• Title/Summary/Keyword: Adverse events

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Clinical Effects of Oseltamivir in Children with Influenza in Busan, in the First Half of 2004 (2004년 상반기에 부산 지역 소아에서 유행한 독감에서 Oseltamivir의 치료 효과)

  • Park, Soo Kyoung;Choi, So Young;Kim, Sung Mi;Kim, Gil Heun;Jung, Jin Hwa;Choi, Im Jung;Cho, Kyung Soon
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.976-985
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    • 2005
  • Purpose : Although influenza is one of the most important causes of acute respiratory tract infections in children, effective antiviral therapies are not common and there are only a few clinical studies on treatment of influenza in children. We evaluated the efficacy of oseltamivir in the treatment of naturally aquired influenza in children during the first half of 2004 in Busan. Methods : From January 2004 to June 2004, throat swabs and nasal washes were performed and cultured for the isolation of influenza virus and tested by rapid antigen detection test(QuickVue influenza test) in children with suspected influenza infections. The children who responded positively to the QuickVue influenza test, we divided into two groups : an oseltamivir treatment group and a control group. We compared their clinical symptoms(including fever duration) and diagnosis. The medical records of patients with influenza virus infection were reviewed retrospectively. Results : A total of 621 individuals were suspected of influenza infection. Influenza viruses were isolated in 79(17.2 percent) out of 621 patients examined. QuickVue influenza tests were positive in 181 cases. The treatment group(83 individuals) received oseltamivir twice daily for 5 days, and the control group(99 individuals) were administered only symptom relief medicine. There was no differences between the two groups in clinical diagnosis and symptoms. Oseltamivir treatment reduced the fever duration and other respiratory symptoms. There were no adverse events associated with oseltamivir treatment. Conclusion : Our data suggest that oral oseltamivir treatment reduces the fever duration and other respiratory symptoms of acute influenza without side effects in children.

Comparison of Antidepressants Tolerability in Cancer Patients Referred for Psychiatric Consultation (정신건강의학과 자문 의뢰된 암 환자의 항우울제 내약성 비교 연구)

  • Ko, Eunmi;Park, Jin-Seong;Ha, Juwon;Lim, Sewon;Kim, Tae-Suk;Ha, Jee Hyun;Paik, Jong-Woo;Lee, Boung Chul;Choe, Byeong Moo;Lee, Kang-Joon;Kim, Sung-Wan;Yang, Jong-Chul;Ko, Young-Hoon;Oh, Kang-Seob
    • Korean Journal of Psychosomatic Medicine
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    • v.21 no.1
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    • pp.3-10
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    • 2013
  • Objectives : Many patients diagnosed with cancer suffer from various psychiatric symptoms such as depression, anxiety and insomnia as well as cancer itself. Patients with cancer are more vulnerable to possible adverse events of psychotropic medications. Although antidepressants are widely used among cancer patients, there is little information about tolerability of antidepressants. This study was conducted to compare tolerability of antidepressants in cancer patients referred for psychiatric consultation. Methods : The participants were cancer patients who had been referred to psychiatrist for their psychiatric symptoms. We retrospectively analyzed the data of patients diagnosed with cancer from 9 general hospitals in Korea. The discontinuation rate for a 6 months period after treatment initiation for three antidepressants(Escitalopram, Mirtazapine, Paroxetine) were compared. Results : Antidepressants were prescribed for 96.3% of subjects and Escitalopram 150(47.2%), Mirtazapine 92(28.9%) and Paroxetine 76(23.9%) were prescribed frequently in order There were no significant differences in discontinuation rates among the three antidepressants during the 6 month period after initiation of pharmacotherapy. But there was a difference in discontinuation rates between inpatients versus outpatients(p<0.0001). Conclusions : In a naturalistic setting for the antidepressant treatment for cancer patients, it seems that there are no differences in discontinuation rates among these three antidepressants. It is therefore essential that such interactions are carefully considered when treating patients of antidepressants who already have cancer.

