Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Objective To investigate the influence of prior percutaneous coronary intervention (PCI) on the outcome of coronary artery bypass grafting (CABG). Methods Clinical data of 5 216 patients from Jiangsu Province CABG registry who underwent primary isolated CABG from 2016 to 2019 were retrospectively analyzed. Patients were divided into a PCI group (n=673) and a non-PCI group (n=4 543) according to whether they had received PCI treatment. The PCI group included 491 males and 182 females, aged 62.6±8.2 years, and the non-PCI group included 3 335 males and 1 208 females, aged 63.7±8.7 years. Multivariable logistic regression and propensity score matching (PSM) were used to compare 30-day mortality, incidence of major complications and 1-year follow-up outcomes between the two groups. Results Both in original cohort and matched cohort, there was no statistical difference in the 30-day mortality [14 (2.1%) vs. 77 (1.7%), P=0.579; 14 (2.1%) vs. 11 (1.6%), P=0.686], or the incidence of major complications (myocardial infarction, stroke, mechanical ventilation≥24 h, dialysis for new-onset renal failure, deep sternal wound infection and atrial fibrillation) (all P>0.05). The rate of reoperation for bleeding in the PCI group was higher than that in the non-PCI group [19 (2.8%) vs. 67 (1.5%), P=0.016; 19 (2.8%) vs. 7 (1.0%), P=0.029]. Both in original cohort and matched cohort, there was no statistical difference in 1-year survival rate between the two groups [613 (93.1%) vs. 4225 (94.6%), P=0.119; 613 (93.1%) vs. 630 (95.2%), P=0.124], while the re-admission rate in the PCI group was significantly higher than that in the non-PCI group [32 (4.9%) vs. 113 (2.5%), P=0.001; 32 (4.9%) vs. 17 (2.6%), P=0.040]. Conclusion This study shows that a history of PCI treatment does not significantly increase the perioperative mortality and major complications of CABG, but increases the rate of cardiogenic re-admission 1 year postoperatively.
Objective To evaluate the effect of perioperative period clinical care mode through fast-track (FT) under nonminimal invasive operation on the inflammatory response of colorectal cancer resection. Methods Fifty-five patients underwent elective colorectal cancer resection were randomized divided into two groups: FT group (n=29) in which patients were performed FT perioperative care and tradition group (n=26) in which patients were received traditional perioperative care. The nonminimal invasive operations were performed in this study. The venous blood samples were respectively collected at 24 h before operation, at 24 h, 72 h, and 7 d after operation, and were used to detect the concentrations of serum C-reactive protein (CRP) and serum amyloid A protein (SAA).Results There was no complication such as infection, fistula of stoma and inflammatory ileus that was potential to influence the study results in two groups, and no patient died. The trend of changes in the concentrations of CRP and SAA of patients was accordant in each group. The peak concentrations of CRP and SAA of patients in FT group were respectively observed at 24 h after operation 〔CRP: (72.36±60.94) mg/L; SAA: (328.97±267.20) mg/L〕, while which were respectively delayed to 72 h after operation in tradition group 〔CRP: (112.71±63.92) mg/L; SAA: (524.18±331.03) mg/L〕. At the same time, the concentrations of CRP and SAA in FT group began to descend 〔CRP: (57.21±30.42) mg/L; SAA: (237.43±215.66) mg/L〕. The peak concentrations of CRP and SAA in tradition group were significantly higher than that in FT group (Plt;0.001) and the concentrations of CRP and SAA in FT group were significantly lower than those in tradition group at 72 h after operation (Plt;0.001). On 7 d after operation, the concentrations of CRP and SAA further decreased, but the difference between two groups was not significant (Pgt;0.05). Likewise, the concentrations of CRP and SAA at 7 d after operation were significant higher than those 24 h and 72 h after operation (Plt;0.001), lower than that 24 h before operation (Plt;0.001), respectively. Conclusion This study demonstrates that perioperative period clinical care mode through FT under non-minimal invasive operation can reduce the inflammatory response of colorectal carcinoma resections and scientific clinical care is an important means to promote quick rehabilitation.
