首页|坤宝丸治疗更年期综合征临床疗效和安全性Meta分析

坤宝丸治疗更年期综合征临床疗效和安全性Meta分析

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目的 系统评价坤宝丸治疗更年期综合征的有效性和安全性。方法 采用计算机检索PubMed,EMbase,The Cochrane Library,Web of Science及中国知网(CNKI)、万方(WanFang)、维普(VIP)数据库自建库起至 2022 年 12 月的相关文献。由 2 位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险,采用RevMan 5。3 软件对纳入研究进行Meta分析。结果 共纳入 13 项研究,涉及 1 590 例更年期综合征患者,其中观察组 803 例,对照组 787 例。按对照组的用药种类进行亚组分析,坤宝丸单用组的临床疗效显著高于氟桂利嗪+谷维素+维生素B1 组[RR = 1。75,95%CI(1。38,2。22),P<0。000 01],坤宝丸联用组临床疗效显著高于戊酸雌二醇+甲羟孕酮组[RR = 1。18,95%CI(1。03,1。34),P = 0。01]和刺五加组[RR = 1。20,95%CI(1。08,1。33),P = 0。000 7];坤宝丸单用组对更年期临床症状调查表(Kupperman)评分显著低于替勃龙组[MD =-6。00,95%CI(-7。72,-4。28),P<0。000 01];坤宝丸联用组卵泡刺激素(FSH)显著低于刺五加组[MD =-25。70,95%CI(-33。22,-18。18),P<0。000 01];坤宝丸联用组促黄体素(LH)显著低于刺五加组[MD =-11。20,95%CI(-12。05,-10。35),P<0。000 01];坤宝丸单用组雌二醇(E2)显著高于替勃龙组[MD =-7。00,95%CI(-11。44,-2。56),P = 0。002]。药品不良反应主要为腹胀、便秘、头晕、阴道出血、体质量增加等,患者均能耐受。结论 坤宝丸对更年期综合征患者的临床疗效、Kupperman评分、激素指标等的改善效果与激素类药物相当,甚至更优。但由于纳入研究的质量不高,尚需更严格、高质量的临床研究进一步证实。
Efficacy and Safety of Kunbao Pills in the Treatment of Menopausal Syndrome:A Meta-Analysis
Objective To systematically review the efficacy and safety of Kunbao Pills in the treatment of menopausal syndrome.Methods Relevant studies in the PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang,and VIP databases from the inception to December 2022 were searched.Two evaluators independently screened the literature,extracted data,and evaluated the risk of bias in the included studies.Meta-analysis was performed by the RevMan 5.3 software.Results A total of 13 studies including 1 590 patients(803 patients in the observation group and 787 patients in the control group)with menopausal syndrome,and subgroup analysis was conducted according to the type of drugs in the control group.The clinical efficacy in the Kunbao Pills monotherapy group was significantly higher than that in the flunarizine + glutathione + vitamin B1 group[RR = 1.75,95%CI(1.38,2.22),P<0.000 01].The clinical efficacy in the Kunbao Pills combination group was significantly higher than that in the estradiol valerate + medroxyprogesterone acetate group[RR = 1.18,95%CI(1.03,1.34),P = 0.01],and that in the Ciwujia group[RR = 1.20,95%CI(1.08,1.33),P = 0.000 7].The Kupperman score in the Kunbao Pills monotherapy group was significantly lower than that in the Tibolone group[MD =-6.00,95%CI(-7.72,-4.28),P<0.000 01].The follicle-stimulating hormone[MD =-25.70,95%CI(-33.22,-18.18),P<0.000 01]and luteinizing hormone[MD =-11.20,95%CI(-12.05,-10.35),P<0.000 01]in the Kunbao Pills combination group were significantly lower than those in the Ciwujia group.The estradiol(E2)level in the Kunbao Pills monotherapy group was significantly higher than that in the Tibolone group[MD =-7.00,95%CI(-11.44,-2.56),P = 0.002].The main adverse reactions were abdominal bloating,constipation,dizziness,vaginal bleeding,weight gain,etc.,which were all tolerated by the patients.Conclusion Compared with hormone therapy,Kunbao Pills in the treatment of patients with menopausal syndrome have comparable or even better clinical efficacy,Kupperman score,and hormone index improvement.However,due to the low-quality of the included studies,more rigorous and high-quality clinical studies are needed for further confirmation.

Kunbao Pillsmenopausal syndromeMeta-analysisrandomized controlled trials

刘辽、程玲、漆也、刘吉峰

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四川省德阳市旌阳区中医院,四川 德阳 618000

四川大学华西医院,四川 成都 610031

坤宝丸 更年期综合征 Meta分析 随机对照试验

四川省德阳市科技计划

2020SZZ105

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(7)
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