Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.
Drug Evaluation ; methods ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional

The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.
China ; epidemiology ; Drug Evaluation ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Product Surveillance, Postmarketing

Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.
China ; Drugs, Chinese Herbal ; adverse effects ; history ; History, Ancient ; Humans ; Medicine in Literature ; Medicine, Chinese Traditional ; history ; Polygonum ; adverse effects ; Risk Assessment

The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Animals ; Aristolochia ; adverse effects ; chemistry ; Aristolochic Acids ; analysis ; therapeutic use ; toxicity ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; analysis ; therapeutic use ; toxicity ; Humans

ObjectiveTo investigate the mechanism and prevention of invisible injury of recurrent laryngeal nerve (RLN) system in thyroid surgery, with the application of intraoperative neuromonitoring ( IONM ) system. MethodsThe type of invisible RLN injury and its protection with the application of IONM system were analyzed. ResultsThe causes of invisible RLN injury mainly included stretching of Berry ligament or the tumor,contusion, thermal injury, cutting of silk and suction injury. RLN invisible injury was recoverable through neurotrophic and symptomatic treatment. No permanent vocal cord paralysis occurred. ConclusionsWith the application of IONM system, some invisible type of RLN injuries can be found. The risk of RLN injury can be reduced if the surgical techniques are improved with the development of study on mechanism of IONM system.

OBJECTIVETo search for the best therapy for simple obesity.

METHODSEighty cases were randomly divided into 3 groups. The body acupuncture group were treated based on the syndrome of heat of stomach and intestine, syndrome of spleen deficiency and stagnation of dampness, and syndrome of spleen and kidney yang-deficiency; the auricular and body acupuncture group were treated by the syndrome treatment of body acupuncture combined with auricular point sticking; the observation group were treated by the combined auricular and body acupuncture treatment plus moving cupping on back-shu points. Body weight, BMI, body fatd, blood lipids and clinically main symptoms before and after treatment were investigated.

RESULTSThe total effective rate was 69.6% in the body acupuncture group, 76.0%. in the auricular and body acupuncture group, and 90.6% treated in the observation group, with significant differences in the therapeutic effect, clinically main symptoms, external indexes of obesity and kidney ang-blood lipid metabolism between the observation group and the body acupuncture group. The various indexes in the auricular and body acupuncture group were superior to those iwere tthe body acupuncture group, with no significant differences in most indexes.

CONCLUSIONAuricular and body acupuncture combined with moving cupping at back-shu points has obvious therapeutic effect on simple obesity and this is a better therapy for simple obesity.

Acupuncture Points ; Acupuncture Therapy ; methods ; Acupuncture, Ear ; methods ; Adult ; Cholesterol, LDL ; blood ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; Obesity ; blood ; therapy

As a common protease with high similarity among coronavirus species, the main protease (M^pro) of SARS-CoV-2 is responsible for the catalytic hydrolysis of viral precursor proteins into functional proteins, which is essential for coronavirus replication and is one of the ideal targets for the development of broad-spectrum antiviral drugs. This paper reviews the main protease inhibitors of SARS-CoV-2, including their molecular structures, potencies and drug-like profiles, binding modes and structure-activity relationships, etc.

COVID-19 epidemic continues to spread around the world till these days, and it is urgent to develop more safe and effective new drugs. Due to the limited P3 biosafety laboratories for directly screening inhibitors of virulent viruses with high infectivity, it is necessary to develop rapid and efficient screening methods for viral proteases and other related targets. The main protease (M^pro), which plays a key role in the replication cycle of SARS-CoV-2, is highly conserved and has no homologous proteases in humans, making it an ideal target for drug development. From two different levels, namely, molecular level and cellular level, this paper summarizes the reported screening methods of SARS-CoV-2 M^pro inhibitors through a variety of representative examples, expecting to provide references for further development of SARS-CoV-2 M^pro inhibitors.

OBJECTIVETo study the effect of laryngotracheal reconstruction (LTR) in children with subglottic stenosis (SGS), and to discuss the indications and the risks of intraoperative and postoperative treatment of LTR.

