Hassan Amber, Waseem Humaira, AlDardeir Nashwa, Nasief Hisham, Khadawardi Khalid, Alwazzan Ahmed B, Alothmani Haneen, Hammad Ziyad
European School of Molecular Medicine, University of Milan, Milan, ITA.
Translational Neuroscience Lab, CEINGE-Biotecnologie Avanzate, Naples, ITA.
Cureus. 2023 Jul 25;15(7):e42422. doi: 10.7759/cureus.42422. eCollection 2023 Jul.
Background Preterm delivery is a significant contributor to neonatal and infant morbidity and mortality. Preventive methods are preferable to treatment protocols for reducing perinatal mortality and morbidity. The calcium channel blocker nifedipine has the potential to be employed as a tocolytic, whereas the phosphodiesterase inhibitor sildenafil citrate promotes smooth muscle relaxation. Objective This study aims to examine the tocolytic effect of nifedipine in combination with sildenafil citrate in managing preterm labour (PTL). Methods After approval from the ethical board, 160 patients fulfilling the selection criteria were enrolled in the study from the outpatient and emergency department of obstetrics and gynaecology, University of Lahore, Pakistan. After taking written informed consent, their demographic profile, i.e., name, age, gestational age at presentation, parity, and expected date of delivery was noted. Patients were randomly assigned in a 1:1 ratio to two study groups (Group A: sildenafil citrate + nifedipine) and (Group B: nifedipine) using a computer-generated random number table to obtain a trial sequence. In group A, each patient was given nifedipine 20 mg orally, followed by 10 mg orally every eight hours for 48 hours and vaginal administration of sildenafil citrate, 25 mg at eight-hour intervals, for 48 hours. In group B, females were given nifedipine 20 mg orally, followed by 10 mg orally every 8 hours for 48 hours. They were kept admitted for 72 hours. SPSS Statistics version 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) was used to enter and analyse the collected data. Mean and standard deviation was calculated for quantitative variables like age, gestational age at presentation, gestational age at delivery, and BMI. Frequency and percentage were calculated for parity and preterm delivery. Results The study involved 160 patients, with the average age in Group A being 29.60±4.9 years and in Group B being 30.96±4.98 years. In terms of gestational age at delivery, Group A had an average of 34.16±1.7 weeks, while Group B had an average of 33.5±1.8 weeks (p-value<0.05). Preterm delivery was observed in 68.5% of Group A and 41.3% of Group B, with a significant p-value of 0.001. The study also discovered that the duration of prolonged pregnancy was significantly higher in Group A compared to Group B, with averages of 14.96±10.37 days and 10.24±8.97 days, respectively (p-value=0.002). Conclusion The results of this study suggest that the combination of sildenafil citrate and nifedipine may offer a promising new approach to improving pregnancy outcomes in cases of PTL. In the present study, sildenafil citrate plus nifedipine showed a significant effect in the management of PTL and prolongation in mean gestational age at delivery.
背景 早产是新生儿和婴儿发病及死亡的一个重要因素。预防方法对于降低围产期死亡率和发病率优于治疗方案。钙通道阻滞剂硝苯地平有作为宫缩抑制剂使用的潜力，而磷酸二酯酶抑制剂枸橼酸西地那非可促进平滑肌松弛。目的 本研究旨在探讨硝苯地平联合枸橼酸西地那非在处理早产（PTL）中的宫缩抑制作用。方法 经伦理委员会批准后，从巴基斯坦拉合尔大学妇产科门诊和急诊科纳入160例符合入选标准的患者。在获得书面知情同意后，记录其人口统计学资料，即姓名、年龄、就诊时的孕周、产次和预产期。使用计算机生成的随机数字表将患者按1:1比例随机分为两个研究组（A组：枸橼酸西地那非 + 硝苯地平）和（B组：硝苯地平）以获得试验序列。在A组中，每位患者口服硝苯地平20 mg，随后每8小时口服10 mg，共48小时，并每8小时阴道给药枸橼酸西地那非25 mg，共48小时。在B组中，女性口服硝苯地平20 mg，随后每8小时口服10 mg，共48小时。她们住院72小时。使用SPSS Statistics 21.0版（IBM公司。2发布于2012年。适用于Windows的IBM SPSS Statistics，版本21.0。纽约州阿蒙克：IBM公司）录入和分析收集的数据。计算年龄、就诊时孕周、分娩时孕周和BMI等定量变量的均值和标准差。计算产次和早产的频率及百分比。结果 该研究涉及160例患者，A组平均年龄为29.60±4.9岁，B组为30.96±4.98岁。在分娩时孕周方面，A组平均为34.16±1.7周，而B组平均为33.5±1.8周（p值<0.05）。A组68.5%的患者发生早产，B组为41.3%，p值为0.001，具有显著性差异。研究还发现，A组延长妊娠的时间明显高于B组，平均分别为14.96±10.37天和10.24±8.97天（p值 = 0.002）。结论 本研究结果表明，枸橼酸西地那非和硝苯地平联合使用可能为改善PTL病例的妊娠结局提供一种有前景的新方法。在本研究中，枸橼酸西地那非加硝苯地平在PTL管理和延长平均分娩孕周方面显示出显著效果。
