• Title/Summary/Keyword: Clinical remission

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Efficacy and Safety of Banhahubak-Tang for Depression Treatment: Study Protocol for a Randomized, Waitlist-Controlled Trial

  • Seung-Ho, Lee;Yunna, Kim;Dohyung, Kwon;Seung-Hun, Cho
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.4
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    • pp.389-400
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    • 2022
  • Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

Outcome of allogeneic hematopoietic stem cell transplantation for childhood acute lymphoblastic leukemia in second complete remission: a single institution study

  • Lee, Eun-Jung;Han, Ji-Yoon;Lee, Jae-Wook;Jang, Pil-Sang;Chung, Nack-Gyun;Jeong, Dae-Chul;Cho, Bin;Kim, Hack-Ki
    • Clinical and Experimental Pediatrics
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    • v.55 no.3
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    • pp.100-106
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    • 2012
  • Purpose: The survival rate for childhood acute lymphoblastic leukemia (ALL) has improved significantly. However, overall prognosis for the 20 to 25% of patients who relapse is poor, and allogeneic hematopoietic stem cell transplantation (HSCT) offers the best chance for cure. In this study, we identified significant prognostic variables by analyzing the outcomes of allogeneic HSCT in ALL patients in second complete remission (CR). Methods: Fifty-three ALL patients (42 men, 79%) who received HSCT in second CR from August 1991 to February 2009 were included (26 sibling donor HSCTs, 49%; 42 bone marrow transplantations, 79%). Study endpoints included cumulative incidence of acute and chronic graft-versus-host disease (GVHD), relapse, 1-year transplant-related mortality (TRM), disease-free survival (DFS), and overall survival (OS). Results: Cumulative incidences of acute GVHD (grade 2 or above) and chronic GVHD were 45.3% and 28.5%, respectively. The estimated 5-year DFS and OS for the cohort was $45.2{\pm}6.8%$ and $48.3{\pm}7%$, respectively. Only donor type, i.e., sibling versus unrelated, showed significant correlation with DFS in multivariate analysis ($p$=0.010). The rates of relapse and 1 year TRM were $28.9{\pm}6.4%$ and $26.4{\pm}6.1%$, respectively, and unrelated donor HSCT ($p$=0.002) and HLA mismatch ($p$=0.022) were significantly correlated with increased TRM in univariate analysis. Conclusion: In this single institution study spanning more than 17 years, sibling donor HSCT was the only factor predicting a favorable result in multivariate analysis, possibly due to increased TRM resulting from unrelated donor HSCT.

A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan;Wang, Tao;Shi, Fan;Yang, Yun-Yi;Su, Jin;Chai, Yan-Lan;Liu, Zi
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5957-5961
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    • 2015
  • Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.

Treatment Results and Prognostic Factors in the Management of Locoregional Recurrent Breast Carcinoma (국소재발유암의 치료성적 및 예후 인자)

  • Moon, Sun-Rock;Lee, Hyung-Sik;Kim, Gwi-Eon;Ahn, Ki-Jung;Suh, Chang-Ok;Kyu, John-Juhn;Min, Jin-Sik;Lee, Kyung-Sik;Kim, Byung-Soo;Noh, Jae-Kyung;Koh, Eun-Hee
    • Radiation Oncology Journal
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    • v.8 no.1
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    • pp.65-71
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    • 1990
  • Between January,1974 and December 1980, fifty eight patients with locoregional recurrent breast carcinoma who did not have evidence of distant metastasis after initial treatment of surgery with or without adjuvant chemotherapy were treated with radiation therapy. Among them, five patients were excluded from this study because of incomplete record or incomplete treatment. The 5-year overall survival and disease free survival from the time of locoregional recurrence was $27\%\;and\;15\%$ respectively. In univariate analysis of prognostic variables, the clinical stage at initial diagnosis, recur duration, number of recurrence sites, size of recurrences, response to the treatment, remission duration were all found to have no significant effect on survival or disease free survival. On the other hand, menopausal status at initial diagnosis, number of positive node at initial surgery, whether or not the use of adjuvant chemotherapy after initial mastectomy had definite prognositc significance. In multivariate analysis of prognostic variables, remission duration, menopausal status at diagnosis, number of axillary node at mastectomy had definite prognostic significance. On the other hand, remission duration more than 12 months, premenopaus at initial mastectomy, less than four positive axillary lymph nodes at mastectomy predicted a good prognosis.

