Introduction: Developing countries are characterized by a high maternal mortality rate, particulary related to the management of childbirth. The author describes in this work 588 childbirth labors that took place with...Introduction: Developing countries are characterized by a high maternal mortality rate, particulary related to the management of childbirth. The author describes in this work 588 childbirth labors that took place without any medical supervision. Method: All patients who reached the hospital with a full cervix dilation were included in the study. The outcomes of those childbirth labors without medical supervision were evaluated at the maternal and neonatal level. Results and Discussion: The average age of the patients was 28.1 ± 13 years with 47% nulliparous and 30% pauciparous. These patients represented 14% of all births;59% of the patients had had three and five prenatal consultations. 71% of them came straight from home and had meconium-stained amniotic fluid. The APGAR score was greater than 6 in 94% of newborns, and 66.7 of them weighed between 2500 and 3500 g. Only 0.9% of patients coming from home needed a caesarean section. Conclusion: Home birth is not yet possible in Africa because it is not supervised by professionals who know the risks of childbirth, its complications and recognize the warning signs;however, the results of this preliminary study show that the issue of home childbirth in Côte d’Ivoire can be reconsidered subject to greater involvement of medical staffs.展开更多
Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical ...Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.展开更多
目的分析上海市2021年新发非利福平耐药肺结核患者手机应用程序(application,APP)督导服药的应用情况及其影响因素,为进一步优化手机APP督导管理方式的应用策略提供依据。方法通过易督导患者管理系统(e-Patient Service System,e-PSS)...目的分析上海市2021年新发非利福平耐药肺结核患者手机应用程序(application,APP)督导服药的应用情况及其影响因素,为进一步优化手机APP督导管理方式的应用策略提供依据。方法通过易督导患者管理系统(e-Patient Service System,e-PSS)平台收集患者管理数据,通过《中国疾病预防控制信息系统》结核病子系统收集患者性别、年龄组、职业、户籍、病原学结果等信息。对手机APP督导管理应用情况及相关影响因素进行统计分析。采用卡方检验和多因素非条件logistic回归分析结核病患者使用手机APP督导服药的影响因素。结果2021年上海市采用e-PSS平台管理患者2687例,其中使用手机APP督导服药的患者790例,占29.4%。使用手机APP督导服药的患者总体服药率为99.8%,总体规则服药率为99.5%,坚持打卡率为24.1%。多因素分析结果显示,病原学结果阳性(OR值为2.328,95%CI为1.474~3.825)及阴性(OR值为1.699,95%CI为1.067~2.809),年龄60岁及以下(≤20岁、>20~40岁、>40~60岁的OR值分别为11.017、16.864、9.002,95%CI分别为3.793~40.430、6.881~55.914、3.674~29.837),职业为农民(OR值为1.801,95%CI为1.289~2.519)的患者更倾向于使用手机APP进行服药管理。结论结核病患者日常服药管理应针对不同类型人群采用不同的督导管理方式,对于>20~40岁年龄组、病原学阳性、职业为农民、有合并症的结核病患者,社区医生可以优先推荐使用手机APP进行服药管理。展开更多
文摘Introduction: Developing countries are characterized by a high maternal mortality rate, particulary related to the management of childbirth. The author describes in this work 588 childbirth labors that took place without any medical supervision. Method: All patients who reached the hospital with a full cervix dilation were included in the study. The outcomes of those childbirth labors without medical supervision were evaluated at the maternal and neonatal level. Results and Discussion: The average age of the patients was 28.1 ± 13 years with 47% nulliparous and 30% pauciparous. These patients represented 14% of all births;59% of the patients had had three and five prenatal consultations. 71% of them came straight from home and had meconium-stained amniotic fluid. The APGAR score was greater than 6 in 94% of newborns, and 66.7 of them weighed between 2500 and 3500 g. Only 0.9% of patients coming from home needed a caesarean section. Conclusion: Home birth is not yet possible in Africa because it is not supervised by professionals who know the risks of childbirth, its complications and recognize the warning signs;however, the results of this preliminary study show that the issue of home childbirth in Côte d’Ivoire can be reconsidered subject to greater involvement of medical staffs.
文摘Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.
文摘目的分析上海市2021年新发非利福平耐药肺结核患者手机应用程序(application,APP)督导服药的应用情况及其影响因素,为进一步优化手机APP督导管理方式的应用策略提供依据。方法通过易督导患者管理系统(e-Patient Service System,e-PSS)平台收集患者管理数据,通过《中国疾病预防控制信息系统》结核病子系统收集患者性别、年龄组、职业、户籍、病原学结果等信息。对手机APP督导管理应用情况及相关影响因素进行统计分析。采用卡方检验和多因素非条件logistic回归分析结核病患者使用手机APP督导服药的影响因素。结果2021年上海市采用e-PSS平台管理患者2687例,其中使用手机APP督导服药的患者790例,占29.4%。使用手机APP督导服药的患者总体服药率为99.8%,总体规则服药率为99.5%,坚持打卡率为24.1%。多因素分析结果显示,病原学结果阳性(OR值为2.328,95%CI为1.474~3.825)及阴性(OR值为1.699,95%CI为1.067~2.809),年龄60岁及以下(≤20岁、>20~40岁、>40~60岁的OR值分别为11.017、16.864、9.002,95%CI分别为3.793~40.430、6.881~55.914、3.674~29.837),职业为农民(OR值为1.801,95%CI为1.289~2.519)的患者更倾向于使用手机APP进行服药管理。结论结核病患者日常服药管理应针对不同类型人群采用不同的督导管理方式,对于>20~40岁年龄组、病原学阳性、职业为农民、有合并症的结核病患者,社区医生可以优先推荐使用手机APP进行服药管理。
