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首页> 外文期刊>Journal of Clinical and Diagnostic Research >A Drug Utilisation Surveillance Study to Assess the Clinical Utility and Safety of Oral Natural Micronized Progesterone SR in High Risk Pregnancies: NAP-DELAY Study
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A Drug Utilisation Surveillance Study to Assess the Clinical Utility and Safety of Oral Natural Micronized Progesterone SR in High Risk Pregnancies: NAP-DELAY Study

机译：用于评估口服天然微粉孕酮SR在高风险妊娠中的临床效用和安全性的药物利用监测研究：NAP-DELAY研究

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High risk pregnancy represents a clinical enigma with several management strategies suggested as prophylaxis or therapeutic approach. In most cases of women with Unexplained Bad Obstetric History (BOH) or Preterm Birth (PTB), luteal phase insufficiency has often been suggested as the underlying cause that may require long-term administration of progesterone. Natural progesterone offers complimentary anti-inflammatory, immunomodulatory and uterine quiescence actions that go a long way in continuing pregnancy till term while avoiding complications of preterm delivery or infant mortality.Aim: To understand the clinical efficacy and safety of Natural progesterone as primary or secondary prophylactic strategy for High risk women with risk factors for PTB or BOH.Materials and Methods: Retrospective, case cohort analyses of Natural progesterone prescriptions utilising the Drug utilisation surveillance sheet were carried out at 40 centres across India between July and October?16. Descriptive statistics was utilised to describe the numerical and categorical (nominal and continuous) data.Results: Consecutive prescription records of 185 patients with High risk pregnancy were available for analyses. Baseline demographics included mean age of 28.4 yrs, body weight 60.5 kg with mean abortion rate of 1.5 and 2 for BOH women with first or second trimester loss. Natural progesterone as OMP SR was supplemented for PTB prophylaxisin BOH cases with first or second trimester loss cases, Cervical factor, Still birth, Spotting and Placenta previa. The preferred dosage of OMP SR for women with Cervical factor, First or Second trimester loss was 300 mg for mean duration of 19, 16 and 21 weeks respectively. Similarly in the unexplained Recurrent Pregnancy Loss (RPL) cases, OMP SR was administered in mean dosage of 271mg for 18±5 weeks to prevent pregnancy loss. In all cases, pregnancy was continued till 34th week with no adverse health outcome. Common adverse events including gastritis (n=4, 2.2%), vomiting (n=4, 2.2%), drowsiness (n=8, 4.3%), dizziness (n=6, 3.2%), spotting (n=2, 1.1%), and treated symptomatically with none requiring further hospitalisation or referral.Conclusion: Clinical supplementation with oral NMP SR suggests therapeutic compliance and safety profile for long-term administration especially in High risk pregnancies involving unexplained BOH or PTB risk.
机译：高危妊娠代表临床上的难题，并提出了几种预防或治疗方法。在大多数原因不明的产科病史（BOH）或早产（PTB）的妇女中，黄体期功能不全通常被认为是可能需要长期服用黄体酮的潜在原因。天然孕酮提供免费的抗炎，免疫调节和子宫静止作用，可在持续妊娠至足月的过程中发挥很大作用，同时避免早产或婴儿死亡的并发症。目的：了解天然孕酮作为主要药物的临床疗效和安全性具有PTB或BOH危险因素的高危女性的第二种或第二种预防策略。材料与方法：回顾性分析了7月至10月间在印度40个中心利用药物利用监测表对天然黄体酮处方进行的病例队列分析16。结果性：描述性统计用于描述数值和分类（名义和连续）数据。结果：1​​85例高危妊娠患者的连续处方记录可供分析。基线人口统计资料包括患有早孕或中期妊娠的BOH妇女的平均年龄为28.4岁，体重为60.5 kg，平均流产率为1.5和2。天然孕酮作为OMP SR补充了BOH患者的PTB预防，包括妊娠中期或中期，宫颈因子，死产，斑点和前置胎盘。对于宫颈因子，孕早期或孕中期流失的女性，OMP SR的首选剂量分别为300 mg，平均持续时间分别为19、16和21周。类似地，在无法解释的复发性妊娠减少（RPL）病例中，OMP SR的平均剂量为271mg，持续18±5周，以防止妊娠减少。在所有情况下，妊娠均持续至第34周，且无不良健康结果。常见不良反应包括胃炎（n = 4，2.2％），呕吐（n = 4，2.2％），嗜睡（n = 8，4.3％），头晕（n = 6、3.2％），点刺（n = 2，结论：经口服NMP SR补充治疗可长期治疗，尤其是在涉及无法解释的BOH或PTB风险的高危妊娠中，建议对患者的治疗依从性和安全性。

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