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Topical Delivery of Modified Da-Cheng-Qi Decoction (加味大承气汤) Using Low-Frequency Ultrasound Sonophoresis for Refractory Metastatic Malignant Bowel Obstruction: An Open-Label Single-Arm Clinical Trial

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Abstract

Objective

To evaluate the efficacy and safety of topical delivery of modified Da-Cheng- Qi Decoction (加味大承气汤, 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.

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Authors and Affiliations

  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

    Ai-ping Tian, Yu-kun Yin & Li Feng

  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

    Lei Yu, Bo-yan Yang, Ning Li, Jian-ying Li & Zhi-min Bian

  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

    Shang-ying Hu

  4. Beijing Chiamery Medical Sciences Institute, Beijing, 100080, China

    Chun-xiao Weng

Authors
  1. Ai-ping Tian
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  2. Yu-kun Yin
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  3. Lei Yu
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  4. Bo-yan Yang
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  5. Ning Li
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  6. Jian-ying Li
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  7. Zhi-min Bian
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  8. Shang-ying Hu
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  9. Chun-xiao Weng
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  10. Li Feng
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Contributions

Tian AP conducted research design and implementation management; Yin YK, Yu L, Yang BY, Li N, LI JY and Bian ZM involved in patient management; Hu SY performed data statistics and analysis; Weng CX contributed to the technical support for low-frequency ultrasound sonophoresis; Feng Li is research consultant.

Corresponding author

Correspondence to Li Feng.

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The authors have declared that there are no conflicts of interest.

Additional information

Supported by the Beijing Hope Run Special Fund of Cancer Foundation of China (No. LC2014B18)

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Tian, Ap., Yin, Yk., Yu, L. et al. Topical Delivery of Modified Da-Cheng-Qi Decoction (加味大承气汤) Using Low-Frequency Ultrasound Sonophoresis for Refractory Metastatic Malignant Bowel Obstruction: An Open-Label Single-Arm Clinical Trial. Chin. J. Integr. Med. 26, 382–387 (2020). https://doi.org/10.1007/s11655-019-3041-7

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  • DOI: https://doi.org/10.1007/s11655-019-3041-7

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