Clinical therapeutics
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Clinical therapeutics · Feb 2020
A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018.
The present study aimed to examine the differences between enrolled subject populations and use of combination therapies as defined by the pivotal clinical trial protocols and the approved indications of anticancer drugs as determined by 3 major regulatory agencies. ⋯ In principle, the approved therapeutic indications should be determined by the characteristics of the pivotal trial subjects and combination therapies. The use of biomarkers can be essential for identifying those patients who are most likely to benefit from a drug. Unfortunately, biomarker-defined subgroups are often insufficient in size to allow meaningful interpretation of results. Consequently, regulatory agencies may deviate from one another and from the pivotal trial protocol when interpreting study results and attempting to define the optimal treatment population. The PMDA-approved indications deviated more liberally from the pivotal trial protocols regarding specification of prior treatment status and the use of co-administered drugs.
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Clinical therapeutics · Feb 2020
Systematic Literature Review of the Burden of Disease and Treatment for Transfusion-dependent β-Thalassemia.
β-Thalassemia is an inherited blood disorder characterized by reduced or no production of adult hemoglobin. Systematic identification of the burden of β-thalassemia with contemporary treatments is lacking in published literature. Thus, a gap exists in understanding the baseline burden on which to assess future treatments. Therefore, a systematic literature review (SLR) was performed to assess management and outcomes in patients with transfusion-dependent β-thalassemia (TDT) who received long-term transfusion regimens. ⋯ Consistent with improvements in transfusion practices and iron monitoring and management, outcomes in patients with TDT have improved. However, iron overload and disease-associated complications remain a challenge in this population. This review supports the burden of disease affecting patients with β-thalassemia and provides a baseline health status against which to assess future improvements in care.
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Clinical therapeutics · Jan 2020
Randomized Controlled TrialInvestigation of the Minimum Local Analgesic Concentration of Epidural Sufentanil Combined With Ropivacaine for Labor Analgesia.
Worldwide, there are only few studies focusing on labor analgesia on the MLAC (minimum local analgesic concentration) or EC50 (median effective concentration) of sufentanil and ropivacaine. Therefore, we determine the MLAC or EC50 of sufentanil and ropivacaine for epidural analgesia by using an up-down sequential allocation and survey its adverse effect in a prospective blinded randomized trial. ⋯ The MLAC of epidural sufentanil or ropivacaine could provide satisfactory and safe analgesia for parturients while having a low incidence rate of side effects.
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Clinical therapeutics · Jan 2020
Frequency of Advanced Cardiac Life Support Medication Use and Association With Survival During In-hospital Cardiac Arrest.
Cardiopulmonary resuscitation is common in the United States, with >200,000 people experiencing an in-hospital cardiac arrest (IHCA) annually. Recent medication shortages have raised the question of the frequency and type of medication used during cardiac arrest resuscitation. We sought to determine the frequency and quantity of medications used during IHCA. ⋯ We found that in a hospital with established rapid response and code blue teams, numerous medications that are not recommended for routine use in cardiac arrest are still administered at significant frequencies. Furthermore, substantial amounts of drugs with known recent shortage are used in IHCA. Inc.
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Clinical therapeutics · Jan 2020
Clinical TrialHypnosis Program Effectiveness in a 12-week Home Care Intervention To Manage Chronic Pain in Elderly Women: A Pilot Trial.
As the prevalence of pain increases with age, taking too much medication can lead to negative side effects in elderly patients. While evidence in the literature has shown that clinical hypnosis is effective in an adult population, there are few studies in an aging population and efficacy has never been established in a home care setting. The goal of this study was to determine the effects of a hypnosis program delivered during home care interventions in elderly women during a 12-week period. ⋯ Taken together, these findings show that a hypnosis intervention is feasible and effective to manage pain in an elderly population.