中西医结合药物治疗输卵管妊娠的Meta-分析

发布时间：2017-12-27 19:34

本文关键词：中西医结合药物治疗输卵管妊娠的Meta-分析　出处：《广州中医药大学》2016年硕士论文　论文类型：学位论文

【摘要】：研究目的：客观评估中西医结合药物治疗输卵管妊娠的科研质量,为中西药结合治疗输卵管妊娠提供疗效和安全性证据；通过对输卵管妊娠的中西药结合治疗与西药治疗在疗效和安全性上的比较,显示中医药在输卵管妊娠中的重要治疗作用。研究方法：1.检索PubMed、Google scholar、Cochrane Library循证医学数据库、Clinical trial、中文知网(Cnki)、万方数据、中文科技期刊数据库(Cqvip),获取对比研究中西医结合药物治疗输卵管妊娠的随机对照试验(RCT),并追索纳入文献的参考文献。2.根据纳入及排除标准,纳入文献进行中西药结合治疗输卵管妊娠的文献计量学研究,对纳入文献的一般情况,诊断标准,纳入及排除标准,疗效判定标准,研究方案等四方面进行描述性分析。3.进一步筛选文献,纳入文献进行荟萃分析,描述中西药结合治疗输卵管妊娠RCT的PICOS(对象、干预、对照、结局和试验设计)。4.依据5.0.2版Cochrane系统评价员手册,客观评价纳入文献的随机方法学。5.采用循证医学中的系统评价专用软件Review Manager5.3(Revman5.3)分析软件,对纳入文献进行定量合成的统计处理。研究结果：1.共检索到可能相关的1496篇文献。根据纳入及排除标准,总纳入62篇比较研究中西药结合治疗输卵管妊娠的随机对照研究文献。2.在文献一般情况方面,纳入文献均发表于2004年以后,且在数量上基本呈上升趋势,主要发表于国家级杂志,占60% (37/62),病例均来源于相关医院住院部,无门诊患者,62篇文献均为单中心研究。在诊断及疗效判定标准方面,所有病例均按西医诊断标准诊断,其中31篇文献采用教科书标准,占66% (33/62)；纳入与排除标准均提到的有58篇,占94% (58/62)；纳入文献中根据自定标准来判断疗效的有39篇,占63% (39/62)。归入研究文献的整体研究方案质量一般,只有14篇描述了随机方法,占19.3%(12/62),均未提及盲法、分配方案隐藏,无一篇提及样本含量的估算；有54篇进行了试验组与对照组间的平衡性检验,占87% (54/62)；有58篇文献的干预措施施行良好,占94%(58/62)；有55篇列出具体的统计学方法并给出P值范围,占89% (55/62)；在不良事件的记录方面,仅有33篇既描述了具体症状、例数,又进行了统计学检验,占53% (33/62)；13篇文献追踪患者治疗后情况,占20.9%(13/62),仅有1篇对退出与失访病例进行记录与分析。3.纳入46篇文献进行荟萃分析,其中有17篇比较研究中药联合甲氨蝶呤与单用甲氨蝶呤的治疗效果,共包含1656例病例,包含中药联合甲氨蝶呤组：847例,甲氨蝶呤单药组：809例。有9篇研究中药联合米非司酮与单用米非司酮的对比效果,其中中药联合米非司酮组：371例,米非司酮单药组：346例；共包含717例病例。将中药、甲氨蝶呤、米非司酮三药联合与甲氨蝶呤、米非司酮两药联合用药做对比研究的有20篇,共1744例病例,其中两药联合组有840例,三药联合组含有904例病例。4.纳入研究的方法学质量一般,质量评分为4分的有4篇,19篇为3分,20篇为2分,3篇为1分。5.中药联合甲氨蝶呤的治疗较单用甲氨蝶呤治疗的总有效率高[RR=1.20, 95%CI (1.12,1.27)],血β-HCG转阴所需时间短[MD=-7.10,95%CI (-10.03,-4.17)],盆腔包块消失时间快 [MD=-7.97,95%CI (-11.68,-4.26)],复查输卵管通畅率高[RR=1.29,95%CI (1.06,1.57)],能有效降低胃肠不适[RR=0.78,95%CI (0.65,0.94)],及口腔溃疡的发生率[RR=0.42,95%CI (0.21,0.84)],但对白细胞的影响无明显差异(P=-0.82)。6.中药联合米非司酮治疗输卵管妊娠较米非司酮单独治疗的总有效率高[RR=1.35,95%CI (1.24,1.47)],血β-HCG转阴所需时间短[MD=-8.39, 95%CI (-10.82,-5.97)],盆腔包块吸收时间快[MD=-21.92,95%CI(-27.30,-16.54)],输卵管复通率高[RR=1.55,95%CI(1.12,2.16)],但关于不良反应的影响无显著性差异(P0.05)。7.中药联合甲氨蝶呤、米非司酮治疗输卵管妊娠较甲氨蝶呤联合米非司酮成功率局[RR=1.22,95%CI(1.17,1.27)],血β-HCG降低至正常时间所需时间短[MD=-5.23, 95%CI(-8.73,-1.74)],盆腔包块消失时间快[MD=-8.42,95%CI (-15.51,-1.34)],输卵管复通率高[RR=1.38,95%Cl(1.11,1.71)],可减少胃肠不适[RR=0.71, 95%CI (0.57,0.89)]、白细胞降低的发生[RR=0.53,95%CI (0.24,1.18)],但口腔溃疡的影响无明显差异(P=0.43)。8.三组研究的治疗总有效率的倒漏斗图表的特征是对称性较差、有一定偏性,考虑可能存在发表性偏倚,或与纳入文献的研究质量有关。研究结论：1.中西医结合药物结合治疗输卵管妊娠的临床试验质量一般,需在试验设计、实施及统计方案等方面加以改进,临床研究者及相关部门应注重监查试验数据、结局的报告是否规范及有无安全性风险,以避免产生较大的研究偏倚风险。2.中西药结合治疗输卵管妊娠是一种有效的治疗方法,治疗后复查输卵管通畅率高,较单纯西药治疗可能可提高育龄期患者的再妊娠率。3.本研究纳入文献质量一般,存在较多偏倚,因此中西医结合药物治疗输卵管妊娠的疗效与安全性评价仍需更多高质量、大样本的多中心随机对照试验加来验证。
[Abstract]:Research purposes: the combination of Chinese medicine and Western medicine for treatment of fallopian tube pregnancy drug quality research objective evaluation, for the combination of Chinese and Western medicine treatment of tubal pregnancy and provide evidence of efficacy and safety of tubal pregnancy; through the combination of Chinese and Western medicine treatment and Western medicine treatment efficacy and safety in the display of Chinese medicine in the treatment of tubal pregnancy important role in. Methods: 1. PubMed, Google scholar, Cochrane retrieval Library evidence-based medicine database and Clinical trial, Chinese