Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial

Lie Wang; Zai-zhong Zhang; Xiao-huang Tu; Zhong-dong Zou; Jian-hua Liu; Yu Wang

doi:10.1007/s11655-009-0272-z

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Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial

OriginalPaper | Updated：2021-08-27

- Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial
- Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial
- 中国结合医学杂志（英文版） 2009年15卷第4期页码：272-278
- Affiliations：
  
  1. Research Institute of General Surgery, Fuzhou General Hospital,Fuzhou,China
  2. Department of Traditional Chinese Medicine, Fuzhou General Hospital,Fuzhou,China
- Author bio：
- Funds：
  
  Supported by Key Medical Program of the “10th Five-Year Plan” of PLA Nanjing Military Area Command (No. 02MA009)
- DOI：10.1007/s11655-009-0272-z
  中图分类号：
- 纸质出版日期：2009，
  
  网络出版日期：2009-8-18，
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Wang, L., Zhang, Zz., Tu, Xh. et al. Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial., Chin. J. Integr. Med. 15, 272–278 (2009). https://doi.org/10.1007/s11655-009-0272-z

Lie Wang, Zai-zhong Zhang, Xiao-huang Tu, et al. Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial[J]. Chinese Journal of Integrative Medicine, 2009,15(4):272-278.
Wang, L., Zhang, Zz., Tu, Xh. et al. Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial., Chin. J. Integr. Med. 15, 272–278 (2009). https://doi.org/10.1007/s11655-009-0272-z DOI：

Lie Wang, Zai-zhong Zhang, Xiao-huang Tu, et al. Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial[J]. Chinese Journal of Integrative Medicine, 2009,15(4):272-278. DOI： 10.1007/s11655-009-0272-z.

摘要

To investigate the efficiency

safety

and possible mechanisms of Qingre Buyi Decoction (清热补益煎剂

QBD) in the treatment of acute radiation proctitis (ARP). This study was a single center

prospective

single blind

randomized

and placebo-controlled clinical trial. A total of 60 patients with ARP was equally and randomly distributed into the control group (conventional treatment) and the combination group (conventional treatment plus QBD). The changes of main Chinese medicine clinical symptoms and signs

including stomachache

diarrhea

mucous or bloody stool before and after treatment

and their adverse reactions were observed after the two-week treatment. Also

D-lactate and diamine oxidase (DAO) levels

hepatic and renal function were measured. Cure rates

effective rates

and recurrence rates were compared between the two groups. The blood levels of both DAO and D-lactate were significantly decreased in the combination group as compared with those in the control group (P<0.05 or P<0.01). All main clinical symptoms and signs were alleviated more significantly in the combination group (P<0.01). The main symptom scores also were significantly decreased after treatment in the control group (P<0.01)

except those for mucous or bloody stool (P>0.05). Compared to the control group

the improvements of stomachache

diarrhea

defecation dysfunction

and stool blood in the combination group were significantly better (P<0.05 or P<0.01). For the combination group

the curative rate

effective rate

and recurrence rate was 76.67%

16.67%

and 6.67%

respectively. On the other hand

for the control group

the rate was 53.33%

16.67%

and 30.00%

respectively. The total curative effect was significantly better in the combination group than in the control group (P<0.05). However

the recurrence rate was similar between the two groups (P>0.05). The hepatic and renal function remained normal in both groups (P>0.05). In addition

no severe adverse event was found in both groups. Addition of QBD to the conventional treatment can effectively alleviate the damage of intestinal mucosal barrier function and improve all main clinical symptoms and signs of the ARP. The combination of conventional treatment with Chinese herbal medicine QBD is effective and safe for ARP.

Abstract

To investigate the efficiency

safety

and possible mechanisms of Qingre Buyi Decoction (清热补益煎剂

QBD) in the treatment of acute radiation proctitis (ARP). This study was a single center

prospective

single blind

randomized

including stomachache

diarrhea

mucous or bloody stool before and after treatment

and their adverse reactions were observed after the two-week treatment. Also

D-lactate and diamine oxidase (DAO) levels

hepatic and renal function were measured. Cure rates

effective rates

except those for mucous or bloody stool (P>0.05). Compared to the control group

the improvements of stomachache

diarrhea

defecation dysfunction

and stool blood in the combination group were significantly better (P<0.05 or P<0.01). For the combination group

the curative rate

effective rate

and recurrence rate was 76.67%

16.67%

and 6.67%

respectively. On the other hand

for the control group

the rate was 53.33%

16.67%

and 30.00%

respectively. The total curative effect was significantly better in the combination group than in the control group (P<0.05). However

the recurrence rate was similar between the two groups (P>0.05). The hepatic and renal function remained normal in both groups (P>0.05). In addition

关键词

Qingre Buyi Decoctionacute radiation proctitisChinese Herbal Medicine

Keywords

Qingre Buyi Decoctionacute radiation proctitisChinese Herbal Medicine

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