• Title/Summary/Keyword: Prospective clinical evaluation

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Characteristics of Active Tuberculosis Patients Requiring Intensive Care Monitoring and Factors Affecting Mortality

  • Filiz, Kosar A.;Levent, Dalar;Emel, Eryuksel;Pelin, Uysal;Turkay, Akbas;Aybuke, Kekecoglu
    • Tuberculosis and Respiratory Diseases
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    • v.79 no.3
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    • pp.158-164
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    • 2016
  • Background: One to three percent of cases of acute tuberculosis (TB) require monitoring in the intensive care unit (ICU). The purpose of this study is to establish and determine the mortality rate and discuss the causes of high mortality in these cases, and to evaluate the clinical and laboratory findings of TB patients admitted to the pulmonary ICU. Methods: The data of patients admitted to the ICU of Yedikule Chest Diseases and Chest Surgery Education and Research Hospital due to active TB were retrospectively evaluated. Demographic characteristics, medical history, and clinical and laboratory findings were evaluated. Results: Thirty-five TB patients (27 males) with a median age of 47 years were included, of whom 20 died within 30 days (57%). The Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores were significantly higher, and albumin and $PaO_2/FIO_2$ levels were significantly lower, and shock, multiple organ failure, the need for invasive mechanical ventilation and drug resistance were more common in the patients who died. The mortality risk was 7.58 times higher in the patients requiring invasive mechanical ventilation. The SOFA score alone was a significant risk factor affecting survival. Conclusion: The survival rate is low in cases of tuberculosis treated in an ICU. The predictors of mortality include the requirement of invasive mechanical ventilation and multiple organ failure. Another factor specific to TB patients is the presence of drug resistance, which should be taken seriously in countries where there is a high incidence of the disease. Finding new variables that can be established with new prospective studies may help to decrease the high mortality rate.

Preliminary Evaluation of Levocetirizine and Cetirizine Induced Liver Injury (임상 자료를 활용한 레보세티리진과 세티리진이 유도한 간손상 평가)

  • Sung, Eun Ji;Moon, Mira;Cho, Yoon Sook;Lee, Hye Suk;Kim, Hyang Sook;Lee, Ju-Yeun
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.3
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    • pp.213-218
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    • 2014
  • Objectives: The aim of this study was to identify the causal relationship between use of levocetrizine or cetrizine, and liver injury, by comparing frequency and pattern of hepatotoxicity in levocetrizine or cetrizine prescribed patients. Methods: This is a retrospective observational study, using data retrieved from electronic medical record system. Among 1164 patients prescribed levocetrizine or cetrizine during study period (Jul, 2009 - Jun, 2010) at Seoul National University Hospital, 543 patients with more than 4- time liver function test (LFT) results were included in final analysis. Liver injury was defined as greater than 3 times elevated level of alanine aminotransferase or 2 times elevated level of alkaline phosphatase or total bilirubin, compared to upper limit of normal, in patient with normal liver function at baseline. The frequency and pattern of liver injury were assessed. Results: Incidence of liver injury in patients prescribed with levotcetrizine or cetrizine were 1.48% and 2.94%, respectively. With few exceptions, most injuries were shown to be hepatocellular type. Rapid recovery was observed after drug cessation and long term use tends to be associated with incidence of liver injury. In patient with digestive system disorder, rate of liver injury was significantly higher (p=0.011). Conclusion: The result of this study implies potential need of liver toxicity monitoring, especially in patients taking long term levecetrizine or cetrizine or in patient with digestive system disorder. However, prospective large scale observational study is needed to confirm liver injury associated with the use of levocetirizine or cetirizine.

The Clinical Study on the Effect of Chuna Treatment for Patients with Herniated Intervertebral Disc of Lumbar Spine (요추간판탈출증(腰椎間板脫出症) 환자(患者)의 추나치료(推拿治療) 효과(效果)에 대(對)한 임상적(臨床的) 고찰(考察))

