A bioequivalence study of the $Kerola^{\circledR}$ intramuscular injections (Dongkwang Pharmaceutical Co., Korea) to the $Tarasyn^{\circledR}$ intramuscular injections (Roche Co., Korea), formulations of ketorolac tromethamine (KTR), was conducted. Sixteen healthy Korean male subjects were received each formulation at the dose of 30 mg as KTR in a $2{\times}2$ crossover study. There was an one-week washout period between the doses. Plasma concentrations of KTR were monitored by a HPLC method. AUC was calculated by the linear trapezoidal method. $C_{max}$ and $T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The differences between the formulations in these parameters were all far less than 20% (i.e., 3.65, 2.59 and 4.35% for AUC, $C_{max}$ and $T_{max}$ respectively). Minimum detectable differences (%) at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were 12.87, 13.44, 20.62%, for AUC, $C_{max}$ and $T_{max}$, respectively. The 90% confidence intervals for these parameters were also within 20%. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the two formulations of KTR are bioequivalent.
A series of experiments were designed to determine the feasibility of single dose of FSH as an effective superovulation method in rabbits. The superovulation treatments examined comparatively were as follows: 1) a single injection of 100 IU PMSG, 2) Multiple injections of 1 IU Super-OV of 2X daily for 3 days, 3) Multiple injections of 6.6 rng Folltropin-V 2X daily for 3 days, 4) Multiple injections of 13.3 rng Folltropn-V l$\times$ daily for 3 days, 5) Single injection of 40 mg Folltropin-V solved in 10% PVP, and 6) Single injection of 40 mg Folltropin-V dissolved in 25% PVP. The results obtained were as follows: The nurnher of ovulation points in the single injection of 40 mg Folltropin-V dissolved in 25% PVP and multiple injections of 6.6 mg Folltropin-V 2X daily for 3 days was averaged 44.6 and 39.2, respectively, which were significantly (P<0.05) more than in a single dose of PMSG or multiple doses of Super-OV. The number of total ova recovered in the single injection of 40 mg Folltropin-V dissolved in 25% PVP and multiple injections of 6.6 mg Folltropin-V 2X daily for 3 days was averaged 30.4 and 25.9, respectively, which were significantly (P<0.05) more than in the single dose of PMSG or multiple doses of Super-OV. A similar result was obtained for the number of fertilized ova recovered from the above six treatments. From the above results it was concluded that a single injection of 40 mg Folltropin-V dissolved in 25% PVP could be an effective and simple method for superovulation in rabbits.
Manchikanti, Laxmaiah;Singh, Vijay;Pampati, Vidyasagar;Falco, Frank J.E.;Hirsch, Joshua A.
The Korean Journal of Pain
/
v.28
no.1
/
pp.11-21
/
2015
Background: Epidural injections are performed utilizing 3 approaches in the lumbar spine: caudal, interlaminar, and transforaminal. The literature on the efficacy of epidural injections has been sporadic. There are few high-quality randomized trials performed under fluoroscopy in managing disc herniation that have a long-term follow-up and appropriate outcome parameters. There is also a lack of literature comparing the efficacy of these 3 approaches. Methods: This manuscript analyzes data from 3 randomized controlled trials that assessed a total of 360 patients with lumbar disc herniation. There were 120 patients per trial either receiving local anesthetic alone (60 patients) or local anesthetic with steroids (60 patients). Results: Analysis showed similar efficacy for caudal, interlaminar, and transforaminal approaches in managing chronic pain and disability from disc herniation. The analysis of caudal epidural injections showed the potential superiority of steroids compared with local anesthetic alone a 2-year follow-up, based on the average relief per procedure. In the interlaminar group, results were somewhat superior for pain relief in the steroid group at 6 months and functional status at 12 months. Interlaminar epidurals provided improvement in a significantly higher proportion of patients. The proportion of patients nonresponsive to initial injections was also lower in the group for local anesthetic with steroid in the interlaminar trial. Conclusions: The results of this assessment show significant improvement in patients suffering from chronic lumbar disc herniation with 3 lumbar epidural approaches with local anesthetic alone, or using steroids with long-term follow-up of up to 2 years, in a contemporary interventional pain management setting.
