目的 系統(tǒng)評(píng)價(jià)氟哌噻噸美利曲辛片聯(lián)合常規(guī)藥物治療難治性胃食管反流?。╮efractory gastroesophageal refluxdisease，RGERD）的療效和安全性。方法 采用Cochrane系統(tǒng)評(píng)價(jià)方法，檢索Pubmed、CNKI、CBM、萬(wàn)方數(shù)據(jù)庫(kù)。檢索從建庫(kù)至2016年1月，氟哌噻噸美利曲辛片聯(lián)合常規(guī)藥物治療難治性胃食管反流病的隨機(jī)對(duì)照試驗(yàn)（RCT），對(duì)符合納入標(biāo)準(zhǔn)的臨床實(shí)驗(yàn)研究進(jìn)行質(zhì)量評(píng)價(jià)和資料提取后，采用RevMan 5.2進(jìn)行Meta分析。結(jié)果 共納入9個(gè)研究共計(jì)1 004例患者，Meta分析結(jié)果顯示，與對(duì)照組（常規(guī)藥物）相比，試驗(yàn)組（氟哌噻噸美利曲辛片聯(lián)合常規(guī)藥物）對(duì)難治性胃食管癥狀應(yīng)答更顯著[OR=5.41，95% CI=（3.20，9.14），P<0.000 01]，6個(gè)研究評(píng)價(jià)了治療4周后的癥狀緩解有效率，結(jié)果實(shí)驗(yàn)組明顯優(yōu)于對(duì)照組[OR=6.18，95% CI=（2.99，12.76），P<0.000 01]，3個(gè)研究評(píng)價(jià)了治療8周后癥狀緩解有效率，結(jié)果顯示實(shí)驗(yàn)組優(yōu)于對(duì)照組[OR=3.96，95% CI=（2.18，7.21），P<0.000 01]，5個(gè)研究均采用漢密爾頓抑郁量表（Hamilton DepressionScale，HAMD）和漢密爾頓焦慮量表（Hamilton Anxiety Scale，HAMA）評(píng)價(jià)治療期末抑郁和焦慮的改善，Meta分析結(jié)果顯示，實(shí)驗(yàn)組對(duì)抑郁和焦慮的改善程度均優(yōu)于對(duì)照組，差異有統(tǒng)計(jì)學(xué)意義（HAMD：SMD=-2.04，95% CI=（-2.98，-1.11），P<0.000 1；HAMA：SMD=-1.23，95% CI=（-1.47，-1.00），P<0.000 01）；5個(gè)試驗(yàn)報(bào)道了治療過(guò)程中的不良反應(yīng)，分析結(jié)果顯示，2組差異無(wú)統(tǒng)計(jì)學(xué)意義（OR=1.65，95% CI=（0.76，3.59），P=0.21），且癥狀均較輕微，可耐受。結(jié)論 分析結(jié)果顯示，氟哌噻噸美利曲辛片聯(lián)合常規(guī)藥物治療難治性胃食管反流病相對(duì)常規(guī)藥物療效更顯著，且不良反應(yīng)無(wú)明顯差異，但該結(jié)論仍需大規(guī)模多中心研究進(jìn)一步證實(shí)。

Objective To evaluate the effectiveness and safety of flupentixol melitrace combined with coventional medicinal therapy for treating refractory gastroesophageal reflux disease (RGERD). Methods The Cochrane systematic review method was adopted to retrieve PubMed, CNKI, CBM, and Wanfang (from their inception to January 2016) for randomized controlled trials (RCTs) of flupentixol melitrace combined with coventional medicinal therapy in treating RGERD. After the quality evaluation and data extraction, the clinical studies according with inclusive criteria were performed the Meta-analysis by RevMan 5.2 software. Results Nine RCTs involving 1004 patients were ultimately identified. The results of Meta-analyses showed that compared with control group (coventional medicinal therapy), the experimental group (flupentixol melitrace combined with coventional medicinal therapy) for RGERD symptom was more significant (OR=5.41, 95% CI=(3.20, 9.14), P<0.000 01); Six RCTs studies evaluated the clinical symptom remission rate after 4 weeks treatment, Meta-analysis showed that experimental group significantly improved the response rate compared with control group (OR=6.18, 95% CI=(2.99, 12.76), P<0.000 01), Three RCTs studies evaluated the clinical symptom remission rate after 8 weeks treatment, also experimental group was significantly better than control group (OR =3.96, 95% CI=(2.18, 7.21), P<0.000 01), five RCTs studies evaluated the improvement of depression and anxiety at the end of the treatment period by Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA), Meta-analysis showed that the experimental group were better than the control group, the difference was statistically significant (HAMD:SMD=-2.04, 95%CI=(-2.98, -1.11), P<0.0001; HAMA:SMD=-1.23, 95%CI=(-1.47, 1.00), P<0.000 01), five RCTs studies reported the adverse effects in the course of treatment, the results shows that there is no statistical difference (OR=1.09, 95%CI=0.46, 2.61, P =0.84), and these symptoms are milder and tolerable. Conclusion The results of meta-analyses indicate that flupentixol melitrace combined with coventional medicinal therapy is more effective than coventional medicinal therapy in treating RGERD, and there is no difference in the adverse effects between two groups. Large scale and multiple center studies are required to validate those conclusions.