补肾健脾方联合孕激素保胎效果分析

The effect of Tonifying-Kidney and Spleen Formula combined with progestin on recurrent spontaneous abortion

目的通过比较补肾健脾方联合孕激素治疗和单纯孕激素治疗对反复自然流产(recurrent spontaneous abortion,RSA)患者的保胎有效率和成功率,分析补肾健脾方联合孕激素的保胎效果。方法采用非随机对照的临床研究方法,收集2009年1月至2012年1月在我院门诊就诊的有RSA史的先兆流产患者348例,符合RSA和肾虚诊断标准者共159例,以是否自愿接受中药辨证治疗,分为治疗组(n=74例)和对照组(n=85例)。治疗组给予补肾健脾方联合孕激素治疗,对照组给予单纯孕激素治疗,两组均干预治疗至超过既往最大流产孕龄的2周,治疗过程中有6例脱落(治疗组2例,对照组4例);治疗后随访监测血孕酮水平,比较治疗前及治疗2周后两组血清孕激素的变化,观察用药后有无不良反应;评价治疗至超过既往最大流产孕龄2周时的保胎有效率,并随访其后的保胎成功率、不同孕周胚胎或胎儿的存活率。结果保胎治疗前治疗组孕酮值为(22.42±6.92)ng/mL,对照组孕酮值为(21.60±7.6)ng/mL,两组比较差异无统计学意义(P=0.489);保胎治疗2周后治疗组血孕酮值为(31.15±9.44)ng/mL,对照组为(22.52±10.53)ng/mL,两组比较差异有显著统计学意义(P<0.001);治疗组65例保胎有效(90.3%),对照组61例保胎有效(75.3%),两组比较差异有统计学意义(P<0.05);治疗组51例保胎成功(70.8%),对照组43例保胎成功(53.1%),两组比较差异有统计学意义(P<0.05);两组比较孕12～37周胎儿的存活率,差异有统计学意义(P<0.05);用药后随访两组均无明显不良反应。结论补肾健脾方联合孕激素治疗对有RSA史及肾虚的先兆流产患者的保胎有效率和保胎成功率均优于单纯孕激素治疗,保胎治疗2周后血孕酮值水平较单纯孕激素治疗组上升明显,孕12～37周的胎儿存活率明显高于单纯孕激素治疗组,补肾健脾方联合孕激素保胎安全有效。

Objective To analyze the abortion prevention effect of Tonifying-Kidney and Spleen Formula combined with progestin through a comparison of effectiveness and the success rate of abortion prevention with a therapy of single progestin on recurrent spontaneous abortion （RSA） patients. Methods Three hundred and forty eight patients with RSA history suffering from a threatened abortion at the clinic of our hospital were collected from Jan, 2009 to Jan. 2012. By a clinical study with non-randomized controlled trials, there were a total of 159 patients corresponded with RSA and kidney deficiency diagnostm criteria. They were divided into the treatment group （n = 74 cases） and the control group （n = 85 cases） based on whether they would like to accept the traditional Chinese medicine （TCM） dialectical therapy. Patients in the treatment group were treated with Tonifying-Kidney and Spleen Formula combined with progestm, while patients in the control group were given the single progestm treatment. Both groups took intervention therapies more than 2 weeks of eldest gestational age of pre- abortion. Six cases had fall off during the treatment （2 cases in the treatment group and 4 cases in the control group）. The progesterone level after the treatment was monitored, to observe and compare the changes of progesterone level in the two groups before and after 2 weeks of treatment as well as adverse effects after taking the medicine. To evaluate the effectiveness rate of abortion prevention that was more than 2 weeks of eldest gestational age of pre-abortion, and the success rate of abortion prevention at follow-up, and the survival rate of embryo or fetus in both groups at different gestational period. Results The progesterone level before treatment was （22.42 ± 6.92） ng/mL in the treatment group, while it was （21. 60 ± 7. 6） ng/mL in the control group, and the difference between the two groups had no statistical significance （P = 0. 489）. The progesterone level after 2 weeks of treatment was （31.15 ± 9.44） ng/mL in the treatment group,higher than that in the control group [-（22.52± 10.53） ng/mL], and the difference had statistical significance （P〈0.001 ）. No obvious adverse effects appeared at follow- up after taking the medicine in the two groups. Sixty-five patients in the treatment group （90.3 %） had effective abortion prevention, significantly higher than those in the control group （61 cases, 75.3%）, （P〈0.05）. Fifty-one patients had successful abortion prevention in the treatment group （70. 8%）, significantly higher than those in the control group （43 cases, 53. 1%）, （P〈0. 05）. The difference of fetal survival rate at 12- 37 weeks between the two groups had statistical significance （P〈0.05）. Conclusions The progesterone level in the treatment group rose significantly compared with that in the control group after the treatment. The effectiveness of Tonifying-Kidney and Spleen Formula combined with progestin is better than single progestin treatment. The fetal survival rate at 12 - 37 weeks in the treatment group was apparently higher than that in the control group. The Tonifying-Kidney and Spleen Formula combined with progestin was safe and effective.