• Title/Summary/Keyword: Protocol

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Preoperative Concurrent Radio-chemotherapy for Rectal Cancer: Report of Early Results (직장암에 대한 수술 전 동시병용 방사선-항암 화학요법: 초기 치료결과 보고)

  • Shin, Seong-Soo;Ahn, Yong-Chan;Chun, Ho-Kyung;Lee, Woo-Yong;Kang, Won-Ki;Park, Young-Suk;Park, Joon-Oh;Song, Sang-Yong;Lim-Do-Hoon;Park, Won;Lee, Jung, Eun;Kang, Min-Kyu;Park, Yung-Je
    • Radiation Oncology Journal
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    • v.21 no.2
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    • pp.125-134
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    • 2003
  • Purpose: To report the early results of preopeartive concurrent radio-chemotherapy (CRCT) for treating rectal cancer. Materials and Methods: From June 1999 to April 2002, 40 rectal cancer patients who either had lesions with a questionable resectability or were candidates for sphincter-sacrificing surgery received preoperative CRCT. Thirty-seven patients completed the planned CRCT course. 45 Gy by 1.8 Gy daily fraction over 5 weeks was delivered to the whole pelvis in the prone position. The chemotherapy regimens were oral UFT plus oral leucovorin (LV) in 12 patients, intravenous bolus 5-FU plus LV in 10 patients, and intravenous 5-FU alone in 15 patients (bolus infusion in 10, continuous infusion in 5). Surgery was planned in 4$\~$6 weeks of the completion of the preoperative CRCT course, and surgery was attempted in 35 patients. Results: The compliance to the current preoperative CRCT protocol was excellent, where 92.5$\%$ (37/40) completed the planned treatment. Among 35 patients, in whom surgery was attempted after excluding two patients with new metastatic lesions in the liver and the lung, sphincter-preservation was achieved in 22 patients (62.9$\%$), while resection was abandoned during laparotomy in two patients (5.7$\%$). Gross complete resection was peformed in 30 patients, gross incomplete resection was peformed in one patient, and no detailed information on the extent of surgery was available in two patients. Based on the surgical and pathological findings, the down-staging rate was 45.5$\%$ (15/33), and the complete resection rate with the negative resection margin 78.8$\%$ (26/33). During the CRCT course, grade 3 $\~$4 neutropenia developed in four patients (10.8$\%$). Local recurrence after surgical resection developed in 12.1$\%$ (4/33), and distant metastases after the preoperative CRCT start developed in 21.6$\%$ (8/37). The overall 3-years survival rate was 87$\%$. Conclusion: Preoperative CRCT in locally advanced rectal cancer is well tolerated and can lead to high resection rate, down-staging rate, sphincter preservation rate, however, longer term follow-up will be necessary to confirm these results.

Bladder Preserving Treatment in Patients with Muscle Invasive Bladder Cancer (근침윤성 방광암 환자의 방광 보존적 치료 결과)

  • Yu, Jeong-Il;Oh, Dong-Ryol;Huh, Seung-Jae;Choi, Han-Yong;Lee, Hyon-Moo;Jeon, Seong-Soo;Yim, Ho-Young;Kim, Won-Suk;Lim, Do-Hoon;Ahn, Yong-Chan;Park, Won
    • Radiation Oncology Journal
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    • v.25 no.2
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    • pp.70-78
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    • 2007
  • [ $\underline{Purpose}$ ]: This study analyzed the tumor response, overall survival, progression free survival and related prognostic factors in patients with muscle invasive bladder cancer subjected to bladder preserving treatment. $\underline{Materials\;and\;Methods}$: Between August 1995 and June 2004, 37 patients with muscle invasive (transitional cell carcinoma, clinically stage T2-4) bladder cancer were enrolled for the treatment protocol of bladder preservation. There were 33 males and 4 females, and the median age was 67 years (range $38{\sim}86\;years$). Transurethral resection of the bladder (TURB) was performed in 17 patients who underwent complete resection. The median radiation dose administered was 64.8 Gy (range $55.8{\sim}67\;Gy$). The survival rate was calculated by the Kaplan-Meier method. $\underline{Results}$: An evaluation of the response rate was determined by abdomen-pelvic CT and cystoscopy at three months after radiotherapy. A complete response was seen in 17 patients (46%). The survival rate at three years was 54.7%, with 54 months of median survival (range $3{\sim}91$ months). During the study, 17 patients died and 13 patients had died from bladder cancer. The progression free survival rate at three years was 37.2%. There were 24 patients (64.9%) who had disease recurrence: 16 patients (43.2%) had local recurrence, 6 patients (16.2%) had a distant recurrence, and 2 patients (5.4%) had both a local and distant recurrence. The survival rate (p=0.0009) and progression free survival rates (p=0.001) were statistically significant when compared to the response rate after radiotherapy. $\underline{Conclusion}$: The availability of complete TURB and appropriate chemoradiotherapy were important predictors for bladder preservation and survival.

