• 한국식품위생안전성학회지
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• 제27권4호
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• pp.395-400
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• 2012

본 연구에서는 한 가지 제품에 여러 기능성 원료를 복합하여 사용하고 있는 복합 건강기능식품의 실태를 파악 및 분석하고 이들 원료들 간의 상호작용에 관한 문헌조사를 토대로 복합건강기능식품의 관리 방안을 도출하고자 하였다. 이를 위해 식약청에 품목제조신고되어 있는 database를 분석하였다. 분석대상이 되는 제품은 총 7319개의 제품 중 "복합 건강기능식품"으로 파악된 제품의 개수는 183개 제품이었으며 이들 제품 중 기능성 원료를 2개 함유하고 있는 제품은 총 177제품, 3가지 이상의 기능성 원료를 함유하고 있는 제품은 모두 6개 제품이 있다. 183개 복합건강기능식품에 기능성 원료로 사용되고 있는 원료들을 순위별로 나열하면 가장 많이 사용되는 기능성 원료가 가르시니아캄보지아로서 41개 제품에서 기능성 원료로 사용되었으며 "옥타코사놀"과 "쏘팔메토열매추출물"이 가장 많은 빈도로 제조되고 있었다. 복합건강기능식품에 사용되고 있는 원료들의 pair를 사용하여 안전성 정보를 검색한 결과 현재 복합 사용되고 있는 건강기능식품에서의 안전성 우려사항은 아직까지 보고된 바 없는 것으로 판단된다. 하지만 복합 건강기능식품의 섭취에 대한 안전선 우려는 여전히 남아있는 상태이므로 이를관리하기 위해서는 부작용에 대한 조기 시그날을 감지하기 위한 부작용 모니터링 제도를 강화할 필요가 있을 것이다. 최근에 개정된 건강기능식품법 시행규칙의 원활한 시행을 통해 복합 건강기능식품의 안전관리를 강화할 수 있을 것으로 기대된다.

• 한방재활의학과학회지
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• 제31권4호
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• pp.157-166
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• 2021

Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

• 한국임상약학회지
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• 제32권3호
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• pp.215-225
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• 2022

Background: Patients with hematologic cancers have a risk of drug-related problems (DRPs) from medications associated with chemotherapy and supportive care. Although the role of oncology pharmacists has been widely documented in the literature, few studies have reported its impact on cost reduction. This study aimed to describe the activities of oncology pharmacists with respect to hematologic diseases and evaluate the associated cost avoidance. Methods: From January to July 2021, patients admitted to the department of hemato-oncology at Seoul National University, Bundang Hospital were studied. The activities of oncology pharmacists were reported by DRP type following the Pharmaceutical Care Network version 9.1 guidelines, and the acceptance rate was calculated. The avoided cost was estimated based on the cost of the pharmacy intervention, pharmacist manpower, and prescriptions associated with the intervention. Results: Pharmacists intervened in 584 prescriptions from 208 patients during the study period. The most prevalent DRP was "adverse drug event (possibly) occurring" (32.4%), followed by "effect of drug treatment not optimal" (28.6%). "Drug selection" (42.5%) and "dose selection" (30.3%) were the most common causes of DRPs. The acceptance rate of the interventions was 97.1%. The total avoidance cost was KRW 149,468,321; the net profit of the avoidance cost, excluding labor costs, was KRW 121,051,690; and the estimated cost saving was KRW 37,223,748. Conclusion: Oncology pharmacists identified and resolved various types of DRPs from prescriptions for patients with hematologic disease, by reviewing the prescriptions. Their clinical service contributed to enhanced patient safety and the avoidance of associated costs.

• 정신신체의학
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• 제24권1호
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• pp.3-8
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• 2016

기능성 소화불량증은 우리나라 성인인구의 7.7%가 이환되어 있는 흔한 소화기 기능성질환이다. 주요 증상은 불편한 식후 충만감, 조기 포만감, 상복부 통증, 상복부 쓰림이다. 이런 증상들이 증상을 설명할 만한 기질적인 문제 없이 만성적으로 나타나는 질환이다. 기능성 소화불량증은 치명적이지는 않지만 대개 건강관련 삶의 질을 저하시키고 다른 소화기 기능성질환(위식도역류질환, 과민성 장증후군, 변비)과 공존할 때 더욱 불편함을 초래할 수 있다. 이러한 기능성 소화불량증과 다른 소화기 기능성질환과의 공존을 '중복 증후군'으로 칭한다. 중복 증후군 환자에서 불안, 신체화장애, 불면 등의 정신건강의학적인 문제가 보다 흔히 연관되어 있다. 그러므로 진료의는 소화불량을 호소하는 환자에게 다른 소화기 기능성질환이 공존하는지 여부를 파악하고, 기저 정신건강의학적 문제를 다루는 것이 필요하다. 기능성 소화불량증 환자에게 위약효과는 40% 안팎으로 매우 큰 편이며, 위약대비 효과가 증명된 위장관 운동촉진제는 네 가지이다. 간혹 이러한 위장관 운동 촉진제의 장기간 투약은 비가역적이거나 치명적인 부작용을 야기할 수 있으므로, 처방의사는 위장관 운동촉진제의 가능한 부작용과 연관된 위험인자를 숙지하고 있어야 한다. 병적 위산역류는 기능성 소화불량증 환자에게 드물지 않으며, 위산분비억제제는 많은 부분의 기능성 소화불량증 환자에게 위장관 운동촉진제 만큼 효과적이다.

