清热利胆颗粒预防腹腔镜联合胆道镜术后胆总管结石复发的效果分析

Clinical effect of Qingre Lidan granules in preventing the recurrence of choledocholithiasis after laparoscopy combined with choledochoscopy

目的 通过回顾性队列研究分析中药清热利胆颗粒对于腹腔镜联合胆道镜术后胆总管结石复发的预防作用。方法 纳入大连医科大学附属第一医院2010年1月1日—2020年12月31日行腹腔镜联合胆道镜取石术治疗的胆总管结石(含合并胆囊结石)住院患者共337例。收集患者相关临床资料,并依据随访结果将患者分为暴露组(常规治疗+清热利胆颗粒组)225例与非暴露组(常规治疗组)112例,详细记录两组患者结石复发的相关情况以及中药清热利胆颗粒的服用情况。观察两组患者胆总管结石的复发率及结石复发的时间,并分析胆总管结石复发的危险因素。计量资料符合正态分布时两组间比较采用成组t检验,不符合正态分布时两组间比较采用Mann-Whithey U检验;计数资料两组间比较采用χ^(2)检验或Fisher确切概率法。使用Kaplan-Meier曲线估计两组患者胆总管结石复发的累积概率,两组间比较采用Log-rank检验。结果 腹腔镜联合胆道镜术后胆总管结石复发26例,其中暴露组12例(5.33%),非暴露组14例(12.5%),暴露组复发率较非暴露组明显降低(χ^(2)=5.394,P=0.020)。暴露组患者结石复发的平均时间为(40.1±26.7)个月,较非暴露组患者的结石复发平均时间(19.2±13.5)个月明显延长(t=2.383,P=0.017)。Kplan-Meier曲线分析显示非暴露组患者不同时间段的累积复发率均高于暴露组(P<0.05)。多因素Logistic回归分析显示胆总管直径≥14 mm(OR=2.935,P=0.031)与多发结石(OR=2.911,P=0.029)是腹腔镜联合胆道镜取石术后胆总管结石复发的独立危险因素。结论 清热利胆颗粒可以有效降低腹腔镜联合胆道镜术后胆总管结石的复发率,并延长结石复发的时间,具有一定的预防术后结石复发的作用。

Objective To investigate the effect of Qingre Lidan granules in preventing the recurrence of choledocholithiasis after laparoscopy combined with choledochoscopy through a retrospective cohort study.Methods A total of 337 inpatients with choledocholithiasis(including those with cholecystolithiasis at the same time)who underwent laparoscopy combined with choledochoscopic lithotomy in The First Affiliated Hospital of Dalian Medical University from January 1,2010 to December 31, 2020 were enrolled, and related clinical data were collected. According to the follow-up results, the patients were divided into exposure group (conventional treatment+Qingre Lidan granules) with 225 patients and non-exposure group (conventional treatment) with 112 patients. The recurrence of choledocholithiasis and the administration of Qingre Lidan granules were recorded in detail for both groups. The recurrence rate of choledocholithiasis and the time to recurrence were observed for both groups, and the risk factors for the recurrence of choledocholithiasis were analyzed. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups;the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. The Kaplan-Meier curve was used to estimate the cumulative probability of choledocholithiasis recurrence in the two groups, and the Log-rank test was used for comparison between two groups. Results A total of 26 patients experienced the recurrence of choledocholithiasis after laparoscopy combined with choledochoscopy, with 12 patients (5.33%) in the exposure group and 14 (12.5%) in the non-exposure group, and the exposure group had a significantly lower recurrence rate than the non-exposure group (χ2=5.394, P=0.020). The exposure group had a significantly longer mean time to the recurrence of choledocholithiasis than the non-exposure group (40.1±26.7 months vs 19.2±13.5 months, t=2.383, P=0.017). The Kaplan-Meier curve analysis showed that the non-exposure group had a significantly higher cumulative recurrence rate than the exposure group in different periods of time (P<0.05). The multivariate logistic regression analysis showed that common bile duct diameter ≥14 mm (odds ratio 〔OR〕=2.935, P=0.031) and multiple calculi (OR=2.911, P=0.029) were independent risk factors for the recurrence of choledocholithiasis after laparoscopy combined with choledochoscopic lithotomy. Conclusion Qingre Lidan granules can effectively reduce the recurrence rate of choledocholithiasis and prolong the time to the recurrence of choledocholithiasis after laparoscopy combined with choledochoscopy and has a certain clinical effect in preventing the recurrence of choledocholithiasis after surgery.