• Title/Summary/Keyword: Adverse outcomes

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Bisphosphonates for Osteoporosis in Nonmetastatic Prostate Cancer Patients Receiving Androgen-deprivation Therapy: A Systematic Review and Meta-analysis

  • Ding, Hui;Yang, Li;Du, Wan;Teng, Yang;Fu, Sheng-Jun;Tao, Yan;Lu, Jian-Zhong;Wang, Zhi-Ping
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.5
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    • pp.3337-3343
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    • 2013
  • This systematic review was conducted to assess the efficacy and safety of bisphosphonates for prevention and treatment of osteopenia or osteoporosis in men with non-metastatic prostate cancer receiving androgendeprivation therapy. We searched for randomised controlled trials (RCTs) of bisphosphonates compared with placebo from Pubmed, Embase, the Cochrane Library, and ISI - Science Citation Index. Meta-analyses of prespecified outcomes (bone mineral density, fractures, and adverse events) were performed using Review Manager. Ten RCTs with a total patient population of 1,017 were identified. There was generally more improvement in bone mineral density of the lumbar spine for patients who received bisphosphonate treatment than placebo or other medical treatment at 12 months (WMD 6.02,95%CI 5.39 to 6.65). Similar effects were also observed for total hip, trochanter or femoral neck bone mineral density. However, there was no significant reduction in fractures. Fever and gastrointestinal symptoms were the most common adverse events (10.4% vs. 1.2%; 0.10% vs. 0.03%). Currently, our meta-analysis suggested that oral and intravenous bisphosphonates caused a rapid increase in spine and hip or femoral BMD in non-metastatic prostate cancer patients receiving androgen-deprivation therapy. Fever and gastrointestinal symptoms were common with the use of bisphosphonates. These short-term trials (maximum of 12 months) did not show fracture reduction. In future, more efficient performance of higher quality, more rigorous, large sample, long-term randomised controlled trials (>12 months) are needed where outcomes are detailed.

Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial

  • Zhang, Li;Chen, Xiaoyun;Cheng, Yanqi;Chen, Qilong;Tan, Hongsheng;Son, Dongwook;Chang, Dongpill;Bian, Zhaoxiang;Fang, Hong;Xu, Hongxi
    • Journal of Ginseng Research
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    • v.43 no.4
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    • pp.676-683
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    • 2019
  • Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

Comparison of endoscopic ultrasound-guided drainage and percutaneous catheter drainage of postoperative fluid collection after pancreaticoduodenectomy

  • Da Hee Woo;Jae Hoon Lee;Ye Jong Park;Woo Hyung Lee;Ki Byung Song;Dae Wook Hwang;Song Cheol Kim
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.26 no.4
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    • pp.355-362
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    • 2022
  • Backgrounds/Aims: Postoperative fluid collection is a common complication of pancreatic resection without clear management guidelines. This study aimed to compare outcomes of endoscopic ultrasound (EUS)-guided trans-gastric drainage and percutaneous catheter drainage (PCD) in patients who experienced this adverse event after pancreaticoduodenectomy (PD). Methods: Demographic and clinical data and intervention outcomes of 53 patients who underwent drainage procedure (EUS-guided, n = 32; PCD, n = 21) for fluid collection after PD between January 2015 and June 2019 in our tertiary referral center were retrospectively analyzed. Results: Prior to drainage, 83.0% had leukocytosis and 92.5% presented with one or more of the following signs or symptoms: fever (69.8%), abdominal pain (69.8%), and nausea/vomiting (17.0%). Within 8 weeks of drainage, 77.4% showed a diameter decrease of more than 50% (87.5% in EUS vs. 66.7% in PCD, p = 0.09). Post-procedural intravenous antibiotics were used for an average of 8.1 ± 4.3 days and 12.4 ± 7.4 days for EUS group and PCD group, respectively (p = 0.01). The EUS group had a shorter post-procedural hospital stay than the PCD group (9.8 ± 1.1 vs. 15.8 ± 2.2 days, p < 0.01). However, the two groups showed no statistically significant difference in technical or clinical success rate, reintervention rate, or adverse event rate. Conclusions: EUS-guided drainage and PCD are both safe and effective methods for managing fluid collection after PD. However, EUS-guided drainage can shorten hospital stay and duration of intravenous antibiotics use.