Kim, Sang-Yun;Kim, Young-Kyun;Yun, Pil-Young;Bae, Ji-Hyun
Maxillofacial Plastic and Reconstructive Surgery
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v.40
/
pp.21.1-21.5
/
2018
Background: The purpose of this study was to evaluate the clinical outcomes of treatment of non-odontogenic atypical orofacial pain using botulinum toxin-A. Methods: This study involved seven patients (seven females, mean age 65.1 years) who had non-odontogenic orofacial pain (neuropathic pain and atypical orofacial pain) and visited the Seoul National University Bundang Hospital between 2015 and 2017. All medication therapies were preceded by botulinum toxin-A injections, followed by injections in the insignificant effects of medication therapies. Five of the seven patients received intraoral injections in the gingival vestibule or mucosa, while the remaining two received extraoral injections in the masseter and temporal muscle areas. Results: In five of the seven patients, pain after botulinum toxin-A injection was significantly reduced. Most of the patients who underwent surgery for dental implantation or facial nerve reconstruction recovered after injections. However, the pain did not disappear in two patients who reported experiencing persistent pain without any cause. Conclusions: The use of botulinum toxin-A for the treatment of non-odontogenic neuropathic orofacial pain is clinically useful. It is more effective to administer botulinum toxin-A in combination with other medications and physical therapy to improve pain.
Journal of the Korea Institute of Information Security & Cryptology
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v.27
no.5
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pp.1049-1058
/
2017
The rapid evolution of mobile technologies and proliferation of mobile devices have created a new channel for marketing by mobile advertising. As mobile advertising is a close relative to online advertising, it also has similar problems such as advertisement injections (Ad injections). Users are exposed to unwanted advertisements and redundant web traffic by injected ads can cause additional charges of mobile devices. Although mobile ad injection can cause many problems it has been merely studied. In this paper, we analyze ad injection activities by mobile applications that exploit a legitimate application (Naver mobile application). We reverse-engineered 2 mobile applications and find out characteristics of mobile ad injections. We compare mobile ad injections with online ad injections and suggest feasible mitigations.
Purpose: A botulinum toxin type A (BoNT - A) injection has been used as a noninvasive management for lower face contouring since 2000. The aim of this study was to compare reduction rate of lower face width for a longtime according to repeated Botox$^{(R)}$ injections on masseter muscles for lower face contouring procedure. Methods: Forty - five patients were analyzed for single session of Botox$^{(R)}$ injection and 13 patients were evaluated for repeated Botox$^{(R)}$ injections for over two years. Single injection group was tracked regular intervals at 1, 3, 6, 10, 12 months after injection, and repeated injection group was measured at every injection time. Twenty - five to thirty units of Botox$^{(R)}$ was injected into each masseteric muscle at five to six points at the prominent portions of the mandibular angle. Standardized frontal view of digital photographs were analyzed by Adobe Photoshop$^{(R)}$ (version CS3) to measure an reduction rate of lower face width. Results: Reduction rate was 3.7%, 6.9%, 6.2%, 4%, 4% at 1, 3, 6, 10, 12 months post injection each other in single injection group. However, more than 8% reduction rate was found in repeated injection group persistently for more than two years. Conclusion: This study shows that effective duration of Botox$^{(R)}$ injection for lower face contouring is expected to continue over one year clinically. Moreover, repeated injections maintained lower reduction rate consistently for a long time. Therefore, repeated injections on masseter muscles at regular intervals are most effective procedure for lower face contouring.
Purpose: Outbreaks resulting from medication injections have recently been on the rise in Korea despite various established guidelines. The objective of this study was to assess the degree to which healthcare professionals are aware of safe injection practice guidelines and to account for the adherence to and the deviation from safe injection guidelines formulated by healthcare providers. Methods: In November 2016, a cross-sectional anonymous questionnaire covering general characteristics of injections, patient safety culture, awareness of safe injection practices, and adherence to and barriers to safe injection guidelines was issued to healthcare providers who administer medication injections or manage and supervise these injections (N=550). Multivariate logistic regression analysis via enter method was performed to define the influencing factors of adherence of safe injection practices. Results: On average, respondents adhere to 17 of the 24 guidelines. Multivariate logistic regression found that those who were more likely to adhere to safe injection guidelines either underwent a patient safety training experience within the last year, provided care in a setting characterized by a highly developed patient safety culture, or were employed as physicians or nurses, as opposed to some other type of care provider. Barriers to safe injection guidelines were attributable to; thoughts of waste to discard leftover medicine, provisions that made adherence cumbersome, a weak culture of compliance, and insufficient amounts of injectable medicine, products, and education. Conclusions: The results of this study indicate that controllable factors like training experience of healthcare providers and patient safety culture were positively associated with adherence to safe injection practices. It was suggested that the training of healthcare providers on safe injection practices be a continuous process to promote patient safety. Additionally, there should be an increased focus on developing and implementing policies to improve patient safety culture from a prevention rather than post-management perspective.