Predicting Oxygen Uptake for Men with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD환자에서 6분 보행검사를 이용한 최대산소섭취량 예측)

  • Kim, Changhwan;Park, Yong Bum;Mo, Eun Kyung;Choi, Eun Hee;Nam, Hee Seung;Lee, Sung-Soon;Yoo, Young Won;Yang, Yun Jun;Moon, Joung Wha;Kim, Dong Soon;Lee, Hyang Yi;Jin, Young-Soo;Lee, Hye Young;Chun, Eun Mi
    • Tuberculosis and Respiratory Diseases
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    • v.64 no.6
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    • pp.433-438
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    • 2008
  • Background: Measurement of the maximum oxygen uptake in patients with chronic obstructive pulmonary disease (COPD) has been used to determine the intensity of exercise and to estimate the patient's response to treatment during pulmonary rehabilitation. However, cardiopulmonary exercise testing is not widely available in Korea. The 6-minute walk test (6MWT) is a simple method of measuring the exercise capacity of a patient. It also provides high reliability data and it reflects the fluctuation in one' s exercise capacity relatively well with using the standardized protocol. The prime objective of the present study is to develop a regression equation for estimating the peak oxygen uptake ($VO_2$) for men with moderate to very severe COPD from the results of a 6MWT. Methods: A total of 33 male patients with moderate to very severe COPD agreed to participate in this study. Pulmonary function testing, cardiopulmonary exercise testing and a 6MWT were performed on their first visits. The index of work ($6M_{work}$, 6-minute walk distance [6MWD]${\times}$body weight) was calculated for each patient. Those variables that were closely related to the peak $VO_2$ were identified through correlation analysis. With including such variables, the equation to predict the peak $VO_2$ was generated by the multiple linear regression method. Results: The peak $VO_2$ averaged $1,015{\pm}392ml/min$, and the mean 6MWD was $516{\pm}195$ meters. The $6M_{work}$ (r=.597) was better correlated to the peak $VO_2$ than the 6MWD (r=.415). The other variables highly correlated with the peak $VO_2$ were the $FEV_1$ (r=.742), DLco (r=.734) and FVC (r=.679). The derived prediction equation was $VO_2$ (ml/min)=($274.306{\times}FEV_1$)+($36.242{\times}DLco$)+($0.007{\times}6M_{work}$)-84.867. Conclusion: Under the circumstances when measurement of the peak $VO_2$ is not possible, we consider the 6MWT to be a simple alternative to measuring the peak $VO_2$. Of course, it is necessary to perform a trial on much larger scale to validate our prediction equation.

Effect of Additional 1 hour T-piece Trial on Weaning Outcome to the Patients at Minimum Pressure Support (최소압력보조 수준에서 추가적 1시간 T-piece 시도가 이탈에 미치는 영향)

