Ki;Kim, Moo-Sang;Park, Seok-Ki;Kim, Yeon-Sun;Chae, Young-Zoo
    • Journal of Food Hygiene and Safety
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    • v.27 no.4
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    • pp.375-387
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    • 2012
  • The objective of this study is investigation of contamination levels and assessment of health risk effects of heavy metals in herbal pills. 31 Items and 93 samples were obtained for this investigation from major herbal medicine producing areas, herbal markets and on-line supermarkets from Jan to Jun in 2010. Inductively coupled plasma mass spectrometer method was conducted for the quantitative analysis of Pb, Cd and As. In addition, the mercury analyzer system was conducted for that of Hg without sample digestion. The average contents of heavy metals in samples were as follows : 0.87 mg/kg for Pb, 0.08 mg/kg for Cd, 2.87 mg/kg for As and 0.16 mg/kg for Hg, respectively. In addition, the average contents of heavy metals in different parts of plants, including cortex, fructus, herba, radix, seed, algae and others were 0.63 mg/kg, 3.94 mg/kg, 1.42 mg/kg, 1.05 mg/kg, 0.16 mg/kg, 22.31 mg/kg and 10.17 mg/kg, respectively. After the estimations of dietary exposure, the acceptable daily intake (ADI), the average daily dose (ADD), the provisional tolerable weekly intake (PTWI) and the relative hazard of heavy metals were evaluated. As the results, the relative hazards compared to PTWI in samples were below the recommended standard of JECFA as Pb 3.1%, Cd 0.9%, Hg 0.5%. Cancer risks through slope factor (SF) by Ministry of Environment Republic Korea and Environmental Protection Agency was $4.24{\times}10^{-7}$ for Pb and $3.38{\times}10^{-4}$ for As (assuming that the total arsenic content was equal to the inorganic arsenic). Based on our results, possible Pb-induced cancer risks in herbal pills according to parts used including cortex, fructus, herba, radix, seed, algae and others were $1.95{\times}10^{-7}$, $1.45{\times}10^{-6}$, $2.14{\times}10^{-7}$, $6.27{\times}10^{-7}$, $1.99{\times}10^{-8}$, $3.61{\times}10^{-7}$ and $9.64{\times}10^{-8}$, respectively. Possible As-induced cancer risks in herbal pills by parts used including cortex, fructus, herba, radix, seed, algae and others were $1.54{\times}10^{-5}$, $7.24{\times}10^{-5}$, $1.23{\times}10^{-4}$, $2.02{\times}10^{-5}$, $3.25{\times}10^{-6}$, $2.18{\times}10^{-3}$ and $5.67{\times}10^{-6}$ respectively. Taken together, these results indicate that the majority of samples except for some samples with relative high contents of heavy metals were safe.