[Reevaluation on adverse reaction monitoring and safety of proprietary Chinese medicines of Chongqing from 2005 to 2011].

OBJECTIVE

To systematically summarize the monitoring over adverse reactions of proprietary Chinese medicines, in order to provide reference for safe clinical medication.

METHOD

By using Excel and SPSS 17.0 were adopted for summarizing ADR monitoring over Chinese patent medicines and comparatively evaluating the non-proprietary Chinese medicines.

RESULT AND CONCLUSION

There were significant differences in data of different state reports of proprietary Chinese medicines and non-proprietary Chinese medicines (P<0.05). The ratio between the serious ADR of proprietary Chinese medicines and the safety risk of non-proprietary Chinese medicines was 1.057 (95% CI:0.915, 1. 221), suggesting that the safety of proprietary Chinese medicines was not higher than the non-proprietary Chinese; as such medicines as Qingkailing, Xuesaitong and Xiangdan have ranked top five for years in terms of ADR and serious ADR, the drug administration and hygiene system shall take more effective control measures for strengthening the monitoring over rational use of drugs; clinical manifestations of severe ADR of proprietary Chinese medicines were dominated by allergic shock, which could not be effectively prevented and monitored by such means as skin test, therefore, pre-clinical treatment risk-benefit evaluation shall be improved.