Study on tolerability for safflower peony ointment in clinical trial phase I / 中国中药杂志

<p><b>OBJECTIVE</b>To evaluate the tolerability for safflower peony ointment and determine its safe dosage, by selecting health volunteers and testing from the initial safety dosage, in order to provide basis for formulating administration scheme of the drug in clinical trial phase II.</p><p><b>METHOD</b>Forty-six healthy volunteers were included in the open, random, dose escalation, self control clinical trial on tolerability for single dosage scheme or multi-dosage. In the single dosage scheme, dosages of test drugs were 2.16 g (four people), 4.32 g (6 people), 6.48 g (6 people), 8.62 g (6 people), 11.46 g (6 people), 15.24 g (including crude drug) for 24 hours, once everyday. In the multi-dosage scheme, dosages of test drugs were 8.62 g (6 people), 11.46 g (including crude drug) once everyday for 7 days.</p><p><b>RESULT</b>The maximum safe dosage of single administration was 15.24 g (including crude drug) , while that of multiple administration 8.62 g (including crude drug). The occurrence rate of side effect was as low as 2.17%, which was recovered by medicines, without severe adverse event.</p><p><b>CONCLUSION</b>The study proves the safe application of single administration and multiple administration of safflower peony ointment in human bodies, which lays a foundation for the application in the clinical trial phase II.</p>

Treatment of gastric precancerous lesions with Weiansan.

AIM: To observe the curative effect of Weiansan (WAS) on gastric precancerous lesions (GPL) and H pylori elimination. METHODS: Seventy-six patients with GPL were randomly divided into two groups: WAS group (n = 42) and Weifuchun (WFC) group (n = 34). The patients in the WAS group were administered 5 g WAS 3 times a day, and the patients in the WFC group took WFC (4 tablets) 3 times a day. To monitor inflammation of gastric mucosa, degree of glandular atrophy (GA), intestinal metaplasia (IM) and dysplasia, and H pylori infection, all patients underwent gastroscopy and biopsy with pathological examination before and after treatment. Fifty male Sprague-Dawley (SD) rats were used in animal experiments. Of these, 10 served as the control group (n = 10), 40 were given ranitidine combined with N-methyl-N(1)-nitro-N-nitrosoguanidine (MNNG) for 12 wk and divided into 4 groups randomly: model group (n = 10), high-dose WAS group (n = 10), low-dose WAS group (n = 10) and WFC group (n = 10). Twelve weeks later, all rats were killed and a 2 cm multiply 1 cm tissue was taken from the lesser curvature of the gastric antrum. H pylori infection was determined by the fast urease method. RESULTS: The curative effect in WAS groups was similar to that in WFC groups. There was no statistical difference in degree of GA, IM and dysplasia between WAS and WFC groups. The rate of H pylori infection in the model group (positive/negative: 9/1) was significantly higher than that in the control group (positive/negative: 1/9) (P < 0.01). H pylori elimination in the high-dose WAS group (positive/negative: 4/6) and low-dose WAS group (positive/negative: 6/4) was similar to that in the WFC group (positive/negative: 4/6) (P > 0.05). CONCLUSION: WAS improves clinical symptoms by suppressing GA, IM and dysplasia and eliminating H pylori.