• Title/Summary/Keyword: Adverse drug reaction

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Arthralgia and Myalgia Associated with the Use of Bisphosphonate: An Active Monitoring Study (비스포스포네이트 제제 관련 관절통 및 근육통에 대한 지역 약국 약사 및 환자 능동적 모니터링)

  • Song, Jung-woo;Park, So-Hee;Yoon, Dongwon;Lee, Mo-Se;Lee, Jung-Min;Kim, Na-Young;Kim, Young-Wook;Lee, Ju-Yeun;Shin, Ju-Young
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.3
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    • pp.180-187
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    • 2021
  • Objective: We investigated arthralgia and myalgia associated with the use of oral bisphosphonate (BP) by conducting a survey of patient. Methods: The pharmacists conducted a survey between 1 Oct 2019 and 30 Sep 2020 among patients who were dispensed BP in community pharmacies to assess their demographic and medical characteristics, and their experiences with, and process for pain. Logistic regression analyses were performed to find the risk factors associated with the pain, and the odds ratios (OR) and 95% confidence intervals (CI) were determined. Results: A total of 160 patients who used BP participated in the survey (74 [46.3%] used risedronate; 61 [38.1%] used alendronate; 23 [14.4%] used ibandronate), and 20 (12.5%) of them experienced pain. Significant statistical differences of the characteristics between patients who experienced pain or not were observed regarding menopause, and parity. Compared with women who had one or two parity, women who had more than three parity were associated with the decreased risk of pain (OR, 0.24; 95% CI, 0.04-0.98). Moreover, steady exercise was associated with the decreased risk of pain compared to less exercise (OR, 0.37; 95% CI, 0.14-0.98). Conclusion: Our findings suggest that the risk of pain in BP-treated patients might be different regarding the different ingredients of BP, and dosing frequency. This survey highlights a need for a further safety research to understand the factors influencing the pain associated with the BP treatment.

The Safety and Immunogenicity of a Trivalent, Live, Attenuated MMR Vaccine, PriorixTM (MMR(Measles-Mumps-Rubella) 약독화 생백신인 프리오릭스주를 접종한 후 안전성과 유효성의 평가에 관한 연구)

  • Ahn, Seung-In;Chung, Min-Kook;Yoo, Jung-Suk;Chung, Hye-Jeon;Hur, Jae-Kyun;Shin, Young-Kyu;Chang, Jin-Keun;Cha, Sung-Ho
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.960-968
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    • 2005
  • Purpose : This multi-center, open-label, clinical study was designed to evaluate the safety and immunogenicity of a trivalent, live, attenuated measles-mumps-rubella(MMR) vaccine, $Priorix^{TM}$ in Korean children. Methods : From July 2002 to February 2003, a total of 252 children, aged 12-15 months or 4-6 years, received $Priorix^{TM}$ at four centers : Han-il General Hospital, Kyunghee University Hospital, St. Paul's Hospital at the Catholic Medical College in Seoul, and Korea University Hospital in Ansan, Korea. Only subjects who fully met protocol requirements were included in the final analysis. The occurrence of local and systemic adverse events after vaccination was evaluated from diary cards and physical examination for 42 days after vaccination. Serum antibody levels were measured prior to and 42 days post-vaccination using IgG ELISA assays at GlaxoSmithKline Biologicals (GSK) in Belgium. Results : Of the 252 enrolled subjects, a total of 199 were included in the safety analysis, including 103 from the 12-15 month age group and 96 from the 4-6 year age group. The occurrence of local reactions related to the study drug was 10.1 percent, and the occurrence of systemic reactions was 6.5 percent. There were no episodes of aseptic meningitis or febrile convulsions, nor any other serious adverse reaction. In immunogenicity analysis, the seroconversion rate of previously seronegative subjects was 99 percent for measles, 93 percent for mumps and 100 percent for rubella. Both age groups showed similar seroconversion rates. The geometric mean titers achieved, 42 days pos-tvaccination, were : For measles, in the age group 12-15 months, 3,838.6 mIU/mL [3,304.47, 4,458.91]; in the age group 4-6 years, 1,886.2 mIU/mL [825.83, 4,308.26]. For mumps, in the age group 12-15 months, 956.3 U/mL [821.81, 1,112.71]; in the age group 4-6 years, 2,473.8 U/mL [1,518.94, 4,028.92]. For rubella, in the age group 12-15 months, 94.5 IU/mL [79.56, 112.28]; in the age group 4-6 years, 168.9 IU/mL [108.96, 261.90]. Conclusion : When Korean children in the age groups of 12-15 months or 4-6 years were vaccinated with GlaxoSmithKline Biologicals' live attenuated MMR vaccine ($Priorix^{TM}$), adverse events were limited to those generally expected with any live vaccine. $Priorix^{TM}$ demonstrated excellent immunogenicity in this population.

