• Gut and Liver
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• 제12권6호
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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.

• Journal of Yeungnam Medical Science
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• 제38권4호
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• pp.337-343
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• 2021

Background: Chromogranin A (CgA) levels have been reported to predict mortality in patients with heart failure. However, information on the prognostic value and clinical availability of CgA is limited. We compared the prognostic value of CgA to that of previously proven natriuretic peptide biomarkers in patients with acute heart failure. Methods: We retrospectively evaluated 272 patients (mean age, 68.5±15.6 years; 62.9% male) who underwent CgA test in the acute stage of heart failure hospitalization between June 2017 and June 2018. The median follow-up period was 348 days. Prognosis was assessed using the composite events of 1-year death and heart failure hospitalization. Results: In-hospital mortality rate during index admission was 7.0% (n=19). During the 1-year follow-up, a composite event rate was observed in 12.1% (n=33) of the patients. The areas under the receiver-operating characteristic curves for predicting 1-year adverse events were 0.737 and 0.697 for N-terminal pro-B-type natriuretic peptide (NT-proBNP) and CgA, respectively. During follow-up, patients with high CgA levels (>158 pmol/L) had worse outcomes than those with low CgA levels (≤158 pmol/L) (85.2% vs. 58.6%, p<0.001). When stratifying the patients into four subgroups based on CgA and NT-proBNP levels, patients with high NT-proBNP and high CgA had the worst outcome. CgA had an incremental prognostic value when added to the combination of NT-proBNP and clinically relevant risk factors. Conclusion: The prognostic power of CgA was comparable to that of NT-proBNP in patients with acute heart failure. The combination of CgA and NT-proBNP can improve prognosis prediction in these patients.

• 대한한의학회지
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• 제40권1호
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

• 대한한의학회지
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• 제40권1호
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• pp.124-152
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

• Safety and Health at Work
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• 제13권3호
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• pp.263-268
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• 2022

Health care workers (HCWs) are more than ten times more likely to be infected with coronavirus infectious disease 2019 (COVID-19) than the general population, thus demonstrating the burden of COVID-19 among HCWs. Factors that expose HCWs to a differentially high-risk of COVID-19 acquisition are important to elucidate, enable appropriate public health interventions to mitigate against high risk and reduce adverse outcomes from the infection. We conducted a systematic review and meta-analysis to summarize and critically analyze the existing evidence on SARS-CoV-2 risk factors among HCWs. With no geographical limitation, we included studies, in any country, that reported (i) the PCR laboratory diagnosis of COVID-19 as an independent variable (ii) one or more COVID-19 risk factors among HCWs with risk estimates (relative risk, odds ratio, or hazard ratio) (iii) original, quantitative study design, and published in English or Mandarian. Our initial search resulted in 470 articles overall, however, only 10 studies met the inclusion criteria for this review. Out of the 10 studies included in the review, inadequate/lack of protective personal equipment, performing tracheal intubation, and gender were the most common risk factors of COVID-19. Based on the random effects adjusted pooled relative risk, HCWs who reported the use of protective personal equipment were 29% (95% CI: 16% to 41%) less likely to test positive for COVID-19. The study also revealed that HCWs who performed tracheal intubations were 34% (95% CI: 14% to 57%) more likely to test positive for COVID-19. Interestingly, this study showed that female HCWs are at 11% higher risk (RR 1.11 95% CI 1.01-1.21) of COVID-19 than their male counterparts. This article presents initial findings from a living systematic review and meta-analysis, therefore, did not yield many studies; however, it revealed a significant insight into better understanding COVID-19 risk factors among HCWs; insights important for devising preventive strategies that protect them from this infection.

