The insufficient reporting of adverse reactions of Chinese proprietary medicines is common. In addition, there is a lack of safety information in the specifications of Chinese proprietary medicines, which led to less evidence for clinical safety of Chinese proprietary medicines in clinical practice. It is urgent to carry out post-marketing clinical safety re-evaluation of Chinese proprietary medicine. Developing a clinical safety evaluation data set for Chinese proprietary medicine may reduce the insufficient reporting of safety information and the inconsistency of data reporting in similar studies, as well as include more studies in systematic reviews, so that they can provide higher-level evidence for clinical safety of Chinese proprietary medicine. This paper proposes a method for developing core data set of clinical safety evaluation of Chinese proprietary medicine: firstly, the application scope of core data set for clinical safety evaluation was determined according to the characteristics of diseases, population, research objectives, administration methods, evaluation methods, etc. Systematic reviews and semi-structured interviews should be conducted to develop the list of original items for clinical safety evaluation. Based on the list, Delphi surveys can be developed in different stakeholders. Then the final core data set can be developed via consensus meetings.

Objective: To conduct a comprehensive and systematic review of the efficacy and safety of Wenxin Keli (WXKL) in the treatment of atrial fibrillation (AF) . Methods: Seven databases (PubMed, The Cochrane Library, Web ofScience, CNKI, Wanfang Database, VIP and SinoMed) were searched to identify relevant randomized controlled trials (RCTs) from inceptions to 1 October, 2018. Two review authors independently assessed the methodological quality andanalyzed data by Cochrane handbook and the Rev Man 5.3 software. Begg.s test was conducted to assess publication biasvia Stata 14 software. Results: Twenty-four RCTs with 2246 patients were included in this review. Compared with blankcontrol, placebo or western medicine alone, WXKL alone or combined with western medicine could effectively reducerapid ventricular rate (MD=-7.14, 95％CI:-8.42——5.87), the frequency and duration of AF. It could also shorten thesinus rhythm conversion time (MD=-3.04, 95％CI:-3.47——2.61), increase the sinus rhythm conversion rate (RR=1.19, 95％ CI: 1.09～1.29) and decrease recurrence rate of AF (RR=0.28, 95％ CI: 0.13-0.59) . Besides, WXKL alone orcombined with western medicine was beneficial for improving the left ventricular ejection fraction (LVEF) (MD=3.44, 95％ CI: 0.87-6.01), left ventricular end diastolic diameter (LVEDD) (MD=-2.47, 95％ CI:-2.86——2.08), left atrialdiameter (LAd) (MD=-0.91, 95％CI:-1.58——0.25) and P wave dispersion (Pd) (MD=-4.04, 95％CI:-4.15——3.93) .WXKL combined with low-dose amiodarone was superior to conventional-dose amiodarone alone in improving themaximum P wave (Pmax) (MD=-8.25, 95％ CI:-10.33——6.17), and WXKL combined with conventional-doseamiodarone is more effective (MD=-13.10, 95％CI:-13.65——12.55) . Compared with the control group, the treatmentgroup had fewer adverse reactions, and the Begg.s test did not find any publication bias. Conclusion: WXKL alone orcombined with western medicine exhibited better therapeutic effects in the treatment of AF, but these results still needhigh-quality evidence to verify.

Objective: This paper analyzed the present clinical researches of traditional Chinese medicine (TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.

Objective To investigate a new automatic inverse optimal solution based on VMAT optimization model and verify its result.Methods A variant of the new automatic inverse optimal solution was proposed in this study,which provided a solution to calculate treatment plan with the minimized number of beams and the minimized levels of their intensities on the basis of VMAT optimization model by customized software tools.The verifications were evaluated on the simulated head-neck phantom by dosimetric parameters.Results Compared with conventional IMRT/VMAT treatment plans,the adaptive optimization program(AOP)plan showed that plan20/40(20 fields with totally 40 sub-fields,m=2)made the best achievement and it was clinicable.Conclusions The proposed new optimization technique provides an effective way to reach an inverse treatment plan with the best compromise and less sub-fields compared with IMRT/VMAT plans.