Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard. Results: From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group (P=0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group (P=0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups (P=0.244). Conclusion: Weitan Waifu patch is a safely and effectively therapeutic method for patients with PGS (cold syndrome) of gastroenterological cancer. Trial registration: International Standard Randomized Controlled Trial Number Register, ISRCTN18291857.
目的： 探讨胃瘫外敷方治疗消化系统肿瘤患者术后胃瘫(寒证)患者的疗效。 方法： 采用多中心、随机、双盲、安慰剂平行对照临床试验，以优效性设计，收集北京4家三级甲等医院确诊的消化系统肿瘤术后胃瘫、且腹部症状中医局部辨证为寒证的患者入组。区组随机化将患者按1∶1比例分组，在常规治疗(营养支持、胃肠减压、促胃动力药)的基础上，治疗组和对照组患者分别给予胃瘫外敷方或安慰剂穴位(中脘、神阙穴)贴敷，治疗14 d或达到有效标准。 结果： 2013年7月15日至2015年6月3日，共招募患者128例，最终120例患者入组进入全分析集(FAS)，其中治疗组60例，对照组60例。88例患者进入符合方案数据分析集(PPS)，其中治疗组45例，对照组43例。FAS中治疗组患者的临床有效率为68.3%，明显优于对照组(41.7%，P＝0.003)。治疗组达到治疗有效所需的中位时间为8 d，明显短于对照组(10 d，P＝0.017)。FAS中治疗组有3例患者出现不良事件，发生率为5.0%(3/60)，分别为轻中度脱皮、瘙痒、恶心，停药后自行缓解；对照组患者未出现不良反应，两组差异无统计学意义(P＝0.244)。 结论： 胃瘫外敷方是消化系统肿瘤术后胃瘫(寒证)患者的一种新的治疗选择。 临床试验注册： 英国国际标准随机对照试验号注册库，ISRCTN18291857.
Keywords: External treatment; Gastroenterological carcinoma; Postsurgical gastroparesis syndrome; Traditional Chinese medicine.