1.Overview of China′s pediatric drug situation and regulatory policy
Hongjie XIAO ; Mengdie ZHOU ; Yang SUN ; Wu ZHONG
Journal of International Pharmaceutical Research 2016;43(4):579-584
Pediatric drug accessibility has become a global problem,pediatric drug shortages and off-label uses are very seri?ous. In China,lack of suitable varieties,appropriate dosage forms and specifications,weak foundations on clinical trials,irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessi?bility,it may need all aspects work together,that is,cooperation of the national macro-policy support,participation of enterprises and medical institutions,to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediat?ric regulation measures and policies and by comparing foreign policies to China′s current situation,we can find out the problems and defects,give appropriate advice,in order to provide advice and reference to promote the development of pediatric drug.
2.Study on Varieties,Indications and Usage Features of Tibetan Medicine Preparations Based on Drug Stan-dards
Tingting KUANG ; Ming SUN ; Zhang WANG ; Xiaoqi ZHU ; Yanhong TANG ; Mengdie CAO ; Yong ZENG ; Minru JIA ; Yi ZHANG ; Daofeng JIANG
China Pharmacy 2017;28(16):2231-2234
OBJECTIVE:To study varieties,indications and usage features of Tibetan medicine preparations,and provide refer-ence for the clinical treatment and new drug development for Tibetan medicine. METHODS:Tibetan medicine preparations in offi-cial standards were collected,variety features(formula scale,license number,pharmaceutical enterprise,name and dosage form, herbal medicine number),action features(indication name,clinical application)and medicine features(category and quantity,me-dicinal part,commonly used drug,frequency,three fruitsuse feature) were summarized. RESULTS:Totally 458 preparations were included,including 18 recorded in Chinese Pharmacopoeia (part 1,2015 edition),200 recorded in Pharmaceutical Stan-dards of the Ministry of Health of China(Tibetan medicine,1995 edition),240 recorded in Tibetan Medicine Standards(six prov-inces). 129 had obtained 430 license numbers,from 52 pharmaceutical companies;the prearations were mainly named byherbal medicine+principal medicine+dosage formprincipal medicine+dosage formandindication+dosage form. Dosage forms had powder,pill,cream,oil,syrup and wine; the number of herbal medicine was(13.81±13.28). The Tibetan preparations were com-monly used in the clinical treatment of diseases of the digestive system,respiratory system,genitourinary system,circulatory sys-tem,infectious and parasitic diseases,etc. 442 medicines had been used,including 297 herbal medicines,70 animal medicines, 47 mineral medicines and other 28 medicines. The common medicinal parts were seed or fruit,root or rhizome,whole grass,flow-er,stem,over-ground part,tuber or bulb,etc. The top 10 frequency of medicines were as follows as Terminalia chebula,Cartha-mus tinctorius,Aucklandia lappa,Amomum kravanh,Phyllanthus emblica,Piper longum,Inula racemosa,Punica granatum, Moschus berezovskii,Adhatoda vasica;and 19% preparations contained three fruits(T. chebula,P. emblica,Terminalia bellirica). CONCLUSIONS:Tibetan medicine preparations have rich varieties,reasonable herbal medicines,more solid preparations,widely clinic application,contain more herbal drugs and commonly usethree fruits,while fewer preparations have obtained license number.
3.A comparative study of two different methods of the costal cartilage cortex harvest with perichondrium preserved
Fei HU ; Maoqi SONG ; Mengdie SUN ; Nianping CHEN
Chinese Journal of Plastic Surgery 2021;37(7):795-801
Objective:To compare two different methods for the harvest of the costal cartilage cortical slice with perichondrium preserved for rhinoplasty patients, and to explore a simple and less invasive method for the costal cartilage cortical slice.Methods:From September 2019 to December 2020, the rhinoplasty patients using the techniques of nasal tip "double arch" stent combined with prosthesis were selected in Shanghai Time Plastic Surgery Hospital, they were randomly divided into observation group and control group. In the observation group, only the cortical slice of costal cartilage with perichondrium was cut and the continuity of costal cartilage was preserved. While in the control group, with the superficial perichondrium preserved, the whole costal cartilage was dissected first, and then pruned it and harvested the cortical slice of costal cartilage with perichondrium. The operation were performed by the same clinicians in both groups. Different variables were compared between the two groups, including the operation time, intraoperative blood loss, length of incision, the degree of chest pain after postoperative 6, 24, 72 h, 1 week, the incidence of intraoperative complications and so on. The severity of chest pain was assessed by visual analogue scale (VAS). The measurement data of the two groups were analyzed by t-test, and the enumeration data were analyzed by χ2 test. Results:For both observation group and the control group, 61 patients were included. In