• 생물정신의학
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• 제18권2호
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• pp.95-100
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• 2011

Objectives To evaluate the drug interactions between aripiprazole and haloperidol, authors investigated plasma concentrations of those drugs by genotypes. Method Fifty six patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders 4th edition diagnosis of schizophrenia were enrolled in this eight-week, double blind, placebo-controlled study. Twenty-eight patients received adjunctive aripiprazole treatment and twenty-eight patients received placebo while being maintained on haloperidol treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then 30 mg for the next 4 weeks. The haloperidol dose remained fixed throughout the study. Plasma concentrations of haloperidol and aripiprazole were measured by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline, week 1, 2, 4 and 8. $^*1$, $^*5$, and $^*10$ B alleles of CYP2D6 and $^*1$ and $^*3$ alleles of CYP3A5 were determined. The Student's T-test, Pearson's Chi-square test, Wilcoxon Rank Sum test and Logistic Regression analysis were used for data analysis. All tests were two-tailed and significance was defined as an alpha < 0.05. Results In the frequency of CYP2D6 genotype, $^*1/^*10$ B type was most frequent (36.5%) and $^*1/^*1$ (30.8%), $^*10B/^*10B$ (17.3%) types followed. In the frequency of CYP3A5 genotype, $^*3/^*3$ type was found in 63.5% of subjects, and $^*1/^*3$ type and $^*1/^*1$ were 30.8% and 5.8% respectively. The plasma levels of haloperidol and its metabolites did not demonstrate significant time effects and time-group interactions after adjunctive treatment of aripiprazole. The genotypes of CYP2D6 and 3A5 did not affect the plasma concentration of haloperidol in this trial. No serious adverse event was found after adding aripiprazole to haloperidol. Conclusion No significant drug interaction was found between haloperidol and aripiprazole. Genotypes of CYP2D6 and 3A5 did not affect the concentration of haloperidol after adding aripiprazole.

• The Korean Journal of Pain
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• 제31권3호
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• pp.155-173
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• 2018

Chronic postsurgical pain (CPSP) is an unwanted adverse event in any operation. It leads to functional limitations and psychological trauma for patients, and leaves the operative team with feelings of failure and humiliation. Therefore, it is crucial that preventive strategies for CPSP are considered in high-risk operations. Various techniques have been implemented to reduce the risk with variable success. Identifying the risk factors for each patient and applying a timely preventive strategy may help patients avoid the distress of chronic pain. The preventive strategies include modification of the surgical technique, good pain control throughout the perioperative period, and preoperative psychological intervention focusing on the psychosocial and cognitive risk factors. Appropriate management of CPSP patients is also necessary to reduce their suffering. CPSP usually has a neuropathic pain component; therefore, the current recommendations are based on data on chronic neuropathic pain. Hence, voltage-dependent calcium channel antagonists, antidepressants, topical lidocaine and topical capsaicin are the main pharmacological treatments. Paracetamol, NSAIDs and weak opioids can be used according to symptom severity, but strong opioids should be used with great caution and are not recommended. Other drugs that may be helpful are ketamine, clonidine, and intravenous lidocaine infusion. For patients with failed pharmacological treatment, consideration should be given to pain interventions; examples include transcutaneous electrical nerve stimulation, botulinum toxin injections, pulsed radiofrequency, nerve blocks, nerve ablation, neuromodulation and surgical management. Physical therapy, cognitive behavioral therapy and lifestyle modifications are also useful for relieving the pain and distress experienced by CPSP patients.

• Asian Pacific Journal of Cancer Prevention
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• 제14권12호
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• pp.7107-7110
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• 2013

Malignant bowel obstruction (MBO), an occasional complication in patients with advanced urological cancer, causes gastrointestinal symptoms such as nausea and vomiting leading to suffering which severely impairs quality of life (QOL). Drug therapy, especially octreotide, a synthetic analog of somatostatin, is reportedly effective in controlling the symptoms of MBO. In the present study, we administered octreotide to urological cancer patients with MBO and evaluated the improvement of subjective symptoms, oral intake, and nasogastric intubation. Fourteen terminally ill urological cancer patients suffering with MBO were included (age range 55-92, 10 male, 4 female). Octreotide was administered at $300{\mu}g/day$ to those patients subcutaneously as a continuous injection. Significant improvements in subjective symptoms were observed in thirteen patients (92.8%), and ten patients (71.4%) were able to resume oral intake. Four patients required nasogastric drainage before the administration of octreotide, but nasogastric intubation was discontinued in all these cases after the use of octreotide. Early initiation of octreotide resulted in better improvement of MBO symptoms, and no adverse event was observed in any of the patients. These results revealed that $300{\mu}g/day$ dose of octreotide is safe and effective for managing gastrointestinal symptoms of terminally ill urological cancer patients with MBO. We also recommend starting the treatment with ocreotide as soon as MBO is diagnosed.

