Construction And Application Study Of The Suitability Evaluation Index System For Reduced Glutathione For Injection

Objectives: To evaluate the efficacy and safety of combined injection of reduced glutathione in the treatment of intrahepatic cholestasis of pregnancy through meta-analysis,to provide evidence-based medical evidence for the construction of the suitability evaluation index system for injection of reduced glutathione;Construction of suitability evaluation index system of reduced glutathione for injection by Delphi method;Formulate the prescription evaluation table of reduced glutathione for injection,and evaluate the rationality of drug use of reduced glutathione for injection in combination with the constructed evaluation index system.Methods:(1)A meta-analysis was conducted on a randomized controlled trial of the combined use of reduced glutathione for injection in the treatment of intrahepatic cholestasis of pregnancy,to evaluate the safety and effectiveness of its combination therapy.(2)The suitability evaluation index system of reduced glutathione for injection was constructed by Delphi method to provide reference for clinical comprehensive evaluation of drugs.(3)Retrospective analysis of inpatient cases using reduced glutathione from January 1,2020 to December 31,2021 in a certain hospital,prescription evaluation based on evaluation indicators,and evaluation of its clinical medication rationality.Results:(1)Through the meta-analysis of the randomized controlled trial of the treatment of intrahepatic cholestasis of pregnancy with reduced glutathione for injection,it was found that compared with the control group,the combination of reduced glutathione for injection significantly improved the clinical efficiency(OR=4.38,95%CI: 2.21～8.69,P<0.0001),significantly reduced the ALT of alanine transaminase(MD=-29.61,95% CI:-36.12～23.10,P<0.0001).The levels of glutamic oxaloacetic transaminase AST(MD=-14.82,95% CI:-20.35～9.29,P<0.0001)and total bile acid TBA(MD=-10.12,95% CI:-14.24～6.00,P<0.0001)significantly reduce itching scores(MD=-1.02,95% CI:-1.57～0.45,P=0.0003<0.05),significantly reduced the cesarean section rate(OR=0.45,95%CI: 0.33～0.61,P<0.0001)Postpartum bleeding rate(OR=0.49,95% CI: 0.29～0.83,P=0.008<0.05)and fetal distress rate(OR=0.28,95% CI:0.16-0.49,P<0.0001).(2)A suitability evaluation index system for reduced glutathione for injection has been constructed and demonstrated by consulting experts through correspondence.(3)The clinical use of reduced glutathione for injection in a certain hospital from January 1,2020 to December 31,2021 was evaluated based on the prescription evaluation table.Among 1813 cases,unreasonable medication was mainly reflected in inappropriate indications(455 cases,97.43%)and unreasonable usage and dosage(12 cases,2.57%).Conclusions:(1)The combination of reduced glutathione for injection may be superior to non combination therapy in reducing itching scores,ALT,AST,TBA,cesarean section rate,postpartum hemorrhage rate,and fetal distress rate in patients with intrahepatic cholestasis of pregnancy.Given the generally low methodological quality of randomized controlled trials,more clinical evidence is still needed when using reduced glutathione for injection in combination therapy in clinical practice.(2)The suitability evaluation index system for reduced glutathione for injection is suitable for clinical use,and it is recommended to further promote its application.(3)There is an unreasonable situation in the use of reduced glutathione for injection in a certain hospital.Clinicians should strictly grasp the indications for the use of reduced glutathione for injection,give correct usage and dosage according to the drug instructions,pay attention to its adverse reactions,and achieve reasonable,safe,and effective drug use to improve the level of clinical rational medication.