• 제목/요약/키워드: Adverse events

검색결과 970건 처리시간 0.033초

Long-term clinical outcome of acute myocardial infarction according to the early revascularization method: a comparison of primary percutaneous coronary interventions and fibrinolysis followed by routine invasive treatment

  • Min, Hyang Ki;Park, Ji Young;Choi, Jae Woong;Ryu, Sung Kee;Kim, Seunghwan;Song, Chang Sup;Kim, Dong Shin;Song, Chi Woo;Kim, Se Jong;Kim, Young Bin
    • Journal of Yeungnam Medical Science
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    • 제34권2호
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    • pp.191-199
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    • 2017
  • Background: This study was conducted to provide a comparison between the clinical outcomes of primary percutaneous coronary intervention (PCI) and that of fibrinolysis followed by routine invasive treatment in ST elevation myocardial infarction (STEMI). Methods: A total of 184 consecutive STEMI patients who underwent primary PCI or fibrinolysis followed by a routine invasive therapy were enrolled from 2004 to 2011, and their major adverse cardiovascular events (MACEs) were compared. Results: Among the 184 patients, 146 patients received primary PCI and 38 patients received fibrinolysis. The baseline clinical characteristics were similar between both groups, except for triglyceride level ($68.1{\pm}66.62$ vs. $141.6{\pm}154.3mg/dL$, p=0.007) and high density lipoprotein level ($44.6{\pm}10.3$ vs. $39.5{\pm}8.1mg/dL$, p=0.005). The initial creatine kinase-MB level was higher in the primary PCI group ($71.5{\pm}114.2$ vs. $35.9{\pm}59.9ng/mL$, p=0.010). The proportion of pre-thrombolysis in MI 0 to 2 flow lesions (92.9% vs. 73.0%, p<0.001) was higher and glycoprotein IIb/IIIa inhibitors were administered more frequently in the primary PCI group. There was no difference in the 12-month clinical outcomes, including all-cause mortality (9.9% vs. 8.8%, p=0.896), cardiac death (7.8% vs. 5.9%, p=0.845), non-fatal MI (1.4% vs. 2.9%, p=0.539), target lesion revascularization (5.7% vs. 2.9%, p=0.517), and stroke (0% vs. 0%). The MACEs free survival rate was similar for both groups (odds ratio, 0.792; 95% confidence interval, 0.317-1.980; p=0.618). The clinical outcome of thrombolysis was not inferior, even when compared with primary PCI performed within 90 minutes. Conclusion: Early fibrinolysis with optimal antiplatelet and antithrombotic therapy followed by appropriate invasive procedure would be a comparable alternative to treatment of MI, especially in cases of shorter-symptom-to-door time.

Efficacy and Safety of Neurokinin-1 Receptor Antagonists for Prevention of Chemotherapy-Induced Nausea and Vomiting: Systematic Review and Meta-analysis of Randomized Controlled Trials

  • Yuan, Dong-Mei;Li, Qian;Zhang, Qin;Xiao, Xin-Wu;Yao, Yan-Wen;Zhang, Yan;Lv, Yan-Ling;Liu, Hong-Bin;Lv, Tang-Feng;Song, Yong
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권4호
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    • pp.1661-1675
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    • 2016
  • Objectives: Can addition of neurokinin-1 receptor antagonists (NK1-RAs) be considered as an ideal strategy for the prevention of chemotherapy-induced nausea and vomiting (CINV)? Researchers differ on this question. Materials and Methods: Electronic databases were searched for randomized control trials (RCTs) that evaluated the effectiveness and safety of NK1-RAs in preventing CINV. The primary end point was complete response (CR) in the acute, delayed, and overall phases after chemotherapy. Subgroup analyses evaluated the types of NK1-RAs, routines of administration, types of malignancies, regimens used in combination with NK1-RAs, and age of patients included in the studies. The incidences of different types of adverse events were also extracted to estimate the safety of NK1-RAs. Results: A total of 38 RCTs involving 13,923 patients were identified. The CR rate of patients receiving NK-RAs was significantly higher than patients in the control groups during overall phase (70.8% vs 56.0%, P<0.001), acute phase (85.1% vs 79.6%, P<0.001), and delayed phase (71.4% vs 58.2%, P<0.001). There were three studies including patients of children or adolescents, the CR rate was also significantly higher in the treatment group (overall phase: OR=2.807, P<0.001; acute phase: OR=2.863, P =0.012; delayed phase: OR=2.417, P<0.001). For all the other outcomes, patients in the NK1-RAs groups showed improvements compared to the control groups (incidence of nausea: 45.2% vs 45.9%, P<0.001; occurrence of vomiting: 22.6% vs 38.9%, P<0.001; usage of rescue drugs: 23.5% vs 34.1%, P<0.001). The pooled side effects from NK1-RAs did not significantly differ from previous reports and the toxicity rates in patients less than eighteen years old also did not diff between the two groups (P=0.497). However, we found that constipation and insomnia were more common in the patients of control groups, whereas diarrhea and hiccups were more frequently detected in patients receiving NK1-RAs. Conclusions: NK1-RAs improved the CR rate of CINV. They are effective for both adults and children. The use of NK1-RAs might be associated with the appearance of diarrhea and hiccups, while decreasing the possibility of constipation and insomnia.

