RESUMEN
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 1â¶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.
Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Neoplasias Gastrointestinales/cirugía , Gastroparesia/tratamiento farmacológico , Complicaciones Posoperatorias/tratamiento farmacológico , Parche Transdérmico , Puntos de Acupuntura , Método Doble Ciego , Humanos , Síndrome , Parche Transdérmico/efectos adversos , Resultado del TratamientoRESUMEN
Surgery, chemotherapy and radiotherapy have been the mainstay of colorectal cancer treatment. There is however current intense research on traditional Chinese medicine (TCM) as novel or additional treatment methods for colorectal cancer. This article reviews the current use of TCM in colorectal cancer so as to increase the awareness of colorectal surgeons. The pathogenesis of colorectal cancer according to TCM is discussed. TCM has been used successfully during the perioperative period to relieve intestinal obstruction, reduce postoperative ileus and reduce urinary retention after rectal surgery. Good results have been reported in the treatment of the complications of chemotherapy and radiation enterocolitis. Favourable results have also been shown in the use of TCM either alone or in combination with chemotherapy to treat advanced colorectal cancer. Molecular studies have shown some TCM compounds to reduce tumour cell proliferation and induce apoptosis. Although the reported results of TCM have been exciting thus far, problems of lack of consensus on treatment regimes and questions on the reliability, validity and applicability of published studies prevent its widespread use. There is now an urgent need for colorectal surgeons to work with TCM physicians in the continuing research on this 6,000-year-old art so as to realize its full potential for our patients.
Asunto(s)
Neoplasias Colorrectales/terapia , Medicina Tradicional China/métodos , Terapia Combinada , HumanosRESUMEN
The effect of the Chinese medicine kyushin administered orally on serum digoxin measurement was studied in an animal model. Administration of 6 pills of kyushin caused a significant increase in the serum concentration of a digoxin-like immunoreactive substance (DLIS). The DLIS concentration increased to a peak value of 1.14 ng/ml at 11/2 hours and declined to 0.5 ng/ml after 24 hours. A one-week administration of 10 pills of kyushin a day produced a steady-state DLIS concentration ranging from 0.91 to 1.07 ng/ml. Among the 7 different kyushin ingredients, toad venom (ch'an-su in Chinese) was the only drug that produced DLIS in the dogs' serum. The similarity in structures of digoxin and toad venom most likely plays an important role in producing a cross-reactivity of DLIS with immunoassay antibody to digoxin. Although these findings require confirmation in human beings, they suggest that this nonprescription drug may seriously compromise the accuracy and interpretation of digoxin concentration measurements.