Clinical Comprehensive Evaluation of Biantong Capsules and Biantong Tablets in Treatment of Constipation
10.13422/j.cnki.syfjx.20240296
- VernacularTitle:便通胶囊/片治疗便秘临床综合评价
- Author:
Zeqi DAI
1
;
Chuchuan WAN
2
;
Wenshuang LI
2
;
Qingran SUN
2
;
Xudong TANG
3
;
Xing LIAO
1
Author Information
1. Center for Evidence-based Chinese Medicine，Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences，Beijing 100700，China
2. NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation，China Pharmaceutical University，Nanjing 211198，China
3. China Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
Biantong capsules;
Biantong tablets;
constipation;
clinical comprehensive evaluation;
Chinese patent medicine
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(19):160-167
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo carry out the clinical comprehensive evaluation of Biantong capsules and Biantong tablets in the treatment of constipation guided by the clinical value of drugs， and to provide a scientific basis for the rational pricing， rational use， and cataloging of Biantong capsules/tablets. MethodThe available evidence and survey data were used for the clinical comprehensive evaluation of Biantong capsules/tablets and three control drugs in the treatment of constipation in terms of the six dimensions including effectiveness， safety， economics， innovation， suitability， and accessibility. ResultIn terms of effectiveness， Biantong capsules/tablets can improve the response rate， with clear pharmacological mechanism. In terms of safety， the absence of toxic reaction， the mild adverse reactions， and the favorable prognosis indicate high safety. In terms of economics， the average daily cost of Biantong capsules/tablets is the lowest among the tested drugs， which indicates a cost-effectiveness advantage. In terms of innovation， Biantong capsules/tablets have been authorized patents in China and listed as members in the third category of new drugs of traditional Chinese medicine/ninth new drugs of traditional Chinese medicine. In terms of suitability， Biantong capsules/tablets are convenient to store and take and have good suitability in terms of drug technical characteristics and drug usage. In terms of accessibility， Biantong capsules/tablets have a wide coverage in hospitals， sufficient capacity， low patient burden， extensive drug catalogue coverage， and no major environmental risk for long-term application. The comprehensive values of the tested drugs follow a descending order of control drug B （84.27 score）， Biantong capsules/tablets （82.47 score）， control drug A （70.47 score）， and control drug C （59.46 score）. The recommendations of the expert panel are Class A （18/18）， which can be directly converted into decision-making. ConclusionBiantong capsules/tablets demonstrate a high clinical comprehensive value in the treatment of constipation， providing a reference for the rational pricing， rational use， and cataloging of drugs.