Growth and Tolerance Assessment of a Lutein-fortified Infant Formula

  • Kon, Igor Ya.;Gmoshinskaya, Maria V.;Safronova, Adilya I.;Alarcon, Pedro;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.17 no.2
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    • pp.104-111
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    • 2014
  • Purpose: To evaluate safety, gastrointestinal tolerance, and growth of a new experimental starter formula (NESF) fortified with lutein, prebiotics, probiotics, nucleotides and beta-carotene, fed to infants within the first months of life. Methods: This was a non-randomized, open, uncontrolled study conducted from December 2010 to May 2011. Twenty-three healthy infants aged 10 days to 2 months old were enrolled. Outcomes included gastrointestinal tolerance, physical growth and safety. Prior to the initiation of the trial, the Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences confirmed that the NESF met all safety and nutritional parameters. Results: NESF was well tolerated. The majority of infants fed this formula passed semi-liquid, yellow or yellow-brown. The mean stool frequency/day was $2.5{\pm}0.4$ on study-day 14 and $1.8{\pm}0.5$ on study-day 28. The mean daily weight gain was $30.9{\pm}3.8$ grams and the mean length gain during the 28 days of follow up was $3.1{\pm}0.8cm$, corresponding to the average physical growth normally seen in the first months of life in Russian infants. Six children left the study: one refused to drink the formula, one left the study as parents changed residence; and one child's parents have recalled their informed consent due to adverse event unrelated to the product. Three infants presented adverse events possibly related to the product (rash; colic and abdominal pain; constipation). Seventeen infants completed the trial. Conclusion: This study demonstrated that lutein-fortified formula is safe, well-tolerated and supported physical growth of evaluated infants.

THE RELATIONSHIP BETWEEN INTRAOPERATIVE FLUID MANAGEMENT AND POSTOPERATIVE ADVERSE OUTCOME IN A ORTHOGNATHIC SURGERY (악교정 수술중 수액요법과 술후 합병증의 연관성)

  • Lyoo, Jung-Ho;Kim, Dai-Yun;Bae, Jun-Su;Yang, Byung-Eun;You, Jun-Yong;Kim, Yong-Gwan
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.23 no.5
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    • pp.428-434
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    • 2001
  • Few topics in operative and perioperative patient management generate more controversy than that of appropriate fluid and electrolyte therapy. especially, controversy has swirled around colloid vs crystalloid therapy and the composition of administered fluids, agreement among clinicians as to what fluid therapy is appropriate, and in what amount, is rare. This controversy likely will be enhanced by Arieff' s provocative article. He described 11 adults and 2 pediatric patients. All developed fatal postoperative pulmonary edema, seemingly caused solely by excessive postoperative fluid administration. From January 1999 to December 1999, we investigated 24 patients, which were operated by orthognathic surgery, about the intraoperative fluid therapy and the associated effect in orthognathic surgery, which is regarded as one of the major surgery of oral and maxillofacial surgery. First, They were devided into two groups, that is one-jaw surgery and two-jaw surgery, and each groups were devided by intraoperative fluid volume of 8ml/kg/hr. Subjective assesment was collected through use of a series of 3 questionnaries. In each questionnaire, a 5-point Liekert scale was used far assessment of following parameters of recovery from anesthesia: headache, dizziness, drowsiness, nausea/vomiting, thirst. The patient completed questionnaire 1 at 4 hour after surgery, questionnaire 2 was completed at 24 hours after surgery, and questionnaire 3 was completed at 48 hours after surgery. This study demonstrated that appropriated perioperative rehydration decreases postoperative adverse outcomes and improved the patient's perception of the postoperative period.

