OBJECTIVE:To probe into the application of pharmacoepidemiology in safety study of TCM injection for sale in order to provide new idea for the study of TCM injection for sale. METHODS:Based on reported ADR events caused by TCM injection in recent year,the main approaches of pharmacoepidemiology were introduced to analyze the safety of TCM injection for sale. RESULTS & CONCLUSION:Pharmacoepidemiology is the main mean for safety study of TCM injection for sale and important basis for the selection of essential drug in China. Descriptive study can provide testimony for countermeasure in the early stage of ADR and analytical study can be used for the selection and detection of etiological hypothesis. Many other methods of pharmacoepidemiology can be used as approaches for safety study of TCM injection for sale.

Objective To explore the measures to prevent recurrent laryngeal nerve (RLN)injury during thyroid surgery.Methods The clinical data of 223 patients undergone thyroid surgery were retrospectively analyzed.Among the 223 surgeries,69 sides were undergone regional protection act of RLN and 191 sides were performed RLN exposure.Results There were 2 cases of RLN injury from the regional protection operation of RLN,including 1 case of temporary nerve injury which could be resulted from surgery clamp and 1 case of permanent nerve injury which might be caused by mistaking ligation during surgery.There was only 1 case of temporary nerve injury in RLN exposure procedure which was probably caused by the postoperative nerve edema and was recovered 2 months after the operation.The total RLN injury rate was 1.35％.Conclusion For benign thyroid lesions and non-dorsal lesions or during partial excision of the gland,the regional protection of RLN is helpful to prevent RLN injury.In cases with dorsal lesions of thyroid or contralateral RLN injury,or during lobe subtotal resection,lobe resection and reoperation,exposing RLN to prevent injury is necessary.Taking different approaches based on the profiles of lesions and surgical procedures to prevent RLN injury can significantly reduce the risk of RLN injury.

Objective To explore the early clinical efficacy of posteromedial approach for treatment of posterior bicondylar tibial plateau fractures.Methods From October 2010 to December 2013,data of 13 patients of posterior bicondylar tibial plateau fracture who were treated with plate and screw fixation through posteromedial approach were retrospectively analyzed.There were8 males and 5 females,in which 7 cases located in the left knee and 6 cases located in the right knee,with an average age of 41.5±6.6 years.An inverted L shaped posteromedial incision was made in the operation.If the fracture line was involving the posteromedial condyle,a locking anatomical plate or L shaped compression plate was used.A 3.5 mm T shaped plate was used to support the posterolateral condyle.Allogeneic bone was used to support the articular surface in the cases with obvious bone defect.Rasmussen score was used for radiological assessment,and HSS knee score was used for efficacy assessment 12 months postoperative.An anteroposterior view and lateral view of the knee were obtained 2,4,12 weeks,6 months and 12 months postoperation.The fracture healing time was judged by X-ray and clinical examinations,additionally,the complications and corresponding outcomes were also recorded.Results All 13 patients had obtained an average of 20.8±9.4 months follow-up (range,8-34 months),and all fractures were healed.The healing time in terms of X-ray was 12 to 24 weeks (mean,15.6±5.2 weeks).After surgery,the Rasmussen score was 1-18 points (mean 15.8 points).7 cases achieved excellent results,4 good,and 2 fair.The excellent and good rate was 84.6％.HSS knee score improved significantly from 38.2±7.8 points (range,26-48 points) to 85.2±7.8 points (range,56-92 points) 12 months postoperation,and the results was excellent in 9 cases,good in 2,fair in 1 and poor in 1,with total excellence and good result of 84.6％.The range of knee activity was 95°-130°.None of the skin and soft tissue complications such as infection,breakage of screw loosening occurred at the time of the latest follow-up,but two cases got chronic pain in the knee postoperation.In the follow-up period,a mild knee gap narrows had been observed in one patient and traumatic arthritis was diagnosed.The pain was partial relieved by oral non-steroidal drugs and intra-articular injection of Sodium Hyaluronate.The other one's pain was significantly relieved by oral non-steroidal drugs,and X ray film shows the knee joint gap has no obvious narrow.Conclusion Posteromedial approach for treatment of posterior bicondylar tibial plateau fractures can obtain a satisfactory therapeutic effect.

