The number of clinical practice guidelines for traditional Chinese patent medicine has been increasing recently. However, the quality of guidelines was still low compared to international guidelines. Considering the characteristics of traditional Chinese patent medicine, we suggested the following items should be taken into account when developing traditional Chinese patent medicine guidelines: ensuring the standardized guidelines of traditional Chinese patent medicine research problem is scientific based on reliable evidence; identifying the common questions according to these research problems; understanding the strength of evidence and how to recommend correctly; inviting some experts in other fields to take part in the development of guidelines; paying more attention on the changes of disease burden and the impact of new methods and technologies when developing the guideline; paying more attention to the non-consensus opinions and evidence supporting these opinions; insisting on quality is the priority, while speed is secondary.
ObjectiveTo systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. MethodsThe PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. ResultsA total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. ConclusionThe research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.
Currently, in precision cardiac surgery, there are still some pressing issues that need to be addressed. For example, cardiopulmonary bypass remains a critical factor in precise surgical treatment, and many core aspects still rely on the experience and subjective judgment of cardiopulmonary bypass specialists and surgeons, lacking precise data feedback. With the increasing elderly population and rising surgical complexity, precise feedback during cardiopulmonary bypass becomes crucial for improving surgical success rates and facilitating high-complexity procedures. Overcoming these key challenges requires not only a solid medical background but also close collaboration among multiple interdisciplinary fields. Establishing a multidisciplinary team encompassing professionals from the medical, information, software, and related industries can provide high-quality solutions to these challenges. This article shows several patents from a collaborative medical and electronic information team, illustrating how to identify unresolved technical issues and find corresponding solutions in the field of precision cardiac surgery while sharing experiences in applying for invention patents.
ObjectiveTo explore the early outcomes of the surgical treatment for patent ductus arteriosus (PDA) combined with intracardiac abnormities via right vertical infra-axillary thoracotomy (RVIAT).MethodsA total of 7 children with PDA combined with intracardiac defects underwent surgery through RVIAT at the Second Affiliated Hospital of Nanjing Medical University from 2016 to 2018. There were 4 males and 3 females, with an average age of 5.3±4.5 years and weight of 18.0±11.2 kg.ResultsIn all patients, PDA was ligated before the repair of intracardiac abnormities. No patient died in hospital. All patients were followed up, with a mean follow-up time of 18.0±8.0 months. No other complications such as residual shunts, arrhythmias, hemorrhaging or wound infection occurred after operations or during the follow-up period.ConclusionRVIAT is an emerging technique used for the surgical repair of PDA combined with intracardiac defects. It yields satisfying cosmetic results, without increasing postoperative complications or mortality.
ObjectiveTo investigate effectiveness and safety of right vertical infra-axillary thoracotomy (RVIAT) in surgical repair for intra-cardiac anomalies combined with patent ductus arteriosus (PDA).MethodsWe retrospectively analyzed the clinical data of 34 patients who underwent intra-cardiac correction of congenital heart defects and PDA ligation simultaneously via RVIAT in our hospital from August 2014 to August 2019. There were 25 males and 9 females with an age range of 0.5-6.1 years.ResultsThe length of incision was 3.0 (3.0, 3.5) cm. The operation time lasted 110.0 (90.0, 121.0) min. The cardiopulmonary bypass time was 45.5 (38.8, 63.5) min and the aortic cross-clamp time was 22.5 (14.8, 34.8) min. The bleeding volume was 20.0 (13.8, 20.0) mL. ICU stay time was 17.0 (5.5, 22.3) h, post-operative mechanical ventilation time was 4.0 (2.0, 6.0) h, total in-hospital cost was 46 (39, 51) thousand yuan. There was no mortality or reoperation during perioperative and follow-up period. Within the median follow-up of 636.0 days, 1 patient had minimal residual ventricular septal defect shunt while no new-onset scoliosis, funnel chest or pectus carinatum was detected. No bilateral mammary developmental asymmetry was observed in the female patients during the follow-up period. All the patients’ parents or guardians were satisfied with the right vertical infra-axillary aesthetic skin incision.ConclusionThe minimally invasive repair for intra-cardiac heart defects combined with PDA via RVIAT is a safe and effective method with minimal invasiveness and excellent cosmesis.
