This article aims to review the recall of refecoxib which increases the incidence of cardiovascular and cerebrovascular diseases and to find the methods to solve problems in post marked monitoring of drug safety.
Objective To compare the efficacy and safety of different cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer. Methods Randomized controlled trials (RCTs) on CDK4/6i for the treatment of HR+/HER2− metastatic or advanced breast cancer were retrieved from databases including PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, Wanfang, VIP, and SinoMed, with the search period ranging from database inception to August 2023. Bayesian network meta-analysis was conducted using R 4.2.0 software. Results A total of 18 RCTs from 25 articles, involving 8 031 patients and 11 treatment regimens, were included. There was no significant difference in progression-free survival (PFS) or overall survival (OS) among different CDK4/6i+ET combinations. The highest cumulative probability for PFS was observed with dalpiciclib (DAL)+fulvestrant (FUL), while ribociclib (RIB)+FUL ranked first for OS. In terms of efficacy, abemaciclib (ABE)+aromatase inhibitors (AI) and ABE+FUL ranked first in objective response rate and clinical benefit rate, respectively. Regarding safety, statistically significant difference in grade 3-4 adverse events was observed among certain types of CDK4/6i (P<0.05). Conclusion Current evidence suggests that CDK4/6i+ET is superior to ET alone for the treatment of HR+/HER2− advanced/metastatic breast cancer. Different CDK4/6i+ET combinations demonstrate comparable or similar efficacy; however, the incidence of adverse reactions is higher with combination therapy. Treatment regimens should be selected based on individual conditions.
Day surgery is a new medical service model, which has developed rapidly in China because of its advantages of safety, efficiency and resource conservation. However, along with the rapid development in quantity, it also presents contradictions such as the mismatch with the previous surgical quality and safety management model, the urgent need for the unification of the new system of quality and safety evaluation indicators at the national level, and the imbalance in the construction of information technology of medical institutions in China, leading to the new problem of uneven quality control of day surgery. This article constructs a “five-in-one” new system for the quality and safety management of day surgery from the perspective of high-quality development, aiming to provide a theoretical basis for the formulation of relevant policies in China and to promote the safe, efficient, and orderly development of day surgeries.
ObjectiveTo break through the key problem in the process of ambulatory surgery operation and management, improve the operational efficiency of hospital, and ensure the quality and safety of medical care through new established ambulatory surgery informative platform.MethodsThrough the analysis of medical requirements and process optimization in ambulatory surgery in Xiangya Hospital, Central South University from March to April, 2020, we constructed an ambulatory surgery informative platform centered on patient behavior tracking.ResultsThere wasa significant difference in the reception time of different appointment modes before and after the launch of information platform [(290.45±50.35) vs. (158.58±40.27) s; t=16.040, P<0.001]. After the platform system went online, patients’ satisfaction with the treatment process, appointment waiting time, and overall satisfaction were higher than before (P<0.05); there was no significant difference in patients’ attitude towards medical staff before and after the system went online (P>0.05). The results of medical staff’s work experience after the system went online showed that the use of information platform could make the work more efficient (91.09%), the process more reasonable (91.09%), accurately and timely grasp the patient’s information (95.05%), guarantee the medical quality and safety (96.04%), and reduce the medical cost (88.12%).ConclusionThe ambulatory surgery informative platform improved our work efficiency and patients’ satisfaction, assured the quality and safety of medical care, and strengthen the multi-disciplinary synergy at the same time.
Day surgery mode is a challenge for surgeons, anesthesiologists, nurses, and managers. Standardized management should be implemented in each management model, no matter centralized management or decentralized management model, by utilizing the theory of enhanced recovery after surgery and information management to establish a system to ensure patient’s safety and medical quality. Only in this way the development of day surgery will be healthy and sustainable.
Advancing patient safety is one of the most important strategies developed by WHO and patients must be in the center of advancing patient safety activities. This paper outlined the importance of partnership between health professionals and patients in patient safety activities in the WHO global patient safety challenges “Safe surgery saves lives”.
This article introduced the structure and features of the medical safety and quality management system of New South Wales (NSW) of Australia. The system was funded by government with overall design, multi-sectors involvement, and explicit roles of government, hospitals, and independent third parties. The system also developed national and state-wide regulations, policies, standards and their certification. The NSW Health Incident Information Management System (IIMS), the guidelines and interventional programs were also established to decrease the medical risk and ensure the healthcare quality. This system will be used for reference to the national medical risk and quality management system of China.
