Effects of kanglaite capsules combined with transcatheter arterial chemoembolization （TACE） on patients with mid or late-stage primary hepatocellular carcinoma （HCC）

Objective： To observe the clinical effects of kanglaite （KLT） capsules combined with transcatheter arterial chemoembolization （TACE） in treating patients with mid or late-stage primary hepatocellular carcinoma （HCC）. Methods： Sixty-five cases were randomly divided into 2 groups, 32 patients in combination group received the treatment of KLT capsules ＋ TACE and 33 patients in control group were treated with TACE alone. The objective response rate （RR）, serum alpha fetoprotein （AFP）, peripheral blood T lymphocyte subgroups （T-LS）, quality of life （QOL）, time to progression （TTP） and adverse reaction were observed and compared between 2 groups. Results： The objective response rate and serum alpha fetoprotein levels had no significant difference between the two groups （P 〉 0.05）. Combination group was superior to control group in quality of life （QOL）, time to progression （TTP）, peripheral blood T lymphocyte subgroups （CD3＋, CD4＋, CD4＋／CD8 ratio） and liver adverse reactions, with significant differences （P 〈 0.05）. Conclusion： KLT capsules combined with TACE is an effective method to treat primary hepatocellular carcinoma （HCC） patients who have lost the opportunity of surgical therapy.

Clinical study on concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer

Objective： To evaluate the clinical effects and toxicity of concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer. Methods： 48 patients with regionally advanced unresectable non-small cell lung cancer were randomized to two groups, 25 patients in the combination group （concurrent chemoradiotherapy ＋ Kanglaite） and 23 patients in the control group （concurrent chemoradiotherapy）. The combination group received chemotherapy of vinorelbine （NVB） plus cisplatin （DDP） regimen, radiotherapy was given with conventional fraction in 2 Gy per fraction and five fractions per week concurrently. The total tumor doses were 56-60 Gy. Combined with Kanglaite injection 200 mud for twenty-one days for two courses in the combination group, the control group was chemoradiotherapy only. Effects and toxicities were evaluated according to the criteria of WHO. Results： The CR rates in the combination group and control group were 24.0% （6/25） and 13.0% （3/23）, respectively （P 〉 0.05）. Response （CR ＋ PR） rates of combination group were 76.0 % （19/25） and 69.6% （16/23） in control group, P 〉 0.05. The incidence rates of grades 3-4 leukocytopenia, grades 3-4 digestive system （nausea and vomiting） and grades 3-4 esophagitis in the combination group and control group were 40.0% （10/25）, 8.0% （2/25）, 16.0% （4/25） and 69.6% （16/23）, 34.8% （8/23）, 43.5% （10/23）, respectively （P 〈 0.05）. KPS and body weight score significantly increased in combination group after the combined treatment, P 〈 0.05. Conclusion： Concurrent chemoradiotherapy combined with Kanglaite injection can relieve side effects of chemoradiotherapy in the treatment of regionally advanced unresectable non-small cell lung cancer, and improve quality of life. Kanglaite injection may increase effective rate of regionally advanced unresectable non-small cell lung cancer combined with concurrent chemoradiotherapy.

Effect and safety of Kanglaite injection combined with chemotherapy in the treatment of advanced colorectal cancer:a systematic review and meta-analysis

