目的 系統(tǒng)評價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（refractory gastroesophageal refluxdisease，RGERD）的療效和安全性。方法 采用Cochrane系統(tǒng)評價方法，檢索Pubmed、CNKI、CBM、萬方數(shù)據(jù)庫。檢索從建庫至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)對照試驗（RCT），對符合納入標(biāo)準(zhǔn)的臨床實驗研究進(jìn)行質(zhì)量評價和資料提取后，采用RevMan 5.2進(jìn)行Meta分析。結(jié)果 共納入9個研究共計1 004例患者，Meta分析結(jié)果顯示，與對照組（常規(guī)藥物）相比，試驗組（氟哌噻噸美利曲辛片聯(lián)合常規(guī)藥物）對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個研究評價了治療4周后的癥狀緩解有效率，結(jié)果實驗組明顯優(yōu)于對照組[OR=6.18，95% CI=（2.99，12.76），P<0.000 01]，3個研究評價了治療8周后癥狀緩解有效率，結(jié)果顯示實驗組優(yōu)于對照組[OR=3.96，95% CI=（2.18，7.21），P<0.000 01]，5個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）評價治療期末抑郁和焦慮的改善，Meta分析結(jié)果顯示，實驗組對抑郁和焦慮的改善程度均優(yōu)于對照組，差異有統(tǒng)計學(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個試驗報道了治療過程中的不良反應(yīng)，分析結(jié)果顯示，2組差異無統(tǒng)計學(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常規(guī)藥物療效更顯著，且不良反應(yīng)無明顯差異，但該結(jié)論仍需大規(guī)模多中心研究進(jìn)一步證實。

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.