• 제목/요약/키워드: Adverse events

검색결과 997건 처리시간 0.025초

Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study

  • Takatsugu Ogata;Yukiya Narita;Zev A. Wainberg;Eric Van Cutsem;Kensei Yamaguchi;Yongzhe Piao;Yumin Zhao;Patrick M. Peterson;Sameera R. Wijayawardana;Paolo Abada;Anindya Chatterjee;Kei Muro
    • Journal of Gastric Cancer
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    • 제23권2호
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    • pp.289-302
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    • 2023
  • Purpose: Liver metastasis (LM) is reported in approximately 40% of patients with advanced/metastatic gastric/gastroesophageal junction adenocarcinoma (metastatic esophagogastric adenocarcinoma; mGEA) and is associated with a worse prognosis. This post-hoc analysis from the RAINBOW trial reported the efficacy, safety, and biomarker outcomes of ramucirumab and paclitaxel combination treatment (RAM+PAC) in patients with (LM+) and without (LM-) LM at baseline. Materials and Methods: Patients (n=665) were randomly assigned on a 1:1 basis to receive either RAM+PAC (LM+: 150, LM-: 180) or placebo and paclitaxel (PL+PAC) (LM+: 138, LM-: 197). The overall survival (OS) and progression-free survival (PFS) were evaluated using stratified Kaplan-Meier and Cox regression models. The correlation of dichotomized biomarkers (VEGF-C, D; VEGFR-1,2) with efficacy in the LM+ versus LM- subgroups was analyzed using the Cox regression model with reported interaction P-values. Results: The presence of LM was associated with earlier progression than those without LM, particularly in patients receiving PL+PAC (hazard ratio [HR], 1.68). RAM+PAC treatment improved OS and PFS irrespective of LM status but showed greater improvement in LM+ than that in LM- (OS HR, 0.71 [LM+] vs. 0.88 [LM-]; PFS HR, 0.47 [LM+] vs. 0.76 [LM-]). Treatment-emergent adverse events were similar between patients with and without LM. No predictive relationship was observed between biomarker levels (VEGF-C, D; VEGFR-1,2) and efficacy outcome (OS, PFS) (all interaction P-values >0.05). Conclusions: RAM provided a significant benefit, irrespective of LM status; however, its effect was numerically stronger in patients with LM. Therefore, RAM+PAC is a clinically meaningful therapeutic option for patients with mGEA and LM.

A narrative review of clinical studies on thread embedding acupuncture treatment for spasticity after stroke

  • Sooran Cho;Eunseok Kim
    • 대한한의학회지
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    • 제43권4호
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    • pp.131-144
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    • 2022
  • Objectives: This study aimed to review clinical studies on thread embedding acupuncture (TEA) for the treatment of patients with post-stroke spasticity (PSS) Methods: Clinical studies related to TEA treatment for PSS were searched for in several electronic databases, including PubMed, Cochrane Library, MEDLINE, OASIS, and CNKI. After the selection/exclusion process, information on study design, disease, experimental/control group, intervention, outcome measurement, between-group differences, and adverse events was extracted. Results: A total of 13 randomized controlled trials were included in this review. The usual frequency of TEA treatment was once every 1-2 weeks, and the treatment most commonly included 4 sessions. In the dorsal area, EX-B2 and the acupoints in governing vessel meridian were commonly used. Acupoints in the meridian of the large intestine were most frequently used in the treatment of upper limb spasticity. Except for HT1, PC6, and PC8, all TEA points for treating PSS of the upper limb were on the Yang meridians. For the lower limb spasticity, the most frequently used acupoints were ST36, GB34, GB30, BL60, and BL57 on Yang meridians, and LR3, SP6, SP9, and SP10 on Yin meridians. TEA treatment showed better effects than conventional treatment for PSS in terms of spasticity, motor dysfunction, and activities of daily livings. Nevertheless, the absence of the follow-up observation, lack of sham TEA treatment, and low quality of the included studies necessitated caution in interpreting the results. Conclusions: The results of this review are expected to provide basic data on the modalities of TEA treatment for PSS and provide insights to facilitate well-designed studies in the future.

