Clinical efficacy and safety of Securflux®, an anti-reflux device for intravenous infusion

2012 ◽  
Vol 14 (1) ◽  
pp. 77-82 ◽  
Author(s):  
Ferran Barreras ◽  
Manuel Cabeza ◽  
Laura Collantes de Terán
Keyword(s):  
Clinical Efficacy ◽  
Intravenous Infusion ◽  
Efficacy And Safety

scholarly journals Efficacy of Yigu® versus Aclasta® in Chinese postmenopausal women with osteoporosis: a multicenter prospective study

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Mei Li ◽  
Qun Cheng ◽  
Ya-nan Huo ◽  
Ai-jun Chao ◽  
Liang He ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Zoledronic Acid ◽  
Postmenopausal Women ◽  
Clinical Efficacy ◽  
Intravenous Infusion ◽  
Percentage Change ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Chinese Postmenopausal Women ◽  
The Mean

Abstract Summary Zoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu®) showed its clinical efficacy consistency with original ZOL (Aclasta®) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu® in Chinese population. Introduction Yigu® has been approved its bioequivalence to Aclasta®. However, the clinical efficacy and safety of Yigu® have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu® and Aclasta® in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL. Methods This was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5 mg Yigu® or Aclasta®. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12 months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12 months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6 months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups. Results A total of 458 postmenopausal women with osteoporosis were enrolled (n = 227, Yigu®; n = 231, Aclasta®). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu® and Aclasta® groups after 12 months of treatment. The mean difference of BMD change at the lumbar spine after 12 months between two groups was 0.15% (95% CI: − 0.71 to 1.00, equivalence margin: − 1.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and β-CTX showed no difference between two groups after 14 days and 6 and 12 months of treatment. As regards the whole sample, BMD significantly increased after 12 months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (β-CTX) and procollagen 1 N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups. Conclusion Intravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu® was equivalent to Aclasta® with respect to efficacy and safety.

Clinical efficacy and safety of the combination therapy of peginterferon alpha and ribavirin in cirrhotic patients with HCV infection

2010 ◽  
Vol 16 (1) ◽  
pp. 38 ◽  
Author(s):  
Hong Ryeol Cheong ◽  
Hyun Young Woo ◽  
Jeong Heo ◽  
Ki Tae Yoon ◽  
Dong Uk Kim ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Clinical Efficacy ◽  
Hcv Infection ◽  
Efficacy And Safety ◽  
Cirrhotic Patients

Review on the Clinical Pharmacology of Hydroxychloroquine Sulfate for the Treatment of COVID-19

2020 ◽  
Vol 21 (6) ◽  
pp. 427-435 ◽  
Author(s):  
Cheng Cui ◽  
Siqi Tu ◽  
Valerie Sia Jie En ◽  
Xiaobei Li ◽  
Xueting Yao ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Clinical Efficacy ◽  
Relevant Literature ◽  
The United States ◽  
Efficacy And Safety ◽  
Open Label ◽  
Infected People ◽  
Treatment Regimens ◽  
Therapeutic Drugs

Background: As the number of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infected people is greatly increasing worldwide, the international medical situation becomes very serious. Potential therapeutic drugs, vaccine and stem cell replacement methods are emerging, so it is urgent to find specific therapeutic drugs and the best treatment regimens. After the publications on hydroxychloroquine (HCQ) with anti- SARS-COV-2 activity in vitro, a small, non-randomized, open-label clinical trial showed that HCQ treatment was significantly associated with reduced viral load in patients with coronavirus disease-19 (COVID-19). Meanwhile, a large prophylaxis study of HCQ sulfate for COVID-19 has been initiated in the United States. HCQ offered a promising efficacy in the treatment of COVID-19, but the optimal administration is still being explored. Methods: We used the keyword "hydroxychloroquine" to conduct a literature search in PubMed to collect relevant literature on the mechanism of action of HCQ, its clinical efficacy and safety, pharmacokinetic characteristics, precautions for clinical use and drug interactions to extract and organize information. Results: This paper reviews the mechanism, clinical efficacy and safety, pharmacokinetic characteristics, exposureresponse relationship and precautions and drug interactions of HCQ, and summarizes dosage recommendations for HCQ sulfate. Conclusion: It has been proved that HCQ, which has an established safety profile, is effective against SARS-CoV-2 with sufficient pre-clinical rationale and evidence. Data from high-quality clinical trials are urgently needed worldwide.

Galcanezumab for the prevention of migraine

2020 ◽  
Author(s):  
Lindsay M Frerichs ◽  
Deborah I Friedman
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Efficacy ◽  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Efficacy And Safety ◽  
Related Peptide ◽  
Calcitonin Gene

Migraine is a common and disabling disorder affecting approximately 1.02 billion people worldwide. Calcitonin gene-related peptide (CGRP) has been identified as playing an important role in the pathophysiology of migraine and several migraine-specific therapies targeting the CGRP ligand or its receptor have been approved since 2018 for the acute and preventive treatment of migraine. This review focuses on the pharmacology, clinical efficacy and safety/tolerability of galcanezumab, an anti-CGRP monoclonal antibody approved for the prevention of migraine.

scholarly journals Comparison of clinical efficacy and safety between dexmedetomidine and propofol among patients undergoing gastrointestinal endoscopy: a meta-analysis

2021 ◽  
Vol 49 (7) ◽  
pp. 030006052110327
Author(s):  
Weihua Liu ◽  
Wenli Yu ◽  
Hongli Yu ◽  
Mingwei Sheng
Keyword(s):  
Clinical Efficacy ◽  
Lower Risk ◽  
Gastrointestinal Endoscopy ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Similar Efficacy ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Weighted Mean

Objective To compare the clinical efficacy and safety of dexmedetomidine and propofol in patients who underwent gastrointestinal endoscopy. Methods Relevant studies comparing dexmedetomidine and propofol among patients who underwent gastrointestinal endoscopy were retrieved from databases such as PubMed, Embase, and Cochrane Library. Results Seven relevant studies (dexmedetomidine group, n = 238; propofol group, n = 239) met the inclusion criteria. There were no significant differences in the induction time (weighted mean difference [WMD] = 3.46, 95% confidence interval [CI] = −0.95–7.88, I2 = 99%) and recovery time (WMD = 2.74, 95% CI = −2.72–8.19, I2 = 98%). Subgroup analysis revealed no significant differences in the risks of hypotension (risk ratio [RR] = 0.56, 95% CI = 0.25–1.22) and nausea and vomiting (RR = 1.00, 95% CI = 0.46–2.22) between the drugs, whereas dexmedetomidine carried a lower risk of hypoxia (RR = 0.26, 95% CI = 0.11–0.63) and higher risk of bradycardia (RR = 3.01, 95% CI = 1.38–6.54). Conclusions Dexmedetomidine had similar efficacy and safety profiles as propofol in patients undergoing gastrointestinal endoscopy.

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