杞菊地黄汤加减联合西药治疗妊娠期高血压疾病的Meta分析

Meta-Analysis of Modified Qiju Dihuang Decoction Combined with Western Medicine in the Treatment of Hypertensive Disorders of Pregnancy

摘要: 目的：基于Meta分析评价杞菊地黄汤加减联合西药治疗妊娠期高血压疾病的有效性及安全性，为中医药治疗妊娠期高血压疾病提供循证医学依据。方法：通过电子及手工检索建库至2025年1月31日在中国知网、万方数据库、维普数据库、PubMed、Embase、Cochrane library发表的杞菊地黄汤加减联合西药治疗妊娠期高血压疾病的随机对照试验研究，纳入的文献按Cochrane系统评价方法，采用Review Manager 5.4.1及Stata/MP 18软件进行Meta分析。结果：最终共纳入24篇文献，合计2553例样本量，其中观察组1276例，对照组1277例。Meta分析结果显示：观察组比对照组更能提高治疗总有效率[OR = 3.19，95% CI (2.47, 4.11)，P < 0.00001]；降低治疗后收缩压水平[MD = −13.91, 95% CI (−16.88, −10.95), P < 0.00001]、治疗后舒张压水平[MD = −10.59, 95% CI (−13.13, −8.04), P < 0.00001]、治疗后24小时尿蛋白水平[SMD = −1.07, 95% CI (−1.37, −0.77), P < 0.00001]；减低胎盘早剥发生率[RR = 0.52, 95% CI (0.20, 1.32), P = 0.17]、剖宫产发生率[RR = 0.52, 95% CI (0.30, 0.93), P = 0.03]、产后出血发生率[RR = 0.28, 95% CI (0.12, 0.64), P = 0.002]、胎儿窘迫发生率[RR = 0.29, 95% CI (0.15, 0.58), P = 0.0005]、不良反应发生率[RD = −0.01, 95% CI (−0.04, 0.02), P = 0.53]。胎盘早剥、不良反应发生率的差异未见统计学意义。结论：杞菊地黄汤加减联合西药治疗妊娠期高血压疾病在提高治疗总有效率，降低血压水平、24 h尿蛋白水平，减低不良母婴结局方面优于单纯西医药治疗。但存在纳入文献的质量不高、部分结局指标具有较高的异质性、评价结果可能存在发表偏倚等因素，故证据可靠性仍需更多高质量、大样本的随机对照试验研究进一步验证。

Abstract: Objectives: To evaluate the effectiveness and safety of modified Qiju Dihuang Decoction combined with Western medicine in the treatment of Hypertensive Disorders of Pregnancy (HDP) by meta-analysis, and thus to provide evidence for clinical application. Methods: The China National Knowledge Infrastructure, Wanfang, VIP, PubMed, Embase and Cochrane Library databases were searched to collect the randomized controlled trial studies of modified Qiju Dihuang Decoction combined with Western medicine in the treatment of HDP from database establishment to January 31, 2025. The included literatures were assessed using the Cochrane system evaluation method, Review Manager 5.4.1 and Stata/MP 18 software programs were then used for meta-analysis. Results: A total of 24 studies were eventually enrolled, including 2553 patients, of which 1276 were in the experimental group and 1277 were in the control group. The results of meta-analysis were as follow: modified Qiju Dihuang Decoction combined with Western medicine is superior to Western medicine alone in improving the total effective rate of treatment [OR = 3.19, 95%CI (2.47, 4.11), P < 0.00001]; lowering the post-treatment systolic blood pressure [MD = −13.91, 95% CI (−16.88, −10.95), P < 0.00001], the post-treatment diastolic blood pressure [MD = −10.59, 95% CI (−13.13, −8.04), P < 0.00001], the post-treatment 24-hour urine protein level [SMD = −1.07, 95% CI (−1.37, −0.77), P < 0.00001]; and reducing the incidence of placental abruption [RR = 0.52, 95% CI (0.20, 1.32), P = 0.17], caesarean section [RR = 0.52, 95%CI (0.30, 0.93), P = 0.03], postpartum hemorrhage [RR = 0.28, 95% CI (0.12, 0.64), P = 0.002], fetal distress [RR = 0.29, 95% CI (0.15, 0.58), P = 0.0005], adverse reactions [RD = −0.01, 95% CI (−0.04, 0.02), P = 0.53]. Yet, the results aforementioned for the incidence of placental abruption and adverse reactions are statistically insignificant. Conclusion: Modified Qiju Dihuang Decoction combined with Western medicine is superior to Western medicine alone in improving the total effective rate of treatment, and reducing the blood pressure, 24 h urine protein level, and the incidence of adverse maternal and fetal outcomes in the treatment of HDP. However, the quality of the included studies is unsatisfactory, some of the indicators have a relatively high heterogeneity and the potential presence of publication bias. Thus, more high-quality and large-scale randomized controlled trial studies are needed to warrant the effects and safety of Qiju Dihuang Decoction in treating patients with HDP.