1. 复旦大学附属妇产科医院中西医结合科,上海,200090
2. 上海中医药大学附属岳阳中西医结合医院妇科,上海,200437
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吕蓓丽, 王海燕, 王采文, 等. 补肾活血化痰方对多囊卵巢综合征伴先兆流产患者保胎疗效的临床研究[J]. 上海中医药杂志, 2018,52(12):53-58.
LYU Beili, WANG Haiyan, WANG Caiwen, et al. Clinical research on tocolysis efficacy of therapy of nourishing kidney, activating blood and resolving phlegm on polycystic ovarian syndrome with threatened abortion[J]. Shanghai Journal of Traditional Chinese Medicine, 2018,52(12):53-58.
吕蓓丽, 王海燕, 王采文, 等. 补肾活血化痰方对多囊卵巢综合征伴先兆流产患者保胎疗效的临床研究[J]. 上海中医药杂志, 2018,52(12):53-58. DOI: 10.16305/j.1007-1334.2018.12.015.
LYU Beili, WANG Haiyan, WANG Caiwen, et al. Clinical research on tocolysis efficacy of therapy of nourishing kidney, activating blood and resolving phlegm on polycystic ovarian syndrome with threatened abortion[J]. Shanghai Journal of Traditional Chinese Medicine, 2018,52(12):53-58. DOI: 10.16305/j.1007-1334.2018.12.015.
目的:观察补肾活血化痰方对肾虚痰湿型及肾虚血瘀型多囊卵巢综合征(PCOS)伴先兆流产患者的保胎疗效。 方法:将149例PCOS伴先兆流产患者随机分为A组(50例)、B组(47例)和C组(52例)。A组予补肾活血化痰方,B组予黄体酮注射液治疗,C组予补肾活血化痰方联合黄体酮注射液治疗。各组均治疗至孕12周,观察临床疗效、保胎有效率及随访妊娠结局,比较中医证候积分及血清绒毛膜促性腺激素(HCG)、孕酮(P)、人胰岛素样生长因子结合蛋白-1(IGFBP-1)、纤溶酶原激活物抑制物-1(PAI-1)水平的变化情况。 结果:①最终完成试验者146例,A组49例,B组45例,C组52例。②A组、B组、C组总有效率分别为85.71%、64.44%、88.46%;组间临床疗效比较,差异有统计学意义(P<0.05),A组与C组相比,差异无统计学意义(P>0.05),但A组、C组均优于B组(P<0.05)。③疗程结束时,A组、B组、C组的保胎有效例数分别为42例(85.71%)、29例(64.44%)、46例(88.46%);组间保胎有效率比较,A组与C组差异无统计学意义(P>0.05),但A组、C组均明显高于B组(P<0.05)。④试验期间,A组、B组、C组的流产率分别为16.33%、40.00%、11.54%。A组与C组的流产率比较,差异无统计学意义(P>0.05),但A组、C组的流产率均明显低于B组(P<0.05)。⑤组间治疗后比较,A组与C组的中医证候积分差异无统计学意义(P>0.05),而A组、C组的中医证候积分均明显低于B组(P<0.05)。⑥各组治疗开始后(孕6、7、8、9周)与治疗前(孕5周)比较,血清HCG水平均明显上升(P<0.05);治疗开始后各孕周与前一孕周比较,血清HCG水平均明显上升(P<0.05)。组间治疗开始后各孕周比较,A组、C组的各孕周血清HCG水平均明显高于B组(P<0.05),而C组孕6、7周的血清HCG水平又明显高于A组(P<0.05)。⑦治疗前后组内比较,B组和C组的P水平明显升高(P<0.05),而A组的P水平差异无统计学意义(P>0.05)。组间治疗后比较,B组与C组相比,P水平差异无统计学意义(P>0.05);B组、C组分别与A组比较,P水平差异有统计学意义(P<0.05)。⑧治疗前后组内比较,A组和C组的IGFBP-1水平明显升高(P<0.05),而PAI-1水平明显降低(P<0.05),B组IGFBP-1和PAI-1水平差异无统计学意义(P>0.05)。组间治疗后比较,A组与C组相比,IGFBP-1升高和PAI-1降低水平差异无统计学意义(P>0.05);A组、C组分别与B组比较,IGFBP-1升高和PAI-1降低水平差异有统计学意义(P<0.05)。 结论:补肾活血化痰方对肾虚痰湿型及肾虚血瘀型PCOS伴先兆流产患者的保胎疗效较佳,可有效调节HCG、IGFBP-1及PAI-1水平,改善临床症状,降低自然流产的发生率,提高继续妊娠率和活产率,从而改善妊娠结局。另外,对于血清P水平偏低、黄体功能不足的PCOS先兆流产患者,可同时联合黄体酮安胎治疗,达到中西医结合优势互补。
Objective:To observe the tocolysis efficacy of prescription of nourishing kidney, activating blood and resolving phlegm in polycystic ovarian syndrome (PCOS) with threatened abortion patients with syndrome of kidney deficiency and phlegm dampness and syndrome of kidney deficiency and blood stasis. Methods 149 PCOS patients with threatened abortion were randomly divided into the group A (50 cases), group B (47 cases) and group C (52 cases). The group A was treated with prescription of nourishing kidney, activating blood and resolving phlegm. The group B was treated with progesterone injection. The group C was treated with prescription of nourishing kidney, activating blood and resolving phlegm combined with progesterone injection. All the groups were treated until pregnancy for 12 weeks, the clinical efficacy and tocolysis efficacy were observed, and the pregnancy outcome was followed up. The changes on TCM syndrome score and serum levels of human chorionic gonadotropin (HCG), progesterone (P), human insulin like growth factor binding protein-1 (IGFBP-1) and plasminogen activator inhibitor-1 (PAI-1) were compared. Results:①Finally 146 cases completed the trial, among 49 cases in the group A, 45 cases in the group B and 52 cases in the group C. ②The total effective rates were 85.71% in the group A, 64.44% in the group B and 88.46% in the group C. There was statistically significant difference on the clinical efficacy among the groups (P<0.05). There was no statistically significant difference on the clinical efficacy between group A and group C (P>0.05), however, the clinical efficacy of group A and group C was both better