ObjectiveTo assess the efficacy of lymphadenectomy in different regions for esophageal squamous cell carcinomas located differently according to the lymph node grouping by Chinese expert consensus. MethodsThe medical records of 1 061 patients (886 males and 175 females with a median age of 60 (54, 65) years with esophageal cancer from March 2011 to December 2017 in our hospital were retrospectively analyzed. According to the pathological report, the lymph nodes were regrouped according to the Chinese lymph nodes grouping standard of esophageal cancer. The metastasis rate of each group of lymph nodes, the 5-year survival rate of metastatic patients and efficacy index (EI) were calculated. ResultsThe upper thoracic esophageal cancer mainly metastasized to the lymph nodes of C201-203 groups. The middle and lower thoracic tumors mainly metastasized to the lymph nodes of C205-207 groups. The lower thoracic tumor had a higher rate of metastasis to the abdominal lymph nodes. According to the metastasis rate, the mediastinal lymph nodes were divided into three regions: an upper mediastinum (C201-204), a middle mediastinum (C205-206), and a lower mediastinum (C207-209). The EIs of lymph nodes of C201-203 and C205-207 groups were higher. For patients with C201-207 groups metastasis, the 5-year survival rates ranged from 13.39% to 21.60%. For patients with positive lymph nodes in each region, tumors at different primary locations had no statistical difference in long-term survival (P>0.05). Patients with lymph nodes of C205 group in the upper thoracic tumors had lower EI and those in the middle and lower thoracic tumors had higher EIs. ConclusionThe effect of lymph node dissection in each area varies with the location of the tumor. No matter where the tumor is, it is necessary to dissect the upper mediastinal lymph nodes, especially the lymph nodes adjacent to the left and right recurrent laryngeal nerves. Group C205 should be classified into the lower mediastinal lymph nodes.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
Objective To learn if appropriate methods and clinically relevant outcomes were used by analyzing methods of outcome assessment in Chinese acute stroke trials. Method Randomised and quasi-randomised controlled trials on acute stroke published before March 2003 in 6 Chinese neurological journals were included. Types of outcome measures, blinding of outcome assessment, duration of follow up, statistical methods used for data analysis and the significance of the results were evaluated. Types of outcomes were classified as death and four levels: ① Pathology. ② Impairment. ③ Disability. ④ Handicap/quality of life. Results Two hundreds and ten trials were included in this analysis. 57% of the trials used outcomes in pathology level, 77% in impairment level, 12% in disability level and none in the quality of life level. No dichotomous data was analyzed for disability measures. Only 16% of the trials reported number of death but few of them designed death as an outcome measure. Duration of follow up ranged from 3h to 3 years (median 17 d, interquartile range 14-30 d). Most trials did not assess outcomes blindly. Results in 95% of the trials were favorable to the tested interventions. Conclusions In Chinese acute stroke trials, outcome measures used were mainly in pathology and impairment levels and very few trials used functional outcome or death. Blinding of outcome assessment was not commonly used. The average duration of follow up was short.
Different from modern medicine, traditional Chinese medicine (TCM) has its unique thought patterns and decision methods. In the process of developing TCM clinical practice guidelines, not only the modern clinical researches should be included, but also the TCM ancient books which had influenced TCM for thousands of years should be included. As an important carrier of TCM, the characteristics of researches in TCM ancient books are different from modern clinical researches. In this paper, we introduced the present situation of the TCM guidelines and how to use TCM ancient books for developing TCM clinical guideline with the guidance of evidence-based method. We used the example of developing of headache TCM guideline to explain how to use TCM ancient books as evidence source for guideline development and explored the application of evidence-based research of TCM ancient books to promote TCM clinical guidelines development.
