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Analysis of the Results of the 2022 Gyeonggi-do Korean Medicine Infertility Support Project (2022년도 경기도 한의약 난임지원사업 결과 분석 연구)

  • Hye-Sung Lee;Hyo-Jung Jung;Su-Ji Choi;Dong-Il Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.4
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    • pp.78-95
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    • 2023
  • Objectives: This study aims to analyze the results of the 2022 Gyeonggi-do Oriental Medicine Fertility Treatment Support Project, review the outcomes and satisfaction of Oriental Medicine fertility support initiatives, and propose progressive fertility treatment support strategies by comparing them with the results of the past three years. Methods: Total of 242 women and 205 spouses participated in the Korean Medicine fertility treatment support project, which encompassed herbal medicine, acupuncture, and counseling treatments over a 3-month period, followed by a 3-month post-treatment follow-up. Data pertaining to patients' general, demographic, and fertility-related characteristics were collected before treatment initiation. During treatment, information regarding the treatments administered by Korean medical doctors was recorded, along with post-treatment outcomes and satisfaction levels. Safety assessments included pre- and post-treatment blood tests and monitoring for adverse events. Results: Among the 242 female subjects, 209 successfully completed the treatment program. Of these, 35 (16.7%) achieved pregnancy, with 30 (15%) attaining pregnancy through herbal monotherapy. Out of the 35 pregnancies, 17 were maintained, while 10 resulted in miscarriage. Notably, 83.8% of patients expressed satisfaction with the treatment outcomes. An analysis spanning three years revealed a continuous increase in the average age of patients, surpassing 38 years in 2022, a critical point in fertility decline age. Additionally, there was a notable rise in the prevalence of patients with a history of gynecological issues, advanced spouse age, and semen abnormalities, which is assumed to have contributed to the decrease in the pregnancy success rate. Conclusions: This study compares the clinical results of the 2022 Gyeonggi-do Korean Medicine Fertility Treatment Support Project with those of the past three years. Based on these findings, recommendations are made to enhance the project, including stricter age criteria for patient selection, enhanced specialized treatment tools for medical doctors, and combining Korean Medicine treatment and medical assisted reproductive technologies, all aimed at increasing pregnancy success rates. These results provide a foundation for the development of fertility support projects and related policies.

Herbal Medicine Treatment for Cold Urticaria: A Systematic Review and Meta-Analysis (한랭 두드러기에 대한 한약 치료: 체계적 문헌 고찰 및 메타분석)

  • Hae-Na Kim;Jeong-Hwa Oh;Hwa-Jung Yoon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.122-144
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    • 2023
  • Objectives : The purpose of this study is to evaluate the effects of herbal medicine treatment in patients with cold urticaria. Methods : We searched randomized controlled trials(RCTs) reporting the effects of herbal medicine for cold urticaria through domestic and international databases from their inception to September 2023. The results were summarized in tables. We assessed the risk of bias in included RCTs through Cochrane risk of bias tool and the data synthesis was conducted through RevMan version 5.4. Results : A total of 12 RCTs were included in this review and all trials compared herbal medicine alone treatment(treatment group) with western medicine alone treatment(control group). The total effective rate(TER) of treatment group was statistically higher than that of control group(RR: 1.49, 95% CI: 1.38 to 1.62, p<0.00001, I2=65%). On the other hand, when comparing except for 1 trial with different evaluation period, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.36, 95% CI: 1.26 to 1.47, p<0.00001, I2=0%). And when comparing 8 trials using the total symptom score(TSS) change index as an indicator of TER, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.38, 95% CI: 1.26 to 1.51, p<0.00001, I2=0%). The treatment group showed more statistically significant decrease compared to the control group in TSS(MD: -2.51, 95% CI: -2.63 to -2.40, p<0.00001, I2=99%). The relapse rate of treatment group was statistically lower than that of control group(RR: 0.19, 95% CI: 0.10 to 0.40, p<0.00001, I2=0%). Mild adverse events such as sleepiness, dizziness were reported in control group and gastric discomfort was reported in treatment group. In the risk of bias assessment, many cases were evaluated as 'Unclear risk'. Conclusions : This review found that herbal medicine alone treatment could more effective and safe than western medicine alone treatment for cold urticaria. But further well-designed researches are needed because of heterogeneity between trials and the quality of the included trials.

