scholarly journals An open-label prospective clinical study of the efficacy and tolerability of brand-name and generic levetiracetam in the monotherapy of focal epilepsy in adults

2018 ◽  
Vol 10 (1S) ◽  
pp. 12-17 ◽  
Author(s):  
V. A. Karlov ◽  
P. N. Vlasov ◽  
I. A. Zhidkova
Keyword(s):  
Clinical Efficacy ◽  
Focal Epilepsy ◽  
Clinical Results ◽  
Prospective Clinical Study ◽  
Brand Name ◽  
Open Label ◽  
International Nonproprietary Name ◽  
Group 2 ◽  
One Year

Objective: to comparatively evaluate the clinical efficacy and tolerability of monotherapy with levetiracetam (LEV), a brand-name drug (bLEV; Keppra, UCB Pharma, Belgium) and its generic (gLEV;  Epiterra, TEVA, Israel) in adolescent (over 16 years of age) and adult patients with focal epilepsy (FE) during a one-year follow-up period.Patients and methods. The patients were divided into two groups: 1) bLEV (n = 143) and 2) gLEV (n = 63). Group 2 received monotherapy with gLEV at baseline, or was switched to it from  another drug within the international nonproprietary name, or to LEV from monotherapy with another antiepileptic drug (AED) due to  inefficiency and/or poor tolerability. The median doses of bLEV and  gLEV were 1000 and 1500 mg/day, respectively.Results and discussion. The results of the clinical trial suggest that LEV shows high efficacy and excellent tolerance in FE therapy. The clinical efficacy of bLEV and gLEV at 12-month follow-up was  high and amounted to 82.5% for the two dosage forms. The  frequency of adverse events was 17.5% for both bLEV and gLEV. The median dose of LEV was 1000 mg/day for Group 1 and 1500 mg/day for Group 2. Higher LEV doses in Group 2 patients were probably  due to their longer disease duration. All patients taking LEV had an  excellent or good quality of life and, when switched from other AEDs,  showed even an improvement. The comparability of clinical  results suggests that there may be bLEV to gLEV and gLEV to bLEV  switches, especially during forced drug supply disruptions; however,  this substitution should be done only after mandatorily discussing  this matter with the patient and telling him about all possible  consequences of this substitution. 

scholarly journals Pulsed Radiofrequency for Chronic Inguinal Neuralgia

2015 ◽  
Vol 2;18 (2;3) ◽  
pp. E147-E155
Author(s):  
Yasser M. Amr
Keyword(s):  
Pain Relief ◽  
Nerve Root ◽  
Small Sample ◽  
Pulsed Radiofrequency ◽  
Group 2 ◽  
One Year ◽  
The One ◽  
Inguinal Neuralgia ◽  
Group 1

Background: Chronic inguinal neuralgia has been reported after inguinal herniorrhaphy, caesarean section, appendectomy, and trauma to the lower quadrant of the abdomen or inguinal region. Objectives: This study was designed to evaluate the efficacy of pulsed radiofrequency in management of chronic inguinal neuralgia. Study Design: Randomized, double-blind controlled trial. Setting: Hospital outpatient setting. Methods: Twenty-one patients were allocated into 2 groups. Group 1 received 2 cycles of pulsed radiofrequency (PRF) for each nerve root. In Group 2, after stimulation, we spent the same time to mimic PRF. Both groups received bupivacaine 0.25% + 4 mg dexamethasone in 2 mL for each nerve root. Visual Analogue Scale (VAS) was assessed. Duration of the first block effective pain relief was reported. Repeated PRF blockade was allowed for any patient who reported a VAS > 30 mm in both groups during the one year follow-up period. The number and duration of blocks were reported and adverse effects were also reported. Results: Significantly longer duration of pain relief was noticed in Group 1 (P = 0.005) after the first block, while the durations of pain relief of the second block were comparable (P = 0.59). In Group 1 the second PRF produced pain relief from the twenty-fourth week until the tenth month while in Group 2, pain relief was reported from the sixteenth week until the eighth month after the use of PRF. All patients in Group 2 received 3 blocks (the first was a sham PRF) during the one year follow-up period. Meanwhile, 2 PRF blocks were sufficient to achieve pain relief for patients in Group 1 except 4 patients who needed a third PRF block. No adverse events were reported. Limitations: Small sample size. Conclusion: For intractable chronic inguinal pain, PRF for the dorsal root ganglion represents a promising treatment modality. Key words: Radiofrequency, chronic, inguinal neuralgia

