中西醫(yī)結合藥物治療輸卵管妊娠的Meta-分析
本文關鍵詞:中西醫(yī)結合藥物治療輸卵管妊娠的Meta-分析 出處:《廣州中醫(yī)藥大學》2016年碩士論文 論文類型:學位論文
更多相關文章: Meta-分析 輸卵管妊娠 中西醫(yī)結合 藥物保守治療
【摘要】:研究目的:客觀評估中西醫(yī)結合藥物治療輸卵管妊娠的科研質(zhì)量,為中西藥結合治療輸卵管妊娠提供療效和安全性證據(jù);通過對輸卵管妊娠的中西藥結合治療與西藥治療在療效和安全性上的比較,顯示中醫(yī)藥在輸卵管妊娠中的重要治療作用。研究方法:1.檢索PubMed、Google scholar、Cochrane Library循證醫(yī)學數(shù)據(jù)庫、Clinical trial、中文知網(wǎng)(Cnki)、萬方數(shù)據(jù)、中文科技期刊數(shù)據(jù)庫(Cqvip),獲取對比研究中西醫(yī)結合藥物治療輸卵管妊娠的隨機對照試驗(RCT),并追索納入文獻的參考文獻。2.根據(jù)納入及排除標準,納入文獻進行中西藥結合治療輸卵管妊娠的文獻計量學研究,對納入文獻的一般情況,診斷標準,納入及排除標準,療效判定標準,研究方案等四方面進行描述性分析。3.進一步篩選文獻,納入文獻進行薈萃分析,描述中西藥結合治療輸卵管妊娠RCT的PICOS(對象、干預、對照、結局和試驗設計)。4.依據(jù)5.0.2版Cochrane系統(tǒng)評價員手冊,客觀評價納入文獻的隨機方法學。5.采用循證醫(yī)學中的系統(tǒng)評價專用軟件Review Manager5.3(Revman5.3)分析軟件,對納入文獻進行定量合成的統(tǒng)計處理。研究結果:1.共檢索到可能相關的1496篇文獻。根據(jù)納入及排除標準,總納入62篇比較研究中西藥結合治療輸卵管妊娠的隨機對照研究文獻。2.在文獻一般情況方面,納入文獻均發(fā)表于2004年以后,且在數(shù)量上基本呈上升趨勢,主要發(fā)表于國家級雜志,占60% (37/62),病例均來源于相關醫(yī)院住院部,無門診患者,62篇文獻均為單中心研究。在診斷及療效判定標準方面,所有病例均按西醫(yī)診斷標準診斷,其中31篇文獻采用教科書標準,占66% (33/62);納入與排除標準均提到的有58篇,占94% (58/62);納入文獻中根據(jù)自定標準來判斷療效的有39篇,占63% (39/62)。歸入研究文獻的整體研究方案質(zhì)量一般,只有14篇描述了隨機方法,占19.3%(12/62),均未提及盲法、分配方案隱藏,無一篇提及樣本含量的估算;有54篇進行了試驗組與對照組間的平衡性檢驗,占87% (54/62);有58篇文獻的干預措施施行良好,占94%(58/62);有55篇列出具體的統(tǒng)計學方法并給出P值范圍,占89% (55/62);在不良事件的記錄方面,僅有33篇既描述了具體癥狀、例數(shù),又進行了統(tǒng)計學檢驗,占53% (33/62);13篇文獻追蹤患者治療后情況,占20.9%(13/62),僅有1篇對退出與失訪病例進行記錄與分析。3.納入46篇文獻進行薈萃分析,其中有17篇比較研究中藥聯(lián)合甲氨蝶呤與單用甲氨蝶呤的治療效果,共包含1656例病例,包含中藥聯(lián)合甲氨蝶呤組:847例,甲氨蝶呤單藥組:809例。有9篇研究中藥聯(lián)合米非司酮與單用米非司酮的對比效果,其中中藥聯(lián)合米非司酮組:371例,米非司酮單藥組:346例;共包含717例病例。將中藥、甲氨蝶呤、米非司酮三藥聯(lián)合與甲氨蝶呤、米非司酮兩藥聯(lián)合用藥做對比研究的有20篇,共1744例病例,其中兩藥聯(lián)合組有840例,三藥聯(lián)合組含有904例病例。4.納入研究的方法學質(zhì)量一般,質(zhì)量評分為4分的有4篇,19篇為3分,20篇為2分,3篇為1分。5.中藥聯(lián)合甲氨蝶呤的治療較單用甲氨蝶呤治療的總有效率高[RR=1.20, 95%CI (1.12,1.27)],血β-HCG轉陰所需時間短[MD=-7.10,95%CI (-10.03,-4.17)],盆腔包塊消失時間快 [MD=-7.97,95%CI (-11.68,-4.26)],復查輸卵管通暢率高[RR=1.29,95%CI (1.06,1.57)],能有效降低胃腸不適[RR=0.78,95%CI (0.65,0.94)],及口腔潰瘍的發(fā)生率[RR=0.42,95%CI (0.21,0.84)],但對白細胞的影響無明顯差異(P=-0.82)。6.中藥聯(lián)合米非司酮治療輸卵管妊娠較米非司酮單獨治療的總有效率高[RR=1.35,95%CI (1.24,1.47)],血β-HCG轉陰所需時間短[MD=-8.39, 95%CI (-10.82,-5.97)],盆腔包塊吸收時間快[MD=-21.92,95%CI(-27.30,-16.54)],輸卵管復通率高[RR=1.55,95%CI(1.12,2.16)],但關于不良反應的影響無顯著性差異(P0.05)。7.中藥聯(lián)合甲氨蝶呤、米非司酮治療輸卵管妊娠較甲氨蝶呤聯(lián)合米非司酮成功率局[RR=1.22,95%CI(1.17,1.27)],血β-HCG降低至正常時間所需時間短[MD=-5.23, 95%CI(-8.73,-1.74)],盆腔包塊消失時間快[MD=-8.42,95%CI (-15.51,-1.34)],輸卵管復通率高[RR=1.38,95%Cl(1.11,1.71)],可減少胃腸不適[RR=0.71, 95%CI (0.57,0.89)]、白細胞降低的發(fā)生[RR=0.53,95%CI (0.24,1.18)],但口腔潰瘍的影響無明顯差異(P=0.43)。8.三組研究的治療總有效率的倒漏斗圖表的特征是對稱性較差、有一定偏性,考慮可能存在發(fā)表性偏倚,或與納入文獻的研究質(zhì)量有關。研究結論:1.中西醫(yī)結合藥物結合治療輸卵管妊娠的臨床試驗質(zhì)量一般,需在試驗設計、實施及統(tǒng)計方案等方面加以改進,臨床研究者及相關部門應注重監(jiān)查試驗數(shù)據(jù)、結局的報告是否規(guī)范及有無安全性風險,以避免產(chǎn)生較大的研究偏倚風險。2.中西藥結合治療輸卵管妊娠是一種有效的治療方法,治療后復查輸卵管通暢率高,較單純西藥治療可能可提高育齡期患者的再妊娠率。3.本研究納入文獻質(zhì)量一般,存在較多偏倚,因此中西醫(yī)結合藥物治療輸卵管妊娠的療效與安全性評價仍需更多高質(zhì)量、大樣本的多中心隨機對照試驗加來驗證。
[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,
【學位授予單位】:廣州中醫(yī)藥大學
【學位級別】:碩士
【學位授予年份】:2016
【分類號】:R714.221
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