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Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease.
Webb, NJA, Lerner, G, Warady, BA, Dell, KM, Greenbaum, LA, Ariceta, G, Hoppe, B, Linde, P, Lee, HJ, Eldred, A, et al
Pediatric nephrology (Berlin, Germany). 2017;(7):1221-1232
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Abstract
BACKGROUND Elevated intact parathyroid hormone (iPTH) levels can contribute to morbidity and mortality in children with chronic kidney disease (CKD). We evaluated the pharmacokinetics, efficacy, and safety of oral paricalcitol in reducing iPTH levels in children with stages 3-5 CKD. METHODS Children aged 10-16 years with stages 3-5 CKD were enrolled in two phase 3 studies. The stage 3/4 CKD study characterized paricalcitol pharmacokinetics and compared the efficacy and safety of paricalcitol with placebo followed by an open-label period. The stage 5 CKD study evaluated the efficacy and safety of paricalcitol (no comparator) in children with stage 5 CKD undergoing dialysis. RESULTS In the stage 3/4 CKD study, mean peak plasma concentration and area under the time curve from zero to infinity were 0.13 ng/mL and 2.87 ng•h/((or ng×h/))mL, respectively, for 12 children who received 3 μg paricalcitol. Thirty-six children were randomized to paricalcitol or placebo; 27.8% of the paricalcitol group achieved two consecutive iPTH reductions of ≥30% from baseline versus none of the placebo group (P = 0.045). Adverse events were higher in children who received placebo than in those administered paricalcitol during the double-blind treatment (88.9 vs. 38.9%; P = 0.005). In the stage 5 CKD study, eight children (61.5%) had two consecutive iPTH reductions of ≥30% from baseline, and five (38.5%) had two consecutive iPTH values of between 150 and 300 pg/mL. Clinically meaningful hypercalcemia occurred in 21% of children. CONCLUSIONS Oral paricalcitol in children aged 10-16 years with stages 3-5 CKD reduced iPTH levels and the treatment was well tolerated. Results support an initiating dose of 1 μg paricalcitol 3 times weekly in children aged 10-16 years.
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Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma.
Kim, HI, Han, SU, Yang, HK, Kim, YW, Lee, HJ, Ryu, KW, Park, JM, An, JY, Kim, MC, Park, S, et al
Annals of surgery. 2016;(1):103-9
Abstract
OBJECTIVE To compare short-term surgical outcomes including financial cost of robotic and laparoscopic gastrectomy. BACKGROUND Despite a lack of supporting evidence, robotic surgery has been increasingly adopted as a minimally invasive modality for the treatment of gastric cancer because of its assumed technical superiority over conventional laparoscopy. METHODS A prospective, multicenter comparative study was conducted. Patients were matched according to the surgeon, extent of gastric resection, and sex. The primary endpoint was morbidity and mortality. Outcomes were analyzed on an intention-to-treat and per-protocol basis. RESULTS A total of 434 patients were enrolled for treatment with either robotic (n = 223) or laparoscopic (n = 211) gastrectomy for intention-to-treat analysis, and a total of 370 patients (n = 185 per treatment) were compared in per-protocol analysis. Results were similar between both analyses. In per-protocol analysis, both groups showed similar overall complication rates (robotic = 11.9% vs laparoscopic = 10.3%) and major complication rates (robotic = 1.1% vs laparoscopic = 1.1%) with no operative mortality in either group. Patients treated with robotic surgery showed significantly longer operative time (robotic = 221 minutes vs laparoscopic = 178 minutes; P < 0.001) and significantly higher total costs (robotic = US$13,432 vs laparoscopic = US$8090; P < 0.001), compared with those who underwent laparoscopic gastrectomy. No significant differences between groups were noted in estimated blood loss, rates of open conversion, diet build-up, or length of hospital stay. CONCLUSIONS The use of robotic systems is assumed to provide a technically superior operative environment for minimally invasive surgery. However, our analysis of perioperative surgical outcomes indicated that robotic gastrectomy is not superior to laparoscopic gastrectomy. Clinical trials identification: NCT01309256.