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A Case Report of Hormone Receptor Positive and HER-2 Receptor Positive Metastatic Breast Cancer Stage IV Patient Treated with a Combination of Traditional Korean Medicine and Chemotherapy for 6 Years (호르몬 수용체 및 HER-2 수용체 양성 유방암 4기 다발성 전이 환자의 6년간의 한양방 병용치료 치험 1례)

  • Park, Kyeong Ju;Lee, A-ram;Kim, Sung su;Seong, Sin
    • Journal of Korean Traditional Oncology
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    • v.24 no.2
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    • pp.13-21
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    • 2019
  • Objective : The purpose of this study is to report and observe effects of Traditional Korean Medicine (TKM) on stage IV metastatic breast cancer patient. Method : A right breast cancer patient diagnosed with metastatic lesions on liver, lung, spleen, multiple bones and skin on right breast April 2013. The patient received Herceptin + Docetaxel + Zometa from May 2013 and started to receive TKM since July 2013 to decrease side effects of chemotherapy. From December 2013 to November 2014, she had received Herceptin 18 times more. The clinical outcomes were measured by computed tomography, laboratory findings including tumor markers (CEA, CA15-3), liver function test (AST, ALT), and numeric rating scales (NRS). Results : After 6 years of TKM treatment combined with standard chemotherapy, tumor size was partially decreased in lung, liver, right pleura and spleen. Levels of tumor markers also showed decrease. There were no severe adverse events induced by TKM based on National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) version 4.0. Conclusion : This case suggests that TKM combined with standard chemotherapy could be a promising method for treating metastatic stage IV breast cancer.

Health Effects from Odor Pollution in Sihwa Industrial Complex (경기도 시화공단 지역주민의 악취오염과 관련된 건강영향 평가)

  • Cho, Soo-Hun;Kim, Sun-Mean;Kim, Young-Su;Kim, Jae-Yong;Choi, Seong-Woo
    • Journal of Preventive Medicine and Public Health
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    • v.32 no.4
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    • pp.473-481
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    • 1999
  • Objectives: In recent days, the problem of odor pollution in community near Sihwa Industrial complex, Kynuggi Province is becoming of significant public concern. We have investigated the health effects of the Sihwa residents from odor pollution comparing with other less polluted areas. Methods: The Ansan and Kuri Cities were selected as control areas. The parents of the elementary and middle school students in these three areas were surveyed with structured questionnaire twice, Nov 1997 and Jure 1998 each. As a exposure index, the ambient air concentrations of five major air pollutants(particulates, $O_3,\;SO_2,\;NO_2$, CO) and subjective odor perception were used. We have focused health outcomes such as the prevalence of nonspecific irritant symptoms, respiratory disease among family members and the score of qualify of life(QOL). Results: Although the mean concentrations of major air pollutants except particulates were similar or lower in Sihwa than other areas, the odor perception rate and the monthly odor perception days were significantly higher. It suggested that odor producing chemical compounds are the major source of environmental pollution problem. There were higher prevalence rates of nonspecific irritant symptoms and respiratory disease among family members in Sihwa than other control areas. The QOL score was also lower in Sihwa. The odor perception proved to be a most important factor in reporting adverse health effects and lowering the QOL score. Conclusion: The residents living near Sihwa industrial complex were suffering from more adverse health symptoms and poorer QOL status than control areas. And it may be due to environmental odor pollution from industrial complex. Therefore, further research will be needed for monitoring of the responsible chemicals emitted from industries.

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Effectiveness of Shortwave Therapy in Management of Knee Osteoarthritis : A Systematic Review and Meta-analysis of Randomized Controlled Trials (무릎 뼈관절염의 단파치료 효과 : 무작위임상시험의 메타분석과 체계적 고찰)

  • Lee, Jae-Hyoung;Cho, Hyuk-Shin;Song, In-Yong
    • The Journal of Korean Physical Therapy
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    • v.26 no.5
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    • pp.331-343
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    • 2014
  • Purpose: The purpose of this study is to assess the effectiveness of short-wave therapy (SWT) for treatment of knee osteoarthritis (OA) as compared to placebo and control, and to assess the question of whether the effects are related to the mode, dosage, and application method. Methods: We searched randomized, placebo-controlled trials using electronic databases. We also manually reviewed sources in order to identify additional relevant studies. Results: Eight studies (597 participants) with OA were included in the meta-analysis. Pulse SWT had a significant effect on pain relief compared with control treatment, while did not favour compared with the placebo group. Pulse SWT had a significant effect on functional improvement compared with control and placebo treatment. Continuous SWT had no effect on pain relief and functional improvement. Capacitive SWT a significant effect on pain relief, functional improvement, and muscle strength. Continuous and capacitive SWT had increased muscle strength significantly. We found no clinical significance of all outcomes except pain and functional improvement in pulsed SWT with low dose. There was no difference in adverse events. None of the participants experienced any serious adverse events. Conclusion: Low dose pulsed SWT provided a short-term clinical benefit for pain relief and functional improvement. Pulsed SWD with low and high dose had effects on pain and function. There seems to be a placebo effect. We found significant effects on pain and function in capacitive SWT. Despite some positive findings, this analysis lacked data on how effectiveness is affected by mode, dosage, and application method of SWT. Further well-designed clinical studies are required in order to confirm the effectiveness of SWT.

