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Abstract：
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.
摘要：
背景技术早产是新生儿和婴儿发病率和死亡率的重要因素。对于降低围产期死亡率和发病率,预防性方法优于治疗方案。钙通道阻滞剂硝苯地平有可能被用作保胎剂，而磷酸二酯酶抑制剂枸橼酸西地那非促进平滑肌松弛.目的探讨硝苯地平联合枸橼酸西地那非治疗早产(PTL)的宫缩作用。方法经伦理委员会批准后，符合选择标准的160例患者从妇产科门急诊纳入研究，拉合尔大学,巴基斯坦。书面知情同意书后，他们的人口概况，即，name,年龄,介绍时的胎龄，奇偶校验，并注明了预计交货日期。使用计算机生成的随机数表将患者以1：1的比例随机分配到两个研究组（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毫克，然后每8小时口服10毫克，持续48小时，阴道给药枸橼酸西地那非，25毫克，间隔8小时，48小时。B组,女性口服硝苯地平20毫克，然后每8小时口服10毫克，持续48小时。他们被录取了72小时。SPSS统计21.0版(IBMCorp.2012年发布IBMSPSSStatisticsforWindows,版本21.0。Armonk,纽约：IBM公司)用于输入和分析收集到的数据。计算了年龄等定量变量的平均值和标准偏差，介绍时的胎龄，分娩时的胎龄，BMI。计算奇偶校验和早产的频率和百分比。结果本研究涉及160例患者,A组平均年龄为29.60±4.9岁，B组为30.96±4.98岁。就分娩时的胎龄而言，A组平均34.16±1.7周,B组平均33.5±1.8周(p值<0.05)。A组为68.5%，B组为41.3%，显著的p值为0.001。该研究还发现，与B组相比，A组的长期妊娠持续时间明显更高，平均14.96±10.37天和10.24±8.97天，分别(p值=0.002)。结论本研究的结果表明，枸橼酸西地那非和硝苯地平的联合使用可能为改善PTL病例的妊娠结局提供了一种有希望的新方法。在本研究中,枸橼酸西地那非加硝苯地平在PTL管理和延长分娩时平均胎龄方面显示出显著效果。
