The research on clinical efficacy evaluation of traditional Chinese medicine (TCM) is a hot and difficult issue in the field of TCM. However, the overall level of current related research also needs to be improved. There are still a lot of academic controversies in the field of TCM clinical efficacy evaluation. The author believed that before conducting research, it is necessary to sort out core issues of TCM clinical efficacy evaluation, which in-clude the concept of TCM clinical efficacy and its evaluation. In recent years, Chinese scholars have conducted a series of studies on these issues and have some achievements. To think and answer these questions will play an important role for the ultimate resolution of problem of TCM clinical efficacy evaluation.

Through analyzing the current situation and coverage controversy of Chinese clinical trial insurance,this paper stated that the attending insurance rate in domestic clinical trials was entirely low.The sponsors,clinical trial institutions,investigators and insurance companies paid attention of different levels to clinical trial insurance.Therefore,the risk awareness of drug/medical device clinical trials should be enhanced.It is necessary to give impetus to clinical trial insurance system,during which all parties need to make a joint effort including government departments,ethics committees,sponsors,clinical trial institutions,investigators and insurance companies.

Objective To investigate the ability of targeting in vitro breast carcinoma and photoacoustic-mediate apoptosis of breast carcinoma of the nanoparticle probe loaded with Fe3O4 and observe its consequence of photoacoustic imaging in vitro.Methods The polymeric multifunctional nanoparticles probe that was loaded with Fe3O4 and connected with Herceptin targeting breast carcinoma was prepared in the use of double emulsion method and carbodiimide method.General physical property,the condition of Herceptin connected with nanoparticles and the ability of targeting of the probe were tested.The different concentration of nanoparticles was imaged by photoacoustic.The inhibiting effect of targeting nanoparticles on breast carcinoma cells was evaluated in vitro.Results The targeting polymeric multifunctional nanoparticles probes loaded with Fe3O,were prepared successfully with average particle diameter of (235.4± 53.75)nm and Zeta potential (-13.4 ± 4.7)mV.Fe3O4 particles dispersed on the shell of the probes.Antibody Hereeptin was successfully connected with the surface of the nanoprobes.There were massive targeting nanoprobes surround the breast carcinoma cell strains SKBR3 in the targeting group in vitro.The photoascoustic signal of the nanoprobes enhanced with the increase of Fe3O4 concentration in photoacoustic experiment in vitro.The apoptotic rate of breast carcinoma increased after the laser irradiation in the cell inhibition experiment in vitro.That proved the obvious inhibition of breast carcinoma cells was caused by photothermal effect of the prepared nanoprobes.Conclusions The prepared polymeric multifunctional nanoparticles probe that was loaded with Fe3O4 and connected with Herceptin targeting breast carcinoma can be used as a photoacoustic contrast agent,which can inhibit the proliferation of breast carcinoma by targeting photoacoustic therapy.

Objective To study the relationship between Y chromosome abnormalities and AZF microdeletions in males with reproductive failure.Methods A case-control study was conducted in 2694 reproductive failure men with age ranges from 23 to 49 years old from the Institute of Reproductive Medicine of Jilin Province.Patients were divided into three groups:spermatogenic failure group (n =1332),disadvantage pregnancy outcomes group (n =994) and adverse birth outcomes group.All patients underwent chromosomal karyotype analysis (G-banding).AZF microdeletions were further investigated in patients with Y chromosomal abnormalities by PCR.The Chi-square test was used to compare the frequency of Y chromosome abnormalities in three groups.Results Of the 51 cases of Y chromosome abnormalities (1.89％,51/2694),32 were (2.40％,32/1332) in the spermatogenic failure group,15 were (1.51％,15/994) in disadvantage pregnancy outcomes group and 4 were (1.09％,4/368) in adverse birth outcomes group.There was no significant difference in Y chromosome abnormalities among different groups (x2 =3.895,P ＞0.05).AZF microdeletions were detected in 10 cases (19.61％,10/51) of Y chromosome abnormalities patients with spermatogenic failure.Conclusions The incidence of Y chromosomal abnormalities in three reproductive failure groups is similar.Chromosome karyotype analysis and AZF microdeletions examination could identify the genetics etiology in males with reproductive failure.

Objective To describe different types of chromosomal abnormalities on male infertility.Methods From May 2006 to May 2012,2034 infertile males with genetic counseling underwent chromosome karyotype analysis,semen routine examination and reproductive hormones levels detection.The data from them were analyzed.Results 267 cases of chromosomal abnormalities were detected in 2034 cases (13.13％).258 cases underwent semen routine examination in 267 cases with chromosomal abnormalities,of which 190 cases of azoospermia,58 cases of oligozoospermia,10 cases of semen normal.In 267 cases of chromosomal abnormalities,including 169 cases (63.30％) of number abnormalities,mainly with azoospermia,157 cases of Klinefelter syndrome (KS) (58.80％),7 cases of 47,XYY (2.62％),4 cases of Turner syndrome (1.50％),1 case of marker chromosome (0.37％) ; 49 cases (18.35％) of structural abnormalities mainly with oligozoospermia,including 32 cases of chromosomal translocations (11.99％),17 cases of inversion (6.37％) ; 4 cases of sex reversal (1.50％) with azoospermia; 45 cases of chromosome polymorphism (16.85％) mainly with oligozoospermia.Non-mosaicism KS patients' age,testicular volume,semen volume,and serum reproductive hormones levels were compared between different groups of semen results,and there were no significant difference except age.Conclusions Chromosome abnormalities were the most important genetic causes of abnormal semen quality and male infertility.It is necessary to be performed chromosome karyotype analysis for infertile males.

Objective To study the relationship between small Y and azoospermia factor (AZF)microdeletions and the effect on male infertility.Methods Data of 379 infertile males of chromosomal karyotype analysis from May 2010 to October 2011 were investigated.Patients with small Y chromosome were also performed C banding and AZF microdeletions,and their fathers and brothers were offered the same examinations.Results Eight patients were small Y chromosome,and their fathers or brothers' chromosome karyotypes were consistent with the probands.Among the 8 cases,there were 3 patients with AZF microdeletions,while their fathers and brothers didn't have microdeletions.Another 5 cases of small Y and their fathers did not exist AZF microdeletions.Conclusions The small Y karyotype is not the key factors that cause male infertility.The reason for infertile patients with small Y and AZF microdeletions was maybe the microdeletions.However,patients with small Y but without AZF microdeletions are not important to male infertility.

OBJECTIVE: To study the clinical value of polysomnography (PSG) and ApneaGraph (AG200) in the diagnosis evaluation of obstructive sleep apnea hypopnea syndrome (OSAHS). METHOD: From January to December in 2012, 67 OSAHS patients diagnosed by PSG were examined by AG200. The apnea hypopnea index (AHI), hypopnea index (HI), apnea index (AI), the lowest oxygen saturation (LSaO2) was were detected and the results were analyzed statistically. RESULT: Significant differences were observed in AI, AHI, LSaO2 between AG200 and PSG (P < 0.05, respectively). No statistically significant difference was found in HI. The differences in HI between AG200 and PSG were not significant (P > 0.05). AHI, HI and LSaO2 was were significantly correlated between AG200 and PSG (r = 0.870, 0.743, 0.374, 0.716, P < 0.01). CONCLUSION AG200 could not replace PSG but could identify the level of upper airway obstruction.
Female ; Humans ; Male ; Polysomnography ; methods ; Sleep Apnea, Obstructive ; diagnosis ; physiopathology

OBJECTIVE: To explore the curative effect of velopharyngoplasty (VPP) combined with hard palate shorting and soft palate forward in the treatment of type II moderately severe obstructive sleep apnea hypopnea syndrome (OSAHS). METHOD: Thirty-two patients with OSAHS with and the obstructed surface located in soft palate were subjected to VPP combined with hard palate shorting and soft palate forward. The ESS scores, result of PSG included AHI and the lowest oxyhemoglobin saturation before and after operation were compared. RESULT: The effective rate of VPP was 78.12% this group. The grade of ESS, PSG and the lowest oxyhemoglobin saturation was statistically significant before and after the operation (P < 0.05). In the other 7 cases whose AHI decrease less than 50%, the grade of ESS, AHI and the lowest oxyhemoglobin saturation was also statistically significant. CONCLUSION VPP combined with hard palate shorting and soft palate forward can improve the surgical effective rate obviously for OSAHS patients.
Adult ; Female ; Humans ; Male ; Middle Aged ; Palate, Hard ; surgery ; Palate, Soft ; surgery ; Pharynx ; surgery ; Sleep Apnea, Obstructive ; surgery ; Syndrome

Objective: To describe the epidemiological characteristics of suicide death and self-harm/suicide in China from 2006 to 2016. Methods: Data in this study are from the datasets of National Death Cause Surveillance from 2006 to 2016 and the National Injury Surveillance Dataset 2016. The age-standardized death rate based on the population census in 2000 was used to describe the trend of suicide over years. This study also described the epidemiological characteristics of suicide death and the demographic characteristics, suicide methods and severity of patients who sought medical help after committing suicide or self-inflicted injury in 2016. Results: Age-standardized suicide mortality had been declining from 9.23/100 000 in 2006 to 5.33/100 000 in 2016 by 42.25%. Suicide mortality increased with age. In 2016, the suicide mortality in China was 7.05/100 000, and among people over 85 years old was 49.49/100 000. In 2016, the dominant two suicide methods were poisoning (39.12%) and sharp injury (25.62%). The first leading method of suicide in rural population, urban population and young people aged 10-to 17-year-old was poisoning (65.13%), sharp injury (29.90%) and fall (25.47%), respectively. As age increased, the severity of suicide/self-inflicted injury increased. The proportions of serious cases among young people aged 10-to 17-year-old and older people aged 60 years old and above who sought medical help after committing suicide or self-inflicted injury were 4.88% and 26.86%, respectively. Conclusion China′s suicide mortality has been declining and special attention should be given to the suicide of old people.

Objective: To analyze the characteristics distribution of falls among students aged 6-17 in 2018, and to provide data support for preventing falls among students and formulating the corresponding policies. Methods: Data of falls among students aged 6-17 in China in 2018 were collected from the the National Injury Surveillance System (NISS) for analyzing its demographic characteristics, injury occurrence and clinical traits of falling. Results: In total, 42 735 cases of fall aged 6-17 were collected from the NISS in China in 2018, which accounted for 54.03% of all cases, with a sex ratio of 2.34∶1, the proportion of students aged 6-11 was the highest(53.78%). The proportion of falls from March to June was the highest(42.12%), and the peak time when falls occurred was forenoon 10:00-10:59(8.40%). School and school-related area(40.40%), home(18.96%) and public residential institution (15.35%) were the sites where falls mainly occurred. The top three activities when falls occurred were leisure activities(47.41%), sports activities(23.90%) and walking(9.77%). Bruise/scrape(54.49%), sprain/strain(21.98%) and fracture(12.69%) were the major nature of injury. The most common body parts falls involved were lower limbs(34.71%), head(29.85%) and upper limbs(25.10%). The injury of falling was mainly characterized by mild ones(83.44%). Conclusion There were more cases of falls on students aged 6-17 from the NISS in China in 2018, mainly males. The epidemiological characteristics were relatively variable, so targeted prevention program of falls should be conducted.