Comparative evaluation of intranasal midazolam-ketamine, dexmedetomidine-ketamine, midazolam-fentanyl, and dexmedetomidine-fentanyl combinations for procedural sedation and analgesia in pediatric dental patients: a randomized controlled trial

  • Abhilasha Agarwal;Afroz Alam Ansari;Rajendra Nath;Rakesh Kumar Chak;Rajeev Kumar Singh;Richa Khanna;Prem Raj Singh
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제23권2호
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    • pp.69-81
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    • 2023
  • Background: In order to assess the effectiveness of various analgesio-sedative combinations for pain relief and sedation in pediatric dental patients, a thorough evaluation of clinical studies and patient outcomes is necessary. Methods: A total of 128 healthy, uncooperative pediatric dental patients were randomly allocated to receive one of the four combinations of drugs via the intranasal (IN) route: Group I received midazolam-ketamine (MK), Group II received dexmedetomidine-ketamine (DK), Group III received midazolam-fentanyl (MF), and Group IV received dexmedetomidine-fentanyl (DF) in a parallel-arm study design. The efficacy and safety of the combinations were evaluated using different parameters. Results: The onset of sedation was significantly faster in the DF group than in the DK, MF, and MK groups (P < 0.001). The depth of sedation was significantly higher in the DK and DF groups than in the MK and MF groups (P < 0.01). DK and DF produced significant intra- and postoperative analgesia when compared with combinations of MK and MF. No significant adverse events were observed for any of the combinations. Conclusions: The DK and DF groups showed potential as analgesio-sedatives in view of their anxiolytic and analgesic effects.

Effectiveness of percutaneous epidural neuroplasty using a balloon catheter in patients with chronic spinal stenosis accompanying mild spondylolisthesis: a longitudinal cohort study

  • Myong-Hwan Karm;Chan-Sik Kim;Doo-Hwan Kim;Dongreul Lee;Youngmu Kim;Jin-Woo Shin;Seong-Soo Choi
    • The Korean Journal of Pain
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    • 제36권2호
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    • pp.184-194
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    • 2023
  • Background: Degenerative lumbar spondylolisthesis (DLS) is frequently associated with lumbar spinal stenosis (LSS) and conservative treatments such as epidural steroid injection do not have long-term benefits in LSS patients with DLS. This study evaluated the effectiveness of percutaneous epidural neuroplasty using a balloon catheter in patients with LSS and DLS. Methods: Patients' sex, age, body mass index, diabetes, hypertension, stenosis grading, pain duration, location, pain intensity, and medications were retrieved from electronic medical records. At 1, 3, and 6 months following the procedure, data on pain severity, medication usage, and physical functional status were analyzed. A generalized estimating equations model was used at the six-month follow-up. Patients were divided into those with DLS (the spondylolisthesis group) and those without DLS (the no spondylolisthesis group) to evaluate whether the effects of percutaneous epidural neuroplasty using a balloon catheter were different. Results: A total of 826 patients were included (spondylolisthesis: 433 patients, 52.4%; no spondylolisthesis: 393 patients, 47.6%). Age, body mass index, hypertension, pain location, and stenosis grading were statistically different between the two groups. The generalized estimating equations analyses with unadjusted and adjusted estimation revealed a significant improvement in the estimated mean numerical rating scale of pain intensities compared to that at baseline in both groups (P < 0.001). Any adverse events that occurred were minor and temporary. Conclusions: Percutaneous epidural neuroplasty using a balloon catheter may be an alternative treatment option for patients with chronic LSS, regardless of accompanying DLS, who have had failed conservative management.

뇌실내출혈을 동반한 뇌내출혈로 인한 편측무시 증상을 호소하는 환자에게 자음건비탕, 침치료, 사지운동을 포함한 한의복합치료 증례 보고 1례 (Case Report: Complex Treatment Using Korean Medicine, Including Jaeumkunbi-tang, Acupuncture, and Limb Activation Exercises for a Patient Suffering Unilateral Neglect due to Intraventricular Hemorrhage Accompanied by Intraventricular Hemorrhage)

  • 신주은;강지윤;김윤식;설인찬;유호룡
    • 대한한방내과학회지
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    • 제44권2호
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    • pp.87-96
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    • 2023
  • Objective: This study reports the effectiveness of the Korean medicine treatment of patients with intracerebral and intraventricular hemorrhages suffering unilateral neglect symptoms. Case presentation: The patient was treated using Korean medicine, including acupuncture, herbal medicine, moxibustion, and a limb activation exercise. We measured Unilateral Neglect Symptom progress with a numeric rating scale, Albert's test, Line bisection test, Clock drawing test, and Catherine Bergego Scale. After eight days of combined Korean medicine and rehabilitation exercise, the Unilateral Neglect Symptom intensity reduced from NRS 8 to 6. In addition, Albert's test score decreased from 2.5% to 0%. The Line bisection test score decreased from 19 mm to 12 mm, and the Clock drawing test score improved from 8 to 10. Last, the Catherine Bergego Scale decreased from 12 to 9. No adverse events were observed during treatment. Conclusion: This study suggested that a complex treatment including Jaeumkunbi-tang, acupuncture, moxibustion, and limb activation exercise can be effective for an intracerebral hemorrhage with intraventricular hemorrhage patient suffering from Unilateral Neglect Symptoms. Consequently, more research is needed in the future.

