1.Efficacy of radial shockwave therapy for promoting healing of delayed of forearm fractures in children with ultrasonic guidance
Shan WANG ; Wei HE ; Fangfang DUAN ; Anyi GUO ; Longhao ZHANG ; Yajun LIU
Chinese Journal of Orthopaedics 2022;42(2):103-110
Objective:To explore the clinical effect of radial extracorporeal shockwave therapy on delayed union of forearm fractures in children with ultrasonic guidance.Methods:A retrospective analysis of information on 18 children with delayed forearm fracture union who received ultrasonic guided extracorporeal shockwave therapy from February 2018 to June 2019 was conducted. Among them, there were 14 males and 4 females; Age: 9.44±3.75 years (range, 3-15 years); All the children were closed forearm fractures, including 13 cases of ulna and 5 cases of radius. Initial fixation methods: intramedullary nails fixation in 8 cases, Kirschner wire fixation in 4 cases, steel plate fixation in 2 cases, external fixation in 2 cases, conservative treatment in 2 cases; The classification of fracture nonunion were: 14 cases of hypertrophy, 4 cases of atrophy; The course of disease was 4.0 (3.0, 6.0) months. The front and lateral X-ray films of the affected side forearm were taken before treatment, 3 months and 6 months after treatment. The scores of callus condition were performed using Lane-Sandhu X-ray scoring standard and Fernandez-Esteve X-ray evaluation standard of callus grade.Results:All children completed treatment and were followed up for 6 months. The bone healing standard was the disappearance of the fracture line shown by anterior and lateral X-ray films. Within 6 months after treatment, 11 patients got bone union. The healing rate was 61.11% (11/18). The average of Lane-Sandhu X-ray scores before treatment, 3 months and 6 months after treatment were 3.0 (1.0, 4.0), 6.0 (4.0, 8.0) and 10.0 (5.0, 12.0), respectively, there were statistically significant differences in pairwise comparisons at each time point. And the average scores of Fernandez-Esteve X-ray evaluation standard for callus grade were 1.0 (1.0, 2.0), 3.0 (2.0, 4.0), and 4.0 (3.0, 4.0), respectively, there were statistically significant differences from 3 months and 6 months after treatment to preoperative group, while there was no statistically significant difference between 3 months and 6 months after treatment. The mixed effects model analysis results showed that only the Lane Sandhu X-ray score and Fernandez Esteve X-ray standard score of callus grade at different follow-up time points were significantly different. There was no statistically significant difference in age, gender, number of shockwave treatments and interval time from the first treatment after the initial fixation.Conclusion:The radial extracorporeal shockwave therapy can effectively treat the delayed healing of forearm fractures in children; the X-ray score has been significantly improved. The treatment is highly accepted by children and their parents, and can be used as one of the methods to treat delayed healing of fractures in children in the future.
2.Application and Analysis of High-quality Evaluation for Jianwei Xiaoshi Tablets
Anyi ZHAO ; Lukun XIAO ; Sha CHEN ; Cong GUO ; Yuzhen LIU ; Zhiguang WANG ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(21):138-146
Jianwei Xiaoshi tablets, as a common variety of Chinese patent medicine with "one product with many manufacturers", have many manufacturers and huge market sales. However, the phenomenon about uneven quality and discrepant price is prominent. Based on this, this study was carried out for the quality evaluation of Jianwei Xiaoshi tablets by applying the high-quality evaluation criteria with the quality as core for Chinese patent medicine, which was based on the full production cycle, from the multi-dimension including raw material selection, production process, quality control, post-marketing research and so on. The evaluation results showed that the quality evaluation scores of Jianwei Xiaoshi tablets from different manufacturers varied greatly (ranging from 35 to 66), indicating that the quality was significantly different. In the actual production, generally inadequate attention was paid to the quality of raw materials, and the quality of raw materials was insufficient with the score ratio of 43%, especially the poor consistency control of them. The role of good manufacturing practice was obvious, and the scores of production process were generally high with the average score ratio of 62%, and the maximum up to 80%. The technological advancement of the manufacturer was outstanding. The score ratio of quality control was only 31% that the internal quality standard of each manufacture almost stayed at the qualified line, which was equal to the national standard, and the consistency of products was insufficient. The post-marketing research was lacking with the score ratio of 37%. Manufacturers with high brand awareness and market share were upper scores, while the others lagged far behind. The results of this evaluation are in line with the overall prediction, which can provide a reference for the high-quality evaluation of Chinese patent medicine, and supply the scientific data for high-quality and high-price application.