Chinese Patients with Gastric Cancer Need Targeted Adjuvant Chemotherapy Schemes

  • Shi, Wen-Tao;Wei, Lei;Xiang, Jin;Su, Ke;Ding, Qiong;Tang, Meng-Jie;Li, Ji-Qiang;Guo, Yi;Wang, Pu;Zhang, Jing-Wei
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권10호
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    • pp.5263-5272
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    • 2012
  • Background: Gastric cancer (GC) is one of the most common cancers in China. Adjuvant chemotherapy (AC) is a routine auxiliary treatment for GC recommended by the guidelines issued in 2011 by the Ministry of Health of the People's Republic of China, but the relevant credible consequences in China have been insufficient because of China's late start and ethical concerns. Methods: A series of databases, including Cochrane Library, MEDLINE, EMBASE, the Chinese database of the National Knowledge Infrastructure and the VIP database, were searched by 2 reviewers independently for studies investigating AC for GC through March 2012. The retrieved literature was screened according to the eligibility criteria. Results: A total of 35 randomized control trials (RCTs) were subjected to the final analysis, including 4,043 patients in treatment group and 3,884 in the control group, as well as 4 clinical-control trials (CCTs), which accessed the final analysis with 238 and 252 patients, respectively. AC reduced the risk of death as a protective treatment with statistical significance (HR=0.91, 95%CI: [0.85, 0.97], P=0.002), and it seemed more effective for Asian than non-Asian patients. The effects of AC were not influenced by the starting time (P>0.05). D2 lymphadenectomy-based chemotherapy was effective (HR=0.89, 95%CI: [0.80, 0.99], P=0.04). Oral S-1 40 mg/m2 after D2 lymphadenectomy might be a better choice for Asians with advanced GC and might result in a greater reduction of adverse events than in non-Asian patients. GRADE quality assessment determined that the strength of the evidence from foreign studies from Europe, the United States and Asian countries other than China was high, while it was moderate for Chinese studies. Conclusion: AC was effective or even curative in Chinese patients in general, although it is still necessary to optimize a targeted AC scheme for Chinese patients with GC.

Phase II Study on Pemetrexed-based Chemotherapy in Treating Patients with Metastatic Gastric Cancer not Responding to Prior Palliative Chemotherapy

  • Wei, Guo-Li;Huang, Xin-En;Huo, Jie-Ge;Wang, Xiao-Ning;Tang, Jin-Hai
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권5호
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    • pp.2703-2706
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    • 2013
  • Purpose: This study was to determine the efficacy and safety of pemetrexed based chemotherapy in treating patients with metastatic gastric cancer who failed to respond to first and (or) second line chemotherapy. Patients and Methods: Metastatic gastric cancer patients who failed first and (or) second line chemotherapy, were enrolled. All patients were recruited from Jiangsu Cancer Hospital & Research Institute, and were treated with pemetrexed $500mg/m2$ (intravenous; on day 1), and a platinum (or irinotecan) every 3 weeks until disease progression, or intolerable toxicity. Evaluation on efficacy was conducted after two cycles of chemotherapy using the Response Evaluation Criteria for Solid Tumors. Toxicity was recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results: From Jun 2011 to May 2013, 23 patients were enrolled. All eligible 23 patients completed at least 2 cycles of chemotherapy with pemetrexed based chemotherapy, and were evaluable. Their median age was 55 years (range 40 to 78 years). Seventeen patients were male and 6 female. Three patients (13%) achieved partial response, five patients (22%) stable, 15 patients (65%) with disease progression, and none with complete response. Grade 2 neutrophil suppression occurred in 4.3%, grade 3 in 13% of patients, and no grade 4 was reported. Thrombocytopenia was encountered as follows: 4.3% grade 2, 4.3% grade 3 and 4.3% grade 4. Incidence of anemia was 34.8% in grade 2, 8.7% grade 3 and 0% grade 4. Only 4.3% of patients required packed red blood cell infusion. Elevated transaminase were 4.3% in grade 2 and 0% in grade 3 or 4. Other toxicity included oral mucositis. Conclusions: Pemetrexed based chemotherapy is mildly effective in treating patients with metastatic gastric cancer with tolerable toxicity.

