The Adverse Reaction Of Potassium Sodium Dehydroandrographolide Succinate Injection: A Systematic And Meta-analysis

ObjectiveThe papers related with adverse reaction of Potassium Sodium Dehydroandrographolide Succinate Injection were analyzed by Meta analysis in order to evaluate the safety of the clinical application and provide reference for clinical use of Potassium Sodium Dehydroandrographolide Succinate Injection.MethodTwo researchers retrieved independently the papers associated with the adverse reaction of Potassium Sodium Dehydroandrographolide Succinate Injection published from January 2000 to December 2016 using databases such as CNKI,Wanfang Data,VIP,CBM,PubMed,MEDLINE,Web of Science,ClinicalTricals.gov and so on.According to the incorporation and exclusion criteria,the papers were compiled and screened using the document management software NoteExpress 3.0.The database was established using the office software Excel 2010 to extract the data from these papers included in the study.The quality of the included papers were evaluated using the biased risk assessment tool recommended by the Cochrane Collaboration.And then meta-analysis of adverse reactions of Potassium Sodium Dehydroandrograpolide Succinate Injection was performed by using the RevMan 5.3 software.The heterogeneity of different studies were examined by Q test and I2 statistic.Moreover,the adverse reactions of Potassium Sodium Dehydroandrograpolide Succinate Injection were analyzed respectively by subgroup analysis according to different age groups,different courses and different control measures.ResultsA total of 50 studies were suit with the incorporation and exclusion criteria.Results of meta-analysis showed that 4090 patients using Potassium Sodium Dehydroandrograpolide Succinate Injection were included(experimental group)and 128 appeared the adverse reactions among them.A total of 3790 patients with the control drug were enrolled(using other medicines)and 288 appeared the adverse reactions.The risk ratio RR=0.48,95%CI(0.34,0.69)and had significant differences(P<0.0001)between the experimental group and the control group.Results of subgroup analyses showed that: ?subgroups of different ages: In the subgroup with age of patients less than 14 years old,the risk of adverse reaction of Potassium Sodium Dehydroandrograpolide Succinate Injection was significantly lower than the control group(P=0.0001).Potassium Sodium Dehydroandrographolide Succinate Injection was used extensively in pediatrics(?14 years old children).?subgroups of different courses of treatment: The risk of adverse reactions of Potassium Sodium Dehydroandrograpolide Succinate Injection in groups with courses of treatment ? 5 days and > 5 days were significantly lower than the control group(P=0.001 and P=0.01,respectively).?subgroups of different control measures: The risk of adverse reactions of Potassium Sodium Dehydroandrograpolide Succinate Injection in groups with ribavirin group and ?-interferon were significantly lower than the control group(P=0.002 and P<0.00001,respectively).The clinical manifestations of adverse reactions to Potassium Sodium Dehydroandrographolide Succinate Injection were analyzed,and the results showed that the main clinical symptoms of Potassium Sodium Dehydroandrographolide Succinate Injection were allergic and gastrointestinal reactions.ConclusionCompared to ribavirin(P=0.002)and ?-interferon(P<0.00001),the risk of adverse reaction of Potassium Sodium Dehydroandrographolide Succinate Injection was low and the results had statistically significant differences.The symptoms of adverse reactions of Potassium Sodium Dehydroandrographolide Succinate Injection in the clinical practice mainly include rash,pruritus,nausea,vomiting,abdominal pain,diarrhea and so on.The occurrence of these adverse reactions may be related to patients,courses of treatment and whether based strictly on the drug instructions and other factors.