Objective The modification of Chinese patent medicines (CPM) instructions is currently the focus of national drug regulation, with policies and regulations being established. Nevertheless, the policies pertaining to CPM instructions have not been thoroughly investigated. This study analyzes the direction and current issues with existing policy items to give a reference for future optimization and adjustment of policies linked to CPM instructions. Methods The official website of the National Medical Products Administration (NMPA) and National Health Commission (NHC) were searched to collect policy documents related to the CPM instructions issued at the national level in China from January 1st 2000 to June 1st 2024. Based on the classification of policy tools (supply-based policy tools, demand-based policy tools, environment-based policy tools) and the dimension of policy development (policy planning, policy implementation, policy supervision, and policy evaluation ), a two-dimensional analytical framework of "policy tools and policy process" was constructed by using the content analysis method and the quantitative analysis method, and policy documents were analyzed. Results The 27 policy texts included in the analysis generated 104 policy entries in total, wherein, environment-based policy tools (74.04%) were used the most in the dimension of policy tools, followed by demand-based policy tools (24.04%) and supply-based policy tools (1.92%). In the dimension of policy development, policy planning tools, policy implementation tools, policy supervision tools, and policy evaluation tools accounted for 24.04%, 52.88%, 17.31%, and 5.77%, respectively. An in-depth analysis of the content of the policy entries discovered that the existing policy took into account the specification of the content of the instruction and the standardization of the expression of writing, the instruction application guidance, etc, and more and more attention was being paid to the content of the characteristics of TCM in the instruction. Conclusion Currently, there is an insufficient amount of policy documents on CPM standards, which are overly focused on environment-based policy tools and the policy implementation process. To achieve the policy goal of regulating and applying CPM specifications, it is recommended to create a balanced and coordinated structure of policy instruments, emphasise the direct promotion and pulling effect of supply and demand, increase the weight of policy evaluation and supervision, and develop a standard system for evaluating CPM specifications.
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 analyse the quality of implementation in clinical application guidelines of the Chinese patent medicines for the treatment of common diseases. MethodsWe retrieved clinical application guidelines of the Chinese patent medicines for the treatment of common diseases published from February, 2019 to August, 2022 in databases. The clinical practice guideline (CPG) implementation evaluation tool was used to evaluate the implementation of the included guidelines. ResultsA total of 29 guidelines were included. The implementation quality of included guidelines was moderate. Thirteen (44.8%) were high quality and 16 (55.2%) were moderate quality. ConclusionThe quality of implementation of clinical application guidelines of the Chinese patent medicines for the treatment of common diseases is higher than that of other traditional Chinese medicine CPG. The CPG implementation evaluation tool can be used in traditional Chinese medicine CPGs and particularity of TCM should also be considered.
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.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) regulate the specific requirements of forming integrity, clear, and transparent reports from title to conclusion. It contains six domains with twenty-one items and seventy-two sub-items and is important to promote the integrity, scientificity, transparency, and applicability of relevant reports. Additionally, it indicates that comprehensive evaluation results reports of post-marketing Chinese patent medicine should refer to PRICE-CPM. Therefore, this article provides a detailed interpretation of the report list and references for future users.
Objective To systematically evaluate the quality of published pharmacoeconomics studies on Chinese patent medicines for neoplasms. Methods Datasets including CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase were searched to collect pharmacoeconomics studies of Chinese patent medicines in neoplasms from the establishment of the database to September 30, 2022. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and quality of health economics studies (QHES) were used to evaluate the reporting quality and methodological quality. Results A total of 25 studies were included, with an average CHEERS 2022 coincidence rate of 40.09% and an average QHES score of 53.2. Conclusion The quantity and quality of pharmacoeconomics studies on Chinese patent medicines in neoplasms are insufficient and flawed. It is suggested to strenthen the collaboration between scientific research institutions and hospitals and standardize the pharmacoeconomics studies on Chinese patent medicines in neoplasms to provide hygienic decision-making evidence for Chinese patent medicines in neoplasms.
ObjectiveTo explore the method and feasibility of establishing patent ductus arteriosus (PDA) model in Bama miniature pig by using autologous jugular vein, and to provide a large animal model for the development of PDA occluder and the study of pulmonary hypertension associated with congenital heart disease. MethodsFive male Bama miniature pigs weighing about 45 kg were selected to gain the PDA model of the autogenous jugular vein, which was fixed by glutaraldehyde and anastomosed between the ascending aorta and the main pulmonary artery. The patency of PDA was confirmed by echocardiography and angiocardiography immediately and one week after the operation. Two animals were selected to undergo transcatheter closure of PDA via femoral vein 1 week after the operation, and the rest were euthanized to obtain PDA and lung tissue for pathological examination. ResultsThe PDA model was successfully established in all five animals with a success rate of 100.0%. Immediately and 1 week after the operation, echocardiography and angiography showed that PDA blood flow was unobstructed, and hematoxylin-eosin staining showed that PDA endothelialization was good. One week after the operation, two animals were successfully treated with transcatheter femoral vein occlusion. The pathological examination of lung tissue showed thickening of the intima and muscular layer of pulmonary arterioles, thickening of pulmonary interstitium and infiltration of neutrophils. ConclusionIt is safe and feasible to establish a large animal model of PDA by using autogenous jugular vein anastomosis between the ascending aorta and the main pulmonary artery. The model can be used for the development of PDA interventional occlusive devices and the pathophysiological study of congenital heart disease-related pulmonary hypertension.
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.
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.
