• Title/Summary/Keyword: treatment protocol

Search Result 850, Processing Time 0.04 seconds

A Protocol of Ludox Treatment for Physiological and Molecular Biological Research of Freshwater Cyanobacteria (퇴적층 남조류 휴면세포의 생리적-분자생물학적 연구를 위한 Ludox 처리법)

  • Keonhee Kim;Kyeong-eun Yoo;Hye-in Ho;Chaehong Park;Hyunjin Kim;Soon-Jin Hwang
    • Korean Journal of Ecology and Environment
    • /
    • v.56 no.1
    • /
    • pp.94-103
    • /
    • 2023
  • Cyanobacterial resting cells, such as akinetes, are important seed cells for cyanobacteria's early development and bloom. Due to their importance, various methods have been attempted to isolate resting cells present in the sediment. Ludox is a solution mainly used for cell separation in marine sediments, but finding an accurate method for use in freshwater is difficult. This study compared the two most commonly used Ludox methods (direct sediment treatment and sediment distilled water suspension treatment). Furthermore, we proposed a highly efficient method for isolating cyanobacterial resting cells and eDNA amplification from freshwater sediments. Most of the resting cells found in the sediment were akinete to the Nostocale and were similar to those of Dolichospermum, Cylindrospermum, and Aphanizomenon. Twenty times more akinetes were found in the conical tube column using the sediment that had no treatment than in the sample treated by suspending the sediment in distilled water. Akinete separated through Ludox were mainly spread over the upper and lower layers in the column rather than concentrated at a specific depth in the column layer. The mibC, Geo, and 16S rDNA genes were successfully amplified using the sediment directly in the sample. However, the amplification products of all genes were not found in the sample in which the sediment was suspended in distilled water. Therefore, 5 g to 10 g of sediment is used without pretreatment when isolating cyanobacterial resting cells from freshwater sediment. Cell isolation and gene amplification efficiency are high when four times the volume of Ludox is added. The Ludox treatment method presented in this study isolates cyanobacterial resting cells in freshwater sediment, and the same efficiency may not appear in other biotas. Therefore, to apply Ludox to the separation of other biotas, it is necessary to conduct a pre-experiment to determine the sediment pretreatment method and the water layer where the target organism exists.

Clinical Outcome of Treatment for Stage IIA, IIB and III Osteosarcomas (Comparative Studies between Invasive Surgical Treatment and Non-invasive HIFU Technique) (진행된 장관골 골육종의 수술 및 비수술적 강력 집속 초음파 치료의 장기 추적 결과)

  • Wenzhi, Chen;Wei, Wang;Zhibiao, Wang;Hui, Zhu;Kequan, Li;Hao, Piao Xiang;Haibing, Su;Chengbing, Jin;Feng, Wu;Jin, Bai;Rhee, Seung-Koo;Kang, Yong-Koo;Bahk, Won-Jong;Chung, Yang-Guk;Huh, Sung-Woo;Lee, Eun-Sang
    • The Journal of the Korean bone and joint tumor society
    • /
    • v.12 no.1
    • /
    • pp.37-46
    • /
    • 2006
  • Purpose: To evaluate the end results between the surgical treatment with neo-adjuvant chemotherapy in Korea and non-invasive high intensity focused ultrasound (HIFU) technique in China for osteogenic sarcomas. Materials and Methods: The surgical treatment with neoadjuvant chemotherapy for total 67 cases (4 IIA, 58 IIB, and 5 III) in Korea since 1993 and the HIFU therapy for total 71 cases (57 II and 14 III) in China since 1997 was performed. In Korea, neo-adjuvant chemotherapy in 66 cases out of total 67 patients, but the adjuvant chemotherapy in only one case was done. On the contrary, in China, full chemotherapy for more than 9 times for 37 patients with stage II out of total 71 cases, but for less than 8 times of partial chemotherapy for 23 patients (stage II) and 14 patients (stage III) was done. The surgical treatment in total 67 Korean patients was done with wide resection and reconstruction for 56 patients, but wide resection without reconstruction for 5 patients and amputation for 6 patients. In china, total 71 patients was treated with average 1.5 times (1~4 times) of HIFU, and if there are some evidences of residual tumor after HIFU with following MRI, the second HIFU therapy was given 2~4 weeks later. After then, the bony defect was in no touch, keep bracing for long time expecting regeneration. All of them were followed for average 46 Mo (12~150 Mo) in Korea, but followed for average 22 Mo (9 years~8 months) in China. Results: The 5 year survival rate (stage II), was average 92.7% (IIA 100%, IIB 85.5%) in Korea series, and average 78.7% (full chemotherapy 91.8%, part chemotherapy 56.6%) in China series. The 3 year survival rate (stage III) was 20% in Korea and 7.1% in China. So, the final overall survival rate was 65.2% in Korea and 51.8% in China. The overall functional outcome score by ISOLS was 24.3 (81%) in Korea and 19.8 (73%) in China. There are 25.4% (17/67 cases) of complications in Korea and 31% (27 complications in 22 patients out of total 71 cases) in China after each treatment. Conclusions: The end results of Korea series which was treated with neoadjuvant chemo- and surgical methods are better than that of non-invasive thermal ablation in china. But we also believe the HIFU, as one of, was also effective to decrease the local recurrence and symptomatic releaf for stage II or even in III of osteogenic sarcomas.