3.Historical Evolution and Key Information Research on Pediatric Famous Classical Formula Yigongsan
Jiangmin SU ; Jun ZHANG ; Cong GUO ; Anyi ZHAO ; Liang JIANG ; Heng ZHANG ; Jipeng DI ; Sha CHEN ; Li LIU ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):205-214
Yigongsan is derived from Xiaoer Yaozheng Zhijue written by QIAN Yi in the Northern Song dynasty, which is the No. 3 formula in the Catalogue of Ancient Famous Classical Formulas(The Second Batch of Pediatrics) released by the National Administration of Traditional Chinese Medicine(TCM) in September 2022, and it can be developed as a class 3.1 new TCM drug. By referring to ancient medical books and modern literature, this study conducted herbal textual research on Yigongsan from five aspects, including historical evolution, origin and processing, dosage conversion, usage and preparation methods, and functional application, then formed the key information table of this formula, in order to provide reference for the development of reference samples and preparations of Yigongsan. Based on the results of the study, it is recommended that Panax ginseng should be removed the basal part of stem(rhizoma), Poria cocos should be removed the peel, Citrus reticulata should be cut into shreds and Glycyrrhiza uralensis should be used. According to 4.13 g/Qian(钱), 1 g/slice for ginger, 3 g for each jujube and 300 mL/Zhan(盏), the doses of Ginseng Radix, Poria, Atractylodis Macrocephalae Rhizoma, Glycyrrhizae Radix et Rhizoma, Citri Reticulatae Pericarpium, Zingiberis Rhizoma Recens, Jujubae Fructus were 1.652, 1.652, 1.652, 1.652, 1.652, 5, 6 g, and the total amount was 19.26 g. The decocting method was to crush the medicinal materials into fine powder with 50-80 mesh, add 300 mL of water and decoct to 210 mL for each dose, then remove the dregs and take it warmly. This formula was recorded in ancient books as the main treatment for the cold-deficiency of spleen and stomach, and Qi stagnation in children with vomiting and diarrhea and lack of appetite. It has been flexibly applied by later generations of physicians, and is often used to treat anorexia, inflammation of the digestive tract, diarrhea and other diseases in children.
4.Quality Uniformity Analysis of 7 Commercially Available Yangyin Qingfei Preparations
Jiangmin SU ; Yongzhen LAO ; Sha CHEN ; Jun ZHANG ; Cong GUO ; Anyi ZHAO ; Jipeng DI ; An LIU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):164-170
ObjectiveTo establish the fingerprint of seven commercially available Yangyin Qingfei preparations, to quantitatively analyze the index components, to evaluate their quality uniformity with multivariate statistical analysis, and to explore the quality differences among different dosage forms. MethodA total of 33 batches of commercially available 7 kinds of Yangyin Qingfei preparations were analyzed by high performance liquid chromatography(HPLC), the fingerprints were established and the common peaks were identified. Paeoniflorin, verbascoside, harpagoside, glycyrrhizic acid and paeonol were selected as the indicators of quality attributes to quantitatively analyze 33 batches of preparations. Based on the administration methods of Yangyin Qingfei preparations, the daily intake was calculated and the radar charts were poltted, and cluster analysis and principal component analysis were used to explore the quality differences of 7 kinds of Yangyin Qingfei preparations and the quality uniformity among different batches of the same dosage form. ResultThe similarity of fingerprints of 7 dosage forms was 0.248-0.956, suggesting that there were significant differences among different dosage forms of Yangyin Qingfei preparations, and a total of 15 common peaks were calibrated, of which peak 7, peak 8, peak 11, peak 13 and peak 15 were paeoniflorin, verbascoside, harpagoside, glycyrrhizic acid and paeonol, respectively. The radar plots showed that the average total daily intake of large honeyed pills and water honeyed pills was the highest, and the uniformity of pill components was better. The quality of 33 batches of samples was divided into poor quality and high quality by cluster analysis. Principal component analysis showed that the uniformity and dosage form of different dosage forms were significantly different, the oral liquid had the best quality homogeneity with the minimum dispersion. And the content of paeonol in different dosage forms was significantly different, which was the key component of quality control of Yangyin Qingfei preparations. ConclusionYangyin Qingfei large honeyed pills and water honeyed pills show high content and good uniformity, which are relatively preferred dosage forms. Different preparation processes have a great influence on the content of paeonol, and its quality control should be emphasized during production. This study provides a scientific method for the comparison of product quality of different dosage forms of traditional Chinese medicine prescriptions, which is helpful for the development of preferred dosage forms of different prescriptions, and provides a reference for efficient use of medication in the clinical practice.