  • Hong, Sang-Bum;Koh, Youn-Suck;Lim, Chae-Man;Ann, Jong-Jun;Park, Wann;Shim, Tae-Son;Lee, Sang-Do;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.4
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    • pp.813-822
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    • 1998
  • Background: Extubation is recommended to be performed at minimum pressure support (PSmin) during the pressure support ventilation (PSV). In field, physicians sometimes perform additional 1 hr T-piece trial to the patient at PSmin to reduce re-intubation risk. Although it provides confirmation of patient's breathing reserve, weaning could be delayed due to increased airway resistance by endotracheal tube. Methods: To investigate the effect of additional 1 hr T-piece trial on weaning outcome, a prospective study was done in consecutive 44 patients who had received mechanical ventilation more than 3 days. Respiratory mechanics, hemodymic, and gas exchange measurements were done and the level of PSmin was calculated using the equation (PSmin=peak inspiratory flow rate $\times$ total ventilatory system resistance) at the 15cm $H_2O$ of pressure support. At PSmin, the patients were randomized into intervention (additional 1 hr T-piece trial) and control (extubation at PSmin). The measurements were repeated at PSmm, during weaning process (in cases of intervention), and after extubation. The weaning success was defined as spontaneous breathing more than 48hr after extubation. In intervention group, failure to continue weaning process was also considered as weaning failure. Results: Thirty-six patients with 42 times weaning trial were satisfied to the protocol. Mean PSmin level was 7.6 (${\pm}1.9$)cm $H_2O$. There were no differences in total ventilation times (TVT), APACHE III score, nutritional indices, and respiratory mechanics at PSmin between 2 groups. The weaning success rate and re-intubation rate were not different between intervention group (55% and 18% in each) and control group (70% and 20% in each) at first weaning trial. Work of breathing, pressure time product, and tidal volume were aggravated during 1 hr T-piece trial compared to those of PSmin in intervention group ($10.4{\pm}1.25$ and $1.66{\pm}1.08$ J/L in work of breathing) ($191{\pm}232$ and $287{\pm}217$cm $H_2O$ s/m in pressure time product) ($0.33{\pm}0.09$ and $0.29{\pm}0.09$ L in tidal volume) (P<0.05 in each). As in whole, TVT, and tidal volume at PSmin were significantly different between the patients with weaning success ($246{\pm}195$ hr, $0.43{\pm}0.11$ L) and the those with weaning failure ($407{\pm}248$ hr, $0.35{\pm}0.10$L) (P<0.05 in each). Conclusion : There were no advantage to weaning outcome by addition of 1 hr T-piece trial compared to prompt extubation to the patient at PS min.

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Establishment and Application of Molecular Genetic Techniques for Preimplantation Genetic Diagnosis of Osteogenesis Imperfecta (골형성부전증의 착상전 유전진단을 위한 분자유전학적 방법의 조건 확립과 적용)

  • Kim, Min-Jee;Lee, Hyoung-Song;Choi, Hye-Won;Lim, Chun-Kyu;Cho, Jae-Won;Kim, Jin-Young;Song, In-Ok;Kang, Inn-Soo
    • Clinical and Experimental Reproductive Medicine
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    • v.35 no.2
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    • pp.99-110
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    • 2008
  • Objectives: Preimplantation genetic diagnosis (PGD) has become an assisted reproductive technique for couples carrying genetic conditions that may affect their offspring. Osteogenesis imperfecta (OI) is an autosomal dominant disorder of connective tissue characterized by bone fragility and low bone mass. At least 95% of cases are caused by dominant mutations in the COL1A1 or COL1A2. In this study, we report on our experience clinical outcomes with 5 PGD cycles for OI in two couples. Methods: Before clinical PGD, we assessed the amplification rate and allele drop-out (ADO) rate of alkaline lysis and nested PCR protocol using heterozygous patient's single lymphocytes in the pre-clinical diagnostic tests for OI. We performed 5 cycles of PGD for OI by nested PCR for the causative mutation loci, COL1A1 c.2452G>A and c.3226G>A, in case 1 and case 2, respectively. The PCR products were analyzed by agarose gel electrophoresis, restriction fragment length polymorphism (RFLP) analysis with HaeIII restriction enzyme in the case 1 and direct DNA sequencing. Results: We confirmed the causative mutation loci, COL1A1 c.2452G>A in case 1 and c.3226G>A in case 2. In the pre-clinical tests, the amplification rate was 94.2% and ADO rate was 22.5% in case 1, while 98.1% and 1.9% in case 2, respectively. In case 1, a total of 34 embryos were analyzed and 31 embryos (91.2%) were successfully diagnosed in 3 PGD cycles. Eight out of 19 embryos diagnosed as unaffected embryos were transferred in all 3 cycles, and in the third cycle, pregnancy was achieved and a healthy baby was delivered without any complications in July, 2005. In case 2, all 19 embryos (100.0%) were successfully diagnosed and 4 out of 11 unaffected embryos were transferred in 2 cycles. Pregnancy was achieved in the second cycle and the healthy baby was delivered in March, 2008. The causative locus was confirmed as a normal by amniocentesis and postnatal diagnosis. Conclusions: To our knowledge, these two cases are the first successful PGD for OI in Korea. Our experience provides a further demonstration that PGD is a reliable and effective clinical techniques and a useful option for many couples with a high risk of transmitting a genetic disease.