  • PDF

Low Dose Cisplatin as a Radiation Sensitizer in Management of Locally Advanced Scluamous Cell Carcinoma of the Uterine Cervix : Evaluation of Acute Toxicity and Early Response (국소 진행된 자궁경부암의 방사선치료와 저용량 cisplatin 항암요법 동시치료시 급성독성 밀 초기반응 평가)

  • Kim Hunjung;Cho Young Kap;Kim Chulsu;Kim Woo Chul;Lee Sukho;Loh J K
    • Radiation Oncology Journal
    • /
    • v.17 no.2
    • /
    • pp.113-119
    • /
    • 1999
  • Purpose : To evaluate possible acute toxicity and early response of concurrent radiation therapy and low dose daily cisplatin as a radiosensitizer in patients with locally advanced uterine cervical carcinomas. Materials and Method : From December 1996 to January 1999, 38 previously untreated Patients with locally advanced squamous cell carcinoma of the uterine cervix (from stage IIB to stage IIIB) were treated at Inha University Hospital. All patients underwent standard pretreatment staging Procedures after the initial evaluation by gynecologists and radiation oncologists. Sixteen Patients with huge cervical mass (>4 cm) were submitted to the group treated with concurrent radiation therapy and low dose daily cisplatin while the remainder was treated with radiation therapy alone. Radiation therapy consisted of 4500 cGy external beam irradiation to whole pelvis (midline block after 3000 cGy), 900$\~$1000 cGy boost to involved parametrium, and high dose-rate intracavitary brachytherapy (a total dose of 3000$\~$3500 cGy/500 cGy per fraction to point A, twice per week). In the group treated with low dose cisplatin concurrently, 10 mg of daily intravenous cisplatin was given from the 1st day of radiation therapy to the 20th day of radiation therapy. Acute toxicity was measured according to expanded common toxicity criteria of the NCI (C) Clinical Trials. Early response data were analyzed at minimum 4 weeks' follow-up after completion of the treatment protocol. Results: Hematolgic toxici쇼 was more prominent in patients treated with radiation therapy and cisplatin. Six of 16 patients (37.5$\~$) treated with radiation therapy and cisplatin and one of 22 patients (4.5$\~$) treated with radiation therapy alone experienced grade 3 leukopenia. In Fisher's exact test, there was statistically significant difference between two groups regarding leukopenia (P=0.030). There was no apparent difference in the frequency of gastrointestinal and genitourinary toxicity between two groups (P=0.066). Three of 16 patients (18.7$\~$) treated with radiation therapy and cisplatin and two of 22 patients (9.1$\~$) treated with radiation therapy alone experienced more than 5 kg weight loss during the treatment. There was no statistically significant difference on weight loss between two groups (P=0.63). Two patients on each group were not evaluable for the early response because of incomplete treatment. The complete response rate at four weeks' follow-up was 80$\~$(16/20) for the radiation therapy alone group and 78$\~$ (11/14) for the radiation therapy and cisplatin group. There was no statistically significant difference in early response between two treatment groups (P=0.126). Conclusion : This study led to the conclusion that the hematologic toxicity from the treatment with concurrent radiation therapy and low dose daily cisplatin seems to be more prominent than that from the treatment of radiation therapy alone. There was no grade 4 hematologic toxicity or mortality in both groups. The hematologic toxicity in both treatment groups seems to be well managable modically. Since the risk factors were not balanced between two treatment groups, the direct comparison of early response of both groups was not possible. However, preliminary results regarding early response for patients with bulky cervical tumor mass treated with radiation therapy and low dose daily cisplatin was encouraging. Longer follow-up is necessary to evaluate the survival data. A phase III study is needed to evaluate the efficacy of concurrent daily low dose cisplatin with radiation therapy in bulky cervical cancer.

