保和丸超微配方制剂与传统汤剂对照治疗功能性消化不良的临床研究

目的：观察保和丸超微配方制剂与传统汤剂对功能性消化不良（痞满证）的疗效及安全性，探讨中药配方制剂与传统汤剂的量效关系。方法：将60例患者随机分为保和丸传统饮片组（20例）和超微配方制剂1／3剂量组（相当于传统饮片生药剂量的1／3）、1／5剂量组（每组各20例），给予相对的治疗药物，疗程7天。观察2组病、证疗效及症状改善情况。结果：保和丸传统饮片对功能性消化不良的显效率为15％，总有效率为75％；1／3剂量组的显效率为15％，总有效率为80％；1／5剂量组的显效率为5％，总有效率为60％。保和丸传统饮片对饮食积滞证的总显效率为65％，总有效率为90％；1／3剂量组的总显效率为55％，总有效率为85％；1／5剂量组的总显效率为35％，总有效率为75％。组间病、证疗效比较差异均无统计学意义（P〉0．05）。试验过程中安全性指标无临床意义的异常变化，亦无不良事件发生。结论：保和丸超微配方制剂对功能性消化不良具有较好的临床疗效，能有效的改善受试者的临床症状，超微配方制剂仅需要传统剂型的1／5即可有效，而1／3超微配方制剂剂量就可以和传统剂量疗效相同。

Treatment for Functional Dyspepsia with Ultra-fine vs. Traditional Decoction of Baohe

Objective ：To investigate effectiveness and safeness of two preparations of Baohe ： ultra-fine preparation vs. traditional decoction for functional dyspepsia （syndrome of stuffiness and fullness） and discover respective dose-effect relationship, nethods：A randomized trial was carried out on 60 patients who were respectively allocated to traditional decoction, or ultra-fine preparation （1/3,1/5 of original herbal dosage） for a course of 7 days to observe the patients＇ conditions. Results：In the order of traditional decoction, 1/3 group and 1/5 group, curative rates and effective rates for dyspepsia were respectively 15% ,75% /15% ,80% /5% ,60% ; curative rates and effective rates for food accumulation were 65%, 90%/55%, 85%/35 %, 75 %, there was no significant difference of any parameters abovementioned between groups （P 〉 0. 05 ）. Safeness-related abnormal change of clinical significance or adversary effect wasn＇ t found. Conclusion： Ultra-fine preparation of Baohe is effective for relieving clinical symptoms of functional dyspepsia at five-fold reduction of original herbal amount, and as effective as traditional decoction at the three-fold reduction of original herbal amount.