柴枳排石汤对保胆取石术后胆囊功能恢复及临床疗效的影响：一项随机对照研究

Effects of Chai-Zhi Paishi Decoction on gallbladder function recovery and clinical outcomes after gallbladder-preserving cholecystolithotomy: a randomized controlled trial

摘要:

目的 探讨柴枳排石汤对保胆取石术后胆囊功能恢复、短期结石复发及相关临床指标的影响。方法 采用单中心、随机、对照、平行分组设计，选取2023年1月—2025年4月在诸暨市中医医院行腹腔镜联合胆道镜保胆取石术的胆囊结石患者80例，将符合纳入标准者按1∶1比例随机分为试验组和对照组。对照组在常规治疗基础上术后给予熊去氧胆酸治疗，试验组在常规治疗基础上给予柴枳排石汤治疗，疗程均为3个月，术后随访6个月。主要观察指标为胆囊功能指标，包括胆囊收缩率（GBEF）、胆囊壁厚度、空腹胆囊收缩素（CCK）水平；其中胆囊结石复发率是术后6个月短期复发观察的结局指标；次要观察指标包括炎症因子、肝胆酶学指标、血脂及胆红素代谢指标、中医证候积分的变化，并进行安全性评价。结果 共73例患者完成随访，其中试验组36例，对照组37例。术后6个月随访期间，两组复发率比较，差异无统计学意义（P >0.05）。治疗6个月后，试验组GBEF升高幅度、胆囊壁厚度降低幅度及空腹CCK升高幅度均大于对照组（P <0.05）。试验组中医证候的主症、次症及总分下降幅度均大于对照组（P <0.05）。试验组白细胞介素-6和高敏C反应蛋白水平下降幅度、表皮生长因子水平升高幅度均大于对照组（P <0.05）。试验组肝功能、胆红素及血脂指标变化幅度均大于对照组（P <0.05）。两组不良事件发生率比较，差异无统计学意义（P >0.05）。结论 柴枳排石汤用于保胆取石术后有助于促进胆囊功能恢复，改善炎症状态、肝胆功能、血脂代谢及中医证候，安全性较好；柴枳排石汤对胆囊结石复发的远期影响仍需进一步随访观察。

Abstract:

Objective To evaluate the effects of Chai-Zhi Paishi Decoction on gallbladder function recovery, short-term gallstone recurrence, and related clinical indicators after gallbladder-preserving cholecystolithotomy.Methods This single-center, randomized, controlled, parallel-group trial enrolled 80 patients with gallstones who underwent laparoscopic and choledochoscopic gallbladder-preserving cholecystolithotomy at Zhuji Hospital of Traditional Chinese Medicine between January 2023 and April 2025. Eligible patients were randomly assigned 1:1 to a trial group or control group. In addition to conventional treatment, the control group received postoperative ursodeoxycholic acid, whereas the trial group received Chai-Zhi Paishi Decoction. Both treatments lasted 3 months, and the patients were followed for 6 months after surgery. The primary outcomes were gallbladder function indicators, including gallbladder ejection fraction (GBEF), gallbladder wall thickness, and fasting cholecystokinin (CCK). Gallstone recurrence within 6 months after surgery was assessed as a short-term outcome. Secondary outcomes included inflammatory factors; hepatobiliary enzymes; lipid and bilirubin metabolism; changes in traditional Chinese medicine syndrome scores; and safety.Results A total of 73 patients completed follow-up, including 36 in the trial group and 37 in the control group. During the 6-month postoperative follow-up, no gallstone recurrence occurred in the trial group, whereas one patient in the control group experienced recurrence (2.7%); the difference was not significant (P > 0.05). After 6 months, the increase in GBEF, decrease in gallbladder wall thickness, and increase in fasting CCK were greater in the trial group than in the control group (P < 0.05). The decreases in interleukin-6 and high-sensitivity C-reactive protein and the increase in epidermal growth factor were greater in the trial group. Improvements in liver function, bilirubin indices, and lipid indices were greater in the trial group than in the control group (P < 0.05). The decreases in primary symptom, secondary symptom, and total traditional Chinese medicine syndrome scores were greater in the trial group than in the control group (P < 0.05). The incidence of adverse events did not differ significantly between the groups (P > 0.05).Conclusion Chai-Zhi Paishi Decoction may promote gallbladder function recovery and improve inflammation, hepatobiliary function, lipid metabolism, and traditional Chinese medicine symptoms after gallbladder-preserving cholecystolithotomy, with good safety. However, gallstone recurrence at 6 months did not differ significantly between the groups, and longer follow-up is needed to determine its long-term effect on recurrence.