Simultaneous Combination Treatment Using High-Intensity Focused Ultrasound and Fractional Carbon Dioxide Laser Resurfacing for Facial Rejuvenation

  • Kang, Hee Yong;Park, Eun Soo;Nam, Seung Min
    • Medical Lasers
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    • 제8권1호
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    • pp.13-18
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    • 2019
  • Background and Objectives High-intensity focused ultrasound (HIFU) can produce small zones of thermal damage. A HIFU procedure is non-invasive and it can achieve rejuvenation of facial skin. Fractional CO2 laser resurfacing delivers thermal damage to the pixilated columnar zone of the skin and so evoke collagen remodeling, the same as HIFU. In many cases, the patients who want rejuvenation with HIFU are also good candidates for cutaneous photorejuvenation such as can be accomplished via fractional CO2 resurfacing. If patients are treated in a single session by remodeling both the superficial and deep compartments of skin by using both modalities, then improvement in rhytides and tightening of sagging skin will optimize the aesthetic result. Materials and Methods Between May 2014 and January 2018, a total of 44 patients were treated with combination HIFU and fractional CO2 laser resurfacing according to our protocol. First, the HIFU was applied to the entire face with an average of 300 treatment lines. Immediately after HIFU treatment, the ultrasound gel was washed off and then fractional CO2 laser resurfacing was performed. We evaluated the patients using 4-point grading scales. The clinician examined the skin for evidence of complications after the completion of treatment. Results All the patients' skin quality showed improvement. Further. the clinical results after duel modality treatment were substantially better than that after the use of either modality alone. The recovery times and the incidence of adverse events when quickly and consecutively performing both treatments were similar as compared to those with employing stepwise treatment. We encountered no complications whatsoever. Conclusion When compared with stepwise therapy, combination therapy with HIFU and fractional CO2 resurfacing offers better, safer and more effective clinical results. Thus, for targeting multiple layers of aging facial skin, this combination therapy can be safely performed in a single treatment session.

Prognosis of Unrepaired Ascending Aorta after the Surgical Replacement of Bicuspid Aortic Valves

  • Hong Ju Shin;Wan Kee Kim;Dong Kyu Kim;Ho Jin Kim;Joon Bum Kim
    • Journal of Chest Surgery
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    • 제56권4호
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    • pp.255-261
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    • 2023
  • Background: The surgical threshold for bicuspid aortic valve (BAV)-related aortopathy is a matter of debate due to its uncertain etiology and prognosis. This study investigated the prognosis of unrepaired BAV aortopathy in patients undergoing surgical aortic valve replacement (SAVR). Methods: We retrospectively analyzed data from 720 patients (age, 60.8±11.5 years; 246 women) who underwent SAVR for BAV disease without aortic repair between 2005 and 2020 at Asan Medical Center. The clinical endpoints were defined as occurrences of sudden death, aortic dissection or rupture, and elective aortic repair. To estimate postoperative changes in the dimensions of the unrepaired aorta, the individual annual aortic expansion rate was calculated. Multiple linear regression models were used to evaluate the risk of aortic expansion. Results: The mean ascending aortic diameter was 39.5±4.6 mm, and 299 patients (41.5%) had a baseline ascending aorta diameter >40 mm. During 70.0±68.3 months of follow-up, the mean annual aortic expansion rate was 0.39±1.96 mm/yr, no aortic dissection or rupture was observed, and sudden deaths were reported in 12 patients (0.34% per person-year). Linear regression analysis revealed no significant correlation between the baseline ascending aortic diameter and postoperative aortic expansion (R2=0.004, β=-0.84, p=0.082). Conclusion: In selected patients undergoing SAVR for a BAV (<55 mm), the risk of adverse aortic events was very low. As this observation contradicts current practice guidelines advocating for proactive aortic replacement in dilated ascending aortas measuring >45 mm, the study results need further validation by studies involving larger populations or randomized controlled trials.