  • Kim, Su-Jang;Jang, Hyeong-Seok;Kim, Sung-Yong;Shin, Joon-Shik
    • The Journal of Korea CHUNA Manual Medicine
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    • v.2 no.1
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    • pp.93-109
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    • 2001
  • Objectives : The aim of present study is to estimate clinical outcome of Chuna treatment and Chuna medicine treatment for patients with H.I.V.D(Herniated Intervertebral Disc) of lumbar spine according to the character of patients and the steps of Chuna therapy, and therefore suggest a prospective, desirable Chuna treatment and patient guidance. Methods : We investigated the 258 cases of outpatients who were diagnosed as the H.I.V.D. on lumbar C.T. or MRI and were treated more than seven times with chuna treatment and more than one time with Chuna medicine treatment In Jaseng Oriental Medicine Hospital from September 1, 1999 to December 31, 2000. We evaluated the subjective symptoms by Hudgin's classification. For the sake of the more objective evaluation for before and after treatment, we calculated the Improvement index and ratio of the four parts to estimate the pain and functional disorder In before and after treatment by Macnab's criteria. Results & Conclusion : The improvement index and ratio showed that the conservative therapy with Chuna therapy improved the symptom of H.I.V.D. much effectively, and especially in the patient groups of male, 30-39 years, standing Job, duration of symptom within one week, the 4th step of chuna treatment, the first step of chuna medicine treatment, and the excellent satisfactory assessment of Chuna treatment. Therefore, it is supposed that the conservative therapy with Chuna therapy and patient guidance should be much actively continued.

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Tiering 'Drug Combinations to Avoid' and 'Drug-age Precaution' DUR Alerts by Severity Level and its Application (병용금기, 연령금기 경고 등급화 방안과 DUR 처방변경률 분석)

  • Lee, Soo Ok;Je, Nam Kyung;Kim, Dong-Sook;Cheun, Bang Ok;Hwang, In Ok
    • YAKHAK HOEJI
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    • v.59 no.6
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    • pp.278-283
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    • 2015
  • The computerized prospective Drug Utilization Review (DUR) program supported by the Korean government has provided alerts to physicians and pharmacists since December 2010. This study aims to propose and apply the tiering system in "drug combinations to avoid (DCA)" and "age-precaution" alerts based on severity to improve the compliance of users. To propose the severity and clinical importance of 647 DCA alerts and 140 age precautions, a Delphi evaluation survey was conducted. An expert panel comprising 5 clinical pharmacists and 5 physicians were participated in mail surveys. Based on the results of Delphi survey, DCA pairs were classified into 3 groups; group 1 (70.6%), 2 (26.9%), and 3 (2.8%). Drug-age precaution ingredients were also classified into three groups; group 1 (53.6%), group 2 (40.7%), and group 3 (5.7%). When this grouping was applied to claim data from 2011 to 2013, the majority of alerts had occurred in the groups of high severity. Presenting DUR alerts with severity level is expected to improve the compliance of clinicians. The implementation of tiering system in DUR criteria should be considered.

Drug Use Evaluation of Anticholinergic Drugs Prescribed to Elderly Patients in the Ambulatory Setting Based on Beers and STOPP Criteria (Beers Criteria 및 STOPP 근거에 의거한 한국 노인 환자의 항콜린성제 약물요법의 적절성 평가)

  • Cheon, Young Ju;Lim, Sung Cil
    • YAKHAK HOEJI
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    • v.58 no.5
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    • pp.328-336
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    • 2014
  • Anticholinergic drugs are included in the efficacy group of various antidepressants, antihistamines, antispasmodics like skeletal muscle relaxants. Elderly patients are often taking anticholinergic drugs due to various diseases such as sleep disorders and dysuria. But the use of anticholinergic drugs is restricted in guidelines such as Beers Criteria or STOPP due to the anticholinergic adverse effects including dry mouth, constipation, difficult urination, delirium, hallucinations and especially cognitive impairment. In this study, we investigated the usage of anticholinergic drugs in out-of-hospital prescription of 4,442 elderly patients. Results of the study were obtained that 32% (n=1,421) of overall patients were prescribed with 1~6 products (average 1.37) of anticholinergic drugs. 70.9% of the 1,421 patients (n=1,007) were prescribed with one drug, 22.7% (n=323) were two drugs and 4.9% (n=70) were three drugs. 27.1% of the 1,421 patients (n=430) were 70~74 years old patients who were the most commonly prescribed with anticholinergic drugs. Amitriptyline, chlorpheniramine, dimenhydrinate and quetiapine were most frequent component of ACB Score 3 drugs and amantadine, baclofen, carbamazepine, cyproheptadine and oxcarbazepine were most frequent of ACB Score 2 drugs. Anticholinergic Drug Scale (ADS) of individual patients presented one point (48.5%, n=689), 2 points (15.4%, n=219), more than 3 points (36.1%, n=513), and up to maximum 12 point (n=1). More than 2 points were more than half (51.5%, n=732). Therefore, additional prospective study in the use and adverse effects of anticholinergic drugs for elderly patients will be required. And national management such as DUR program will be required for elderly drug administration from now on.

