Objective

2

To perform a clinical comprehensive evaluation of Xianyu capsules in the treatment of epilepsy with wind-phlegm obstruction syndrome to provide methodological references for clinical rational medication and post-marketing research on Chinese medicine.

Method

2

Based on evidence-based medicine，clinical epidemiology，clinical medicine，evidence-based pharmacy， and pharmacoeconomics，the clinical comprehensive evaluation was carried out from the "6 + 1" dimensions of safety，effectiveness，economy，innovation，suitability，and accessibility， as well as characteristics of traditional Chinese medicine （TCM） using public data，literature data，pharmaceutical research，questionnaire survey， and other information by qualitative and quantitative evaluation methods in combination. Multi-criteria decision analysis （MCDA） model and CSC software V2.0 were adopted to evaluate the clinical value of Xianyu capsules. The evaluation results of each dimension were divided into four grades，

i.e.

， A，B，C， and D.

Result

2

Multiple sources of safety evidence such as spontaneous reporting system （SRS） monitoring data，literature reports， and clinical studies showed that the main adverse reactions of Xianyu capsules were dizziness，drowsiness， and nausea，and there were no serious adverse reactions. Due to the sufficient evidence and the controllable risk， they were graded B for the safety. Meta-analysis showed that Xianyu capsules combined with conventional western medicine in the treatment of epilepsy were better than conventional western medicine alone in reducing the frequency of seizures （times/month） and improving the total clinical effective rate，and they were graded B for the effectiveness. The results of pharmacoeconomic research showed that Xianyu capsules combined with conventional western medicine （magnesium valproate sustained-release tablets） had cost-effectiveness advantages over magnesium valproate sustained-release tablets alone in the treatment of epilepsy，but the level of incremental effect was not significant. Therefore， they were graded B for economy. Xianyu capsules are the only Chinese patent medicine that can treat epilepsy under the list of phlegm-eliminating and orifices-opening agents with aromatics in the current national medical insurance catalogue. They are designed for the syndrome of wind-phlegm obstruction with clear syndrome type. The company has insisted on inheritance and innovation based on the classic famous prescriptions by virtue of modern science and technology，and obtained a number of patents for invention. Hence， they were graded A for the innovation. The questionnaire results showed that the use of drugs could meet the medication needs of clinical doctors and patients，and the publicity materials such as instructions and labels were accurate and complete without exaggeration and misleading. The information service of drug instructions，labels， and packaging was normative. According to the comprehensive questionnaire and the information service results of Chinese patent medicine，they were graded A for the suitability. Compared with the price of similar drugs，the price of Xianyu capsules is moderate. The cost of treatment accounts for a high proportion of per capita disposable income and is generally affordable. Because of a wide sales scope， sustainable medicinal material resources， and good availability，they were graded B for the accessibility. Xianyu capsules are derived from the combination of the classic prescriptions Qianzhengsan and Tianma Goutengyin， which are designed for the syndrome of wind-phlegm obstruction with rich experience in human use. Hence， they were rated as grade B for TCM characteristics. Based on the evidence evaluation results of "6 + 1" dimensions of Xianyu capsules，the comprehensive evaluation of clinical value was B.

Conclusion

2

The clinical value of Xianyu capsules in the treatment of epilepsy with wind-phlegm obstruction syndrome is high，and the TCM characteristics are prominent. It is suggested to convert into the relevant policy results of basic clinical medication management according to the procedure.