• Title/Summary/Keyword: clinical efficacy

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A Pilot Study of the Korean Version of Speech Handicap Index (SHI) (한국어판 말장애지수(The Korean Version of Speech Handicap Index)에 대한 예비연구)

  • Park, Sung Shin;Choi, Seong Hee;Cha, Wonjae;Hong, Young Hye;Jeong, Nyun Gi;Sung, Myung-Whun;Hah, J. Hun
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.24 no.1
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    • pp.41-46
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    • 2013
  • Background & Objectives : The Speech Handicap Index (SHI) is used to assess speech problem of head and neck cancer patients. The aim of this preliminary study was to evaluate the reliability and validity the Korean version SHI. Materials and Methods : Sixteen patients with oral cavity cancer and 26 normal control were participated in the study. Test-retest reliability of the Korean version of SHI was completed by 20 out of 42 subjects after 2weeks. Mann-Whitney U test was used to compare the Korean version of SHI scores between normal population and patients group. The relationship between the Korean version of SHI and diadochokinesis (DDK) was investigated using Spearman correlation coefficients. Results : The Korean version of SHI provided a high internal consistency (${\alpha}$=0.99) and test-retest reliability (Spearman rho 0.98). The mean SHI scores [total (T), speech (S), and psychosocial (P)] in normal population were 0.8 (T), 0.2 (S) and 0.4 (P), whereas those in patients group were 58.1 (T), 27.9 (S) and 27.0 (P) respectively. There were significant differences in total SHI score as well as in all of the sub-SHI scores between two groups. Moreover, significant correlation between the Korean version of SHI parameters (T, S, P) and sequential motion rate (SMR) were yielded in patients group. Conclusion : The Korean version of SHIwas reliable and valid. It can be useful as a supplementary clinical tool for diagnosing and measuring treatment efficacy of speech problems related to oral cavity cancer.

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Gene Therapy Using GM-CSF Gene Transferred by a Defective Infectious Single-cycle Herpes Virus in Micro-residual Organotropic Head and Neck Squamous Cell Cancer Model (향장기성 두경부 편평세포암종의 미세잔존암 모델에서 GM-CSF 유전자를 이입시킨 제한복제성 헤르페스바이러스 벡터를 이용한 종양백신의 유전자 치료)

  • Kim Se-Heon;Choi Eun-Chang;Kim Han-Su;Chang Jung-Hyun;Kim Ji-Hoon;Kim Kwang-Moon
    • Korean Journal of Head & Neck Oncology
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    • v.19 no.1
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    • pp.25-33
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    • 2003
  • Background and Objectives: The Herpes Simplex type 2 Defective Infectious Single Cycle virus (DISC virus) is attenuated virus originally produced as viral vaccines but are also efficient gene transfer vehicle. The main goals of this study were to examine the efficiencies of the gene transfer using DISC vectors for various head and neck squamous cell carcinoma cell lines and to evaluate the efficacy of vaccination with DISC virus carrying a immunomodulatory genes (GM-CSF) as cancer therapy in a organotopic oral cavity squamous cell cancer model. Materials and Methods : We determinated the gene transfer efficiency of DISC virus by x-gal stain method and proved gene and protein expression of DISC-GMCSF transfected SCCVII cells by RT-PCR and ELISA method. Also we evaluated the ex vivo vaccination effects of SCCVII/GMCSF (DISC-GMCSF transfected SCCVII vaccine) vaccine on preventing the recurrence of micro-residual tumor. After the vaccination of SCCVII/GMCSF, specific cytotoxic T-cell responses was evaluated by CTL assay. Results: At an MOI of 10 DISC virus showed 64-88% of transfection rates in various head and neck squamous cancer cell lines. SCCVII cells transduced by DISC virus vector (MOI=10) carrying the GM-CSF gene, produced 4.5 nanogram quantities of GM-CSF per $10^6$ cells. In vivo vaccination using tumor cells transduced ex vivo with DISC-GMCSF resulted in better protection rate against subsequent tumor recurrence in organotopic oral cavity cancer model. Although tumor free survival rate was not statistically significantly increased in vaccination group (p=0.078), tumor specific cytotocic T-cell responses were significantly increased in SCCVII/GMCSF vaccination group. Conclusion: These data demonstrate that; 1) The DISC virus vector is capable of efficient gene transfer to various head and neck squamous cancer cell lines, 2) GM-CSF secreting genetically modified tumor vaccine (SCCVII/GMCSF) efficiently protected against tumor recurrence in organotopic micro-residual oral cavity cancer model and produced tumor specific cytotoxic T-cell response. DISC virus-mediated, cytokine gene transfer may prove to be useful as a clinical therapy for head and neck cancers.

