Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases

Cao, Shan; Zhang, Wenhao; Zhao, Ziwei; Mingli, Heng; Bu, Huaien; Wang, Hongwu; Liu, Xinghui; Wang, Zhong; Cai, Yan; Ma, Yuyan; Cui, Shihong; Jihong, Deng; Ding, Guifeng; Yajuan, Ding; Linhong, Dong; Zhentao, Duan; Liu, Fan; Yang, Fan; Fu, Fang; He, Jie; Shuying, Ji; Lin, Jingfeng; Li, Hong; Li, Hongying; Tao, Ling; Lu, Wei; Luo, Xian; Zhihui, Lv; Fengchun, Ma; Dafeng, Ma; Shi, Tianyun; Juying, Sun; Sun, Xiulan; Hong, Teng; Wang, Jinhua; Wang, Ruihua; Wang, Ying; Wang, Zhengling; Xi, Jie; Xu, Min-Juan; Xu, Zhihong; Qian, Yan; Cuirong, Yang; Yang, Y.B.; Yin, Jie; Jin-hua, YU; Wen-jun, Yuan; Zhang, Guanli; Zhang, Meihua; Zhao, Renda; Yonghong, Zhong; Zhou, Jian

doi:10.1016/s0254-6272(18)30896-3

Cited by 2 publications

(3 citation statements)

References 10 publications

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“…A postmarketing safety surveillance and reevaluation of motherwort injection in China conducting in 2015 showed that the incidence of adverse drug reactions (ADRs) was only 0.79‰ (8/10 094), the reported adverse events mainly included fever, chills, eyelid edema, pruritus, rash, nausea, and palpitation. All of these ADRs were mild in severity [30].…”

Section: Discussionmentioning

confidence: 99%

Motherwort Injection for Preventing Postpartum Hemorrhage in Women with Vaginal Delivery: A Systematic Review and Meta-Analysis of Randomized Evidence

Cai²,

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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Background. Motherwort injection, a common traditional Chinese medicine, is widely used for the prevention of postpartum hemorrhage (PPH), which has been found to be potential benefit in clinical practice.Objectives. This study aimed to conduct a rigorous systematic review of randomized evidence to offer a comprehensive overview regarding the efficacy and safety of motherwort injection in maternal women with virginal delivery.Methods. We included all randomized controlled trials involving pregnant women in vaginal delivery comparing motherwort injection or combination of motherwort injection and oxytocin with oxytocin alone for preventing postpartum hemorrhage. Paired reviewers independently screened citations, assessed risk of bias, and extracted data. Random-effects model by Mantel-Haenszal method was applied to pool the data. Predefined subgroup analyses and sensitivity analyses were conducted to explore the heterogeneity and robustness of results. The GRADE approach was used to rate the quality of evidence.Main Results. 37 randomized controlled trials involving 7887 participants were included, all of which were at moderate to high risk of bias. Meta-analyses of eight trials showed no significant difference in blood loss and PPH events between oxytocin versus motherwort injection (very low quality). However, pooling of 29 trials suggested a reduced risk of blood loss (within 2 hours: MD -55.06mL, 95% CI -84.06 to -26.06; within 24 hours: MD -85.57 mL, 95% CI -94.26 to -76.88, very low quality), PPH events (RR 0.29, 95% CI 0.21 to 0.39, low quality), and adverse events (Peto OR 0.53, 95% CI 0.40 to 0.70, very low quality) in participants treated with motherwort injection and oxytocin versus oxytocin alone.Conclusions. The current evidence supports the suggestion that the additional use of motherwort injection on oxytocin had a preferable outcome. However, given that the evidence is not definitive with low quality, further careful designed and conducted randomized controlled trials in larger population are warranted to conform the effects.

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Section: Discussionmentioning

confidence: 99%

Motherwort Injection for Preventing Postpartum Hemorrhage in Women with Vaginal Delivery: A Systematic Review and Meta-Analysis of Randomized Evidence

Cai²,

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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“…Given that the routine practice of using LJI is widespread in China, studies addressing the effects of LJI have been accumulating over the past few years. Most clinical trials and experience indicate that prophylactic use of LJI alone or in combination with carboprost tromethamine may have a good effect on the prevention of postpartum hemorrhage after delivery [3,8,9] . However, no well-designed and systematic evaluation of the efficacy and safety of LJI in combination with carboprost tromethamine has been found.…”

Section: Introductionmentioning

confidence: 99%

“…Most clinical trials and experience indicate that prophylactic use of LJI alone or in combination with carboprost tromethamine may have a good effect on the prevention of postpartum hemorrhage after delivery. [3,8,9] However, no welldesigned and systematic evaluation of the efficacy and safety of LJI in combination with carboprost tromethamine has been found. Therefore, we undertook a meta-analysis to assess the efficacy and safety of carboprost tromethamine combined with LJI for the prevention of postpartum hemorrhage in high-risk pregnant women to provide new evidence-based medical evidence for clinical treatment.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of carboprost tromethamine combined with leonurus japonicus for prevention of postpartum hemorrhage in high-risk pregnant women

Zong¹,

Cao²

2021

Medicine

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Background: No well-designed and systematic evaluation of the efficacy and safety of leonurus japonicus injection (LJI) in combination with carboprost tromethamine has been found. Therefore, we undertook a meta-analysis to assess the efficacy and safety of carboprost tromethamine combined with LJI for the prevention of postpartum hemorrhage in high-risk pregnant women to provide new evidence-based medical evidence for clinical treatment.Methods: This systematic review and meta-analysis would be performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. The following databases including EMBASE, MEDICINE, Wanfang, China National Knowledge Infrastructure database, and Cochrane central controlled trial registries were searched by 2 reviewers from inception to July 2021. Mesh and keyword search terms were "motherwort," "Yimucao," "leonurus japonicas," "carboprost tromethamine," and "postpartum hemorrhage." Any cohort studies that assessed the efficacy and safety of carboprost tromethamine combined with LJI for the prevention of postpartum hemorrhage would be included. P < .05 was set as the level of significance.Results: The review would add to the existing literature by showing compelling evidence and improved guidance in clinic settings.OSF registration number: 10.17605/OSF.IO/2WC53.

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Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases

Cited by 2 publications

References 10 publications

Motherwort Injection for Preventing Postpartum Hemorrhage in Women with Vaginal Delivery: A Systematic Review and Meta-Analysis of Randomized Evidence

Motherwort Injection for Preventing Postpartum Hemorrhage in Women with Vaginal Delivery: A Systematic Review and Meta-Analysis of Randomized Evidence

Efficacy of carboprost tromethamine combined with leonurus japonicus for prevention of postpartum hemorrhage in high-risk pregnant women

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