• 셀메드
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• 제5권1호
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• pp.3.1-3.3
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• 2015

Pharmacovigilance is the study of the safety of drugs under the practical conditions of clinical usage in large communities. Aim of this study was to assess the pharmacovigilance awareness among a focus group of Ayurveda physicians in Sri Lanka who participated for their postgraduate studies. A questionnaire which was suitable for assessing the basic knowledge, attitude and the practice of pharmacovigilance was designed and submitted among group of Ayurveda physicians (n = 30) who participated for postgraduate studies in Institute of Indigenous Medicine, University of Colombo, Sri Lanka. Among participants30% of the subjects knew the term pharmacovigilance, 20% were aware of the unavailability of the National Pharmacovigilance Program for Ayurveda and Traditional Medicine in Sri Lanka, 70% believe about Adverse Drug Reactions (ADRs) may be occurred from Ayurveda medicine, 60% indicated that Most labeled counterfeit drugs, inappropriate use and standardization problems as the most important causes of ADRs associated with Ayurvedicdrugs, 70% physicians accepted their ignorance about pharmacovigilance and admitted that there was a need for better training of this subject and 90% admitted that there should be a national pharmacovigilance programme for Ayurveda medicines in Sri Lanka. We strongly suggest that there is an urgent need for a regular training and the introduce ADRs reporting system among the Ayurveda physicians. Also systematic pharmacovigilance programme is essential to build up for reliable information on the safety and effective practice of Ayurveda medicine in Sri Lanka.

• The Korean Journal of Pain
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• 제29권1호
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• pp.40-47
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• 2016

Background: Neuropathic pain, including paresthesia/dysesthesia in the lower extremities, always develops and remains for at least one month, to variable degrees, after percutaneous endoscopic lumbar discectomy (PELD). The recently discovered dual analgesic mechanisms of action, similar to those of antidepressants and anticonvulsants, enable nefopam (NFP) to treat neuropathic pain. This study was performed to determine whether NFP might reduce the neuropathic pain component of postoperative pain. Methods: Eighty patients, who underwent PELD due to herniated nucleus pulposus (HNP) at L4-L5, were randomly divided into two equal groups, one receiving NFP (with a mixture of morphine and ketorolac) and the other normal saline (NS) with the same mixture. The number of bolus infusions and the infused volume for 3 days were compared in both groups. The adverse reactions (ADRs) in both groups were recorded and compared. The neuropathic pain symptom inventory (NPSI) score was compared in both groups on postoperative days 1, 3, 7, 30, 60, and 90. Results: The mean attempted number of bolus infusions, and effective infused bolus volume for 3 days was lower in the NFP group for 3 days. The most commonly reported ADRs were nausea, dizziness, and somnolence, in order of frequency in the NFP group. The median NPSI score, and all 5 median sub-scores in the NFP group, were significantly lower than that of the NS group until postoperative day 30. Conclusions: NFP significantly reduced the neuropathic pain component, including paresthesia/dysesthesia until 1 month after PELD. The common ADRs were nausea, dizziness, somnolence, and ataxia.

• Journal of Acupuncture Research
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• 제35권2호
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• pp.61-68
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• 2018

Background: This study was performed to review the efficacy of national and international randomized controlled trials (RCT) investigating Chuna manipulative treatment for ankle sprains. Methods: Online databases (PubMed, Cochrane, EMBASE, CNKI, NDSL, OASIS), were searched for studies where Chuna treatment was performed for ankle sprains up to October 12th, 2017. Only RCT were selected that fulfilled the inclusion/exclusion criteria. Data were analyzed using the Cochrane risk of bias tool. Results: There were 676 studies retrieved from the databases, resulting in analysis of 24 RCT. There was an average of 7 treatment visits over a 7 day period and the most frequent evaluation tool used was efficacy rate, with drug therapy being the most common control used in the trials. In 15 RCT, several Chuna methods were used in combination, amongst which, the osteopathic technique was most common. Statistically significant improvement in evaluation indices was reported in 19 RCT, and in 3 RCT, statistically significant improvement was reported, but not for all indices. In the remaining 2 RCT, there were no significant differences in any of the evaluation indices. No adverse reactions were reported in any of the RCT, although it was unknown whether all the trial protocols indicated that adverse reactions should be monitored, and for this reason, the risk of bias was unclear. Conclusion: The review of 24 studies suggest that Chuna manipulative treatment for ankle sprains was effective in most cases, although, potential bias in these studies was difficult to evaluate.

