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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 reflux disease,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Rev Man 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 Depression Scale,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 systematically evaluate the efficacy and safety of flupenthixol and melitracen tablets combined with conventional drugs in the treatment of refractory gastroesophageal reflux disease (RGERD). Methods The Cochrane systematic review method was used to search Pubmed, CNKI, CBM and Wanfang database. To retrieve the randomized controlled trials (RCTs) of flupenthixol and melitracen tablets in combination with conventional drugs for the treatment of refractory gastroesophageal reflux disease from the establishment of the library to January 2016, and to evaluate the quality of clinical trials meeting the inclusion criteria After data extraction, Meta-analysis was performed using Rev Man 5.2. Results A total of 1 004 patients were enrolled in 9 studies. Meta-analysis showed that compared with the control group (conventional drugs), the test group (flupenthixol-mesylate tablets combined with conventional drugs) had no effect on refractory gastroesophageal symptoms Response was more significant [OR = 5.41,95% CI = (3.20,9.14), P <0.000 01]. Six studies evaluated the effective rate of symptom relief after 4 weeks of treatment. The results in the experimental group were significantly better than those in the control group [OR = 6.18, 95% CI = (2.99, 12.76), P <0.000 01]. Three studies evaluated the effective rate of symptom relief after 8 weeks of treatment. The results showed that the experimental group was superior to the control group [OR = 3.96,95% CI = 2.18, 7.21), P <0.000 01]. All five studies evaluated the improvement of depression and anxiety at the end of treatment by Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA). Meta-analysis The results showed that the improvement of depression and anxiety in 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? There was no significant difference between the two groups (OR = 1.65, OR = 1.65, P = 0.0001); 5 trials reported the adverse reactions during the course of treatment. , 95% CI = (0.76, 3.59), P = 0.21), and the symptoms are mild, tolerable. Conclusions The results of the analysis showed that the efficacy of flupentixol and melitracen tablets in combination with conventional drug treatment of refractory gastroesophageal reflux disease was significantly higher than that of conventional drugs with no significant difference in adverse reactions, but this conclusion still needs large-scale multicenter study Further confirmed.