• Title/Summary/Keyword: Trials

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Cell Therapy in Kidney Transplantation (신장이식 분야의 세포 면역치료)

  • Jeon, Hee Jung;Yang, Jaeseok
    • Korean Journal of Transplantation
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    • v.28 no.3
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    • pp.121-134
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    • 2014
  • Current immunosuppressants have nonspecific immuosuppressive effects, and are not helpful for tolerance induction. Consequently, transplant patients cannot discontinue using them, and their nonspecific immunosuppressive effects result in many side effects, including infection and malignancy. However, most of cellular immunotherapy can have donor antigen-specific immunsuppressive effects. Therefore, cell therapy could be an alternative or adjunctive to nonspecific immunosuppressants. Polyclonal or antigen-specific Foxp3+ regulatory T cells have been actively tried for prevention of acute rejection, treatment of chronic rejection, or tolerance induction in clinical trials. Regulatory macrophages are also under clinical trials for kidney transplant patients. IL-10-secreting type 1 regulatory T cells and donor- or recipient-derived tolerogenic dendritic cells will also be used for immunoregulation in clinical trials of kidney transplantation. These cells have antigen-specific immunoregulatory effects. Mesenchymal stromal cells (MSCs) have good proliferative capacity and immunosuppressive actions independently of major histocompatibility complex; therefore, even third-party MSCs can be stored and used for many patients. Cell therapy using various immunoregulatory cells is now promising for not only reducing side effects of nonspecific immunosuppressants but also induction of immune tolerance, and is expected to contribute to better outcomes in transplant patients.

Comparison of Extracorporeal Shock Wave Therapy Versus Injection Therapy for Shoulder Disorders: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Dajeong Kim;Hyunjoong Kim
    • Physical Therapy Rehabilitation Science
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    • v.12 no.1
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    • pp.48-55
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    • 2023
  • Objective: The purpose of this study is to compare the effects of extracorporeal shock wave therapy (ESWT) and injection therapy through qualitative and quantitative analysis by synthesizing randomized controlled trials (RCTs) conducted on patients with various shoulder diseases. Design: A systematic review and meta-analysis of randomized controlled trials Methods: This review conducted a literature search through international electronic databases in January 2023 to compare the effects of ESWT and injection therapy. Qualitative analysis was performed as a risk of bias tool, and quantitative analysis was synthesized with a random effect model to show the effect size as a standardized mean difference (SMD). Results: Five RCTs involving 298 individuals with shoulder disorders were included in this systematic review and meta-analysis. ESWT showed a moderate effect on pain (SMD=-0.44; 95% CI, -0.95 to 0.06) and a large effect on shoulder function (SMD =-0.81; 95% CI, -1.70 to 0.07) than injection therapy. A significant difference was found in the shoulder range of motion, showing a large effect size (SMD=1.50; 95% CI, 0.58 to 2.43). Conclusions: When considering treatment options for the management of patients complaining of shoulder disorders, it is appropriate to recommend ESWT first rather than injection therapy to increase the range of motion of the joint. In addition, ESWT is safe for pain control and shoulder function improvement, and a positive prognosis could be expected.

Effect of Robot-Assisted Wearable Exoskeleton on Gait Speed of Post-Stroke Patients: A Systematic Review and Meta-Analysis of a Randomized Controlled Trials

  • Chankyu Kim;Hyun-Joong Kim
    • Physical Therapy Rehabilitation Science
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    • v.11 no.4
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    • pp.471-477
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    • 2022
  • Objective: The greatest motor impairment after stroke is a decreased ability to walk. Most stroke patients achieve independent gait, but approximately 70% do not reach normal speed, making it difficult to reach a standard of daily living. Therefore, a wearable exoskeleton is recommended for optimal independent gait because different residual disorders hinder motor function after stroke. This review synthesized the effect on gait speed in randomized controlled trials (RCTs) in which gait training using a wearable exoskeleton was performed on post-stroke patients for qualitative and quantitative analysis. Design: A systematic review and meta-analysis of a randomized controlled trials Methods: RCTs using wearable exoskeletons in robotic rehabilitation of post-stroke patients were extracted from an international electronic database. For quality assessment and quantitative analysis, RevMan 5.4 was used. Quantitative analysis was calculated as the standardized mean difference (SMD) and presented as a random effect model. Results: Five studies involving 197 post-stroke patients were included in this review. As a result of the analysis using a random effect model, gait training using a wearable exoskeleton in post-stroke patients showed a significant improvement in gait speed compared to the non-wearing exoskeleton (SMD=1.15, 95% confidence interval: 0.52 to 1.78). Conclusions: This study concluded that a wearable exoskeleton was more effective than conventional gait training in improving the gait speed in post-stroke patients.