• 한국환경과학회지
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• 제26권2호
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• pp.249-256
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• 2017

In this study, we evaluated the potential of 70% ethanol extract from Persicaria nepalensis (PNE) as a cosmetic ingredient by primary skin irritation, ocular irritation, and maximization tests for delayed hypersensitivity in New Zealand white rabbits and Hartley guinea pig. Skin safety study was performed to evaluate the potential toxicity of PNE using the primary irritation test. In the primary irritation test, 50% PNE was applied to the skin, and no adverse reactions such as erythema and edema were observed at the intact skin sites. Therefore, PNE was classified as a practically non-irritating material based on a primary irritation index of "0.0.". In the ocular irritation test, the 50% PNE applied did not show any adverse reactions in the different parts of rabbit eyes, including the cornea, iris, and conjunctiva. Thus, PNE was classified as a practically non-irritating material based on an acute ocular irritation index of "0.0.". Skin sensitization was tested by the Guinea Pig Maximization Test (GPMT) and Freund's Complete Adjuvant (FCA) using an intradermal injection of 10% PNE. Edema and erythema were not observed 24 and 48 h after the topical application of PNE in skin sensitization test, which exhibited a sensitization score of "0.0.". Therefore, it can be suggested that P. nepalensis could be used as potential candidates for cosmoceutical ingredients, without any major side effects.

• Asian Pacific Journal of Cancer Prevention
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• 제14권7호
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• pp.4205-4208
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• 2013

Objective: The aim of this study was to explore change and significance of serum carcino-embryonic antigen (CEA) before and after gefitinib therapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Forty patients with advanced NSCLCs in III~IV stages were selected as study objects given gefitinib therapy combined with routine local radiotherapy until tumor progression or intolerable toxicity. After treatment, all patients were divided into control and non-control groups according to the results of evaluation based on RECIST 1.1 (Response Evaluation Criteria in Solid Tumors in 2009). Peripheral fasting blood from all patients was collected in the early morning and serum CEA was assessed by electro-chemiluminescence immunoassay (ECLIA) before and after treatment. Before treatment, patients were divided into high CEA group (CEA level > 50 ng/mL) and low CEA group (CEA level ${\leq}$ 50 ng/mL). Adverse reactions were noted and progression-free survival (PFS) in both groups was recorded after long-term follow-up that ended in December, 2012. Results: There was no difference between control and non-control groups in CEA level before treatment (P>0.05), whereas serum CEA decreased more markedly lower in the control group after treatment (P<0.01). All patients were divided into high CEA group (26) and low CEA group (14) according to serum CEA level. There was no statistically significant difference between two groups in adverse reactions (P>0.05) but the rate in former group was lower. Additionally, survival rates at 9 and 12 months in high CEA group were clearly higher than in the low CEA group (P<0.01). Conclusions: Serum CEA level can serve as a biochemical index to evaluate the prognosis with gefitinib treatment for NSCLC.

• Asian Pacific Journal of Cancer Prevention
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• 제16권12호
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• pp.4993-4996
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• 2015

Background: To evaluate the efficacy and safety of albumin-bound paclitaxel-based chemotherapy in treatment for patients with advanced esophageal cancer who failed in first-line chemotherapy. Materials and Methods: We collected29 advanced esophageal cancer patients who received albumin-bound paclitaxel-based chemotherapy fromJune 2009 to September 2013, and the efficacy and safety of the compound were evaluated. These patients were treated with $100-150mg/m^2$ nab-paclitaxel on days 1,8. The cycle was repeated every 3 weeks. Clinical efficacy was evaluated every two cycles. Results: Of the 29 patients, two persons interrupted treatment because of adverse reactions, failed to evaluate efficacy effect. The rest of 27 patients who could be evaluated for short-term response, 10 patients (37%) achieved partial response, 2 (7.4%) remained stable disease, and 15 (55.6%) had progressivedisease. The objective response rate was 37%, and the disease control rate was 44.4%.The median time to progression was 6.6 months.The major adverse reactions includedalopecia (62.07%), neutropenia (65.5%), gastrointestinalreaction (10.3%) andsensory neuropathy(6.8%). Conclusions: The albumin-bound paclitaxel-based chemotherapy is efficacy and safety in treatment for patients with advanced esophageal cancer who failed in first-line chemotherapy.