Efficacy and Safety of Trastuzumab Added to Standard Treatments for HER2-positive Metastatic Breast Cancer Patients

  • Zhu, Zhen-Li;Zhang, Jun;Chen, Mei-Lan;Li, Ke
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7111-7116
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    • 2013
  • Introduction: Trastuzumab, an HER2-targeting agents, has shown efficacy in metastatic HER2-positive breast cancer patients. Single-agent clinical trials have evaluated therapeutic regimens using trastuzumab for metastatic breast cancer patients. The aim of our study is to evaluate the efficacy and safety of trastuzumab in combination with chemotherapy or hormone therapy in HER2-positive metastatic breast cancer patients. Methods: A literature research was conducted in PubMed and to identify appropriate studies from relevant reviews. Randomized controlled trials comparing chemotherapy or hormone therapy regimens in combination with trastuzumab were eligible. Dadta on clinical outcomes, including safety, efficacy, and patient characteristics were collected. Results: Seven articles describing five trials were included in our systematic review and meta-analysis. Partners of trastuzumab included in trials were anthracycline, paclitaxel, docetaxel, anastrozole and letrozole. The addition of trastuzumab to chemotherapy improved the overall survival (HR=0.79, 95%CI 0.65-0.96), while to hormone therapy did not (HR=0.85 95%CI 0.56-1.30). All trastuzumab-containing regimens increased cardiac toxicity (RR=3.37, 95%CI 1.26-9.02) and grade III-IV adverse events. Conclusions: Our study supports the addition of trastuzumab to chemotherapy which is effective and tolerated for metastatic breast cancer with HER2+ patients. Of note, more adverse events will occur followed the use of trastuzumab, especially cardiac toxicity, with two treatment regimens.

Stereotactic body radiation therapy for liver oligo-recurrence and oligo-progression from various tumors

  • Cha, Yu Jin;Kim, Mi-Sook;Jang, Won-Il;Seo, Young Seok;Cho, Chul Koo;Yoo, Hyung Jun;Paik, Eun Kyung
    • Radiation Oncology Journal
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    • v.35 no.2
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    • pp.172-179
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    • 2017
  • Purpose: To evaluate the outcomes of stereotactic body radiation therapy (SBRT) for patients with liver oligo-recurrence and oligo-progression from various primary tumors. Materials and Methods: Between 2002 and 2013, 72 patients with liver oligo-recurrence (oligo-metastasis with a controlled primary tumor) and oligo-progression (contradictory progression of a few sites of disease despite an overall tumor burden response to therapy) underwent SBRT. Of these, 9 and 8 patients with uncontrollable distant metastases and patients immediate loss to follow-up, respectively, were excluded. The total planning target volume was used to select the SBRT dose (median, 48 Gy; range, 30 to 60 Gy, 3-4 fractions). Toxicity was evaluated using the Common Toxicity Criteria for Adverse Events v4.0. Results: We evaluated 55 patients (77 lesions) treated with SBRT for liver metastases. All patients had controlled primary lesions, and 28 patients had stable lesions at another site (oligo-progression). The most common primary site was the colon (36 patients), followed by the stomach (6 patients) and other sites (13 patients). The 2-year local control and progression-free survival rates were 68% and 22%, respectively. The 2- and 5-year overall survival rates were 56% and 20%, respectively. The most common adverse events were grade 1-2 fatigue, nausea, and vomiting; no grade ${\geq}3$ toxicities were observed. Univariate analysis revealed that oligo-progression associated with poor survival. Conclusion: SBRT for liver oligo-recurrence and oligo-progression appears safe, with similar local control rates. For liver oligo-progression, criteria are needed to select patients in whom improved overall survival can be expected through SBRT.