Objective:To evaluate the clinical efficacy and safety of Kanglaite injection combined with chemotherapy and chemotherapy alone in the treatment of advanced colorectal cancer.Methods:PubMed,Cochrane library,CNKI,VIP,Wanfang database were systematically searched by inputting keywords to explore the efficacy of Kanglaite injection combined with chemotherapy in the treatment of advanced colorectal cancer.A random-effects model was selected to evaluate the treatment outcomes.The screening of literature,the extraction of data and the assessment of methodology were independently undertaken by two reviewers.Meta analysis was performed using Revman5.3 software and stata15.0 software.Results:A total of 12 RCTs were included,with 792 cases.Compared with chemotherapy alone,Metaanalysis suggested that Kanglaite injection combined with chemotherapy can improve clinical efficiency(RR=1.45,95%CI:1.21-1.74,P<0.0001)and improve patients'quality of life(RR=1.55,95%CI:1.32-1.82,P<0.00001),improve the patient's immune function(CD3+cells:SWD=1.42,95%CI:1.11-1.73;CD4+/CD8+cell ratio:SWD=0.95,95%CI:0.66-1.25;NK cell activity:SWD=3.24,95%CI:2.81-3.66,P<0.00001);Leukopenia rate(RR=0.63,95%CI:0.54-0.74,P<0.0001),incidence of gastrointestinal adverse reactions(RR=0.56,95%CI:0.48-0.66,P<0.00001),incidence of peripheral neurotoxicity(RR=0.79,95%CI:0.65-0.96,P=0.02)were lower than the chemotherapy alone group,the difference was statistically significant.In improving the hand-foot syndrome and oral mucositis after chemotherapy,there was some difference between the Kanglaite injection combined with chemotherapy group and the chemotherapy alone group,but the difference was not significant.Puber bias detection and sensitivity analysis were performed with clinically effective relative risk(RR)as indicators.The results suggested that the publication bias was not obvious.The results of this study are stable.Conclusion:Compared with chemotherapy alone group in the treatment of advanced colorectal cancer,Kanglaite injection combined with chemotherapy can improve the effective rate,quality of life,immune function of patients and reduce the incidence of leukopenia after chemotherapy,gastrointestinal adverse reactions and peripheral neurotoxicity.

Network pharmacology-based elucidation of molecular biological mechanisms of Kanglaite injection for treatment of non-small cell lung cancer

Objective: To investigate the effective compounds, potential targets and molecular mechanism of Kanglaite injection (KLTi) in the treatment of Non-Small Cell Lung Cancer (NSCLC) based on network pharmacology. Methods: The active compounds and targets of KLTi which extracted and isolated from Coix Seed were screened by Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP). The related genes of NSCLC were obtained by searching the Human Gene Database (GeneCards) and Online Mendelian Inheritance in Man (OMIM). The candidate targets of KLTi in the treatment of NSCLC were obtained after extracting the intersection network. The "drug-component-target-disease" network was constructed with the help of Cytoscape 3.7.2. The Protein- Protein Interaction networks were constructed on the STRING platform and core network modules were screened. The Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis of candidate genes were performed using Metascape platform, and a "pathway-target- compounds" network was constructed to further screen key genes and active compounds. Results: A total of 11 compounds, 22 candidate targets, 206 GO functions and 12 KEGG pathways were obtained. Conclusion: The active compounds of KLTi in the treatment of NSCLC are stigmasterol, stigmasterol α1 and ergosterol. The key targets are PGR, NCOA2, PTGS2, NR3C2, and PTGS1. The core GO functions included receptor activity and binding, neuronal signal transmission and hormone stimulation;KEGG mainly involves cancer pathways, neuroactive ligand-receptor interactions and calcium signaling pathways. This study reveals the molecular biological mechanism of KLTi in the treatment of NSCLC, which is speculated to be related to neuroendocrine, providing a new basis and therapeutic direction for subsequent clinical application and experimental research.

A Meta-analysis of the efficacy and safety of Kanglaite injection combined with chemotherapy in the treatment of pancreatic cancer

Objective:To investigate the efficacy and safety of Kanglaite injection(KLT)combined with chemotherapy in the treatment of pancreatic cancer.Methods:PubMed,EMBASE,the Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang Database,VIP Data,and Chinese Biomedical Database(CBM)were searched to get the studies about KLT plus chemotherapy for pancreatic cancer(from established to May 2019).Data extraction and bias risk assessment were carried out by two authors independently according to the retrieval method.RevMan(version 5.3)were employed for data analysis.Results:A total of 151 literatures were retrieved and 11 literatures were finally included.A total of 614 patients were included,including 308 in the treatment group and 306 in the control group.The results of meta-analysis showed that compared with chemotherapy alone,KLT combined with chemotherapy could improve the effective rate[Porr=0.0009,OR=1.96,95%CI(1.32,2.92)]and disease control rate[Pdcr<0.00001,OR=2.53,95%CI(1.76,3.62)],improve KPS score[P<0.00001,OR=3.59,95%CI(2.00,6.44)]and body mass indexes[P=0.0003,OR=3.45,95%CI(1.78,6.69)],prolong progression free survival(PFS)and overall survival(OS),reduce the rate of myelosuppression[P=0.03,OR=0.54,95%CI(0.30,0.95)],but could not reduce the occurrence of neurotoxicity[P=0.49,OR=0.80,95%CI(0.42,1.51)]and digestive tract reaction[P=0.51,OR=0.83,95%CI(0.48,1.44)].Conclusion:KLT combined with chemotherapy can improve the curative effect of pancreatic cancer,improve the quality of life of patients,prolong the survival of patients,and reduce the incidence of bone marrow suppression.However,due to the limitation of the quality and quantity of included literatures,this conclusion needs to be verified by high-quality study.