• Asian Pacific Journal of Cancer Prevention
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• 제14권10호
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• pp.5699-5703
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• 2013

Objective: To investigate the clinical effects of whole brain radiotherapy concomitant with targeted therapy for brain metastasis in non-small cell lung cancer (NSCLC) patients with chemotherapy failure. Materials and Methods: Of the 157 NSCLC patients with chemotherapy failure followed by brain metastasis admitted in our hospital from January 2009 to August 2012, the combination group (65 cases) were treated with EGFR-TKI combined with whole brain radiotherapy while the radiotherapy group (92 cases) were given whole brain radiotherapy only. Short-term effects were evaluated based on the increased MRI in brain 1 month after whole brain radiotherapy. Intracranial hypertension responses, hematological toxicity reactions and clinical effects of both groups were observed. Results: There were more adverse reactions in the combination group than in radiotherapy group, but no significant differences were observed between the two groups in response rate (RR) and disease control rate (DCR) (P>0.05). Medium progression free survival (PFS), medium overall survival (OS) and 1-year survival rate in combination group were 6.0 months, 10.6 months and 42.3%, while in the radiotherapy group they were 3.4 months, 7.7 months and 28.0%, respectively, which indicated that there were significant differences in PFS and OS between the two groups (P<0.05). Additionally, RPA grading of each factor in the combination group was a risk factor closely related with survival, with medium PFS in EGFR and KRAS mutation patients being 8.2 months and 11.2 months, and OS being 3.6 months and 6.3 months, respectively. Conclusions: Whole brain radiotherapy concomitant with target therapy is favorable for adverse reaction tolerance and clinical effects, being superior in treating brain metastasis in NSCLC patients with chemotherapy failure and thus deserves to be widely applied in the clinic.

• Asian Pacific Journal of Cancer Prevention
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• 제15권14호
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• pp.5697-5699
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• 2014

Objective: To investigate the optimal timing of radiotherapy with alternating/sequential radio-chemotherapy for limited-stage small cell lung cancer (LS-SCLC). Methods: 91 patients with LS-SCLC were retrospectively analyzed and divided into two groups according to the number of chemotherapy cycles before radiotherapy. If the patient received radiotherapy after 3 cycles or fewer cycles of chemotherapy, classification was into the early group, if not, into the late group. All patients received 6 cycles of standard chemotherapy (EP/EC) and conventional radiotherapy (56 gy~ 60 gy/28 f ~30 f). Results: The response rate (RR) of the early and late groups were 85.7% and 81.6%, respectively, with no significant difference (p>0.05). In contrast, the progression-free survival (PFS) in the early group was better than that in the late group (11.8 months vs 9.86 months), and the difference was significant (p<0.05). There was no significant difference between two groups in adverse reactions, which gastrointestinal irritation and bone marrow suppression being the most common (p>0.05). Conclusions: Radiotherapy after 3 cycles or fewer cycles of chemotherapy does not bring significant benefits for RR of patients with LS-SCLC, but it could significantly prolong their PFS without increase in adverse reactions.

• Journal of Microbiology and Biotechnology
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• 제17권4호
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• pp.611-615
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• 2007

The purpose of this study was to evaluate the immunogenicity and safety of Salmonella Typhi Vi capsular polysaccharide vaccine (Vi vaccine) in Korea. The immunogenicity of a single dose of Vi vaccine was evaluated in 157 subjects (75 children and 82 adults) before and at 1, 6, and 12 months after vaccination. Immunogenicity was measured with a passive hemagglutination assay (PHA), quantified as geometric mean titers (GMTs) and seroconversion rates. The safety of the vaccine was investigated by determining adverse reactions occurring within 4h, 3 days, and 1 month after injection. The seroconversion rate for children and adults 1 month after vaccination was 96.92% and 89.02%, respectively. In the case of children, the GMTs of Vi antibodies before vaccination were $5.87{\pm}1.34\;and\;142.59{\pm}2.39$ at one month after vaccination. For adults, the GMTs before and one month after vaccination were $5.58{\pm}1.28\;and\;58.56{\pm}3.67$, respectively. Vi antibodies persisted for as long as 6 and 12 months after vaccination. All adverse reactions in adults and children were minor and did not require treatment. The Vi CPS vaccine was safe and immunogenic in adults and children older than 5 years.

• 한방비만학회지
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• 제12권2호
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• pp.28-43
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• 2012

Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.