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The Influence of Flush Methods on Transfemoral Catheter Cerebral Angiography: Continuous Flush versus Intermittent Flush.
Lee, HJ, Yang, PS, Lee, SB, Yi, JS, Ryu, SY, Kim, TW, Lee, TJ, Yang, JH, Lee, IW, Kim, JK, et al
Journal of vascular and interventional radiology : JVIR. 2016;(5):651-7
Abstract
PURPOSE To evaluate the influence of different flush methods on transfemoral cerebral angiography (TFCA). MATERIALS AND METHODS This single-blind randomized controlled trial included 50 patients who had undergone TFCA. Balanced block randomization was used to allocate participants into intermittent-flush (n = 25) and continuous-flush (n = 25) groups. Differences in procedure duration, amounts of contrast medium and heparinized saline used, heparin dose, blood loss, fluoroscopy time, radiation dose, and occurrence of new embolic signal (NES) on diffusion-weighted imaging (DWI) were compared between the two groups. RESULTS The procedure duration was shorter in the continuous-flush group (mean 26.5 min ± 3.7) than in the intermittent-flush group (mean 29.6 min ± 2.8) (P = .004). Amounts of injected contrast medium (mean 20.2 mL ± 4.4 vs 57.1 mL ± 9.0), wasted heparinized saline (mean 19.8 mL ± 9.6 vs 92.3 mL ± 16.7), and aspirated blood (mean 4.7 mL ± 1.3 vs 13.2 mL ± 2.9) were lower in the continuous-flush group than in the intermittent-flush group (P < .001). The amount of injected (or infused) heparinized saline, heparin dose, fluoroscopy time, radiation dose, and occurrence of NES on DWI did not differ between the groups (P > .05). CONCLUSIONS The use of continuous flushing during TFCA reduced the procedure time, amount of contrast medium needed, amount of wasted heparinized saline, and blood loss, but no difference in the occurrence of NES on DWI was noted between the groups.
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Comparison of treatment with preservative-free versus preserved sodium hyaluronate 0.1% and fluorometholone 0.1% eyedrops after cataract surgery in patients with preexisting dry-eye syndrome.
Jee, D, Park, M, Lee, HJ, Kim, MS, Kim, EC
Journal of cataract and refractive surgery. 2015;(4):756-63
Abstract
PURPOSE To compare treatment with preservative-free and preserved sodium hyaluronate 0.1% and fluorometholone 0.1% eyedrops after cataract surgery in patients with preexisting dry-eye syndrome. SETTING Bucheon St. Mary's Hospital, Catholic University of Korea, Seoul, Korea. DESIGN Randomized controlled study. METHODS Patients with cataract and dry-eye syndrome were randomly divided into 2 groups. Group 1 patients were treated with preservative-free sodium hyaluronate 0.1% and preservative-free fluorometholone 0.1% eyedrops 4 times a day in the first month and twice a day in the second month. Group 2 patients were treated with preserved eyedrops using the same schedule. Ocular Surface Disease Index (OSDI) score, tear-film breakup time (TBUT), Schirmer I test, corneal fluorescein staining, impression cytology, and antioxidant and inflammatory cytokine activities in tears were evaluated. RESULTS Both groups comprised 40 patients. At 2 months, the OSDI score, TBUT, Schirmer I score, fluorescein staining score, impression cytology findings, and goblet cell count were significantly better in Group 1 than in Group 2 (P<.05). The interleukin-1β and tumor necrosis factor-α concentrations were significantly less in the tears of Group 1 patients than in the tears of Group 2 patients, and catalase and superoxide dismutase 2 fluorescence intensities were significantly greater in the tears of Group 1 patients than in the tears of Group 2 patients (P<.05). CONCLUSIONS Preservative-free sodium hyaluronate 0.1% and fluorometholone 0.1% eyedrops can improve the symptoms and signs of dry-eye syndrome after cataract surgery. Preservative-free fluorometholone eyedrops may have antiinflammatory and antioxidant effects in tears of patients with dry-eye syndrome. FINANCIAL DISCLOSURE No author has a financial or proprietary interest in any material or method mentioned.