  • PDF

Concurrent Chemoradiotherapy in Locally Advanced Carcinoma of The Uterine Cervix : A Phase I/II Prospective Study (국소적으로 진행된 자궁경부암의 방사선치료와 복합 항암화학요법의 동시치료 결과)

  • Kang One Chul;Choi Eun Kyung;Chung Weon Kuu;Kim Jong Hoon;Chang Hyesook;Kim Yong Man;Kim Young Tak;Nam Joo Hyun;Mok Jung-Eun;Lee Moo-Song
    • Radiation Oncology Journal
    • /
    • v.16 no.3
    • /
    • pp.311-323
    • /
    • 1998
  • Purpose : Prospective, single arm, Phase I/II clinical trial was performed to assess the efficacy and toxicity of the concurrent chemotherapy and definitive radiotherapy (RT) in patients with previously untreated locally advanced carcinoma of the uterine cervix. Methods and Materials : From Mar 1992 to January 1997, a total of 73 patients with advanced cervical carcinoma were entered on the protocol but 5 patients were excluded in analysis because of patients' refusal of treatment. Their ages ranged from 31 to 77 years, median 58 years. The International Federation of Gynecology and Obstetrics (FIGO) stage distribution was as follows: IIB 46, IIIA 2, IIIB 15 and IVA 5. RT consisted of external beam irradiation to 4,140-5,040 cGy/23-28 fractions plus high dose rate intracavitary treatments to deliver a dose of 30-35 Gy to point A in 6-7 fractions. During the intracavitary treatments parametrial boost was delivered for point B dose of 60 Gy in stage IIB and 65 Gy in stage IIIB. Two cycles of concurrent 5-fluorouracil and cisplatin (FP) chemotherapy (5-fluorouracil 1,000 mg/$m^2$/day continuous infusion for 4 days, day 1-4, 29-32 and cisplatin 20 mg/$m^2$/day intravenous bolus for 3 days day 1-3, 29-31) administered starting on day 1 of RT. Results : The median follow-up was 24 months (range 4-68+). Sixty-four patients were evaluable for survival rate in this protocol: The 5-year actuarial and disease-free survival rate were 52$\%$ and 64$\%$, respectively. The 5-rear actuarial survival for stage IIB and III+IVA patients were 58$\%$ and 36$\%$, respectively The 5-year disease-free survival rate for stage IIB and III+IVA patients were 71$\%$ and 40$\%$, respectively. Of the 68 patients evaluated for patterns of failure, overall recurrence rate was 27.9$\%$ (19/68) : local failure in 5.9$\%$ (4/68), distant metastasis in 10.3$\%$ (7/68) and both in 11.8$\%$ (8/68). Of the 64 patients evaluated for response at one month after the completion of treatment the complete response rate was 78$\%$ (50/64). Concurrent chemoradiation appear to be a well-tolerated regimen but there were two treatment-related deaths. Conclusion : Concurrent chemotherapy of FP with high-dose definitive RT in locally advanced carcinoma of the uterine cervix is feasible and effective with acceptable toxicities. This chemoradiation regimen may offer a modest survival benefit for advanced stage. Further follow-up of these patients will evaluate the impact of this regimen on the long-term local control and their survival.