Therapeutic Effects of Kanglaite Injection Combined with Chemotherapy on Advanced Non-small-cell Lung Cancer

The objective of this study was to study the therapeutic effect of Kanglaite injection combined with chemotherapy in the treatment of late-stage nonsmall-cell lung cancer(NSCLC)and also to observe the effect of the combination treatment on immune function.92 patients with advanced stage of NSCLC who admitted to First Hospital of Zibo city hospital from May 2017 to October 2018 were randomly divided into experimentagroup and control group,with 46 cases,respectively.The control group was treated with chemotherapy only while the experimental group was treated with Kanglaite injection combined with chemotherapy which was the basic treatment for patients,and the total treatment effective rate,adverse reaction rate,and immune index of the treatments on two groups were compared.The total treatment effective rate of the experimental group was 80.43%,which was significantly higher than that of the control group,which was 63.04%.The incidence of adverse reactions in the experimental group was 36.96%,which was lower than that of the control group(78.26%).The immune indexes of the experimental group(CD3+,CD4+,IgG,and IgA)were better than that of the control group,respectively.The differences between the two groups were statistically significant(P<0.05).During the chemotherapy of late-stage or advanced NSCLC,the addition use of Kanglaite injection has a significant effect on improving tumor control and reducing the side effects of chemotherapy,and helps to improve the immune function of patients;thus,it is worth promoting.

Effect of kanglaite injection combined with chemotherapy on tumor factors, angiogenesis and immunoglobulin in patients with lung adenocarcinoma

Objective:To explore the effect of Kanglaite injection combined with chemotherapy on the levels of tumor factors, angiogenesis and immunoglobulin in patients with lung adenocarcinoma.Method: A total of 88 patients with lung adenocarcinoma in our hospital and the Fifth Peoples Hospital of Wuxi from February 2014 to December 2017 were divided randomly into observation group and control group according to the visiting time, 44 cases for each group. The observation group was treated with chemotherapy combined with Kanglaite injection, and the control group was treated with chemotherapy only.Both groups were treated for 6 weeks and then the levels of CEA, CA125, CA199, VEGFA, VEGFB, VEGFC, and IgA, IgM, IgG after treatment in both groups were compared.Result: Before treatment, there were no significant differences in the levels of CEA, CA125 and CA199 between two groups. The level of CEA in the observation group (29.88±7.07) μg/L was lower than that in the control group,and the difference was statistically significant. The levels of CA125 and CA199 after treatment were lower than those before treatment, but with no significant difference. Between the two groups, there was no significant difference of the levels of VEGFA,VEGFB and VEGFC before treatment, the level of VEGFA after treatment in the observation group (80.49±12.29) ng/mL was lower than that in the control group and the difference was statistically significant, and the levels of VEGFB and VEGFC after treatment were also lower than those before treatment, but with no significant difference. The levels of IgA, IgM and IgG before treatment in two groups had no significant difference, The level of IgM after treatment in the observation group (1.52±0.30) g/L was lower than that in the control group, with a statistical difference. The levels of IgA and IgG after treatment were lower than those before treatment, but with no significant difference;No serious adverse reaction was observed after treatment in both groups.Conclusion: Kanglaite injection combined with chemotherapy has a good clinical effect in lung adenocarcinoma, which can effectively inhibit the high expression of tumor markers, reduce angiogenesis, enhance body immunity, and can be recommended for clinical application.

