目的 系统评价氟哌噻吨美利曲辛片联合常规药物治疗难治性胃食管反流病（refractory gastroesophageal refluxdisease，RGERD）的疗效和安全性。方法 采用Cochrane系统评价方法，检索Pubmed、CNKI、CBM、万方数据库。检索从建库至2016年1月，氟哌噻吨美利曲辛片联合常规药物治疗难治性胃食管反流病的随机对照试验（RCT），对符合纳入标准的临床实验研究进行质量评价和资料提取后，采用RevMan 5.2进行Meta分析。结果 共纳入9个研究共计1 004例患者，Meta分析结果显示，与对照组（常规药物）相比，试验组（氟哌噻吨美利曲辛片联合常规药物）对难治性胃食管症状应答更显著[OR=5.41，95% CI=（3.20，9.14），P<0.000 01]，6个研究评价了治疗4周后的症状缓解有效率，结果实验组明显优于对照组[OR=6.18，95% CI=（2.99，12.76），P<0.000 01]，3个研究评价了治疗8周后症状缓解有效率，结果显示实验组优于对照组[OR=3.96，95% CI=（2.18，7.21），P<0.000 01]，5个研究均采用汉密尔顿抑郁量表（Hamilton DepressionScale，HAMD）和汉密尔顿焦虑量表（Hamilton Anxiety Scale，HAMA）评价治疗期末抑郁和焦虑的改善，Meta分析结果显示，实验组对抑郁和焦虑的改善程度均优于对照组，差异有统计学意义（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个试验报道了治疗过程中的不良反应，分析结果显示，2组差异无统计学意义（OR=1.65，95% CI=（0.76，3.59），P=0.21），且症状均较轻微，可耐受。结论 分析结果显示，氟哌噻吨美利曲辛片联合常规药物治疗难治性胃食管反流病相对常规药物疗效更显著，且不良反应无明显差异，但该结论仍需大规模多中心研究进一步证实。

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.