HowNet (Cnki), Wanfang Data, Chinese journal database (Cqvip), random controlled trials get combined with drugs in the treatment of tubal pregnancy comparative study of Chinese and Western Medicine (RCT), and searched references included in the. 2. according to the inclusion and exclusion criteria, the bibliometric study of tubal pregnancy treated with combination of Chinese and Western medicine was included in the literature. The descriptive analysis was conducted in four aspects, including general situation, diagnostic criteria, inclusion criteria and exclusion criteria, curative effect criteria and research plan. 3., we further screened the literature, included in the literature, and conducted meta-analysis to describe the PICOS (object, intervention, control, outcome and trial design) of Chinese and Western medicine in the treatment of RCT of tubal pregnancy. 4. according to the 5.0.2 Cochrane system evaluator's manual, the random methodology of the literature was objectively evaluated. 5. the software Review Manager5.3 (Revman5.3) analysis software of the system evaluation software in evidence-based medicine was used to deal with the quantitative synthesis of the included literature. Results: 1. a total of 1496 relevant documents were retrieved. According to the inclusion and exclusion criteria, a total of 62 randomized controlled studies on the combination of Western medicine and Western medicine in the treatment of tubal pregnancy were included. 2., in the literature general situation, the literature was published after 2004, and the number is basically on the rise. It is mainly published in national magazines, accounting for 60% (37/62). All cases were from the relevant hospital inpatients, no outpatients, and 62 papers were single center research. In terms of criteria in diagnosis and treatment, all cases according to the diagnostic criteria of Western medicine diagnosis, of which 31 articles with standard textbooks, accounting for 66% (33/62); the inclusion and exclusion criteria were mentioned in 58, accounting for 94% (58/62); included in the literature according to the custom standard to judge the curative effect of the 39 articles, accounting for 63% (39/62). The overall research program in the research literature quality in general, only 14 papers describe the random method, accounting for 19.3% (12/62), were not mentioned blind method, the distribution plan, without a mention of sample size estimation; 54 tested the balance between test group and control group, accounting for 87% (54/62) there are 58 articles; interventions performed well, accounting for 94% (58/62); 55 articles lists the specific statistical method and gives the value range of P, accounting for 89% (55/62); the adverse events recorded, only 33 articles describe the specific symptoms, number of cases, and conducted statistical tests, accounting for 53% (33/62); 13 articles follow patients after treatment, accounted for 20.9% (13/62), only 1 pieces of exit and lost cases were recorded and analyzed. 3. 46 articles were included in the meta analysis. 