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Immunogenicity and safety of enhanced-inactivated poliovaccine(eIPV) in healthy Korean infants (한국 영아에서 eIPV의 면역원성과 안정성)

  • Kim, Jung Soo;Hong, Young Jin;Kim, Jong Duk;Jang, Young Taek;Kang, Jin Han
    • Clinical and Experimental Pediatrics
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    • v.49 no.8
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    • pp.864-869
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    • 2006
  • Purpose : We evaluated the immunogenicity and safety of eIPV(Imovax $Polio^{(R)}$) in a group of healthy Korean infants on a three-dose primary vaccination. Methods : Eighty one healthy infants aged 8-10 weeks were enrolled, and 79(male 42, female 37) completed the study. Three doses of eIPV were injected intramuscularly at 2, 4 and 6 months of age as of primary vaccination. Most subjects received concomitant vaccines such as DTaP and/or Hib at 2, 4, and 6 months of age. Immediate reactions were monitored for 30 minutes after each injection. Local and systemic events were recorded for 72 hours following each immunization by parents/guardians. Poliovirus specific neutralizing antibodies were measured using enzyme immuno-assay (EIA) at prior to and 1 month after the third dose. An antibody titer of 1:8 or higher was considered seroprotective. Geometric mean titers(GMTs) to each poliovirus type antigen were also measured. Results : One month after the third dose of eIPV, all infants(100 percent) were seroprotective. The geometric mean titers(GMTs) were 1,532(95 percent CI : 1,312-1,788) in type 1 and 835(95 percent CI : 684-1,018) in type 2 and 846(95 percent CI : 692-1,035) in type 3. Overall, local reactions were observed in 10 percent of infants and systemic reactions in 26.2 percent of infants. All reactions were observed within 3 days after vaccination and resolved without treatment. Conclusion : eIPV(Imovax $Polio^{(R)}$) is a well-tolerated and highly immunogenic vaccine. It can be administered either alone or simultaneously with other routine vaccines to Korean infants.

A Study on the Decision Point and a Standard of Judgment under the Duty of Inter-hospital Transfer for Patients of Doctor - Focused on the Trend of Supreme Court's Decisions - (의사의 전원의무(轉院義務) 위반 여부의 판단기준과 전원시점 판단 - 판례의 동향을 중심으로 -)

  • Choi, Hyun-tae
    • The Korean Society of Law and Medicine
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    • v.20 no.1
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    • pp.163-201
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    • 2019
  • Doctor has the duty of an inter-hospital transfer, known as inter-facility or secondary transfer, when the diagnostic and therapeutic facilities required for a patient are not available at the given hospital. Also, the decision to transfer the patient to an another facility is rely on whether ill patient is the benefits of care, including clinical and non-clinical reasons, available at the another facility against the potential risks. Crucial point to note is that issues about 'inter-hospital transfer' is limited to questions occurred in the course of transfer between emergency medicals (facilities). 'emergency medical (facility)' is specified by Medical Law, article 3 and the duty of an inter-hospital transfer includes any possible adverse events, medical or technical, during the transfer. Because each medical facility has an different ability to care for a patient in an emergency condition, coordination between the referring and receiving hospitals' emergency medicals would be important to ensure prompt transfer to the definitive destination avoiding delay at an emergency. Simultaneously, transfer of documents about the transfer process, medical record and investigation reports are important materials for maintaining continuity of medical care. Although the duty of an inter-hospital transfer is recognized as one of duty of doctor and more often than not it occurs, there is constant legal conflict between a doctor and a patient related to the duty of the inter-hospital transfer. Therefore, we need clear and specific legal standard about the inter-hospital transfer. This paper attempts to review the Supreme Court's cases associated to the inter-hospital transfer and to compare opinion of the cases with guideline for an inter-hospital transfer already given. Furthermore, this article is intended to broaden our horizons of understanding the duty of an inter-hospital transfer and I wish this article helps to resolve the settlement and case dealt with the duty of inter-hospital transfer.

Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants (한국의 건강한 영아를 대상으로 DTPa-IPV 혼합백신을 접종한 경우와 DTPa 백신과 IPV 백신을 각각 투여하였을 경우의 면역원성, 반응원성 및 안전성)

  • Kim, Chang Hwi;Cha, Sung Ho;Shin, Son Moon;Kim, Chun Soo;Choi, Young Youn;Hong, Young Jin;Chey, Myoung Jae;Kim, Kwang Nam;Hur, Jae Kyun;Jo, Dae Sun;Kim, Sung Shin;Lee, Sang Lak;Song, Eun Song;Ramakrishnan, Gunasekaran;Ok, Jin Ju;Van Der Meeren, Olivier;Bock, Hans L.;Kim, Jung Soo
    • Pediatric Infection and Vaccine
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    • v.17 no.2
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    • pp.156-168
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    • 2010
  • Purpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, $Infanrix^{TM}$ IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-ose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were ${\geq}99.5%$ and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.

Favorable Outcome in Elderly Asian Patients with Metastatic Renal Cell Carcinoma Treated with Everolimus: The Osaka Urologic Oncology Group

  • Inamoto, Teruo;Azuma, Haruhito;Nonomura, Norio;Nakatani, Tatsuya;Matsuda, Tadashi;Nozawa, Masahiro;Ueda, Takeshi;Kinoshita, Hidefumi;Nishimura, Kazuo;Kanayama, Hiro-Omi;Miki, Tsuneharu;Tomita, Yoshihiko;Yoshioka, Toshiaki;Tsujihata, Masao;Uemura, Hirotsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.4
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    • pp.1811-1815
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    • 2014
  • Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probably reflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratory analysis of elderly patients in the RECORD-1 Trial showed that patients ${\geq}$ 65 y.o. had superior median PFS than overall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relative benefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for older patients with metastatic renal cell cancer (mRCC), in daily practice. Materials and Methods: 172 consecutive IRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at 39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% had progressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had received other therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusion criterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters were mandatory. EVE administration was approved by the institutional review board at each participating institution and signed informed consent was obtained from all patients. Results: Median time of the whole cohort to last follow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup. There were 86 (50%) patients ${\geq}$ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Median survival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases, histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency of adverse events in elderly patients treated with EVE was no greater than that in younger patients, although such toxicity may have had a greater impact on their quality of life. Conclusions: Older patients should not generally be excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.

Mid-Term Results of Mitral Valve Repair Using a Partial Flexible Band and a Completely Rigid Ring in Patients with Degenerative Mitral Regurgitation (퇴행성 승모판막역류 환자에서 Partial Flexible Band와 Complete Rigid Ring을 이용한 승모판막 성형술의 중기 결과 비교)

  • Kim, Kyung-Hwan;Ahn, Hyuk;Hwang, Ho-Young;Choi, Jin-Ho;Kim, Ki-Bong
    • Journal of Chest Surgery
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    • v.43 no.5
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    • pp.475-481
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    • 2010
  • Background: We evaluated mid-term results of mitral annuloplasty using a flexible band and a completely rigid ring for mitral valve repair in patients with degenerative mitral regurgitation (MR). Material and Method: From January 2004 to September 2008, 71 patients (M:F=36:35, $55{\pm}13$ years) underwent mitral valve repair with mitral annuloplasty for degenerative MR. Ring annuloplasty was done using a Cosgrove-Edwards flexible band (Group I, n=43) or a Carpentier-Edwards classic ring (Group II, n=28). There were no differences in preoperative characteristics of the participants. Average duration of follow-up was 36 months (range: 2~69 mos). Result: There was no in-hospital mortality. Postoperative morbidity, which included atrial fibrillation (n=7) and low cardiac output syndrome (n=5) in groups I and II were similar. There was one late death in group II. The proportion exhibiting freedom from recurrent mitral regurgitation ($\geq$moderate) at 4 years in Groups I and II were, respectively, 94.5 and 91.8%, (p=0.695). Left ventricular ejection fraction decreased in the early postoperative period ($7{\pm}2$ days) and recovered by last follow-up ($25{\pm}16$ mos; p=0.002). The pattern was similar in groups I and II (p=0.905). Re-operation was performed in 3 patients (1 in Group I and 2 in Group II, p=0.316). Four-year event-free survival (free of adverse valve-related events) was 95.2% for Group I and 92.6% for Group II; this difference was not significant, p=0.646). Conclusion: The type of technique used in mitral annuloplasty to repair the mitral valve repair after degenerative MR did not affect mid-term clinical and functional results.

