溃疡性结肠炎中医综合治疗方案疗效评价研究

【作者】 韩昌圣；

【导师】 王新月；

【作者基本信息】 北京中医药大学 ， 中医内科， 2010， 博士

【摘要】 1研究目的以溃疡性结肠炎(UC)慢性复发型和慢性持续型患者为研究对象,采用多中心、随机、平行对照临床试验设计,以传统西药柳氮磺胺吡啶为对照,探讨中医综合治疗方案对溃疡性结肠炎的临床疗效、患者生活质量、用药安全性的影响并进行评价,明确其有效性和安全性,建立优化的溃疡性结肠炎中医规范化治疗方案。2研究方法本课题依据相关标准,进行严格的临床研究设计,结合具体临床实际,采用随机、阳性对照的方法,以东直门医院、中日友好医院和首都医科大学附属复兴医院的门诊和住院患者为研究对象,选择溃疡性结肠炎慢性复发型和慢性持续型病例60例。中药组采用中医综合治疗方案分期、分部位治疗,将其分为活动期、恢复期、缓解期进行辨证治疗,分别给予溃结Ⅰ、Ⅱ、Ⅲ号方,并结合不同病变部位给予栓剂或保留灌肠治疗。西药组活动期给予柳氮磺胺吡啶(SASP)每日4-6g,分4次口服；缓解期改为每日1-3g维持缓解巩固治疗；病变部位在直、乙结肠者用柳氮磺胺吡啶栓剂0.5-1g,2次／日。疗程均为3个月,对有效病例随访6个月,主要观察临床综合疗效、中医证候疗效、临床主要症状变化、内镜黏膜疗效、黏膜病理疗效、临床活动指数和内镜指数、血小板计数、复发率及生活质量量表评分的变化,以及安全性指标检测。3研究结果3.1临床近期疗效经过3月的治疗后,经统计学分析,在临床综合疗效、中医证候疗效、内镜黏膜疗效和黏膜病理疗效以及内镜指数方面,中药组和对照组均较治疗前有明显改善(P<0.05),而中药组疗效均优于对照组(P<0.05)。可见,两组治疗UC的临床近期疗效均较满意,中药组疗效更著。3.2临床远期疗效治疗3个月后,对经治疗完全缓解及有效的患者(中药组28例,对照组20例)进行了随访,调查治疗后6个月内的复发情况,发现中药组在6个月后随访时的复发率低于对照组,两者存在非常显著性差异(P<0.01)。动态观察治疗2周、4周、3月后及随访6月的证候积分,可以看出两组均能有效地改善临床症状,其中中药组疗效优于对照组(P<0.05)。从起效的时间段来看,两组在治疗2周后效果相当,无显著差异；从治疗4周后中药组疗效开始优于对照组,治疗3月后疗效优势则更加明显；治疗后6月随访结果显示,中药组疗效较稳定,而对照组积分回升,症状反弹。而在临床活动指数、血小板计数、大便潜血和大便红细胞计数以及生活质量量表评分方面,治疗3月后中药组和对照组均较治疗前有明显改善(P<0.05),中药组疗效更优于对照组(P<0.05)。治疗后6个月随访,中药组较治疗后变化不明显,而对照组则均有明显改变,两组比较具有显著性差异,P<0.05。以上结果说明,中药组在远期疗效和抗复发方面更显优势。3.3安全性疗效两组不良反应比较,在3个月的治疗过程中,中药组无1例出现不良反应,而对照组则有8例出现不良反应,其不良反应率为27.59%。在血常规方面,中药组治疗前后红细胞、血红蛋白、白细胞计数无统计学差别,治疗后中药组与对照组比较亦无明显差异。对照组白细胞计数治疗后明显低于治疗前,白细胞有下降的趋势。尿常规方面,中药组治疗前后尿常规阳性率统计无明显差别,对照组治疗后尿常规阳性率高于治疗前,具有统计学意义,P<0.05。肝肾功能方面,中药组治疗前后均无明显变化,对照组治疗后肝功能指标ALT和AST均高于治疗前,具有统计学意义,P<0.05。心电图方面,中药组治疗后心电图阳性率明显低于治疗前,对照组治疗前后心电图变化无明显差别。治疗后中药组与对照组比较具有显著性差异,P<0.01,对照组心电图阳性率增多。由此看出,中药组在临床长期用药方面更具安全性,对照组则在粒细胞、尿常规、肝功能和心电图等方面可引起不同程度的不良反应。4结论以中医辨证论治和西医临床分期相结合、整体脏腑辨证论治与局部用药相结合的中医综合治疗方案治疗溃疡性结肠炎取得了令人满意的临床综合疗效。本方案有效地阻抑了愈后复发,其中在提高完全缓解率及有效率、改善中医证候积分、临床活动指数、内镜指数方面作用皆优于后者,且未出现明显的毒副作用。而中药组的低复发率、低不良反应率都表明本方案能有效阻抑慢性复发型活动期及慢性持续型UC患者愈后复发。因此,本中医综合和治疗方案在临床近期疗效、远期疗效和安全性疗效方面,均明显优于西药柳氮磺胺吡啶,尤其是在改善UC患者生活质量和抗复发方面更显示出其强大的优势,从而为UC中医规范化治疗方案的建立和优化提供可靠的依据。更多还原

