1.Construction of blood quality monitoring indicator system in blood banks of Shandong
Qun LIU ; Xuemei LI ; Yuqing WU ; Zhiquan RONG ; Zhongsi YANG ; Zhe SONG ; Shuhong ZHAO ; Lin ZHU ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Xiaojuan FAN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):249-257
【Objective】 To establish a blood quality monitoring indicator system, in order to continuously improve blood quality and standardized management. 【Methods】 Based on the research of literature and standards, and guided by the key control points of blood collection and supply process, the blood quality monitoring indicator system was developed. Through two rounds of Delphi expert consultation, the indicator content was further revised and improved according to expert opinions after six months of trial implementation. The indicator weight was calculated by questionnaire and analytic hierarchy process. 【Results】 A blood quality monitoring indicator system covering the whole process of blood collection and supply was constructed, including five primary indicators, namely blood donation service, blood component preparation, blood testing, blood supply and quality control, as well as 72 secondary indicators, including definitions, calculation formulas, etc. Two rounds of expert consultation and two rounds of feasibility study meeting were held to revise 17 items and the weight of each indicator was obtained through the analytic hierarchy process. After partial adjustments, a blood quality monitoring indicator system was formed. 【Conclusion】 A blood quality monitoring indicator system covering the whole process of blood collection and supply has been established for the first time, which can effectively evaluate the quality management level of blood banks and coordinate blood quality control activities of blood banks in Shandong like pieces in a chess game, thus improving the standardized management level
2.Application of quality monitoring indicators of blood testing in blood banks of Shandong province
Xuemei LI ; Weiwei ZHAI ; Zhongsi YANG ; Shuhong ZHAO ; Yuqing WU ; Qun LIU ; Zhe SONG ; Zhiquan RONG ; Shuli SUN ; Xiaojuan FAN ; Wei ZHANG ; Jinyu HAN ; Lin ZHU ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):258-266
【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P<0.05). The unqualified rate of HBsAg, anti HCV, anti HIV and anti TP was (0.15±0.09)%, (0.05±0.04)%, (0.06±0.03)% and (0.20±0.05)% respectively. The average unqualified rate, average hemolysis rate, average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰, 0.08‰, 0.01‰ and 0.02‰ respectively. There were differences in the retest concordance rates of four HBsAg, anti HCV and anti HIV reagents, and three anti TP reagents among 17 blood bank laboratories (P<0.05). The usage rate of ELISA reagents was (114.56±3.30)%, the outage rate of ELISA was (10.23±7.05) ‰, and the out of range rate of ELISA was (0.90±1.17) ‰. There was no correlation between the out of range rate, outrage rate and usage rate (all P>0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.
3.Application of quality control indicator system in blood banks of Shandong
Qun LIU ; Yuqing WU ; Xuemei LI ; Zhongsi YANG ; Zhe SONG ; Zhiquan RONG ; Shuhong ZHAO ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Xuejing LI ; Bo ZHOU ; Chenxi YANG ; Haiyan HUANG ; Guangcai LIU ; Kai CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):267-274
【Objective】 To establish an effective quality monitoring indicator system for blood quality control in blood banks, in order to analyze the quality control indicators for blood collection and supply, and evaluate blood quality control process, thus promoting continuous improvement and standardizing management of blood quality control in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation services, component preparation, blood testing, blood supply and quality control was established. The Questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shandong, which clarified the definition and calculation formula of indicators. The quality monitoring indicator data from January to December 2022 in each blood bank were collected, and 20 quality control indicators data were analyzed by SPSS25.0 software. 【Results】 The average pass rate of key equipment monitoring, environment monitoring, key material monitoring, and blood testing item monitoring of 17 blood banks were 99.47%, 99.51%, 99.95% and 98.99%, respectively. Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05), and the Pearson correlation coefficient (r) between the total number of blood quality testing items and the total amount of blood component preparation was 0.645 (P<0.05). The average discarding rates of blood testing or non-blood testing were 1.14% and 3.36% respectively, showing significant difference among blood banks of varied scales (P<0.05). The average discarding rate of lipemic blood was 3.07%, which had a positive correlation with the discarding rate of non testing (r=0.981 3, P<0.05). There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without (P<0.05). The average discarding rate of abnormal color, non-standard volume, blood bag damage, hemolysis, blood protein precipitation and blood clotting were 0.20%, 0.14%, 0.06%, 0.06%, 0.02% and 0.02% respectively, showing statistically significant differences among large, medium and small blood banks(P<0.05).The average discarding rates of expired blood, other factors, confidential unit exclusion and unqualified samples were 0.02%, 0.05%, 0.003% and 0.004%, respectively. The discarding rate of blood with air bubbles was 0.015%, while that of blood with foreign body and unqualified label were 0. 【Conclusion】 The quality control indicator system of blood banks in Shandong can monitor weak points in process management, with good applicability, feasibility, and effectiveness. It is conducive to evaluate different blood banks, continuously improve the quality control level of blood collection and supply, promote the homogenization and standardization of blood quality management, and lay the foundation for comprehensive evaluation of blood banks in Shandong.