High-dose chemotherapy and autologous peripheral blood stem cell transplantation in the treatment of children and adolescents with Ewing sarcoma family of tumors

  • Seo, Juhee;Kim, Dong Ho;Lim, Jung Sub;Koh, Jae-Soo;Yoo, Ji Young;Kong, Chang-Bae;Song, Won Seok;Cho, Wan Hyeong;Jeon, Dae-Geun;Lee, Soo-Yong;Lee, Jun Ah
    • Clinical and Experimental Pediatrics
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    • 제56권9호
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    • pp.401-406
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    • 2013
  • Purpose: We performed a pilot study to determine the benefit of high-dose chemotherapy and autologous peripheral blood stem cell transplantation (HDCT/autoPBSCT) for patients with Ewing sarcoma family of tumors. Methods: We retrospectively analyzed the data of patients who received HDCT/autoPBSCT at Korea Cancer Center Hospital. Patients with relapsed, metastatic, or centrally located tumors were eligible for the study. Results: A total of 9 patients (3 male, 6 female), with a median age at HDCT/autoPBSCT of 13.4 years (range, 7.1 to 28.2 years), were included in this study. Patients underwent conventional chemotherapy and local control either by surgery or radiation therapy, and had achieved complete response (CR, n=7), partial response (n=1), or stable disease (n=1) prior to HDCT/autoPBSCT. There was no transplant-related mortality. However, the median duration of overall survival and event-free survival after HDCT/autoPBSCT were 13.3 months (range, 5.3 to 44.5 months) and 6.2 months (range, 2.1 to 44.5 months), respectively. At present, 4 patients are alive and 5 patients who experienced adverse events (2 metastasis, 2 local recur, and 1 progressive disease) survived for a median time of 2.8 months (range, 0.1 to 10.7 months). The 2-year survival after HDCT/autoPBSCT was $44.4%{\pm}16.6%$ and disease status at the time of HDCT/autoPBSCT tended to influence survival ($57.1%{\pm}18.7%$ of cases with CR vs. 0% of cases with non-CR, P=0.07). Conclusion: Disease status at HDCT/autoPBSCT tended to influence survival. Further studies are necessary to define the role of HDCT/autoPBSCT and to identify subgroup of patients who might benefit from this investigational treatment.

Radiosurgical Techniques and Clinical Outcomes of Gamma Knife Radiosurgery for Brainstem Arteriovenous Malformations

  • Choi, Hyuk Jai;Choi, Seok Keun;Lim, Young Jin
    • Journal of Korean Neurosurgical Society
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    • 제52권6호
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    • pp.534-540
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    • 2012
  • Objective : Brainstem arteriovenous malformation (AVM) is rare and radiosurgical management is complicated by the sensitivity of the adjacent neurological structures. Complete obliteration of the nidus is not always possible. We describe over 20 years of radiosurgical procedures for brainstem AVMs, focusing on clinical outcomes and radiosurgical techniques. Methods : Between 1992 and 2011, the authors performed gamma knife radiosurgery (GKRS) in 464 cerebral AVMs. Twenty-nine of the 464 patients (6.3%) reviewed had brainstem AVMs. This series included sixteen males and thirteen females with a mean age of 30.7 years (range : 5-71 years). The symptoms that led to diagnoses were as follows : an altered mentality (5 patients, 17.3%), motor weakness (10 patients, 34.5%), cranial nerve symptoms (3 patients, 10.3%), headache (6 patients, 20.7%), dizziness (3 patients, 10.3%), and seizures (2 patients, 6.9%). Two patients had undergone a previous nidus resection, and three patients had undergone a previous embolization. Twenty-four patients underwent only GKRS. With respect to the nidus type and blood flow, the ratio of compact type to diffuse type and high flow to low flow were 17 : 12 and 16 : 13, respectively. In this series, 24 patients (82.8%) had a prior hemorrhage. The mean target volume was 1.7 $cm^3$ (range 0.1-11.3 $cm^3$). The mean maximal and marginal radiation doses were 38.5 Gy (range 28.6-43.6 Gy) and 23.4 Gy (range 18-27 Gy), and the mean isodose profile was 61.3% (range 50-70%). Results : Twenty-four patients had brainstem AVMs and were followed for more than 3 years. Obliteration of the AVMs was eventually documented in 17 patients (70.8%) over a mean follow-up period of 77.5 months (range 36-216 months). With respect to nidus type and blood flow, the obliteration rate of compact types (75%) was higher than that of diffuse types (66.7%), and the obliteration rate of low flow AVMs (76.9%) was higher than that of high flow AVMs (63.6%) (p<0.05). Two patients (6.9%) with three hemorrhagic events suffered a hemorrhage during the follow-up period. The annual bleeding rate of AVM after GKRS was 1.95% per year. No adverse radiation effects or delayed cystic formations were found. Conclusion : GKRS has an important clinical role in treatment of brainstem AVMs, which carry excessive surgical risks. Angiographic features and radiosurgical techniques using a lower maximal dose with higher isodose profiles are important for lesion obliteration and the avoidance of complications.

