The observation of single-agent gemcitabine maintenance therapy in patients with metastatic breast cancer

Objective:The aim of the study was to evaluate the efficacy and tolerability of single-agent gemcitabine in the maintenance treatment of histologically confirmed metastatic breast cancer cases.Methods:The 45 patients carried efficacious chemotherapy were divided into maintenance therapy group(n=23) and control group(n=22) according to the different treatment methods.Patients in the maintenance therapy group received gemcitabine therapy until 6 cycles,disease progression or adverse effect intolerance.Within the control group,the patients were given best supportive care.Follow-up was made until disease progression,death or 2 years.The short-term clinical efficacy and adverse effects,progression-free survival(PFS) and median survival of recurrence(MSR) of these two groups were compared and analyzed.Results:Compared with the control group,the experiment group had higher response rate(RR;73.9% vs 31.8%;P<0.05),and significantly progress of median PFS(13.1 vs 9.6 months;P<0.05).However,the progression of MSR had no statistically difference with the control group(23.3 vs 21.1 months;P>0.05).Most of the treatment-related adverse events were mild,and the most common adverse event was hematologic toxicity.The 3 cases occurred grades 3–4 neutropenia and 3 cases occurred grades 3–4 thrombocytopenia.The 1 patient stopped treatment because of grade 3 allergic reaction,and 4 patients required dose reduction for grade 4 adverse events.Other adverse effects were grades 1–2,and all were recovered after symptomatic treatment.There was no significant side effect which threatened the life.Conclusion:In the extension maintenance treatment,gemcitabine can consolidate the therapeutic effect in advance and significantly prolong median PFS of metastatic breast cancer patients.In conclusion,gemcitabine monotherapy with a favorable safety profile is an effective maintenance treatment in metastatic breast cancer patients.

The Safety-influencing Factors in Use of the Tonics of Chinese Medicine: A Meta-analysis Based on the Case Reports in Periodicals

Objective: To identify the possible safety-influencing factors in use of the tonics of Chinese medicine. Methods: The related case reports published in periodicals published from 1949 to 2006 were analyzed with the bibliometrics method. Possibility on safety assessment of Chinese materia medica was discussed as well with the method of link analysis. Results: The total number of the tonics selected for the present study was 101, including 44 single drugs and 46 set prescriptions with adverse drug reactions (ADR) found in these tonics. It was found that ADR of 10 single drugs and 29 preparations were not specified in authoritative Chinese materia medica monographs. Among all the set prescriptions, the problem of injection has been standing on the top. Statistical analysis on single factor demonstrates that the most frequently referred ADR come from drug abuse (accounting for 29.20%), and overdose (24.54%). Conclusion: The safety problem of injection remains in a trend of robust growth at least for a period of time, thus reappraisal of the safety issue for the tonics of injection is imperative. It is essential for the public to take doctor’s advice to guarantee safe administration of the tonics, especially for the patients with allergic constitution or those suffering from the liver and heart diseases.