河南省中医院(河南中医药大学第二附属医院),河南省郑州市金水区东风路6号,450002
dzhqn@126.com
收稿:2022-10-29,
修回:2023-02-27,
纸质出版:2023-06-17
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党志博,罗磊,李梦阁等.理气降逆法中药复方治疗胃食管反流病的临床疗效及对复发率的影响的Meta分析[J].中医杂志,2023,64(12):1225-1234.
DANG Zhibo,LUO Lei,LI Mengge,et al.Recurrence Rate and Clinical Effect of Gastroesophageal Reflux Disease Treated with Compound Formulas for Rectifying Qi and Directing Counterflow Downward:a Meta Analysis[J].Journal of Traditional Chinese Medicine,2023,64(12):1225-1234.
党志博,罗磊,李梦阁等.理气降逆法中药复方治疗胃食管反流病的临床疗效及对复发率的影响的Meta分析[J].中医杂志,2023,64(12):1225-1234. DOI: 10.13288/j.11-2166/r.2023.12.008.
DANG Zhibo,LUO Lei,LI Mengge,et al.Recurrence Rate and Clinical Effect of Gastroesophageal Reflux Disease Treated with Compound Formulas for Rectifying Qi and Directing Counterflow Downward:a Meta Analysis[J].Journal of Traditional Chinese Medicine,2023,64(12):1225-1234. DOI: 10.13288/j.11-2166/r.2023.12.008.
目的
2
对理气降逆法中药复方治疗胃食管反流病(GERD)的临床疗效及复发率进行Meta分析,为该方法的临床应用提供依据。
方法
2
检索中国知网、万方数据知识服务平台、维普中文科技期刊数据库、Medline、Embase、Cochrane Library 2001年1月1日至2022年12月31日收录的文献,根据纳入标准及排除标准筛选理气降逆法治疗胃食管反流病的随机对照试验,使用RevMan 5.3软件对其进行方法学评估,并对复发率及临床疗效(临床总有效率、中医证候积分、烧心症状积分、反酸症状积分、内镜有效率)进行Meta分析。
结果
2
23项研究被纳入Meta分析。所有研究数据资料完整,未见选择性报道偏倚,但分配隐藏及盲法均未报道。与质子泵抑制剂(PPI)相比,理气降逆法中药复方可显著降低GERD的复发率[
RR
=0.31,95%
CI
(0.22,0.45),
Z
=6.29,
P
<0.01],且从肝论治[
RR
=0.28,95%
CI
(0.17,0.47),
Z
=4.86,
P
<0.01]及从胃论治[
RR
=0.35,95%
CI
(0.21,0.59),
Z
=3.98,
P
<0.01]均可显著降低GERD的复发率。理气降逆法中药复方的临床总有效率显著优于PPI[
RR
=1.22,95%
CI
(1.17,1.28),
Z
=8.34,
P
<0.01],且从肝论治[
RR
=1.23,95%
CI
(1.15,1.32),
Z
=6.23,
P
<0.01]及从胃论治[
RR
=1.21,95%
CI
(1.13,1.30),
Z
=5.58,
P
<0.01]均可显著提高GERD的临床总有效率。理气降逆法中药复方可显著改善GERD患者的中医证候总积分[
SMD
=-1.30,95%
CI
(-1.80,-0.80),
Z
=5.09,
P
<0.01],且从肝论治[
SMD
=-1.19,95%
CI
(-1.79,-0.59),
Z
=3.87,
P
<0.01]及从胃论治[
SMD
=-1.47,95%
CI
(-2.45,-0.50),
Z
=2.96,
P
<0.01]均可显著降低GERD的中医证候总积分。理气降逆法中药复方可显著降低GERD患者的烧心症状积分[
SMD
=-0.81,95%
CI
(-1.20,-0.42),
Z
=4.05,
P
<0.01],且从肝论治[
SMD
=-1.05,95%
CI
(-1.72,-0.37),
Z
=3.04,
P
<0.01]及从胃论治[
SMD
=-0.54,95%
CI
(-0.84,-0.24),
Z
=3.48,
P
<0.01]均可显著降低GERD的烧心症状积分。理气降逆法中药复方可显著改善GERD患者的反酸症状积分[
SMD
=-0.72,95%
CI
(-1.10,-0.34),
Z
=3.73,
P
<0.01],且从肝论治[
SMD
=-0.82,95%
CI
(-1.39,-0.25),
Z
=2.80,
P
<0.01]及从胃论治[
SMD
=-0.58,95%
CI
(-1.06,-0.11),
Z
=2.40,
P
=0.02]均可显著降低GERD的反酸症状积分。理气降逆法中药复方与PPI治疗的GERD内镜有效率差异无统计学意义[
RR
=1.05,95%
CI
(0.73,1.51),
Z
=0.28,
P
=0.78],从肝论治[
RR
=1.33,95%
CI
(0.76,2.35),
Z
=0.99,
P
=0.32]或从胃论治[
RR
=0.79,95%
CI
(0.59,1.05),
Z
=1.61,
P
=0.11]差异亦均无统计学意义。
结论
2
理气降逆法中药复方可改善患者中医症状,尤其是烧心和反酸症状,同时在降低复发率、提高临床总有效率方面具有优势。
Objective
2
To conduct a meta-analysis of the recurrence rate and clinical effect of the compound formulas with the function of rectifying
qi
and directing counterflow downward (RQ-DCD) in treatment of gastroesophageal reflux disease (GERD), thereby providing reference for the clinical application of this method.