Cyclophosphamide in the Treatment of Idiopathic UIP and NSIP (통상성 간질성 폐렴과 비특이성 간질성 폐렴의 치료에 있어 Cyclophosphamide의 역할)

  • Jeon, Kyeongman;Chung, Man Pyo;Shin, Sung-Chul;Yu, Chang Min;Koh, Won-Jung;Suh, Gee Young;Kim, Hojoong;Kwon, O Jung;Kim, Tae Sung;Lee, Kyung Soo;Han, Joungho
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.2
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    • pp.175-187
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    • 2003
  • Background : Although corticosteroid and cytotoxic agent such as cyclophosphamide have been used for the treatment idiopathic interstitial pneumonia (IIP), efficacy of these toxic drugs are unclear because previous reports included the patients who did not undergo surgical lung biopsy and none evaluated the response according to histopathologic entities of IIP. To answer this, we retrospectively analyzed the treatment response and side effects of corticosteroids and cyclophosphamide therapy in patients with idiopathic UIP and NSIP. Methods : Among 61 patients with UIP and 26 patients with NSIP diagnosed by surgical lung biopsy at Samsung Medical Center from July 1996 to June 2002, those who received corticosteroid or cyclophosphamide therapy for at least 6 months and were followed for at least one year after the initiation of treatment were enrolled (32 UIP, 23 NSIP). Treatment response of 55 patients was assessed by ATS response criteria (clinical symptoms, pulmonary function test and radiological findings). Adverse reactions to either agent (42 cases of cyclophosphamide${\pm}$low-dose prednisolone, 49 cases of prednisolone alone) were also analyzed. Results : Irrespective of treatment regimen, NSIP showed more favorable response than UIP (6 months: 78.3% vs. 9.4%, 12 months: 69.6% vs. 9.4%, p<0.001). Cyclophosphamide showed comparable response to corticosteroid in NSIP while its efficacy was as poor as those of corticosteroid therapy in UIP. Significant adverse reaction to drug more frequently occurred in corticosteroid group (35.7%) than cyclophosphamide group (14.3%) (p=0.017). Conclusion : Cyclophosphamide is effective and more tolerable than corticosteroids in the treatment of idiopathic nonspecific interstitial pneumonia.

Clinical and Bacteriologic Efficacy of Cefdinir on Pharyngitis and Pharyngotonsillitis Caused by Group A Beta Hemolytic Streptococci in Children (Group A-beta Hemolytic Streptococci에 의한 소아 인두편도염에 있어서 Cefdinir의 항균력과 임상적 및 세균학적 효과에 관한 연구)

