OBJECTIVETo explore the safety and efficacy of Shaobei injection in the management of I(-II( degree rectal prolapse.

METHODSA total of 80 patients eligible for the inclusion criteria were divided into 2 groups: 40 patients in the treatment group (treated with Shaobei injection) and 40 cases in the control group (treated with Xiaozhiling) respectively. The short-term efficacy was identified by the length of rectal prolapse and the depth of rectocele demonstrated by the defecography while the long-term efficacy was evaluated by the length of rectal prolapse. In addition, the safety was assessed by the occurrence of postoperative complications.

RESULTSThe variation of the lengths of rectal prolapse and the depth of rectocele demonstrated by the defecography at the sixth month follow up in the two groups did not reach significant difference (P>0.05). After 2 year follow up, 37 patients (92.5%) in the treatment group and 35 cases(87.5%) in the control group was cured. Therefore, there was no significant difference in the long term efficacy between the two groups (P>0.05). The adverse events in the therapy group(10%) was less than that in the control group (45%)(P<0.01).

CONCLUSIONSShaobei injection in the management of I(-II( degree rectal prolapse has a similar efficacy of short-term and long-term higher safety compared to Xiaozhiling injection.