1.Research on the standardization of “Indications”in package inserts for Chinese patent medicines
Meiwei ZHANG ; Keqian LI ; Keyu YAO ; Yan ZHU
China Pharmacy 2025;36(5):513-518
OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia (Volume Ⅰ) and various national and regional standards. Identification criteria were established for syndrome, pathogenesis, disease name, and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements, followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these, the majority (7 991) contained symptom terminology, followed by disease names (5 867) and pathogenesis descriptions (5 167). Within disease name terminology, Western medical disease names predominated (4 446), followed by traditional Chinese medicine disease names (2 018). The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably, the secondary classifications of “disease name”, as well as the tertiary classification of “disease name+symptoms” and “symptoms”, failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome:“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information, adhere to standardized formatting, and employ appropriate conjunctions and punctuation. For non-prescription patent medicines, package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.
2.Clinical study on Qigong Pills combined with IVF-ET technique in the treatment of PCOS infertility with phlegm-dampness type
Meiwei ZHANG ; Wenqing YIN ; Xiaoxia LI ; Yan ZHAO ; Lei WANG
International Journal of Traditional Chinese Medicine 2025;47(5):601-606
Objective:To explore the effects and safety of Qigong Pills in IVF-ET outcome of PCOS infertility patients with phlegm-dampness type.Methods:A randomized controlled trial study was carried out. In the Reproductive and Genetic Medicine Center of Dalian Women and Children Medical Center (Group) from January 2021 to December 2023, 60 patients with sputum and damp-induced PCOS infertility assisted by in-vitro fertilization and embryo transfer (IVF-ET) were enrolled and randomly divided into 2 groups by block randomization method, with 30 cases in each group. Patients in both groups took ethinylestradiol cyproterone tablets orally on the 2nd to 5th day of the 1st menstrual cycle before IVF-ET cycle, and received down-regulation treatment on the 18th to 20th day of menstruation. After confirming that the down-regulation standard was reached, Qigong Pills was added to the treatment group, and placebo was taken orally until the trigger day. Two groups of patients underwent transvaginal ultrasound-guided ovarian aspiration after injection of chorionic gonadotropin (hCG) for 24-36 h. The total amount of Gn, the days of Gn, the endometrial thickness of HCG, the number of eggs obtained, the rate of diprokaryotic (2PN) fertilization, the number of transferable embryos, the number of high-quality embryos, the rate of high-quality embryos, the incidence of OHSS and the clinical pregnancy rate were compared between the two groups.Results:Among the 60 patients, 28 cases in the final treatment group and 27 cases in the control group were included in the outcome index evaluation. During controlled hyperstimulation (COH), the total Gn [2 025 (1 575, 2 325) U vs. 2 700 (2 025, 3 150) U, Z=-3.67] and the number of Gn days of the treatment group [10 (8,11) d vs. 11 (9,13) d, Z=-2.31] were lower than those in control group ( P<0.001 or P<0.05). There was no statistical significance in endometrial thickness between 2 groups on HCG day ( P>0.05); the number of high-quality embryos [3 (3, 4) vs. 2 (2, 3), Z=0.11] and the rate of high-quality embryos [46.28% (87/188) vs. 35.19% (57/162), Z=4.42] in the treatment group were higher than those in the control group ( P<0.05). There was no statistical significance in the number of eggs obtained, the fertilization rate of 2PN and the number of transferable embryos between the two groups ( P>0.05). The incidence of OHSS was 3.6% (1/28) in the treatment group and 11.1% (3/27) in the control group, without statistical significance ( P=0.352). The clinical pregnancy rate was 53.6% (15/28) in the treatment group and 37.0% (10/27) in the control group, without statistical significance ( P=0.218). There was no significant difference in the safety indexes of liver and kidney function between 2 groups ( P>0.05). Conclusion:Qigong Pills combined with IVF-ET can effectively reduce the total amount of Gn and the number of days of treatment in PCOS infertility patients with phlegm-dampness type, increase the number and rate of high-quality embryos, and improve the outcome of IVF-ET, and it is safe and effective.
3.Yang Jun's Clinical Experience in Refined Direct Moxibustion for Treating Functional Dyspepsia of Stuffiness-Fullness Type
Meiwei LI ; Jinjin ZHENG ; Xin WANG ; Wei AN ; Chenhui GAO ; Lan MEI ; Qingping ZHANG ; Jun YANG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(7):1713-1718
This article systematically summarizes the clinical experience of Professor Yang Jun,a nationally renowned traditional Chinese medicine(TCM)physician,in applying refined direct moxibustion(applying a moxibustion pen made by Chinese medical extract)to treat functional dyspepsia(FD)of the stuffiness-fullness type.Based on decades of clinical practice,Professor Yang innovatively established a moxibustion therapy system for FD,which centers on TCM syndrome differentiation and treatment.The system emphasizes the refined identification of epigastric stuffiness and fullness syndrome,particularly focusing on the relative significance of abdominal distension and poor appetite.Its therapeutic features lie in establishing the principle of"prioritizing mind regulation while holistically harmonizing body and spirit",combined with personalized moxibustion dosage control and a unique refined direct moxibustion technique.By optimizing the configuration of each step in moxibustion therapy,the system maximizes therapeutic efficacy,providing novel theoretical foundations and clinical strategies for moxibustion treatment of stuffiness-fullness type of FD.