ObjectiveTo systematically review the efficacy of Chinese medicine injection (CMI) for treating heart failure (HF).MethodsCNKI, WanFang Data, VIP, The Cochrane Library, PubMed, and EMbase databases were electronically searched from inception to January 2021 to identify randomized controlled trials (RCTs) on CMI for treating HF. Two reviewers independently screened literature, extracted data, and evaluated the risk of bias of included studies. Network meta-analysis was then performed by RevMan 5.2 software and Stata 16.0 software.ResultsA total of 47 studies were included involving 4 902 patients and 5 types of CMIs, including Shenmai, Shenfu, Yiqi Fumai (lyophilized), Shengmai, and Danhong injections. The results of network meta-analysis showed that the efficacy of combined CMIs was superior to conventional Western medicine alone. For the main efficacy, Shenmai, Shengmai, and Shenfu injections had significant advantages in improving the total clinical effectiveness. Shengmai, Shenmai, and Yiqi Fumai (lyophilized) injections were significantly more effective for reducing NT pro-BNP levels than other injections. Shenfu and Shengmai injections were significantly more effective for reducing BNP levels than other injections. Shenmai, Danhong and Shengmai injections were significantly more effective for improving the left ventricular ejection fraction than the other injections. These CMIs showed similar advantages for secondary efficacy indicators as for main efficacy indicators.ConclusionsThe combined 5 types of CMIs for treating HF can improve the clinical efficacy when compared with conventional Western medicine treatment. Shenmai injection, Yiqi Fumai injection (lyophilized), and Shengmai injection, which is part of Sheng Mai San, have clear advantages in terms of the overall curative effect or on individual indices.
ObjectiveTo analyze the clinical characteristics of thrombo embolism (TE) in Chinese hypertrophic cardiomyopathy (HCM) patients. MethodsThis study retrospectively analyzed HCM patients admitted to West China Hospital of Sichuan University. The endpoints were defined as a composite of TE events, including ischemic stroke, transient ischemic attack, and peripheral arterial embolization. ResultsA total of 537 HCM patients were included with a median follow-up of 4.2 years. Forty-two patients reached the TE endpoint and the incidence was 1.9%. The annual incidence of TE was approximately 1.1% and 6.6% for HCM patients without/with atrial fibrillation, respectively. The recurrence rate of TE was high (approximately 26.2%). The mean age was 66.4±13.7 years for the first TE, and the incidence of TE was significantly increased at age ≥70 years. ConclusionThe incidence of TE is high in HCM patients, especially in those with atrial fibrillation, and the recurrence rate of TE is also high.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
With the increasing popularity of chest spiral CT screening, the detection rate of lung cancer in China is increasing. According to the characteristics of lung cancer in China and the progress of lung cancer researches at home and abroad, Chinese Medical Association guidelines for clinical diagnosis and treatment of lung cancer are updated once a year. It is of great guiding significance to standardize and improve the clinical diagnosis and treatment of lung cancer for thoracic surgeons. The surgical diagnosis and treatment of lung cancer in the guidelines mainly include: (1) surgical treatment of stage Ⅰ-Ⅱ non-small cell lung cancer (NSCLC); (2) surgical treatment of resectable stage Ⅲ NSCLC; (3) surgical treatment of multiple primary lung cancer; and (4) surgical treatment of locally resectable small cell lung cancer. Based on the Chinese Medical Association guidelines for clinical diagnosis and treatment of lung cancer (2019 edition), this paper interprets the hot issues related to the surgical treatment of lung cancer.
The post-marketing clinical safety re-evaluation studies of traditional Chinese medicine injections have obtained safety evidence of various research types such as active monitoring, passive monitoring and literature review. However, there is a lack of comprehensive evaluation methods that can effectively integrate the data of the above research types. So far, it is impossible to further produce more comprehensive and objective high-level evidence-based evidence, which seriously affects the supervision and management of traditional Chinese medicine injections and clinical rational use. The key to establishment of a comprehensive evaluation method is to first establish a comprehensive evaluation of the core indicators of the preferred method, the formation of weighted quantitative scoring model applied to the comprehensive evaluation method. Mixed methods research (MMR) can effectively and deeply integrate different types of research data and scientifically and normatively complete the screening of indicators in the evaluation model through repeated quantitative and qualitative research on data. Secondly, for the most critical index weighting and weight adjustment research in the model construction research, the author innovatively combines the analytic hierarchy process with the invariant weight sub-constraint method, and introduces the quantitative research part of the MMR design. It ensures the accurate weighting of indicators in the process of model construction. Therefore, based on the research on the core outcome set proposed for the core outcome outcomes of the effectiveness test, this paper proposes the use of MMR to carry out index screening and weight adjustment research based on multi-source complex data, and to construct a comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injections that integrates different research types of data. It provides measurement tools and new methods for the comprehensive evaluation of post-marketing clinical safety of traditional Chinese medicine injections.