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Surgical resection in patients with advanced primary carcinoma of liver has high risks of early recurrence and incidence of portal vein tumor thrombus, caused by insufficient resi-dual liver volume after two-steps hepatotomy. At present, the treatment for patients with advanced primary carcinoma of liver is limited, thus can't satisfy the requirement of patient for treatment. The authors introduce the clinical experience of a patient with hepatocellular carcinoma and insufficient residual liver volume who underwent preventive immunotherapy plus target therapy after associa-ting liver partition and portal vein ligation for staged hepatectomy, in order to provide reference for relevant treatment.
ABSTRACT
OBJECTIVE:To investigate the clinical efficacy of Bacterial lysates capsule in the treatment of acute attack of asthma in children,and its effects on inflammatory factors and respiratory mechanics indexes.METHODS:A total of 87 children with acute attack of asthma in our hospital were divided into observation group (44 cases) and control group (43 cases).Control group was given glucocorticoid Beclomethasone dipropionate aerosol 0.05 mg,tid;observation group was additionally given Bacterial lysates capsule 3.5 mg,qd,on the basis of control group.Both groups received 120 days of treatment.Peripheral Thl/Th2 cell factor levels (IFN-γ,IL-2,IL-4,IL-5,IL-10,IL-13),lung function indexes (FVC,FEV1,PEF),respiratory mechanics indexes (mean airway pressure,respiratory resistance,static compliance,measured plateau pressure) and clinical efficacies were observed in 2 groups.RESULTS:Before treatment,there was no statistical significance in Th1/Th2 cell factors,lung function indexes or respiratory mechanics indexes between 2 groups (P＞0.05);after treatment,the levels of IFN-γ,IL-2,IL-10,FVC,FEV1 and PEF were increased significantly,while the levels of IL-5 and IL-3 were decreased significantly;IL-4 level of control group was decreased significantly;the levels of IL-2,IL-4,IL-10,FVC,FEV1 and PEF in observation group were significantly better than control group,with statistical significance (P＜0.05).Mean airway pressure,respiratory resistance and measured plateau pressure of observation group were significantly lower than those of control group,while static compliance was significantly higher than control group,with statistical significance (P＜0.05).Response rate of clinical control in observation group was 77.27％,which was significantly higher than 55.81％ of control group,with statistical significance (P＜0.05).CONCLUSIONS:Bacterial lysates capsule shows significantly therapeutic efficacy for acute attack of asthma,relieves airway inflammation and improves the immunity level of the body so as to improve airway respiratory mechanics parameters.
ABSTRACT
In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA's industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.