In 2019, the newly revised Drug Administration Law of the People's Republic of China was issued and implemented,clearly proposing that China should establish a pharmacovigilance system. As a new traditional Chinese medicine(TCM) dosage form created in China, TCM injections have been widely used in clinic, and its pharmacovigilance has attracted much attention. In response to this situation, the project team convened a group of clinical, pharmaceutical and evidence-based medicine experts from all over the country to form an expert group, which formulated the Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections in strict accordance with the requirements of the group standards of the Chinese Association of Chinese Medicine.
View Article and Find Full Text PDFWorld J Clin Cases
September 2021
Background: Madelung's disease (MD) is a rare disorder of lipid metabolism, characterized by the growth of unencapsulated masses of adipose tissue symmetrically deposited around the neck, shoulders, or other sites around the body. Its pathological mechanism is not yet known. One of the most common comorbidities in MD patients is liver disease, especially chronic alcoholic liver disease (CALD); however, no reports exist of acute kidney injury (AKI) with MD.
View Article and Find Full Text PDFZhongguo Zhong Yao Za Zhi
February 2018
Under the theoretical guidance of "combination of disease and syndrome, correspondence between syndrome and prescription, and dynamic space-time", 11 135 acute ischemic stroke patients were collected from hospital information system(HIS) of many 3A grade hospitals of traditional Chinese medicine. Complex network analysis was adopted to obtain the core syndrome elements in different periods of acute ischemic stroke patients, and it was found that the core syndrome elements were blood stasis syndrome, phlegm, endogenous wind, Yin deficiency, Qi deficiency, heat, hyperactivity of liver Yang, liver, and kidney of patients in hospital for the first day, and during 8-14 d in hospitalization, the core syndrome elements were blood stasis, phlegm, Yin deficiency, Qi deficiency, endogenous wind, hyperactivity of liver Yang, liver, and kidney. The data with "improved" and "cured" treatment outcomes were adopted for complex network analysis and correlation analysis to identify the Chinese and Western medicine group modules in patients with different disease conditions in different phases after hospitalization.
View Article and Find Full Text PDFHerein we report a case of Kimura's disease with unusual manifestations. A 46-year- old Chinese man presented with mass in scrotum which gradually increased in size for approximately 7 years. A computerized tomographic scan of abdomen revealed a soft-tissue density shadow in scrotum and enlargement of lymph nodes in groin and retroperitoneum.
View Article and Find Full Text PDFZhongguo Zhong Yao Za Zhi
August 2017
In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection (Xingxue), the design method of a multi-center, large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information, diagnostic information, medication information, and adverse event information.
View Article and Find Full Text PDFZhongguo Zhong Yao Za Zhi
December 2015
To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data.
View Article and Find Full Text PDFRepairing initial slight damage site into stable structures by engineering techniques is the leading strategy to mitigate the damage growth on large-size components used in laser-driven fusion facilities. For KH2PO4 crystals, serving as frequency converter and optoelectronic switch-Pockels cell, micro-milling has been proven the most promising method to fabricate these stable structures. However, tool marks inside repairing pit would be unavoidably introduced due to the wearing of milling cutter in actual repairing process.
View Article and Find Full Text PDFZhongguo Zhen Jiu
December 2014
Objective: To compare the efficacy on vertebrobasilar insufficiency (VBI) between auricular acupuncture therapy and oral administration of medicine.
Methods: Sixty patients of VBI were randomized into an auricular acupuncture therapy group and a medicine group, 30 cases in each one. In the auricular acupuncture group, acupuncture was applied bilaterally to gan (CO12) and jiejie (HX8) on the ears and needles were retained for 15 min.
It is of vital significance to conduct active postmarketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China Food and Drug Administration. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The expert consensus for postmarketing surveillance focuses on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.
View Article and Find Full Text PDFThe regulations on basic clinical use of parenterally administered Chinese medicine, issued jointly in 2008, by the ministry of health (MOH), China food and drug administration (SFDA) and the state administration of traditional Chinese medicine (SATCM). Integrating actual clinical practice, these presented doctors and nurses with detailed specifications for the safe use of parenterally administered Chinese medicine. The regulations emphasize the use of Chinese medicine pattern differentiation, use in strict accordance with instructions, and they prohibit use combined with other medicines.
