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西地那非单药与西地那非联合波生坦治疗新生儿持续性肺动脉高压的疗效比较

Comparison Of The Efficacy Of Sildenafil Alone Versus Sildenafil Plus Bosentan In Newborns With Persistent Pulmonary Hypertension.

作者信息

Fatima Nazia, Arshad Sohail, Quddusi Ahmed Iqbal, Rehman Abdur, Nadeem Aashee, Iqbal Imran

机构信息

Department of Pathology, Ayub Medical College, Abbottabad, Pakistan.

Oral Pathology, Ayub Medical College, Abbottabad, Pakistan.

出版信息

J Ayub Med Coll Abbottabad. 2018 Jul-Sep;30(3):333-336.

PMID:30465360
Abstract

BACKGROUND

Persistent pulmonary hypertension is a serious disease among new-borns. Inhaled nitric oxide is first line of therapy along with extracorporeal membrane oxygenation. Pulmonary vasodilators such as sildenafil, bosentan and milrinone are also used to treat persistent pulmonary hypertension especially in resource limited centres where inhaled nitric oxide is not available. The objective of this study was to compare the effect of sildenafil alone and sildenafil with bosentan on severity of tricuspid regurgitation and duration of hospitalization in new-borns with persistent pulmonary hypertension.

METHODS

This was single blinded clinical trial conducted at The Children's Hospital & the Institute of Child Health, Multan, Pakistan, from July 2016 to December 2016. New-borns with pulmonary hypertension were admitted and divided into two groups. Group A was treated with sildenafil (2mg per kg per dose three times a day) and group B with both sildenafil (2 mg per kg per dose three times a day) and bosentan (1 mg per kg per dose twice a day).

RESULTS

There were 50 new-borns in each group. The mean age, sex distribution and baseline TR measurement (mmHg) at the time of admission was similar in both the groups. Measurement of TR (mmHg) after 72 hours admission was significantly less in Group B as compared to group A (11±4.62 versus 23±4.78), p-value<0.0001. The mean duration of hospital stays (days) was 10.12±5.20 in group A and 7.56±3.77 in group B (p-value <0.0001). There was no mortality in any group and no case of hypotension in both groups.

CONCLUSIONS

The combined use of sildenafil and bosentan is more effective than sildenafil alone for control of pulmonary hypertension in resource limited centres.

摘要

背景

持续性肺动脉高压是新生儿中的一种严重疾病。吸入一氧化氮与体外膜肺氧合是一线治疗方法。西地那非、波生坦和米力农等肺血管扩张剂也用于治疗持续性肺动脉高压,尤其是在无法获得吸入一氧化氮的资源有限的中心。本研究的目的是比较单独使用西地那非和西地那非联合波生坦对持续性肺动脉高压新生儿三尖瓣反流严重程度和住院时间的影响。

方法

这是一项于2016年7月至2016年12月在巴基斯坦木尔坦儿童医院和儿童健康研究所进行的单盲临床试验。患有肺动脉高压的新生儿入院后分为两组。A组接受西地那非治疗(每千克体重每次2毫克,每日三次),B组接受西地那非(每千克体重每次2毫克,每日三次)和波生坦(每千克体重每次1毫克,每日两次)联合治疗。

结果

每组有50名新生儿。两组入院时的平均年龄、性别分布和基线三尖瓣反流测量值(毫米汞柱)相似。入院72小时后,B组的三尖瓣反流测量值(毫米汞柱)明显低于A组(11±4.62对23±4.78),p值<0.0001。A组的平均住院天数为10.12±5.20天,B组为7.56±3.77天(p值<0.0001)。两组均无死亡病例,也无低血压病例。

结论

在资源有限的中心,西地那非和波生坦联合使用比单独使用西地那非更有效地控制肺动脉高压。

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