Yukgunja-tang for Irritable Bowel Syndrome: A Protocol for a Systematic Review and Meta-Analysis

  • Kangwook Lee;Seok-Jae Ko;Minjeong Kim;Chaehyun Park;Min-Seok Cho;Jae-Woo Park
    • 대한한방내과학회지
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    • 제44권3호
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    • pp.285-293
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    • 2023
  • Background: Irritable bowel syndrome (IBS) is a digestive disorder characterized by abdominal discomfort or pain accompanied by a change in stool condition. Owing to its complicated mechanisms, a standard treatment for IBS has not yet been established. Yukgunja-tang (YGT) is a Korean herbal medicine known in Asia to be effective in the treatment of gastrointestinal symptoms. In this study, we will conduct a systematic review of randomized controlled trials (RCTs) to assess the efficacy and safety of YGT in IBS treatment. Methods and analysis: English databases, such as Embase, Medline (via PubMed), Allied and Complementary Medicine Database, and Cochrane Central Register of Controlled Trials, will be searched for articles published up to April 2023. Additional databases, such as five Korean, one Chinese, and one Japanese database, will be included. RCTs and quasi-RCTs will also be included in the assessment of the efficacy of YGT. The overall efficacy rate will be the primary outcome, and data such as IBS quality-of-life measurements, global symptom scores, and adverse events will be the secondary outcomes. Review Manager Version 5.3 will be used for evaluation, and the risk of bias (RoB) will be evaluated using Cochrane Collaboration's RoB tool. The Grading of Recommendations Assessment, Development, and Evaluation approach will be used to score the quality of evidence. Conclusion: This study will demonstrate the efficacy and safety of YGT for treating patients with IBS.

Effect of prehydration solution on hearing threshold after chemotherapy in patients with head and neck cancers: a retrospective study

  • Dongbin Ahn;Kyu-Yup Lee;Eunjung Oh;Minji Oh;Boseung Jung;Da Jung Jung
    • Journal of Yeungnam Medical Science
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    • 제40권2호
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    • pp.164-171
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    • 2023
  • Background: The study aimed to evaluate the effect of prehydration solution on hearing thresholds after cisplatin chemotherapy. Methods: In this retrospective cohort study, we reviewed the data of patients who underwent ≥3 courses of cisplatin-based chemotherapy for locally advanced head and neck cancers at a tertiary referral center (n=64). The dextrose solution (DW) group (n=26) received 2 L of normal saline and 1 L of 5% dextrose. The Hartmann solution (HS) group (n=38) received 2 L of normal saline and 1 L of HS. Hearing data were measured 1 day before starting the first course of chemotherapy, and again 20 days after the first, second, and third courses of chemotherapy. The severity of hearing loss was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE). Results: Thresholds at all frequencies after chemotherapy were greater in the DW group than in the HS group. The increase in thresholds in 1 to 4 kHz after the third course of chemotherapy was greater in the DW group than in the HS group. CTCAE grades after the second and third courses of chemotherapy were greater in the DW group than in the HS group. Logistic regression showed that the odds ratio for CTCAE grade 3 or 4 after the third course of chemotherapy in the DW group was 4.84 on univariate analysis. Conclusion: Prehydration using a solution with salt was associated with a decrease in change in hearing thresholds after cisplatin chemotherapy in patients with head and neck cancers.

Application of cold atmospheric microwave plasma as an adjunct therapy for wound healing in dogs and cats

  • Jisu Yoo;Yeong-Hun Kang;Seung Joon Baek;Cheol-Yong Hwang
    • Journal of Veterinary Science
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    • 제24권4호
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    • pp.56.1-56.13
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    • 2023
  • Background: Cold atmospheric plasma is a novel innovative approach for wound care, and it is currently underrepresented in veterinary medicine. Objectives: To investigate the efficacy and safety of using cold atmospheric microwave plasma (CAMP) as an adjunct therapy for wound healing in dogs and cats. Methods: Wound healing outcomes were retrospectively analyzed using clinical records of client-owned dogs and cats who were first managed through standard wound care alone (pre-CAMP period) and subsequently via CAMP therapy (CAMP period). The degree of wound healing was estimated based on wound size and a modified wound scoring system. Results: Of the 27 acute and chronic wounds included in the analysis, 81.48% showed complete healing after the administration of CAMP as an adjunct therapy to standard care. Most wounds achieved complete healing in < 5 weeks. Compared with the pre-CAMP period, the rate of wound healing significantly increased every week in the CAMP period in terms of in wound size (first week, p < 0.001; second week, p = 0.012; third week, p < 0.001) and wound score (first week, p < 0.001; second week, p < 0.001; third week, p = 0.001). No adverse events were noted except for mild discomfort and transient erythema. Conclusions: CAMP is a well-tolerated therapeutic option with immense potential to support the treatment of wounds of diverse etiology in small animal practice. Further research is warranted to establish specific criteria for CAMP treatment according to wound characteristics.