Abstract��OBJECTIVE To investigate the clinical use of ornidazole injection in a wide patient population by the post-marketing hospital centralized monitoring method in order to regulate and guide its rational use, improve the drug specification, and provide a basis for the drug therapy. METHODS A prospective, multi-center, large sample hospital centralized monitoring method was adopted. Five sentinel hospitals in Hubei Province were selected, and hospitalized patients who received ornidazole injection treatment from July 1, 2015 to October 31, 2015 were observed. The basic information of the patients was recorded, as well as the drug use and adverse events, and then statistical analysis was made. RESULTS A total of 4396 cases were enrolled in this study, most of them were middle-aged female patients. Ornidazole injection was mainly used before surgeries to prevent infections and after surgeries for treatment of anaerobic infections, abdominal infections and pelvic infections. Irrational drug use existed in clinic, mainly concentrating at unreasonable dosing frequency, excessive dripping speed, and long duration of use. Eleven cases of adverse reactions were collected during the monitoring, indicating an incidence of adverse drug reactions of 2.5��, and most of the adverse drug reactions occurred within 30 min post drug administration. CONCLUSION The manufacturers should make further investigation on the dripping speed and quality standard of ornidazole injection to further improve the information in the package insert and regulate the clinical use.
ZHANG Q L, WANG Z, JING Z W, et al. Study on 5 800 cases of post-marketing safety intensive hospital monitoring of Qingkailing injection [J]. Chin J Pharmacovigil (�й�ҩ�ﾯ��), 2015,12(7):417-419.
XIE Y M, LIAO X, ZHAO Y B, et al. Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine(draft version for comments) [J]. China J Chin Mater Med (�й���ҩ��־), 2013,38(18):2919-2924.
JIANG J J,XIE Y M. The quality control optimization for hospital centralized monitoring of TCM injections based on on-site inspection [J]. J Tradit Chin Med (��ҽ��־), 2014,55(17):1506-1508.
DU J, DENG P, CHEN X, et al. Characterization of ornidazole metabolites in human bile after intraveneous doses by ultraperformance liquid chromatography/quadrupole time-of-flight mass spectrometry[J]. Acta Pharm Sin B(ҩѧѧ��Ӣ�İ�), 2012, 2(2):159-167.
RAETHER W, H?NEL H. Nitroheterocyclic drugs with broad spectrum activity[J]. Parasitol Res, 2003, 90(suppl 1):S19-S39.
YANG W, WANG L X, XlE Y M. Safety analysis of commonly used TCM injections in 10 029 centralized monitoring hospitalized patients with infections diseases [J]. J Tradit Chin Med (��ҽ��־), 2014,55(8):666-669.
ZHAO Y, SHI C, HUANG P. Analysis of clinical use of post-marketing hospital centralized monitoring of Xiyanping injection [J]. China J Chin Mater Med (�й���ҩ��־), 2016, 41(4):743-747.
WANG Y Y, DU X X, XIE Y M. Technical Manual for Clinical Safety Evaluation of Chinese Medicine Injection (��ҩע����ٴ���ȫ�����ۼ���ָ��) [M]. Beijing:People's Health Publishing House, 2013:123.
CHEN W B, PAN X L. Diagnostics (���ѧ) [M]. 7th ed. Beijing:People's Health Publishing House, 2008:16-466.
JIANG J J, XIE Y M. Discussion on establishment of quality control system for intensive hospital monitoring on traditional Chinese medicine injections [J]. China J Chin Mater Med (�й���ҩ��־), 2012,37(18):2689-2691.
DIAO M Y. The effects of chinese and western medicine in the treatment of ulcerative colitis [J]. Chin J Integr Tradit West Med Dig(�й�����ҽ���������־), 2009, 17(4):264-265.
SONG L X, ZHANG Y M. Reasons analysis on vascular injury by venous transfusion [J]. Guide China Med(�й�ҽҩָ��), 2012, 9(25):300-301.