氨氯地平片联合硝苯地平缓释片治疗妊娠期高血压患者的临床研究

Clinical trial of amlodipine tablets combined with nifedipine sustained release tablets in the treatment of hypertensive patients during pregnancy

目的观察氨氯地平片联合硝苯地平缓释片治疗妊娠期高血压患者的临床疗效及安全性。方法将165例妊娠期高血压患者随机分为对照A组62例、对照B组58例和试验组45例。对照A组给予氨氯地平片每次10 mg,qd,口服;对照B组给予硝苯地平缓释片每次10 mg,bid,口服;试验组给予氨氯地平片每次5 mg,qd,口服+硝苯地平缓释片每次10 mg,qd,口服。3组患者均治疗7 d。比较3组患者的临床疗效,血压,以及药物不良反应的发生情况。结果治疗后,试验组、对照A组和对照B组的总有效率分别为93.33%(42例/45例),77.42%(48例/62例)和72.41%(42例/58例),试验组的总有效率与对照A组和对照B组比较,差异均有统计学意义(均P<0.05)。治疗后,试验组、对照A组和对照B组的收缩压分别为(114.15±10.60),(131.35±11.38)和(131.75±10.67)mmHg,舒张压分别为(80.88±5.21),(93.31±4.94)和(94.36±3.95)mmHg,试验组的上述指标与对照A组和对照B组比较,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应主要有头痛和水肿,对照A组的药物不良反应主要有头昏和乏力,对照B组的药物不良反应主要有头痛和面部潮红。试验组、对照A组和对照B组的总药物不良反应发生率分别为6.66%,8.06%和8.62%,两两比较,差异均无统计学意义(均P>0.05)。结论氨氯地平片联合硝苯地平缓释片治疗妊娠期高血压患者的临床疗效显著,其能有效地改善患者血压,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of amlodipine tablets combined with nifedipine sustained release tablets in the treatment of hypertensive patients during pregnancy. Methods A total of 165 hypertensive patients during pregnancy were randomly divided into control A group(n=62 cases), control B group(n=58 cases) and treatment group(n=45 cases). Control A group was given amlodipine tablets 10 mg per time, qd, orally. Control B group was given nifedipine sustained release tablets 10 mg per time, bid, orally. Treatment group was given amlodipine tablets 5 mg per time, qd, orally + nifedipine sustained release tablets 10 mg per time, qd, orally. Three groups were treated for 7 days. The clinical efficacy, blood pressure and adverse drug reactions were compared among three groups. Results After treatment, the total effective rates of treatment, control A and control B groups were 93. 33%( 42 cases/45 cases),77. 42%( 48 cases/62 cases) and 72. 41%( 42 cases/58 cases),there were statistically significant differences between treatment group and control A and control B groups( all P < 0. 05). After treatment, the systolic blood pressure of the treatment group, control A group and control B group were( 114. 15 ± 10. 60),( 131. 35 ± 11. 38) and( 131. 75 ± 10. 67) mm Hg, the diastolic blood pressure were( 80. 88 ± 5. 21),( 93. 31 ± 4. 94) and( 94. 36 ± 3. 95) mm Hg,there were statistically significant differences between treatment group and control A and control B groups( all P < 0. 05). The adverse drug reactions of treatment group were headache and edema. The adverse drug reactions of control A group were dizziness and fatigue. The adverse drug reactions of control B group were headache and facial flushing. The total incidences of adverse drug reactions in treatment,control A and control B groups were 6. 66%,8. 06% and 8. 62% without significant differences( all P≥0. 05). Conclusion Amlodipine tablets combined with nifedipine sustained-release tablets have significant clinical efficacy in the treatment of pregnant patients with hypertension,which can significantly improve the patients’ blood pressure,without increasing the incidence of adverse drug reactions.