Treatment Results of Radical Radiotherapy in Uterine Cervix Cancer (자궁경부암 환자의 근치적 방사선치료성적)

  • Huh Seung Jae;Kim Bo Kyong;Lim Do Hoon;Shin Seong Soo;Lee Jeong Eun;Kang Min Kyu;Ahn Yong Chan
    • Radiation Oncology Journal
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    • v.20 no.3
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    • pp.237-245
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    • 2002
  • Purpose : This study was conducted to evaluate the treatment results, prognostic factors, and complication rates after high dose rate (HDR) brachytherapy in patients with uterine cervix cancer who were treated with curative aim. Materials and Methods : Of 269 cervix cancer patients treated at the department of radiation oncology, Samsung Medical Center from September 1994 to July 1998, the 106 who were treated with radical radio-therapy were analyzed. The median age was 61 years (range 22 to 89). All patients except 4 with carcinoma in situ (CIS) were given external beam radiotherapy (range $30.6\~50.4\;Gy$ to whole pelvis) and HDR brachytherapy. The common regimens of HDR brachytherapy were a total dose of $24\~28\;Gy$ with $6\~7$ fractions to point A at two fractions per week. The median overall treatment time was 55 days (range 44 to 104) in patients given both external beam radiotherapy and HDR brachytherapy. Results : Early responses of radiotherapy were evaluated by gynecologic examination and follow-up MRI 1 month after radiotherapy. Treatment responses were complete remission in 72 patients, partial response in 33 and no response in 1. The overall survival (OS) rate of all patients was $82\%,\;and\;73\%$, and the disease free survival (DFS) rate was $72\%,\;and\;69\%$, at 3, and 5 years, respectively. The pelvic control rate (PCR) was $79\%$ at both 3 and 5 years. According to the FIGO stage,3 and 5 year OS were $100\%\;and\;50\%$ in CIS/IA, $100\%\;and\;100%$ in IB, $83\%\;and\;69\%$ in IIA, $87\%\;and\;80\%$ in IIB, and $62\%\;and\;62\%$ in III, respectively. The 3 year OS in 4 patients with stage IVA was $100\%$. Three-year DFS were $80\%$ in CIS/IA, $88\%$ in IB, $100\%$ in IIA, $64\%$ in IIB, $58\%$ in III, and $75\%$ in IVA. Three-year PCR were $100\%$ in CIS/IA, $94\%$ in IB, $100\%$ in IIA, $84\%$ in IIB, $69\%$ in III, and $50\%$ in IVA. By univariate analysis, FIGO stage and treatment response were significant factors for OS. The significant factors for DFS were age, FIGO stage, treatment response and overall treatment time (OTT). For pelvic control rate, treatment response and OTT were significant factors. By multivariate analysis, FIGO stage had a borderline significance for OS (p=0.0825) and treatment response had a borderline significance for DFS (0=0.0872). A total of 14 patients $(13\%)$ experienced rectal bleeding, which occurred from 3 to 44 months (median, 13 months) after the completion of radiotherapy. Conclusion : HDR brachytherapy protocol of Samsung Medical Center combined with properly optimal external beam pelvic irradiation is a safe and effective treatment for patients with uterine cervix cancer. The authors found that OTT of less than 55 days had a positive impact on pelvic control and survival rate.