Our team proposed and constructed an Expert-knowledge and Data-driven Comprehensive Evaluation Model of Chinese Patent Medicine (EDCEM-CPM) using the machine learning algorithm. This model could improve the system of the comprehensive evaluation of the Chinese patent medicine in technology and provide measurement tools for Chinese patent medicine according to its characteristics. The model evaluates the multi-dimensional value of Chinese patent medicine by data pre-treatment, clustering algorithms, and data training steps, such as automatic learning weighting. This evaluation model is already in practice. In this paper, we introduced the establishment of the model with the calculation process for reference.
Comprehensive evaluation research of Chinese patent medicine (CPM) is performed to demonstrate the comprehensive value of CPM from multiple dimensions and to clarify the clinical value and positioning, so as to provide references for decision-making in health or drug policies. Therefore, to standardize and promote comprehensive evaluation studies on CPM, the current guideline introduced the specific requirements on the applicable subject, basic principles, and major evaluation content, thereby providing guidance for researchers in the future.
The emergence of new-generation artificial intelligence technology has brought numerous innovations to the healthcare field, including telemedicine and intelligent care. However, the artificial intelligent medical device sector still faces significant challenges, such as data privacy protection and algorithm reliability. This study, based on invention patent analysis, revealed the technological innovation trends in the field of artificial intelligent medical devices from aspects such as patent application time trends, hot topics, regional distribution, and innovation players. The results showed that global invention patent applications had remained active, with technological innovations primarily focused on medical image processing, physiological signal processing, surgical robots, brain-computer interfaces, and intelligent physiological parameter monitoring technologies. The United States and China led the world in the number of invention patent applications. Major international medical device giants, such as Philips, Siemens, General Electric, and Medtronic, were at the forefront of global technological innovation, with significant advantages in patent application volumes and international market presence. Chinese universities and research institutes, such as Zhejiang University, Tianjin University, and the Shenzhen Institute of Advanced Technology, had demonstrated notable technological innovation, with a relatively high number of patent applications. However, their overseas market expansion remained limited. This study provides a comprehensive overview of the technological innovation trends in the artificial intelligent medical device field and offers valuable information support for industry development from an informatics perspective.
ObjectiveTo propose policy recommendations for improvement of the affordability of high cost medicines with significant public health implications under the patent system in China. MethodsThrough literature analysis and market investigation, this study targeted expensive life saving medicines under the patent protection, which are critical for the treatment of eight diseases with the most significant disease burden and critical social, economic and political impact for case studies, estimated the individual and insurance direct economic burden of medicines treatment. ResultsChemical product patent protection enhanced medicines price monopoly. The targeted medicines brought huge financial burden to Chinese citizens, especially to the rural residents. Breaking chemical product patent protection, achieving parallel importation or making generic drugs enter into the China's market, can save huge amount of medicines procurement budget for the government, and benefit the general public. ConclusionDeveloping and implementing medicines registration and intellectual property right protection strategies with public health perspective, adding continuously improved basic health insurance programs, can effectively promote the affordability of high cost medicines with significant public health, social, political and economic implications.
This case was a 58-year-old female patient with patent ductus arteriosus (PDA) and severe aortic stenosis. Upon admission, she had severe heart failure and severe edema of both lower extremities unable to lie flat. After cardiac function adjustment and under general anesthesia, she underwent a one-stop operation of PDA occlusion and transcarotid transcatheter aortic valve replacement due to the severe aortic arch stenosis which brought high risk in transfemoral artery approach. Her symptoms improved significantly, and she was discharged only 6 days after operation. At the follow-up 3 months after operation, the aortic valve transvalvular pressure gradient improved significantly, the ductus arteriosus murmur disappeared, and the patient recovered well.