Cognitive Behavioral Therapy for Primary Insomnia: A Meta-analysis (만성 일차성 불면증 환자에게 적용한 인지행동중재의 효과: 메타분석)

  • Kim, Ji-Hyun;Oh, Pok-Ja
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.9
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    • pp.407-421
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    • 2016
  • This paper reports a meta-analysis of sixteen studies that evaluated the efficacy of cognitive behavioral therapy (CBT) for persistent primary insomnia. PubMed, Cochrane Library, EMBASE, CINAHL and several Korean databases were searched between January 2015 and June 2015. The main search strategy involved the terms that indicate CBT-I (Cognitive Behavioral Therapy-Insomnia) and presence of insomnia. Methodological quality was assessed using Cochrane's Risk of Bias. Data were analyzed by the RevMan 5.3 program of Cochrane Library. Sixteen clinical trials met the inclusion criteria, resulting in a total of 1503 participants. Stimulus control, sleep restriction, sleep hygiene education, and cognitive restructuring were the main treatment components. CBT-I was conducted for a mean of 5.4 weeks, 5.5 sessions, and an average of 90 minutes per session. The effects of CBT-i on total sleep time (d=-0.31), sleep onset latency (d=-0.29), awakening time after sleep onset (d=-0.55), sleep efficiency (d=-0.70), insomnia severity (d=-0.77) and sleep belief (d=-0.64) were significant. Overall, we found a range from small to moderate effect size. CBT-I also was effective for anxiety (d=-0.30) and depression (d=-0.35). The findings demonstrate that CBT-I interventions will lead to the improvement of both sleep quality and quantity in patients with insomnia.

The Role of Adjuvant Treatment in Patients with High-Grade Meningioma

  • Cho, Minjae;Joo, Jin-Deok;Kim, In Ah;Han, Jung Ho;Oh, Chang Wan;Kim, Chae-Yong
    • Journal of Korean Neurosurgical Society
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    • v.60 no.5
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    • pp.527-533
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    • 2017
  • Objective : To investigate the efficacy of adjuvant treatment in patients with high-grade meningioma. Methods : A retrospective analysis was performed for patients with high-grade meningioma, World Health Organization grade 2 or 3, in a single center between 2003 and 2014. The patients were reviewed according to age at diagnosis, sex, the location of meningioma, degree of tumor resection, histological features, and type of adjuvant treatment. These factors were analyzed by Firth logistic regression analyses. Results : Fifty-three patients with high-grade meningioma were enrolled. Thirty-four patients received adjuvant treatment; conventional radiotherapy or radiosurgery. Clinical follow-up ranged from 13-113 months with a median follow-up of 35.5 months. Gross total removal (GTR), Simpson grade 1 or 2, was achieved in 29 patients and, among them, 13 patients received adjuvant treatment. In the other 24 patients with non-GTR, conventional adjuvant radiotherapy and radiosurgery were performed in 11 and 10 patients, respectively. The other 3 patients did not receive any adjuvant treatment. Radiation-related complications did not occur. Of the 53 patients, 19 patients had suffered from recurrence. The recurrence rate in the adjuvant treatment group was 23.5% (8 out of 34). On the other hand, the rate for the non-adjuvant treatment group was 57.9% (11 out of 19) (odds ratio [OR]=0.208, p=0.017). In the GTR group, the recurrence rate was 7.5% (1 out of 13) for patients with adjuvant treatment and 50% (8 out of 16) for patients without adjuvant treatment (OR=0.121, p=0.04). Conclusion : Adjuvant treatment appears to be safe and effective, and could lead to a lower recurrence rate in high-grade meningioma, regardless of the extent of removal. Our results might be used as a reference for making decisions when planning adjuvant treatments for patients with high-grade meningioma after surgery.

