Clinical Effectiveness of Erlova in EGFR-Mutated Non-Small Cell Lung Cancer: An Affordable Price with Clinical Benefit

Background: Thyrosin kinase inhibitors (TKIs) is approved for the first line treatment of non-small cell lung cancer (NSCLC) patients with  epidermal growth factor receptor (EGFR) mutation. This study performed to assess clinical effectiveness and safety of Erlova (generic form of Erlotinib). Methods: Somatic mutations of EGFR gene were studied in tumor tissue by polymerase chain reaction (PCR) and bi-directional sequencing in 513 chemonaive and histologically verified lung adenocarcinoma Iranian patients. Patients  with EGFR mutation received Erlova at 150 mg/day  as first line treatment. Primary endpoint was progression free survival (PFS). Results: About 21% (n=109) cases had EGFR mutation. Most EGFR mutations were  occurred at exon 19. Among them, sixty nine patients treated with Erlova. Median PFS was 11.4 months and objective response rate (ORR) was about  88%. Most frequent treatment related adverse events was  skin rash. Conclusion: Our findings showed Erlova had remarkable effectiveness. In  mutation-positive patients with EGFR, Erlova can be used  safely instead of  other tyrosine-kinase inhibitors.     

《医疗质量管理办法》中医疗质量概念及相关问题探讨

采用文献复习和实证研究经验的方法对《医疗质量管理办法》中涉及的医疗质量概念及相关问题进行探讨。《医疗质量管理办法》中的医疗质量的定义存在重大缺失,没有涉及医疗服务的结果,特别是患者安全。医疗质量的定义应与国际相关权威机构保持一致,应高度重视医疗服务的结果,特别是患者安全。     

The clinical dilemma of JAK inhibitor failure in myelofibrosis: Predictive characteristics and outcomes

Two Janus-associated kinase inhibitors (JAKi) (initially ruxolitinib and, more recently, fedratinib) have been approved as treatment options for patients who have intermediate-risk and high-risk myelofibrosis (MF), with pivotal trials demonstrating improvements in spleen volume, disease symptoms, and quality of life. At the same time, however, clinical trial experiences with JAKi agents in MF have demonstrated a high frequency of discontinuations because of adverse events or progressive disease. In addition, overall survival benefits and clinical and molecular predictors of response have not been established in this population, for which the disease burden is high and treatment options are limited. Consistently poor outcomes have been documented after JAKi discontinuation, with survival durations after ruxolitinib ranging from 11 to 16 months across several studies. To address such a high unmet therapeutic need, various non-JAKi agents are being actively explored (in combination with ruxolitinib in first-line or salvage settings and/or as monotherapy in JAKi-pretreated patients) in phase 3 clinical trials, including pelabresib (a bromodomain and extraterminal domain inhibitor), navitoclax (a B-cell lymphoma 2/B-cell lymphoma 2-xL inhibitor), parsaclisib (a phosphoinositide 3-kinase inhibitor), navtemadlin (formerly KRT-232; a murine double-minute chromosome 2 inhibitor), and imetelstat (a telomerase inhibitor). The breadth of data expected from these trials will provide insight into the ability of non-JAKi treatments to modify the natural history of MF.     

A Pre-Protocol/Post-Protocol Quality Improvement Initiative Specific to One Hospital for Security of Pathologic Specimen

ObjectiveThe objective of this study was to reduce errors in a pathologic specimen with the help of a protocol systematizing the pathology specimen management process in the operating room.Materials and methodThis quasi-experimental study was carried out in the operating room unit of a research and training hospital. A protocol systematizing the process of specimen management in secure surgical pathology and prepared in light of the current literature was used as an intervention, and the effectiveness of the protocol was tested.ResultsIt was determined that the rate of adverse events decreased from .3226% (68 of 21,078) to .032% (6 of 18,706) after the protocol systematizing the surgical pathology specimen management process prepared by the researchers, and the protocol was found to be effective by 90% (P = .03).ConclusionBased on the data obtained in this study, we recommend the use of a pathologic specimen management protocol in the operating room.     

A comparative safety review of histone deacetylase inhibitors for the treatment of myeloma

Introduction: Dysregulation of histone deacetylase (HDAC) activity is an epigenetic hallmark of multiple myeloma (MM), leading to aberrant gene expression and cellular signaling in myeloma cell growth, survival and resistance to therapy. Hyper-methylation at diagnosis is a frequent observation, which eventually may convert to hypo-methylation during advanced phases.

Areas covered: A literature search on ‘HDAC inhibitors’ and ‘multiple myeloma’ was carried out using PubMed and Google Scholar in the preparation of this overview on clinical efficacy and safety data.

Expert opinion: First-generation non-selective HDAC inhibitors have demonstrated minimal single-agent activity in refractory MM. Subsequently, combination therapy has proven an improvement in progression-free survival (PFS) but not response rates. The main concerns are associated with toxicities. Ongoing studies on new and more selective agents, i.e. Romidepsin or Ricolinostat, are promising in terms of better efficacy and less toxicity.     

脑出血围手术期护理安全中细节管理的重要性分析

目的分析脑出血围手术期护理安全中细节管理的重要性。方法将于2018年6-10月在该院接受治疗的60例脑出血围术期患者作为该研究的常规组。将于2018年11月-2019年3月在该院接受治疗的60例脑出血围术期患者作为该研究的细节组。该院于2018年11月开始实施细节管理,以加强保障脑出血围术期患者的安全。对比两组患者的护理满意度、手术失败率、死亡率、住院时间及日常生活能力。结果细节组护理满意度明显高于常规组(P<0.05)。常规组的手术失败率、死亡率为均高于细节组,差异无统计学意义(P>0.05);细节组的住院时间明显短于常规组(P<0.05),ADL评分明显大于常规组(P<0.05)。结论细节管理在脑出血围手术期护理安全中具有相当重要性,可提升护理满意度,加快恢复速度,提升恢复效果。