四磨汤治疗功能性消化不良的Meta分析及对肝脾气滞证功能性消化不良患者的临床疗效观察
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摘要
目的：
运用Meta分析评价四磨汤治疗功能性消化不良的临床疗效和安全性；临床研究四磨汤对肝脾气滞型功能性消化不良(FD)患者的临床疗效及血清中生长抑素(SS),P物质(SP)的影响,为四磨汤治疗FD肝脾气滞证的临床有效性和安全性提供更多依据。
方法：
Meta分析以电子检索四磨汤治疗功能性消化不良的临床随机对照试验。按照Cochrane协作网的相关方法评价纳入文献质量和提取有效数据进行Meta分析。临床研究选择符合纳入标准的84例肝脾气滞型FD患者,随机分为治疗组和对照组,治疗组给予四磨汤口服液+模拟多潘立酮片,对照组给予模拟四磨汤+多潘立酮片,疗程为14天。观察患者的一般情况,三大常规,肝肾功能,心电图等。评定两组疾病疗效,中医症候疗效,各症状的疗效,ELISA法检测血清中SS、SP的含量变化。
结果：
1.Meta分析共纳入16个研究,包括1466例患者。Meta分析结果提示,四磨汤的临床总有效率高于对照组[OR=2.08,95%CI(1.56,2.79),P<0.00001]；6篇文献安全性分析提示：四磨汤组不良反应的发生率明显低于对照组[OR=0.29,95%CI(0.16,0.51),P<0.0001]。
2.临床研究纳入病例84例,脱落4例,实验结束后治疗组39例,对照组41例。两组治疗前一般情况如性别、年龄、病程、病情程度等方面无显著差异(P>0.05)；中医症候总积分、各症状积分相比无明显差异(P>0.05)；血清SS、SP含量亦无统计学差异(P>0.05)。
3.经治疗后,两组疾病疗效相比无统计学差异(P>0.05)；治疗组中医症候总积分减少,与对照组比较差异有统计学意义(P<0.05)；各症状疗效比较：胃脘痞满、餐后饱胀、食量减少、嗳气反酸、恶心呕吐本组前后积分有差异(P<0.05),但两组之间积分及各疗效两组比较无明显差异(P>0.05)；胁肋胀满,太息,大便不畅本组前后积分、治疗后两组积分及各疗效两组比较差异均有统计学意义(P<0.05)。
4.治疗组患者血清中SS含量降低,SP含量上升,但与对照组相比差异无统计学意义(P>0.05)；
5.两组脱落病例比较无统计学差异(P>0.05)。
结论：
1. Meta分析表明四磨汤治疗FD疗效明显,且安全性较高。
2.四磨汤对FD肝脾气滞证患者临床疗效显著。
3.四磨汤在改善患者某些症状方面优于吗丁啉。
4.四磨汤治疗肝脾气滞证FD患者可能与调节血清SS,SP的含量有关。
5.四磨汤无明显不良反应,安全性好,值得临床应用。
Objective:Use Meta analysis to evaluate the clinical effect and safety of simotang for functional dyspepsia patients.To study the effect of Simo decoction(SD) on patients with functional dyspepsia with qi stagnancy of both liver and spleen and the influence of the SS and SP in the patients' serum. To provide more basis for SD's efficacy and safety on FD.
Methods:We searched identify randomized controlled trials about simotang for FD patients. The methodological quality was assessed and the data was extracted according to the Cochrane Reviewer's Handbook and related methods;84cases of FD with qi stagnancy of both liver and spleen were divided randomly into two groups:the treating group and the contrasting group. SD and simulative Domperidone was taken in the treating group, and simulative SD and Domperidone in the contrasting group. Treatment for14days. Observe patients of the general conditions, the three conventional, liver and kidney function, electrocardiogram, etc.Assess the two groups of disease curative effect, the curative effect of every symptom, and detect the SS and SP in the patients'serum by ELISASixteen eligible studies involving
Result:
1.1466FD patients were included.The results of meta-analyses showed that SD could precisely improve the total effects more than the control group [OR=2.09,95%CI(1.56,2.79), P<0.00001]. The Security Analysis of the5literature suggest that Compared with the control group, The adverse reactions risk of simtang is lower than the control group,[OR=0.3,95%CI(0.16,0.54), P<0.0001]
2.84cases were observed in this research among which4cases shed off,39cases in the treating group and41cases in the contrasting group. Before treatment,there were no significant differences in gender,age duration, and degree of illness,symptoms of traditional Chinese medicine total score, each symptom scores,the SS and SP in the patients'serum between the treating group and the contrasting group (P>0.05).
3. After treatment:there were no significant differences in disease curaive effect and some symptoms (P>0.05), there were significant differences in total score of symptoms and another symptoms(P<0.05).
4. SD can reduce the the content of ss and sp in the in the patients' serum(P<0.05), but there were no significant differences between the treating group and the contrasting group (P>0.05).
5. There were no significant differences in the shed off cases between the treating group and the contrasting group
Conclusion:
1. Meta-analysis shows that SD canimprove the therapeutic effect on FD patients and have high security.
2. SD have significant clinical curative effect on patients with functional dyspepsia with qi stagnancy of both liver and spleen.
3. SD have better curative effect on some symptoms than Domperidone.
4. SD can regulate the the content of ss and sp in the in the patients'serum, and it's may be one of the possible mechanism to therapy FD.