Comparison of Activity Capacity Change and GFR Value Change According to Matrix Size during 99mTc-DTPA Renal Dynamic Scan (99mTc-DTPA 신장 동적 검사(Renal Dynamic Scan) 시 동위원소 용량 변화와 Matrix Size 변경에 따른 사구체 여과율(Glomerular Filtration Rate, GFR) 수치 변화 비교)

  • Kim, Hyeon;Do, Yong-Ho;Kim, Jae-Il;Choi, Hyeon-Jun;Woo, Jae-Ryong;Bak, Chan-Rok;Ha, Tae-Hwan
    • The Korean Journal of Nuclear Medicine Technology
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    • v.24 no.1
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    • pp.27-32
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    • 2020
  • Purpose Glomerular Filtration Rate(GFR) is an important indicator for evaluating renal function and monitoring the progress of renal disease. Currently, the method of measuring GFR in clinical trials by using serum creatinine value and 99mTc-DTPA(diethylenetriamine pentaacetic acid) renal dynamic scan is still useful. After the Gates method of formula was announced, when 99mTc-DTPA Renal dynamic scan is taken, it is applied the GFR is measured using a gamma camera. The purpose of this paper is to measure the GFR by applying the Gates method of formula. It is according to effect activity and matrix size that is related in the GFR. Materials and Methods Data from 5 adult patients (patient age = 62 ± 5, 3 males, 2 females) who had been examined 99mTc-DTPA Renal dynamic scan were analyzed. A dynamic image was obtained for 21 minutes after instantaneous injection of 99mTc-DTPA 15 mCi into the patient's vein. To evaluate the glomerular filtration rate according to changes in activity and matrix size, total counts were measured after setting regions of interest in both kidneys and tissues in 2-3 minutes. The distance from detector to the table was maintained at 30cm, and the capacity of the pre-syringe (PR) was set to 15, 20, 25, 30 mCi, and each the capacity of post-syringe (PO) was 1, 5, 10, 15 mCi is set to evaluate the activity change. And then, each matrix size was changed to 32 × 32, 64 × 64, 128 × 128, 256 × 256, 512 × 512, and 1024 × 1024 to compare and to evaluate the values. Results As the activity increased in matrix size, the difference in GFR gradually decreased from 52.95% at the maximum to 16.67% at the minimum. The GFR value according to the change of matrix size was similar to 2.4%, 0.2%, 0.2% of difference when changing from 128 to 256, 256 to 512, and 512 to 1024, but 54.3% of difference when changing from 32 to 64 and 39.43% of difference when changing from 64 to 128. Finally, based on the presently used protocol, 256 × 256, PR 15 mCi and PO 1 mCi, the GFR value was the largest difference with 82% in PR 15 mCi and PO 1 mCi. conditions, and at the least difference is 0.2% in the conditions of PR 30 mCi and PO 15 mCi. Conclusion Through this paper, it was confirmed that when measuring the GFR using the gate method in the 99mTc-DTPA renal dynamic scan. The GFR was affected by activity and matrix size changes. Therefore, it is considered that when taking the 99mTc-DTPA renal dynamic scan, is should be careful by applying appropriate parameters when calculating GFR in the every hospital.

Critical Success Factor of Noble Payment System: Multiple Case Studies (새로운 결제서비스의 성공요인: 다중사례연구)

