摘要
目的评价固肾安胎丸治疗复发性流产的有效性及安全性。方法计算机检索中国知网(CNKI)、万方数据库(Wanfang)、维普数据库(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、EMbase、Cochrane Library、Web of science 8个数据库有关固肾安胎丸治疗复发性流产的随机对照试验,检索时间为自建库至2023年3月,根据纳入标准和排除标准对文献进行筛选,采用Cochrane手册“偏倚风险评估工具”进行质量评价。运用Review Manager 5.3、STATA 16软件对结局指标进行Meta分析。结果最终纳入研究14项,共1339例患者。Meta分析结果显示,应用固肾安胎丸的试验组在提高有效率[RR=1.25,95%CI(1.18,1.33),P<0.00001]、活产率[RR=1.27,95%CI(1.17,1.39),P<0.00001]、孕酮(P)[MD=8.47,95%CI(5.82,11.11),P<0.00001]、人绒毛膜促性腺激素(hCG)[SMD=5.46,95%CI(3.83,7.09),P<0.00001]、雌二醇(E2)[MD=112.87,95%CI(101.60,124.15),P<0.00001],减少不良反应[RR=0.40,95%CI(0.23,0.69),P<0.001]方面均优于运用常规疗法的对照组,在降低早产率方面无明显改善作用。在凝血方面,与对照组比较,试验组D二聚体(D-D)[MD=-43.09,95%CI(-80.13,-6.04),P=0.02]、纤溶酶原激活物抑制物1(PAI-1)[MD=-29.63,95%CI(-32.52,-26.73),P<0.00001]、纤维蛋白原(FIB)[MD=-0.49,95%CI(-0.57,-0.41),P<0.00001]、凝血酶原时间(PT)[MD=0.83,95%CI(0.62,1.04),P<0.00001]均有下降,而对凝血酶时间(TT)则无显著性作用。结论在复发性流产患者保胎过程中应用固肾安胎丸能有效改善患者症状及提高保胎成功率,具有良好的安全性,且在一定程度上可改善合并有血栓前状态患者的凝血功能,纠正高凝状态。
Objective This article aims to evaluate the efficiency and safety of Gushen Antai Pills in the treatment of recurrent spontaneous abortion by meta-analysis.Methods Databases including CNKI,Wanfang,Cochrane Library,SinoMed CBM,VIP,PubMed,EMbase,and Web of science were searched from their inception to March 2023,and the articles related to randomized controlled trial of Gushen Antai Pills in the treatment of recurrent abortion were screened according to the inclusion criteria and exclusion criteria.The“biased risk assessment tool”was used for quality evaluation.Meta-analysis of outcome measures was performed using Review Manager 5.3 and STATA 16 software.Results Fourteen studies with a total of 1339 patients were included.Metaanalysis showed that the trial group using Gushen Antai Pills had a greater improvement in response rates[RR=1.25,95%CI(1.18,1.33),P<0.00001],live birth rate[RR=1.27,95%CI(1.17,1.39),P<0.00001],progesterone(P)[MD=8.47,95%CI(5.82,11.11),P<0.00001],human chorionic gonadotropin(hCG)[SMD=5.46,95%CI(3.83,7.09),P<0.00001],estradiol(E2)[MD=112.87,95%CI(101.60,124.15),P<0.00001],reducing adverse effects[RR=0.40,95%CI(0.23,0.69),P<0.001]than the control group using conventional therapy.There was no significant improvement in preterm birth rate.D-Dimer(D-D)[MD=-43.09,95%CI(-80.13,-6.04),P=0.02],plasminogen activator inhibitor-1(PAI-1)[MD=-29.63,95%CI(-32.52,-26.73),P<0.00001],fibrinogen(FIB)[MD=-0.49,95%CI(-0.57,-0.41),P<0.00001],and prothrombin time(PT)[MD=0.83,95%CI(0.62,1.04),P<0.00001]in the trial group were significantly lower than those in the control group in terms of coagulation.But thrombin time(TT)did not change significantly.Conclusion The application of Gushen Antai Pills in patients with recurrent miscarriage during fetal preservation can effectively improve the patient’s symptoms and the success rate of fetal preservation.Gushen Antai Pills showed good safety,improved the coagulation function in patients with prethrombotic state to a certain extent,and corrected the hypercoagulable state.
作者
杨易
李艳红
隋娟
任梦雪
陈瑞雪
毕红
YANG Yi;LI Yanhong;SUI Juan;REN Mengxue;CHEN Ruixue;BI Hong(Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2023年第10期1441-1451,共11页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家自然科学基金项目(82274574)
中央本级重大增减支项目(2060302)
中国中医科学院科技创新工程(CI2021A02413)。
关键词
复发性流产
固肾安胎丸
META分析
系统评价
凝血功能
高凝状态
recurrent spontaneous abortion
Gushen Antai Pills
Meta-analysis
systematic evaluation
coagulation function
hypercoagulable state
作者简介
杨易,女,硕士研究生,研究方向:中医药防治复发性流产。Email:m13819307638@163.com;通信作者:毕红,女,研究方向:中医药防治复发性流产。Email:Jing9468@126.com。
