Abstract: Objective　To investigate the effectiveness and safety of peritoneal perfusion with Kailaite Injection and cisplatin for gastric cancer of spleen deficiency and dampness retention syndrome（SDDRS） with malignant ascites.Methods　We enrolled 82 inpatients with gastric cancer（adenocarcinoma of the stomach） of SDDRS with malignant ascites from Department of GI Medicine，Fourth Hospital of Hebei Medical University from January 2013 to June 2016 and divided them into combination group receiving peritoneal perfusion with Kailaite Injection and cisplatin and cisplatin group receiving peritoneal perfusion with cisplatin by block randomization method.The effectiveness and safety of treatment regimen were evaluated after 2 courses of treatment by the volume of ascites and response maintenance duration，quality of life，adverse events and TCM syndrome score.Results　Compared with the cisplatin group，combination group achieved better response（P=0.008），significantly improved quality of life and TCM syndrome score（P<0.05），and had obviously less nausea/vomiting events（P<0.05）．However，no significant difference was found in disease control rate between these two groups（P=0.364）．Conclusion　Peritoneal perfusion with Kailaite Injection and cisplatin can enhance the clinical response，improve the control rate of malignant ascites due to gastric cancer and TCM syndrome score，as well as reduce the adverse events.

Key words: Stomach neoplasms, Malignant ascites, Spleen deficiency and dampness retention, Intraperitoneal perfusion, Adverse reaction

摘要： 目的　探讨康莱特注射液联合顺铂腹腔灌注治疗脾虚湿困型胃癌恶性腹腔积液的临床疗效与安全性。方法　收集2013年1月—2016年6月在河北医科大学第四医院消化内科住院治疗的中医证型为脾虚湿困型的胃癌恶性腹腔积液患者82例，病理类型为腺癌，采用随机数字表法分为联合组与单药组，每组41例。联合组给予康莱特注射液联合顺铂腹腔灌注治疗，单药组给予单药顺铂腹腔灌注治疗，两组均治疗2个疗程。比较两组患者治疗后的腹腔积液临床疗效、生活质量、毒副作用和中医证候临床疗效。结果　联合组有效率高于单药组（P=0.008）。两组疾病控制率比较，差异无统计学意义（P=0.364）。联合组生活质量优于单药组，恶心/呕吐轻于单药组，中医证候临床疗效优于单药组（P<0.05）。结论　康莱特注射液联合顺铂腹腔灌注能提高脾虚湿困型胃癌恶性腹腔积液的控制率，减少毒副作用，改善中医证候，起到增效减毒的功效。

关键词: 胃肿瘤, 腹腔积液, 脾虚湿困, 腹腔灌注, 毒副作用