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Successful Treatment of a Korean Infant with Giant Cell Hepatitis with Autoimmune Hemolytic Anemia Using Rituximab

  • Kim, Young Ho;Kim, Ju Whi;Lee, Eun Joo;Kang, Gyeong Hoon;Kang, Hyoung Jin;Moon, Jin Soo;Ko, Jae Sung
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.2
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    • pp.180-187
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    • 2020
  • Giant cell hepatitis with autoimmune hemolytic anemia (AHA) is a rare disease of infancy characterized by the presence of both Coombs-positive hemolytic anemia and progressive liver disease with giant cell transformation of hepatocytes. Here, we report a case involving a seven-month-old male infant who presented with AHA followed by cholestatic hepatitis. The clinical features included jaundice, pallor, and red urine. Physical examination showed generalized icterus and splenomegaly. The laboratory findings suggested warm-type AHA with cholestatic hepatitis. Liver biopsy revealed giant cell transformation of hepatocytes and moderate lobular inflammation. The patient was successfully treated with four doses of rituximab. Early relapse of hemolytic anemia and hepatitis was observed, which prompted the use of an additional salvage dose of rituximab. He is currently in clinical remission.

The Study on the Safety and Case Series of the Acute Lymphocytic Leukemia using Rhus Verniciflua Stokes Extract (Nexia) (건칠(乾漆) 추출물(Nexia)의 독성 실험과 급성 림프 구성 백혈병환자의 임상증례군 보고)

  • Park, Jae-Woo;Kim, Kyung-Suk;Jung, Hyun-Sik;Choi, Won-Cheol;Yoon, Seong-Woo
    • Journal of Korean Traditional Oncology
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    • v.11 no.1
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    • pp.1-21
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    • 2006
  • This study was undertaken to evaluate safety and antitumor activity of Nexia, a processed extract of Rhus verniciflua STOKES by heating according to Korean patent 0504160 through toxicology, cancer research and clinical application. Nexia did not exhibit any toxicological symptoms through 13 week continuous treatment, dosage accumulation study and anaphylaxis response. The lifespan of four patients with acute lymphocytic leukemia under complete remission were 110, 83, 97, and 86 months after treatment of Nexia, respectively. These data suggest that Nexia, a processed extract by removing allergen from Rhus verniciflua STOKES, may have safety and antitumor activity and also still need continuous study on its mechanism and clinical trial.

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Lack of Association between Polymorphisms in Genes MTHFR and MDR1 with Risk of Childhood Acute Lymphoblastic Leukemia

  • Kreile, Madara;Rots, Dmitrijs;Piekuse, Linda;Cebura, Elizabete;Grutupa, Marika;Kovalova, Zhanna;Lace, Baiba
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.22
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    • pp.9707-9711
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    • 2014
  • Background: Acute lymphoblastic leukemia (ALL) is a complex disease caused by interactions between hazardous exogenous or/and endogenous agents and many mild effect inherited susceptibility mutations. Some of them are known, but their functional roles still requireinvestigation. Age is a recognized risk factor; children with disease onset after the age of ten have worse prognosis, presumably also triggered by inherited factors. Materials and Methods: The MDR1 gene polymorphisms rs1045642, rs2032582 and MTHFR gene polymorphisms rs1801131 and rs1801133 were genotyped in 68 ALL patients in remission and 102 age and gender matched controls; parental DNA samples were also available for 42 probands. Results: No case control association was found between analyzed polymorphisms and a risk of childhood ALL development. Linkage disequilibrium was not observed in a family-based association study either. Only marginal association was observed between genetic marker rs2032582A and later disease onset (p=0.04). Conclusions: Our data suggest that late age of ALL onset could be triggered by mild effect common alleles.