Utilizing the Application of High-Intensity Yttrium Aluminum Garnet (YAG) Lasers Focused on Acupoint Irradiation (경혈 조사를 중심으로 본 고출력 Yttrium Aluminum Garnet (YAG) 레이저의 활용)

  • Maeum Lee;Yoomin Choi;Subin Ahn;Gihyang Lee;Eunhee Lee;Myungjin Yim;Hyung-Sik Seo;Eui-hyoung Hwang;Insoo Jang
    • Korean Journal of Acupuncture
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    • v.40 no.4
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    • pp.141-148
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    • 2023
  • Objectives : The purpose of this study is to investigate on the application of the yttrium aluminum garnet (YAG) lasers for acupoints irradiation. Methods : We conducted a systematic search for peer-reviewed studies published from inception to November 2023, in the following electronic databases: PubMed, Scopus, and Web of Science in English, Science ON, Oriental Medicine Advanced Searching Integrated System (OASIS) and Research Information Sharing Service (RISS) in Korean, and China National Knowledge Infrastructure (CNKI) and Wanfang in Chinese, and Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii) in Japanese. Inclusion criteria were original articles including clinical and experimental studies related with YAG lasers for acupoints including Ashi or meridian sinews. Results : Among the 8 selected studies, there were 7 studies on human subjects and 1 study on animals, 7 studies on Nd:YAG (1,064 nm) laser, and 1 study on Er:YAG (2,940 nm) laser. A total of 16 acupoints were used, 15 of which were in the face and 1 of which was located in the foot. In addition, there were two studies using Ashi. 4 studies looked at the effect of pain relief, 2 studies looked at safety, 1 study looked at changes in blood flow, and 1 study looked at the effect of skin care. There were no reported adverse events, and the YAG laser was confirmed to be safe and effective in pain relief, beautifying the skin, and increasing blood flow. Conclusions : We suggest that high intensity YAG lasers can be applied to laser acupuncture or laser moxibustion. YAG lasers are considered to be worth using for various clinical indications of Korean medicine because of photobiomodulation effects, analgesic action, and deep penetration depth. Further scientific research and clinical evidences should be warranted.

Proof-of-concept study of the caninized anti-canine programmed death 1 antibody in dogs with advanced non-oral malignant melanoma solid tumors

  • Masaya Igase;Sakuya Inanaga;Shoma Nishibori;Kazuhito Itamoto;Hiroshi Sunahara;Yuki Nemoto;Kenji Tani;Hiro Horikirizono;Munekazu Nakaichi;Kenji Baba;Satoshi Kambayashi;Masaru Okuda;Yusuke Sakai;Masashi Sakurai;Masahiro Kato;Toshihiro Tsukui;Takuya Mizuno
    • Journal of Veterinary Science
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    • v.25 no.1
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    • pp.15.1-15.15
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    • 2024
  • Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%). Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions: The present study demonstrated that ca-4F12-E6 was well-tolerated in non-OMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.

Analysis of Research Trends in Traditional Chinese Medicine Treatments for Pes Anserine Bursitis from 2014 to 2024: Using the Search Results of China National Knowledge Infrastructure (거위발 점액낭염의 중의학적 치료에 대한 2014-2024년도의 연구 동향 분석: China National Knowledge Infrastructure를 중심으로)

  • Ja-Yean Son;Seok-Gyu Yang;Hea-Ju Kim;Seol Jung;Dong-Gyu Kim;Young-Hoon Lee;Kangmoo Goo;Na-young Kim;Dong Hwan Lee;Yu-Ra Im;Hyun-Woo Cho
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.2
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    • pp.135-147
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    • 2024
  • Objectives The aim of this study is to investigate the research trends in traditional Chinese medicine (TCM) treatment for pes anserine bursitis using the search results from the China National Knowledge Infrastructure (CNKI). Methods We searched for clinical studies on pes anserine bursitis in the CNKI electronic database. We analyzed the publication year, study type, participant demographics, treatment methods and duration, evaluation criteria, adverse events, and the results of each article. Results Seventeen studies published from January 1, 2014 to January 1, 2024 were selected. Among the 17 selected studies, 14 were randomized controlled trials and 2 were case reports. The most frequently used treatment intervention was acupuncture. Nine types of acupuncture were identified, including electro-acupuncture, pharmacopuncture, acupotomy, floating acupuncture, and other new types of acupuncture. The most commonly used evaluation outcome was effective rate. Conclusions Various TCM treatments for pes anserine bursitis were introduced, and we could identify the effectiveness of TCM in treating pes anserine bursitis. However, it is anticipated that more well-designed and high-quality evaluation studies will be required in the future.

Comparison of Veno-arterial Extracorporeal Membrane Oxygenation Configurations for Patients Listed for Heart Transplantation

  • Jung Ae Hong;Ah-Ram Kim;Min-Ju Kim;Dayoung Pack;Junho Hyun;Sang Eun Lee;Jae-Joong Kim;Pil Je Kang;Sung-Ho Jung;Min-Seok Kim
    • Korean Circulation Journal
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    • v.53 no.8
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    • pp.535-547
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    • 2023
  • Background and Objectives: Veno-arterial extracorporeal membrane oxygenation (VAECMO) as a bridge to eventual heart transplantation (HT) is increasingly used worldwide. However, the effect of different VA-ECMO types on HT outcomes remains unclear. Methods: This was a retrospective observational study of 111 patients receiving VA-ECMO and awaiting HT. We assessed 3 ECMO configuration groups: peripheral (n=76), central (n=12), and peripheral to central ECMO conversion (n=23). Cox proportional hazards regression and landmark analysis were conducted to analyze the effect of the ECMO configuration on HT and in-hospital mortality rates. We also evaluated adverse events during ECMO support. Results: HT was performed in the peripheral (n=48, 63.2%), central (n=10, 83.3%), and conversion (n=11, 47.8%) ECMO groups (p=0.133) with a median interval of 10.5, 16, and 30 days, respectively (p<0.001). The cumulative incidence of HT was significantly lower in the conversion group (hazard ratio, 0.292, 95% confidence interval, 0.145-0.586, p=0.001). However, there was no difference in in-hospital mortality (log-rank p=0.433). In the landmark analysis, in-hospital mortality did not differ significantly among the 3 groups. Although we did note a trend toward lower HT in the conversion group, the difference was not statistically significant. Surgical site bleeding occurred mainly in the central, while limb ischemia occurred mainly in the peripheral groups. Conclusions: We suggest that if patients are being stably supported with their initial ECMO configuration, whether it is central or peripheral, it should be maintained, and ECMO conversion should only be cautiously performed when necessary.

Association Between Body Mass Index and Clinical Outcomes According to Diabetes in Patients Who Underwent Percutaneous Coronary Intervention

