In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Objective To investigate the relationship between insomnia,gastrointestinal symptoms,and glycosylated hemoglobin(HbA1c)levels in individuals diagnosed with type 2 diabetes mellitus(T2DM),as well as the related influencing factors.Methods A total of 910 T2DM patients treated in our multicenter from January 2022 to December 2022 were enrolled in this study.General information(gender,age,smoking and drinking history,exercise,course of disease,treatment and complications),HbA1c,Athens Insomnia Scale(AIS)scores and Gastrointestinal Symptoms Rating Scale(GSRS)scores of patients were collected.The differences of sleep and gastrointestinal symptoms between groups were analyzed,and the correlation between the differences and HbA1c was analyzed.Furthermore,the risk factors for non-standard HbA1c were analyzed.Results The AIS score and GSRS score in the HbA1c control group were less than those in the non-standard group(P＜0.01).Insomnia was reported by 37.0％of T2DM patients,and the HbA1c level in the insomnia group was significantly higher than that in the non-insomnia group(10.00％±2.38％vs.8.26％±1.73％,P＜0.01).Gastrointestinal symptoms were present in 57.5％of T2DM patients,and the HbA1c levels in the group with gastrointestinal symptoms were significantly higher than those in the group without gastrointestinal symptoms(9.26％±2.23％vs.8.43％±1.98％,P＜0.01).Furthermore,26.3％of T2DM patients experienced both insomnia and gastrointestinal symptoms.Remarkably,the HbA1c levels in the group with both insomnia and gastrointestinal symptoms were significantly higher than those in the group without either condition(10.18％±2.44％vs.8.45％±1.86％,P＜0.01).Correlation analysis demonstrated a significant association between sleep quality,gastrointestinal function,and HbA1c levels(P＜0.01).The logistic regression analysis result revealed that age,GSRS score,AIS score,and the presence of insomnia combined with gastrointestinal symptoms were independent risk factors for predicting HbA1c≥6.5％(P＜0.01).Having both insomnia and gastrointestinal symptoms concurrently was the strongest risk factor for substandard HbA1c control,and the risk of blood sugar control may increase about 5 times when both appear together.Conclusion Insomnia and gastrointestinal symptoms are common comorbidities in T2DM patients,showing a cross-interfering relationship,and they appear together with poor blood sugar control,interact causally,and amplify each other.

Objective To minimize variations in treatment outcomes of L5/S1 percutaneous intervertebral radiofrequency thermocoagulation(PIRFT)arising from physician proficiency and achieve precise quantitative risk assessment of the puncture paths.Methods We used a self-developed deep neural network DWT-UNet for automatic segmentation of the magnetic resonance(MR)images of the L5/S1 segments into 7 key structures:L5,S1,Ilium,Disc,N5,Dura mater,and Skin,based on which a needle insertion path planning environment was modeled.Six hard constraints and 6 soft constraints were proposed based on clinical criteria for needle insertion,and the physician's experience was quantified into weights using the analytic hierarchy process and incorporated into the risk function for needle insertion paths to enhance individual case adaptability.By leveraging the proposed skin entry point sampling sub-algorithm and Kambin's triangle projection area sub-algorithm in conjunction with the analytic hierarchy process,and employing various technologies such as ray tracing,CPU multi-threading,and GPU parallel computing,a puncture path was calculated that not only met clinical hard constraints but also optimized the overall soft constraints.Results A surgical team conducted a subjective evaluation of the 21 needle puncture paths planned by the algorithm,and all the paths met the clinical requirements,with 95.24%of them rated excellent or good.Compared with the physician's planning results,the plans generated by the algorithm showed inferior DIlium,DS1,and Depth(P<0.05)but much better DDura,DL5,DN5,and AKambin(P<0.05).In the 21 cases,the planning time of the algorithm averaged 7.97±3.73 s,much shorter than that by the physicians(typically beyond 10 min).Conclusion The multi-constraint optimal puncture path planning algorithm offers an efficient automated solution for PIRFT of the L5/S1 segments with great potentials for clinical application.

Objective To minimize variations in treatment outcomes of L5/S1 percutaneous intervertebral radiofrequency thermocoagulation(PIRFT)arising from physician proficiency and achieve precise quantitative risk assessment of the puncture paths.Methods We used a self-developed deep neural network DWT-UNet for automatic segmentation of the magnetic resonance(MR)images of the L5/S1 segments into 7 key structures:L5,S1,Ilium,Disc,N5,Dura mater,and Skin,based on which a needle insertion path planning environment was modeled.Six hard constraints and 6 soft constraints were proposed based on clinical criteria for needle insertion,and the physician's experience was quantified into weights using the analytic hierarchy process and incorporated into the risk function for needle insertion paths to enhance individual case adaptability.By leveraging the proposed skin entry point sampling sub-algorithm and Kambin's triangle projection area sub-algorithm in conjunction with the analytic hierarchy process,and employing various technologies such as ray tracing,CPU multi-threading,and GPU parallel computing,a puncture path was calculated that not only met clinical hard constraints but also optimized the overall soft constraints.Results A surgical team conducted a subjective evaluation of the 21 needle puncture paths planned by the algorithm,and all the paths met the clinical requirements,with 95.24%of them rated excellent or good.Compared with the physician's planning results,the plans generated by the algorithm showed inferior DIlium,DS1,and Depth(P<0.05)but much better DDura,DL5,DN5,and AKambin(P<0.05).In the 21 cases,the planning time of the algorithm averaged 7.97±3.73 s,much shorter than that by the physicians(typically beyond 10 min).Conclusion The multi-constraint optimal puncture path planning algorithm offers an efficient automated solution for PIRFT of the L5/S1 segments with great potentials for clinical application.

