ABSTRACT
To systemically evaluate the clinical efficacy and safety of Hongjin Xiaojie Capsules for hyperplastic disease of breast(HDBA), so as to provide the evidence for its clinical application. The inclusion criteria are the RCT of single administration of Hongjin Xiaojie Capsules for treatment of HDBA. We retrieved following databases(CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed) from their inception to October 1, 2019. Two researchers independently screened out literatures and extracted data, and assessed the methodological quality of eligible RCT according to the criteria in Cochrane Handbook for Systematic Reviews of Interventions. RevMan 5.3 was used for data analysis, binary data was summarized by risk ratio(RR) with confidence intervals(CI) of 95%, and continuous data were summarized by mean difference(MD) with CI of 95%. To estimate the sample size of systematic review, trial sequential analysis(TSA) was performed base on software TSA v0.9 version. Totally 14 RCTs were included, involving 3 057 patients. The results of Meta-analysis showed a significantly higher cure rate(RR=1.13, 95%CI[1.03, 1.25], P=0.01) and higher total effective rate(RR=1.09, 95%CI[1.05, 1.13], P<0.000 1) in Hongjin Xiaojie Capsules group than those in the Juyuansuan Tamoxifen group. The incidence of adverse events was significantly higher in Juyuansuan Tamoxifen group than that in Hongjin Xiaojie Capsules group(RR=0.28 95%CI[0.16, 0.49], P<0.001), and the adverse events included nausea, vomiting, abdominal pain, diarrhea, irregular menstruation, amenorrhea, unclear vision, dizziness and headache. The TSA for the cure rate demonstrated that the current available data reached the expected value. However, due to the low effect intensity of evidence, the pooled results might be affected by high risk bias of trials. The quality of evidence of included trials was generally low or very low. Inverted funnel diagram showed possible publication bias. This review suggested that Hongjin Xiaojie Capsules were potentially effective and safe in treatment of HDBA, especially, the incidences of drug-related adverse events from Hongjin Xiaojie Capsules were significantly lower than those from tamoxifen. However, because of lack of high-quality evidence for drawing a conclusion, more rigorously designed and high-quality trials are needed to confirm the efficacy and safety of Hongjin Xiaojie Capsules.
Subject(s)
Breast Diseases , Drugs, Chinese Herbal , Breast Diseases/therapy , Capsules , Drugs, Chinese Herbal/therapeutic use , Female , Humans , Hyperplasia/drug therapy , Treatment OutcomeSubject(s)
Nevus , Skin Abnormalities , Skin Neoplasms , Dermoscopy , Diagnosis, Differential , Humans , Nevus/diagnosis , Skin Neoplasms/diagnosisABSTRACT
AIM: To investigate the intervenient effect of compound traditional Chinese medicine on dendritic cells (DCs) in peripheral blood in vitro. METHODS: DCs in peripheral blood were cultured for five days with medium which had GM-CSF and IL-4. The compound traditional Chinese medicine were added into the medium and the cells were collected on the 5th day. Surface markers of CD83 and CD86 in DCs were analyzed by flow cytometry. The capability of DC to stimulate the proliferation of T lymphocytes was evaluated by allogeneic mixed lymphocyte reaction. The content of IL-12 in cell culture supernatant was detected by ELISA. RESULTS: The expression of CD83 and CD86 was increased significantly(P<0.001) after the addition of the compound traditional Chinese medicine. The capability of DC to stimulate the proliferation of T lymphocytes was increased evidently (P<0.05). However the production of IL-12 was decreased obviously(P<0.001). CONCLUSION: The compound traditional Chinese medicine has immunoregulation of DC, It can enhance the presenting capability of antigen in DCs and inhibit the production of IL-12.
Subject(s)
Dendritic Cells/drug effects , Dendritic Cells/metabolism , Drugs, Chinese Herbal/pharmacology , Antigens, CD/metabolism , B7-2 Antigen/metabolism , Cell Proliferation , Cells, Cultured , Dendritic Cells/immunology , Enzyme-Linked Immunosorbent Assay , Flow Cytometry , Granulocyte-Macrophage Colony-Stimulating Factor , Humans , Immunoglobulins/metabolism , Interleukin-12/metabolism , Interleukin-4/pharmacology , Lymphocyte Culture Test, Mixed , Membrane Glycoproteins/metabolism , Microscopy , T-Lymphocytes/cytology , T-Lymphocytes/immunology , CD83 AntigenABSTRACT
AIM: To explore the effects of pcDNA3.1-IL-15 transfected on co-stimulatory molecule expression and immune function on murine bone marrow-derived dendritic cells (DCs). METHODS: Recombinant plasmid pcDNA3.1-IL-15 was constructed and used to transfect DCs. The expression of CD40, CD80 and CD86 on the transfected DCs was analyzed by flow cytometry. Murine splenocytes were stimulated with the transfected DCs. CD4+ and CD8+ T cell subsets in the splenocytes were analyzed by flow cytometry. The proliferation of splenocytes was detected by MTT colorimetry. The IFN-gamma in the culture supernatant of the splenocytes was detected by ELISA. RESULTS: pcDNA3.1-IL-15-transfected DCs expressed higher level of CD40, CD80 and CD86, and induced proliferation of CD4+ T cells and CD8+ T cells in the splenocytes. But the ratio of CD4+/CD8+ T cells was lower than that in the spleen cells stimulated by untransfected DCs or DCs transfected with pcDNA3.1. CONCLUSION: pcDNA3.1-IL-15 can improve the expression of co-stimulatory molecules on DCs and enhance their immune function.