硝苯地平缓释片联合硫酸镁注射液治疗妊娠高血压综合征患者的临床研究

Clinical trial of nifedipine sustained-release tablets combined with magnesium sulfate injection in the treatment of pregnancy-induced hypertension syndrome

目的观察硝苯地平缓释片联合硫酸镁注射液治疗妊娠高血压综合征(PIH)患者的临床疗效及安全性。方法将80例PIH患者随机分为对照组和试验组,每组40例。对照组给予硫酸镁治疗,首剂量为2.5~4.0 g,于5 min内完成注射,之后以1.0~2.0 g·h^-1静脉滴注,24 h总量不应超过30 g。试验组在对照组治疗的基础上,给予硝苯地平初始剂量20 mg·d^-1,顿服,之后根据血压控制情况调整剂量,硝苯地平最大量不超过60 mg·d^-1。2组患者均连续治疗7 d。比较2组患者的临床疗效,妊娠结局,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为90.00%(36例/40例)和72.50%(29例/40例),早产发生率分别为2.50%和15.00%,差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应均以胃肠道反应和嗜睡为主。试验组和对照组的总药物不良反应发生率分别为7.50%和5.00%,差异无统计学意义(P>0.05)。结论硝苯地平缓释片联合硫酸镁注射液治疗PIH的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of nifedipine sustained-release tablets combined with magnesium sulfate injection in the treatment of pregnancy-induced hypertension syndrome(PIH).Methods Eighty patients with PIH were randomly divided into control and treatment groups with 40 cases per group.Control group was treated with magnesium sulfate,the first dose was 2.5-4.0 g,the injection was completed within 5 min,then 1.0-2.0 g·h^-1 was given intravenously,and the total amount should not exceed 30 g in 24 hours.Treatment group was given nifedipine with an initial dose of 20 mg·d^-1,and then adjusted the dose according to blood pressure control,the maximum amount of nifedipine was no more than 60 mg·d^-1,on the basis of control group.Two groups were treated for 7 days.The clinical efficacy,pregnancy outcomes and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 90.00%(36 cases/40 cases)and 72.50%(29 cases/40 cases),the incidences of premature delivery were 2.50%and 15.00%,the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were gastrointestinal reactions and somnolence.The total incidences of adverse drug reactions in treatment and control groups were 7.50%and 5.00%without significant difference(P>0.05).Conclusion Nifedipine sustained-release tablets combined with magnesium sulfate injection have a clinical efficacy in the treatment of PIH,without increasing the incidence of adverse drug reactions.