The study of quality control of Chinese medicine has always been the hot and the difficulty spot of the development of traditional Chinese medicine (TCM), which is also one of the key problems restricting the modernization and internationalization of Chinese medicine. Multivariate statistical analysis is an analytical method which is suitable for the analysis of characteristics of TCM. It has been used widely in the study of quality control of TCM. Multivariate Statistical analysis was used for multivariate indicators and variables that appeared in the study of quality control and had certain correlation between each other, to find out the hidden law or the relationship between the data can be found,.which could apply to serve the decision-making and realize the effective quality evaluation of TCM. In this paper, the application of multivariate statistical analysis in the quality control of Chinese medicine was summarized, which could provided the basis for its further study.
Medicine, Chinese Traditional ; standards ; Multivariate Analysis ; Quality Control

As a characteristic tumor therapy in China, Chinese medicine (CM) plays an important position in comprehensive treatment of tumor. It's a critical issue of objective realization, analysis and evaluation of CM safety for scientific decision-making in tumor safe medication and it also is a pivotal issue which affects the international communication. The safety evaluation of CM includes three phases: pre-clinical safety evaluation, clinical trials (micro-dose studies and traditional clinical trials) and post-marketing CM safety assessment. The key point of evaluation should be distinguished among different stages and various types of CM (such as classic formulas, Chinese herbal extracts, etc). Emphasis should be given to chronic toxicity when evaluating oral Chinese herbal , microdose studies and quality control must be underlined while injection is evaluated and more attention should be pay to the dose-effect relationship and time-effect relationship when turned to toxic Chinese medicine , and so as for the toxicity grading study. Moreover, we should constantly improve CM safety assessment method in various stages of tumor treatment, such as introducing the concept of syndrome classification theory, bringing in metabonomics and real-world research method which are similar to the CM therapeutic concept. Most importantly, we must keep its own feature of CM theory when we learn the concept of safety evaluation from abroad. Actively exploring the anti-tumor medicine safety evaluation methods and strategies is of great significance for clinical and experimental research, and it can provide supportability platform to CM's international communication.
Animals ; Combined Modality Therapy ; Humans ; Medicine, Chinese Traditional ; adverse effects ; methods ; Neoplasms ; therapy ; Safety

OBJECTIVETo study the effect of Compound Ezhu Powder (CEP) on serum levels of CA125 and CA19-9, and the expression of cyclin D protein in endometriosis patients, thus providing theoretical evidence for clinical application of CEP.

METHODSTotally 69 all endometriosis patients underwent surgical treatment at Department of Gynecology and Obstetrics, Tianjin Nankai Hospital from January 2011 to January 2013 were randomly assigned to group A (35 cases) and group B (34 cases). Meanwhile, 30 patients with uterine fibroids who prepared for surgical treatment during the same period were recruited as the control group. Patients in group A took EZP 3 months before surgery. No treatment was given to patients in group B and the control group. The serum CA125 level and the expression of cyclin D in the ectopic endometrium and the eutopic endometrium were detected in the 3 groups before surgery.

RESULTSThe expression of cyclin D was higher in group A and group B than in the control group (P < 0.05). The serum levels of CA125 and CA19-9 were significantly lower in group A than in group B (P < 0.05). The expression of cyclin D in the ectopic endometrium was lower in group A than in group B, but with no statistical difference (P > 0.05). The expression of cyclin D in the eutopic endometrium was significantly lower in group A than in group B with statistical difference (P < 0.05). Meanwhile, the serum CA125 level was positively correlated with the serum CA19-9 level (r = 0.45, P < 0.05).

CONCLUSIONSThe expression of cyclin D obviously increased in endometriosis patients, which was associated with the occurrence of endometriosis. CEP could lower serum levels of CA125 and CA19-9, and down-regulate the expression level of cyclin D, indicating its roles in inhibiting the cell cycle.

