Drugs under special management include narcotic drugs,psychotropic drugs,toxic drugs for medical use,radiopharmaceuticals,and pharmaceutical precursor chemicals.Supervising and guiding the clinical use of drugs under special management is one of the important responsibilities of the Pharmaceutical Management and Drug Therapy Committee(Group)of medical institutions.The standard for drugs under special management is led by the Pharmaceutical Professional Committee of the China Hospital Association,which standardizes 16 key elements of organizational management,process management,and quality control management drugs under special management in medical institutions.It can guide the standardized implementation of Pharmaceuticals under special control work in various levels and types of medical institutions.This article elaborates on the methods and contents of formulating standards for Pharmaceuticals under special management,to provide reference and inspiration for medical institutions to carry out special drug drug management and daily related work.

Objective:To compare the effectiveness of areola approach endoscopic thyroidectomy (AET) and conventional open thyroidectomy (OT) in treating papillary thyroid carcinoma.Methods:Four hundred and twenty-eight female patients with papillary thyroid carcinoma who were treated at the Department of General Surgery, Beijing Friendship Hospital between January 2017 and January 2020 were included according to the inclusion and exclusion criteria, of whom 183 underwent AET (AET group) and 245 underwent OT (OT group). Direct comparison and subsequent propensity score matching methodology were utilized to compare the differences between the two operation methods in terms of surgical time, intraoperative parathyroid transplantation rate, intraoperative nerve injury, postoperative complications, reoperation rate, number of lymph node dissections, postoperative lymph node metastasis at 2 years, and route tumor implantation. Data analysis was performed by using SPSS 25.0 software. The metric data of normal distribution was represented by mean ± standard deviation ( ± s), and the t-test was used for between-group comparison. The Chi-test was used for between-group comparison of count data. Results:The AET group had an age of (38.89±9.08) years, weight of (62.10±10.45) kg, and height of (161.97±5.31) cm; the OT group had an age of (45.88±12.47) years, weight of (65.11±12.72) kg, and height of (161.62±5.24) cm. The differences in age, weight, and body mass index between the two groups were statistically significant ( P<0.05). The surgical time in the AET group was (183.00±137.22) min, which was significantly longer than (87.94±28.25) min of the OT group ( t=16.67, P<0.001). The parathyroid transplantation rate in the OT group was significantly higher than that in the AET group (49.39% vs 34.97%, χ2=8.87, P=0.003). There were no statistically significant differences between the two groups in terms of intraoperative nerve injury, postoperative complications, reoperation rate, number of lymph node dissections, postoperative lymph node metastasis at 2 years, and route tumor implantation. After propensity score matching based on differences in age, weight, body mass index, and soon, 183 cases of AET (AET-PS group) and OT (OT-PS group) were obtained for statistical analysis. The surgical time in the AET-PS group was (137.22±32.77) min, which was significantly longer than (90.26±29.35) min of the OT-PS group ( t=14.44, P<0.001). The parathyroid transplantation rate in the OT-PS group was significantly higher than that in the AET-PS group (53.01% vs. 34.97%, χ2=12.08, P=0.001). There were no statistically significant differences between the two groups in terms of intraoperative nerve injury, postoperative complications, reoperation rate, number of lymph node dissections, postoperative lymph node metastasis at 2 years, and route tumor implantation. Conclusions:AET and OT are equally safe and effective in treating papillary thyroid carcinoma. AET surgery can be performed safely and feasibly under strict adherence to surgical principles.

Objective:To summarize the surgical experience of carotid body tumor (CBT)and analyze the risk factors.Methods:The clinical and follow-up data of 133 patients with carotid body tumor undergoing surgery at the First Medical Center of PLA General Hospital from Nov 2005 to Apr 2019 were retrospectively analyzed.Results:All of 142 tumors were successfully resected. No patients died perioperatively. Thirty-three (23.2%) cases underwent simple tumor resection, 82 (57.8%) cases underuent tumor resection combined with external carotid artery ligation, 13 (9.2%) cases did internal carotid artery reconstruction, 10 (7.0%) cases had total or external carotid artery repairment, and 4 (2.8%) cases underwent total or internal carotid artery ligation. There were 53 complications, including 43 cases of cranial nerve injury, with an average operating time of 161min (60-500 min), an average blood loss of 308 ml (20-3 000 ml). The follow-up time ranged from 1 to 162 months. No death occurred during the follow-up period.Conclusions:Tumor size and Shamblin typing are surgical risk factors. Most of ShamblinⅠtype tumor can do simple resection, but type Ⅱ and Ⅲ often need to ligate the external carotid artery. Use of great saphenous vein has a favorable long-term patency rate.

