| 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 giveâ… ,â…¡,â…¢ulcer 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. |
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