Objective To systematically evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) as first-line treatment for advanced non-small cell lung cancer (NSCLC). MethodsPubMed, The Cochrane Library, and EMbase databases were searched for clinical randomized controlled trials (RCTs) of ICIs as first-line treatment for NSCLC patients. The search period was from database inception to January 2023. Quality evaluation was conducted using the improved Jadad scale, and meta-analysis was performed using RevMan 5.4 software. ResultsTwelve RCTs were included, all of which were assessed as high-quality literature, involving a total of 7 121 patients. Meta-analysis results showed that, compared with chemotherapy, ICIs as first-line treatment for NSCLC patients significantly improved median overall survival (OS) [HR=0.72, 95%CI (0.64, 0.80), P<0.001] and median progression-free survival (PFS) [HR=0.65, 95%CI (0.53, 0.78), P<0.001], and improved objective response rate (ORR) [RR=1.52, 95%CI (1.28, 1.79), P<0.001]. Subgroup analysis showed that, compared with the ICIs monotherapy group, the ICIs combination therapy group significantly improved OS, PFS, and ORR in NSCLC patients. In terms of safety, the risk of any grade treatment-related adverse events (TRAEs) and grade 3-5 TRAEs in the ICIs group was lower than that in the chemotherapy group. The incidence of TRAEs leading to treatment discontinuation was higher in the ICIs group than in the chemotherapy group. Subgroup analysis showed that the incidence of any grade, grade 3-5, and TRAEs leading to treatment discontinuation was higher in the immune combination therapy group than in the immune monotherapy group. Conclusion ICIs as first-line treatment for NSCLC patients can significantly improve OS, PFS, and ORR compared with chemotherapy. Compared to immune monotherapy, immune combination therapy can significantly improve the efficacy in NSCLC patients, but patients have a higher risk of TRAEs.
ObjectiveTo understand the current research status of conservative mastectomy with breast reconstruction for breast cancer, so as to provide a reference for surgeons and patients with breast cancer to choose surgical method. MethodThe recently domestic and foreign literature on the research of conservative mastectomy with breast reconstruction for breast cancer was reviewed and summarized. ResultsAt present, conservative mastectomy mainly included nipple sparing mastectomy, skin sparing mastectomy, and skin reduction mastectomy. All three surgical methods were safe and effective in the treatment of breast cancer, and the complications could be controlled. When combined with breast reconstruction, the better cosmetic effect could be obtained, and the postoperative satisfaction and quality of life of patients were markedly improved. ConclusionsAfter comprehensively preoperative evaluation for patients with breast cancer, conservative mastectomy provides a treatment choice for them. After conservative mastectomy, individualized reconstruction scheme is formulated according to size and sagging degree of breast, as well as individual expectations of patients, which can obtain a higher quality of life while treating diseases for patients with breast cancer.
Objective To explore the safety and complications of repeated sternotomy after mitral valve repair and prevention strategies. Methods We retrospectively analyzed the clinical data of 88 consecutive patients of non-rheumatic mitral valve disease who underwent repeated sternotomy for failure of first-time mitral valve repair in our hospital from January 2009 through June 2015. There were 53 males and 35 females with a mean age of 36.1±17.5 years in the patients who underwent repeated sternotomy. Meanwhile 88 patients who underwent the first-time sternotomy for mitral valve repair simultaneously were randomly recruited as a control group, and there were 57 males and 31 females with a mean age of 39.9±12.6 years. The clinical outcomes were analyzed retrospectively and compared between the two groups. Results No major injury was observed in the patients who underwent repeated sternotomy. Eight patients (9.1%) in the repeated sternotomy group required femoral artery cannulation. Cardiopulmonary bypass (CPB) time was longer in the femoral artery cannulation group than that in the aortic cannulation group (155.5±59.0 minvs. 119.5±39.9 min,P=0.023). While there was no statistical difference in aortic cross-clamp time (P=0.786). Eight patients (9.1%) in the repeated sternotomy group used extra-pericardium approach. There was no significant difference in CPB time (P=0.255) or aortic cross-clamp time (P=0.360) between the patients who used extra-pericardium approach and those used routine approach. There was no statistical difference in post-operative complications between the patients who used different sternotomy strategies. Although CPB time (123.0±3.0 minvs. 95.4±37.1 min,P=0.000) or aortic cross-clamp time (79.0±36.3 minvs. 67.5±29.1 min,P=0.026) was longer in the repeated sternotmy group, the major outcomes were similar between the repeated sternotmy group and the first-time sternotmy group (P＞0.05). Conclusion Repeated sternotomy after mitral valve repair is relatively safe. With appropriate strategies, repeated sternotomy is not associated with increased risk of operative morbidity.