4.Yang Jun's Clinical Experience in Treating Bronchial Asthma with Warming Needle Moxibustion via Governor Vessel-Unblocking and Conception Vessel-Regulating Method
Wei AN ; Jinjin ZHENG ; Meiwei LI ; Lan MEI ; Chenhui GAO ; Ming ZHANG ; Qingping ZHANG ; Jun YANG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(10):2509-2513
This article introduces Professor Yang Jun's clinical experience in treating bronchial asthma using warming needle moxibustion via the governor vessel-unblocking and conception vessel-regulating method.Professor Yang posits that asthma pathogenesis-whether triggered by internal imbalances or external pathogens-ultimately stems from yin-yang disharmony leading to rebellious lung qi and impaired diffusion/descending functions.Thus,restoring dynamic yin-yang balance constitutes the core therapeutic principle.As the governor and conception vessels govern the body's yin-yang regulation,Professor Yang's decades of clinical practice substantiate that"harmonizing these vessels determines life's vitality".His protocol combines warming needle moxibustion with press needles to activate governor-conception vessel functions,achieving five therapeutic effects:(1)yin-yang harmonization,(2)qi movement regulation,(3)meridian unblocking,(4)visceral stabilization,and(5)pathogen elimination,demonstrating remarkable efficacy.
5.Screening the immunophenotypic characteristics of acute promyelocytic leukemia by multiparameter flow cytometry
Ting LI ; Ping WU ; Man CHEN ; Aixian WANG ; Minjing FU ; Xueying WU ; Junyi ZHEN ; Meiwei GONG ; Hui WANG
Chinese Journal of Laboratory Medicine 2024;47(7):747-754
Objective:To explore and screen the immunophenotypic characteristics of acute promyelocytic leukemia (APL) by multiparameter flow cytometry (MFC).Methods:A retrospective and descriptive study. A total of 130 acute myeloid leukemia (AML) patients who registrated in Hebei Yanda Lu Daopei Hospital were studied, among which there were 44 classical APL (cAPL), 24 microgranular variant of APL (APLv) and 62 non-APL patients (including NPM1 mut AML and AML with KMT2A rearrangement). MFC immunotyping was used to analyze and compare the median expression intensity (MEI) of side scatter (SSC), along with the ratio of the MEI on leukemic cells with those on lymphocytes (T/L MEIR), the median fluorescence intensity (MDFI) of CD34, myeloperoxidase (MPO), CD64 and CD9 on leukemic cells, as well as the ratios of these MDFIs on leukemic cells with those on lymphocytes (T/L MDFIR). Receiver operating characteristic (ROC) curve was drawn to evaluate the diagnostic efficiency of the multiparameters model for distinguishing cAPL and non-APL, APLv and non-APL. Results:The MEI and T/L MEIR of SSC in the cAPL group were higher than those in the APLv and non-APL groups ( P<0.05), and these two parameters in APLv group were higher than those in the non-APL group, respectively ( P<0.05). The MDFIs of CD34 in cAPL and APLv groups were higher than those in the non-APL group ( P<0.05), and the T/L MDFIR of CD34 was higher in APLv group than non-APL group ( P<0.05). The MDFIs of MPO and CD9, as well as the T/L MDFIRs in cAPL and APLv groups were both higher than those in the non-APL group, respectively ( P<0.05). The MDFI and T/L MDFIR of CD64 in the cAPL group were higher than those in non-APL group, respectively ( P<0.05). ROC curve results showed that the area under the curve (AUC) of MEI of SSC, the MDFI of CD64 and CD9, as well as the T/L MEIR of SSC and T/L MDFIR of CD9 were 0.932, 0.816, 0.893, 0.960 and 0.894 for diagnosing cAPL, respectively, and the AUC of these parameters were 0.725, 0.737, 0.791, 0.729 and 0.736 for diagnosis APLv, respectively ( P<0.05). Conclusion:MFC method can analyze and screen the immunophenotypic characteristics of APL for differential diagnosis of cAPL, APLv and non-APL patients.