Investigation of the efficacy and safety of ultrasound-standardized autologous blood injection as treatment for lateral epicondylitis

  • Braaksma, Christel;Otte, Jill;Wessel, Ronald N.;Wolterbeek, Nienke
    • Clinics in Shoulder and Elbow
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    • v.25 no.1
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    • pp.57-64
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    • 2022
  • Background: There are various conservative treatment options for lateral epicondylitis (LE). The aim is to evaluate pain, daily functioning, and complications after ultrasound-standardized autologous blood injections in patients with LE. Methods: For this prospective cohort study, consecutive patients (>18 years) diagnosed with LE were included. Autologous blood was injected using a medical device containing an injection disposable with 12 small needles (Instant Tennis Elbow Cure [ITEC]) device. Patient-Rated Tennis Elbow Evaluation (PRTEE), subjective elbow score (SES), palpation and provocation pain, satisfaction, and complications of treatment were measured at baseline and two months after treatment. Paired t-tests and Fisher's exact tests were used for calculating the difference between pre- and post-treatment outcomes. Results: Fifty-five elbows were analyzed. Mean time between pre- and post-treatment was 11.1 weeks (standard deviation [SD], 8.9 weeks). The mean PRTEE score decreased from 68.2 (SD, 15.7) before surgery to 53.2 (SD, 25.9; p<0.001) after. The mean SES improved from 36.9 (SD, 20.8) to 51.7 (SD, 27.4; p<0.001). Despite this improvement, only 44.7% of patients showed relevant clinical improvement in PRTEE, and 37.3% showed significant clinical improvement based on SES. Four patients reported a complication and the injection disposable failed three times. Conclusions: Ultrasound-standardized autologous blood injection using the ITEC device is not an effective tool in reducing symptoms related to LE. This study showed that only half of all patients experienced a positive effect. In this heterogeneous cohort of patients, we showed no added value of ultrasound standardization.

Endoscopic Resection of Undifferentiated Early Gastric Cancer

  • Yuichiro Hirai;Seiichiro Abe;Mai Ego Makiguchi;Masau Sekiguchi;Satoru Nonaka;Haruhisa Suzuki;Shigetaka Yoshinaga;Yutaka Saito
    • Journal of Gastric Cancer
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    • v.23 no.1
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    • pp.146-158
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    • 2023
  • Endoscopic resection (ER) is widely performed for early gastric cancer (EGC) with a negligible risk of lymph node metastasis (LNM) in Eastern Asian countries. In particular, endoscopic submucosal dissection (ESD) leads to a high en bloc resection rate, enabling accurate pathological evaluation. As undifferentiated EGC (UD-EGC) is known to result in a higher incidence of LNM and infiltrative growth than differentiated EGC (D-EGC), the indications for ER are limited compared with those for D-EGC. Previously, clinical staging as intramucosal UD-EGC ≤2 cm, without ulceration, was presented as 'weakly recommended' or 'expanded indications' for ER in the guidelines of the United States, Europe, Korea, and Japan. Based on promising long-term outcomes from a prospective multicenter study by the Japan Clinical Oncology Group (JCOG) 1009/1010, the status of this indication has expanded and is now considered 'absolute indications' in the latest Japanese guidelines published in 2021. In this study, which comprised 275 patients with UD-EGC (cT1a, ≤2 cm, without ulceration) treated with ESD, the 5-year overall survival (OS) was 99.3% (95% confidence interval, 97.1%-99.8%), which was higher than the threshold 5-year OS (89.9%). Currently, the levels of evidence grades and recommendations for ER of UD-EGC differ among Japan, Korea, and Western countries. Therefore, a further discussion is warranted to generalize the indications for ER of UD-EGC in countries besides Japan.