View Article and Find Full Text PDFIt is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs).
View Article and Find Full Text PDFCurrently, there are many traditional Chinese medicine (TCM) injections for treating ischemic stroke in the market, most of them have the efficacy of promoting blood circulation and removing blood stasis, but their reasonable applications are worth consideration. From the angles of traditional Chinese medicine and modern medicine, TCM injections that are commonly used in clinics were detected for their indications and pharmacological effects, compared in terms of their characteristics of clinical application, precautions, prohibition on use, caution and adverse reactions and categorized, in order to help clinicians with reasonable application of TCM injections.
View Article and Find Full Text PDFShuxuetong injection is a kind of compound injection which is made from traditional Chinese medicine Hirudo and Pheretime, which has a clear anticoagulant, fibrinolytic promoting, blood rheology improving, blood lipids regulating and cell protecting effect, and the injection has been widely used in clinical. Especially, the injection has often been combined with other Chinese and modern medicine in the treatment of cerebral infarction disease. However, there are still many non-standard and irrational aspects in clinical practice so as to make a more reasonable and safer use of Shuxuetong injection.
View Article and Find Full Text PDFObjective: To determine the association between levels of basic metabolic elements and degeneration and ossification of the ligamentum flavum (LF).
Subjects: Fourteen consecutive patients with degenerative lumbar stenosis, 11 with ossification of the thoracic ligamenta flava, and 11 control subjects.
Methods: The basic elements of calcium (Ca), phosphorus (P), magnesium (Mg), zinc (Zn), copper (Cu), manganese (Mn), molybdenum (Mo), and fluoride (F) in the specimens were measured using atomic absorption spectrometry, the phosphomolybdic blue method, and a fluoride-selected electrode.
Purpose: To determine the indications and benefits of ectopic implantation in the salvage of amputated thumb.
Basic Procedures: Two cases of avulsed amputated thumbs were temporarily ectopically implanted onto the forearm and foot, with microvascular anastomoses. When the stump condition allowed, and the soft-tissue defects were repaired, the ectopic implanted thumbs were replanted to their anatomic positions.
Objective: To investigate the clinical characteristics, treatment options and causes of misdiagnosis of ipsilateral femoral neck and shaft fractures.
Methods: Among 20 patients with ipsilateral femoral neck and shaft fractures, 19 were treated operatively and 1 was treated conservatively. Sixteen cases of femoral shaft fractures were treated by open reduction and internal fixation with compressive plate, and 2 cases were treated with interlocking intramedullary nailing.
Objective: To evaluate the treatment for patients with major vascular injuries associated with traumatic orthopedic injuries.
Methods: A total of 196 patients, aged from 4-67 years with the mean age of 29.88 years, had major vascular injuries associated with traumatic orthopedic injuries and were treated in our hospital in a period of 44 years.
Objective: To investigate the biomechanical effect of major extremity vessels to choose appropriate repair methods for vascular injuries of the extremities.
Methods: The data of 385 patients (337 males and 48 females, aged 18-71 years, mean=32.6 years) including 403 injured vessels, who suffered from vascular injuries of the extremities and were treated in our hospital from October 1960 to August 2005, were studied retrospectively in this article.
Objective: To investigate the morphological changes of deep fascia subjected to distraction in a rabbit model of leg lengthening.
Methods: The animal model of leg lengthening was established in 20 New Zealand white rabbits using a unilateral external fixator with 4 half pins medially fixed to the tibia, and osteotomy was performed between the second and the third pins. The distraction was initiated 7 days after the osteotomy procedure, with the rate of 1 and 2 mm/d in 2 steps, and proceeded until 10% and 20% increases in the initial length of the tibia had been achieved.
Objective: To introduce a posteromedial approach through the medial border of the medial head of gastrocnemius for reduction and reattachment of bony avulsion of the posterior cruciate ligament (PCL) from the tibia.
Methods: Eleven patients with avulsed tibial attachment of the PCL underwent an operative reduction and internal fixation through the posteromedial approach of the gastrocnemius in our department from February 1998 to March 2000. The skin incision was reversed L-shaped along the medial border of the medial head of the gastrocnemius and the posterior capsule was exposed by dissecting the medial border and lateral retraction, avoiding the damage of the popliteal neurovascular structures.