  • PDF

Effects of Administration of Oxytocin Antagonist on Implantation and Pregnancy Rates in Patients with Repeated Failure of IVF/ICSI Treatment (체외수정시술의 반복적인 실패 환자에서 옥시토신 길항제 주입이 착상 및 임신에 미치는 영향)

  • Ahn, Jun-Woo;Kim, Chung-Hoon;Kim, So-Ra;Jeon, Gyun-Ho;Kim, Sung-Hoon;Chae, Hee-Dong;Kang, Byung-Moon
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.36 no.4
    • /
    • pp.275-281
    • /
    • 2009
  • Objective: This study was performed to evaluate the effect of oxytocin antagonist on the outcome of IVF/ICSI cycles in infertile patients with repeated failure of IVF/ICSI treatment. Method: Forty patients who had experienced two or more failures of IVF/ICSI treatment without low ovarian reserve, were recruited for this prospective randomized study. All patients received controlled ovarian stimulation (COS) using GnRH antagonist multidose protocol (MDP). For the intervention group, intravenous administration of atosiban (mixed vasopressin $V_{1A}$/oxytocin antagonist) started with a bolus dose 6.75 mg one hour before embryo transfer (ET) and continued at an infusion rate of 18 mg/hour. After ET, administered atosiban was reduced to 6 mg/hour and continued for 2 hours. The main efficacy endpoints were clinical pregnancy rate and implantation rate. Results: Patients' characteristics were comparable in the intervention and control groups. COS parameters and IVF results were also similar. The number of uterine contractions for 3 minutes measured just before ET was significantly lower in the intervention group than control group ($3.5{\pm}1.4$ vs $8.7{\pm}2.2$, p<0.001). While there was no statistically significant difference in the clinical pregnancy rate between control group and intervention group (20.0% and 40.0%, p=0.168), the implantation rate was significantly higher in the intervention group, with 16.9% (11/65) compared with 6.0% (4/67) in the control group (p=0.047). There were no differences in ectopic pregnancy rate and miscarriage rate between the two groups. Conclusion: This study demonstrates that administration of oxytocin antagonist during ET can improve the implantation rate probably by decreasing the frequency of uterine contractions in infertile patients undergoing IVF/ICSI treatment.

Strategic Direction and Road Map of Expanding Prevention of Winter Disease in the Summer (동병하치 확산을 위한 전략적 방향과 이행방안)

  • Song, Ho-Sueb
    • Journal of Acupuncture Research
    • /
    • v.27 no.3
    • /
    • pp.147-157
    • /
    • 2010
  • Objectives : The purpose of this study was to propose appropriate strategic directions and road maps for successful achievement of programs preventing winter disease in the summer. Methods : Details on programs preventing winter disease in the summer such as clear concept, theoretical basis, current status, intervention or available prescriptions and indication/contraindication/caution were prepared through the related journal review, upon which an observational study was devised and done for simulation to find out even a trivial problem and to guarantee the safety beforehand. The experimental group was divided into 5 groups by the size of pill and the way ginger is treated; 1cm pill with ginger group, 3cm pill group without ginger, 3cm pill group dipped into ginger, 3cm pill group applying ginger to acupoints and 3cm pill group with ginger Results 1. program preventing winter disease in the summer was defined as representative winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis and rheumatoid arthritis, and preventive care in the summer, reinforcing deficient yang qi of five viscera by using exuberant yang qi from summer heat. 2. It was based upon historically established theories which is 'nourishing yang qi in the spring and summer', 'long summer, namely rainy spell in the summer overwhelms the winter, because of earth winning water according to the five phases theory' and 'To replenish yang qi is major principle to treat winter diseases, which can be most appropriately and timely applied to the patient with deficient yang qi of five viscera inherently, especially in the three dog days of the summer, because of exuberant exterior yang qi and deficient interior yang qi in the five viscera'. 3. In the adjacent China and Taiwan, acupoint applying method in the three dog days named 'San Fu Tie' have been stirring a boom throughout the nation, in which Xiaochuan Gao was used as a basic prescription and it mainly was applied at bilateral $BL_{13}$, $_{15}$ and $_{17}$ for about 4 hours. As far as domestic current status, the necessity of adopting the above method prior to Herbal formula was also recognised, because not a few koreans have apprehension for the safety of it including medicinal herbs and are reluctant to take it any more due to negative advertisement of narrow minded doctors' association. 4. Indication of acupoint applying method in the three dog days included most of winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis. contraindication was pregnant woman and the weak such as infants and the old. More attention was paid to grasp firmly the normal reaction following the treatment for preventing side effect and teasing blister. recommendation was also given to abstain from food inducing phlegm and dampness such as meat, shrimp and crab as well as cold drinks and foods 5. In the simulation observational study based upon the above findings following review the related articles, no blister was shown on the acupoints icluding bilateral $BL_{13}$, $_{15}$ and $_{17}$ in every experimental group during 24hr observation following the acupoint applying treatment with pills made by modified and devised prescription. At 4 hr, the effectiveness of it reached a peak showing redness and mild tenderness and there is little difference between groups 3cm pills groups regardless of the way ginger was treated. abdominal distention and growling was found in all the volunteers during the treatment at CV 8. Strategic directions and road maps : Through successful fulfillment of the program preventing winter disease in the summer, Korean traditional medicine should be integrated into mainstream national health care services. Cultural access was thought to be as important as Scientific EBM approach. First of all, To evoke potential cultural homogeneity from campaigns and press advertisement was needed for promoting public awareness about preventing winter disease in the summer by enhancing immunity via acupoint applying treatment in the three dog days, and then indigenous name as Sambokcheop, protocol, Clinical Research Form for data collection of it should be developed and prepared. Once the first step was taken this summer, through a thorough data collection and scrutinized scientific evaluation, drawbacks should be compensted for and the efficacy and safety should be substantiated.

