• Title/Summary/Keyword: clinical benefit rates

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Statins and Clinical Outcomes in Patients With Low to Moderate Risk but With Non-obstructive Carotid Plaques: The SCOPE-CP Study

  • Minjae Yoon;Chan Joo Lee;Sungha Park;Sang-Hak Lee
    • Korean Circulation Journal
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    • v.52 no.12
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    • pp.890-900
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    • 2022
  • Background and Objectives: Some individuals exhibit discrepancies between risk classifications assessed using clinical factors and those obtained by vascular imaging. We aimed to evaluate whether statins provide clinical outcome benefits in patients classified as having low to moderate cardiovascular risk but with carotid plaque. Methods: This was a retrospective propensity score matching study. A total of 12,158 consecutive patients undergoing carotid ultrasound between January 2012 to February 2020 were screened. Individuals with low to moderate cardiovascular risk who were not currently recommended for statin therapy but had carotid plaques were included. Among 1,611 enrolled individuals, 806 (statin group: 403, control group: 403) were analyzed. The primary outcomes were major adverse cardiovascular and cerebrovascular events (MACCEs: cardiovascular death, myocardial infarction, coronary revascularization, and ischemic stroke or transient ischemic attack) and all-cause mortality. Results: During the median follow-up of 6.0 years, the incidence of MACCEs did not differ between the groups (6.1 and 5.7/1,000 person-years in the control and statin groups, respectively; adjusted hazard ratio [HR], 0.95; p=0.90). The incidence of all-cause mortality did not differ (3.9 and 3.9/1,000 person-years, respectively; adjusted HR, 1.02; p=0.97). Kaplan-Meier curves revealed similar rates of MACCEs (log-rank p=0.72) and all-cause mortality (log-rank p=0.99) in the 2 groups. Age and smoking were independent predictors of MACCEs. Subgroups exhibited no differences in clinical outcomes with statin use. Conclusions: Benefit of statin therapy was likely to be limited in low to moderate risk patients with carotid plaques. These results could guide physicians in clinical decision-making regarding cardiovascular prevention.

Dual trigger in normally-responding assisted reproductive technology patients increases the number of top-quality embryos

  • Sukur, Yavuz Emre;Ulubasoglu, Hasan;Ilhan, Fatma Ceylan;Berker, Bulent;Sonmezer, Murat;Atabekoglu, Cem Somer;Aytac, Rusen;Ozmen, Batuhan
    • Clinical and Experimental Reproductive Medicine
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    • v.47 no.4
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    • pp.300-305
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    • 2020
  • Objective: The feasibility of a gonadotropin-releasing hormone agonist (GnRHa) trigger in normal responders is still a matter of debate. The aim of this study was to compare the number of mature oocytes, the number of good-quality embryos, and the live birth rate in normal responders triggered by GnRHa alone, GnRHa and human chorionic gonadotropin (hCG; a dual trigger), and hCG alone. Methods: A retrospective cohort study was conducted at the infertility clinic of a university hospital. Data from 200 normal responders who underwent controlled ovarian hyperstimulation and intracytoplasmic sperm injection with a GnRH antagonist protocol between January 2016 and January 2017 were reviewed. The first study group consisted of patients with cycles triggered by GnRHa alone. The second study group consisted of patients with cycles triggered by both GnRHa and low-dose hCG (a dual trigger). The control group consisted of patients with cycles triggered by hCG alone. Results: The groups were comparable in terms of demographics and cycle characteristics. The numbers of total oocytes retrieved and metaphase II oocytes were similar between the groups. The total numbers of top-quality embryos were 3.2±2.9 in the GnRHa group, 4.4±3.2 in the dual-trigger group, and 2.9±2.1 in the hCG group (p=0.014). The live birth rates were 21.4%, 30.5%, and 28.2% in those groups, respectively (p=0.126). Conclusion: In normal responders, a dual-trigger approach appears superior to an hCG trigger alone with regard to the number of top-quality embryos produced. However, no clinical benefit was apparent in terms of live birth rates.