Primary Arthroplasty for Unstable and Failed Intertrochanteric Fractures: Role of Multi-Planar Trochanteric Wiring Technique

  • Javahir A. Pachore;Vikram Indrajit Shah;Sachin Upadhyay;Shrikunj Babulal Patel
    • Hip & pelvis
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    • v.35 no.2
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    • pp.108-121
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    • 2023
  • Purpose: The primary objective of the current study is to demonstrate the trochanteric wiring technique. A secondary objective is to evaluate the clinico-radiological outcomes of use of the wiring technique during primary arthroplasty for treatment of unstable and failed intertrochanteric fractures. Materials and Methods: A prospective study including follow-up of 127 patients with unstable and failed intertrochanteric fractures who underwent primary hip arthroplasty using novel multi-planar trochanteric wiring was conducted. The average follow-up period was 17.8±4.7 months. Clinical assessment was performed using the Harris hip score (HHS). Radiographic evaluation was performed for assessment of union of the trochanter and any mechanical failure. P<0.05 was considered statistically significant. Results: At the latest follow-up, the mean HHS showed significant improvement from 79.9±1.8 (at three months) to 91.6±5.1 (P<0.05). In addition, no significant difference in the HHS was observed between male and female patients (P=0.29) and between fresh and failed intertrochanteric fractures (P=0.08). Union was achieved in all cases of fractured trochanter, except one. Wire breakage was observed in three patients. There were five cases of limb length discrepancy, three cases of lurch, and three cases of wire-related bursitis. There were no cases of dislocation or infection. Radiographs showed stable prosthesis in situ with no evidence of subsidence. Conclusion: Use of the proposed wiring technique was helpful in restoring the abductor level arm and multi-planar stability, which enabled better rehabilitation and resulted in excellent clinical and radiological outcomes with minimal risk of mechanical failure.

Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study

  • Young-Mok Park;Hyung-Il Seo;Jae-Hoon Kim;Sung Pil Yoon;Haeshin Lee;Moon Sue Lee
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.26 no.1
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    • pp.98-103
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    • 2022
  • Backgrounds/Aims: This study aimed to evaluate clinical application of InnoSEAL Plus (a mussel-inspired catecholamine hemostat) as a new hemostatic material for humans. Methods: Patients treated with topical hemostatic patches after liver resection were enrolled. They were divided into an experimental group (InnoSEAL Plus group) and two control groups (TachoSil® group and Surgicel Fibrillar® group) for efficacy evaluation. Results: A total of 15 patients were enrolled. Each group had five patients. The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil® group, and 40.0% (2/5 patients) in the Surgicel Fibrillar® group, showing no significant difference in the success rate among these groups (p > 0.05). All three groups exhibited 100% success rate for 10-minute hemostasis. Both InnoSEAL Plus and TachoSil® groups had one patient developing adverse events, which were treated easily with drug administrations. Conclusions: InnoSEAL Plus is expected to be functionally not inferior to other conventional hemostatic agents. However, it is necessary to confirm this through multicenter prospective studies in the future.

Evaluation of Usefulness and Fabrication of Femur Phantom on Quality Control of Bone Mineral Density Using 3D Printing Technology (3D 프린팅기술을 이용한 골밀도 정도관리 대퇴골 팬텀 제작 및 유용성 평가)

  • Da-Yeong, Hong;Jeong, Lee;Jun-Ho, Lee;Jae-Won, Mun;Han-Saem, Oh;Yu-Won, Jeong;Seong-Hyun, Jin;Jong-Min, Hong;In-Ja, Lee
    • Journal of radiological science and technology
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    • v.46 no.1
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    • pp.1-8
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    • 2023
  • As the demand for bone mineral density testing increases in Korea, which is close to an aging society, it is necessary to evaluate the repeatability of equipment such as femur phantom other than l-spine for more accurate diagnosis. However, in clinical practice, it is often not possible to proceed such evaluation due to insufficient quality control conditions. Therefore, this study is to evaluate the usefulness of the femur phantom after fabricating the same using 3D printing technology. The femur phantom was output using GlowFill filament and FDM 3D printing type. Each phantom was repeatedly scaned 20 times to compare whether the existing l-spine phantom and the fabricated femur phantom were suitable as a phantom for quality control. Each time the seven researchers took three times, the location of the femur phantom was readjusted, and then scanned to confirm the error between the researchers. As a result of conducting repeatability evaluation using femur phantom, the coefficient of variation rate was 2%, which was within the minimum precision tolerance of 2.5%. The reproducibility between the researcher was also found to be suitable as the average coefficient of variation was 0.031 and the coefficient of variation rate was 3.1%, which was within the minimum precision error range of 5%. In conclusion, it is considered that the prospective attitude and usefulness of the femur phantom fabricated by 3D printing in clinical practice will be sufficient.