Inter-fractional Target Displacement in the Prostate Image-Guided Radiotherapy using Cone Beam Computed Tomography (전립선암 영상유도 방사선 치료시 골반내장기의 체적변화에 따른 표적장기의 변화)

  • Dong, Kap Sang;Back, Chang Wook;Jeong, Yun Jeong;Bae, Jae Beom;Choi, Young Eun;Sung, Ki Hoon
    • The Journal of Korean Society for Radiation Therapy
    • /
    • v.28 no.2
    • /
    • pp.161-169
    • /
    • 2016
  • Purpose : To quantify the inter-fractional variation in prostate displacement and their dosimetric effects for prostate cancer treatment. Materials and Methods : A total of 176 daily cone-beam CT (CBCT) sets acquired for 6 prostate cancer patients treated with volumetric-modulated arc therapy (VMAT) were retrospectively reviewed. For each patient, the planning CT (pCT) was registered to each daily CBCT by aligning the bony anatomy. The prostate, rectum, and bladder were delineated on daily CBCT, and the contours of these organs in the pCT were copied to the daily CBCT. The concordance of prostate displacement, deformation, and size variation between pCT and daily CBCT was evaluated using the Dice similarity coefficient (DSC). Results : The mean volume of prostate was 37.2 cm3 in the initial pCT, and the variation was around ${\pm}5%$ during the entire course of treatment for all patients. The mean DSC was 89.9%, ranging from 70% to 100% for prostate displacement. Although the volume change of bladder and rectum per treatment fraction did not show any correlation with the value of DSC (r=-0.084, p=0.268 and r=-0.162, p=0.032, respectively), a decrease in the DSC value was observed with increasing volume change of the bladder and rectum (r=-0.230,p=0.049 and r=-0.240,p=0.020, respectively). Conclusion : Consistency of the volume of the bladder and rectum cannot guarantee the accuracy of the treatment. Our results suggest that patient setup with the registration between the pCT and daily CBCT should be considered aligning soft tissue.

