摘要
第一部分临床研究
目的:观察化浊解毒消溃煎治疗消化性溃疡(Peptic ulcer,PU)浊毒内蕴证的临床疗效。
方法:采用随机对照法。将符合纳入标准的病例80例按“随机数字表法”随机分为治疗组和对照组,治疗组40例,对照组40例,治疗组服用化浊解毒消溃煎,对照组服用盐酸雷尼替丁胶囊,两组均服药6周。观察治疗前后主要症状改善情况及胃镜、幽门螺旋杆菌(Helicobacter pylori,Hp)变化情况。
结果:(1)临床症状疗效比较:治疗后治疗组临床症状总有效率87.5%,对照组75.0 %。两组比较,治疗组优于对照组(P<0.05)。(2)治疗前后主要症状积分比较:在治疗6周后,治疗组和对照组各症状均比治疗前有改善(P<0.05),在症状改善方面,治疗组与对照组比较有显著差异(P<0.05)。(3)胃镜疗效比较:治疗后治疗组胃镜总有效率95%,对照组胃镜总有效率72.5%。两组比较有显著差异(P<0.05),治疗组优于对照组。(4)对Hp影响的比较:治疗组治疗前Hp阳性31例,治疗后Hp阳性8例,清除率74.2%;对照组治疗前Hp阳性30例,治疗后Hp阳性16例,清除率46.7%。两组比较有显著差异(P<0.05)。(5)远期疗效的比较:治疗组复发率为9.5%,对照组为38.9%,两组比较有显著差异(P<0.05)。(6)安全性评估:治疗前后两组病人血、尿、便常规,心电图、肝肾功能均无明显变化,提示两组药物均无明显毒副作用。
结论:临床研究表明,化浊解毒消溃煎能改善消化性溃疡浊毒内蕴证的临床症状,抑杀Hp,提高溃疡愈合质量,降低复发率,其疗效作用优于雷尼替丁胶囊组。从临床角度验证了化浊解毒消溃煎治疗消化性溃疡的实用性和可行性。
第二部分实验研究
目的:通过给胃溃疡大鼠模型灌服药物,并检测相关指标,探讨化浊解毒消溃煎治疗消化性溃疡的作用机制,为临床研究提供实验依据。
方法:用随机数字表法,将40只Wistar健康雄性大鼠随机分为5组:正常对照组(A组)、模型组(B组),雷尼替丁组(C组),化浊解毒消溃煎低剂量组(D组),化浊解毒消溃煎高剂量组(E组),每组8只。除正常组外,其余各组大鼠均采用乙酸侵蚀胃壁制造胃溃疡大鼠模型。造模后第二天开始灌胃给药:化浊解毒消溃煎高剂量组按22.1g /( k g·d )灌服化浊解毒消溃煎;化浊解毒消溃煎低剂量组按5.5g /( k g·d )灌服化浊解毒消溃煎;雷尼替丁组按31.25mg/( k g·d )灌服雷尼替丁;正常组、模型组每日灌胃等容积的蒸馏水;各组均连续灌胃10天,每日1次。末次给药后禁食24小时,断头取血,每只取血2ml,并留取标本检测以下指标:血小板活化因子(PAF)、降钙素相关基因肽(CGRP)、胃粘膜大体观、溃疡指数(UI)、胃粘膜组织病理观察。
结果:(1)胃粘膜肉眼观:计算溃疡指数和溃疡抑制率发现,雷尼替丁组、中药小剂量组和中药大剂量组均有效,但以中药大剂量组效果最为明显。(2)胃粘膜组织学观察:HE染色切片:模型组大鼠:溃疡处于进展期,部分溃疡深达肌层,表面炎性坏死、渗出,可见大量炎症细胞浸润。雷尼替丁组大鼠:溃疡处于愈合期,新生腺体覆盖溃疡面,边缘新生腺体部分呈囊状扩张,底部肉芽组织内新生血管丰富。中药低剂量组大鼠:溃疡处于愈合期,溃疡面留有少量坏死组织,周围再生腺体扩张呈不规则样,粘膜下肉芽组织增生,炎症细胞浸润,毛细血管丰富。中药高剂量组大鼠:溃疡处于愈合期,溃疡面积缩小,边缘再生腺体部分囊状扩张且再生腺体数量增多,腺体间结缔组织减少。肉芽组织中胶原纤维数量比较多,慢性炎症细胞浸润,新生毛细血管丰富。(3)中药大、小剂量组与雷尼替丁组的血浆CGRP水平显著高于模型组(P<0.05),而血浆PAF水平显著低于模型组(P<0.05)。
结论:化浊解毒消溃煎可能是通过降低胃溃疡大鼠血浆PAF含量及升高CGRP含量,从而改善胃粘膜微循环,增高胃粘膜保护因子的水平,降低胃粘膜攻击因子的能力而起到治疗消化性溃疡的作用。
The first department
Objective: To observe the therapeutic effect of Huazhuo jiedu Xiaokui Jian decoction on peptic ulcer(PU) patients with retention of turbid toxins syndrome.
