Yuan Shaofei, Gao Fengli, Xin Zhong, Guo Haijun, Shi Suqin, Shi Lei, Yang Xia, Guan Jingzhi
Department of Pharmacy, The Second Affiliated Hospital of Baotou Medical College, Baotou.
Department of Pharmacy, Huhhot First Hospital, Yuquan District, Huhhot, Inner Mongolia.
Medicine (Baltimore). 2019 Jun;98(24):e16026. doi: 10.1097/MD.0000000000016026.
To compare the clinical efficacy and safety of phloroglucinol (PHL) and magnesium sulfate (MS) in the treatment of threatened abortion through systematic review.
Foreign databases, such as the Cochrane Library, PubMed and EMBASE, and Chinese databases, including the China Biology Medicine disc (SinoMed), China National Knowledge Infrastructure (CNKI), Chongqing VIP (VIP) and WanFang Data, were searched. Published randomized controlled trials (RCTs) documents obtained from these databases were included if they were associated with the research objective. The search timeframe was from the beginning of the establishment of each database to May 2018. Document selection, data abstraction and document quality evaluation were independently performed by 2 investigators. A combined analysis of the data was performed for those documents that fulfilled the study requirements; Rev Man 5.3 and Stata 12.0 software were used to compare and analyze the 2 drugs in terms of the total effective rate (TER), rate of adverse events, time required to relieve uterine contractions, onset time, time of complete relief of uterine contraction symptoms, medication duration and length of hospital stay.
A total of 21 RCT trials were included in the present research, according to the inclusion criteria. However, the quality of the included studies was low. The meta-analysis suggested that the TER and drug onset time of PHL were higher than those for MS, while the rate of adverse events, the time required to relieve uterine contractions, time to complete relief of uterine contraction symptoms, drug continuous treatment time and length of hospital stay were shorter than those for MS.
The clinical efficacy of PHL is better than that of MS, and PHL obviously results in fewer adverse reactions than MS. However, due to poor quality of evidence, high quality, multi-center RCTs with large samples are required for further verification.
通过系统评价比较间苯三酚(PHL)与硫酸镁(MS)治疗先兆流产的临床疗效及安全性。
检索Cochrane图书馆、PubMed、EMBASE等外文数据库以及中国生物医学文献数据库(SinoMed)、中国知网(CNKI)、维普资讯(VIP)、万方数据等中文数据库。纳入与研究目的相关的已发表的随机对照试验(RCT)文献。检索时间范围为各数据库建库至2018年5月。由2名研究者独立进行文献筛选、数据提取及文献质量评价。对符合研究要求的文献进行数据合并分析;采用Rev Man 5.3和Stata 12.0软件比较分析2种药物的总有效率(TER)、不良事件发生率、缓解宫缩所需时间、起效时间、宫缩症状完全缓解时间、用药疗程及住院时间。
本研究共纳入21项RCT试验,符合纳入标准。但纳入研究的质量较低。Meta分析提示,PHL的TER及药物起效时间高于MS,而不良事件发生率、缓解宫缩所需时间、宫缩症状完全缓解时间、药物持续治疗时间及住院时间均短于MS。
PHL的临床疗效优于MS,且PHL所致不良反应明显少于MS。但由于证据质量较差,需开展高质量、大样本的多中心RCT进一步验证。