Objective:To investigate the clinicopathological characteristics and prognostic factors of Siewert Ⅱ and Ⅲ adenocarcinoma of esophagogastric junction (AEG).Methods:The retrospetcive cohort study was conducted. The clinicopathological data of 399 patients with AEG who were admitted to Peking University People′s Hospital from January 1998 to December 2015 were collected. There were 318 males and 81 females, aged 66(range, 19-87)years. Observation indicators: (1) clinicopathological characteristics of Siewert Ⅱ and Ⅲ AEG; (2) follow-up and survival; (3) prognostic factors analysis. Patients were followed up by telephone interview and outpatient examination to detect postoperative survival up to December 2018. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Kaplan-Meier method was used to draw survival curves and calculate survival rates. Log-rank test was used for survival analysis. Univariate and multivariate analyses were done using the COX proportional hazard model. Results:(1) Clinicopathological characteristics of Siewert Ⅱ and Ⅲ AEG. Of 399 patients, 198 cases were Siewert Ⅱ AEG and 201 cases were Siewert Ⅲ AEG. There were 130 cases undergoing transthoracic radical AEG surgery, 172 cases undergoing trans-abdominal proximal gastrectomy and 97 cases undergoing transabdominal total gastrectomy. The age, tumor diameter, cases with surgical method as transthoracic radical AEG surgery, transabdo-minal proximal gastrectomy and transabdominal total gastrectomy, the number of positive lymph nodes, cases in tumor TNM stage Ⅰ, Ⅱ, Ⅲ, Ⅳ were (65±10)years, (5.1±2.4)cm, 102, 68, 28, 17(range, 12?22), 20, 57, 117, 4 for patients with Siewert Ⅱ AEG, versus (62±12)years, (6.3±3.2)cm, 28, 104, 69,18(range, 14?27), 16, 41, 134, 10 for patients with Siewert Ⅲ AEG, showing significant differ-ences betweeen them ( t=2.83, ?3.82, χ2=66.97, U=17 407.05, 17 532.00, P<0.05). (2) Follow-up and survival. All 399 patients were followed up for 34(range, 2?160)months. The 5-year overall survival rate was 29.3% for patients with Siewert Ⅱ AEG, versus 37.0% for patients with Siewert Ⅲ AEG, showing no significant difference betweeen them ( χ2=1.46, P>0.05). The median survival time and 5-year overall survival rate were 29.0 months [95% confidence interval ( CI) as 23.4?34.6 months] and 22.9% for patients undergoing transthoracic radical AEG surgery, 43.0 months(95% CI as 33.9?52.1 months) and 34.7% for patients undergoing transabdominal proximal gastrectomy, 54.0 months (95% CI as 37.6?70.4 months)and 44.3% for patients undergoing transabdominal total gastrectomy, showing a significant difference in the survival among the 3 groups ( χ2=13.81, P<0.05). Of the 198 Siewert Ⅱ AEG patients, the 5-year overall survival rate was 24.6% for the 96 patients undergoing transabdominal surgery, versus 35.4% for the 102 patients undergoing transthoracic surgery, showing no significant difference in the survival between them ( χ2=3.10, P>0.05). Of the 201 Siewert Ⅲ AEG patients, the 5-year overall survival rate was 40.0% for the 173 patients undergoing transabdominal surgery, versus 16.1% for the 28 patients undergoing transthoracic surgery, showing a significant difference between them ( χ2=11.32, P<0.05). (3) Prognostic factors analysis. Results of univariate analysis showed that surgical method, pathological N staging, patholgical M staging were related factors for prognosis of Siewert Ⅱ and Ⅲ AEG ( hazard ratio=0.68, 1.25, 2.18, 95% CI as 0.54?0.86, 1.15?1.36, 1.28?3.73, P<0.05). Results of multivariate analysis showed that transthoracic approach, pathological stage N2?N3 and pathological stage M1 were independent risk factors for prognosis of Siewert Ⅱ and Ⅲ AEG ( hazard ratio=0.64, 1.25, 2.18, 95% CI as 0.51?0.80, 1.16?1.35, 1.28?3.70, P<0.05). Conclusions:Compared with Siewert Ⅲ AEG, Siewert Ⅱ AEG has a smaller tumor diameter, less positive lymph nodes, poorer prognosis. Transthoracic approach is preffered for the Siewert Ⅱ AEG. Transthoracic approach, pathological stage N2?N3 and pathological stage M1 are independent risk factors for prognosis of Siewert Ⅱ and Ⅲ AEG.

