不同赋形剂调制双柏散外敷治疗急性胆囊炎临床研究简

目的：观察双柏散外敷治疗急性胆囊炎患者的临床疗效，确定不同赋形剂调制对其临床疗效的影响，筛选双柏散外敷的最佳赋形剂。方法：本研究对符合方案集分析（简称PPS）的250例急性胆囊炎进行前瞻性临床研究，分为对照组和双柏散治疗组，后者根据不同的赋形剂又分为蜜组、酒组和水组。观察各组症状总分与改善、右上腹痛改善时间、腹部压痛改善时间、腹部反跳痛改善时间等指标改变，及其与不同的赋形剂的关系。结果：（1）临床疗效：生存分析检验结果显示两组在腹痛改善时间和反跳痛缓解时间差异有统计学意义（P〈O．05）。（2）不同赋形剂与疗效的关系表明：蜜组症状评分明显低于其他组，差异有统计学意义（P〈O．05）；蜜组右上腹痛改善时间和腹部压痛改善时间短于对照组和其他组，具有显著性差异（P〈O．05）；但反跳痛改善时间比较没有显著性差异（P〉O．05）。结论：加味双柏散外敷治疗急性胆囊炎疗效明确，蜜为合适的赋形剂。

Clinical Research of Shuangbai Powder of Different Excipients Modulation by External Application in Treatment of Acute Cholecystitis

Objective： To observe the clinical efficacy of Shuangbai Powder by external application for the patients with acute choleeystitis, and to determine the clinical efficacy of the different modulations of the excipients, screening the best exeipient for Shuangbai Powder external application. Methods ： This research was a prospective clinical study on the 250 patients with acute cholecystitis which were analysed by perprotocol population set （ PPS ）, and the patients were divided into the control group and the treatment group, and the treatment group was divided into the honey group, the alcohol group and the water group according to different excipients. It was to observe the relationships of different excipients with the improvement of the symptom score, the time of the right upper quadrant pain improvement, the abdominal tenderness improvement and the abdominal rebound tenderness improvement in each group. Resuhs ： （ 1 ） Clinical efficacy ： the survival analysis of the test results indicated that the difference had statistical significance on the abdominal pain improvement time and rebounding pain relief time between the control group and the treatment group （ P〈0.05 ）. （ 2 ） The relationships of different exeipients and effects indicated the symptom scores and the improved scores for the honey group were lower than that of others （ P〈O.05 ）; the improved time of right upper quadrant pain of the honey group was shorter than that of the control group （ P〈O.05 ）; the abdominal tenderness improvement time of the honey group was significantly shorter than that of the other groups （ P〈O.05 ）; there was no significant difference between groups with different excipients on the rebound improve time （ P〉0.05 ）. Conclusion ： The study shows that the treatment efficacy for acute cholecystitis by Shuangbai Powder was definite, and honey is the suitable excipient.