Granisetron in the Treatment of Radiotherapy-Induced Nausea and Vomiting (방사선치료 중 오심 및 구토에 대한 그라니세트론의 효과)

  • Hong, Seong-Eon;Kang, Jin-O
    • Radiation Oncology Journal
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    • v.17 no.2
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    • pp.141-145
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    • 1999
  • Purpose : Granisetron is a potent, the most selective 5-HT3 receptor antagonist and is reported to b effective in treatment of radiation-induced emesis. The antiemetic efficacy and safety of oral granisteron was evaluated in patients with receiving highly emetogenic treatment by conventional fractionated irradiation. Materials and Methods : Patients with various cancers who were being treated with irradiation were accrued into the present study. The intensity of nausea was evaluated on first 24 hours and on day-7 by patients according to the degree of interference with normal daily life as followings; a) none; b) present but no interference with normal daily life (mild): c) interference with normal daily life (moderate): and d) bedridden because of nausea (severe). Non or mild state was considered to indicate successful treatment. The efficacy of antiemetic treatment was graded as follows; a) complete response; no vomiting, no worse than mild nausea and receive no rescue antiemetic therapy over the 24h period, b) major response; either one episode of vomiting or moderate/severe nausea or had received rescue medication over 24h period, or any combination of these, c) minor response; two to four episodes of vomiting over the 24h period, regardless of nausea and rescue medication, d) failure; more than four medication. The score of the most symptom was recorded and the total score over 24 hours was summarized. The complete or major response was considered to indicate successful treatment. Results : A total of 10 patients were enrolled into this study, and all were assessable for efficacy analysis. Total nausea control was achieved in 90$\%$ (9/10:none=60$\%$ plus mild=30$\%$) of total patients after 7 days. The control of vomiting by granisteron was noted in seven patients (70$\%$) of complete response and three (30$\%$) of major response with a hundred-percent successful treatment over 7 days. The minor response or treatment failure were not observed. No significant adverse events or toxicities from granisetron were recorded in patient receiving granisetron. Conclusion : We concluded that granisetron is a highly effective antiemetic agent in controlling radiotherapy-induced nausea or vomiting with a minimal toxicity profile.

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Clinical Outcomes and Prognosis of Patients with Stent Fracture after Successful Drug-Eluting Stent Implantation (관상동맥 약물 방출 스텐트 삽입 후 스텐트 골절에 대한 임상결과 및 예후)