Adult ; Antigens, Tumor-Associated, Carbohydrate ; blood ; CA-125 Antigen ; blood ; CA-19-9 Antigen ; blood ; Cyclin D1 ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; Endometriosis ; blood ; drug therapy ; Female ; Humans

Animals ; Body Water ; Brain ; anatomy & histology ; Male ; Organ Size ; Rats ; Rats, Wistar ; Specific Gravity

Objective To localize Der f 2 in the body of Dermatophagoides farinae.Methods Live mites were embedded.Serial mite paraffin sections were made and checked under light microscope.The sections were incubated with anti-recombinant Der f 2 monoclonal antibody as the first antibody.They were then reacted with the fluorescent isothiocyanate conjugated goat anti-mouse IgG as the secondary antibody.The sections were examined with fluorescent light microscopy.Results Der f 2 reacting with immunofluorescent antibodies was found localized in the tissue and contents of the mid-gut of the mite.Conclusion The major allergen Der f 2 distributes in the gut and fecal pellets of Dermatophagoides farinae.

Objective To explore effects of ginsenosides Rg1 on the expression of poly(ADP-ribose) polymerase-1 (PARP-1) and tumor necrosis factor receptor (TNFR) 1 in cortex cells after focal cerebral ischemia in rats. Methods Ninety healthy rats were randomly divided into sham-operative group, focal cerebral ischemia group, ginsenoside Rg 1groups (low, medium and high concentrations) and drug control group. Rats were intraperitoneally injected saline 45 mg/kg, saline 45 mg/kg+ginsenosides Rg1 10, 20 and 40 mg/kg, nimodipine 1 mg/kg 5 d before surgery, respectively. Focal cerebral isch?emia model was made by middle cerebral artery occluding in rats. The neurological deficit score and TTC staining were used to verify the success of the rat model. The expressions of PARP-1 and TNFR1 were evaluated by immunohistochemical meth?od and Western blot technique. Results There were obvious symptoms of neurological deficit and large pale infarct area in focal cerebral ischemia group compared with those of sham-operative group. There were higher percentages of neurological deficit score and infarct area in ginsenosides Rg1 groups and positive control group than those of sham-operative group, but which were lower than those of ischemia group (P<0.05). There were no significant differences between ginsenosides Rg1 groups and positive control group. The positive cells of PARP-1 and TNFR1 were higher in ginsenosides Rg1 low-dose group than those of sham-operative group and positive control group, while ones of medium and high-dose Rg1 group were higher than those of sham-operative group, and were lower than those of ischemia group (P<0.05). Compared with sham-op?erative group, PARP-1 and TNFR1 expression strips were significantly enhanced in ischemia group. Expression strips were higher in ginsenosides Rg1 low-dose group than those of sham-operative group. Expression strips were higher in ginsen?osides Rg1 medium-dose group than those of sham-operative group, but which were lower than those of ischemia group, and ones of high-dose group were lower than ischemia group (P<0.05). Conclusion Ginsenoside Rg1 shows protective effects on focal ischemia injury, which may be related with down-regulation of the expression of PARP-1 and TNFR1.

Objective To evaluate whether serum complement C3 concentration was associated with the prevalence and incidence of prediabetes in an adult population. Methods A cross-sectional (n=10 539) and prospective cohort (n=3 064, followed up for-6 years, mean:2.8 y) study was performed on subjects recruited from the Health Management Center of Tianjin Medical University General Hospital in Tianjin. Measurements of serum C3 concentration, blood fasting glucose and other potential confounding factors were assessed at baseline and per year during the follow-up period. Prediabetes was defined according to the criteria of American Diabetes Association. Adjusted Logistic and Cox proportional hazards regression models were used to assess the associations between C3 quintiles and prediabetes. Results The prevalence and incidence of prediabetes were 19.9% and 99.5 per 1 000 person-year, respectively. In cross-sectional analysis, after adjusted for potential confounders, the odds ratios (95% confidence interval) of prediabetes for increasing quintiles of C3 were 1.00 (reference), 1.18 (0.98-1.42), 1.11 (0.92-1.34), 1.38 (1.15-1.65) and 1.63 (1.36-1.95) (P for trend<0.000 1). In cohort analysis, in the final multivariate models, the hazard ratios (95% confidence interval) for prediabetes across C3 quintiles were 1.00 (reference), 1.20 (0.94-1.54), 1.48 (1.16-1.88), 1.38 (1.09-1.76) and 1.53 (1.21-1.95) (P for trend <0.001), respectively. Conclusion The study suggests that the elevated C3 level is significantly associated with the prevalence and incidence of prediabetes, which means that C3 can be used as a biomarker in early prevention of prediabetes and diabetes.

