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目的:系统评价复方玄驹胶囊联合化学药对比单用化学药治疗多囊卵巢综合征(PCOS)的疗效,为临床用药提供循证依据。方法:计算机检索PubMed、Embase、Cochrane 图书馆、中国生物医学文献数据库、维普网、中国期刊全文数据库、万方数据,检索时限为自建库起至2019年4月5日,收集复方玄驹胶囊联合化学药(试验组)对比单用化学药(对照组)治疗PCOS疗效 [总有效率、排卵率、妊娠率、血清卵泡刺激素(FSH)水平、血清促黄体生成素(LH)水平、睾酮水平、子宫内膜增厚程度]的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取并用改良后的Jadad量表进行质量评价后,采用STATA 14.0软件进行Meta分析,采用TSA 0.9软件对总有效率进行试验序贯分析。结果:共纳入15项RCT,合计1 259例患者。Meta分析结果显示,试验组患者总有效率[RR=1.27,95%CI(1.13,1.44),P<0.001]、排卵率[RR=1.18,95%CI(1.03,1.37),P<0.001]、妊娠率[RR=1.34,95%CI(1.11,1.61),P<0.001]、血清雌激素水平{FSH [SMD=-0.66,95%CI(-0.51,-0.82),P<0.001]、LH [SMD=-1.24,95%CI(-1.39, -1.08),P<0.001]、睾酮 [SMD=-1.59,95%CI(-1.76,-1.41),P<0.001] }及子宫内膜增厚程度[SMD=1.20,95%CI(1.04,1.37),P<0.001]均优于对照组,差异均有统计学意义。试验序贯分析提示结果可靠。结论:复方玄驹胶囊联合化学药对比单用化学药治疗PCOS在提高总有效率、排卵率、妊娠率、子宫内膜增厚程度,降低血清雌激素水平方面均优于单用化学药。
OBJECTIVE: To systematically evaluate the efficacy of Compound xuanju capsules combined with chemical medicine versus chemical medicine alone in the treatment of polycystic ovarian syndrome (PCOS), in order to provide evidence-based medicine guidelines for clinical medication. METHODS: Retrieved from PubMed, Embase, Cochrane library, CBM, VIP, CJFD and Wanfang database from database establishment to Apr. 5, 2019, randomized controlled trials (RCTs) about therapeutic efficacy (total response rate, ovulation rate, pregnancy rate, FSH level, LH level, testosterone level, degree of endometrial thickening) of Compound xuanju capsules combined with chemical medicine (trial group) versus chemical medicine alone (control group) in the treatment of PCOS were collected. After data extraction and quality evaluation of included studies with modified Jadad scale, Meta-analysis was conducted by using STATA 14.0 software. Trial sequential analysis (TSA) was conducted by using TSA 0.9 software. RESULTS: A total of 15 RCTs were included, involving 1 259 patients. The results of Meta-analysis showed that the total response rate [RR=1.27,95%CI(1.13,1.44),P<0.001], ovulation rate [RR=1.18,95%CI(1.03,1.37),P<0.001], pregnancy rate [RR=1.34,95%CI(1.11,1.61),P<0.001], serum hormone level {FSH [SMD=-0.66,95%CI (-0.51, -0.82),P<0.001], 95%CI(-1.76,-1.41),P<0.001], LH [SMD=-1.24,95%CI(-1.39, -1.08),P<0.001], testosterone [SMD=-1.59,95%CI(-1.76,-1.41),P<0.001]} and endometrial thickness [SMD=1.20,95%CI(1.04,1.37),P<0.001] of the trial group were better than those of the control group, with statistical significance. The results of TSA were reliable. CONCLUSIONS: In the treatment of PCOS, Compound xuanju capsules combined with chemical medicine is better than chemical medicine alone in improving total response rate, pregnancy rate, ovulation rate and endometrial thickness, and reducing serum hormone levels.
多囊卵巢综合征化学药复方玄驹胶囊疗效Meta分析试验序贯分析
Polycystic ovarian syndromeChemical medicineCompound xuanju capsuleTherapeutic efficacyMeta- analysisTrial sequential analysis
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