OBJECTIVETo investigate the clinical efficacy of Shenzhe Zhuyun mixture (SZM) in treating esophageal lesion in patients with systemic sclerosis.

METHODSSixty-four patients conforming to the inclusion criteria were randomly divided into 2 groups, the treated group and the control group treated respectively by SZM and cisapride, with the blank preparation imitating the contrast one, the treatment course to both groups was 2 months. The clinical efficacy, the changes in symptom scores of esophageal lesion, the orthostatic and clinostatic time of barium passing through esophagus, the clinostatic esophageal emptying index of barium, and the widest transverse diameter of ectatic esophageal segment, as well as the influence of treatment on patients' quality of life were observed.

RESULTSThe total effective rate in the treated group was superior to that in the control group (96.9% vs 56.2%, P < 0.01). Symptom of esophageal lesion was significantly improved after treatment in both groups (P<0.01), and the improvement in the treated group was better than that in the control group (P <0.01). The time of Barium passing through esophagus, both orthostatic and clinostatic, and the esophageal emptying index of barium were improved in the treated group (P < 0.01), but the change of the widest transverse diameter of ectatic esophagus was insignificantly improved. While in the control group, excepting the clinostatic time of barium passing through was improved (P<0.01), the other indexes showed no obvious change. Patients' quality of life was significantly improved in the treated group, but improvement didn't revealed in the control group.

CONCLUSIONSZM can reinforce esophageal dynamic function in patients with systemic sclerosis, it can be an effective TCM prescription in treating esophageal lesion for them.