ObjectiveTo systematically search and sort out the clinical research literature on the treatment of AIDS by traditional Chinese medicine compound preparations by using the evidence map method, and to understand the distribution of evidence in this field. MethodsThe CNKI, WanFang Data, VIP, CBM, PubMed and Cochrane Library databases were electronically searched to collect studies on the treatment of AIDS with traditional Chinese medicine compound preparations from inception to August 2022. The distribution characteristics of evidence were analyzed and presented in the form of charts and words. ResultsA total of 337 articles were included, involving 268 intervention studies, 66 observational studies and 4 systematic reviews/meta-analysis. A total of 92 kinds of traditional Chinese medicine compound preparations were obtained, and the literature quantity of different preparations was obviously stratified, with Kangaibaosheng preparation being the most frequently reported. In recent years, the number of published literature has been declining, the quality of literature is generally low, and the level of evidence is not high. As for the intervention duration, this field tends to have a longer intervention observation period. As for the outcome indicators, the evaluation criteria of some indicators are not uniform, and the characteristics of TCM advantages are not reflected. The quantity and quality of systematic reviews/meta-analyses were insufficient. No normative consensus or guidelines for the treatment of AIDS with traditional Chinese medicine compound preparations had been formed. Conclusionstudies on the effectiveness and safety of traditional Chinese medicine compound preparations in treating AIDS has initially formed a certain scale of evidence group. In the future, it is necessary to further improve the quality of studies, explore outcome indicators that can reflect the advantages of TCM efficacy, and formulate relevant guidelines in a standardized manner.
The 12th Asian Conference on Pharmacoepidemiology (ACPE) has been successfully held from October 11st to 13rd, 2019 in Kyoto, Japan. More than 600 representatives from 33 countries and regions participated in the meeting. The arrangement of this conference mainly included: education session program, contributed papers report, symposium and poster presentation, which provided good opportunity for participants to communicate. Moreover, it promoted the dissemination and utilization of advanced methods and technologies of global pharmacoepidemiology, especially in Asia region, and provided technical support in order to ensure the safety and efficacy of public. Moreover, it was the first time that the symposium on herbal and Traditional Medicines has been set up in the ACPE. This paper introduced the main details of the contents
As a science which focuses on evidence, the decision making process of evidence medicine encounters an opportunity for development in the big data era. The starting point is shifting forward from evidence to data. The big data technology is playing an active role in evidence's collection, process and utilization. Evidence is more objective, righteous, authentic, transparent and easier to collect. Thus, to initiate evidence-based medicine research in the big data era and to structure an evidence-based medicine intelligent service platform, a full-scaled strategy should be developed in order to improve the quality of evidence. To promote the complete publicity of clinical research data, structuralized clinical data standard should be constructed. To provide a pathway to patients' follow-up data, portable and wearable monitoring devices should be popularized. To avoid risks from utilization of clinical research big data, regulations of clinical data usage should be implemented.
Ethical issues in clinical research are receiving increasing attention. The application of research projects, the registration of clinical trials and the publication of scientific researches have always been involved with ethical issues. This paper elaborates ethical development and changes in Chinese clinical research from the aspects of the development of medical ethics, the establishment of ethics laws and regulations, international certification of medical ethics committee, the advantages, challenges, opportunities and innovation and development of TCM clinical research ethics as well as the certification system of TCM research ethics.
Objective To investigate the current situation of clinical studies on puerarin for ischemic stroke and the reliability of these evidence. Methods By electronic searching and handsearching, we collected all the published clinical study reports on puerarin for ischemic stroke and assessed all the included reports according to clinical epidemiologic standard. Results 35 RCTs, 22 non-randomized controlled trials and 17 case serials studies were included and analysed. Conclusions Current quality of clinical studies of puerarin for ischemic stroke is not good enough to provide reliable evidence.