Chinese Clinical Oncology

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Systematic review of efficacy and safety of elemene injection combined with conventional chemotherapy for malignant serous effusions

ZHANG Zhiyu, QIN Shukui.
  

  1. Department of Oncology, Cancer Center of PLA, 81 Hospital Affiliated to Nangjing University of Chinese Medicine, Nangjing 210002, China
  • Received:2017-05-21 Revised:2017-07-20 Online:2017-09-30 Published:2017-09-30
  • Contact: QIN Shukui

Abstract: Objective To provide important reference for clinical rational drug use and scientific decision based on the systematic review of efficacy and safety of elemene injection combining with routine chemotherapy drugs in treating malignant serous effusions. Methods Papers and data of randomized controlled clinical trials (RCT) of elemene injection combining with routine chemotherapy drugs for malignant serous effusions published from Jan. 1996 to Feb. 2017 were retrieved by computer from the following databases: WanFang Data Knowledge Service Platform, China National Knowledge Infrastructure and Full-text database of Chinese Sci & Tech Journals. The quality of materials was under assessment of Juni evaluation standards and Cochrane system evaluation method. Revman 5.0 software was used for Meta analysis and funnel analysis was used to evaluate publication bias. Results Seven hundred and thirty papers were searched preliminarily and 22 RCTs (1288 subjects) were bring to meta-analysis. In which overall response rate (RR=1.42,95%CI: 1.25-1.60;P<0.01)and quality of life improvement rate(RR=2.08,95%CI: 1.76-2.47;P<0.01) of combining group (elemene combining with chemotherapy) were significantly better than control group (only chemotherapy). Compared with control group, the incidence of gastrointestinal reactions, myelosuppression and hepatic and renal impairment in combining group were obviously decreased, however, the incidence of fever reaction increased markedly. There was no significant difference of chest pain rate between the two groups (29.79% vs. 22.27%) after intrapleural therapy (RR=1.37,95%CI: 0.96-1.96;P=0.08).The Juni quality evaluation standard showed that the RCT quality evaluation was only in B and C and the GRADE system’s evidence quality was intermediate. Funnel analysis did not show any publication bias. Conclusion Elemene injection combining with chemotherapy drugs may have significant synergies effect. It is a good therapy choice for malignant serous effusions with the better safe as well as efficacy, improving the life quality and tolerability of the patients However, in view of the limitation of scientific research level at that time, the quality of original literatures included in this research are a little bit lower. Therefore the large-scale and high quality clinical researches including RCT or real world study (RWS) should be carried out to acquire further strong and more high evidence to support conclusion of this Meta analysis.

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