观察低分子肝素钙联合丹参治疗早发型重度子痫前期的临床疗效。

选取2006年1月至2012年6月于河北省儿童医院妇产科住院分娩的116例早发型重度子痫前期孕妇为研究对象，年龄为20~ 35岁，孕龄为26~ 34孕周。按照自愿原则，将其分为A组（n＝26，采用硫酸镁+低分子肝素钙+丹参治疗），B组（n＝28，采用硫酸镁+低分子肝素钙治疗），C组（n＝30，采用硫酸镁+丹参治疗），D组（n＝32，以硫酸镁为主的综合治疗）。4组孕妇的年龄、孕龄、体质量指数、孕次、产次、视网膜病变程度等比较，差异均无统计学意义（P>0.05）（本研究遵循的程序符合河北省儿童医院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象的知情同意，并与之签署临床研究知情同意书）。对4组患者治疗后自觉症状改善率、水肿消退率、平均动脉压（MAP）、24 h尿蛋白定量、产后出血量、凝血指标[凝血酶原时间（PT）、部分凝血活酶时间（APTT）]、纤溶指标及血脂水平[甘油三酯（TG）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）、载脂蛋白（apo) A、apoB]、视网膜病变发生率及并发症进行统计学分析。

A组患者自觉症状改善率显著高于D组，且差异有统计学意义（χ²＝4.438 7；P<0.05），与B, C组比较，差异均无统计学意义（χ²＝0.388 5, 0.384 9；P＝0.50）。A组患者的水肿消退率显著高于B, D组，且差异均有统计学意义（χ²＝2.230 0，4.346 7；P<0.05），与C组比较，差异无统计学意义（χ²＝0.595 8，P>0.05）。本研究结果亦显示，A组患者的MAP及24 h尿蛋白定量显著较D组下降，且差异均有统计学意义（t＝5.077, 4.962；P<0.05），但A组患者的产后出血量和B组、C组、D组比较，差异均无统计学意义（t＝0.259 7, 1.076 9, 1.518 5；P>0.05）。A组患者的PT、APTT、Fg、DD水平与B组、C组、D组比较，差异均有统计学意义（PT：t＝5.255 6, 3.363 9, 4.882 0；P<0.05。APTT：t＝2.311 2, 2.846 7, 3.686 6；P<0.05。Fg：t＝5.671 4, 3.799 2, 20.824 7；P<0.05。DD：t＝ 4.266 8, 9.720 1, 7.046 0；P<0.05）。此外，A组患者TG、TC、apo-B水平下降，而HDL及apo-A水平增加，与D组比较，差异均有统计学意义（t＝3.081 4, 2.889 1, 2.532 6, 1.717 0, 4.282 8，t＝2.207 6；P< 0.05）。治疗后A组、B组患者的视网膜病变发生率与治疗前比较，差异均有统计学意义（χ² ＝3.172 0，2.876 9；P<0.05）。C组和D组与治疗前比较，差异均无统计学意义（χ²＝1.124 9, 1.460 3；P>0.05）。治疗后A组分别与B, C, D组比较，差异均无统计学意义（χ²＝0.341 6, 1.940 8, 1.804 7；P>0.05）。同时，A组患者的并发症发生率显著低于D组，且差异有统计学意义（χ²＝3.134 4，P<0.05），但与B组和C组比较，差异均无统计学意义（χ²＝0.000 0, 2.181 9；P>0.05）。

低分子肝素钙联合丹参治疗早发型重度子痫前期较单一用药具有更好的临床疗效。

To investigate the clinical effects of low molecular heparin calcium combined with salvia miltiorrhiza on early onset severe pre-eclampsia.

A total of 116 patients (aged 20-35 years) with early onset severe pre-eclampsia at 26-34 weeks of gestational age were divided into four group by their own will, group A (n=26, magnesium sulfate+ low molecular heparin calcium+ salvia miltiorrhiza) , group B (n =28, magnesium sulfate + low molecular heparin calcium) , group C (n =30, magnesium sulfate+ salvia miltiorrhiza) , group D (n=32, magnesium sulfate conventional treatment only) . There were no significant differences among four groups about age, gestational age, body weight index, gravidity, parity as well as degrees of retinopathy. The study protocol was approved by the Ethical Review Board of Investigation in Children Hospital of Hebei Province. Informed consent was obtained from all participates. Improvement of symptoms, edema disappeared, mean arterial pressure (MAP) , 24 hours urinary protein excretion, postpartum bleeding, prothrombin time (PT) , activated partial thromboplastin time (APTT) , fibrinogen (Fg) , D-dimer (DD) , triglyceride(TG) , total cholesterol (TC) , high density lipoprotein cholesterol (HDL-C) , low density lipoprotein cholesterol (LDL-C) , apolipoprotein (apo) A, apoB, incidence rate of retinopathy, and complications were analyzed statistically among four groups.

The symptoms improved rate of group A was higher than that of group D [92.31% (24/ 26) vs． 65.63%(21/ 32)], with significant difference (χ²=4.438 7, P<0.05) , but there were no significant differences between group A and group B, group A and group C (χ² =0.388 5, 0.384 9; P =0.50) ．Compared with group A, the edema disappeared rate of group B and group D were lower with statistically significant difference (χ² =2.230 0, 4.346 7; P<0.05) ．The level of MAP and urine protein of group A were lower than those of group B, with significant difference (t=5.077, 4.962; P<0.05) , but there were no significant differences on postpartum bleeding among four groups (t=0.259 7, 1.076 9, 1.518 5, P> 0.05) ．Compared with group A, the level of PT, APTT, Fg and DD of group B, group C and group D had significant differences (PT: t=5.255 6, 3.363 9, 4.882 0; P<0.05．APTT: t=2.311 2, 2.846 7, 3.686 6; P<0.05．Fg: t=5.671 4, 3.799 2, 20.824 7; P<0.05．DD: t=4.266 8, 9.720 1, 7.046 0; P<0.05) ．In addition, compared with group D, the level of TG, TC, apo-B of group A were decreased and the level of HDL and apo-A were increased, with significant differences (t=3.081 4, 2.889 1, 2.532 6, 1.717 0, 4.282 8, 2.207 6; P<0.05) ．There had significant differences of retinopathy incidence rated before and after the treatment in both group A and group B (χ²=3.172 0, 2.876 9; P<0.05) , and there had no significant differences in both group C and group D (χ² =1.124 9, 1.460 3; P>0.05) ．And compared with groups A, the retinopathy incidence rates of group B, C and D had no significant differences (χ² =0.341 6, 1.940 8, 1.804 7; P>0.05) ．Furthermore, the complication rate of group A were significant lower than that of group D (χ² =3.1344, P<0.05) , but there had no significant differences between group A and B, group A and group C (χ² =0.000 0, 2.181 9; P>0.05) .

The clinical effects of low molecular heparin calcium combined with salvia miltiorrhiza in the treatment of early onset severe preeclampsia are better than single medication.