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Objective To evaluate the efficacy and safety of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding.Methods It was designed as a multi-center,stratified randomized,double-blind,positive drug parallel controlled and non-inferiority study.From October 2014 to April 2015,at 40 hospitals,patients with peptic ulcer hemorrhage confirmed by gastroendoscopy were enrolled and divided into the ilaprazde sodium group (10 mg ilaprazole sodium for injection every 24 h,the first dose doubled) and the positive control group (40 mg of omeprazole sodium for injection every 12 h).The course of both treatment was 72 h.The hemostasis rate of overall group at 72 h,the clinical rebleeding rate at four to seven days,the blood transfusion rate,the incidence of switching to other treatments and the incidence of adverse reactions were compared between the two groups.A chi-square test or Fisher's exact probability method were performed for statistical analysis.Results A total of 533 patients with peptic ulcer bleeding were enrolled,355 patients in the ilaprazole sodium group and 178 patients in the positive control group.The hemostasis rates of ilaprazole sodium group and positive control group at 72 h were 97.69 ％ (339/347) and 97.14 ％ (170/175),respectively,and the difference was not statistically significant (P＞0.05).There were no rebleeding patients in both groups at four to seven days.The blood transfusion rates of ilaprazole sodium group and positive control group were 5.07 ％ (18/355) and 3.37 ％ (6/178).The incidence of switching to other treatments was 0.56％ (2/355) and 0.56％ (1/178),respectively,and the differences were not statistically significant (both P＞ 0.05).The incidence of adverse reactions in the ilaprazole sodium group was 3.94％ (14/355),which was lower than that of positive control group (8.43％,15/178).And the difference was statistically significant (Fisher's exact probability method,P=0.042).Conclusions The efficacy of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding is similar to that of omeprazole sodium for injection.Moreover,the smaller the dose,the lower the frequency of administration and the better the safety.
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OBJECTIVE:To provide reference for better improving the risk perception of Omeprazole sodium for injection in nurses in a third-grade class-A hospital,strengthening risk management of ward drugs and ensuring safety of patients. METHODS:Nurses in the clinical departments in a third-grade class-A hospital where usage frequency of Omeprazole sodium for injection was relatively more were adopted as study subjects and a self-designed questionnaire was used to investigate on related knowledge on medication risk in nurses in emergency department,gastroenterology department,ICU and CCU in 2012 and 2014. RESULTS:51 and 81 questionnaires were distributed in 2012 and 2014,and 51 and 81 were effectively received with effective recovery of 100%and 100%,respectively. In both surveys,100% surveyed nurses could correctly choose one solvent at least,1.96% and 3.70%nurses could correctly choose 2 solvents;correct answering rates of intravenous administration time were 94.12% and 96.30%,re-spectively;correct answering rates of stable duration after preparation were both lower than 9%;correct answering rates of adverse reaction of this drug were 3.92% and 1.23%,respectively;correct answering rates of interaction of this drug were 1.96% and 6.17%,respectively;correct answering rates of stable formulation of this drug were 17.65%and 22.22%,respectively;the propor-tion of nurses observing ADRs were 25.49% and 13.58%,respectively;the proportion of nurses finding inappropriate compatibility were 15.69% and 22.22%,respectively,Ornidazole and sodium chloride injection was the most used incompatible drug;45% or more nurses hoping to strengthen the continuing education of nursing personnel. CONCLUSIONS:Nurses in this third-grade class-A hospital lack certain knowledge on the medication risk of Omeprazole sodium for injection,the drug risk management is not sufficient,and awareness prevention of drug risk is relative weak. It is suggested that the hospital should strengthen drug risk management system,nurses should strengthen the learning about drug risk and play the role of clinical pharmacists in the drug risk management to reduce the related drug risk and incidence of adverse reactions.
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Objective To select omeprazole content changes smaller with dispensing method and to seek for rationality of off-label uses.Methods To measure content change of omeprazole sodium for injection mixed by different subscriptions at different time through HPLC, and compared effect of different dispensing methods on content of omeprazole sodium for injection.Results 10 mL 0.9%sodium chloride injection was chosed as dissolvent,the change of omeprazole sodium for injection content would be minor, and stability of drug solution was superior.Conclusion Dispensing methods of drug impact on its'security and validity, which is part of discuss category about medicine rational use as well.Off-label uses could not vest in unreasonable use, which should contingent on specific document,data and actual environment of medical treatment.
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OBJECTIVE:To study the stability of omeprazole sodium solution for injection under the influence of metal ion calcium and magnesium.METHODS:HPLC was adopted to determine the variation of the content of omeprazole sodium solution acted by metal ion calcium and magnesium of different concentrations in different time.The change in colour and luster was also observed.RESULTS:Omeprazole sodium solution tended to disintegrate rapidly along with the prolonging of time,and increase with the increasing of concentration;when Mg2+ was added,change in color was seen,with no degradation substance produced;when Ca2+was added,change in color was also seen,with white deposit produced.CONCLUSION:Ca2+ and Mg2+ show significant influence on the stability of omeprazole sodium solution.