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Lorlatinib is an oral small molecule inhibitor of anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (ROS1) kinase developed by Pfizer for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Based on results from a phase I/II trial, lorlatinib received approval in Japan in September 2018 and in the USA in November 2018 for the treatment of ALK-positive NSCLC. This article summarizes the milestones in the development of lorlatinib leading to the first global approval for this indication.
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Clinical Trial Controlled Clinical Trial
Safety of implantation of a cardioverter-defibrillator without general anesthesia in an electrophysiology laboratory.
Implantable cardioverter-defibrillators (ICDs) have conventionally been implanted in an operating room under general anesthesia. This study was performed to evaluate ICD implantation without general anesthesia by 2 electrophysiologists in an electrophysiology laboratory. Between February and September 1994, 27 consecutive patients (22 men and 5 women, mean age 59 +/- 15 years) who underwent ICD implantation by 2 electrophysiologists were included in this study. ⋯ Mean time from implantation to discharge was 2.5 +/- 2.1 days. During late follow-up (n = 23; mean 12.4 +/- 5.8 weeks), all devices were functioning appropriately. In conclusion, this report demonstrates that ICD implantation can be successfully and safely performed by a team of 2 electrophysiologists using local anesthesia and intravenous sedation.(ABSTRACT TRUNCATED AT 250 WORDS)
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J. Thorac. Cardiovasc. Surg. · Aug 1988
Randomized Controlled Trial Comparative Study Clinical TrialDipyridamole preserved platelets and reduced blood loss after cardiopulmonary bypass.
Cardiopulmonary bypass activates and depletes platelets, which may contribute to postoperative bleeding. In addition, activated platelets may be deposited in the coronary vasculature after ischemia and cardioplegia, which may delay recovery of cardiac function and metabolism and may contribute to early bypass graft occlusion. The antiplatelet agent dipyridamole reduces platelet activation and depletion and may decrease postoperative bleeding and transfusion requirements. ⋯ Postoperative blood loss and blood product transfusions were significantly reduced with both oral and intravenous dipyridamole (p = 0.04 by analysis of variance). Dipyridamole preserved platelets and reduced postoperative bleeding. Intravenous dipyridamole resulted in higher platelet counts than oral dipyridamole and may be required to reduce postoperative bleeding in high-risk patients.
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Impaired body representation (i.e. disrupted body awareness or perception) may be a critical, but understudied, factor underlying phantom limb pain (PLP). This cross-sectional study investigated whether adults with lower-limb loss (LLL) and PLP demonstrate impaired body representation as compared to Pain-Free peers with and without LLL. ⋯ Following lower-limb loss, adults with phantom limb pain (PLP) demonstrate impaired body representation as compared to Controls with intact limbs, evidenced by slower response times and reduced accuracy when completing a task requiring mental rotation. Importantly, 80% of participants with pre-task PLP reported reduced pain intensity during the task, providing compelling evidence for future investigations into whether imagery-based, mind-body interventions have positive effects on PLP.
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During the past few years, the research of chronic neuropathic pain has focused on neuroinflammation within the central nervous system and its impact on pain chronicity. As part of the ERA-Net NEURON consortium, we aimed to identify immune cell patterns in the cerebrospinal fluid (CSF) of patients with herpes zoster neuralgia and patients with polyneuropathy (PNP), which may contribute to pain chronicity in these neuropathic pain conditions. Cerebrospinal fluid of 41 patients (10 herpes zoster and 31 PNP) was analyzed by flow cytometry identifying lymphocyte subsets: CD4+ (T-helper cells), CD8+ (cytotoxic T cells), CD19+ (B cells), and CD56+ (natural killer [NK]) cells. ⋯ The analysis of the individual follow-up showed a worsening of the pain condition if NK-cell frequency was low. Low NK-cell frequency is associated with signs of central sensitization (MPS), whereas high NK-cell frequency might prevent central sensitization. Therefore, NK cells seem to play a protective role within the neuroinflammatory cascade and may be used as a marker for pain chronicity.