【Abstract】 1 Background and ObjectiveWe took chronic recurrent and chronic resistant type Ulcerative Colitis (UC) as the object of the study. The study adopted multi-center, random, parallel experimental design compared with Sulfasalazine (SASP). We deeply investigated the mechanism of Chinese Medicine in treating from the aspects of clinical general therapeutic effect, patients’living quality, the safety of medicine. We deeply analyzed its effect and safety in order to offer better standardized TCM method in UC treating2 MethodsThe study was strictly designed under the relative guidance. In combination with actual clinical situation, adopting random positive control method.60 cases of chronic recurrent type and chronic resistant type were selected from out patient clinic (OPD) and ward of DongZhimen Hospital, China Japan Friendship Hospital and Fu Xing Hospital attached to Capital Medicine University. The TCM group adopted general plan, treating by stages and positions. We separated patients as active period, convalescence, relieved period so as to diagnose and treated based on overall analysis of the illness and patents’condition. We giveⅠ,Ⅱ,Ⅲulcer prescription respectively with different suppositories in different position or remaining an enema. The active period group in Western Medicine received Sulfalazine (SASP), (4-6g/d) and took 4 times a day. The relieved period group received Sulfalazine(1-3g/d) to consolidate treatment. Illness position in rectum and B colo received SASP (0.5-1g/d).Both treatment course was 3 months and attended 6 months, main observed: Clinical genera effect, therapeutic effect of mucous membrane under endoscopes, therapeutic effect of mucous member, pathology mucous, the change of clinical activity index, the count of blood platelet, the relapse rate and safety index.3 Results3.1 Clinical recent curative effectAfter three months of treatment, the analysis of statistic show that the treated group and control group all have significant improvement (P<0.01).In the aspect of clinical general therapeutic effect, the TCM syndrome, therapeutic effect of mucous membrane under endoscope, the therapeutic effect of pathology mucous and endoscope index. Treated group is better than control group on all level. As we see, two groups all have satisfied clinical therapeutic effect, and the treated group had better effect.3.2 Clinical forward curative effects After curing 3 months, we took random visit to the patients who totally relieved after the treatment (28 cases in treated group,20 cases in control group) in order to investigate relapse situation in six month after treatment. We found the relapse rate in six months of treated group is obviously lower than that of control group (p<0.01)We observe the Symptom integral of 2weeks,4 weeks and 3months dynamically. We can see that two groups can improve clinical therapeutic effect and treated group hand better treatment than control group (p<0.05). From the time came into effect, two groups had same effect after 2 weeks’treatment and had no significant difference. After 4weeks of treatment, treated group come to being superior with control group. After 3 months the superiority is more significant. The random visit after treatment show that the treated group had stable therapeutic effect, but the integral of control group rise up again and the symptom bound. Therefore we can see that the treated group is safer in the long term. In the aspect of the change of clinical activity index, the count of platelet, Fecal occult blood, Fecal red blood cell count and the living qualities appraisal, treated group and control group all have significant improvement after 3 months’treatment (p<0.05). Treated group had better therapeutic effect than control group (p<0.05).The relapse rate in 6 months of treated group is obviously lower than that of control group. Comparing two groups, there are significant different (p<0.05).The result above reflects that treated group has more advantage in therapeutic effect and resisting relapse in the long term.3.3 Security curative effectsDuring 3 months of treatment, there was no obvious ill-effect on treated group, but 8cases of control group had ill-effect. The rate of ill-effect is 27.95%. In the aspect of blood, there were no statistic differences in RBC, Hemogolbin, and White blood cell count in treated group. Whit blood cell count decreased significantly after treatment in control group. The White blood cell had decreasing trends.In the aspect of Vrine, there were no significant different in vrine positive statistic rate in treated group after treatment. The vrine positive statistic rate in control group was higher than before. It has sense in statistic (p<0.05).In the aspect of ECG, ECG positive rate was much lower than before in treated group. There was no difference in control group. A remarkably different can be seen compared with them (p<0.01). The ECG positive rate in control group was increasing.Therefore, we can conclude that the treated group is safer in long term. It has caused different degrees of ill-effect in Granulocyte, Liver function and CEG in control group.4 Conclusions We have got satisfied therapeutic effect in treating UC by using the method of determination of treatment based on differentiation of syndromes, curing by stages and phased delivery. This method resists the relapse effectively. Especially in the ratio of relived, the ratio of effecting, the change of TCM syndrome, endoscope index, clinical activity index compared with Western Medicine. It had no obvious effect either. The low ratio of relapse and ill-effect all reflects that this method can restrain the relapse of chronic recurrent type and chronic resistant type. Therefore, the general TCM method shows its superiority in near and distant therapeutic effect, and safety of the treatment.Especially in the betterment of living quality and restraining of relapse. It proves reliable basis in contributing better standardized TCM pan in UC.更多还原