PCL Reconstruction using Arthroscopic Posterior Transseptal technique (관절경하 후격막 통과 도달법을 이용한 후방 십자 인대의 재건술)

  • Kim, Jin-Goo;Kang, Yeong-Hun;Kang, Kyoung-Min
    • Journal of the Korean Arthroscopy Society
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    • v.4 no.2
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    • pp.111-116
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    • 2000
  • Purpose : We reviewed the results of arthroscopic posterior cruciate ligament reconstruction using Achilles tendon allograft, and the efficacy of the surgical technique using gradual tibial tunneling and posterior transseptal technique. Materials and Methods : From september 1997 to September 1999, 8 patients with complete PCL injury were treated by arthroscopic PCL reconstruction using Achilles tendon allograft. Mean follow-up period was 21.7 months. Mean preoperative posterior laxity was 14mm. The clinical outcome was assessed by Telos stress test, Lysholm knee score and IKDC score. Result : There was no complication such as infection and neurovascular injury. Posterior translation using Telos device was less than 5mm in 6 cases$(75\%)$, and between 6 to 10mm in 2 cases$(25\%)$. The mean Lysholm knee score was 45 preoperatively and improved to 87 postoperatively. In IKDC system, 2 of 8 patients were group A and 6 were group B. Conclusion : Arthroscopic PCL reconstruction using achilles tendon allograft and posterior transseptal technique shows reliable stability, short operative time and minimizing donor site morbidity but needs more long term follow-up.

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Efficacy of Nab-Paclitaxel Plus Gemcitabine and Prognostic Value of Peripheral Neuropathy in Patients with Metastatic Pancreatic Cancer

  • You, Min Su;Ryu, Ji Kon;Choi, Young Hoon;Choi, Jin Ho;Huh, Gunn;Paik, Woo Hyun;Lee, Sang Hyub;Kim, Yong-Tae
    • Gut and Liver
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    • v.12 no.6
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    • pp.728-735
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    • 2018
  • Background/Aims: The combination of nab-paclitaxel and gemcitabine (nab-P/Gem) is widely used for treating metastatic pancreatic cancer (MPC). We aimed to evaluate the therapeutic outcomes and prognostic role of treatment-related peripheral neuropathy in patients with MPC treated with nab-P/Gem in clinical practice. Methods: MPC patients treated with nab-P/Gem as the first-line chemotherapy were included. All 88 Korean patients underwent at least two cycles of nab-P/Gem combination chemotherapy (125 and $1,000mg/m^2$, respectively). Treatment-related adverse events were monitored through periodic follow-ups. Overall survival and progression-free survival were estimated by the Kaplan-Meier method, and the Cox proportional hazards regression linear model was applied to assess prognostic factors. To evaluate the prognostic value of treatment-related peripheral neuropathy, the landmark point analysis was used. Results: Patients underwent a mean of $6.7{\pm}4.2$ cycles during $6.3{\pm}4.4$ months. The median overall survival and progression-free survival rates were 14.2 months (95% confidence interval [CI], 11.8 to 20.3 months) and 8.4 months (95% CI, 7.1 to 13.2 months), respectively. The disease control rate was 84.1%; a partial response and stable disease were achieved in 30 (34.1%) and 44 (50.0%) patients, respectively. Treatment-related peripheral neuropathy developed in 52 patients (59.1%), and 13 (14.8%) and 16 (18.2%) patients experienced grades 2 and 3 neuropathy, respectively. In the landmark model, at 6 months, treatment-related peripheral neuropathy did not have a significant correlation with survival (p=0.089). Conclusions: Nab-P/Gem is a reasonable choice for treating MPC, as it shows a considerable disease control rate while the treatment-related peripheral neuropathy was tolerable. The prognostic role of treatment-related neuropathy was limited.