Journal of Physiology & Pathology in Korean Medicine
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v.35
no.6
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pp.219-227
/
2021
The purpose of this study is to analyze the side effects (ADR) of Traditional Chinese Medicine (TCM) injections by age, injection type, symptoms, and causes, and to find preventive solutions for ADR. For the ADR of TCM injection data collected during the search period from January 1, 2010 to December 31, 2020, the correlation between each section was analyzed by subdividing it into age, injection type, symptoms and causes. CNKI, PubMed, and EMBASE were used to collect the clinical data. 'Chinese herbal injection', 'Traditional Chinese Medicine injection', 'Chinese herbal injection side effect', 'Chinese herbal injection adverse drug reaction' were used for the keyword from the database. All data were collected mainly for TCM injection and the causes of ADR due to TCM injection. However, data not related to the relevant study or TCM injection were excluded from this study. Among a total of 941 studies collected during the search period from January 1, 2010 to December 31, 2020, a total of 10 studies were selected for final analysis. In 1462 clinical data sets, ADR by gender was higher in males than females. By age, 41 to 60 years were the most common. The incidence of ADR by injection type was highest in the blood regulating injection type. Data analysis showed Xueshuantong injection had the highest ADR. Among the symptoms of ADR, skin diseases were the most common. The most common cause of ADR was the unreasonable use of drugs. In China, for ADR management, the use of TCM injections is recommended according to the basic principles for the clinical use of TCM injections established by the Chinese government. In this study, we analyzed the current status and causes of ADR in TCM injections, and found a preventive solution. It is expected that it can be used as basic data to increase the usability of pharmacopuncture and herbal medicines in Korea in the future.
Dhruv S. Shankar;Edward S. Mojica;Christopher A. Colasanti;Anna M. Blaeser;Paola F. Ortega;Guillem Gonzalez-Lomas;Laith M. Jazrawi
Clinics in Shoulder and Elbow
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v.26
no.1
/
pp.32-40
/
2023
Background: The purpose of this study was to identify predictors of the time from initial presentation to total shoulder arthroplasty (TSA) in patients with primary glenohumeral osteoarthritis (OA) and rotator cuff (RTC) arthropathy who were conservatively managed with corticosteroid injections. Methods: We conducted a retrospective cohort study of patients who underwent TSA from 2010 to 2021. Kaplan-Meier survival analysis was used to estimate median time to TSA for primary OA and RTC arthropathy patients. The Cox proportional hazards model was used to identify significant predictors of time to TSA and to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Statistical significance was set at P<0.05. Results: The cohort included 160 patients with primary OA and 92 with RTC arthropathy. In the primary OA group, median time to TSA was 15 months. Significant predictors of shorter time to TSA were older age at presentation (HR, 1.02; 95% CI, 1.00-1.04; P=0.03) and presence of moderate or severe acromioclavicular joint arthritis (HR, 1.45; 95% CI, 1.05-2.01; P=0.03). In the RTC arthropathy group, median time to TSA was 14 months, and increased number of corticosteroid injections was associated with longer time to TSA (HR, 0.87; 95% CI, 0.80-0.95; P=0.003). Conclusions: There are distinct prognostic factors for progression to TSA between primary OA patients and RTC arthropathy patients managed with corticosteroid injections. Multiple corticosteroid injections are associated with delayed time to TSA in RTC arthropathy patients.
The control of the fuel to be introduced into the combustion chamber under idling and low-load conditions is known to be a problem in Diesel engines, owing to the relatively small fraction of the full-load fuel needed under light loads. Thus, particular attention should be paid to the behavior of the injector with reference to short injection events. This work presents the results of an experimental campaign carried out with two different types of common rail injectors, a standard injector and a modified one. The latter, coming from a simple modification realized in a standard injector, exhibits linear behavior between injected fuel and solenoid energizing time in the field of short injections. A direct comparison of the two injection behaviors suggests a possible way to better control short or pilot injections.
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