ABSTRACT
This study was aimed to provide a reference for the development, registration, and clinical use of hospital traditional Chinese medicine (TCM) preparations, in order to analyze and assess their safety and risk. It also provided a reference for the technical review and supervision of hospital TCM preparations. Through collecting review materials of hospital TCM preparations from 2012 to 2014 in the Sichuan Food and Drug Administration, 21 preparations developed by clinical experiences were screened out. Analysis was made on their ingredients, preparation process and acute toxicity data. The results showed that 98 kinds of Chinese herbal medicines were contained in 21 preparations. The dosages of herbs were in compliance with theChina Pharmacopoeia2010 Edition. Preparation processes of 16 preparations were made by water extraction, grinding and other traditional techniques. The preparation processes of the remaining 5 preparations were involved with alcohol extraction or alcohol precipitation. Acute toxicity test data were obtained with experimental data in mice. Clinical usages of preparation were much lower than MTD or LD50. It was concluded that these hospital TCM preparations developed by clinical experiences were with high safety.
ABSTRACT
Objective To evaluate the clinical application of vaginal hysterectomy. Methods Clinical data of 118 patients with benign uterine diseases treated by vaginal hysterectomy (Vaginal Group) were retrospectively reviewed and were compared with those of 124 patients who underwent open hysterectomy (Open Group). Results The operative time (50 1 min?15 3 min), the intraoperative blood loss (150 4 ml?56 ml), the number of patients with a need for postoperative analgesics (26 cases), the postoperative pyrexia (42 cases), the time to first getting out of bed (26 4 h?6 3 h) and the length of hospitalization (5 2 d?1 2 d) in the Vaginal Group were significantly less than those in the Open Group (70 3 min?12 4 min, 212 2 ml?70 3 ml, 124 cases, 94 cases, 48 5 h?12 1 h, 8 2 d?2 2 d, respectively; P =0 000). There were no statistical significances between the two groups in occurrence of intra- or post- operative complications (Vaginal Group: 0 8%, 1/118, Open Group: 5 6%, 7/124; ? 2=2 982, P =0 084). Conclusions Vaginal hysterectomy has the advantages over open hysterectomy in minimal invasion and rapid recovery.