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MDCT urography for detecting recurrence after transurethral resection of bladder cancer: comparison of nephrographic phase with pyelographic phase.
Kim, JY, Kim, SH, Lee, HJ, Kim, MJ, Kim, YH, Cho, SH
AJR. American journal of roentgenology. 2014;(5):1021-7
Abstract
OBJECTIVE The purpose of this study was to prospectively compare nephrographic phase MDCT urography performed with oral hydration and a diuretic with standard pyelographic phase MDCT in the detection of recurrence after transurethral resection. SUBJECTS AND METHODS The study included 140 MDCT urographic examinations of 121 patients (87 men, 34 women; age range, 46-88 years) at risk of urinary tract cancer recurrence. Acquisition was performed 60 seconds (nephrographic phase) and 420 seconds (pyelographic phase) after contrast injection. Two radiologists independently recorded the presence of recurrent lesions in each phase. The reference standard was histologic findings and prospective clinical decision. Distention and opacification were compared for each radiologist in each segment in each phase by kappa statistic and Spearman rank coefficient. Generalized estimating equations for logistic regression analysis were used to compare performance for each radiologist and phase and were adjusted for possibility within patient correlation. RESULTS Urinary tract distention was rated significantly better at the pyelographic phase for all segments (p < 0.001). The degree of opacification provided by each radiologist for the same segment showed high correlation. There were 59 bladder recurrences in 38 patients and 19 upper tract recurrences in 13 patients. For recurrence detection in the bladder, the overall accuracy was significantly higher for the nephrographic phase than the pyelo-graphic phase (91.7% [354/386] vs 83.2% [321/386], p = 0.038). For recurrence detection in the upper tract, the overall accuracy was significantly higher in the nephrographic phase than in the pyelographic phase (86.7% [260/300] vs 80% [240/300], p = 0.028). CONCLUSION Use of nephrographic phase MDCT urography is associated with a higher rate of detection of urinary tract recurrence than is pyelographic phase MDCT, which suggests the value of this technique for evaluating the urinary tract after transurethral resection.
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Laparoscopy-assisted pylorus-preserving gastrectomy is better than laparoscopy-assisted distal gastrectomy for middle-third early gastric cancer.
Suh, YS, Han, DS, Kong, SH, Kwon, S, Shin, CI, Kim, WH, Kim, HH, Lee, HJ, Yang, HK
Annals of surgery. 2014;(3):485-93
Abstract
OBJECTIVE The purpose of this study is to compare the surgical, oncologic safety and the nutritional, functional benefit of laparoscopy-assisted pylorus-preserving gastrectomy (LAPPG) with laparoscopy-assisted distal gastrectomy (LADG) for middle-third early gastric cancers (EGC). BACKGROUND Of those patients with middle-third EGC, it is still difficult to determine which procedure is better between LADG and LAPPG despite alleged advantages of LAPPG. METHODS For middle-third EGC, a retrospective analysis was performed comparing those who underwent LADG and those who underwent LAPPG. To evaluate surgical and oncologic safety, clinicopathologic differences including the postoperative morbidity, the pattern of lymph node metastasis and recurrence were analyzed. Postoperative protein, albumin, quantification of abdominal fat area using abdomen computed tomography, and the incidence of postoperative gallstone were compared for the evaluation of functional advantages. RESULTS The overall postoperative morbidity rate was similar between LADG (n = 176) and LAPPG (n = 116). Delayed gastric emptying was less frequent in LADG than in LAPPG (1.7% vs 7.8%); however, the rates of all the other complications were significantly higher in LADG than in LAPPG (17.0% vs 7.8%). The number of examined lymph nodes and metastatic lymph nodes at each lymph node station was not significantly different and 3-year recurrence-free survival rates were also similar between LADG and LAPPG (98.8% vs 98.2%). Decreases in serum protein and albumin in postoperative 1 to 6 months and abdominal fat area in postoperative 1 year were significantly greater in LADG than in LAPPG. The 3-year cumulative incidence of gallstone was significantly higher in LADG than in LAPPG (6.5% vs 0.0%). CONCLUSIONS For middle-third EGC, LAPPG can be considered as a better treatment option than LADG in terms of nutritional advantage and lower incidence of gallstone.