Reappraisal of Anatomic Outcome Scales of Coiled Intracranial Aneurysms in the Prediction of Recanalization

  • Lee, Jong Young;Kwon, Bae Ju;Cho, Young Dae;Kang, Hyun-Seung;Han, Moon Hee
    • Journal of Korean Neurosurgical Society
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    • v.53 no.6
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    • pp.342-348
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    • 2013
  • Objective : Several scales are currently used to assess occlusion rates of coiled cerebral aneurysms. This study compared these scales as predictors of recanalization. Methods : Clinical data of 827 patients harboring 901 aneurysms treated by coiling were retrospectively reviewed. Occlusion rates were assessed using angiographic grading scale (AGS), two-dimensional percent occlusion (2DPO), and volumetric packing density (vPD). Every scale had 3 categories. Followed patients were dichotomized into either presence or absence of recanalization. Kaplan-Meier analysis was conducted, and Cox proportional hazards analysis was performed to identify surviving probabilities of recanalization. Lastly, the predictive accuracies of three different scales were measured via Harrell's C index. Results : The cumulative risk of recanalization was 7% at 12-month, 10% at 24-month, and 13% at 36-month of postembolization, and significantly higher for the second and third categories of every scale (p<0.001). Multivariate-adjusted hazard ratios (HRs) of the second and third categories as compared with the first category of AGS (HR : 3.95 and 4.15, p=0.004 and 0.001) and 2DPO (HR : 4.87 and 3.12, p<0.001 and 0.01) were similar. For vPD, there was no association between occlusion rates and recanalization. The validated and optimism-adjusted C-indices were 0.50 [confidence (CI) : -1.09-2.09], 0.47 (CI : -1.10-2.09) and 0.44 (CI : -1.10-2.08) for AGS, 2DPO, and vPD, respectively. Conclusion : Total occlusion should be reasonably tried in coiling to maximize the benefit of the treatment. AGS may be the best to predict recanalization, whereas vPD should not be used alone.

Prospective Randomized Trial for Postoperative Adjuvant Chemotherapy in Gastric Cancer Patients without Serosal Invasion -Preliminary Report- (장막 침윤이 없는 위암 환자에서 수술 후 보조적 화학 요법에 대한 전향적 연구 -중간 보고-)

  • Kim Yong-Ho;Kim Byung-Sik;Lee Chang-Hwan;Kim Wan Su;Yook Jung-Whan;Oh Sung-Tae;Park Kun-Choon
    • Journal of Gastric Cancer
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    • v.1 no.4
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    • pp.221-227
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    • 2001
  • Purpose: We have carried out prospective randomized clinical trial to compare survival benefit and side effect among three postoperative adjuvant chemotherapeutic regimens in serosa-negative gastric cancer patients. Materials and Methods: Total 317 cases were recognized as serosa negative and randomized into three groups at operating room. Out of them, 172 cases were excluded because of various reasons and 135 cases were analyzed finally; Group A 36 cases, Group B 49 cases, Group C 50 cases. Group A were treated with intravenous FP combination therapy, group B with MF combination therapy and group C with oral $UFT^{(R)}$ (mixture of Tegafur and Uracil) for one year. The median follow-up period was 30 months. Results: $88.9\%$ of Group A, $83.7\%$ of Group B and $90.4\%$ of Group C received adequate chemotherapy. The complication rates of Group A ($44.4\%$) was significantly higher than group B ($20.4\%$) and group C ($24.0\%$)(P<0.05). Most frequent complications were nausea and vomiting. The 3-year survival rates and disease-free survival rates were $92.2\%$ and $89.9\%$ respectively (Group A: $96.6\%,\;87.8\%$, B: $90.3\%,\;87.7\%$, C: $95.7\%,\;93.8\%$). There were no significant differences in survival rate and disease-free survival rate among the three groups (P>0.05). Conclusion: This study might suggest that the survival benefit of postoperative adjuvant chemotherapy for gastric Pseudomonas aeruginosa, and therefore it may be a useful adjunct tool for detection of Pseudomonas aeruginosa infection in combination with other conventional techniques.

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Low Coverage and Disparities of Breast and Cervical Cancer Screening in Thai Women: Analysis of National Representative Household Surveys

  • Mukem, Suwanna;Meng, Qingyue;Sriplung, Hutcha;Tangcharoensathien, Viroj
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.18
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    • pp.8541-8551
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    • 2016
  • Background: The coverage of breast and cervical cancer screening has only slightly increased in the past decade in Thailand, and these cancers remain leading causes of death among women. This study identified socioeconomic and contextual factors contributing to the variation in screening uptake and coverage. Materials and Methods: Secondary data from two nationally representative household surveys, the Health and Welfare Survey (HWS) 2007 and the Reproductive Health Survey (RHS) 2009 conducted by the National Statistical Office were used. The study samples comprised 26,951 women aged 30-59 in the 2009 RHS, and 14,619 women aged 35 years and older in the 2007 HWS were analyzed. Households of women were grouped into wealth quintiles, by asset index derived from Principal components analysis. Descriptive and logistic regression analyses were performed. Results: Screening rates for cervical and breast cancers increased between 2007 and 2009. Education and health insurance coverage including wealth were factors contributing to screening uptake. Lower or non-educated and poor women had lower uptake of screenings, as were young, unmarried, and non-Buddhist women. Coverage of the Civil Servant Medical Benefit Scheme increased the propensity of having both screenings, while the universal coverage scheme increased the probability of cervical screening among the poor. Lack of awareness and knowledge contributed to non-use of both screenings. Women were put off from screening, especially Muslim women on cervical screening, because of embarrassment, fear of pain and other reasons. Conclusions: Although cervical screening is covered by the benefit package of three main public health insurance schemes, free of charge to all eligible women, the low coverage of cervical screening should be addressed by increasing awareness and strengthening the supply side. As mammography was not cost effective and not covered by any scheme, awareness and practice of breast self examination and effective clinical breast examination are recommended. Removal of cultural barriers is essential.