Humans ; Asthma/drug therapy* ; Biological Therapy

OBJECTIVE：To unscramble the Notice on Standardizing the Allocation and Use of Licensed Pharmacists in Drug Retail Enterprises （called Notice for short ）and related document ，and to give some suggestions to provide reference for the industry and policy decision departments. METHODS ：The background and content of Notice were described briefly ；the problemsexisting in the corresponding provincial differentiated allocation policy and the difficulties existing in the implementation were analyzed to give some relevant suggestions. RESULTS & CONCLUSIONS ：The main contents of Notice contained adhering to the policy of licensed pharmacists ，steadily improving the allocation level of licensed pharmacists ，refining and implementing the allocation requirements ，and strengthening the implementation of supervision and inspection responsibilities ；giving full play to the role of licensed pharmacists and continuously strengthening the team building. At present ，drug administrations of many provinces in China have issued specific policies on the differentiated allocation of licensed pharmacists and pharmaceutical technicians ，which are mainly divided into four schemes. The author believes that the classification method of drug retail enterprises implemented in Shandong and Guangdong provinces are the most scientific. The implementation of differentiated allocation of pharmacists with health（pharmacy）professional title in drug retail enterprises can alleviate the problem of insufficient licensed pharmacists to a certain extent ，but the disadvantage is that it can not achieve accurate registration and control as well as the management of licensed pharmacists ，which is easy to produce policy gaps ；after the “affiliation licensed pharmacist ’s certificate ”phenomenon， the“certificate affiliation of pharmacist with health （pharmacy）professional title ”phenomenon appeared. It is suggested that the provincial drug supervision and administration departments should try the differentiated allocation scheme of hierarchical management；learn from the management experience of licensed pharmacists and pharmaceutical technicians in Guangdong province， develop relevant platforms to manage the information of pharmaceutical technicians uniformly ； strengthen the communication and interaction with the health and human resource security department as well as the mutual promotion mechanism of personnel information screening ，so as to solve the core bottleneck of licensed pharmacists ’quality.

Objective To study the incidence and prevalence in the children aged 1-2 years and 1-6 years with cerebral palsy(CP) in Qinghai province,and to identify the epidemiological characteristics and control status of the children with CP.Methods A stratified cluster random sampling method was used to conduct epidemiological survey of 10 000 children in Qinghai province.Children diagnosed as CP were asked to fill in the CP questionnaires,including children's development,and the status of prevention and treatment of CP.Compared with the children diagnosed as CP,4 healthy children at the same age were asked to fill in the questionnaires related to children's development.SPSS 15.0 statistical software was used for data analysis.Results Seven children with CP were diagnosed at the aged 1-2 years,and the total incidence rate was 3.3‰(7/2 148 cases).The incidence between the urban (0) and the rural areas (12‰) (7/582 cases) was significantly different(P =0.000 1),while there was no significant difference statistically between boys (5 cases) and girls (2 cases) (P ＞ 0.05).Fifty-four children with CP were diagnosed at the age of 1-6 years,and the total prevalence rate was 5.4‰(54/10 000 cases).The prevalence between the urban (2.3‰,17/7 348 cases) and the rural areas (13.9‰,37/2 652 cases) was statistically different (x2 =49.144,P ＜ 0.01),while there was no significant difference statistically between boys (31 cases) and girls (23 cases) (P ＞ 0.05).The proportions of various types of CP were as follows:29 cases(53.70％) of spastic type,9 cases(16.67％) of hypotonia,7 cases (12.96％) of mixed type,4 cases (7.41％) of ataxia,3 cases (5.56％) of rigidity and2 cases (3.70％) of dyskinetic,respectively.Among the spastic types,there were 16 cases (55.17％)of spastic quadriplegia,6 cases (20.69％) of spastic hemiplegia,4 cases (13.79 ％) of spastic diplegia,2 cases (6.89 ％) of spastic monoplegia and 1 case (3.45％) of spastic triplegia,respectively.The top three risk factors were premature (13 cases,24.1％),hypoxic-ischemic encephalopathy (9 cases,16.7％) and maternal threatened abortion (8 cases,14.8％).The first three complications were mental retardation,language dysfunction and epilepsy.Conclusions The incidence and prevalence of CP in children in Qinghai province are very high,which is higher in the rural areas than that in the urban areas.The most common CP is spastic type.The main risk factors for CP are preterm labor,hypoxic-ischemic encephalopathy and maternal threatened abortion.Intellectual disability,speech disability and epilepsy are the most common complications of CP.Maternal and perinatal infant health care and early intervention need to be further strengthened.