scholarly journals Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence

2018 ◽  
Vol 32 (6) ◽  
pp. 691-701 ◽  
Author(s):  
Tianmei Si ◽  
Nan Li ◽  
Huafei Lu ◽  
Shangli Cai ◽  
Jianmin Zhuo ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Hazard Ratio ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
First Relapse ◽  
Continued Use ◽  
One Year ◽  
Long Acting ◽  
Post Hoc

Background: Limited data are available to help identify patients with schizophrenia who are most likely to benefit from long-acting injectable antipsychotics. Aim: To investigate the efficacy of long-acting injectable antipsychotic paliperidone palmitate one-month formulation for preventing relapses, factors influencing time to first relapse, and the effect of different antipsychotic adherence levels on time to first relapse in Chinese patients with schizophrenia. Methods: This was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75–150 mg eq.) or switching to another antipsychotic(s). Results: There were 362/367 patients (age=31.4±10.75 years) included in the analysis of time to first relapse (primary outcome) and 327/362 patients (39/327, poor antipsychotic adherence (<80%)) willing to receive antipsychotics were included in the exposure/adherence analysis. Overall, 84.6% (95% confidence interval=79.2–88.7) patients remained relapse-free. Poor adherence during follow-up (hazard ratio=2.97, 95% confidence interval=1.48–5.98, p=0.002) and frequent hospitalizations in the previous year (hazard ratio=1.29, 95% confidence interval=1.02–1.62, p=0.03) were associated with a significant risk of shorter time to first relapse in the univariate analysis. In patients with poor adherence, ‘no use’ (hazard ratio=13.13, 95% confidence interval=1.33–129.96, p=0.03) and ‘interrupted use’ (hazard ratio=11.04, 95% confidence interval=1.03–118.60, p=0.047) of paliperidone palmitate one-month formulation (vs continued use) showed a significantly higher risk of relapse; this was not observed in patients with good (≥80%) antipsychotic adherence. No new safety concerns were identified. Conclusion: Continued use of paliperidone palmitate one-month formulation/long-acting injectable antipsychotic was effective in preventing schizophrenia relapses, especially in patients with suboptimal antipsychotic adherence.

scholarly journals Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial

2020 ◽  
Vol 9 (9) ◽  
pp. 3023
Author(s):  
Youngjae Park ◽  
Yoon Jae Lee ◽  
Jung Hee Koh ◽  
Jennifer Lee ◽  
Hong-Ki Min ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Clinical Efficacy ◽  
Stromal Vascular Fraction ◽  
Skin Fibrosis ◽  
Therapeutic Modality ◽  
Efficacy And Safety ◽  
Open Label ◽  
Adipose Tissues ◽  
Hand Disability

Background: Stromal vascular fraction (SVF) has recently emerged as a potential therapeutic modality, due to its multipotent cellular components in tissue regeneration. Systemic sclerosis (SSc) is a progressive autoimmune disease that results in hand disability by skin fibrosis and microangiopathies. We performed an open-label study to investigate the efficacy and safety of SVF injection in SSc patients (Clinical Trial number: NCT03060551). Methods: We gathered 20 SSc patients with hand disability, planning for a 24-week follow-up period. SVF was extracted from autologous adipose tissues, processed by the closed system kit, and injected into each finger of SSc patients. We observed various efficacy and safety profiles at each follow-up visit. Results: Among the 20 initially enrolled patients, eighteen received SVF injection, and were completely followed-up for the whole study period. Patients received 3.61 × 106 mesenchymal stem cells into each finger on average. Skin fibrosis, hand edema, and quality of life were significantly improved, and 31.6% of active ulcers were healed at 24 weeks after injections. Semiquantitative results of nailfold capillary microscopy were ameliorated. There was no single serious adverse event related to the procedure. Conclusions: Injection of SVF derived from autologous adipose tissues is tolerable, and shows clinical efficacy in SSc patients.