Efficacy of First-Line Targeted Therapy in Real-World Korean Patients with Metastatic Renal Cell Carcinoma: Focus on Sunitinib and Pazopanib

  • Kim, Myung Soo;Chung, Ho Seok;Hwang, Eu Chang;Jung, Seung Il;Kwon, Dong Deuk;Hwang, Jun Eul;Bae, Woo Kyun;Park, Jae Young;Jeong, Chang Wook;Kwak, Cheol;Song, Cheryn;Seo, Seong Il;Byun, Seok-Soo;Hong, Sung-Hoo;Chung, Jinsoo
    • Journal of Korean Medical Science
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    • v.33 no.51
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    • pp.325.1-325.10
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    • 2018
  • Background: To evaluate survival outcomes and prognostic factors for overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC) who received sunitinib (SU) and pazopanib (PZ) as first-line therapy in real-world Korean clinical practice. Methods: Data of 554 patients with mRCC who received SU or PZ at eight institutions between 2012 and 2016 were retrospectively reviewed. Based on the targeted therapy, the patients were divided into SU (n = 293) or PZ (n = 261) groups, and the clinicopathological variables and survival rates of the two groups were compared. A multivariable Cox proportional hazard model was used to determine the prognostic factors for OS. Results: The median follow-up was 16.4 months (interquartile range, 8.3-31.3). Patients in the PZ group were older, and no significant difference was observed in the performance status (PS) between the two groups. In the SU group, the dose reduction rate was higher and the incidence of grade 3 toxicity was more frequent. The objective response rates were comparable between the two groups (SU, 32.1% vs. PZ, 36.4%). OS did not differ significantly between the two groups (SU, 36.5 months vs. PZ, 40.2 months; log-rank, P = 0.955). Body mass index, Eastern Cooperative Oncology Group PS > 2, synchronous metastasis, poor Heng risk criteria, and liver and bone metastases were associated with a shorter OS. Conclusion: Our real-world data of Korean patients with mRCC suggested that SU and PZ had similar efficacies as first-line therapy for mRCC. However, PZ was better tolerated than SU in Korean patients.

The Pregnancy Rate following Myomectomy in Infertile Women (불임여성에서 자궁근종절제술 후 임신율에 관한 연구)

  • Won, J.G.;Bai, S.W.;Kim, J.Y.;Yi, J.W.;Lee, B.S.;Kim, J.S.;Lee, K.S.;Park, K.H.;Cho, D.J.;Song, C.H.
    • Clinical and Experimental Reproductive Medicine
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    • v.24 no.2
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    • pp.193-198
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    • 1997
  • To evaluate the efficacy of transabdominal myomectomy in the management of infertile patients, and to analyze on the results of abdominal myomectomy in 38 infertile patients with no other detectable cause except myomas were undertaken at the Department of Obstetrics and Gynecology in Yonsei University Hospital from 1990 to 1996. The results are as follows; 1. Average age of patients was 31.1 years. The infertility duration ranged 12 months to 144 months, and average infertility period of patients was 29.4 months. 2. Fourteen of the 38 patients (8 of 23 patients with primary infertility, 6 of 15 patients with secondary infertility) conceived following myomectomy, with a pregnancy rate of 36.8%. 3. Patients with less than 4 years of infertility showed a higher pregnancy rate after myomectomy than those with more than 4 years of infertility (42.4% vs 0%, p<0.05). 4. Patients younger than 35 years showed significantly higher pregnancy rate than those older than 35 years (46.4% vs 9.0%, p<0.05). 5. The removal of a solitary myoma produced a significantly higher pregnancy rate than that of multiple myomas (47.8% vs 20.0%, p<0.05), and the size of the myomas did not influenced the pregnancy rate after myomectomy (p>0.1). 6. The average time period from operation to conception was 12.1 months. Eight of the 14 patients (57.1%) conceived in the first year after operation and 12 patients (85.7%) condeived within two years. In conclusion myomas are a possible cause of infertility and myomectomy can be strongly recommended with good success expectation for the infertile women if uterine myoma be considered as the main cause of infertility. And factors affecting the pregnancy rate after myomectomy in these patients are the age of the patient, the duration of infertiluty, and the number of myoma.