Stem cell niche as a prognostic factor in leukemia

  • Lee, Ga-Young;Kim, Jin-A;Oh, Il-Hoan
    • BMB Reports
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    • v.48 no.8
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    • pp.427-428
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    • 2015
  • Despite high interests on microenvironmental regulation of leukemic cells, little is known for bone marrow (BM) niche in leukemia patients. Our recent study on BMs of acute myeloid leukemia (AML) patients showed that the mesenchymal stromal cells (MSCs) are altered during leukemic conditions in a clinical course-dependent manner. Leukemic blasts caused reprogramming of transcriptomes in MSCs and remodeling of niche cross-talk, selectively suppressing normal primitive hematopoietic cells while supporting leukemogenesis and chemo-resistance. Notably, differences in BM stromal remodeling were correlated to heterogeneity in subsequent clinical courses of AML, i.e., low numbers of mesenchymal progenitors at initial diagnosis were correlated to complete remission for 5-8 years, and high contents of mesenchymal progenitor or MSCs correlated to early or late relapse, respectively. Thus, stromal remodeling by leukemic cell is an intrinsic part of leukemogenesis that can contribute to the clonal dominance of leukemic cells over normal hematopoietic cells, and can serve as a biomarker for prediction of prognosis. [BMB Reports 2015; 48(8): 427-428]

Change in the treatment strategy for pediatric Crohn's disease

  • Kim, Mi-Jin;Choe, Yon-Ho
    • Clinical and Experimental Pediatrics
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    • v.53 no.9
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    • pp.830-833
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    • 2010
  • Crohn's disease is characterized by chronic inflammation involving any portion of the gastrointestinal tract. Treating Crohn's disease is a major challenge for clinicians, as no curative therapy currently exists. Pediatric Crohn's disease is characterized by frequent relapses, a wide extent of disease, a high prevalence of extraintestinal manifestations, and a severe clinical course. The classic therapeutic approach is known as the 'step-up' strategy, and follows a progressive course of treatment intensification as disease severity increases. Although this approach is usually effective for symptom control, many patients become either resistant to or dependent on corticosteroids. The efficacy of infliximab suggests that, rather than a progressive course of treatment, early intense induction may reduce complications associated with conventional treatment and improve quality of life. Intensive early therapy with infliximab is known as the 'top-down' strategy. Such therapy offers the potential for altering the natural history of Crohn's disease, and is changing treatment paradigms. However, the relatively new concept of an early aggressive or 'top-down' treatment approach is not yet widely accepted, especially in pediatric patients. The results of our current study demonstrate that early and intensive treatment of pediatric Crohn's disease patients with infliximab, at initial diagnosis, was more effective for maintaining remission and reducing flares.

Tumor Immunology and Immune Checkpoint Inhibitors in Non-Small Cell Lung Cancer

  • Jung, Chi Young;Antonia, Scott J.
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.1
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    • pp.29-41
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    • 2018
  • Lung cancer is one of the most commonly diagnosed cancers and the leading cause of cancer-related deaths worldwide. Although progress in the treatment of advanced non-small cell lung cancer (NSCLC) has been made over the past decade, the 5-year survival rate in patients with lung cancer remains only 10%-20%. Obviously, new therapeutic options are required for patients with advanced NSCLC and unmet medical needs. Cancer immunotherapy is an evolving treatment modality that uses a patient's own immune systems to fight cancer. Theoretically, cancer immunotherapy can result in long-term cancer remission and may not cause the same side effects as chemotherapy and radiation. Immunooncology has become an important focus of basic research as well as clinical trials for the treatment of NSCLC. Immune checkpoint inhibitors are the most promising approach for cancer immunotherapy and they have become the standard of care for patients with advanced NSCLC. This review summarizes basic tumor immunology and the relevant clinical data on immunotherapeutic approaches, especially immune checkpoint inhibitors in NSCLC.