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Which method is more effective in treatment of calcific tendinitis in the shoulder? Prospective randomized comparison between ultrasound-guided needling and extracorporeal shock wave therapy.
Kim, YS, Lee, HJ, Kim, YV, Kong, CG
Journal of shoulder and elbow surgery. 2014;(11):1640-6
Abstract
HYPOTHESIS Ultrasound (US)-guided needling with subacromial corticosteroid injection is more effective than extracorporeal shock wave therapy (ESWT) for function restoration and pain relief in patients with calcific tendinitis of the shoulder. METHODS Fifty-four patients diagnosed with unilateral painful calcific tendinitis were randomly allocated to a US needling or ESWT group. The US needling group underwent US-guided needling and received a subacromial corticosteroid injection. The ESWT group received ESWT 3 times a week. All patients were prospectively evaluated; American Shoulder and Elbow Surgeons, Simple Shoulder Test, and visual analog scale for pain scores were recorded before the procedure and at 6 weeks, 12 weeks, 6 months, 12 months, and the last follow-up. The size and morphology of the deposits were evaluated by radiography. RESULTS The average follow-up period was 23.0 months. At last follow-up, the mean size of the deposits was significantly different between the 2 groups (P = .001); it decreased to 0.5 mm from 14.8 mm in the US needling group and to 5.6 mm from 11.0 mm in the ESWT group. There were also significant improvements in clinical outcomes in both groups after treatment (P < .05). At 1-year follow-up, the US needling group had significantly better scores than the ESWT group with regard to the American Shoulder and Elbow Surgeons assessment (90.3 and 74.6, respectively; P = .001), Simple Shoulder Test (83.3 and 70.8, respectively; P = .015), and visual analog scale for pain (1.4 and 3.3, respectively; P = .003).The initial calcium deposit sizes and clinical outcomes were weakly correlated in both groups (P > .05). CONCLUSION Both treatment modalities for calcific tendinitis improved clinical outcomes and eliminated calcium deposits. US-guided needling treatment, however, was more effective in function restoration and pain relief in the short term.
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Pharmacokinetics of a new once-daily controlled-release formulation of aceclofenac in Korean healthy subjects compared with immediate-release aceclofenac and the effect of food: a randomized, open-label, three-period, crossover, single-centre study.
Bae, SK, Kim, SH, Lee, HW, Seong, SJ, Shin, SY, Lee, SH, Lim, MS, Yoon, YR, Lee, HJ
Clinical drug investigation. 2012;(2):111-9
Abstract
BACKGROUND A new controlled-release formulation of aceclofenac 200 mg (Clanza CR®) developed by Korea United Pharm., Inc., South Korea, for once-daily (od) dosing provides biphasic aceclofenac release consisting of immediate release of 85 mg followed by sustained release of 115 mg. Food has been known to affect the rate and extent of absorption of several drugs, in both immediate-release and controlled-release formulations. OBJECTIVE The aim of this study was to evaluate the relative bioavailability of a new controlled-release formulation of aceclofenac (200 mg od; Clanza CR®) in comparison with immediate-release aceclofenac (100 mg twice daily [bid], Airtal®) and to assess the effect of food on the pharmacokinetics of the new controlled-release aceclofenac formulation. METHODS This study was designed as a randomized, open-label, three treatment-period, crossover, single-centre study with a 1-week washout in 41 healthy adults. The three treatments consisted of immediate-release aceclofenac 100 mg bid administered under fasting conditions; controlled-release aceclofenac 200 mg od administered under fasting conditions; and controlled-release aceclofenac 200 mg od administered immediately after a standardized high-fat breakfast. Plasma concentrations of aceclofenac were determined using a high-performance liquid chromatography method. RESULTS In the fasted state, the 90% confidence intervals (CIs) of the least squares geometric mean ratios (GMRs) for the area under the plasma concentration-time curve from time zero to 24 hours (AUC(24)) and the peak plasma concentration (C(max)) of aceclofenac for the controlled-release and immediate-release formulations of aceclofenac were all within the bioequivalence criteria range of 0.8-1.25. The 90% CIs of the GMRs for the AUC(24) and C(max) of aceclofenac for the controlled-release formulation of aceclofenac in the fed and fasted states were also within the bioequivalence range. Both aceclofenac formulations were well tolerated in all subjects, and no serious adverse effects were observed. CONCLUSION The results demonstrate that controlled-release aceclofenac 200 mg is equivalent to immediate-release aceclofenac 100 mg when administered at the same total daily dose. Additionally, the bioavailability of controlled-release aceclofenac was not affected by high-fat foods.