5. SD is safe and has no obvious side effects in clinical.
运用Meta分析评价四磨汤治疗功能性消化不良的临床疗效和安全性；临床研究四磨汤对肝脾气滞型功能性消化不良(FD)患者的临床疗效及血清中生长抑素(SS),P物质(SP)的影响,为四磨汤治疗FD肝脾气滞证的临床有效性和安全性提供更多依据。
方法：
Meta分析以电子检索四磨汤治疗功能性消化不良的临床随机对照试验。按照Cochrane协作网的相关方法评价纳入文献质量和提取有效数据进行Meta分析。临床研究选择符合纳入标准的84例肝脾气滞型FD患者,随机分为治疗组和对照组,治疗组给予四磨汤口服液+模拟多潘立酮片,对照组给予模拟四磨汤+多潘立酮片,疗程为14天。观察患者的一般情况,三大常规,肝肾功能,心电图等。评定两组疾病疗效,中医症候疗效,各症状的疗效,ELISA法检测血清中SS、SP的含量变化。
结果：
1.Meta分析共纳入16个研究,包括1466例患者。Meta分析结果提示,四磨汤的临床总有效率高于对照组[OR=2.08,95%CI(1.56,2.79),P<0.00001]；6篇文献安全性分析提示：四磨汤组不良反应的发生率明显低于对照组[OR=0.29,95%CI(0.16,0.51),P<0.0001]。
2.临床研究纳入病例84例,脱落4例,实验结束后治疗组39例,对照组41例。两组治疗前一般情况如性别、年龄、病程、病情程度等方面无显著差异(P>0.05)；中医症候总积分、各症状积分相比无明显差异(P>0.05)；血清SS、SP含量亦无统计学差异(P>0.05)。
3.经治疗后,两组疾病疗效相比无统计学差异(P>0.05)；治疗组中医症候总积分减少,与对照组比较差异有统计学意义(P<0.05)；各症状疗效比较：胃脘痞满、餐后饱胀、食量减少、嗳气反酸、恶心呕吐本组前后积分有差异(P<0.05),但两组之间积分及各疗效两组比较无明显差异(P>0.05)；胁肋胀满,太息,大便不畅本组前后积分、治疗后两组积分及各疗效两组比较差异均有统计学意义(P<0.05)。
4.治疗组患者血清中SS含量降低,SP含量上升,但与对照组相比差异无统计学意义(P>0.05)；
5.两组脱落病例比较无统计学差异(P>0.05)。
结论：
1. Meta分析表明四磨汤治疗FD疗效明显,且安全性较高。
2.四磨汤对FD肝脾气滞证患者临床疗效显著。
3.四磨汤在改善患者某些症状方面优于吗丁啉。
4.四磨汤治疗肝脾气滞证FD患者可能与调节血清SS,SP的含量有关。
5.四磨汤无明显不良反应,安全性好,值得临床应用。
Objective:Use Meta analysis to evaluate the clinical effect and safety of simotang for functional dyspepsia patients.To study the effect of Simo decoction(SD) on patients with functional dyspepsia with qi stagnancy of both liver and spleen and the influence of the SS and SP in the patients' serum. To provide more basis for SD's efficacy and safety on FD.
Methods:We searched identify randomized controlled trials about simotang for FD patients. The methodological quality was assessed and the data was extracted according to the Cochrane Reviewer's Handbook and related methods;84cases of FD with qi stagnancy of both liver and spleen were divided randomly into two groups:the treating group and the contrasting group. SD and simulative Domperidone was taken in the treating group, and simulative SD and Domperidone in the contrasting group. Treatment for14days. Observe patients of the general conditions, the three conventional, liver and kidney function, electrocardiogram, etc.Assess the two groups of disease curative effect, the curative effect of every symptom, and detect the SS and SP in the patients'serum by ELISASixteen eligible studies involving
Result:
1.1466FD patients were included.The results of meta-analyses showed that SD could precisely improve the total effects more than the control group [OR=2.09,95%CI(1.56,2.79), P<0.00001]. The Security Analysis of the5literature suggest that Compared with the control group, The adverse reactions risk of simtang is lower than the control group,[OR=0.3,95%CI(0.16,0.54), P<0.0001]
2.84cases were observed in this research among which4cases shed off,39cases in the treating group and41cases in the contrasting group. Before treatment,there were no significant differences in gender,age duration, and degree of illness,symptoms of traditional Chinese medicine total score, each symptom scores,the SS and SP in the patients'serum between the treating group and the contrasting group (P>0.05).
3. After treatment:there were no significant differences in disease curaive effect and some symptoms (P>0.05), there were significant differences in total score of symptoms and another symptoms(P<0.05).
4. SD can reduce the the content of ss and sp in the in the patients' serum(P<0.05), but there were no significant differences between the treating group and the contrasting group (P>0.05).
5. There were no significant differences in the shed off cases between the treating group and the contrasting group
Conclusion:
1. Meta-analysis shows that SD canimprove the therapeutic effect on FD patients and have high security.
2. SD have significant clinical curative effect on patients with functional dyspepsia with qi stagnancy of both liver and spleen.
3. SD have better curative effect on some symptoms than Domperidone.
4. SD can regulate the the content of ss and sp in the in the patients'serum, and it's may be one of the possible mechanism to therapy FD.
5. SD is safe and has no obvious side effects in clinical.
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