Efficacy and Safety of Sorafenib for Advanced Non-Small Cell Lung Cancer: a Meta-analysis of Randomized Controlled Trials

  • Wang, Wei-Lan;Tang, Zhi-Hui;Xie, Ting-Ting;Xiao, Bing-Kun;Zhang, Xin-Yu;Guo, Dai-Hong;Wang, Dong-Xiao;Pei, Fei;Si, Hai-Yan;Zhu, Man
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권14호
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    • pp.5691-5696
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    • 2014
  • Background: Many clinical trials have been conducted to evaluate sorafenib for the treatment of advanced NSCLC, but the results for efficacy have been inconsistent. The aim of this study was to evaluate the efficacy and safety of sorafenib in patients with advanced NSCLC in more detail by meta-analysis. Methods: This meta-analysis of randomized controlled trials (RCTs) was performed after searching PubMed, EMBASE, ASCO Abstracts, ESMO Abstracts, and the proceedings of major conferences for relevant clinical trials. Two reviewers independently assessed the quality of the trials. Outcomes analysis were disease control rate (DCR), progression- free survival (PFS), overall survival (OS) with 95% confidence intervals (CI) and major toxicity. Subgroup analysis was conducted according to sorafenib monotherapy, in combination with chemotherapy or EGFR-TKI to investigate the preferred therapy strategy. Results: Results reported from 6 RCTs involving 2, 748 patients were included in the analysis. Compared to sorafenib-free group, SBT was not associated with higher DCR (RR 1.31 (0.96- 1.79), p=0.09), PFS (HR 0.82 (0.66-1.02), p=0.07) and OS (HR 1.01 (0.92-1.12), p=0.77). In terms of subgroup results, sorafenib monotherapy was associated with significant superior DCR and longer PFS, but failed to show advantage with regard to OS. Grade 3 or greater sorafenib-related adverse events included fatigue, hypertension, diarrhea, oral mucositis, rash and HFSR. Conclusions: SBT was revealed to yield no improvement in DCR, PFS and OS. However, sorafenib as monotherapy showed some activity in NSCLC. Further evaluation may be considered in subsets of patients who may benefit from this treatment. Sorafenib combined inhibition therapy should be limited unless the choice of platinum-doublet regimen, administration sequence or identification of predictive biomarkers are considered to receive better anti-tumor activity and prevention of resistance mechanisms.

혈중지질에 대한 진피추출물의 유효성 평가를 위한 인체적용시험 : 무작위배정, 이중맹검 (Clinical Trial to Evaluate the Efficacy of Extract of Citri Pericarpium on Serum Lipid Profiles in Subjects: a Randomized, Double-blind)

  • 이진상;도은주;곽민아;박현진;하일도;성기준;김미려
    • 대한본초학회지
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    • 제26권1호
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    • pp.125-132
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    • 2011
  • Objectives : This study was performed to evaluate the efficacy of extract from Citri Pericarpium (CP) on lipid-lowering effect in semi-healthy subjects with increased serum levels of total cholesterol and triglyceride. Methods : A experimental group (n=45) and placebo group (n=46) were randomly established based on the plasma lipid profiles (triglyceride, total cholesterol etc.) in the semi-healthy subjects, then all subjects randomly took experimental or placebo capsules, which contain 1,200 mg of CP or the same dose of soluble starch per day with regular meals for 8 weeks by double-blind method. Results : One-hundred forty (140) subjects were screened, then 91 subjects enrolled in the study. No serious adverse events were reported for trial period. The CP treatment showed statistically significant decrease in serum levels of triglyceride both at 4-weeks (p<0.01) and at 8-weeks (p=0.0001). Futhermore, there was significant difference in the triglyceride levels between CP-treated and placebo group. The CP-treated but not placebo group, experienced decrease in serum levels of total cholesterol at 8-weeks. Then there was no significant difference in the total cholesterol levels between the two groups. In addition, statistically significant difference of AST, ALT, ${\gamma}$-GT serum levels wasn't shown before and after trial in two groups. Conclusion : These results demonstrate that CP can significantly suppress the elevated triglyceride but not total cholesterol level. Therefore, CP may play a role in the improvement of blood lipid levels, as an effective functional food.