Method: The case-control study was adopted. The selected cases according to“Randomized Number Scale”were randomly divided into two groups: 40 patients in treatment group were treated with Huazhuojiedu Xiaokui Jian decoction; 40 patients in control group were treated with Ranitidine. Both groups were treated for six weeks. Observe the changes of Clinical symptoms’, gastroscopy and Helicobacter pylori(Hp) before and after treatment .
Result:(1)Comparison of clinical symptom therapeutic effect: In treatment group the total efficiency is 87.5%,which is significantly higher than that of control group(P<0.05).In control group the total efficiency is 75.0 %. (2) Comparison of the main clinical symptoms before and after treatment: After 6 weeks of treatment, all the main clinical symptoms were improved after treatment in treatment group and control group(P<0.05). There was a significantly difference between treatment group and control group after treatment (P<0.05). (3) Comparison of Gastroscopic therapeutic effect: In treatment group the total efficiency is 95%,which is significantly higher than that of control group(P<0.05).In control group the total efficiency is 72.5%. (4) Comparison of the effect on HP: In treatment group Hp positive patients were 31 before treatment, the patients were 8 after treatment; the clearance rate is 74.2%, which is significantly higher than that of control group (P<0.05).In control group Hp positive patients were 30 before treatment, the patients were 16 after treatment; the clearance rate is 46.7% (5) Comparison of prostecdtive efficacy: The ulcer recurrence rate in treatment group was 9.5% while in control group was 38.9%.There was a significantly difference between two groups(P<0.05). (6) Evaluation of therapeutic safety in the two groups: There were neither obvious changes in blood, urine or stool rules nor in Electrocardiogram or liver-renal function before and after treatment. In the course of the treatment, all patients had no undesirable response, which pointed the fact that the drug of two groups have no toxic and side effect.
Conclusion: The study indicates that Huazhuojiedu Xiaokui Jian decoction can improve the clinical syndrome of peptic ulcer patients with retention of turbid toxins syndrome, restrain or eliminate Hp, improve the quality of ulcer healing and decrease the recurrence rate of Peptic Ulcer. Its curative effect is better than that of Ranitidine. It is verified that Huazhuojiedu Xiaokui Jian decoction is feasible and practicable in treating Peptic Ulcer from clinical curative effective aspect.
The Second Department
Objective: To study the mechanism of Huazhuojiedu Xiaokui Jian decoction in treating gastric ulcer by feeding drugs and observing correlated indexes in rat model. To provide experimental evidence for clinical research.
Method: 40 healthy male Wistar rats were selected randomly and divided into five groups: normal group(A), model group(B), ranitidine group(C), Huazhuojiedu Xiaokui Jian low dose group(D), Huazhuojiedu Xiaokui Jian large dose group(E) , each group had 8 rats. Rats models were made by using acetic acid to erode the gastric mucosa except the normal group. After 24 hours of the operation, the drug was given. The amount of Huazhuojiedu Xiaokui Jian decoction given to group E and group D was22.1g/( kg?d ) and 5.5g/( kg?d ) respectively. The amount of ranitidine given to group C was 31.25mg/( kg?d ). The distilled water was given to group A and group B respectively. Ten days later, all the rats were killed to observe the following index: platelet activating factor(PAF), calicitonin gene related peptide(CGRP), gastric mucosa, ulcer index(UI) and pathology of gastric mucosa tissue.
Result: (1)Observation of gastric mucosa: Through calculating ulcer index and ulcer inhibition ratio, we found that there was therapeutic effect on ranitidine group, lower dose group and large dose group, but it was the most manifestion in large dose group.(2)observation of gastric mucosa tissue: HE tincted microtome section: Model group: ulcer in progression period, some ulcer reached to muscular layer, inflammatory necrosis, exfiltration, inflammatory cell infiltration. Ranitidine group: ulcer in convalescent period, some regenerated glandular organ in borderline showed crytomere distension and neogenesis vascellum was abundance in granulated tissue. granulated tissue. Low dose Group: ulcer in convalescent period, necrotic tissue was decreased in ulcer surface, regenerated glandular organ was irregularly distented, mucus secretion was abundance, granulationtissue hyperblastosised, inflammatory cell infiltration and abundanced in micrangium. Large dose group: ulcer in convalescent period, ulcer diminished, regenerated glandularorgan in borderline showed cryptomere distension, quantity of regenerated glandular organ was increased, tela cellulose diminished, quantity of collagenous fibrils was increased and abundance in micrangium. (3)Level of CGRP in low dose group, large dose group and ranitidine group was increased significantly than that of model group(P<0.05),while PAF level was dropped significantly in those groups than that of in model group(P<0.05).
Conclusion: Huazhuojiedu Xiaokui Jian may improve the microcirculation of gastric mucosa by increasing the level of protective factors such as CGRP and decreasing the level of aggressive factors such as PAF to cure peptic ulcer.
引文
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