  • Chung, Ji-Young;Sin, Seon-Hee;Ahn, Young-Min;Ahn, Byung-Moon;Sin, Young-Gyu;Bae, Young-Min;Park, Soo-Eun;Kim, Jong-Guk;Lee, Jong-Guk;Ma, Saung-Hyuk;Chang, Jin-Kun;Cha, Sung-Ho
    • Pediatric Infection and Vaccine
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    • v.10 no.1
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    • pp.95-101
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    • 2003
  • Objective : To determine the clinical and bacteriologic efficacy and safety of Cefdinir in acute pharyngitis and pharyngotonsillitis caused by group A beta hemolytic streptococci in pediatric patients. Methods : Children aged 3 through 12 years who visited the hospitals enrolled in this study with signs and symptoms of pharyngitis or pharyngotonsillitis since May to December 2002, were taken throat culture and given Cefdinir(12 mg/kg/day, in three divided doses) for 7 days. Two hundred thirty five patients were enrolled and 90 patients who showed positive culture results were followed up for the signs and symptoms during the treatment to determine clinical efficacy. Follow-up culture were done at the end of the study and bacteriologic efficacy was determined Results : Ninety out of 235 patients who visited the hospitals with the signs and symptoms of pharyngitis showed positive growth on throat culture. Seventy nine patients were clinically and microbiologically assessable. The bacteriologic eradication rates of S. pyogenes were 100% in all the children treated with Cefdinir. Clinical cure rates were not different between less than 7 days-treated group(75%) and just 7 days-treated group(98.6%)(P=0.077). Two patients reported adverse reaction during Cefdinir treatment. Antimicrobial sensitivity of Cefdinir against S. pyogenes was 100% with range of MIC being less than 0.5 ${\mu}g/mL$. Conclusion : It seems that Cefdinir is one of reliable and well-tolerated drugs for the treatment of group A beta hemolytic streptococcal pharyngotonsillitis in children. It needs to be investigated short term efficacy in terms of improving drug compliance and impact of economic point of view. We can recognized that still high rate of the erythromycin resistant group A streptococci in our community should be monitored every year.

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The Short Term Efficacy of Entecavir Therapy in Chronic Hepatitis B (만성 B형 간염 환자에서 엔테카비어의 단기 치료 효과)

  • Kim, Hyun;Chae, Hee-Bok;Jeon, Won-Joong;Park, Seon-Mee;Youn, Sei-Jin;Eun, Jong-Ryul;Lee, Heon-Ju
    • Journal of Yeungnam Medical Science
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    • v.25 no.1
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    • pp.31-40
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    • 2008
  • Background/Aims : Entecavir is a synthetic nucleoside analogue, cyclopentyl guanine nucleoside, which has a potent antiviral effect and the least viral breakthrough in hepatitis B virus (HBV) replication. Entecavir has been available in Korea since 2007 but there are few reports on its effects. The aim of this study was to evaluate the virological response (VR) and biochemical response (BR) to entecavir in HBV patients at 3, 6 and 9 months after treatment with entecavir. Materials and Methods : Thirty-three chronic hepatitis B patients who took entecavir for at least 9 months were enrolled. We investigated VR and BR by retrospectively reviewing medical records. Patients who satisfied the following criteria were chosen: 1) initial alanine aminotransferase (ALT) levels = 1.5upper limit of normal (ULN) and 2) initial HBV DNA levels = $5\;log_{10}\;copies/ml$. We measured ALT levels every 3 months until month 9. HBV DNA was measured every 2 or 3 months by polymerase chain reaction (PCR) method. Results : Most patients taking entecavir showed good BR (ALT < 40 IU/L). The BR rates were 61%, 73% and 67% at months 3, 6 and 9, respectively. VR (HBV DNA < $5\;log_{10}\;copies/ml$ or 2 log lower than initial HBV DNA) rates were 82%, 91% and 91% at months 3, 6 and 9, respectively. Undetectable HBV DNA (HBV DNA < 4 log10 copies/ml) rates were 49%, 73% and 85% at months 3, 6 and 9, respectively. Two patients presented with virological breakthrough without adverse effects until month 9. Conclusions : Entecavir showed good BR and VR from month 3 and these effects continued through the 9-month observation period. This suggests that entecavir is also a good choice for the first line treatment of chronic hepatitis B (CHB). Further studies are needed to determine the long-term efficacy and drug resistance of entecavir in Korean CHB patients.

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