在资源匮乏环境中使用拉替拉韦口服混悬剂治疗新生儿的可接受性和可行性。
Acceptability and Feasibility of Using Raltegravir Oral Granules for the Treatment of Neonates in a Low-resource Setting.
机构信息
From the Department of Paediatrics and Children Health, University of KwaZulu-Natal, Durban, South Africa.
Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu-Natal, Durban, South Africa.
出版信息
Pediatr Infect Dis J. 2020 Jan;39(1):57-60. doi: 10.1097/INF.0000000000002539.
BACKGROUND
Raltegravir granules for oral suspension, now recommended by World Health Organization for use in neonates with HIV infection, may be challenging for caregivers because of the multistep preparation required.
METHODS
We evaluated the acceptability and feasibility of preparing granules for oral suspension in a low-to-middle-income country setting. Thirty-four caregivers and 10 health-care workers were enrolled from an HIV clinic in Durban, South Africa. Health-care workers were provided with pictorial instruction booklet, demonstration kit and guidance on preparation of granules for oral suspension. The health-care workers then trained caregivers on the preparation of granules for oral suspension. Caregivers were evaluated during the preparation process and instructed to practice at home with a sample kit and return to the clinic for repeat evaluation 5-7 days later. Caregivers and health-care workers were interviewed and participated in a focus group discussion regarding their experiences.
RESULTS
The median age of the caregivers was 31 years (interquartile range: 9.7); 70% had received secondary-level education, 37% were employed. The median preparation time was 7.95 minutes (interquartile range: 5.08 minutes) and 7.48 minutes (3.55 minutes) at initial and repeated observation, respectively. Major errors were insufficient mixing time and incorrect suspension volume. The average number of errors between the 2 observation time points was significantly reduced at the repeat session (2.5 vs. 0.87, P = 0.023). Most participants found the preparation difficult at first but gained confidence over time.
CONCLUSION
Despite the complexity involved in the preparation of the granules for oral suspension, with practice, this formulation was found to be acceptable and feasible to majority of participants in this low-resource setting. As a result, this formulation was included in the 2018 World Health Organization recommendations for first line in neonates living with HIV.
背景
世界卫生组织推荐将拉替拉韦颗粒口服混悬液用于感染 HIV 的新生儿，由于需要多步制备，可能会给护理人员带来挑战。
方法
我们评估了在中低收入国家环境中制备拉替拉韦颗粒口服混悬液的可接受性和可行性。在南非德班的一家 HIV 诊所招募了 34 名护理人员和 10 名卫生保健工作者。为卫生保健工作者提供了图文并茂的使用说明书、示范工具包，并指导他们如何制备拉替拉韦颗粒口服混悬液。然后，卫生保健工作者对护理人员进行了拉替拉韦颗粒口服混悬液的制备培训。在制备过程中对护理人员进行了评估，并指导他们在家中使用样本试剂盒进行练习，然后在 5-7 天后返回诊所进行重复评估。对护理人员和卫生保健工作者进行了访谈，并就他们的经验参加了焦点小组讨论。
结果
护理人员的中位年龄为 31 岁（四分位距：9.7）；70%接受过中学教育，37%有工作。初始观察和重复观察的中位准备时间分别为 7.95 分钟（四分位距：5.08 分钟）和 7.48 分钟（3.55 分钟）。主要错误是混合时间不足和混悬液体积不正确。在重复观察时，两次观察时间点之间的平均错误数明显减少（2.5 比 0.87，P = 0.023）。大多数参与者一开始觉得准备工作很困难，但随着时间的推移，他们逐渐有了信心。
结论
尽管拉替拉韦颗粒口服混悬液的制备过程复杂，但经过实践，在这种资源有限的环境下，大多数参与者认为这种制剂是可以接受和可行的。因此，这种制剂被纳入了 2018 年世界卫生组织推荐用于 HIV 感染新生儿的一线治疗方案。
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