Objective:To investigate the clinical experience about the transconjunctival lower eyelid blepharoplasty with correction of the eyelid orbital sulcus deformity.Methods:This group received 67 cases from June 2016 to July 2018, including 3 males and 64 females. The average age was 22 years. All the cases were diagnosed as lower eyelid bag with different degrees of fat herniation after orbital septum, with no or slight lower eyelid skin relaxation. Orbital sulcus of different degree appeared with outline of bony orbital margin, or accompanied by underdevelopment of the suborbital region. Through a transconjunctival incision or with short external canthal incision, the adipose mass was fully exposed behind the anterior wall of lower eyelid, the arcuate edge was released, and the pedicled orbital fat was transferred to the gap between the orbital eyelid sulcus and fixed in the lower orbital margin. If there was insufficient fat behind the orbital septum, a retroauricular fascia graft was used to make up.Results:No postoperative complications occured in all cases. After followed up for more than 3-month, 3 of 67 cases showed mild fat bulging pouch deformity in bilateral eyelids and 1 case was in unilateral eyelid. In other cases, deformity of the pouch and the eyelid orbital sulcus were improved significantly, and dynamic expression (orbicularis muscle contraction) showed no local uplift in lower eyelid morphology.Conclusion:The transconjunctival lower eyelid blepharoplasty with correction of the eyelid orbital sulcus deformity can obtain good clinical results in lower eyelid area.

Objective To investigate the effect of Kangaroo care(KC)on diminishing neonatal pain during heel lancing. Methods Sixty neonates were divided randomly into two equal groups:intervention group and control group,which 30 cases in each group.In the intervention group,neonates were treated with KC(neonates were put in direct and continuous skin-to-skin contact with his/her mom)from 20 mins before heel lancing to 1 mins after the end of the lancing.In the control group,neonates were treated with regular care.The differences in heart rate,blood oxygen saturation,facial pain expression,crying duration and DAN(Douleur Aigue Nouveaune)scores between two groups were compared at 7 time points from 10s before the heel lancing to 10s after the lancing. Results The results of repeated measu te at 7 time points after heel lancing.There were significant interaction effect between time and main effect(P<0.01),which showed that the heart rate of two groups were not equal at different time points.Compared with the time effects(P<0.01)which showed that two groups of neonatal heart rate of the two groups would accelerate with time extension. There were significant differences(all P<0.05)in heart rate at 7 time points between two groups and smaller heart rate varied range in intervention group.The results of repeated measures analysis for neonatal blood oxygen saturation at 7 time points after heel lancing. There were significant interaction effect between time and main effects(P<0.01),which showed that the blood oxygen saturation of two groups were not equal at different time points.Compared with the time effect(P<0.01),which showed that two groups of neonatal blood oxygen saturation would reduce with time extension.There were significant differences(all P<0.05)in blood oxygen saturation of two groups at 30s,40s and 50s after heel lancing and smaller blood oxygen saturation varied range in intervention group.The crying duration and DAN scores in intervention group were significantly reduced compared with the controls(all P<0.05).Conclusions
Heel lancing could lead to moderate to severe pain of neonates.KC could effectively diminish the neonatal pain degree caused by heel lancing.

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy