腹腔热灌注化疗联合健脾温肾利水法治疗恶性腹水患者的临床观察

Observation of Clinical Effect on the Treatment of Malignant Ascites by Hyperther⁃mic Intraperitoneal Chemotherapy Combined with the Method of Strengthening the Spleen,Warming the Kidney,and Promoting Urination

目的探讨腹腔热灌注化疗(Hyperthermic intraperitoneal chemotherapy,HIPEC)联合健脾温肾利水法治疗恶性腹水的临床疗效。方法选取2018年1月—2020年4月期间上海中医药大学附属岳阳中西医结合医院收治的120例肿瘤伴有恶性腹水患者作为研究对象,按随机数字表法分为对照组和治疗组,每组各60例。对照组采用西医常规药物治疗,治疗组采用中西结合治疗。对照组患者在超声引导下穿刺置管,每24 h间断引流腹水1000~1500 ml,第4天行热灌注化疗,化疗药物为生理盐水和顺铂注射液,次日再放出灌注液,根据病情拔管。每周热灌注化疗1次,连续两周。治疗组在对照组治疗基础上同时采用口服补脾温肾利水的中药膏方治疗,膏方组成为附子理中丸合济生肾气丸加减。两组患者开始治疗4周后对疗效进行评估,评估指标包括:临床总疗效评价、疗效性、免疫功能、生存率、安全性。结果治疗后治疗组患者临床总有效率89.47%(51/57)高于对照组74.14%(43/58),差异有统计学意义(P<0.05)。治疗后两组患者腹围、尿量、KPS评分较治疗前明显改善,差异有统计学意义(P<0.05);且治疗组较对照组明显改善,差异有统计学意义(P<0.05)。治疗后两组患者血清CD3^(+)、CD4^(+)、NK细胞水平均较治疗前升高,差异有统计学意义(P<0.05);血清CD8^(+)水平变化不明显与治疗前比较,差异无统计学意义(P>0.05);且治疗组血清CD3^(+)、CD4^(+)、NK细胞水平均高于对照组,差异有统计学意义(P<0.05)。两组患者随访12个月,对照组中位生存期5.4个月和治疗组中位生存期7.9个月比较,差异有统计学意义(P<0.05);对照组患者生存率6个月43.10%、9个月27.58%、12个月10.34%与治疗组患者同期生存率66.67%、43.86%、19.30%比较,治疗组患者同期生存率明显高于对照组,差异有统计学意义(P<0.05)。两组患者治疗后,骨髓抑制、恶心呕吐、腹痛、皮疹、发热、肝肾功能、血常规等不良反应发生率比较,差异无统计学意义(P>0.05)。结论温肾利水法联合腹腔热灌注化疗用于恶性腹水的治疗,可以提高临床总疗效,改善临床症状,提高机体免疫力,最终达到提高患者生存率的目的,同时中西结合治疗并不提高治疗副作用的发生率,具有较高的安全性。

Objective To explore the clinical effect on the treatment of malignant ascites by hyperthermic intrap⁃eritoneal chemotherapy(HIPEC)combined with the method of strengthening the spleen,warming the kidney,and promoting urination.Methods A total of 120 patients with tumors and malignant ascites admitted to Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2018 to April 2020 were selected as the research objects.They were divided into a control group and a treatment group with 60 cases in each group by random number table.The control group was treated with conventional Western medicine,and the treatment group was treated with a combination of traditional Chinese and Western medicine.Patients in the control group were punctured and intubated under the guidance of ultrasound,and 1000~1500 ml of ascites was drained intermittently every 24 hours.On the 4th day,HIPEC was performed.The chemotherapy drugs were normal saline and cisplatin injection,and the perfusate was released the next day.The catheter was extubated according to the condition.HIPEC was given once a week for two consecutive weeks.On the basis of the treatment of the control group,the treatment group was also treated with the traditional Chinese medicine ointment for invigorating the spleen,warming the kidney,and promoting urination.The composition of the ointment is the modified Fuzi Lizhong Pill and Jisheng Shenqi Pill.The efficacy in the two groups was evaluated after four weeks of treatment.The evaluation criteria include the evaluation of the total clinical efficacy,effi⁃cacy indicators,immune function indicators,survival rates,and safety indicators.Results The total effective rate of pa⁃tients in the treatment group was 89.47%(51/57),which was higher than that of patients in the control group(74.14%,43/58),and the difference was statistically significant(P<0.05).After treatment,the abdominal circumference,urine vol⁃ume,and KPS score of the two groups were significantly improved(P<0.05);and the treatment group was significantly improved compared with the control group(P<0.05).After treatment,the serum CD3^(+),CD4^(+),and NK cell levels in the two groups were significantly higher(P<0.05);There was no significant difference in the level of serum CD8^(+)compared with that before treatment(P>0.05).In addition,the serum CD3^(+),CD4^(+),and NK cell levels in the treatment group were significantly higher than those in the control group(P<0.05).The two groups of patients were followed up for 12 months.The median survival time of the control group and the treatment group was 5.4 and 7.9 months,respectively(P<0.05);the survival rate of the control group was six months(43.10%),nine months(27.58%),and 12 months(10.34%),which was significantly higher than that of the treatment group(66.67%,43.86%,and 19.30%)during the same period.In ad⁃dition,the survival rate of the treatment group was significantly higher than that of the control group(P<0.05).After treat⁃ment,there was no significant difference in the incidence of adverse reactions such as bone marrow suppression,nausea and vomiting,abdominal pain,rash,fever,liver and kidney function,and blood routine between the two groups(P>0.05).Con⁃clusion HIPEC combined with the method of strengthening the spleen,warming the kidney,and promoting urination for the treatment of malignant ascites can improve the overall clinical efficacy,clinical symptoms,and the body′s immunity,ulti⁃mately increasing the survival rate of patients.At the same time,the combination of traditional Chinese and Western therapy does not increase the incidence of side effects of treatment and has high safety.The combination of traditional Chinese and Western medicine in the treatment of malignant ascites is worthy of further promotion and application.