Hemiarthroplasty for Distal Humerus Fracture: A Systematic Review and Meta-analysis for Functional Outcome

  • Kwak, Jae-Man;Kholinne, Erica;Sun, Yucheng;Lee, Gwan Bum;Koh, Kyoung Hwan;Chun, Jae-Myeung;Jeon, In-Ho
    • Clinics in Shoulder and Elbow
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    • v.21 no.3
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    • pp.120-126
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    • 2018
  • Background: Treatment of distal humerus fractures in osteoporotic elderly patients is often challenging. For non-reconstructible fractures with open reduction and internal fixation, total elbow arthroplasty (TEA) is an acceptable alternative. However, the relatively high complication rates and lifelong activity restrictions make TEA less ideal for elderly or low-demand patients. Efforts to identify or develop alternate procedures that benefit relatively young, high-demand patients have resulted in increased interest in hemiarthroplasty. This systematic review reports the clinical outcomes of hemiarthroplasty for distal humeral fractures. Methods: We systematically reviewed the databases of PubMed, Ovid MEDLINE, and Cochrane Library. All English-language studies published before June 2017 were considered for possible inclusion. Search terms included 'distal humerus fracture' and 'hemiarthroplasty'. Studies reporting outcomes (and a minimum of 1 year clinical follow-up) in human subjects after hemiarthroplasty (Latitude system) for distal humeral fractures were assessed for inclusion. Patient demographics, clinical and radiographic outcomes, and complications were recorded, and homogenous outcome measures were analyzed. Results: Nine studies with a total of 115 patients met the inclusion criteria. Among the included studies, the weighted mean follow-up time was 35.4 months. Furthermore, the weighted mean of the postoperative range of motion ($107.6^{\circ}$ flexion-extension, $157.5^{\circ}$ for pronation-supination) and functional outcomes (Mayo elbow performance scores: 85.8, Disabilities of the Arm, Shoulder and Hand score: 19.6) were within the acceptable range. Conclusions: Our study indicates that hemiarthroplasty is a viable option for comminuted distal humerus fracture. Satisfactory functional outcomes were observed in most patients.

Limited Clinical Significance of Splenectomy and Splenic Hilar Lymph Node Dissection for Type 4 Gastric Cancer

  • Kunitomo, Aina;Misawa, Kazunari;Ito, Yuichi;Ito, Seiji;Higaki, Eiji;Natsume, Seiji;Kinoshita, Takashi;Abe, Tetsuya;Komori, Koji;Shimizu, Yasuhiro
    • Journal of Gastric Cancer
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    • v.21 no.4
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    • pp.392-402
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    • 2021
  • Purpose: Type 4 gastric cancer (GC) has a very poor prognosis even after curative resection, and the survival benefit of splenectomy for splenic hilar lymph node (LN; #10) dissection in type 4 GC remains equivocal. This study aimed to clarify the clinical significance of splenectomy for #10 dissection in patients with type 4 GC. Materials and Methods: The data of a total of 56 patients with type 4 GC who underwent total gastrectomy with splenectomy were retrospectively analyzed. Postoperative morbidity, state of LN metastasis, survival outcomes, and therapeutic value index (TVI) of each LN station were evaluated. TVI was calculated by multiplying the incidence of LN metastasis at each nodal station and the 5-year overall survival (OS) of patients who had metastasis to each node. Results: Overall, the postoperative morbidity rate was 28.6%, and the incidence of #10 metastasis in the patients was 28.6%. The 5-year OS rate for all patients was 29.9%, and most patients developed peritoneal recurrence. Moreover, the 5-year OS rates with and without #10 metastasis were 6.7% and 39.1% (median survival time, 20.4 vs. 46.0 months; P=0.006). The TVI of #10 was as low as 1.92. Conclusions: The clinical significance of splenectomy in the dissection of #10 for type 4 GC is limited and splenectomy for splenic hilar dissection alone should be omitted.