OBJECTIVE:To establish HPLC fingerprint for the leaves of Camptotheca acuminante in Guizhou.METHODS:HPLC method was performed.The determination was performed on Gemini-NX C18 column with mobile phase consisted of acetonitrile-0.2％ phosphoric acid (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelength was set at 370 ran,and the column temperature maintained at 30 2.The sample size was 10 μtL.Using sorbitol as a reference,HPLC fingerprints of 14 batches of the leaves of C.acuminante were determined.The chromatographic fingerprint was analyzed with Similarity Evaluation System for Chromatographic Fingerprint of TCM (2004 A) in terms of common peak indentification,similarity evaluation and cluster analysis.RESULTS:There were 10 common peaks in HPLC fingerprints for 14 batches of the leaves of C.acuminate.And the similarity of 13 batches of the leaves of C.acuminate was greater than 0.90,and that of another one was less than 0.90.The leaves of C.acuminate were classified into 3 groups.CONCLUSIONS:The established fingerprint can provide reference for identification and quality evaluation of the leaves of C.acuminate.

OBJECTIVE: To evaluate image quality of female pelvic computed tomography (CT) scans reconstructed with the adaptive statistical iterative reconstruction (ASIR) technique combined with low tube-voltage and to explore the feasibility of its clinical application. MATERIALS AND METHODS: Ninety-four patients were divided into two groups. The study group used 100 kVp, and images were reconstructed with 30%, 50%, 70%, and 90% ASIR. The control group used 120 kVp, and images were reconstructed with 30% ASIR. The noise index was 15 for the study group and 11 for the control group. The CT values and noise levels of different tissues were measured. The contrast to noise ratio (CNR) was calculated. A subjective evaluation was carried out by two experienced radiologists. The CT dose index volume (CTDIvol) was recorded. RESULTS: A 44.7% reduction in CTDIvol was observed in the study group (8.18 +/- 3.58 mGy) compared with that in the control group (14.78 +/- 6.15 mGy). No significant differences were observed in the tissue noise levels and CNR values between the 70% ASIR group and the control group (p = 0.068-1.000). The subjective scores indicated that visibility of small structures, diagnostic confidence, and the overall image quality score in the 70% ASIR group was the best, and were similar to those in the control group (1.87 vs. 1.79, 1.26 vs. 1.28, and 4.53 vs. 4.57; p = 0.122-0.585). No significant difference in diagnostic accuracy was detected between the study group and the control group (42/47 vs. 43/47, p = 1.000). CONCLUSION: Low tube-voltage combined with automatic tube current modulation and 70% ASIR allowed the low CT radiation dose to be reduced by 44.7% without losing image quality on female pelvic scan.
Adult ; Aged ; Body Mass Index ; Feasibility Studies ; Female ; Genital Diseases, Female/diagnosis/*radiography ; Humans ; Middle Aged ; Pelvis/*radiography ; Radiation Dosage ; Radiographic Image Interpretation, Computer-Assisted ; Signal-To-Noise Ratio ; *Tomography, X-Ray Computed

BACKGROUND:Chronic visceral pain is one of major complaints of irritable bowel syndrome which seriously affects patient’s quality of life. Recent researches have shown that moxibustion therapy has positive effects on aleviating chronic visceral pain in irritable bowel syndrome patients.
OBJECTIVE: To study the clinical utility of moxibustion in coping with chronic visceral pain of irritable bowel syndrome patients, and shed light on the theoretical basis of moxibustion analgesia, thereby to give insights into the further research and application on moxibustion.
METHODS: With the key words of “moxibustion, irritable bowel syndrome, visceral pain, abdominal pain” in Chinese and in English, respectively, a computer-based search was performed in CNKI, VIP, Wanfang and PubMed databases for articles published from January 1990 to October 2014. After the initial screening, the remained articles went through further selection and categorization.
RESULTS AND CONCLUSION:The result shows promising results of moxibustion on relieving chronic visceral pain for both two subtypes of irritable bowel syndrome patients, diarrhea type and constipation type. Moxibustion may exert an analgesic effect on chronic visceral pain in irritable bowel syndrome patients through regulation of visceral hypersensitivity, gastrointestinal motility disorders, brain-gut axis and neuroendocrine system disorders, immune dysfunction and low-grade inflammation in the gut, psychological abnormalities, and alteration of intestinal flora. However, to fuly understand the analgesia effect of moxibustion and elucidate its mechanism, more standardized randomized controled trials employing advanced scientific techniques and equipments wil stil be needed in the future.