ABSTRACT
After the completion of the pilot work of traditional Chinese medicine formula granules （TCMFGs）， the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work， this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards， mainly involving the executive standards and distinguishing technologies of raw materials， the adding process of excipients in the procedure item， the rationality of quality control methods， the information content and reproducibility of characteristic chromatograms， the nomenclature and accessibility of reference materials， etc. The common problems such as the coverage of standards， specification differences， and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards， accelerate the research and development of reference materials， advocate the use of high-quality raw materials， explore the evaluation methods of high-quality products， and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards， promote the continuous improvement of TCMFGs standard system， and ensure the healthy and orderly development of the TCMFGs industry.
ABSTRACT
PURPOSE: To evaluate the prognosis of nasopharyngeal carcinoma (NPC) patients who developed bone-only metastasis after primary treatment and the stratification of these patients into different risk groups based on independent prognostic factors. MATERIALS AND METHODS: Eighty NPC patients who developed bone-only metastasis after definitive radiotherapy from October 2005 to December 2010 were enrolled. All these patients received palliative treatment for bone metastasis, including chemotherapy and/or radiotherapy. Clinical features, treatment modality, and laboratory parameters were examined with univariate and multivariate analyses. RESULTS: The median follow-up time was 15.5 months (range, 2-67 months) for the whole cohort. The median overall metastatic survival (OMS) time and the 2-year estimate OMS rate were 26.5 months and 52%, respectively. Multivariate analysis indicated that patients with short metastases-free interval, multiple bone metastases sites, high serum lactic dehydrogenase levels, and treated with radiotherapy or chemotherapy alone had significantly worse outcomes. Patients were stratified into three different risk groups based on the number of adverse factors present. The OMS curves of the three groups were all significantly different (p<0.001). CONCLUSION: Severl prognostic factors were found to be associated with worse outcomes. According to the number of adverse factors present, bone-only metastasis patients can be stratified into three risk groups with significantly different prognoses. Such grouping may help in improving the design of clinical trials and in guiding individualized treatment for NPC patients with bone-only metastasis.