健脾活血法治疗慢性萎缩性胃炎脾虚血瘀证的临床研究
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摘要
研究目的:
     通过随机、对照的临床试验,观察健脾活血法治疗慢性萎缩性胃炎脾虚血瘀证的临床疗效、安全性及随访3个月的远期疗效。
     研究方法:
     选取符合纳入标准的患者63例,随机分为试验组32例,对照组31例。试验组患者口服健脾活血方,对照组服用胃复春片,疗程均为3个月。疗程结束后观察临床疗效。停药3个月后进行远期疗效观察。
     研究结果:
     1.两组治疗后总体疗效比较:试验组32例中,痊愈2例,显效14例,有效13例,无效3例,总有效率为90.63%;对照组31例中,痊愈2例,显效7例,有效12例,无效10例,总有效率为67.74%。经Wilcoxon秩和检验,两组比较有统计学差异(P<0.05)。说明试验组的总体临床疗效优于对照组。组内比较发现:除大便干燥、大便稀溏两组症状未见明显好转外(P>0.05),试验组与对照组对其它症状均有疗效(P<0.05)。经组间比较发现:试验组对胃胀、胃痛、胃中嘈杂及饮食减少的改善程度优于对照组,两组比较有统计学意义(P<0.05或P<0.01)。试验组胃胀、乏力症状的起效时间早于对照组,其余症状起效时间与对照组相当。
     2.两组治疗后均复查胃镜,治疗后病理组织学疗效比较:试验组胃黏膜萎缩、肠上皮化生的总有效率分别为65.63%、68.75%,对照组分别为45.16%、48.39%,经统计学分析其差异均有统计学意义(P<0.05)。试验组炎症活动性及Hp感染的改善程度亦优于对照组(P<0.05),但异型增生及慢性炎症的疗效两组比较无明显统计学意义(P>0.05)。
     3.停药3个月后随访两组临床疗效,试验组32例中,治愈5例,显效16例,有效9例,无效1例,总有效率96.88%;对照组31例中,治愈1例,显效10例,有效10例,无效10例,总有效率67.74%。经Wilcoxon秩和检验,两组比较有显著统计学差异(P<0.01),治疗组远期疗效明显优于对照组。
     4.在观察过程中,两组均无明显不良反应。
     研究结论:
     健脾活血方治疗慢性萎缩性胃炎脾虚血瘀证有较好的临床疗效,能够改善患者的临床症状及病理表现,并具有良好的安全性。
Objective:
     To observe the clinical effect and safety by using the method of JianPiHuoXue prescription in treating Chronic Atrophic Gastritis with Spleen deficiency and Blood stasis Syndrome. And observe the long-term curative effect after following up for3months.
     Methods:
     This research was based on63cases of outpatients who were conformed to inclusion criteria. They were randomly divided into two groups. One group was the treatment group,32patients of which were treated by JianPiHuoXue prescription. The other group was the control group, with31patients being treated WeiFuChun. Both groups were treated for three months. Then we can observe the clinical effect when the course was finished. Long-term observation would be carry on after stop using treatment for three months.
     Result:
     1.The overall curative effect comparison of two groups after the treatment:In the test group,2cases recovered and14cases significantly improved,13cases improved,3ineffectual cases. The total effective rate of test group was90.63%. In the control group,2cases recovered and7cases significantly improved,12cases improved,10ineffectual cases. The total effective rate of control group was67.74%. There was statistically significant difference in the total effective rate between the treatment group and control guoup(P<0.05). The effective rate from the test group was clearly superior.Comparison within groups found:Excepting diarrhoea and astriction were of no avail(P>0.05), the two groups both had curative effect to the other syndromes(P<0.05). Comparison among groups found:The test group has symptomatic improvement in stomach bloated,stomach pain.stomach noisy and diet reduction. The comparison of two groups had statistical significance(P<0.05or P<0.01). The time of test group on alleviating stomach bloated and tired was shorter than the control group. Other syndromes had curative effect almost in the same time of the two groups.
     2.The two groups both reexamined the gastrofiberscope, and the comparison of curative effect of two groups of histopathology after the treatment found:The total efficiency of gastric atrophy,intestinal metaplasia of two groups was65.63%and68.75%respectively,while the control group was45.16%and48.39%respectively. The comparison of two groups had statistical significance(P<0.05).The improvement rate of inflammatory activity and H.pylori infection of test group was also better than the control group(P<0.05). But dysplasia and chronic inflammation curative effect between the two groups had no obvious statistical significance(P>0.05).
     3.After three months of untreatment,5cases recovered,16cases significantly improved,9cases improved and1ineffectual cases in the test group. The total effective rate of test group was96.88%. In the control group,1cases recovered,10cases significantly improved,10cases improved and10ineffectual cases. The total effective rate of control group was67.74%. There was statistically significant difference in the total effective rate between the treatment group and control guoup(P<0.01).The long-term clinical efficacy of the test group was better than the control group.
     4.In the observation, the two groups both didn't find significant adverse reaction.
     Conclusion:JianPiHuoXue prescription has significant efficacy in treating Chronic Atrophic Gastritis with Spleen deficiency and Blood stasis Syndrome.The prescription can improve clinical symptoms and pathology, besides it also has good security.
引文
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