Evidence map›Paper›PMID 30777117›Full record

ArticleTrials2019

Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial.

Sheling Xie, Peng Yan, Chen Yao, Xiaoyan Yan, Yuliang Huo, Junhua Zhang, Si Liu, Zhiqiao Feng, Hongcai Shang, Lixin Xie

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02937974 (Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD:a Multicentre Randomised Controlled Trial), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02937974 phase4unknown statusnot on this map

Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD:a Multicentre Randomised Controlled Trial

TypeinterventionalSponsorChinese PLA General HospitalRan2016 to 2018Enrolled254ConditionsPulmonary Disease, Chronic ObstructiveArmsXuebijing, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
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  3. Review
  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Sheling XieDepartment of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.
Peng YanDepartment of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.
Chen YaoPeking University Clinical Research Institute, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
Xiaoyan YanPeking University Clinical Research Institute, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
Yuliang HuoBeijing Blue Balloons Technology Co., Ltd., 168 Beiyuan Road, Chaoyang District, Beijing, 100191, China.
Junhua ZhangTianjin University of Traditional Chinese Medicine, 312 Anshan West Road, Nankai District, Tianjin, 300193, China.
Si LiuTianjin Chase Sun Pharmaceutical Co., Ltd., 20 Quanfa Road, Wuqing Development Area, Tianjin, 301700, China.
Zhiqiao FengTianjin Chase Sun Pharmaceutical Co., Ltd., 20 Quanfa Road, Wuqing Development Area, Tianjin, 301700, China.
Hongcai ShangKey Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, 5 Haiyuncang, Dongcheng District, Beijing, 100700, China.
Lixin XieDepartment of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China. xielx301@126.com.
Chinese PLA General Hospital · CNPeking University · CNBeijing University of Chinese Medicine · CNTianjin University of Traditional Chinese Medicine · CN

Funding

Development Center for Medical Science and Technology of the National Health and Family Planning Commission of the People's Republic of China WK-2016-HR-02
6 · The paper itself

Abstract

backgroundAcute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used in Asia as an adjunct treatment for AECOPD to improve the patients' symptoms. Xuebijing (XBJ) injection is one of the major herbal medicines used in TCM. Previous small-sample clinical trials have proven its efficacy and safety in the treatment of AECOPD; however, the current data on XBJ as an adjunct therapy are insufficient. The present study will be a multi-center randomized clinical trial (RCT) to evaluate the efficacy and safety of XBJ injection in AECOPD and explore its influence on the immune function based on the altered levels of T cells.

methodsThis study will be a prospective, randomized, placebo-controlled, blinded, multi-center trial. A total of 300 eligible patients will be randomly assigned to the treatment or placebo control group in a 1:1 ratio using a central randomization system. The treatment group will receive routine medication plus XBJ injection, and the control group will receive routine medication plus 0.9% NaCl injection. The patients will receive the corresponding treatment for 5 days starting within 24 h of enrollment. The primary outcome, the of rate endotracheal intubation, will be evaluated on day 28 after treatment. The secondary outcomes will include changes in immune and inflammatory indicators, respiratory support, mortality rate after 28 days, blood gas analysis, improvement in Acute physiology and chronic health evaluation (APACHE) II scores and clinical symptoms, and the length and cost of intensive care unit stay and hospitalization. The safety of the interventions will be assessed throughout the trial. DISCUSSION: This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of XBJ injection as adjuvant therapy for AECOPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of the disease and identify the underlying mechanisms.

trial registrationClinicalTrials.gov, NCT02937974 . Registered on 13 October 2016. Chinese clinical trial registry, ChiCTR-IPR-17011667. Registered on 15 June 2017.

Indexed as

AdultAgedAged, 80 and overChinaDisease ProgressionDrugs, Chinese HerbalFemaleHumansImmunologic FactorsInjectionsLungMaleMiddle AgedMulticenter Studies as TopicProspective StudiesPulmonary Disease, Chronic ObstructiveDrugs, Chinese HerbalImmunologic FactorsXuebijingAcute exacerbation of chronic obstructive pulmonary diseaseEfficacyImmunomodulationSafetyXuebijing injection

Identifiers

PMID30777117
PMCPMC6380049
OpenAlexW2922369759

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.