생강 건조 분말의 임신 및 멀미에 의한 오심, 구토 개선 기능성에 대한 체계적 고찰 (Systematic review of the effect of dried ginger powder on improvement of nausea and vomiting associated with early pregnancy or motion sickness)

  • 곽진숙;백주은;정세원;김주희;김지연;권오란
    • Journal of Nutrition and Health
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    • 제47권1호
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    • pp.45-50
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    • 2014
  • 생강 건조 분말의 임신 또는 멀미로 인해 발생하는 오심, 구토 개선 기능성을 평가하기 위하여 체계적 고찰을 실시하였다. 2013년 3월 기준으로 DB 검색을 통해 870건의 자료를 수집하여, 선정/제외 기준에 따라 선별한 결과 총 12건의 연구가 평가되었다. 12건 (2,694명) 중 11건 (2,630명)의 연구에서 통계적으로 유의한 개선 효과 나타났으며 (p < 0.05), 효과를 보이는 일일 섭취량은 0.25~2.5 g이었다. 특히 임신부 대상 연구 9건에서는 모두 유의한 개선 효과를 보였고, 멀미에 대한 효과를 관찰한 3건의 연구 중 1,741명을 대상으로 한 대규모 연구 1건을 포함한 2건에서 구토를 유의하게 개선시키는 것으로 보고되었다. 해당 연구에서 모두 생강섭취로 인한 이상 반응은 없는 것으로 확인되었다.

임플란트 환자의 일반적 특성 및 구강관심도에 따른 기능별 만족도 연구 (Study for general characters of dental implant patients and satisfaction level of function by dental interest level)

  • 유은미;황윤숙
    • 한국치위생학회지
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    • 제9권3호
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    • pp.456-467
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    • 2009
  • For this study, self-completion survey for 149 implant patients of dental clinics and hospitals in Seoul and Kyunggi areahas been executed in order to provide basic data for increasing patient satisfaction level by effective consultation and various information for the patients who want dental implantation. The conclusion of the study is like below. 1. In terms of demographics of the study, sample size of female patients(n=85) was more than that of male patients(n=64) and patients in their 50s were major age group. When it comes to the educational level, university graduates were 85 and high school graduates were 44. And 132 were married and 6 were single. In the income level, monthly income between KRW 2~4 million was major group(n=59). 2. In the study, patients' most concern was complication or adverse events(n=41), and price(n=39) & annual dental check-up(n=49) were following it. And 80 patients responded that dental health is the most valuable(n=80) and whole body health was following(n=37). In terms of knowledge on dental implant, 100 patients responded 'know just a little', 31 and 13 answered 'generally know' and 'well know' each. 3. As a result of analyzing implant patients' satisfaction level by segment, general satisfaction rate was highest as 4.20, social satisfaction rate was 4.20, psychological function was 4.06 and masticatory function was 3.90. 4. Based on the result of comparing patient satisfaction level by general characters of dental implant patient, chewing function was the highest in the age group of 60s with score of 4.21 and in terms of social function, the group with over KRW 8 million of monthly income showed highest score with 4.54. When it comes to the psychological function, patients in their 70s showed highest satisfaction level with 4.52. In the end, patients in their 70s showed highest score with 4.81 in the overall satisfaction and it was also statistically significant. 5. In the overall satisfaction level by interest in dental health, appearance showed highest score with 4.57 and it was also significantly higher than that of whole body. In the variance by dental knowledge, 'well know' group showed highest score with 4.58, and that of 'just a little' group was 4.33. That means there are correlations between dental knowledge and satisfaction level. 6. As a result of analyzing correlations amongst variances of the study, there were strong positive correlations among them. And there were very significantly positive correlations especially between social and psychological function and between psychological and overall satisfaction level. In conclusion, higher psychological function has strong relations with both social function and overall satisfaction level(p<.001).

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