  • PDF

Nasal Continuous Positive Airway Pressure Titration and Time to Reach Optima1 Pressure in Sleep Apnea Syndrome (수면 무호흡 증후군에서 지속적 양압 치료시의 최적압 및 그 도달기간)

  • Lee, Kwan-Ho;Lee, Hyun-Woo
    • Tuberculosis and Respiratory Diseases
    • /
    • v.42 no.1
    • /
    • pp.84-92
    • /
    • 1995
  • Background: Nasal applied continuous positive airway pressure(CPAP) is a highly effective method of treatment for obstructive sleep apnea syndrome. More than a decade of accumulated experience with this treatment modality confirmed that it is unquestionably the medical treatment of choice for patients with obstructive sleep apnea syndrome. However it takes long time to reach optimal CPAP pressure. To save the time to reach optimal pressure, it is necessary to clarify the time to reach optimal pressure for treatment of obstructive sleep apnea syndrome. Method: CPAP pressure is titrated during an overnight study according to a standardized protocol. Just before the presleep bio-calibration procedures, the technician applies the nasal mask and switches on the clinical CPAP unit. Initial positive for pressure is typically 3.0 centimeters of water pressure. After sleep onset, the technician gradually increases the pressure until sleep-disordered breathing events disappear or become minimal. The pressure must maintain maximal airway patency during both NREM and REM sleep to be considered effective. Before recommending a final pressure setting, sleep recording and oximetry data are reviewed by an American Board of Sleep Medicine certified Sleep Specialist and a Registrered Polysomnographic Technologist. Results: We examined the time required to reach optimal pressure during routine CPAP titration in 127 consecutively evaluated individuals diagnosed with sleep-disordered breathing. Results indicate that 33% of patients required more than four hours to attain satisfactory titration. This indicates that a four-hour session is marginally enough time, at best, to determine a proper CPAP pressure setting. Moreover, 60 of 127 patients required further adjustment after optimal pressure was reached. These additional pressure trials were needed to confirm that higher pressures were not superior for eliminating sleep-disordered breathing events. Conclusions: The data presented underscore the logistical difficulty of titrating CPAP during split-night studies without modifying the titration procedure. Futhermore, the time needed to reach optimal pressure makes it improbable that proper CPAP titration can be performed during a 2-3 hour nap study.

  • PDF

Isolation and Characteristics of Yersinia spp. from Mineral Spring Waters (먹는 샘물에서 분리한 Yersinia spp.의 분리 및 특성)

  • 이택수;박부길;오덕환
    • Journal of the Korean Society of Food Science and Nutrition
    • /
    • v.30 no.5
    • /
    • pp.796-801
    • /
    • 2001
  • A total of 277 mineral spring water samples in Kangwon province from 1999 to 2000 were analyzed for the presence of Yersinia spp. by the conventional Food and Drug Administration protocol, and presumptive strains were identified by morphological, cultural and biochemical tests according to Bergey’s manual. Also, the biotypes, serotypes, and susceptibility to 12 antibiotics were tested. Among the total 277 mineral spring water samples, 40 samples (14.4%) were found to be contaminated with Yersinia species. Among the 40 strains of Yersinia spp. isolates, 33 strains (82.5%) for Yersinia enterocolitica, 4 strains (10%) for Yersinia frederiksenii, 2 strains (5%) for Yersinia intermedia, and 1 strain (2.5%) for Yersinia sakazaki were identified, respectively. Of 40 Yersinia spp. isolates, Yersinia enterocolitica (82.5%) was the most predominant species in the mineral spring water samples compared to other Yersinia species. Compared to direct culture method after KOH treatment and KOH treatment method after cold enrichment for better isolation ratio of according to comparision of Yersinia species, the detection ration (18.5%) of KOH treatment method after cold enrichment was about 3 times better than that (6.1%) of direct culture method after KOH treatment. According to serotypes of Y. enterocolitica isolates, O : 5 (12.9%) was the most predominant and followed by O : 3 (9.7%), O : 8 (6.5%), and O : 9 (3.2%), and others. For biotypes of Y. enterocolitica isolates, 1A (71.0%) was the most predominantly abundant and followed by 3A (12.9%), 3B (9.7%), 1B (3.2%) and 5 (3.2%). Also, an antibiotic susceptibility test showed that Yersinia spp. isolates were very susceptible to the antibiotics tested, but they were very strongly resistant to ampicillin, cephalothin and carbenicillin.

  • PDF

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
    • /
    • v.55 no.1
    • /
    • pp.69-87
    • /
    • 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.