Objective:To summarize the midterm to long-term outcomes and experiences of endovascular treatment (ET) of spontaneous isolated superior mesenteric artery dissection (SISMAD).Methods:The clinical data of 31 SISMAD patients from Jan 2011 to Dec 2019 treated with ET was retrospectively analyzed.Results:Successful ET was achieved in 29 patients with a technical success rate of 93.5%. A total of 36 self-expandable bare stents were planted in 28 patients and plain old balloon angioplastry (POBA) was performed in 1 patient. Abdominal pain disappeared within 24 hours in 89.3% of the patients after stenting. The rate of perioperative complication was 3.2%. There was no SMA dissection rupture bleeding, nor perioperative death occurred. The mean follow-up time was 53.5 (range, 6 to 110) months. There was no dissecting aneurysm formation, no SMA rupture and bleeding, and no stent rupture during the follow-up. The post ET 1-year, 3-year, and 5-year free from reintervention rate were 100%, 100%, and 91.7%, respectively.Conclusions:ET for SISMAD is safe and effective with satisfactory perioperative and midterm to long-term outcomes.

[摘 要] 目的：探讨miR-125a-5p通过调控Bcl-2相关永生基因4（Bcl-2-associated athanogene 4，BAG4）的表达抑制胃癌细胞迁移和侵袭的分子机制。方法：选用2014年1月至2015年12月兰州大学第一医院手术切除的82例胃癌组织标本及配对的癌旁组织以及人胃癌细胞系MGC803、BGC823、SGC7901、HGC27及人胃黏膜上皮细胞（GES-1），qPCR法检测胃癌组织、癌旁组织及胃癌细胞系中miR-125a-5p的表达水平。分别将miR-125a-5p mimic、miR-125a-5p inhibitor、（si-BAG4）siRNA-BAG4及阴性对照质粒转染至胃癌细胞，划痕愈合实验和Transwell侵袭实验分别检测miR-125a-5p/BAG4信号轴对胃癌细胞迁移和侵袭能力的影响。WB检测胃癌细胞中BAG4蛋白的表达。荧光素酶报告基因实验验证miR-125a-5p和BAG4之间的靶向调控关系。结果：miR-125a-5p在胃癌组织和细胞系中均低表达（均P<0.01）。miR-125a-5p的表达与患者的性别（P=0.953）、年龄（P=0.772）、肿瘤部位(P=0.867)、组织学分级（P=0.745）和肿瘤大小（P=0.088）无相关性，与胃癌患者的T分期（P=0.003）、N分期（P=0.001）、M分期（P=0.027）和TNM分期（P=0.035）显著相关，差异有统计学意义。miR-125a-5p低表达是胃癌患者总生存时间的独立危险因素。过表达miR-125a-5p显著抑制胃癌细胞的迁移和侵袭能力（均P<0.01）。敲降BAG4可逆转miR-125a-5p inhibitor对胃癌细胞迁移和侵袭能力的抑制作用。荧光素酶报告基因实验证实miR-125a-5p可与BAG4 3'非翻译区（untranslated regions，UTR）结合抑制其表达。结论：miR-125a-5p通过靶向下调BAG4的表达水平进而抑制胃癌细胞的迁移和侵袭。

Objective:To investigate the value of brainstem auditory evoked potential (BAEPs) combined with cochlear electrogram (ECochG) monitoring in the protection of auditory function during microvascular decompression (MVD) for patients with facial spasm (HFS).Methods:Clinical data of 908 patients with HFS who received MVD treatment in our hospital from January 2018 to December 2020 were retrospectively analyzed. The patients were divided into BAEPs group ( n=309), ECochG group ( n=301) and BAEPs+ECochG group ( n=298) according to the different methods of auditory nerve function monitoring. Waveform extraction rate, mean extraction time, amplitude, latency, intraoperative warning effect of 3 monitoring methods, as well as hearing status immediately after surgery and during follow-up were compared in patents from the 3 groups. Results:(1) The overall waveform extraction rate in ECochG group and BAEPs+ECochG group was significantly higher than that in BAEPs group, and the average waveform extraction time in ECochG group and BAEPs+ECochG group was significantly shorter than that in BAEPs group ( P<0.05). The amplitude of compound action potential (CAP) wave in ECochG group was significantly higher than that of V wave in BAEPs group, and the latency of CAP wave was also significantly earlier than that of V wave ( P< 0.05). (2) A total of 48 patients of the 288 patients in the BAEPs group showed warning signs; a total of 73 of the 292 patients in the ECochG group showed warning signs; and a total of 65 of the 292 patients in the BAEPs+ECochG group showed warning signs. (3) There was significant difference in hearing grading (American Association of Otolaryngology Head and Neck Surgery [AAO-HNS] grading) among the 3 groups immediately after surgery ( H=18.041, P=0.000), and the average rank suggested that the hearing of patients in the BAEPs+ECochG group was superior to the other two groups. All patients were followed up for an average of 15 months (ranged 3-24 months); there was still a significant difference in AAO-HNS grading among the 3 groups ( H=29.625, P=0.000), and the hearing of patients in the BAEPs+ECochG group was still superior to the other two groups. Conclusion:The combined application of ECochG and BAEPs monitoring can reflect the changes of intraoperative hearing impairment comprehensively, accurately and timely, which is of great significance for the protection of auditory function in HFS patients during MVD.