4.Quality monitoring indicator system in blood banks of Shandong: applied in blood donation services, component preparation and blood supply process
Yuqing WU ; Hong ZHOU ; Zhijie ZHANG ; Zhiquan RONG ; Xuemei LI ; Zhe SONG ; Shuhong ZHAO ; Zhongsi YANG ; Qun LIU ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):275-282
【Objective】 To establish an effective quality indicator monitoring system, scientifically and objectively evaluate the quality management level of blood banks, and achieve continuous improvement of quality management in blood bank. 【Methods】 A quality monitoring indicator system that covers the whole process of blood collection and supply was established, the questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong. Statistical analysis of 21 quality monitoring indicators in terms of blood donation service (10 indicators), blood component preparation (7 indicators ), and blood supply (4 indicators) from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed. 【Results】 The average values of quality monitoring indicators for blood donation service process of 17 blood banks were as follows: 44.66% (2 233/5 000) of regular donors proportion, 0.22% (11/50) of adverse reactions incidence, 0.46% (23/5 000) of non-standard whole blood collection rate, 0.052% (13/25 000) of missed HBsAg screening rate, 99.42% (4 971/5 000) of first, puncture successful rate, 86.49% (173/200) of double platelet collection rate, 66.50% (133/200) of 400 mL whole blood collection rate, 99.25% (397/400) of donor satisfaction rate, 82.68% (2 067/2 500) of use rate of whole blood collection bags with bypass system with sample tube, and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood (P<0.05). The platelet collection rate, incidence of adverse reactions to blood donation, and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks (P<0.05). The average quality monitoring indicators for blood component preparation process of 17 blood banks were as follows: the leakage rate of blood component preparation bags was 0.03% (3/10 000), the discarding rate of lipemic blood was 3.05% (61/2 000), the discarding rate of hemolysis blood was 0.13%(13/10 000). 0.06 case had labeling errors, 8 bags had blood catheter leaks, 2.76 bags had blood puncture/connection leaks, and 0.59 cases had non-conforming consumables. The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks (P<0.05), and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks (P<0.05). The average values of quality monitoring indicators for blood supply process of 17 blood banks were as follows: the discarding rate of expired blood was 0.023% (23/100 000), the leakage rate during storage and distribution was of 0.009%(9/100 000), the discarding rate of returned blood was 0.106% (53/50 000), the service satisfaction of hospitals was 99.16% (2 479/2 500). The leakage rate of blood components during storage and distribution was statistically different with that of blood component preparation bags between different blood banks (P<0.05). There were statistically significant differences in the proportion of regular blood donors, incidence of adverse reactions, non-standard whole blood collection rate, 400 mL whole blood collection rate, double platelet collection rate, the blood bag leakage rate during preparation process, the blood components leakage rate during storage and distribution as well as the discarding rate of lipemic blood, hemolysis blood, expired blood and returned blood among large, medium and small blood banks (all P<0.05). 【Conclusion】 The establishment of a quality monitoring indicator system for blood donation services, blood component preparation and blood supply processes in Shandong has good applicability, feasibility and effectiveness. It can objectively evaluate the quality management level, facilitate the continuous improvement of the quality management system, promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.
