【目的】 观察基于经方柴胡桂枝干姜汤和活络效灵丹化裁的消瘀散结方治疗痰瘀互结型中危型肺结节的临床疗效。 【方法】 将104例符合纳入标准的痰瘀互结型中危型肺结节患者按随机数字表法随机分为试验组和对照组，每组各52例，因 疫情等原因，最终共完成97例，其中试验组48例，对照组49例。在健康宣教基础上，对照组仅给予定期随访，试验组给予 消瘀散结方汤药治疗，疗程为3个月。观察2组患者治疗前后中医证候积分及最大肺结节面积的变化情况，并评估2组患者 整体上和不同结节类型的中医证候疗效和西医疗效。【结果】（1）中医证候积分方面，治疗后，试验组的中医证候积分分布情 况较治疗前明显改善（P < 0.01），而对照组较治疗前无明显改善（P > 0.05）；治疗后组间比较，试验组对中医证候积分分布情 况的改善作用明显优于对照组（P < 0.01）。（2）中医证候疗效方面，从整体上来看，试验组的总有效率为 81.25%（39/48），对 照组为 20.41%（10/49），组间比较（秩和检验），试验组的整体中医证候疗效明显优于对照组（P < 0.01）。从结节类型来看， 试验组对多发性结节、混合实性结节、纯磨玻璃结节、实性结节的中医证候疗效均优于对照组，其中以多发性结节和混合 实性结节的疗效更为显著，差异均有统计学意义（P < 0.05或 P < 0.01）。（3）最大肺结节面积方面，治疗后，试验组的最大肺 部结节面积较治疗前明显缩小（P < 0.01），而对照组较治疗前无明显缩小（P > 0.05）；组间治疗后及治疗前后差值比较，差异 均有统计学意义（P < 0.05或 P < 0.01），提示试验组对最大肺结节面积的缩小作用明显优于对照组。（4）西医疗效方面，从整 体上来看，试验组的总有效率为 45.83%（22/48），对照组为 6.12%（3/49），组间比较（秩和检验），试验组的整体西医疗效明 显优于对照组（P < 0.01）。从结节类型来看，试验组在治疗多发性结节方面的西医疗效优于对照组（P < 0.01），而2组在治疗 混合实性结节、实性结节及纯磨玻璃结节方面的西医疗效差异均无统计学意义（P > 0.05）。【结论】 消瘀散结方能够显著改善 痰瘀互结型中危型肺结节患者的临床症状，能有效稳定、缩小甚至消除部分肺结节，其组方思想具有进一步研究推广价值。

Objective To observe the clinical efficacy of Xiaoyu Sanjie Prescription， which is derived from classical prescriptions Chaihu Guizhi Ganjiang Tang and Huoluo Xiaoling Dan， in treating middle-risk lung nodules of phlegm blended with blood stasis type. Methods A total of 104 cases of patients with middle-risk lung nodules of phlegm blended with blood stasis type who met the inclusion criteria were randomly divided into the trial group and the control group，with 52 cases in each group. Eventually，a total of 97 cases completed the trial for epidemic outbreak，of which 48 cases were in the trial group and 49 cases were in the control group. Both groups received health training，and then the control group was only given regular follow-up，while the trial group was treated with Xiaoyu Sanjie Prescription orally. The course of treatment covered three months. The changes in traditional Chinese medicine（TCM）syndrome scores and the area of maximum lung nodule of patients in the two groups before and after treatment were observed. After treatment， overall TCM syndrome efficacy and overall western medicine efficacy as well as their efficacies for various nodules types in the two groups were assessed. Results（1）After treatment，the distribution of the grade of TCM syndrome scores in the trial group was improved significantly when compared with that before treatment（P < 0.01）， while that in the control group showed no significant improvement（P > 0.05），and the intergroup comparison after treatment showed that the improvement in the trial group was significantly superior to that in the control group（P < 0.01）.（2）The total effective rate of overall TCM syndrome efficacy in the trial group was 81.25%（39/48），and that in the control group was 20.41% （10/49）；the intergroup comparison（tested by rank sum test）showed that the overall TCM syndrome efficacy in the trial group was significantly superior to that in the control group（P < 0.01）. In terms of the efficacy for various nodule types， the trial group had stronger TCM syndrome efficacy for multiple nodules， mixed solid nodules， pure ground glass nodules and solid nodules than the control group，in particular the efficacy for multiple nodules and mixed solid nodules，and the differences were all statistically significant（P < 0.05 or P < 0.01）.（3）After treatment，the area of the maximum lung nodule in the trial group was significantly reduced（P < 0.01），whereas there was no significant reduction in the control group compared with that before treatment（P > 0.05）. Statistically significant difference was shown in the post-treatment area between the two groups and in the pre - and posttreatment difference of the area between the two groups（P < 0.05 or P < 0.01），which suggested that the trial group􀆳s effect on the reduction of maximum lung nodule area was significantly superior to that of the control group.（4）With regard to the efficacy of western medicine， on the whole， the total effective rate of overall western medicine efficacy in the trial group was 45.83%（22 / 48）， while that in the control group was 6.12%（3 / 49）， and the intergroup comparison（tested by rank sum test）showed that the overall western medicine efficacy in the trial group was significantly superior to that in the control group（P < 0.01）. The western medicine efficacy for multiple nodules in the trial group was superior to that in the control group（P < 0.01），while no statistically significant difference was presented in western medicine efficacy for mixed solid nodules，solid nodules，and pure ground glass nodules between the two groups（P > 0.05）. Conclusion Xiaoyu Sanjie Prescription is effective on relieving the clinical symptoms of patients with middle-risk lung nodules of phlegm blended with blood stasis type，and is effective on stabilizing， reducing or even eliminating some of the lung nodules. The compatibility principle of the formula deserves further discussion.

R259.63

重庆市卫生健康委中医药科研计划项目（编号：2024ZYZD003）