ABSTRACT
ObjectiveTo observe the clinical efficacy of modified Tuoli Xiaodusan （TLXDS） in adjuvant treatment of Helicobacter pylori （Hp）-positive peptic ulcer （PU） with cold-heat complex syndrome and explore its regulating effect on invasive/protective factors. MethodA total of 136 patients were randomly assigned into the control group （68 cases， including 4 cases missing， 3 cases eliminated， and 61 cases completed） and the TLXDS group （68 cases， including 4 cases missing， 1 case eliminated， and 63 cases completed）. Both groups adopted the quadruple therapy of acid suppression and Hp eradication. The patients in the control group received Weinai'an capsules orally at 4 capsules/time and 3 times/day， and those in the TLXDS group took modified TLXDS orally at 1 dose/day. The administration of both groups lasted for 8 consecutive weeks and the follow-up lasted for 12 months. Electronic gastroscopy was carried out before and after treatment for evaluating the healing of ulcer， the score of mucosal morphology， and the maturity of regenerated mucosa. The Hp infection and the score of cold-heat complex syndrome were evaluated before and after treatment. The serum levels of gastrin （GAS）， prostaglandin E2 （PGE2）， pepsinogen （PG）-Ⅰ， PG-Ⅱ， epidermal growth factor （EGF）， and trefoil factor 2 （TFF-2） were determined before and after therapy. The recurrence of Hp and PU was recorded， and the drug safety was evaluated. ResultAfter treatment， the mucosal morphology score and the traditional Chinese medicine （TCM） syndrome score in the TLXDS group were lower than those in the control group （P<0.01）. The levels of GAS， PG-Ⅰ， and PG-Ⅱ in the TLXDS group were lower than those in the control group （P<0.01）， whereas those of PGE2， EGF， and TFF-2 showed an opposite trend （P<0.01）. After treatment， the Hp eradication rate in the TLXDS group was 95.24% （60/63）， higher than that （83.61%， 51/61） in the control group （χ2=4.467， P<0.05）. The total effective rate of TCM syndromes in the TLXDS group was 98.41% （62/63）， higher than that （81.97%， 50/61） in the control group （χ2=9.589， P<0.01）. The total effective rate of the TLXDS group under gastroscopy was 98.41% （62/63）， higher than that （86.89%， 53/61） in the control group （χ2=4.525， P<0.05）. The excellent and good rate of regenerated mucosal maturity in the TLXDS group was 92.06% （58/63）， also higher than that （73.77%， 45/61） in the control group （χ2=7.372， P<0.01）. After 12 months of follow-up， the TLXDS group had lower PU recurrence rate ［19.05% （12/63） vs 37.70% （23/61）， χ2=5.325， P<0.05］ and lower Hp recurrence rate ［15.00% （9/60） vs 33.33% （17/51）， χ2=5.165， P<0.05） than the control group. No adverse reactions related to TLXDS were detected. ConclusionModified TLXDS-assisted quadruple therapy demonstrates significant short-term clinical efficacy and high Hp eradication rate for Hp-positive PU （cold-heat complex syndrome） patients. Moreover， it can adjust the levels of invasive/protective factors to facilitate ulcer healing and reduce the recurrence rates of Hp and PU in a long term， with good clinical safety.