目的:研究柴郁排石散对肝内胆管结石的临床疗效及其安全性。方法:按照随机对照平行双盲的方法,将60例肝内胆管结石患者随机分为对照组和治疗组,分别给予茴三硫片和柴郁排石散,2次/天,共45天,观察治疗前后临床症状、体征、实验室及影像学指标变化情况。结果:用药45天后,两组主要临床症状、体征、白细胞计数、中性粒细胞比值、血清总胆红素均明显改善;其中治疗组疗效显著由于对照组。治疗组疼痛缓解时间、退热时间、黄疸消退时间均明显早于对照组。柴郁排石散治疗组总有效率达86.7%,对照组总有效率33.4%(P〈0.01)。两组患者于用药期间均未发现明显不良反应。结论:柴郁排石散治疗肝内胆管结石具有疗效肯定、安全性高、服用方便等优点,具有广阔的临床应用价值。
Objective: To explore the effects of Chaiyupaishi granules (CYPS) on the calculus of intrahepatic duct due to stagnation of the liver-qi and its primary safety. Methods: Randomized double-blind controlled clinical trial method was used in this study. Sixty cases of calculs of intrahepatic duct patients were divided into control and CYPS group (n=30) randomly, and were given with anethol trithione (37.5mg, bid., PO) and CYPS (58.5g, bid., PO. ) for 45 days, respectively. The clinical symptoms, physical signs, laboratory indexes and abdominal B-ultrasound were observed to evaluate their effects. Results: CYPS improved clinical symptoms, physical signs, abdominal B-ultrasound, leucocyte count, ratio of neutrophil and level of serum total bilirubin significantly compared with the control group. The time course of odynolysis, pyretolysis and jaundice regression in CYPS group were shorter than that in control group. The total effective rate of CYPS was 86.7%, which was superior to the control group (33.4%, P〈0.01 ). There were no obvious adverse effects in both of the two groups. Conclusion: CYPS have affirmative therapeutic effect on calculs of intrahepatic duct with the convenient and safe qualities.