6.An Overview of Fermentation Technology Evolution and Process Control of Sojae Semen Praeparatum
Wang-min LIN ; Qian-qian WENG ; Ai-ping DENG ; Jia-chen ZHAO ; Yue ZHANG ; Hai-yang WANG ; Ya-feng REN ; Shui-li ZHANG ; Bing YU ; Zhi-lai ZHAN ; Lu-qi HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(11):222-232
The historical evolution, fermentation technology and key links of Sojae Semen Praeparatum (SSP) were sorted out by consulting ancient books and modern literature, and the influencing factors and control methods of quality were analyzed and summarized in order to provide reference for the quality control of SSP. After analysis, it was found that in the fermentation process of SSP, fermentation strains, miscellaneous bacteria, temperature and humidity were all important factors affecting the quality of SSP. The condition control of "post fermentation" process has been paid more attention to in the past dynasties. In addition, the delicious SSP recognized in ancient times should be made from mold fermentation, and the breeding and application of fermented mold may be the key point to solve the quality problem of SSP. Therefore, based on the evaluation indexes of SSP in the past dynasties, it is of great significance to study and optimize the technological conditions such as strain, temperature and humidity in depth to improve the quality of SSP.
7.Formation and evolution of commodity specification and grade of traditional Chinese medicine.
Peng-Ying LI ; Hai-Yang WANG ; Jian LI ; Zhi-Lai ZHAN ; Guang YANG
China Journal of Chinese Materia Medica 2016;41(5):764-768
As an important reference index to evaluate the quality of Chinese medicinal materials, the commodity specification and grade of traditional Chinese medicine has an effect on the medicinal material's price, can promote "high quality and high price" of the traditional Chinese medicine, prompt market transactions more convenient and standard, and has a great significance to the development of the whole traditional Chinese medicine industry. The formation of traditional Chinese medicine specifications and grades experienced a long historical development process. In order to provide the reference for modification of the product specifications and grades standards and management of traditional Chinese medicine products, the author consulted a large number of materia medica books and related references, sorted and analyzed the historical development process. The author divided the formation and development process into four stages, including germination stage before the Southern and Northern Dynasties, development stage of Tang and Song Dynasty, mature period of the Ming and Qing Dynasties and the inheritance development stage since the foundation of the People's Republic. The author believes that the clinical curative effect is the driving force to promote the development of commodity specifications and grades. In addition, the national pharmaceutical policy, international status, the level of science and technology also influence the development of commodity specifications and grades in some extents. Finally, the author provides three piece of suggestions for the modification of the product specifications and grades standards, according to the historical development rule.
8.MRI and diffusion-weighted imaging in the diagnosis of autoimmune pancreatitis
Yuexi CHEN ; Guozhao LI ; Xiang ZHANG ; Xiaohui DUAN ; Fang ZHANG ; Liejing LU ; Meiwei CHEN ; Kun ZHAO ; Yueyao CHEN ; Jun SHEN
Chinese Journal of Hepatic Surgery(Electronic Edition) 2015;(1):42-45
Objective To investigate the value of magnetic resonance imaging (MRI) and diffusion-weighted imaging (DWI) in the diagnosis of autoimmune pancreatitis (AIP). Methods Clinical data of 11 patients pathologically diagnosed with AIP in Sun Yat-sen Memorial Hospital, Sun Yat-sen University from January 2013 to June 2014 were analyzed retrospectively. There were 7 males and 4 females with a mean age of (54±15) years old. The informed consents of all patients were obtained and local ethical committee approval had been received. Apparent diffusion coefifcient (ADC) of the pancreatic lesions was measured by MRI scan, multiphase dynamic enhanced scan and DWI. The imaging features of AIP by MRI and DWI were observed. Results The AIP lesions displayed iso-or slightly hypo-intense signal on T1WI and slightly hyper-intense signal on T2WI by MRI and continuous gradual enhancement by multiphase dynamic enhanced scan. The average ADC of the lesions by DWI was (1.09±0.09)×10-3 mm2/s and the pancreatic lesions displayed high signal. Diffusely swelling pancreas with plump shape, sausage-like appearance was observed in 7 cases. Local mass were observed at the pancreatic head in 3 cases. Mass in the pancreatic body and tail was observed in 1 case. Capsule-like ring-like shadow was observed around the pancreas in 6 cases by MRI and iso-or slightly hypo-intense signal on T1WI and slightly lower-or hyper-intense signal on T2WI were observed. No enhancement or hypo-enhancement was observed in arterial phase by multiphase dynamic enhanced scan. Delayed enhancement was observed in delayed phase. The enhancement degree was mildly lower than that of pancreatic parenchyma. Multiple enlarged lymph nodes were observed around the pancreas and at the retroperitoneum in 4 cases. Conclusions MRI is useful for the diagnosis of AIP. The dynamic enhanced scan and DWI ifndings can be used as the direct images for diagnosing AIP and have a high clinical reference value.

Result Analysis
Print
Save
E-mail