Objective To describe the reference intervals and their sources of tumor markers in clinical laboratories all over China.And make a comparison of difference between different testing systems.Methods The questionnaires about reference intervals of tumor markers testing were distributed to participants.The information was collected by external quality assessment software system based on website, which including upper and lower limits, sources, validation information and testing systems.The analytes were AFP, CEA, total-PSA, CA125, CA153, CA199, ferritin and free-PSA. The participants were classified according to the testing systems they used.The mean, median, maximum and minimum of each group were calculated using Microsoft Excel 2007.The difference of reference intervals between different testing systems were compared by Kruskal-Wallis test.Results The main source of reference intervals was instructions of testing system manufactures ( 83.1% for mean of 8 ratios ) .The next in sequence were instructions of reagent manufactures(8.4% for mean), National Guide to Clinical Laboratory Procedures (4.6%for mean), determined by their own laboratory(2.0% for mean) and the rest (1.9% for mean). There were 48.0% ( 1 906/3 967 ) of analytes whose reference intervals had been validated.Difference of reference intervals which was with P value of Kruskal-Wallis test with <0.05 was found between different testing system groups except the upper limit of free prostate specific antigen ( PSA ) .Conclusions Most clinical laboratories establish the reference intervals of tumor markers on the basis of instructions of testing system manufactures.The reference intervals among different testing systems have statistically significance.

Child ; Clinical Trials as Topic ; Drug Design ; Drugs, Investigational ; Humans ; Research Design

In order to evaluate the ability of human standing balance scientifically, we in this study proposed a new evaluation method based on the chaos nonlinear analysis theory. In this method, a sinusoidal acceleration stimulus in forward/backward direction was forced under the subjects' feet, which was supplied by a motion platform. In addition, three acceleration sensors, which were fixed to the shoulder, hip and knee of each subject, were applied to capture the balance adjustment dynamic data. Through reconstructing the system phase space, we calculated the largest Lyapunov exponent (LLE) of the dynamic data of subjects' different segments, then used the sum of the squares of the difference between each LLE (SSDLLE) as the balance capabilities evaluation index. Finally, 20 subjects' indexes were calculated, and compared with evaluation results of existing methods. The results showed that the SSDLLE were more in line with the subjects' performance during the experiment, and it could measure the body's balance ability to some extent. Moreover, the results also illustrated that balance level was determined by the coordinate ability of various joints, and there might be more balance control strategy in the process of maintaining balance.
Acceleration ; Biomechanical Phenomena ; Humans ; Models, Biological ; Motion ; Nonlinear Dynamics ; Postural Balance ; physiology

In order to develop safe training intensity and training methods for the passive balance rehabilitation train- ing system, we propose in this paper a mathematical model for human standing balance adjustment based on T-S fuzzy identification method. This model takes the acceleration of a multidimensional motion platform as its inputs, and human joint angles as its outputs. We used the artificial bee colony optimization algorithm to improve fuzzy C--means clustering algorithm, which enhanced the efficiency of the identification for antecedent parameters. Through some experiments, the data of 9 testees were collected, which were used for model training and model results validation. With the mean square error and cross-correlation between the simulation data and measured data, we concluded that the model was accurate and reasonable.
Algorithms ; Cluster Analysis ; Fuzzy Logic ; Humans ; Models, Theoretical ; Postural Balance