  • Byung Gyu Kim;Sung-Jin Hong;Byeong-Keuk Kim;Yong-Joon Lee;Seung-Jun Lee;Chul-Min Ahn;Dong-Ho Shin;Jung-Sun Kim;Young-Guk Ko;Donghoon Choi;Myeong-Ki Hong;Yangsoo Jang
    • Korean Circulation Journal
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    • v.53 no.12
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    • pp.843-854
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    • 2023
  • Background and Objectives: We evaluated the effect of diabetes on the relationship between body mass index (BMI) and clinical outcomes in patients following percutaneous coronary intervention (PCI) with drug-eluting stent implantation. Methods: A total of 6,688 patients who underwent PCI were selected from five different registries led by Korean Multicenter Angioplasty Team. They were categorized according to their BMI into the following groups: underweight (<18.5 kg/m2), normal weight (18.5-24.9 kg/m2), overweight to obese (≥25.0 kg/m2). Major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of death, nonfatal myocardial infarction, stroke, and target-vessel revascularization, were compared according to the BMI categories (underweight, normal and overweight to obese group) and diabetic status. All subjects completed 1-year follow-up. Results: Among the 6,688 patients, 2,561 (38%) had diabetes. The underweight group compared to normal weight group had higher 1-year MACCE rate in both non-diabetic (adjusted hazard ratio [HR], 2.24; 95% confidence interval [CI], 1.04-4.84; p=0.039) and diabetic patients (adjusted HR, 2.86; 95% CI, 1.61-5.07; p<0.001). The overweight to obese group had a lower MACCE rate than the normal weight group in diabetic patients (adjusted HR, 0.67 [0.49-0.93]) but not in non-diabetic patients (adjusted HR, 1.06 [0.77-1.46]), with a significant interaction (p-interaction=0.025). Conclusions: Between the underweight and normal weight groups, the association between the BMI and clinical outcomes was consistent regardless of the presence of diabetes. However, better outcomes in overweight to obese over normal weight were observed only in diabetic patients. These results suggest that the association between BMI and clinical outcomes may differ according to the diabetic status.

Clinical Efficacy of the Transradial Approach in Percutaneous Intervention for a Malfunctioning Arteriovenous Fistula (혈액 투석 동정맥루의 기능 부전에 대한 인터벤션 치료 시 경요골 동맥 접근법의 유용성)

  • Hyun Young Choi;Gyoo-Sik Jung;Hee Kang;Ye Na Kim;Hyung Hwan Moon;Jong Hyouk Yun
    • Journal of the Korean Society of Radiology
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    • v.83 no.3
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    • pp.658-668
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    • 2022
  • Purpose To evaluate the effectiveness of the transradial artery approach (TRA) for treating malfunctioning arteriovenous fistulas (AVFs) in patients on hemodialysis. Materials and Methods A retrospective analysis was conducted in this single-center study of TRA endovascular procedures in 73 patients (43 male and 30 female; mean age of 67.4 years (range, 42-92 years) with malfunctioning AVFs, between January 2008 and April 2019. Patients' baseline and lesion characteristics, technical and clinical success, and complications were evaluated, and functional patency was analyzed using the Kaplan-Meier method. Results Radial artery approaches were successful in all patients. Angioplasty performed using the TRA achieved technical and clinical success rates of 98.6%(72/73) and 91.7%(67/73), respectively. The median primary patency time was 18.8 ± 15.9 months. The primary functional patency rates at 3, 6, and 12 months were 82.1%, 68.6%, and 63.9%, respectively. There were no major complications or adverse events, such as hand ischemia, related to the radial artery approach. Conclusion In selected cases, the TRA can be used complementary to the transvenous approach to treat malfunctioning AVFs.

Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

  • Tae Won Choi;Je Hwan Won;Hwan Jun Jae;Yong Sun Jeon;Sang Woo Park;Gi-Young Ko;Nam Yeol Yim;Jong Yun Won;Chang Won Kim;Jinoo Kim
    • Korean Journal of Radiology
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    • v.25 no.6
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    • pp.565-574
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    • 2024
  • Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

Phase I Clinical Trial of Prostate-Specific Membrane Antigen-Targeting 68Ga-NGUL PET/CT in Healthy Volunteers and Patients with Prostate Cancer

  • Minseok Suh;Hyun Gee Ryoo;Keon Wook Kang;Jae Min Jeong;Chang Wook Jeong;Cheol Kwak;Gi Jeong Cheon
    • Korean Journal of Radiology
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    • v.23 no.9
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    • pp.911-920
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    • 2022
  • Objective: 68Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N,N',N''-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68Ga-NGUL in healthy volunteers and the lesion detection rate of 68Ga-NGUL in patients with prostate cancer. Materials and Methods: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68Ga-NGUL (2 MBq/kg; 96-165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared. Results: All 12 participants (six healthy adults aged 31-32 years and six prostate cancer patients aged 57-81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68Ga-NGUL PET/CT or conventional imaging. Among them, 68Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions. Conclusion: 68Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68Ga-NGUL is a valuable option for prostate cancer imaging.