than that of group B (P<0.05). ③At the end of treatment, the numbers of effective tocolysis were 42 cases (85.71%) in the group A, 29 cases (64.44%) in the group B and 46 cases (88.46%) in the group C. There was no statistically significant difference on the effective rate of tocolysis between group A and group C (P>0.05), however, the effective rate of tocolysis of group A and group C was both higher than that of group B (P<0.05). ④During the trial, the abortion rates were 16.33% in the group A, 40.00% in the group B and 11.54% in the group C. There was no statistically significant difference on the abortion rate between group A and group C (P>0.05), however, the abortion rate of group A and group C was both lower than that of group B (P<0.05). ⑤After treatment, there was no statistically significant difference on TCM syndrome score between group A and group C (P>0.05), however, the TCM syndrome score of group A and group C was both lower than that of group B (P<0.05). ⑥Compared with treatment before (pregnancy for 5 weeks), the serum HCG level was significantly increased in all groups after treatment (pregnancy for 6,7, 8 and 9 weeks) (P<0.05). After treatment, compared with previous gestational week, the serum HCG level was significantly increased at different gestational weeks (P<0.05). After treatment, the serum HCG level in the group A and group C was significantly higher than that in the group B at each gestational week (P<0.05), and the serum HCG level in the group C at sixth and seventh gestational week was significantly higher than that in the group A (P<0.05). ⑦Compared with treatment before, the P level was significantly increased in the group B and group C after treatment (P<0.05); however, in the group A, there was no statistically significant difference on P level between treatment before and after(P>0.05). After treatment, there was no statistically significant difference on P level between group B and group C (P>0.05). Compared with group A, there was statistically significant difference on P level in the group B and group C, respectively (P<0.05). ⑧Compared with treatment before, the IGFBP-1 level was significantly increased (P<0.05) and the PAI-1 level was significantly decreased (P<0.05) in the group A and group C after treatment. In the group B, there were no statistically significant differences on the levels of IGFBP-1 and PAI-1 between treatment before and after (P>0.05). After treatment, there were no statistically significant differences on the increase level of IGFBP-1 and decease level of PAI-1 between group A and group C (P>0.05). Compared with group B, there were statistically significant differences on the increase level of IGFBP-1 and decease level of PAI-1 in the group A and group C, respectively (P<0.05). Conclusion:Prescription of nourishing kidney, activating blood and resolving phlegm shows better tocolysis efficacy in PCOS with threatened abortion patients with syndrome of kidney deficiency and phlegm dampness and syndrome of kidney deficiency and blood stasis, which can effectively regulate the levels of HCG, IGFBP-1 and PAI-1, improve the clinical symptoms, reduce the occurrence of spontaneous abortion and enhance the ongoing pregnancy rate and live birth rate, and thus improve the pregnancy outcome. Furthermore, for the PCOS patients with threatened abortion whose P level was lower and luteal function was insufficient, this prescription and progestin can be used simultaneously for tocolysis to achieve complementary advantages of traditional Chinese and western medicine.
补肾活血化痰方多囊卵巢综合征先兆流产保胎黄体酮人胰岛素样生长因子结合蛋白-1纤溶酶原激活物抑制物-1
prescription of nourishing kidney activating blood and resolving phlegmpolycystic ovarian syndromethreatened abortiontocolysisprogesteronehuman insulin like growth factor binding protein-1plasminogen activator inhibitor-1
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