Effect of kanglaite injection and docetaxel in treating advanced stage esophageal cancer on tumor markers, angiogenesis and immune function in elderly patients

Objective:To investigate the effect of Kanglaite injection combined with docetaxel in advanced esophageal cancer on tumor markers, angiogenesis and immune function in elderly patients.Method:A total of 130 patients with advanced esophageal cancer admitted in our hospital from October 2014 to July 2017were selected and divided into two groups according to the time of admission, 65 cases in each group, set as observation group and control group, all patients were treated with conventional radiotherapy (cisplatin combined with 5-fluorouracil), the observation group was given Kanglaite injection combined with docetaxel on the basis of this, while the control group only was given docetaxel treatment, the treatment period was 6 weeks, tumor markers, VEGF and immune function of both group after treatment were compared.Result: After treatment, the levels of carbohydrate antigen 125 (CA125), carbohydrate antigen 19-9 (CA19-9) and carcino-embryonic antigen (CEA) in the observation group were lower than those in the control group, the difference was statistically significant;VEGF level in the observation group after treatment was lower than the control group, the difference was statistically significant;After treatment, the levels of CD3+, CD4+ and CD4+/CD8+ in the observation group were higher than those in the control group, while the levels of CD8+ in the observation group was lower than those in the control group, the difference was statistically significant.Conclusion: Kanglaite injection combined with docetaxel in the treatment of elderly patients with advanced esophageal cancer is better, effectively reducing the level of tumor markers and vascular endothelial growth factor, improve immune function, it isworthy of clinical application.

The efficacy of Kanglaite injection during treatment with tyrosine kinase inhibitor in elderly patients with non-small cell lung cancer

Objective Epidermal growth factor receptor–tyrosine kinase inhibitors(EGFR–TKIs) are widely used in the treatment of EGFR mutation-positive non-small cell lung cancer(NSCLC) patients. The Kanglaite injection(KLT) is a novel broad-spectrum anti-cancer injection produced from traditional Chinese medicinal herbs(coix seed). After its approval in 1995, KLT has become the most popular anti-cancer drug in China. As of this writing, no standard treatment guideline is available for elder patients with NSCLC, and the role of traditional Chinese medicinal herbs, including KLT, combined with TKI treatment remains unknown. This retrospective study evaluated the efficacy and safety of KLT in elderly NSCLC patients during TKI treatment.Methods Thirty elderly patients aged 71-79 years with histopathologically confirmed NSCLC attending the General Hospital of the Shenyang Military Region were enrolled in the study and received EGFR-TKI treatment. All participants received 200 m L KLT injections at the same time on days 1–21. Erlotinib(150 mg) or gefitinib(250 mg) was administered daily from days 1 to 21, and the cycle was repeated every 21 days. The endpoint of the primary study was the disease control rate.Results Thirty elderly patients were enrolled in this study. The objective response rate was 21.3% [95% confidence interval(CI): 8.6% to 35.2%], whereas the disease control rate was 80.4%(95% CI: 71.8% to 97.0%). The grade 3 or 4 adverse effects included leucopenia(13.7%), neutropenia(13.4%), anemia(2.9%), and nausea or vomiting(2.7%). Conclusion The administration of KLT combined with erlotinib or gefitinib showed high efficacy in elderly NSCLC patients. The adverse effects of the drug combination were well tolerated by the patients. KLT combined with TKI treatment might provide a satisfactory therapeutic strategy for elderly NSCLC patients.

Clinical Observation on Effect of Kanglaite(康莱特)in Treating Pulmonary Carcinoma Patients withLung-Qi Deficienoy and ImmunologicInadequacy sfter Pneumonectomy

Objective: To study the effect of Kanglaite (KLT) in treating pulmonary carcinoma (PC) patients with Lung-Qi Deficiency and immunologic inadequacy (LDII) after pneumonectomy. Methods: Thirtysix patients of PC-LDII were treated with KLT and the lymphocyte subset was examined before and after treatment. Results: The markedly effective rate of treatment was 50. 0 % and the total effective rate 66. 7%. Immunological examination showed that the lymphocyte subset of patients tended to get normal and the difference between pre-treatment and post-treatment was significant. Conclusion: KLT could improve the symptom ofLung-Qi Deficiency and markedly strengthen the immune function of PC patients.