  • Park, Arum;Lee, Kyoung Jun
    • Journal of Intelligence and Information Systems
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    • v.20 no.4
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    • pp.59-87
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    • 2014
  • In MIS field, the researches on payment services are focused on adoption factors of payment service using behavior theories such as TRA(Theory of Reasoned Action), TAM(Technology Acceptance Model), and TPB (Theory of Planned Behavior). The previous researches presented various adoption factors according to types of payment service, nations, culture and so on even though adoption factors of identical payment service were presented differently by researchers. The payment service industry relatively has strong path dependency to the existing payment methods so that the research results on the identical payment service are different due to payment culture of nation. This paper aims to suggest a successful adoption factor of noble payment service regardless of nation's culture and characteristics of payment and prove it. In previous researches, common adoption factors of payment service are convenience, ease of use, security, convenience, speed etc. But real cases prove the fact that adoption factors that the previous researches present are not always critical to success to penetrate a market. For example, PayByPhone, NFC based parking payment service, successfully has penetrated to early market and grown. In contrast, Google Wallet service failed to be adopted to users despite NFC based payment method which provides convenience, security, ease of use. As shown in upper case, there remains an unexplained aspect. Therefore, the present research question emerged from the question: "What is the more essential and fundamental factor that should takes precedence over factors such as provides convenience, security, ease of use for successful penetration to market". With these cases, this paper analyzes four cases predicted on the following hypothesis and demonstrates it. "To successfully penetrate a market and sustainably grow, new payment service should find non-customer of the existing payment service and provide noble payment method so that they can use payment method". We give plausible explanations for the hypothesis using multiple case studies. Diners club, Danal, PayPal, Square were selected as a typical and successful cases in each category of payment service. The discussion on cases is primarily non-customer analysis that noble payment service targets on to find the most crucial factor in the early market, we does not attempt to consider factors for business growth. We clarified three-tier non-customer of the payment method that new payment service targets on and elaborated how new payment service satisfy them. In case of credit card, this payment service target first tier of non-customer who can't pay for because they don't have any cash temporarily but they have regular income. So credit card provides an opportunity which they can do economic activities by delaying the date of payment. In a result of wireless phone payment's case study, this service targets on second of non-customer who can't use online payment because they concern about security or have to take a complex process and learn how to use online payment method. Therefore, wireless phone payment provides very convenient payment method. Especially, it made group of young pay for a little money without a credit card. Case study result of PayPal, online payment service, shows that it targets on second tier of non-customer who reject to use online payment service because of concern about sensitive information leaks such as passwords and credit card details. Accordingly, PayPal service allows users to pay online without a provision of sensitive information. Final Square case result, Mobile POS -based payment service, also shows that it targets on second tier of non-customer who can't individually transact offline because of cash's shortness. Hence, Square provides dongle which function as POS by putting dongle in earphone terminal. As a result, four cases made non-customer their customer so that they could penetrate early market and had been extended their market share. Consequently, all cases supported the hypothesis and it is highly probable according to 'analytic generation' that case study methodology suggests. We present for judging the quality of research designs the following. Construct validity, internal validity, external validity, reliability are common to all social science methods, these have been summarized in numerous textbooks(Yin, 2014). In case study methodology, these also have served as a framework for assessing a large group of case studies (Gibbert, Ruigrok & Wicki, 2008). Construct validity is to identify correct operational measures for the concepts being studied. To satisfy construct validity, we use multiple sources of evidence such as the academic journals, magazine and articles etc. Internal validity is to seek to establish a causal relationship, whereby certain conditions are believed to lead to other conditions, as distinguished from spurious relationships. To satisfy internal validity, we do explanation building through four cases analysis. External validity is to define the domain to which a study's findings can be generalized. To satisfy this, replication logic in multiple case studies is used. Reliability is to demonstrate that the operations of a study -such as the data collection procedures- can be repeated, with the same results. To satisfy this, we use case study protocol. In Korea, the competition among stakeholders over mobile payment industry is intensifying. Not only main three Telecom Companies but also Smartphone companies and service provider like KakaoTalk announced that they would enter into mobile payment industry. Mobile payment industry is getting competitive. But it doesn't still have momentum effect notwithstanding positive presumptions that will grow very fast. Mobile payment services are categorized into various technology based payment service such as IC mobile card and Application payment service of cloud based, NFC, sound wave, BLE(Bluetooth Low Energy), Biometric recognition technology etc. Especially, mobile payment service is discontinuous innovations that users should change their behavior and noble infrastructure should be installed. These require users to learn how to use it and cause infra-installation cost to shopkeepers. Additionally, payment industry has the strong path dependency. In spite of these obstacles, mobile payment service which should provide dramatically improved value as a products and service of discontinuous innovations is focusing on convenience and security, convenience and so on. We suggest the following to success mobile payment service. First, non-customers of the existing payment service need to be identified. Second, needs of them should be taken. Then, noble payment service provides non-customer who can't pay by the previous payment method to payment method. In conclusion, mobile payment service can create new market and will result in extension of payment market.

A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.1
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    • pp.69-87
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    • 2003
  • Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.