Methods
2
Databases including China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, VIP Chinese Science and Technology Journal Database, Medline, Embase, and Cochrane Library were searched from January 1st, 2001 to December 31st, 2022, for randomized controlled trials (RCTs) on the treatment of GERD using RQ-DCD method according to the inclusion and exclusion criteria. The methodology was evaluated, and meta-analyses were conducted on the recurrence rate and clinical effect including total clinical effective rate, traditional Chinese medicine (TCM) syndrome score, heartburn symptom score, acid reflux symptom score, endoscopic effective rate using RevMan 5.3 software.
Results
2
Twenty-three RCTs were included. Data was complete, and no selective reporting bias was found, but neither allocation concealment nor blinding was reported. Compared to proton pump inhibitors (PPI), the RQ-DCD compound formulas can significantly reduce the recurrence rate of GERD (
RR
= 0.31, 95%
CI
[0.22, 0.45],
Z
= 6.29,
P
<0.01); subgroup analysis showed that both treatment based on liver (
RR
= 0.28, 95%
CI
[0.17, 0.47],
Z
= 4.86,
P
<0.01) and treatment based on stomach (
RR
= 0.35, 95%
CI
[0.21, 0.59],
Z
= 3.98,
P
<0.01) can significantly reduce the recurrence rate. The clinical total effective rate of the RQ-DCD compound formulas was significantly higher than PPI (
RR
= 1.22, 95%
CI
[1.17, 1.28],
Z
= 8.34,
P
<0.01), the subgroup analysis showed that both the treatment based on the liver (
RR
= 1.23, 95%
CI
[1.15, 1.32],
Z
= 6.23,
P
<0.01) and the treatment based on the stomach (
RR
= 1.21, 95%
CI
[1.13, 1.30],
Z
= 5.58,
P
<0.01) significantly improved the total effective rate. The RQ-DCD compound formulas can significantly improve the total TCM syndrome score (
SMD
= -1.30, 95%
CI
[-1.80, -0.80],
Z
= 5.09,
P
<0.01), and both the treatment based on the liver subgroup (
SMD
= -1.19, 95%
CI
[-1.79 , -0.59],
Z
= 3.87,
P
<0.01) and the treatment based on the sto-mach (
SMD
= -1.47, 95%
CI
[-2.45, -0.50],
Z
= 2.96,
P
<0.01) can significantly reduce the total score of TCM syndromes. The method of RQ-DCD can significantly reduce the score of heartburn symptom (
SMD
= -0.81, 95%
CI
[-1.20, -0.42],
Z
= 4.05,
P
<0.01), so as the subgroups treatment based on liver (
SMD
= -1.05, 95%
CI
[-1.72, -0.37],
Z
= 3.04,
P
<0.01) and treatment based on stomach (
SMD
= -0.54, 95%
CI
[-0.84, -0.24],
Z
= 3.48,
P
<0.01). The RQ-DCD compound formulas can significantly improve the score of acid reflux symptom (
SMD
= -0.72, 95%
CI
[-1.10, -0.34],
Z
= 3.73,
P
<0.01), so as the subgroups treatment based on liver (
SMD
= -0.82, 95%
CI
[-1.39, -0.25],
Z
= 2.80,
P
<0.01) and treatment based on stomach (
SMD
= -0.58, 95%
CI
[-1.06, -0.11],
Z
= 2.40,
P
= 0.02). There was no statistically significant difference in the endoscopic effective rate between the RQ-DCD compound formulas and PPI treatment (
RR
= 1.05, 95%
CI
[0.73, 1.51],
Z
= 0.28,
P
= 0.78), so as the subgroup analysis in terms of treatment based on liver (
RR
= 1.33, 95%
CI
[0.76, 2.35],
Z
= 0.99,
P
= 0.32) and treatment based on the stomach (
RR
= 0.79, 95%
CI
[0.59, 1.05],
Z
= 1.61,
P
= 0.11).
Conclusion
2
The RQ-DCD compound formulas can improve the TCM symptoms in patients with GERD, especially heartburn and acid reflux, and has certain advantages in reducing the recurrence rate and increasing total clinical effect.
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