• 대한한방부인과학회지
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• 제34권3호
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• pp.175-191
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• 2021

Objectives: This study aims to analyze the medical record of eight cases of polycystic ovary syndrome (PCOS) in a local Korean medicine clinic, in order to provide evidence on Korean medicine treatment of PCOS and to suggest the direction of future studies. Methods: The medical records of eight cases diagnosed with PCOS based on 2003 Rotterdam Criteria and whose total testosterone level was 0.53 ng/ml and over were retrospectively analyzed. The primary outcome was total testosterone level, and the secondary outcomes included luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels, LH/FSH ratio, weight, last mentrual period (LMP), numerical rating scale (NRS) score of dysmenorrhea, and other associated symptoms pre- and post-treatment. Korean medicine treatment consists of the complex herbal prescription consisting of Yukmijihwang-tang, Baekho-tang, Daesiho-tang, and Gyejibokryeong-hwan, modified according to symptoms; acupuncture and electroacupuncture on 中脘 (CV12), 下脘 (CV10), 關元 (CV4), 石門 (CV5), 合谷 (LI4), 太衝 (LR3), 三陰交 (SP6), and 懸鍾 (GB39); and indirect moxibustion on 神闕 (CV8). Results: The average total testosterone level lowered statistically significantly after the treatment. The average FSH and LH levels lowered with insignificance, while the average LH/FSH ratio and weight lowered statistically significantly. During the treatment period of three to six months, every patient had the menstrual cycle shortened except for one case; and two cases with infertility problem succeeded in being pregnant. There was no adverse event. Conclusions: The Korean medicine treatment was found effective in treating PCOS, especially regarding hyperandrogenism, amenorrhea or oligomenorrhea, and infertility.

• 대한한의학방제학회지
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• 제30권4호
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• pp.241-248
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• 2022

Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

• Pediatric Infection and Vaccine
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• 제29권3호
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• pp.147-154
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• 2022

코로나바이러스-19 (COVID-19)는 일반적으로 성인에 비해 소아에서 임상적으로 경한 양상을 보이며, 대부분의 소아에서 약 7일간의 격리가 끝나면 증상이 호전되어 특별한 이벤트 없이 퇴원하게 된다. 우리는 통상적인 임상경과와는 다르게, 격리 해제시점 또는 퇴원을 고려하고 있는 시점에 갑자기 악화된 임상증상을 보이는 3명의 청소년 환아들을 경험하였다. 세 명의 아이들은 공통적으로 신경학적 질환을 기저질환으로 가지고 있었다. Case 1은 울리히 선천성 근디스트로피로 진단받고 밤에만 이중양압기로 호흡보조를 받던 17세 남환의 경우로, 첫 COVID-19 증상 이후 9일이 지나고 증상 호전되어 퇴원을 준비하던 중 심폐정지가 발생하였다. Case 2는 뇌출혈 및 뇌경색 이후 병상에 누워 지내며 기관절개관 삽입 후 가정용 인공호흡기로 호흡보조를 받던 12세 여자 환아로, 증상이 호전되어 퇴원하였으나 첫 COVID-19 증상 이후 11일이 지난 후 심폐정지가 발생하였다. Case 3의 경우 조산아로 출생하여 뇌실출혈 및 수두증 진단받고 병상에 누워 지내나 호흡보조는 받지 않았던 12세 남자 환아로, 첫 증상 이후 호전추세였으나 10일 후 다기관 기능부전 확인되어 입원 진행하였다. 항바이러스제, 스테로이드제, 경험적 항생제가 투여되었고 중환자실 치료를 시행하였다. 세 환아들 중 2명 (case 1, 3)은 치료를 통해 호전되었으나, 1명 (case 2)는 심부전 진행하여 사망하였다. 이러한 경험에 비추어 볼 때, COVID-19 격리 기간이 끝나고 퇴원 가능한 시점이라도 갑작스러운 증상 악화를 보일 가능성이 있기에, 긴장을 놓지 않고 임상 증상의 변화를 확인하고 필요시 빠른 조치를 취해야 할 것으로 생각된다. 특히 신경학적 또는 호흡기적 만성 질환을 갖는 아이들에게 주의가 더 필요할 것으로 생각된다.

• Journal of Periodontal and Implant Science
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• 제53권4호
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• pp.306-317
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• 2023

Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ² test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.