scholarly journals Arthroscopic Management for the Unstable Inferior Leaf of the Lateral Meniscus Anterior Horn and Associated Cysts through a Direct Inframeniscal Portal: A Retrospective Study

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Dongyang Chen ◽  
Qiangqiang Li ◽  
Ye Sun ◽  
Jianghui Qin ◽  
Yao Yao ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Full Range ◽  
Lateral Meniscus ◽  
Clinical Results ◽  
Anterior Horn ◽  
Arthroscopic Management ◽  
The Mean ◽  
Magnetic Resonance Scanning ◽  
One Year

Introduction. To investigate the clinical results of arthroscopic management for the unstable inferior leaf of the lateral meniscus anterior horn and associated cysts through an inframeniscal portal. Methods. From March 2005 to October 2014, 64 patients with an unstable inferior leaf of the lateral meniscus anterior horn and associated cysts underwent arthroscopic management with an inframeniscal portal. The mean age of the patients was 36.9 years (range, 18 to 49 years). The mean follow-up period was 28 months (range, 24 to 44 months). Clinical results were assessed using physical examination, the Lysholm knee score, and postoperative magnetic resonance scanning. Results. The median Lysholm score improved significantly at 1 year after surgery and at final follow-up. Magnetic resonance scanning at least one year after the operation revealed no recurrent meniscal tears or cysts. No reoperations were required after an average follow-up of 28 months. All patients reported significant symptomatic relief after the operation. They had full range of motion at three months and returned to normal activities and sports one year after surgery. Conclusion. The direct inframeniscal portal can provide an effective approach to manage lesions in the anterior horn of the lateral meniscus with predictable clinical outcomes.

scholarly journals Minimum Two-Year Follow-Up of Cases with Recurrent Disc Herniation Treated with Microdiscectomy and Posterior Dynamic Transpedicular Stabilisation

2010 ◽  
Vol 4 (1) ◽  
pp. 120-125 ◽  
Author(s):  
Tuncay Kaner ◽  
Mehdi Sasani ◽  
Tunc Oktenoglu ◽  
Ahmet Levent Aydin ◽  
Ali Fahir Ozer
Keyword(s):  
Disc Herniation ◽  
Clinical Results ◽  
Prospective Clinical Study ◽  
Low Back ◽  
Failed Back Syndrome ◽  
Recurrent Disc Herniation ◽  
Rod System ◽  
Disc Herniations ◽  
Vas Scores

The objective of this article is to evaluate two-year clinical and radiological follow-up results for patients who were treated with microdiscectomy and posterior dynamic transpedicular stabilisation (PDTS) due to recurrent disc herniation. This article is a prospective clinical study. We conducted microdiscectomy and PDTS (using a cosmic dynamic screw-rod system) in 40 cases (23 males, 17 females) with a diagnosis of recurrent disc herniation. Mean age of included patients was 48.92 ± 12.18 years (range: 21-73 years). Patients were clinically and radiologically evaluated for follow-up for at least two years. Patients’ postoperative clinical results and radiological outcomes were evaluated during the 3rd, 12th, and 24th months after surgery. Forty patients who underwent microdiscectomy and PDTS were followed for a mean of 41 months (range: 24-63 months). Both the Oswestry and VAS scores showed significant improvements two years postoperatively in comparison to preoperative scores (p<0.01). There were no significant differences between any of the three measured radiological parameters (α, LL, IVS) after two years of follow-up (p > 0.05). New recurrent disc herniations were not observed during follow-up in any of the patients. We observed complications in two patients. Performing microdiscectomy and PDTS after recurrent disc herniation can decrease the risk of postoperative segmental instability. This approach reduces the frequency of failed back syndrome with low back pain and sciatica.

Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study

2009 ◽  
Vol 92 (3) ◽  
pp. S107 ◽  
Author(s):  
C. Seitz ◽  
C. Gerlinger ◽  
T. Faustmann ◽  
T. Strowitzki
Keyword(s):  
Term Treatment ◽  
Open Label ◽  
Follow Up Study ◽  
Long Term Treatment ◽  
One Year

Operative Treatment of Syndesmotic Disruptions Without Use of a Syndesmotic Screw: A Prospective Clinical Study

1994 ◽  
Vol 15 (8) ◽  
pp. 407-414 ◽  
Author(s):  
Ken Yamaguchi ◽  
Christopher H. Martin ◽  
Scott D. Boden ◽  
Panos A. Labropoulos
Keyword(s):  
External Rotation ◽  
Clinical Results ◽  
Cadaveric Study ◽  
Deltoid Ligament ◽  
Prospective Clinical Study ◽  
Fibular Fracture ◽  
Static View ◽  
Pronation External Rotation ◽  
Rotation Stress

A new protocol for the selected omission of transsyndesmotic fixation in Weber class C ankle fractures was prospectively evaluated in 21 consecutive patients. As proposed in a previous cadaveric study ( J. Bone Joint Surg., 71A:1548–1555, 1989), the protocol suggested that transsyndesmotic fixation was not required if (1) rigid bimalleolar fracture fixation was achieved or (2) lateral without medial fixation was obtained (i.e., with accompanying deltoid tears) if the fibular fracture was within 4.5 cm of the joint. According to this protocol, only 3 of 21 patients (14%) required transsyndesmotic fixation. Ten of the patients who did not receive transsyndesmotic fixation underwent pronation-external rotation stress radiographs in a fashion analogous to the previous cadaveric study. At 1- to 3-year follow-up, no stress (N = 10) or static view (N = 18) widening of the mortise or syndesmosis was seen in any patient, which supports (with the above guidelines) a limited, rather than routine, use of supplemental transsyndesmotic fixation. Clinical results from this prospective study seem to substantiate previously proposed biomechanical guidelines for the selected omission of transsyndesmotic fixation. Given these guidelines, transsyndesmotic fixation was unnecessary in many cases and the need can be determined before surgery by assessing the integrity of the deltoid ligament and level of the fibular fracture.

scholarly journals Clinical Efficacy and Imaging Analysis for the Surgical Treatment of Thoracolumbar Infections in Elderly Patients

2021 ◽  
Author(s):  
Yanlong Zhong ◽  
Benyu Tang ◽  
Qi Lai ◽  
Yonghong Sheng ◽  
Chao Li ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Elderly Patients ◽  
Clinical Efficacy ◽  
Short Form ◽  
Effective Measure ◽  
Imaging Results ◽  
Sf 36 ◽  
Operative Complications ◽  
One Year

Abstract BackgroundFew reports have been conducted to comparing surgical results and safety evaluations between the different types of infections in geriatric patients. The aim of this study is to investigate the safety and efficacy of surgical treatment for thoracolumbar infections in elderly patients.Methods21 patients with pyogenic spondylodiscitis (PS) and 26 patients with tuberculous spondylodiscitis (TS) were enrolled in the study. All patients were treated using one-stage posterior debridement, decompression, and pedicle screw fixation. Comparison of operative safety parameters between the two groups. Clinical efficacy was evaluated using visual analog scale (VAS) score, the American Spinal Injury Association (ASIA) grade, the short form (SF)-36 survey and Oswestry disability index (ODI) to determine patient quality of life pre- and post-operatively. Results Hospitalisation and intensive care unit duration in the PS group were significantly shorter than in the TS group (P<0.05). The total incidence of post-operative complications for both groups was 44.7%. More complications occurred in the TS group, but the difference was not significant. The VAS and SF-36 scores (physical component) were significantly better in the PS group six months post-operatively, and the SF-36 (mental component) scores were significantly better in the PS group at the one-year follow-up. Neurological status in both groups improved post-operatively, and 83% of the patients were satisfied with the results of their operation. Imaging results showed that bone graft fusion improved in both groups at six months, one year and at the final follow-up. ConclusionSurgical treatment can provide satisfactory clinical and imaging results for thoracolumbar infection in patients over 65 years old. Although the incidence of peri-operative complications in the elderly is high, it is controllable and surgical treatment remains a safe and effective measure.

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