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Coenzyme Q10 in combination with steroid therapy for treatment of sudden sensorineural hearing loss: a controlled prospective study.
Ahn, JH, Yoo, MH, Lee, HJ, Chung, JW, Yoon, TH
Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery. 2010;(6):486-9
Abstract
OBJECTIVE To evaluate the therapeutic efficacy of coenzyme Q10 added to systemic steroid in patients with idiopathic sudden sensorineural hearing loss. DESIGN A controlled prospective study. SETTING Asan medical center, University of Ulsan College of Medicine. PARTICIPANTS Between August 2007 and October 2008, the first 60 patients diagnosed with sudden sensorineural hearing loss were managed with systemic steroid treatment for 2 weeks including 5-day hospitalisation. And the second 60 patients were managed with coenzyme Q10 for 2 weeks added to previous management. MAIN OUTCOME MEASURES We evaluated auditory function by pure tone audiometry and speech discrimination score. Auditory evaluations were performed before and 3 months after treatment using Siegel's criteria. The degree of improvement in four-tone average hearing and speech discrimination score was calculated from the results before and after treatment. RESULTS The total hearing improvement rate after the treatment was 75.0% (90/120 patients) in this study. Although 47 patients (78.3%) of coenzyme Q10 group showed better hearing improvement than 43 patients (71.7%) of control group, there was no significant difference. However, the coenzyme Q10 group showed significantly higher improvement in speech discrimination score. CONCLUSION From this study, we suggest that coenzyme Q10 may have beneficial effects in the treatment of sudden sensorineural hearing loss.
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Rocuronium-induced withdrawal movements associated with different Rocuronium injection method.
Baek, SH, Woo, CM, Lee, HJ, Yoon, JY, Kwon, JY, Shin, SW
Paediatric anaesthesia. 2008;(6):515-9
Abstract
OBJECTIVES One hundred and twenty patients (3-15 years old) were randomly enrolled (four groups: each group = 30 patients) in the study. AIM: The aim of this study was to compare the incidence and intensity of rocuronium-induced withdrawal movements in children injected with a typical intravenous bolus injection of rocuronium or with an infusion injection of rocuronium. BACKGROUND Intravenous bolus injection of rocuronium produces pain and withdrawal movement. METHODS Immediately after loss of consciousness by thiopental sodium (5 mg x kg(-1)), 0.6 mg x kg(-1) (B0.6, I0.6) or 0.9 mg x kg(-1) rocuronium (B0.9, I0.9) was injected by different method, either a bolus injection over 5 s (B0.6, B0.9) or an infusion injection lasting for 1 min (I0.6, I0.9). The withdrawal movement of the patients to the injection of rocuronium was assessed (four-grade score: 0-3). Intubating condition was assessed. Rocuronium-induced muscle relaxation time was measured by single twitch stimulation fade out. RESULTS The incidence (group B: 100%, group I: 33.3%) and the intensity of the withdrawal movements were significantly lower in the infusion groups compared with the bolus groups (P < 0.05). The intubating conditions for all groups were clinically acceptable (good to excellent). There was no significant difference in the muscle relaxation time between the different injection groups (I0.6; 105.6 +/- 7.7 vs B0.6; 114.6 +/- 8.0, I0.9; 69.2 +/- 3.6 vs B0.9; 73.4 +/- 1/0). CONCLUSIONS The infusion injection of rocuronium for tracheal intubation significantly reduced the incidence and intensity of withdrawal movement on injection of rocuronium, and it neither delays the onset of muscle relaxation nor deteriorates the intubating condition.