METHODSFrom September 2008 to February 2010, 5 children (4 girls and 1 boy, aged 4 to 6 years) were treated by LTR. Among the 5 children, there were 2 congenital SGS and 3 acquired SGS. One had mild grade III SGS, 3 had severe grade III SGS, and one had grade IV SGS. One child with mild III SGS was treated by single-stage LTR, and the rest four children were treated by double-stage LTR. The surgical technique consisted of cricoid lamina midline vertical incision, rib cartilage graft interposition and endotracheal tube (ETT) stenting for 2 to 3 weeks.

RESULTSFour children with grade III SGS were de-cannulated 3 months after operation, and the child with grade IV SGS got de-cannulated 6 months after operation. Of all children, rib cartilage graft grower well, and the size of subglottis were amplified by grade III SGS to grade I SGS, and grade IV SGS to grade II SGS. All children obtained stable airway. One child with grade IV SGS who had hoarseness got effective phonation during follow-up 2 years after operation.

CONCLUSIONSLTR is a safe and effective treatment for pediatric subglottic stenosis. The important factors of successful operation are correct assessment and evaluation of the severity and overall medical status and selection of suitable surgical techniques.

Child ; Child, Preschool ; Female ; Humans ; Laryngostenosis ; surgery ; Larynx ; surgery ; Male ; Reconstructive Surgical Procedures ; methods ; Trachea ; surgery ; Treatment Outcome

OBJECTIVETo investigate the therapeutic effects of multiple level surgery in treating obstructive sleep apnea-hypopnea syndrome (OSAHS).

METHODSOne hundred ninety two patients with OSAHS diagnosed by polysomnography were treated through uvulopalatopharyngoplasty (UPPP). Thirty patients were combined with sub-mucous resection of the nasal septum. Forty four patients received sub-mucous resection of the nasal septum and partial inferior turbinectomy. Two patients received sub-mucous resection of the nasal septum and partial resection of the tongue base. Two patients received genioglossus advancement and partial resection of the tongue base. Three patients received partial resection of the tongue base. In addition, the patients with the nasal disease and/or the lingual fat, AHI > 40 times/h, LSaO(2) < 0.64 and/or BMI > 30 kg/m(2) received tracheotomy before general anaesthesia.

RESULTSOne hundred ninety two patients were treated through UPPP. One hundred ninety one patients were successful, one patient died of pneumothorax and cardiac arrest during the incision of the trachea. All patients were followed-up for 6-37 months, among them, 132 patients showed therapeutic effect, with the effective rate as 68.7%. Fifty five patients were cured (AHI < 5 times/h); 39 patients had significant effect (AHI < 20 times/h and decreased > or = 50%); 38 patients were effective (AHI decreased > or = 50%). However, 60 patients did not have any therapeutic effect, with the ineffective rate as 31.3%. Fifty four patients had palatopharyngeal and nasal cavity emphasis, 24 patients had palatopharyngeal and oropharyngeal emphasis, 96 patients had palatopharyngeal and nasal cavity and oropharyngeal emphasis. Some patients were treated with UPPP, which made effective rate as 15 (68.2%), 12 (63.2%), 29 (55.8%). The others were treated with multiple level operations, which made effective rate as 25 (78.1%), 5 (5/5), 33 (75.0%). The effective rate was 60.2% (56/93) by simple UPPP and it was 77.8% (63/81) by multiple level treatment in patients with multiple level obstruction. There was statistical significance between them (chi(2) = 6.2, P = 0.01).

CONCLUSIONSThe effective rate was improved through multiple level operations in OSAHS patients. The serious complications could be prevented through tracheotomy before general anaesthesia in patients with severe OSAHS who needed multiple level surgery.

Adult ; Aged ; Apnea ; surgery ; Female ; Humans ; Male ; Middle Aged ; Nasal Mucosa ; surgery ; Otorhinolaryngologic Surgical Procedures ; methods ; Palate ; surgery ; Pharynx ; surgery ; Polysomnography ; Sleep Apnea, Obstructive ; diagnosis ; surgery ; Tongue ; surgery ; Treatment Outcome ; Uvula ; surgery