Objective To investigate the safety and mid-term efficacy of percutaneous endovascular angioplasty(PTA) and stent implantation for transplantation renal arterial stenosis (TRAS).Methods Retrospective analysis was performed on 18 patients with TRAS admitted to of department vascular surgery,PLA General Hospital from Jan 2011 to Dec 2018.Results PTA and stent implantation were performed in all 18 patients via ipsilateral or contralateral femoral artery including 4 cases of PTA alone,8 cases of PTA plus stent,6 cases of stent implanted directly.Three of the 18 patients underwent ipsilateral femoral artery catheterization and 15 underwent contralaterally.A total of 14 stents were implanted,all of were balloon expanding stents,of which 2 were drug-coated stents,and the technical success rate was 100％.The average dosage of contrast agent was 64 ml,the stenosis rate of renal artery before interventional treatment was 50％-99％,and that after interventional treatment reduced to 10％-30％.The systolic blood pressure decreased from (157.2 ± 43.0) mmHg preoperatively to (129.8 ± 8.6) mmHg postoperatively.The SCr level decreased from (258.8 ± 214.7) μ mol/L to (176.3 ± 101.1) μmol/L.Preoperative urea nitrogen decreased from (15.7 ± 1.6) mmol/L to (10.6 ± 1.1) mmol/L postoperatively (P ＜ 0.05).Mean postoperative follow-up time was 42.4 months (3-93 months).17 cases were cured,1 case was ineffective,1 case suffered restenosis after 30 days,and was given remedy PTA plus stenting.Conclusions TRAS is a vascular factor leading to grafted renal failure,the endovascular treatment of TRAS is safe,effective and has good mid-term result.

Objective: To evaluate the safety and efficacy of the drug coated balloon(DCB) for complex TASC C/D superficial femora-popliteal artery diseases. Methods: Patency, target lesion revascularization (TLR) rate, clinical improvement and safety endpoints of femora-popliteal lesions in 68 patients from PLA General Hospital treated with DCB were retrospectively analyzed from June 2016 to June 2018. The mean age of the patients were (72.7±13.2) years old. Rutherford categories were from 2 to 5, and ABI baseline were 0.56±0.22. Results: There were 76 limbs treated by DCB in total in this study. Mean lesion length was (26.7±15.3) cm. 73.6% of lesions were totally occluded, 26.4% were of stenosis and 61.8% were highly calcified. Stent implantation was performed in 36.8% cases. Kaplan Meier estimates of primary patency were 74.2%±7.6% and 67.7%±6.4% at 1 and 2 years, respectively, whereas freedom from TLR was 81.4%±5.1% and 73.6%±5.4%. ABI were 0.83±0.16 at 1 year, and 0.79±0.24 at 2 years. Major amputation rate was 2.9% and mortality rate was 2.9% and 4.4% at 1 year and 2 years respectively. Diabetes, highly calcification, renal insufficiency and re-stenotic lesions were identified as predictors of restenosis. Conclusions DCB are safe and effective in delaying restenosis in complex TASC C/D superficial femora-popliteal artery disease as found by midterm follow-up.

B lymphocytes are not the only source of Igs,instead,various non-B cell types,including the normal epithelial cells and cancer cells,also own the ability to produce different types of Igs.The non-B cell derived Igs possess their own characteristics.For instance,they are highly conserved in V (D)J rearrangement patterns;each Ig has its own rearrangement pattern of the variable region of IgH.The non-B Igs are closely related with tumors.They are highly expressed in different tumors,including clear cell renal cell carcinoma,lung cancer,breast cancer,and they act as a tumor promoter through different mechanisms.As to the digestive system tumors,several digestive organs or their corresponding tumors could produce Igs,such as stomach,liver,pancreas,small intestine and colon.The Igs derived from these organs may participate in the innate immune responses,as well as the tumorigenesis processes.A more detailed study on the non-B cell derived Igs may provide new therapeutic targets for malignant tumors,including tumors from digestive system.