17 of them compared the efficacy of methotrexate combined with methotrexate alone, including 1656 cases, including Chinese medicine plus methotrexate group: 847 cases, methotrexate monotherapy group: 809 cases. There are 9 studies on the effect of mifepristone combined with mifepristone, including mifepristone combined with mifepristone: 371 cases, mifepristone monotherapy group: 346 cases; a total of 717 cases. A comparative study of Chinese medicine, methotrexate, mifepristone, three drugs combined with methotrexate and mifepristone combined with two drugs has made 20 comparative studies, including 1744 cases, of which two drug combination group has 840 cases, three drug combination group contains 904 cases. 4. the quality of the methodology included in the study was general, with a quality score of 4 points in 4, 19 for 3, 20 for 2, and 3 for 1. 5. treatment of traditional Chinese medicine combined with methotrexate compared with the total effective rate of methotrexate in the treatment of high [RR=1.20, 95%CI (1.12,1.27)], serum -HCG negative short time [MD=-7.10,95%CI (-10.03, -4.17)], pelvic mass disappeared time [MD=-7.97,95%CI (-11.68, -4.26)], review of tubal patency rate of [RR=1.29,95%CI (1.06,1.57)], can effectively reduce gastrointestinal discomfort ([RR=0.78,95%CI 0.65,0.94)], the incidence of [RR=0.42,95%CI and oral ulcer (0.21,0.84), but there was no significant difference in the effects of the white blood cells (P=-0.82). 6. traditional Chinese medicine combined with mifepristone in the treatment of tubal pregnancy with mifepristone treatment the total effective rate of high [RR=1.35,95%CI (1.24,1.47)], serum -HCG negative short time [MD=-8.39, 95%CI (-10.82, -5.97)], pelvic mass absorption time [MD=-21.92,95%CI (-27.30, -16.54)], fallopian tube recanalization rate of [RR=1.55,95%CI (1.12,2.16), but no significant effect on the adverse reaction (P0.05). 7. traditional Chinese medicine combined with methotrexate and mifepristone in treatment of tubal pregnancy with mifepristone combined with methotrexate (1.17,1.27), the success rate of [RR=1.22,95%CI, serum -HCG decreased to normal time required for a short time [MD=-5.23, 95%CI (-8.73, -1.74)], pelvic mass disappeared time [MD=-8.42,95%CI (-15.51, -1.34)], the recanalization rate of fallopian tube high [RR=1.38,95%Cl (1.11,1.71)], can reduce gastrointestinal discomfort and [RR=0.71, 95%CI (0.57,0.89)], leukopenia occurred in [RR=0.53,95%CI (0.24,1.18)], but no significant difference between the effects of oral ulcer (P= 0.43). 8., the funnel chart of the total effective rate of the three groups is characterized by poor symmetry and bias. Considering publication bias may be related to the quality of research included in the literature. Conclusion: the quality of clinical trials of combined treatment of tubal pregnancy with 1. drugs of traditional Chinese medicine and Western medicine in general, needs to be improved in the aspects of design, implementation and test of statistical programs, clinical researchers and relevant departments should focus on monitoring test data, the outcome of the report is standard and there is no security risk,
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R714.221

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