重庆市某三级甲等综合医院门/急诊微生态调节剂处方点评

Review on Prescriptions of Micro-Ecological Modulators in the Outpatient/Emergency Department of a Class 3A General Hospital in Chongqing

目的 为临床合理使用微生态调节剂提供参考。方法 调取医院信息系统中该院2017年1月至2022年5月门/急诊微生态调节剂处方信息,参考《药品未注册用法专家共识》《超说明书用药专家共识》《医疗机构超药品说明书用药管理专家共识》及药品说明书,对微生态调节剂处方中超药品说明书用药情况进行统计分析。结果 5年间,该院门/急诊处方共763 082张;其中微生态调节剂处方共182 854张,涉及双歧杆菌三联活菌肠溶胶囊(68 632张,37.53%)、双歧杆菌四联活菌片(64 268张,35.15%)、枯草杆菌二联活菌肠溶胶囊(43 755张,23.93%)、枯草杆菌二联活菌颗粒(6 199张,3.39%);微生态调节剂超药品说明书用药主要表现为超适应证(136 263张,74.52%)、超用法用量(72 924张,39.88%)、超适应人群(464张,0.25%)及超给药途径(139张,0.08%),其中大部分超药品说明书用药有循证依据支持,疗效和安全性确切。结论 微生态调节剂超药品说明书用药情况较普遍,但需大量高质量研究进一步探索。随着法律与配套政策不断完善,我国超药品说明书用药的管理也日趋规范,医疗机构应在建立超药品说明书用药管理制度的基础上,对医务人员进行充分培训;医务人员自身也应加强循证用药意识,及时将既往习惯用药调整为新指南或循证依据推荐的方案。建议相关部门持续推进微生态调节剂相关临床研究,及时更新药品说明书信息,制订微生态调节剂临床用药原则,以更好地指导微生态调节剂的合理使用,保障患者用药的安全有效。

Objective To provide a reference for the rational use of micro-ecological modulators in the clinic.Methods The information of the outpatient/emergency micro-ecological modulators prescriptions in the hospital information system(HIS) from January 2017 to May 2022 was searched,and the off-label drug use in the micro-ecological modulators prescriptions was statistically analyzed by referring to the Expert Consensus on Unregistered Use of Drugs,the Expert Consensus on Off-Label Drug Use,Expert Consensus on Management of Off-Label Drug Use in Medical Institutions,and the drug instructions.Results During the five years,there were 763 082 outpatient/emergency prescriptions in the hospital.Among them,there were 182 854 prescriptions of micro-ecological modulators,involving Bifid Triple Viable Capsules Dissolving at Intestines(68 632 prescriptions,37.53%),Combined Bifidobacterium,Lactobacillus,Enterococcus and Bacillus Cereus Tablets,Live(64 268 prescriptions,35.15%),Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-Coated Capsules(43 755 prescriptions,23.93%),Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines,Live(6 199 prescriptions,3.39%).The off-label drug use of micro-ecological modulators was mainly manifested in over-indication(136 263 prescriptions,74.52%),over-usage and over-dosage(72 924 prescriptions,39.88%),over-adaptation population(464 prescriptions,0.25%) and over-administration route(139 prescriptions,0.08%),most of off-label drug use was supported by evidence-based evidence,with accurate efficacy and safety.Conclusion The off-label use of micro-ecological modulators is common,which still needs a large number of high-quality studies to further explore.With the continuous improvement of laws and supporting policies,the management of off-label drug use in China has become increasingly standardized.Medical institutions should fully train medical personnel on the basis of establishing the management system of off-label drug use in hospitals,medical staff should also strengthen the awareness of evidence-based drug use,and timely adjust the previous habitual drug use to plans recommended by new guidelines or evidence-based basis.It is suggested that relevant departments should continue to promote the clinical research of micro-ecological modulators,timely update the drug instructions,and formulate the principles of clinical use of micro-ecological modulators,so as to better guide the rational use of micro-ecological modulators and ensure the safety and effectiveness of patients′ medication.