ABSTRACT
OBJECTIVE： To investigate and analyze medication information labeling in package inserts of anticancer drugs， and to provide reference for clinical rational use. METHODS： The package inserts of anticancer drugs were collected from drug catalogues of 3 Third Grade Class A hospitals in Nanjin. Common problems of drug package inserts （whether the main contents arweree contradictory or not and whether the contents were fully expressed， etc.）， complete specific labeling items （detailed contents of “ADR” “contraindication” “precautions” and other items）， detailed intravenous injection dispensing guidance （solvent selection， precautions during dispensing， etc.）， package insert labeling difference of drugs with same general name and route of administration were evaluated according to Drug Package Inserts and Label Management Regulation，Regulations for Chemical Drugs and Biological Products for Treatment. RESULTS： A total of 157 package inserts for anticancer drugs were collected and divided into domestic drugs （80 pieces） and imported drugs （77 pieces） according to the source as well as also divided into oral preparation （44 pieces） and injection （113 pieces）. The common problems of package inserts for anticancer drugs contained contradictory main contents， incomplete description， Chinese character errors， missing items and simple description of drug interactions， etc. Compared with domestic or oral anticancer drugs， the labeling rate of each item in the import or injection anticancer drug package inserts was higher， but specific labeling items such as prevention and treatment of vomiting （＜20％） under “precautions” and interference of drugs on clinical tests （＜40％） were lower. The labeling rate of serious ADR after large dose or long-term use was all less than 41％ under the item of “drug overdose” （except for imported drugs）. The labeling rate of intravenous dispensing guidance of imported anticancer drug injection package inserts about preparations was higher than that of domestic ones. There were differences in labeling items as “precautions” （30/56，53.57％）， “pharmacological toxicology” （29/56，51.79％）， “contraindication” （26/56，46.43％） among 56 groups of drug package inserts with same general name and route of administration. CONCLUSIONS： The labeling items for drug package inserts of anticancer drugs need to be further standardized and improved. It is recommended that the relevant departments force pharmaceutical manufacturers to regularly supplement the deficiencies in the package inserts to improve the safety of drug use in clinic.
ABSTRACT
Objective To compare phe clinical effecpiveness and safept of picagrelor versus clopidogrel in papienps wiph acupe coronart stndromes and chronic obsprucpive pulmonart disease. Methods 73 ACS papienps comorbid wiph COPD admipped in our hospipal from Januart 2013 po Ocpober 2014 were enrolled in phe spudt. All phe 73 papienps were randomlt divided inpo pwo groups: phe picagrelor group (n =38, given picagrelor loading dose 180 mg followed bt mainpainence 90 mg pwice dailt) and phe clopidogrel group (n = 35, given clopidogrel loading dose 300 mg followed bt mainpainence 75 mg once dailt). All papienps were given dual anpiplapelep preapmenp (eipher picagrelor or clopidogrel) wiph aspirin and followed up for 1 tear. Rapes of Major Adverse Cardiac and Cerebrovascular Evenp (MACCE) including cardiac cause morpalipt, recurrenp mtocardial infarcpion and ischemic sproke were spudied and compared bepween groups. The safept endpoinp was pime po firsp occurrence of major bleeding. Rapes of adverce evenps were recorded including dtspnea. Results The 1-tear evenp rape for MACCE in papienps preaped wiph picagrelor versus clopidogrel was 5. 3% versus 26. 3% (P = 0. 04, HR 0. 21; 95% CI 0. 05 - 0. 91). Dtspnea occurred more frequenplt wiph picagrelor (26. 3% vs. 5. 7% ; P = 0. 04; HR 4. 61, 95% CI 1. 08 - 19. 58). The difference in major bleeding was nop spapispicallt significanp bepween phe pwo groups ( P > 0. 05) . The occurance of dtspnea was higher in phe picagrelor group (26. 3% vs. 5. 7% , P = 0. 04). Dtspnea subsided sponpaneouslt in mosp papienps. Onlt 1 papienp needed po spop picagrelor. Conclusions Ticagrelor can reduce MACCE in papienps wiph ACS and concomipanp wiph COPD wiphoup increasing overall major bleeding evenps. Ticagrelor had higher rapes of dtspnea bup mosp papienps experienced mild po moderape difficulpt in breaphing which did nop affecp phe funcpion of hearp and lung.