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The Effects of Vero Cell Co-culture on Mouse Embryo Development (Vero Cell과의 공동배양이 체외에서 생쥐 배아발생에 미치는 영향)

  • Lee, Yoon;Park, June-Hong;Kang, He-Na;Kim, Yong-Bong;Lee, Eung-Soo;Park, Sung-Kwan
    • Clinical and Experimental Reproductive Medicine
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    • v.24 no.2
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    • pp.233-239
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    • 1997
  • Embryos of most mammalian species grown in vitro would undergo developmental arrest at the approximate time of genomic activation. Stage-specific cell block and the resulting rapid loss of embryo viability in conventional culture media have limited the duration for which embryos may be cultured prior to transfer. As a result, embryos are usually transferred to the uterus at the 4-to 8-cell stage to avoid the loss of viability associated with long-term in vitro culture. Early transfer has led to asynchrony of the endometrium-trophectoderm interaction at the time of implantation and a resultant reduction in the rate of implantation. To overcome these problems, a variety of co-culture systems has been devised in which embryos can develop for a longer period prior to embryo transfer. Vero cells, derived from African green monkey kidney, share a common embryologic origin with cells from the genital tract. In addition, they are potentially safe to use, since they are highly controlled for viruses and other contaminants. Therefore, co-culture using Vero cells has been widely utilized to enhance embryo viability and development, although not without controversies. We thus designed a series of experiments to demonstrate whether Vero cells do indeed enhance mouse embryo development as well as to compare the efficacy of co-culturing mouse 1-cell embryos on Vero cell monolayer in both Ham's F-10 and human tubal fluid (HTF) culture media. 1-cell stage ICR mouse embryos were cultured either in the presence of Vero cells (Group A) or in conventional culture medium alone (Group B). In Ham's F-10 significantly more 3-to-8cell embryos developed in group A than group B (59.8 versus 10.0%; p<0.01). In contrast, there was no significant difference in embryonic development both group A and group B in HTF. However, significant differences were noted only in later embryonic stage (13 and 0%; p<0.05 of group A and B respectively, hatching or hatched). In Ham's F-10, we also could observe the beneficial effect of Vero cell on hatching process (70.7 and 42.1%; p<0.05 of group A and group B respectively).

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Analysis of Experimental Study Tendency on Oriental Herbal Medicines for Male Infertility - Focusing on Domestic Theses for a Degree - (남성 불임에 관한 실험연구 동향 분석 - 학위논문 중심으로 -)

  • Bae, Sang-Eun;Kim, Hee-Jeong;Lee, Seung-Yeol;Kim, Heung-Su;Kim, Chul-Soo;Ha, In-Hyuck;Lee, Jin-Ho
    • The Journal of Korean Obstetrics and Gynecology
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    • v.27 no.1
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    • pp.120-139
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    • 2014
  • Objectives: The tendency of experimental studies on the male infertility was analyzed through focusing on domestic theses for a degree to indicate the hereafter direction for its study in oriental herbal medicine. Methods: 35 domestic theses for a degree published after 2003 were analyzed. And theses were classified by year, study design, degree and subjects. Results: The followings are the results of this study. 1. 35 theses were reviewed. 11 master dissertations and 24 doctorate dissertations 2. In the annual publishing tendency, the number of theses began to increase from 2003 and the theses have been published actively from 2005. 3. Classified by study design, 19 in vitro & in vivo and 16 in vitro experimental studies were performed. 4. In the medication and prescription, the studies with single medication were 32, and prescription were 3. In the studies with single medication, four studies on Ginseng Radix (人蔘) were the most. 5. In theses related to single medication, BoYang-Yak was most prefered, followed BoYeum-Yak, BoKi-Yak, SabJung-ChukNyo-JiDae-Yak. 6. Analysed 35 theses by subject, concentrational experiments were 23, periodical experiment were 3, concentrational & periodical experiment was 1. 7. In theses related to herb medication, the themes were Body & testicular weight, sperm parameters, testosterone level, CREM mRNA level & CREM protein, seminiferous tubule and antioxidant activity. 8. Related to herb medication's antioxidant activity efficacy were 7 theses. Conclusions: If there are more diverse studies on medication, prescription, external treatment methods and experiment methods in the future, this will be very helpful for the clinical treatment of male infertility.