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.

Purpose: This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice. Materials and Methods: This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety. Results: A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%). Conclusion Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.

Guided by the emphasis on learning process, the educational reform has designed a "trinity" comprehensive evaluation system (quantitative clinical practice, in-class medical record analysis, and staged comprehensive written test) as the formative evaluation of the course. Through this assessment system, students' self-learning potential is stimulated, clinical skills practice is strengthened, and "taking exams to promote learning and taking exams to promote teaching" is realized. In the practice of teaching reform, it has been found that compared with the conventional teaching class, the students in the teaching reform class have higher participation and are more satisfied with the process assessment of the "trinity" comprehensive evaluation system.

Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) has become the standard first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with EGFR-sensitive mutations. However, acquired resistance cannot be avoided during the targeted treatment of EGFR-TKI, which may lead to the progression of NSCLC. Among them, approximately 50% of patients present with primary lung lesions and/or initial metastastic lesion progression. As a major local treatment, radiation therapy plays an irreplaceable role in the management of patients with advanced cancer. Stereotactic body radiation therapy (SBRT), which is implemented with the Cyberknife, is the most advanced radiation therapy technology to better meet clinical needs. In recent years, based on the abovementioned patterns of tumor recurrence, the treatment mode of pulmonary-lesion SBRT combined with EGFR-TKI can improve the tumor-free survival in advanced NSCLC patients, which has attracted widespread attention. In this article, the clinical research progresses on this combined therapeutic strategy were reviewed.

Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.

Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.

OBJECTIVETo systematically evaluate the efficacy and safety of acupuncture on diarrhea-predominant irritable bowel syndrome (IBS) in the past five years.

METHODSOnline databases, including CNKI, VIP, WANFANG, PubMed, CBM, ScienceDirect OnSite, Cochrane Library, etc. were searched for randomized controlled trials (RCTs) of acupuncture for diarrhea-predominant IBS. Retrieval time was from January of 2011 to January of 2016. According to modified Jadad standard, the bias risk and quality assessment of each RCT included were evaluated by two researchers. RevMan 5.3 software was adopted for the meta-analysis.

RESULTSTotally 17 RCTs were included with 1 333 patients. The result of meta-analysis indicated the total effective rate of clinical symptoms improvement in the acupuncture group or acupuncture combined with western medicine group was superior to that in the western medicine group (=3.92, 95%:2.83~5.43,<0.01), and the funnel plot was basically symmetry. The result of meta-analysis showed 3-month recurrence rate:=0.22, 95%:0.12~0.41 (<0.01), indicating the recurrence rate in the acupuncture group was lower than that in the western medicine group in three month.

CONCLUSIONSAcupuncture for diarrhea-predominant irritable bowel syndrome is superior to conventional treatment of western medication, which can improve the clinical symptoms and reduce the recurrence rate of patients.

Objective:To study the solubility of repaglinide in meglumine aqueous solution. Methods: In order to increase the solubility of repaglinide, meglumine was used to react with repaglinide and obtain a molecular complex. The structure and composition of meglumine-repaglinide complex was analyzed by DSC, HPLC and HPLC-MS. Results:Meglumine and repaglinide formed a molecu-lar complex, and their best molar ratio was 1 ∶1. With the concentration increase of meglumine, the solubility of repaglinide also in-creased. The stability of molecular complexes decreased with the temperature increase. Conclusion:Meglumine plays a good role in the solubilization of repaglinide.

Objective:To explore advantage of intravascular ultrasound (IVUS) guiding coronary intervention .Meth‐ods:A total of 100 patients with left main (LM) lesion were selected and equally divided into IVUS group (n=50 , received stent implantation under IVUS guidance ) and control group [n=50 ,received stent implantation after coro‐nary angiography (CAG) evaluation without IVUS examination ) .Instant condition after stent implantation and fol‐low-up results after 12 months were compared between two groups .Results:There were no significant difference in general data ,percentages of LM opening ,body part and tail lesions ,different types of plaques between two groups , P>0.05 all .During hospitalization ,there were no significant difference in percentage of emergency coro‐nary artery bypass grafting (0% vs .4% ) and mortality (0% vs .4% ) between IVUS group and control group (P>0.05) .However ,after 12 months ,compared with control group ,there were significant reductions in incidence rates of in-stent restenosis (16% vs .4% ) and late stent malapposition (34% vs .6% ) in IVUS group , P< 0.05 ,<0.01. Conclusion:IVUS guiding left main lesion intervention is helps to select more appropriate therapeutic plan , reduce tissue injury and improve long -term therapeutic effect .

Objective:To explore influence of risk factors of ischemic cerebral stroke (ICS)on its onset.Methods:A total of 350 patients diagnosed as ICS were selected as stroke group among 12241 >40 years people from Dongli dis- trict of Harbin city,another 350 >40 years non-ICS people,who were randomly selected from the same district, were enrolled as control group.ICS risk factors were compared between two groups,multi-factor Logistic regres- sion analysis was used to analyze independent risk factors for ICS.Results:(1)There were no significant difference in age,nationality,education,marriage and professions between two groups except food taste (P<0.01); (2) Multifactor Logistic regression analysis indicated that hypertension (OR=5.853,95%CI:3.188~10.673),hyper- lipidemia (OR=5.601,95%CI:2.378~ 9.635),carotid artery plaque (OR=4.963,95%CI:2.350~9.843), heart disease (OR=4.568,95%CI:2.535~7.745),hyperhomocysteinemia (OR=4.076,95%CI:3.001~8.270), apparent overweight (OR=3.421,95%CI:1.598~6.476)and family history of cerebrovascular diseases (OR=3.065,95%CI:2.543~4.236)were independent risk factors for ICS in both groups (P<0.01 all).According to OR value from big to small,risk factors for ICS were hypertension,hyperlipidemia,carotid artery plaque,heart disease,hyperhomocysteinemia,apparent weight and family history of cerebrovascular diseases respectively.Conclu-sion:Besides traditional risk factors like hypertension,dyslipidemia and family history of cerebrovascular diseases, other risk factors such as carotid artery plaque,heart disease,family history of cerebrovascular disease and apparent overweight are also important risk factors for stroke.