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Chinese Journal of Hospital Pharmacy. 2014, (16) Core

Application of the Bradford Hill criteria to assess the causality of sitagliptin-induced digestive system adverse drug reactionsChinese Full Text

PENG Yuan;WANG Cheng-cheng;TANG Li;ZHANG Zhi-yong;Department of Pharmacy,West China Hospital,Sichuan University;West China School of Pharmacy,Sichuan University;

Abstract: OBJECTIVE To assess the causality of sitagliptin-induced digestive system adverse drug reactions after signals mining,and to attempt to provide some references for clinical.METHODS All relative literatures were searched systematically and screened according to the inclusion criteria.Included studies and U.S.A adverse event reporting system（AERS）data mining information were evaluated and analyzed critically.RESULTS 36 sitagliptin vs placebo RCTs,25 sitagliptin vs positive drug RCTs,5 case reports and 410 reports from the AERS were included.The results demonstrated that the causality of sitagliptin-induced digestive system adverse drug reactions fulfilled the Bradford Hill criteria:the consistency,specificity,temporality,plausibility,coherence,experimental evidence and analogy,except that the strength was weak and the biological gradient was not defined clearly.CONCLUSION Causality of sitagliptin-induced digestive system adverse drug reactions is strong,it should be noted the occurrence of the digestive system of ADRs during medication,while the relationship of ADRs and gender,age,etc.need further studies.
Keywords：

the Bradford Hill criteria; sitagliptin; digestive system; adverse drug reaction; causality;

  • DOI：

    10.13286/j.cnki.chinhosppharmacyj.2014.16.21

  • Series：

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  • Classification Code：

    R977.15

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