  • Kim, In-Soo;Han, Jae-Bok;Jang, Seong-Joo
    • Journal of radiological science and technology
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    • v.37 no.2
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    • pp.109-116
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    • 2014
  • Many studies have suggested that in the era of Drug-Eluting Stents(DES) are one of the causes of In-Stent Restenosis(ISR) of Stent Fracture(SF). The present study sought to evaluate clinical characteristics of patients with stent fracture after successful DES implantation. The 4,701 patients were selected for analysis who underwent a follow-up coronary angiography irrespective of ischemic symptoms. The overall incidence of SF was 32 patients(male:female=19:13, Av. age $62.44{\pm}9.8$year, 0.68%). Fractures of Sirolimus-Eluting Stents(SES), Paclitaxel-Eluting Stents(PES), Biolimus A9-Eluting Stents(BES), Everolimus-Eluting Etents(EES), Endothelial Progenitor Cell Capture Stent(EPC) and Zotarolimus-Eluting Stents(ZES) are accounted for 19(59.4%), 9(28.1%), 2(6.3%), 1(3.1%), 1(3.1%) and 0(0%) respectively. SF developed in the left Anterior Dscending(LAD) artery in 16 patients(50%) and in complex(type B2, C) lesions in 25 patients(69.4%). Ten patients were treated with heterogenous DES, the rest being treated with either homogenous DES(3 patients), plain old balloon angioplasty(3 patients), or conservative medical treatment(17 patients). None of the patients with SF suffered from cardiac death during a follow-up period of $32.9{\pm}12.4$ months. The overall rate of DES fracture over up to 3.7 years of follow-up was 0.68% with higher incidence in SES than in PES. SF frequently occurred in the LAD artery and in complex lesions. Of the patients with SF, coronary intervention was performed only when the binary restenosis lesion was significant. During the follow-up, patients with SF have continued on combination antiplatelet therapy. There is a very low rate of major adverse cardiac events(post-detection of SF), especially cardiac death associated with SF.

Tuberculin Reactivity in Neonates Vaccinated with BCG at Primary Care Clinics - With Two Types of BCG Vaccine and Two Strengths of PPD - (개원가의 신생아 BCG 접종 후 투베르쿨린 반응 평가 -접종 방법과 PPD 종류에 의한 차이 비교-)

  • Kim, Wan Ju;Lee, Sun Ho;Ahn, Sang Yoon;Yang, Seung Jae;Oh, Sung Hee
    • Pediatric Infection and Vaccine
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    • v.9 no.2
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    • pp.208-214
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    • 2002
  • Purpose : The number of newborns vaccinated with BCG of Tokyo 172 strain, which has been claimed to cause lesser degree of local adverse events including scar, has recently been increasing. However, tuberculin response to this vaccine has inadequately been studied, especially with newborns cared at primary care clinics. We, therefore, performed a study in newborns vaccinated with BCG at private pediatric offices and evaluated the response to PPD 2TU or PPD 5TU following vaccination with percutaneous or intradermal BCG. Methods : Two hundred infants who had been cared at three private pediatric offices were retrospectively enrolled in the study. One hundred fifty one infants had received percutaneous BCG(Tokyo strain); 129 infants had had tuberuclin test with PPD 2TU and the rest of 22 infants with PPD 5TU. Forty nine infants had received intradermal BCG(28 infants Copenhagen strain, I infant French strain, 20 infants unknown); 35 infants had had tuberculin test with PPD 2TU, 14 infants(11%) with PPD 5TU. Results : In infants vaccinated with percutaneous BCG, the mean induration diameter in tuberculin test was significantly greater with PPD 5TU($12.4{\pm}3.5mm$) compared to PPD 2TU ($9.2{\pm}4.4mm$). In infants vaccinated with intradermal BCG, the mean induration diameters in tuberculin test were $5.7{\pm}5.1mm$ to PPD 2TU and $6.6{\pm}4.8mm$ to PPD 5TU, which were not significantly different. The tuberculin response to PPD 2TU was significantly greater in infants vaccinated with percutaneous BCG compared to those with intradermal BCG. The tuberculin response to PPD 5TU was also significantly greater in infants vaccinated with percutaneous BCG compared to those with intradermal BCG. Conclusion : Percutaneous BCG(Tokyo strain) seems to cause greater response to tuberculin compared to intradermal BCG and PPD 2TU induces weaker response compared to PPD 5TU. Acknowledging some discrepancies from the previously reported data, which might have been due to the different source of the study subjects, more studies are needed to establish the range of tuberculin response following BCG vaccination in order to differentiate from tuberculosis.

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