【目的】 探讨参姜舟车散 （由理中丸、二陈汤和舟车丸加减组方而成） 治疗恶性胸腔积液 （malignant pleural effusion，MPE） 饮停胸胁证患者的临床疗效。 【方法】将80例MPE饮停胸胁证患者随机分为治疗组和对照组，每组各40例。在常规西医治疗基础上，对照组给予口服安体舒通和速尿片治疗，治疗组给予口服参姜舟车散治疗。以21 d为1个疗程，共治疗2个疗程，并随访1个月。观察2组患者治疗前后中医证候积分、美国东部肿瘤协作组 （ECOG） 的Karnofsky体力状态 （KPS） 评分和睡眠状态自评量表 （SRSS） 评分的变化情况，并评价2组患者的疾病疗效、中医证候疗效和安全性。 【结果】（1） 疾病疗效方面，治疗并随访1个月后，治疗组的总有效率为67.5% （27/40） ，对照组为45.0% （18/40） ，组间比较 （ χ2检验） ，治疗组的疾病疗效明显优于对照组 （P＜0.05） 。 （2） 中医证候疗效方面，治疗2个疗程后，治疗组的总有效率为92.5% （37/40） ，对照组为 50.0 % （20/40） ，组间比较 （χ2检验） ，治疗组的中医证候疗效明显优于对照组 （P＜0.01） 。 （3） 中医证候积分方面，治疗后，除对照组的呼吸困难外，2组患者的中医证候各项主证积分 （包括干咳、胸闷、胸痛、气紧、呼吸困难） 、兼证积分和总积分均较治疗前明显降低 （P＜0.05或P＜0.01） ，且治疗组对中医证候各项主证积分、兼证积分和总积分的降低作用均明显优于对照组 （P＜0.05或P＜0.01） 。 （4） 生活质量方面，治疗后，2组患者的KPS评分和SRSS评分均较治疗前明显改善 （P＜0.01） ，且治疗组对KPS评分和SRSS评分的改善作用均明显优于对照组 （P＜0.05或P＜0.01） 。 （5） 安全性方面，2组均无严重不良反应发生，均以轻度症状为主，治疗组的不良反应发生率为7.5% （3/40） ，对照组为12.5% （5/40） ，组间比较，差异无统计学意义（P＞0.05） 。 【结论】参姜舟车散治疗MPE饮停胸胁证患者具有较好的疗效，可有效缓解中医临床证候，改善患者生活质量，且无明显毒副作用。

Objective To investigate the clinical efficacy of Shen Jiang Zhouche Powder （composed of modified Lizhong Pill，Erchen Decoction，and Zhouche Pill ） in the treatment of malignant pleural effusion （MPE） patients with fluid retention in the chest and hypochondrium syndrome. Methods Eighty MPE patients with fluid retention in the chest and hypochondrium syndrome were randomly divided into the treatment group and the control group，with 40 cases in each group. Both groups were given conventional western medical treatment，and additionally the control group was treated with Spironolactone and Furosemide Tablets orally while the treatment group was treated with Shen Jiang Zhouche Powder orally. A total of 21 days constituted one course of treatment，and both groups were treated for two courses and then were followed up for one month. The changes of traditional Chinese medicine （TCM） syndrome scores， scores of Karnofsky Performance Status （KPS） established by Eastern Cooperative Oncology Group （ECOG） ，and scores of self-rating scale of sleep （SRSS） in the two groups were observed before and after treatment. After treatment，the clinical efficacy，TCM syndrome efficacy and clinical safety of the two groups were evaluated. Results （1） After treatment and one-month follow-up，the total clinical effective rate in the treatment group was 67.5%（27/40） and that in the control group was 45.0%（18/40），and the intergroup comparison （by chi-square test） showed that the clinical efficacy of the treatment group was significantly superior to that in the control group （P＜0.05） . （2） After two courses of treatment，the total effective rate of TCM syndrome improvement in the treatment group was 92.5% （37/40） and that of the control group was 50.0% （20/40） ，and the intergroup comparison （by chi-square test） showed that the TCM syndrome efficacy in the treatment group was significantly superior to that in the control group （P＜0.01） . （3） After treatment，except for the score of dyspnea in the control group，the scores of each of the main symptoms （including dry cough，chest tightness，chest pain，tightness of breath，dyspnea） and accompanied symptoms as well as the total TCM syndrome scores in the two groups were significantly decreased compared with those before treatment （P＜0.05 or P＜0.01） ，and the decrease of the scores of each of the main symptoms and accompanied symptoms as well as the total TCM syndrome scores were significantly superior to those in the control group （P＜0.05 or P＜0.01） . （4） After treatment，the scores of KPS and SRSS in the two groups were significantly improved compared with those before treatment （P＜0.01），and the improvement in the treatment group was significantly superior to that in the control group （P＜0.05 or P＜ 0.01） . （5） There were no obvious adverse reactions occurring in both groups，while only mild symptoms of the adverse reactions were presented. The incidence of adverse reactions in the treatment group was 7.5%（3/40） and that in the control group was 12.5%（5/40），and the difference was not statistically significant between the two groups （P＞0.05） . Conclusion Shen Jiang Zhouche Powder exerts certain clinical efficacy in the treatment of MPE patients with fluid retention in the chest and hypochondrium syndrome， which is effective on alleviating the clinical symptoms of TCM，and improving the quality of life of patients，without obvious toxicity or side effects.

R273

重庆市卫生健康中医药科研项目 （编号：2024ZYYB004）