Spinal Cord Injury and Neuro-Regeneration (척수 손상과 신경 재생)

  • Ahn, Joo-Hyun;Park, Hyung-Youl;Kim, Young-Hoon
    • Journal of the Korean Orthopaedic Association
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    • v.54 no.6
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    • pp.498-508
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    • 2019
  • Recent advances in the understanding of the pathophysiology of spinal cord injury (SCI) and new therapeutic approaches have provided promising results for this incurable and debilitating central nervous system injury. Various neuro-protective and neuro-regenerative trials have been attempted to overcome SCIs. This review summarizes the reported experimental and clinical data regarding neuro-regenerative trials with the proven pathophysiology of SCI. In addition, the prerequisites for safe and effective clinical trials are discussed.

Recent Progress in Immunotherapy for Advanced Gastric Cancer (진행성 위암에 대한 면역 요법의 최신 지견)

  • Byeong Seok Sohn
    • Journal of Digestive Cancer Research
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    • v.10 no.1
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    • pp.22-30
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    • 2022
  • Immune checkpoint inhibition has been established as a new treatment option for various types of carcinoma, and many clinical trials are being actively conducted as a treatment for advanced or metastatic gastric cancer, either as a monotherapy with an immune checkpoint inhibitor or as a combination therapy with standard chemotherapy. In the CheckMate-649 clinical trial to confirm the efficacy of the combination of nivolumab and chemotherapy (FP) in advanced gastric cancer and gastroesophageal junction cancer, nivolumab group showed improvement in overall survival in programmed death ligand 1-positive cancer patients compared with placebo group. Also, the combination therapy of pembrolizumab, trastuzumab and chemotherapy (FP) in first-line treatment was tested through the KEYNOTE-811 trial. The pembrolizumab group showed 22.7% of improvement in objective response rate compared with placebo group. Accordingly, the combination of nivolumab/pembrolizumab with standard chemotherapy was approved for the first-line treatment. In KEYNOTE-059 trials for patients with progressive disease after at least two lines of chemotherapy, pembrolizumab monotherapy showed improvement in objective response rate and overall survival, and the use of pembrolizumab was approved for the third-line or more treatment. In this article, we review the result of clinical trials related to immune checkpoint inhibitors that have been recently introduced in the treatment of gastric cancer.

Effects of Cardiovascular Training on Interleukin-6 in Stroke Patients: a Systematic Review and Meta-analysis of Randomized Controlled Trials

  • Jeong Keun Song;Ju Hui Moon
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.115-122
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    • 2023
  • Objective: A previous study reported that cardiovascular training (CT) decreased interleukin-6 (IL-6), a pro-inflammatory cytokine with bidirectional effects. However, because of conflicting results of increasing and decreasing IL-6 levels in stroke patients, it is essential to clarify the effects of CT on IL-6 levels in this population. Therefore, this review aimed to investigate the effects of CT on IL-6 levels in stroke patients through a meta-analysis of randomized controlled trials (RCTs), synthesizing and analyzing the effects qualitatively and quantitatively. Design: A systematic review and meta-analysis of randomized controlled trials. Methods: In this review, conducted in April 2023, electronic databases (Web of Science, CINAHL, Embase, MEDLINE, Google Scholar) were searched to ascertain the effects of CT on IL-6 levels in stroke patients. For qualitative evaluation, ReVMan, provided by the Cochrane Group, was used, and for quantitative evaluation, a random-effects model and SMD (Standardized Mean Difference) were used. Results: Three RCTs measured IL-6 in 117 patients with stroke. The experimental group to which CT was applied showed no significant change compared to the control group.The result of analysis using the random effect model is SMD=-0.23; 95% confidence interval, -0.66 to 0.20. Conclusions: CT does not affect IL-6 levels in stroke patients. These results suggest that CT can be applied regardless of its positive or negative effect on IL-6 levels in stroke patients.

Effects of cold water immersion and compression garment use after eccentric exercise on recovery

  • Maruyama, Tatsuhiro;Mizuno, Sahiro;Goto, Kazushige
    • Korean Journal of Exercise Nutrition
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    • v.23 no.1
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    • pp.48-54
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    • 2019
  • [Purpose] The combined effect of different types of post-exercise treatment has not been fully explored. We investigated the effect of combined cold water immersion (CWI) and compression garment (CG) use after maximal eccentric exercise on maximal muscle strength, indirect muscle damage markers in the blood, muscle thickness, and muscle soreness score 24 h after exercise. [Methods] Ten men performed two trials (CWI + CG and CON) in random order. In the CWI + CG trial, the subjects performed 15 min of CWI (15℃), followed by wearing of a lower-body CG for 24 h after exercise. In the CON trial, there was no post-exercise treatment. The exercise consisted of 6 × 10 maximal isokinetic (60°·s-1) eccentric knee extensions using one lower limb. The maximal voluntary contraction (MVC) and maximal isokinetic (60°·s-1) strength during knee extension, as well as the indirect muscle damage markers, were evaluated before exercise and 24 h after exercise. [Results] The maximal muscle strength decreased in both trials (p < 0.001), with no difference between them. The exercise-induced elevation in the myoglobin concentration tended to be lower in the CWI + CG trial than in the CON trial (p = 0.060). The difference in the MVC, maximal isokinetic strength, muscle thickness, and muscle soreness score between the trials was not significant. [Conclusion] CWI followed by wearing of a CG after maximal eccentric exercise tended to attenuate the exercise-induced elevation of indirect muscle damage markers in the blood.