AIM:To investigate the effect of batroxobin on thromboxane A 2(TXA 2)level in canine heart ischemia/reperfusion (I/R) injury and the cardioprotective mechanism of batroxobin against I/R injury. METHODS: Canine heart ischemia was induced by ligation of the left anterior descending coronary artery for 30 min followed by 90 min reperfusion.Batroxobin was intravenously administered before heart ischemia and 15 min before reperfusion.The level of plasma thromboxane (TXA 2) ,creatine phosphokinase (CK), lactic dehydrogenase (LDH ) and the concentration of myocardial TXA 2 were measured. The pathological changes in I/R myocardium were observed. RESULTS: In I/R group, TXA 2 levels of both plasma and myocardium increased significantly,and myocardium was injured obviously. Myocyte cells of central zone of I/R heart showed intracellular edema, swollen and damaged mitochondria, and fragmentation of cristae and concentrated nucleus. Plasma CK and LDH level was also elevated. Both ways of batroxobin administration reduced TXA 2 level apparently and plasma CK?LDH were also reduced significantly. LVEDP lowered while +dp/dt max elevated greatly,the mortality of I/R canine reduced obviously. CONCLUSION: Batroxobin decreased TXA 2 levels of both plasma and myocardium significantly, and could afford protection from I/R injury.

Objective:To investigate the clinical effect of percutaneous curved kyphoplasty in the treatment of old osteoporotic vertebral body with endplate fracture.Methods:Clinical data of 58 patients suffering from old osteoporotic vertebral bodies with endplate fractures from January 2018 to January 2020 were analyzed retrospectively. All patients had a single vertebral body fracture and were treated with bilateral injection of bone cement with percutaneous kyphoplasty (PKP). According to the shape of the puncture device, the patients were divided into a curved needle group and a ordinary group. There were 28 cases in the curved needle group, including 7 males and 21 females, aged 60-84 years old, with an average age of 71.8±7.8 years. The distribution of vertebral bodies with fractures: T 11 3 cases, T 12 5 cases, L 1 6 cases, L 2 5 cases, L 3 3 cases, L 4 4 cases, and L 5 2 cases. In the ordinary group, there were 30 cases, 8 males and 22 females, with an average age of 73.2±8.4 years (range, 61-88 years). The vertebral body distribution of fracture: T 11 3 cases, T 12 5 cases, L 1 7 cases, L 2 4 cases, L 3 4 cases, L 4 5 cases, and L 5 2 cases. The surgery time, amount of bone cement injection, and bone cement leakage rate were compared between the two groups, as well as the visual analogue scale (VAS) and Oswestry disability index (ODI) at 1 week, 6 months, and 1 year after surgery. Preoperative and postoperative vertebral midpoint height and kyphosis Cobb angle were measured. Results:All patients were followed up for 12-24 months, with an average of 14.7±2.9 months. The bone cement leakage rate in curved needle group (18%, 5/28) was lower than that in ordinary group (23%, 7/30), but there was no significant statistical difference (χ 2=0.27, P=0.607). The amount of bone cement injection and surgery time in curved needle group (5.0±0.5 ml, 55.2±6.9 min) were significantly higher than those in ordinary group (3.4±0.6 ml, 42.9±3.6 min, P<0.05) . The scores of VAS (2.3±1.0, 2.6±1.5) and ODI (27.5%±9.7%, 28.7%±11.3%) in curved needle group were lower than those in ordinary group (2.7±1.0, 4.5±1.1 and 31.8%±10.5%, 43.1%±13.4%) at 6 months after surgery and at the last follow-up after surgery. In the curved needle group, the Cobb angle was 25.5°±3.5° preoperatively, 18.4°±1.6° postoperatively, and 20.5°±4.9°at the last follow-up. The height of the vertebral body was 14.2±1.9 mm before surgery, 21.5±2.2 mm after surgery, and 20.1±3.6 mm at the last follow-up. Compared with the preoperative results, the kyphosis Cobb angle decreased and the height of the fractured vertebral body increased at the last follow-up, and the differences were statistically significant ( P<0.05). In the ordinary group, the Cobb angle was 24.4°±3.6° preoperatively, 23.1°±4.0° postoperatively, and 27.8°±2.9° at the last follow-up. The height of the vertebral body was 14.5±1.8 mm before surgery, 15.4±2.0 mm after surgery, and 12.7±1.0 mm at the last follow-up. At the last follow-up, the kyphosis Cobb angle increased and the height of the fractured vertebral body decreased compared with preoperative and postoperative 1 week, and the differences were statistically significant ( P<0.05). At 1 week after surgery, 6 months after surgery and the last follow-up, the Cobb angle of curved needle group was lower than that of ordinary group ( P<0.05), the height of vertebral body was higher than that of ordinary group ( P<0.05). Conclusion:Flexible application of percutaneous curved kyphoplasty in the treatment of old osteoporotic vertebral body with endplate fractures can effectively increase the riveting force of bone cement in the vertebral body, restore the height of endplate, and reduce the occurrence of kyphosis and chronic low back pain.