The National Survey of Open Lung Biopsy and Thoracoscopic Lung Biopsy in Korea (개흉 및 흉강경항폐생검의 전국실태조사)

  • 대한결핵 및 호흡기학회 학술위원회
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.1
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    • pp.5-19
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    • 1998
  • Introduction: Direct histologic and bacteriologic examination of a representative specimen of lung tissue is the only certain method of providing an accurate diagnosis in various pulmonary diseases including diffuse pulmonary diseases. The purpose of national survey was to define the indication, incidence, effectiveness, safety and complication of open and thoracoscopic lung biopsy in korea. Methods: A multicenter registry of 37 university or general hospitals equipped more than 400 patient's bed were retrospectively collected and analyzed for 3 years from the January 1994 to December 1996 using the same registry protocol. Results: 1) There were 511 cases from the 37 hospitals during 3 years. The mean age was 50.2 years(${\pm}15.1$ years) and men was more prevalent than women(54.9% vs 45.9%). 2) The open lung biopsy was performed in 313 cases(62%) and thoracoscopic lung biopsy was performed in 192 cases(38%). The incidence of lung biopsy was more higher in diffuse lung disease(305 cases, 59.7%) than in localized lung disease(206 cases, 40.3%) 3) The duration after abnormalities was found in chest X-ray until lung biopsy was 82.4 days(open lung biopsy: 72.8 days, thoracoscopic lung biopsy: 99.4 days). The bronchoscopy was performed in 272 cases(53.2%), bronchoalveolar lavage was performed in 123 cases(24.1%) and percutaneous lung biopsy was performed in 72 cases(14.1%) before open or thoracoscopic lung biopsy. 4) There were 230 cases(45.0%) of interstitial lung disease, 133 cases(26.0%) of thoracic malignancies, 118 cases(23.1%) of infectious lung disease including tuberculosis and 30 cases (5.9 %) of other lung diseases including congenital anomalies. No significant differences were noted in diagnostic rate and disease characteristics between open lung biopsy and thoracoscopic lung biopsy. 5) The final diagnosis through an open or thoracoscopic lung biopsy was as same as the presumptive diagnosis before the biopsy in 302 cases(59.2%). The identical diagnostic rate was 66.5% in interstitial lung diseases, 58.7% in thoracic malignancies, 32.7% in lung infections, 55.1 % in pulmonary tuberculosis, 62.5% in other lung diseases including congenital anomalies. 6) One days after lung biopsy, $PaCO_2$ was increased from the prebiopsy level of $38.9{\pm}5.8mmHg$ to the $40.2{\pm}7.1mmHg$(P<0.05) and $PaO_2/FiO_2$ was decreased from the prebiopsy level of $380.3{\pm}109.3mmHg$ to the $339.2{\pm}138.2mmHg$(P=0.01). 7) There was a 10.1 % of complication after lung biopsy. The complication rate in open lung biopsy was much higher than in thoracoscopic lung biopsy(12.4% vs 5.8%, P<0.05). The incidence of complication was pneumothorax(23 cases, 4.6%), hemothorax(7 cases, 1.4%), death(6 cases, 1.2%) and others(15 cases, 2.9%). 8) The 5 cases of death due to lung biopsy were associated with open lung biopsy and one fatal case did not describe the method of lung biopsy. The underlying disease was 3 cases of thoracic malignancies(2 cases of bronchoalveolar cell cancer and one malignant mesothelioma), 2 cases of metastatic lung cancer, and one interstitial lung disease. The duration between open lung biopsy and death was $15.5{\pm}9.9$ days. 9) Despite the lung biopsy, 19 cases (3.7%) could not diagnosed. These findings were caused by biopsy was taken other than target lesion(5 cases), too small size to interpretate(3 cases), pathologic inability(11 cases). 10) The contribution of open or thoracoscopic lung biopsy to the final diagnosis was defininitely helpful(334 cases, 66.5%), moderately helpful(140 cases, 27.9%), not helpful or impossible to judge(28 cases, 5.6%). Overall, open or thoracoscopic lung biopsy were helpful to diagnose the lung lesion in 94.4 % of total cases. Conclusions: The open or thoracoscopic lung biopsy were relatively safe and reliable diagnostic method of lung lesion which could not diagnosed by other diagnostic approaches such as bronchoscopy. We recommend the thoracoscopic lung biopsy when the patients were in critical condition because the thoracoscopic biopsy was more safe and have equal diagnostic results compared with the open lung biopsy.

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