Does the Retrieval of at Least 15 Lymph Nodes Confer an Improved Survival in Patients with Advanced Gastric Cancer?

  • Kim, Yong Il
    • Journal of Gastric Cancer
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    • v.14 no.2
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    • pp.111-116
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    • 2014
  • Purpose: The standard surgical procedure recommended to treat gastric cancer in advanced cases is dissection of D2 lymph nodes (LNs). However, the optimum number of LNs that should be retrieved in advanced gastric cancer (AGC) remains debatable. Therefore, this study aimed to investigate the optimum number of retrieved LNs and determine the clinical implications of retrieved LN numbers on the treatment of AGC. Materials and Methods: Of 575 AGC patients reviewed, 369 who underwent open curative gastrectomy with D2 or more extensive LN dissection at our institution were analyzed according to their clinicopathologic characteristics and number of LNs retrieved. Results: Multivariate regression analysis revealed that tumor size (P=0.006), depth of invasion (P=0.000), LN metastasis (P=0.000), and stage (P=0.000) were independent variables with predictive value. The 5-year survival rates were differed significantly according to the numbers of LNs retrieved ([1] 15~25 vs. >25 and [2] 15~39 vs. ${\geq}40$) in patients with differentiated carcinoma. Conclusions: Tumor size, depth of invasion, LN metastasis, and stage were independent predictive factors for survival. The number of retrieved LNs was significantly associated with a long-term survival benefit in patients with differentiated carcinoma. Therefore, our data suggest that the retrieval of a minimum of 15 LNs may not be sufficient to warrant a recommendation for further curative surgery and that extensive LN dissection should be considered in advanced carcinoma of the differentiated type.

Glutathione S-transferase P1 and DNA Polymorphisms with the Response to Chemotherapy and the Prognosis of Bone Tumor

  • Yang, Li-Min;Li, Xiu-Hua;Bao, Cui-Fen
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.11
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    • pp.5883-5886
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    • 2012
  • Osteosarcoma is the most common primary bone malignancy in children and adolescents, and its clinical outcome is poor. We evaluated the response of GSTP1, ERCC1 and ERCC2 to chemotherapy among osteosarcoma patients, and the role of these genes on the prognosis of osteosarcoma. 187 patients with osteosarcoma were administered with methotrexate, cisplatin/adriamycin, actinomycin D, cyclophosphamide, or vincristine treatment. GSTP1, ERCC1 and ERCC2 polymorphism was genotyped by PCR-RFLP assay. The results showed the average survival time of 187 patients were 38.4 months. 97 patients showed response to neoadjuvant chemotherapy. The GSTP1 Val and ERCC2 A/A genotypes had significantly higher rates of response to chemotherapy, with adjusted OR (95% CI) of 2.19 (1.15-6.21) and 2.88 (1.14-13.25). Individuals with ERCC2 A/A genotype were likely to have a lower risk of death from oseosarcoma, and the adjusted HR was 0.32 (0.13-0.95). Our study indicated test of GSTP1 and ERCC2 Lys751Gln polymorphisms might be a candidate pharmacogenomic factors to be explored in the future to identify the osteosarcoma patients who might benefit from chemotherapy.

Early Effective Parenteral Nutrition for Preterm Infants (미숙아의 효과적인 조기 정맥영양)

  • Lee, Byong-Sop
    • Neonatal Medicine
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    • v.16 no.2
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    • pp.110-120
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    • 2009
  • Mimicking fetal nutrition is the goal of early paretneral nutrition (PN) in very low birth weight infants, however the limited metabolic capacity of immature organs raises concern about the toxicity of metabolites to the developing brain. Starting parenteral amino acids from the first day of life, with a rate of 1.0 to 1.5 g/kg/day, is generally recommended to prevent endogenous protein breakdown by maintaining a positive nitrogen balance. A greater of amino acid infusion rate in the range of the fetal transfer rate (3.5-4.0 g/kg/day) is well tolerated during the early days after birth in VLBWI, however the influence on growth and long-term neurodevelopmental outcome remains unknown. Limited data are available from controlled trials regarding the effects of early supplementation with lipid emulsions on neonatal morbidity. Considering the role of long-chain polyunsaturated fatty acids in the neurodevelopment, the choice of an optimal lipid emulsion should be based on the quality as well as the quantity of the lipid contents. Little is known about the clinical benefit of higher rates of glucose infusion by permitting high serum glucose level or co-administration with insulin.