the observation group, there were 3 males (4.9%) and 58 females (95.1%), aged (28.6±5.4) years old, and BMI (21.76±1.65) kg/m 2. In the control group, there were 2 males (3.3%) and 59 females (96.7%), aged (45.8±5.7) years old, and BMI (22.25±1.47) kg/m 2. There were no significant differences in gender composition, age and BMI between the two groups ( P>0.05). The double arch stent of nasal tip could be made by the costal cartilage cortical slices obtained in the two groups. In the control group, two cases of pleural rupture occurred and their prognosis was good after effective treatment, with no complications such as hematoma, infection or pleural injury. In the observation group, there were no complications such as hematoma, infection or pleural injury. The operation time, incision length and intraoperative blood loss in the observation group were significantly lower than those in the control group [(18.54±3.62) min vs. (25.75±3.75) min; (1.68±0.26) cm vs. (2.16±0.32) cm; (16.79±7.86) ml vs. (25.46±8.49) ml; P<0.05]. The VAS score in the observation group was lower than that in the control group after postoperative 6, 24, 72 h, 1 week [(2.76±0.62) vs. (3.87±0.68)scores; (2.37±0.45) vs. (3.12±0.55) scores; (1.76±0.45) vs. (2.57±0.53) scores; (1.17±0.44) vs. (1.85±0.51) scores; P<0.05]. Conclusions:Compared with the conventional method of whole costal cartilage harvest, the method of harvesting the costal cartilaginous cortical slice with the costal perichondrium preserved and preserving the continuity of the costal cartilage can reduce the trauma and bleeding, shorten the operation time, simplify the operation process, and significantly reduce the postoperative chest pain.
4.A comparative study of two different methods of the costal cartilage cortex harvest with perichondrium preserved
Fei HU ; Maoqi SONG ; Mengdie SUN ; Nianping CHEN
Chinese Journal of Plastic Surgery 2021;37(7):795-801
Objective:To compare two different methods for the harvest of the costal cartilage cortical slice with perichondrium preserved for rhinoplasty patients, and to explore a simple and less invasive method for the costal cartilage cortical slice.Methods:From September 2019 to December 2020, the rhinoplasty patients using the techniques of nasal tip "double arch" stent combined with prosthesis were selected in Shanghai Time Plastic Surgery Hospital, they were randomly divided into observation group and control group. In the observation group, only the cortical slice of costal cartilage with perichondrium was cut and the continuity of costal cartilage was preserved. While in the control group, with the superficial perichondrium preserved, the whole costal cartilage was dissected first, and then pruned it and harvested the cortical slice of costal cartilage with perichondrium. The operation were performed by the same clinicians in both groups. Different variables were compared between the two groups, including the operation time, intraoperative blood loss, length of incision, the degree of chest pain after postoperative 6, 24, 72 h, 1 week, the incidence of intraoperative complications and so on. The severity of chest pain was assessed by visual analogue scale (VAS). The measurement data of the two groups were analyzed by t-test, and the enumeration data were analyzed by χ2 test. Results:For both observation group and the control group, 61 patients were included. In the observation group, there were 3 males (4.9%) and 58 females (95.1%), aged (28.6±5.4) years old, and BMI (21.76±1.65) kg/m 2. In the control group, there were 2 males (3.3%) and 59 females (96.7%), aged (45.8±5.7) years old, and BMI (22.25±1.47) kg/m 2. There were no significant differences in gender composition, age and BMI between the two groups ( P>0.05). The double arch stent of nasal tip could be made by the costal cartilage cortical slices obtained in the two groups. In the control group, two cases of pleural rupture occurred and their prognosis was good after effective treatment, with no complications such as hematoma, infection or pleural injury. In the observation group, there were no complications such as hematoma, infection or pleural injury. The operation time, incision length and intraoperative blood loss in the observation group were significantly lower than those in the control group [(18.54±3.62) min vs. (25.75±3.75) min; (1.68±0.26) cm vs. (2.16±0.32) cm; (16.79±7.86) ml vs. (25.46±8.49) ml; P<0.05]. The VAS score in the observation group was lower than that in the control group after postoperative 6, 24, 72 h, 1 week [(2.76±0.62) vs. (3.87±0.68)scores; (2.37±0.45) vs. (3.12±0.55) scores; (1.76±0.45) vs. (2.57±0.53) scores; (1.17±0.44) vs. (1.85±0.51) scores; P<0.05]. Conclusions:Compared with the conventional method of whole costal cartilage harvest, the method of harvesting the costal cartilaginous cortical slice with the costal perichondrium preserved and preserving the continuity of the costal cartilage can reduce the trauma and bleeding, shorten the operation time, simplify the operation process, and significantly reduce the postoperative chest pain.