枳术宽中胶囊治疗功能性消化不良的系统评价和Meta分析
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广东省科学技术厅自筹经费类科技计划项目(粤科规财字〔2015〕110号)


Effect of Zhizhu Kuanzhong Capsule in Treatment of Functional Dyspepsia: A Systematic Review and Meta-analysis
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    摘要:

    目的 评价枳术宽中胶囊治疗功能性消化不良(functional dyspepsia, FD)的临床疗效和安全性。方法 筛选枳术宽中胶囊治疗FD的随机对照试验(randomized controlled tests, RCTs),提取数据并采用Cochrane偏倚风险评估工具进行方法学质量评价,采用Revman 5.0进行Meta分析。结果 共纳入21篇RCTs,共包括2 399例患者,文献质量较低。Meta分析结果显示,总有效率方面,枳术宽中胶囊治疗FD优于促消化药物(RR=1.15,95% CI为1.04~1.26,Z=2.72,P=0.007),枳术宽中胶囊结合促消化药物治疗FD优于单纯促消化药物(RR=1.28, 95% CI为1.18~1.39,Z=5.81, P=0.000),枳术宽中胶囊结合抗抑郁药物治疗FD优于单纯抗抑郁药物(RR=1.38, 95% CI为1.21~1.56,Z=4.98,P=0.000),枳术宽中胶囊结合抑酸药治疗FD优于单纯抑酸药(RR=1.25, 95% CI为1.09~1.43,Z=3.16, P=0.002)。另外,枳术宽中胶囊对比促消化药物在改善FD患者腹胀、胃痛方面优于促消化药物(腹胀积分:MD=-0.75, 95% CI为-1.20~-0.31,Z=3.30,P=0.001;胃痛积分:MD=-0.60, 95% CI为-0.91~-0.30,Z=3.88,P=0.000)。结论 枳术宽中胶囊单用或联用西药治疗FD可提高临床疗效,改善患者的腹胀、胃痛等消化系统症状,但尚需高质量临床试验进一步验证其疗效。

    Abstract:

    Objective To investigate the clinical effect and safety of Zhizhu Kuanzhong Capsule in the treatment of functional dyspepsia (FD). Methods Randomized controlled trials (RCTs) of Zhizhu Kuanzhong Capsule in the treatment of FD were screened out and related data were extracted. The Cochrane tool for assessing the risk of bias was used for methodological quality assessment, and Revman 5.0 was used for the meta-analysis. Results A total of 21 RCTs were included, with a total of 2 399 patients, and the quality of these articles was low. The meta-analysis showed that Zhizhu Kuanzhong Capsule had a significantly better overall response rate in the treatment of FD than prokinetic drugs [risk ratio(RR)=1.15,95% confidence interval(CI): 1.04 to 1.26;Z=2.72, P=0.007\]; Zhizhu Kuanzhong Capsule combined with prokinetic drugs had a significantly better effect in the treatment of FD than prokinetic drugs alone (RR=1.28,95% CI: 1.18 to 1.39;Z=5.81, P=0.000); Zhizhu Kuanzhong Capsule combined with antidepressants had a significantly better effect in the treatment of FD than antidepressants alone (RR=1.38, 95% CI: 1.21 to 1.56;Z=4.98, P=0.000); Zhizhu Kuanzhong Capsule combined with acid inhibitors had a significantly better effect in the treatment of FD than acid inhibitors alone (RR=1.25, 95% CI: 1.09 to 1.43;Z=3.16, P=0.002). In addition, compared with prokinetic drugs, Zhizhu Kuanzhong Capsule had significantly better effects in improving abdominal distension and stomachache in patients with FD [abdominal distension score: mean difference (MD)=-0.75, 95% CI:-1.20 to -0.31,Z=3.30, P=0.001; stomachache score: MD=-0.60, 95% CI:-0.91 to -0.30, Z=3.88, P=0.000\]. Conclusion Zhizhu Kuanzhong Capsule alone or combined with Western medicine treatment can improve the clinical outcome of FD and relieve the digestive symptoms such as abdominal distension and stomachache, but high-quality clinical trials are needed to further validate its clinical effect.

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胡学军,杨小静,刘少南,黄智斌.枳术宽中胶囊治疗功能性消化不良的系统评价和Meta分析[J].安徽中医药大学学报,2018,37(1):16-22

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  • 在线发布日期: 2018-02-08