• Journal of Gastric Cancer
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• 제16권3호
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• pp.177-181
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• 2016

Purpose: The International Organization for Standardization-5fluorouracil (FU) 10 trial found that bolus 5-FU and l-leucovorin was not inferior to S-1 in the treatment of gastric cancer (GC). Continuous 5-FU and the rapid injection of 5-FU have different anti-cancer effects. Thus, bolus 5-FU and l-leucovorin treatment might be useful for oral FU-resistant GC. Materials and Methods: We retrospectively analyzed the medical records of all patients with S-1 or capecitabine-resistant, unresectable, or recurrent GC treated with bolus 5-FU and l-leucovorin between January 2010 and December 2015 at Hokkaido University Hospital. The bolus 5-FU and l-leucovorin regimen consisted of intravenous l-leucovorin ($250mg/m^2/2h$) and bolus 5-FU ($600mg/m^2$) administered once weekly followed by a 2-week rest period; each cycle was repeated every 8 weeks. Results: A total of 14 patients were identified. The disease control rate was 35.7%. The median progression-free survival was 1.6 months (95% confidence interval [CI], 1.3~2.0 months), and the median overall survival was 6.3 months (95% CI, 4.7~7.9 months). No patient died from treatment-related causes. The most common severe adverse event associated with bolus 5-FU and l-leucovorin was neutropenia, which occurred in 21.4% of patients. Conclusions: Bolus 5-FU and l-leucovorin treatment might be useful for oral FU-resistant GC. We are planning a multi-center prospective phase II trial to evaluate the efficacy and safety of bolus 5-FU and l-leucovorin treatment for pre-treated unresectable or recurrent GC to confirm the results of this limited, retrospective study.

• Asian Pacific Journal of Cancer Prevention
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• 제16권15호
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• pp.6237-6241
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• 2015

Usage of traditional, complementary and alternative medicine (TCAM) has gained popularity over the past few years. However, very little is known about TCAM use among Malaysian cancer patients. This study aimed to identify the determinants of TCAM usage among cancer patients with determination of relationships between demographic factors, patient satisfaction with conventional treatment, knowledge on TCAM and healthcare professional influence. Patient's perceptions towards TCAM were also determined. A simple random convenient sampling method was used to recruit 354 patients from Hospital Kuala Lumpur between February to April 2013. All were directly interviewed with a structured questionnaire. In this study, 172 respondents were TCAM users. There was no significant differences between demographic background of respondents in the usage of TCAM. Minimal correlation was found between patient satisfaction with the conventional treatment and usage of TCAM (r=0.091). A poor correlation was found between healthcare professional's influence and TCAM usage (r=-0.213) but the results suggested that increase in influence would decrease TCAM usage. Patient TCAM knowledge correlated negatively with the TCAM usage (r=-0.555) indicated that cancer patients are less likely to use TCAM when they have more TCAM knowledge. Healthcare professionals should be fully equipped with the necessary TCAM knowledge while maintaining patient satisfaction with the conventional treatment. They should also intervene on patient TCAM usage where a potential drug interaction or a harmful adverse event can occur.

• Asian Pacific Journal of Cancer Prevention
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• 제16권8호
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• pp.3351-3354
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• 2015

Background: Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in the pediatric age group. All patients with RMS regardless of their initial stage or group receive combination chemotherapy as 'standard therapy' consisting of vincristine, actinomycin-D and cyclophosphamide. Actinomycin-D was not readily available in Turkey at one time. Carboplatin was used instead in order to prevent delays in treatment. The aim of this report is to present the results of patients with rhabdomyosarcoma receiving carboplatin or actinomycin-D therapy. Materials and Methods: Twenty four patients with rhabdomyosarcoma treated between December 2000 and June 2011 were included in this retrospective study. The patients were treated according to International Rhabdomyosarcoma Study Group guidelines. Eleven patients were treated with actinomycin-D and 13 with carboplatin ($250mg/m^2/dose$ for 2 days). The two groups were then compared in terms of 2- and 5-year overall survival (OS) and hematological and non-hematological toxicities. Results: Age, sex, stage and the mean duration of follow-up were similar in both groups (p>0.05). Two- and five-year OS levels were 68.2% in the carboplatin group and 78.0% and 40.0%, respectively, in the actinomycin-D group. There was no statistical difference in the number of febrile episodes (p=0.86) and no other hematological and non-hematological adverse effects were recorded in both groups. Conclusions: The findings show that carboplatin can be used as an alternative drug in the primary treatment of rhabdomyosarcoma in the event that actinomycin-D is unavailable or not tolerated.