复方苦参注射液腹腔灌注治疗恶性腹水疗效及安全性观察(1)
摘要：目的 观察复方苦参注射液治疗恶性腹水的临床疗效及安全性。方法 将139例恶性腹水患者随机分为试验组和对照组，腹水引流完全后分别给予复方苦参注射液30 mL、顺铂100 mg腹腔灌注，每周1次，连用3次。观察2组患者治疗前后尿量、腹围、血象、肝肾功能变化及胃肠道反应，评估总体疗效及安全性。结果 治疗组总有效率为80.56%(58/72)，对照组为86.57%(58/67)，2组总体疗效相当。试验组骨髓抑制、肝肾损害及恶心呕吐等胃肠道不良反应的发生率均明显低于对照组。结论 复方苦参注射液腹腔灌注治疗恶性腹水的疗效与顺铂相当，安全性明显优于后者。
关键词：恶性腹水;复方苦参注射液;顺铂;腹腔灌注
DOI：10.3969/j.issn.1005-5304.2015.02.009
中图分类号：R273;R285.6文献标识码：A 文章编号：1005-5304(2015)02-0028-03
, 百拇医药
Efficacyand Safety of Compound Kushen Injection Used for Peritoneal Perfusion on Patients with Malignant AscitesLIU Jia-qi (Hubei Xinhua Hospital， Wuhan 430022， China)
Abstract：Objective To observe the clinical efficacy and safety of compound Kushen Injection in the patients with malignant ascites. Methods Totally 139 patients with malignant ascites were randomly divided into treatment group and control group. 30mL compound Kushen Injection was given to the treatment group， and 100mg cisplatin was given to the control group through peritoneal perfusion once a week， for 3 weeks. The changes of urine volume， abdominal perimeter， blood-Rt， function of liver and kidney， and gastrointestinal reaction were detected before and after treatment， with a purpose to evaluate the total efficacy and safety. Results The total effective rate was 80.56% (58/72) in treatment group， and 86.57% (58/67) in the control group， without significant difference between the two groups. The incidences of bone marrow suppression， liver and kidney damage， and nausea and vomiting of gastrointestinal reaction were lower in the treatment group than the control group. Conclusion The effects of compound Kushen Injection and cisplatin have equal efficacy for the treatment of malignant ascites， but the former was superior to the latter on safety.
, http://www.100md.com
Key words：malignant ascites;compound Kushen Injection;cisplatin;peritoneal perfusion
恶性腹腔积液为消化道肿瘤及妇科肿瘤的常见并发症之一。当腹水逐渐增多时患者可因压迫出现呼吸困难、恶心、呕吐、腹胀、下肢水肿等症状，从而严重影响生活质量。目前，最常用的控制晚期恶性腹水的方法为单纯腹腔穿刺抽液，或腹腔穿刺抽液后腹腔注射化疗药等，但不能满意控制腹水。复方苦参注射液作为一种中药复方制剂，主要成分为苦参碱、氧化苦参碱、槐果碱、皂苷等，临床研究显示该药具有抗癌止痛、调节免疫力、抑制癌肿等功效[1]。近年来已有研究者将其联合顺铂等化疗药物应用于恶性胸腹水的控制，并取得了较好疗效[2]。笔者对2013年1月-2014年6月期间收治的恶性腹水患者采用复方苦参注射液单药腹腔灌注治疗，旨在进一步明确其疗效及安全性，现报道如下。
1 资料与方法
1.1 纳入标准
①有明确的恶性肿瘤病史;②本次入院查体移动性浊音阳性;③腹水细胞学找到癌细胞或腹水肿瘤标志物检测阳性;④利尿剂治疗效果不佳;⑤腹腔灌注前均签署知情同意书。
1.2 排除标准
①血红蛋白<80 g/L;②白细胞计数(WBC)<4.0×109/L;③血小板计数<100×109/L;④肝肾功能异常;⑤KPS评分<60分;⑥合并腹腔感染。
1.3 一般资料, http://www.100md.com(刘佳琪)
关键词：恶性腹水;复方苦参注射液;顺铂;腹腔灌注
DOI：10.3969/j.issn.1005-5304.2015.02.009
中图分类号：R273;R285.6文献标识码：A 文章编号：1005-5304(2015)02-0028-03
, 百拇医药
Efficacyand Safety of Compound Kushen Injection Used for Peritoneal Perfusion on Patients with Malignant AscitesLIU Jia-qi (Hubei Xinhua Hospital， Wuhan 430022， China)
Abstract：Objective To observe the clinical efficacy and safety of compound Kushen Injection in the patients with malignant ascites. Methods Totally 139 patients with malignant ascites were randomly divided into treatment group and control group. 30mL compound Kushen Injection was given to the treatment group， and 100mg cisplatin was given to the control group through peritoneal perfusion once a week， for 3 weeks. The changes of urine volume， abdominal perimeter， blood-Rt， function of liver and kidney， and gastrointestinal reaction were detected before and after treatment， with a purpose to evaluate the total efficacy and safety. Results The total effective rate was 80.56% (58/72) in treatment group， and 86.57% (58/67) in the control group， without significant difference between the two groups. The incidences of bone marrow suppression， liver and kidney damage， and nausea and vomiting of gastrointestinal reaction were lower in the treatment group than the control group. Conclusion The effects of compound Kushen Injection and cisplatin have equal efficacy for the treatment of malignant ascites， but the former was superior to the latter on safety.
, http://www.100md.com
Key words：malignant ascites;compound Kushen Injection;cisplatin;peritoneal perfusion
恶性腹腔积液为消化道肿瘤及妇科肿瘤的常见并发症之一。当腹水逐渐增多时患者可因压迫出现呼吸困难、恶心、呕吐、腹胀、下肢水肿等症状，从而严重影响生活质量。目前，最常用的控制晚期恶性腹水的方法为单纯腹腔穿刺抽液，或腹腔穿刺抽液后腹腔注射化疗药等，但不能满意控制腹水。复方苦参注射液作为一种中药复方制剂，主要成分为苦参碱、氧化苦参碱、槐果碱、皂苷等，临床研究显示该药具有抗癌止痛、调节免疫力、抑制癌肿等功效[1]。近年来已有研究者将其联合顺铂等化疗药物应用于恶性胸腹水的控制，并取得了较好疗效[2]。笔者对2013年1月-2014年6月期间收治的恶性腹水患者采用复方苦参注射液单药腹腔灌注治疗，旨在进一步明确其疗效及安全性，现报道如下。
1 资料与方法
1.1 纳入标准
①有明确的恶性肿瘤病史;②本次入院查体移动性浊音阳性;③腹水细胞学找到癌细胞或腹水肿瘤标志物检测阳性;④利尿剂治疗效果不佳;⑤腹腔灌注前均签署知情同意书。
1.2 排除标准
①血红蛋白<80 g/L;②白细胞计数(WBC)<4.0×109/L;③血小板计数<100×109/L;④肝肾功能异常;⑤KPS评分<60分;⑥合并腹腔感染。
1.3 一般资料, http://www.100md.com(刘佳琪)