This study taking gestodene (GEST) as a model, investigated the factors affecting reservoir-type intravaginal ring (IVR)'s drug release. This paper reported a gestodene intravaginal ring of reservoir design, comprising a gestodene silicone elastomer core encased in a non-medicated silicone sheath, separately manufactured by reaction injection moulding at 80 degrees C and heating vulcanization at 130 degrees C is reported. The test investigated the factors affecting drug release through a single variable method, taking the drug release rates of 21 days as standards. When changing the thickness of the controlling sheath outside, the ratio of the first day of drug release and mean daily release (MDR), named the relatively burst effect, is closing to 1 with the thickness of controlling sheath increasing, while the 1.25 mm sheath corresponding to 1.04 controlled the burst release effectively; a positive correlation (r = 0.992 2) existed between the average drug release (Q/t) and drug loading (A) within a certain range. The C6-165 controlling sheath with high solubility of GEST is easier to achieve controlled release of the drug; GEST crystalline power is more effective to implement controlled release of drugs among difficent states of the drug. A 1/4 fractional segment core gives a relatively burst effect of 1.76, while the 1/1 and 1/2 are 1.93 and 1.87 separately, at the same drug loading, concluding that use of a fractional segment core would allow development of a suitable GEST reservoir IVR. In summary, GEST reservoir-type IVR could be adjusted by the thickness of controlling sheath, the loading of drug, the material properties of controlling sheath, the dispersion state of drug, the additive composition and structure of intravaginal ring, to control the drug release behavior and achieve the desired drug release rate.
Administration, Intravaginal ; Contraceptive Agents, Female ; administration & dosage ; Contraceptive Devices, Female ; Delayed-Action Preparations ; Drug Delivery Systems ; methods ; Norpregnenes ; administration & dosage ; chemistry ; Silicone Elastomers ; chemistry ; Solubility

Recently,thesituationofchemicalsubstancesillegallyaddedinTCMandhealthproductsismoreandmorecomplex and subtle, which not only results in latent danger and harm to customers, but also induce supervision difficulty and challenge for su-pervision departments. The variety and composition of chemical substances added illegally, analytical methods and relative state laws and regulations were illustrated in detail in the paper, which can provide the basis for the rational and safe use of TCM and health prod-ucts, and provide the reference and technology support for the supervision departments.

Objective To investigate the relationship between interleukin 1β( IL?1β) , interleukin?33 ( IL?33) , neutrophil?to?lymphocyte ratio ( NLR ) and atrial fibrillation. Methods Eighty?two patients with nonvalvular atrial fibrillation treated in the department of cardiology in the Fourth People′s Hospital of Jinan from October 2015 to October 2016 were enrolled in the study,including 43 patients with persistent atrial fibrillation and 39 patients with paroxysmal atrial fibrillation. 50 healthy subjects were selected as the control group. Enzyme linked immunosorbent assay (ELISA) was used to determine the concentration of IL?1βand IL?33,and the left atrial diameter ( LAD) was measured by echocardiography. Results ( 1) The concentrations of IL?1β,NLR and LAD in the paroxysmal atrial fibrillation group were (24. 44±4. 89) ng/L,(2. 51±1. 22) %,(36. 16± 6. 12) mm,the concentrations of IL?1β,NLR and LAD in the persistent atrial fibrillation group were (26. 95±5. 86) ng/L,(5. 7±1. 8) %,(39. 36±4. 78) mm and the values in the control group were (19. 53±4. 51) ng/L,(1. 82 ± 0. 41 ) %, ( 33. 31 ± 2. 89 ) mm, respectively. The differences among the three groups were statistically significant ( F=16. 74,11. 82,14. 85,P<0. 01) . The indexes of paroxysmal atrial fibrillation group and persistent atrial fibrillation group were higher than those of the control group ( P<0. 01 ) . ( 2 ) In the persistent atrial fibrillation group, NLR and LAD were ( 5. 7 ± 1. 8 )% , and ( 39. 36 ± 4. 78 ) mm, higher than those of the paroxysmal atrial fibrillation group ( (2. 51±1. 22)%,(36. 16±6. 12) mm),the differences were statistically significant ( P<0. 01) . However,the level of IL?1βin the persistent atrial fibrillation group was not significantly different from that in the paroxysmal atrial fibrillation group ( (26. 95±5. 86) ng/L vs. (24. 44±4. 89) ng/L,P>0. 05). (3) The concentrations of IL?33 in the paroxysmal atrial fibrillation group,atrial fibrillation group, control group were ( 48. 31 ± 4. 72 ) ng/L, ( 50. 03 ± 2. 18 ) ng/L, ( 56. 87 ± 5. 12 ) ng/L, respectively. The difference among the three groups has no statistical significance ( F=2. 52, P>0. 05 ) . ( 4 ) NLR level was positively correlated with LAD ( r=0. 32,P=0. 002) . There was no significant correlation among IL?1β,IL?33 and LAD ( r=0. 16, P=0. 11, r=0. 02, P=0. 37 ) . Conclusion The levels of IL?1β, NLR and LAD in peripheral blood of patients with atrial fibrillation were significantly higher than those in patients with sinus rhythm,and there was a positive correlation between NLR and LAD.

