1.Investigation on current status of advanced schistosomiasis in Shanggao County
Wuming TAO ; Yuanhua MAO ; Fei HU ; An NING
Chinese Journal of Schistosomiasis Control 2014;(6):693-694
Objective To understand the current status of advanced schistosomiasis patients, so as to provide the reference for improving the medical care of them in Shanggao County. Methods The data of advanced patients in Shanggao County were collected from the Information Management System for the Advanced Schistosomiasis Chemotherapy and Assistance in Jiangxi Province and a field survey including the epidemiological investigation physical examinations and B ultrasound examinations was performed in 2014. All the data were analyzed statistically and compared with those in 2010. Results Among the 128 ad?vanced schistosomiasis patients the male female ratio was 2.46 1 the average age was 68.02±6.19 years and the patients old?er than 65 years contributed to 64.84%for the all. The proportions of clinically types of ascites splenomegaly multiple granulo?ma in the colon dwarf general and haemorrhage were 57.81% 12.50% 2.34% 0 26.57% and 0.78% respectively. The ultrasound examinations revealed the average diameter of the main trunk of portal vein was 12.70 ± 1.91mm in 2014 which was significantly broader than that of 12.05 ± 0.34mm in 2010 P < 0.01 . Conclusions The advanced schistosomiasis patents in Shanggao County decreases with years and shows an aging trend. Some advanced schistosomiasis patients are worse therefore the chemotherapy and salvation work still should be strengthened.
2.Open, multicenter, phase Ⅳ clinical trial of Shenbei Guchang capsules in treatment of diarrhea type irritable bowel syndrome.
Chun-Hua QIU ; Liang-Ping LI ; Chu-Min ZHANG ; Chun-Sheng LIU ; Tao LIANG ; Yi JIAN ; Hong-Bin WANG ; Yang ZHANG ; Guang-Shang WANG ; Xin-Xi XIE ; Shu-An CHEN ; Wei-Ming HE ; Xu ZHANG ; Yong-Su JIANG ; Jing LIAO ; Dong CHEN ; Bi LIU ; Wen-Bin PAN
China Journal of Chinese Materia Medica 2016;41(10):1947-1951
To evaluate the safety and effectiveness of Shenbei Guchang capsules in treatment of diarrhea type irritable bowel syndrome (yang deficiency of spleen and kidney) under widely used conditions, an open, multicenter, controlled, phase Ⅳ clinical trial was conducted in the drug clinical trial centers of 16 domestic hospitals. 2 123 patients from June 10, 2011 to November 29, 2012 were enrolled in the trial. Drug clinical trial was approved by Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital Ethics Committee before implementation. Before the start of trial, subjects were selected according to the research scheme and inclusion criteria, then they would step into the 14 d study after signing Informed Consent Form. All subjects were treated according to the research scheme, evaluated the conditions and filled in CFR sheet, to provide the evaluation data and information on safety and efficacy of Shenbei Guchang capsules. Shenbei Guchang capsules were used to treat diarrhea type irritable bowel syndrome in widely used conditions (2 123 cases), and 2 029 cases of them entered FAS set, cure+markedly effective in 1 921 cases, with a comprehensive curative effect rate of 94.68%; 2 010 cases of them entered PPS set, cure+markedly effective in 1 906 cases, with a comprehensive curative effect rate of 94.83%. The primary symptoms of IBS were abdominal pain and diarrhea. After treatment, both abdominal pain and diarrhea were improved, with significant differences (P<0.000 1). There were significant differences in traditional Chinese medicine symptom scores on both post-treatment day 7 and day 14 as compared with the conditions before treatment (P<0.000 1). 35 cases of adverse events occurred during the trial with an incidence of 1.65%, including 12 cases of drug-related adverse events (adverse reaction) with an incidence of 0.57%, mainly manifested as nausea, abdominal distension and dry mouth, most of which would be spontaneously relieved without any measures. No serious adverse events occurred. The commercially available Shenbei Guchang capsules are proved safe and effective for the treatment of diarrhea type irritable bowel syndrome (yang deficiency of spleen and kidney) under widely used conditions (2 123 cases), and can be continued for clinical promotion and application.