Effect of Acupuncture and Moxibustion for Vitiligo: A Scoping Review of Randomized Controlled Trials (백반증의 침구(鍼灸) 치료 효과: 무작위 대조 시험에 대한 주제 범위 문헌 고찰)

  • Do Kyung Han;Jeewon Shon;Won Gun An
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.145-155
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    • 2023
  • Objectives : The aim of this study is to review the effect of acupuncture/moxibustion on vitiligo. Methods : Using 5 databases(Pubmed, EMBASE, Cochrane Library, RISS, OASIS) clinical studies about effect of acupuncture/moxibustion on vitiligo were searched. Only randomized controlled trials(RCTs) were selected to analyze. Results : Total 235 studies were searched. After screening those studies 5 studies were selected from china and Iran. 3 studies used effective rate to measure the effect of acupuncture for vitiligo. 1 study used Vitiligo Area Scoring Index(VASI) and 1 study assessed 4 grade of repigmentation to prove acupuncture's effect on vitiligo. All studies showed repigmentation in acupuncture/moxibustion group. Adverse effects reported in the five studies were temporary erythema, itching, and dryness. Conclusions : These findings suggest that acupuncture and moxibustion can be considered a safe treatment for vitiligo. However, due to the small number of RCTs conducted on acupuncture and moxibustion for vitiligo, more RCTs should be conducted to confirm the effectiveness of acupuncture and moxibustion for vitiligo.

Acupuncture Treatment for Restless Legs Syndrome: A Review of Randomized Controlled Trials

  • Go Eun Chae;Hyun Woo Kim;Hye Jeong Jo;Ahra Koh;Young Jin Lee;Ji Eun Choi;Woo Young Kim
    • Journal of Acupuncture Research
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    • v.40 no.4
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    • pp.308-318
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    • 2023
  • To determine the effectiveness of acupuncture in treating restless legs syndrome (RLS), we conducted a literature review of randomized controlled trials (RCTs) that utilized acupuncture as an intervention for patients diagnosed with RLS. Relevant clinical studies (n = 158) from seven databases (the Cochrane Library, PubMed, Embase, CNKI, KISS, RISS, and OASIS) were included based on the inclusion and exclusion criteria and analyzed. Moreover, 6 RCTs were selected for review. In all six studies, it was indicated people who underwent acupuncture treatment showed significant improvements in their overall health. An increase in the treatment efficacy rate, sleep quality, and quality of life indicators after the acupuncture treatment was confirmed. The severity of pain as assessed using the visual analog scale (VAS) scores and International RLS Study Group Rating Scale (IRLSRS) scores and the severity of RLS symptoms were significantly reduced. Any significant side effects were not reported. Acupuncture is suggested as an effective and safe treatment method for RLS. However, further large-scale RCT studies are needed to confirm our findings.

A Review of Domestic and International Clinical Research Trends on Pharmacopuncture Treatment for Fractures (골절의 약침치료에 대한 임상 연구 동향)

  • Hea Sun Chun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.37 no.6
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    • pp.185-192
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    • 2023
  • The purpose of this study is to analyze trends in domestic and international clinical research studies on pharmacopuncture treatment for fractures. We searched five online databases (PubMed, CNKI, RISS, KISS, and OASIS), and selected a total of 13 clinical research studies from Korea and China. Selected studies were analyzed according to publication year, subject, intervention, treatment method, evaluation scale, adverse event, risk of bias, etc. A total of 10 case studies and 3 randomized controlled trials were included. The study subjects were more often female, and the most common type of fracture was vertebral compression fracture. In Korea, herbal medicine preparations and bee venom were used for pharmacopuncture solution, whereas in China, both herbal medicine preparations and Western medicine preparations were used. All studies commonly used local acupoint needling, and in most cases, the treatment period for case study was less than 1 month, and the observation period of randomized controlled trials was diverse. The most frequently used evaluation scale was numeric rating scale, adverse events were mentioned in only three studies, and no adverse events were reported. Overall risk of bias of all included randomized controlled trials was judged "some concerns". According to this study, pharmacopuncture treatment for fractures was found to be relatively effective and safe, but research that complements the limitations of this study is needed.