Good medicinal herbs, good drugs. Good evaluation method and indices are the prerequisite of good medicinal herbs. However, there exist numerous indices for quality evaluation and control in Chinese medicinal materials. However, most of these indices are non-interrelated each other, as well as having little relationship with efficiency and safety. The results of different evaluatior methods may not be consistent, even contradictory. Considering the complex material properties of Chinese medicinal materials, single method and index is difficult to objectively and comprehensively reflect the quality. Therefore, it is essential to explore the integrated evaluation methods. In this paper, oriented by the integrated evaluation strategies for traditional Chinese medicine quality, a new method called integrated quality index (IQI) by the integration of empirical evaluation, chemical evaluation, and biological evaluation was proposed. In addition, a study case of hypertoxic herb Aconitum carmichaelii Debx. was provided to explain this method in detail. The results suggested that in the view of specifications, the average weight of Jiangyou aconite was the greatest, followed by Weishan aconite, Butuo aconite, Hanzhong aconite, and Anxian aconite; from the point of chemical components, Jiangyou aconite had the characteristic with strong efficacy and weak toxicity, next was Hanzhong aconite, Butuo aconite, Weishan aconite, and Anxian aconite; taking toxicity price as the index, Hanzhong aconite and Jiangyou aconite have the lower toxicity, while Butuo aconite, Weishan aconite, and Anxian aconite have the relatively higher one. After the normalization and integration of evaluation results, we calculated the IQI value of Jiangyou aconite, Hanzhong aconite, Butuo aconite, Weishan aconite, and Anxian aconite were 0.842 +/- 0.091, 0.597 +/- 0.047, 0.442 +/- 0.033, 0.454 +/- 0.038, 0.170 +/- 0.021, respectively. The quality of Jiangyou aconite is significantly better than the others (P < 0.05) followed by Hanzhong aconite, which is consistent with the traditional understanding of genuineness. It can be concluded that IQI achieves the integrated control and evaluation for the quality of Chinese medicinal materials, and it is an exploration for building the good medicinal herbs standards. In addition, IQI provides technical supports for the geoherbalism evaluation, selective breeding, the development of precision decoction pieces, high quality and favourable price in market circulation, and rational drug use.
Aconitum ; chemistry ; Drugs, Chinese Herbal ; standards ; Medicine, Chinese Traditional ; standards

The stable and controllable quality of decoction pieces is an important factor to ensure the efficacy of clinical medicine. Considering the dilemma that the existing standardization of processing mode cannot effectively eliminate the variability of quality raw ingredients, and ensure the stability between different batches, we first propose a new strategy for Chinese medicine processing technologies that coupled with individuation processed and cybernetics. In order to explain this thinking, an individual study case about different grades aconite is provided. We hope this strategy could better serve for clinical medicine, and promote the inheritance and innovation of Chinese medicine processing skills and theories.
Chemistry, Pharmaceutical ; methods ; standards ; Cybernetics ; standards ; Drug Therapy ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; toxicity ; Humans ; Quality Control

Quality control is one of the key scientific tissues in the modernization of traditional Chinese medicines (TCM). In order to overcome the deficiencies of assessment indexes, including little systematization and quantification, as well as loose association with clinical efficacy and dosage, a new integrated method named controllability pyramid ( CP) is first proposed in this paper. In addition, some study cases are used to explain how this model is constructed. We hope the establishment of CP could promote the clinical-orien- ted integrated innovation research of TCM, and provide control strategy and technology examples for improving the quality of Chinese medicines and clinical efficacy.
China ; Drug Evaluation ; methods ; standards ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; standards ; Humans ; Medicine, Chinese Traditional ; standards ; Quality Control