The aim of the research was to investigate the pharmacokinetics (PK) of enteric-coated mycophenolate sodium (EC-MPS) by quantification of the active metabolite of mycophenolic acid (MPA) after multiple escalating oral doses in Han kidney transplant recipients. A total of 28 Han postoperative kidney transplant recipients were given a multiple-dose of 540, 720 or 900 mg of EC-MPS two times a day in combination with tacrolimus for 6 days. Blood specimens were collected at each time point from 0 to 12 h after EC-MPS administration. MPA plasma concentrations were measured by UPLC-UV. The relationship between the EC-MPS dose and its PK parameters was assessed. In the range from 540 to 900 mg,and AUCdid not increase with dose escalation. The AUC,,andfor the 540 720 and 900 mg doses were not significantly different, respectively (>0.05). AUCandwere increased less than proportionally with increasing EC-MPS dose levels. Inter-individual variability in AUC,andwere considerable. Nonlinear PK relationships were found from the doses of 540-900 mg of EC-MPS.

Objective: The aim of this study was to investigate the correlation between different genotypes of CYP2C19, ERCC2 and XRCC1 and clinical indexes of gastroesophageal reflux and hiatal hernia in Xinjiang. Methods: The clinical data of 101 patients with gastroesophageal reflux and hiatal hernia clinically diagnosed by people′s hospital of Xinjiang Uygur Autonomous Region from January 2016 to December 2017 were prospectively studied, and Wilcoxon rank sum test was used to analyze the genotypes and relevant clinical indicators. Results: There was statistically significant difference in the distance of hiatal hernia between patients with CYP2C19 containing A/A homozygous genotype and those with other two genotypes (A/G or G/G) (P<0.05), and there was statistically significant difference in intrabolus pressure (IBP) between patients with G/G homozygous genotype and those with A/G heterozygous genotype (P<0.05). Esophageal sphincter lower esophageal sphincter (LES) residual pressure, LES relaxation rate and percentage of invalid swallowing between patients with ERCC2 containing A/C heterozygous genotype and those with A/A homozygous genotype also has significant statistical difference (P<0.05). The more C contained in the genotype, the lower IBP maximum (on average), and this pattern has statistical significance (P<0.05); There was no statistical difference for all clinical indicators among different XRCC1 genotypes. Conclusions Different genotypes of CYP2C19 and ERCC2 are closely related to the clinical indexes of gastroesophageal reflux and hiatal hernia. CYP2C19 containing A/G or G/G genotype is correlated with gastroesophageal reflux disease (GERD) and the incidence of hiatal hernia. The population containing A/G and G/G genotypes of CYP2C19 may be with a high incidence of hiatal hernia. Homozygous G/G genotype may be a high risk factor for aggravating reflux esophagitis. A/C and C/C genotypes contained in ERCC2 genotype were correlated with the incidence of hiatal hernia. The more C bases contained in ERCC2 genotype, the greater the effect of reducing IBP, indicating that the more C bases contained in ERCC2 genotype may be negatively correlated with the prevalence of hiatal hernia.

This study is to improve the quality standard and supply the scientific basis for Anemarrhenae Rhizoma and its raw processed products. Steroidal saponin including timosaponin BⅡ, timosaponin AⅢ and flavonoids including neomangiferin and mangiferin were selected as the indicative components. Silica gel G thin layer chromatography(TLC) and polyamide TLC were used to detect the two types of compounds, respectively. The contents of timosaponin BⅡ and timosaponin AⅢ were determined by HPLC-ELSD and the content of neomangiferin, mangiferin and isomangiferin were determined by HPLC-UV. Moisture, total ash and acid insoluble ash were determined according to Chinese Pharmacopoeia(2015 edition). And 80% ethanol was selected as the solvent and the content determination of total extract were determined. The fingerprints of Anemarrhenae Rhizoma and its raw processed products were established by HPLC-UV and HPLC-ELSD. The results showed that the methods of TLC and HPLC have been successfully stablished. There are 2 and 3 peaks which have been identified by HPLC-ELSD and HPLC-UV, respectively. The HPLC fingerprint methods are specific and can be used to identify and quality control for Anemarrhenae Rhizoma and its raw processed products in the mass. Comparing to Chinese Pharmacopoeia(2015 edition), the TLC identification and content determination were revised and the total extract determination and HPLC fingerprints were added in the present study. Our results can be used as the scientific basis of quqlity control for Anemarrhenae Rhizoma and its raw processed products.
Anemarrhena ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; Reference Standards ; Rhizome