Topical Delivery of Modified Da-Cheng-Qi Decoction () Using Low-Frequency Ultrasound Sonophoresis for Refractory Metastatic Malignant Bowel Obstruction: An Open-Label Single-Arm Clinical Trial.
10.1007/s11655-019-3041-7
- Author:
Ai-Ping TIAN
1
;
Yu-Kun YIN
1
;
Lei YU
2
;
Bo-Yan YANG
2
;
Ning LI
2
;
Jian-Ying LI
2
;
Zhi-Min BIAN
2
;
Shang-Ying HU
3
;
Chun-Xiao WENG
4
;
Li FENG
5
Author Information
1. Department of Traditional Chinese Medicine, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
2. Department of Comprehensive Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
3. Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
4. Beijing Chiamery Medical Sciences Institute, Beijing, 100080, China.
5. Department of Traditional Chinese Medicine, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. Fengli8535@163.com.
- Publication Type:Clinical Trial
- Keywords:
Da-Cheng-Qi Decoction;
low-frequency ultrasound sonophoresis;
metastatic malignant bowel obstruction;
objective performance criteria;
topical delivery
- MeSH:
Administration, Cutaneous;
Adult;
Aged;
Drugs, Chinese Herbal;
administration & dosage;
Female;
Humans;
Intestinal Neoplasms;
complications;
secondary;
Intestinal Obstruction;
drug therapy;
etiology;
Male;
Middle Aged;
Ultrasonic Therapy;
methods
- From:
Chinese journal of integrative medicine
2020;26(5):382-387
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To evaluate the efficacy and safety of topical delivery of modified Da-Cheng- Qi Decoction (, MDCQD) by low-frequency ultrasound sonophoresis (LFUS) in patients with refractory metastatic malignant bowel obstruction (MBO) using an objective performance criteria (OPC) design.
METHODS:Fifty patients with refractory metastatic MBO were enrolled in this open-label single-arm clinical trial. Alongside fasting, gastrointestinal decompression, glycerol enema, intravenous nutrition and antisecretory therapy, a 50 g dose of MDCQD (prepared as a hydrogel) was applied through topical delivery at the site of abodminal pain or Tianshu (S 25) using LFUS for 30 min, twice daily for 5 consecutive days. The overall outcome was the remission of intestinal obstruction, and improvement on abdominal pain, abdominal distention, nausea and vomiting scores. Indicators of safety evaluation included liver and renal function as well as blood coagulation indicators.
RESULTS:Among 50 patients, 5 patients (10%) showed complete remission of intestinal obstruction and 21 patients (42%) showed improvement of intestinal obstruction. The overall remission rate of bowel obstruction was 52%. The results of the symptom score, based on the severity and frequency of the episode, are as follows: 26 patients (52%) showed improvment on symptom scores, 20 patients (40%) did not respond to treatment, and 4 patients (8%) discontinued treatment due to intolerance. No serious adverse effects or abnormal changes on liver and renal function or blood coagulation were observed.
CONCLUSION:Topical delivery of MDCQD at 100 g/day using LFUS can improve the treatment response in patients with refractory metastatic MBO.