5.Core stability training applying the sling exercise therapy pattern can significantly improve the balance of stroke survivors
Sijia LUO ; Jianqiu GONG ; Tong ZHU ; Xiaoqiong DONG ; Xiabin XU ; Shuli TENG ; Yuefeng WU
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(6):517-521
Objective:To observe the impact of core stability training in the sling exercise therapy pattern on the balance of stroke survivors.Methods:Sixty stroke survivors were randomly divided into a control group ( n=30) and an experimental group ( n=30). In addition to routine rehabilitation training, the control group received traditional core stability training, while the experimental group underwent core stability training applying the sling exercise therapy pattern. Before and after 4 weeks of training, the standing balance of both groups was evaluated using the Prokin balance trainer, with the length and area of motion recorded when performing the balance test with the eyes open and closed. Surface electromyography was used to record the average EMG (AEMG) values of the bilateral erector spinae and multifidus muscles during the balance testing. Results:After the 4 weeks of training the length and the area of progression of the center of the pressure were both significantly smaller for both groups than before the training with the eyes both open and closed. The average length and area in the experimental group were significantly less than among the controls. The AEMG values recorded during the balance tests were significantly higher than those before the intervention for both groups, with the multifidus muscle averages on the affected side significantly greater in the experimental group than among the controls when performing the balance test with the eyes closed.Conclusion:Core stability training in the sling exercise therapy pattern is superior to conventional core stability training because it can better improve the balance of stroke survivors.
6.Construction and validation of a risk prediction model for diabetes mellitus in patients with vitiligo
Baizhang LI ; Pan KANG ; Xiaoying ZHANG ; Guannan ZHU ; Shuli LI ; Chunying LI
Chinese Journal of Dermatology 2022;55(7):576-582
Objective:To analyze risk factors for diabetes mellitus in patients with vitiligo, and to construct and validate a prediction model.Methods:A total of 110 vitiligo patients with diabetes mellitus (comorbidity group) and 4 505 vitiligo patients without diabetes mellitus (control group) were collected from the medical record database in Xijing Hospital, the Fourth Military Medical University from January 2010 to October 2021, and matched for gender and age at a ratio of 1∶4 by using a propensity score method. After matching, the matched pairs were randomly divided into a training set and a test set at a ratio of 4∶1. Univariate and multivariate logistic regression analyses were used to assess demographic and clinical characteristics of patients in the training set, screen differential factors, and construct a prediction model. A five-fold cross-validation method was used for internal validation after construction of the prediction model. The discrimination (area under the curve [AUC]) , calibration (Hosmer-Lemeshow test) and accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of the prediction model were evaluated in the test set.Results:A total of 107 cases in the comorbidity group and 428 cases in the control group were successfully matched. The training set included 430 cases, and the test set included 105 cases. Based on multivariate logistic regression results, a total of 6 factors were included in the prediction model, including course of vitiligo (odds ratio [ OR] = 1.04, 95% confidence interval [ CI]: 1.02 - 1.07, P<0.001) , high-sugar/high-fat/high-salt diet ( OR = 3.19, 95% CI: 1.38 - 7.38, P = 0.007) , family history of diabetes ( OR = 23.23, 95% CI: 9.72 - 55.50, P<0.001) , metabolic comorbidities ( OR = 12.53, 95% CI: 5.60 - 28.07, P<0.001) , autoimmune comorbidities ( OR = 5.89, 95% CI: 2.52 - 13.76, P<0.001) , and acral vitiligo ( OR = 3.84, 95% CI: 1.45 - 10.19, P = 0.007) . Five-fold cross-validation results showed a good predictive performance of the prediction model, with the AUC being 0.902 (95% CI: 0.864 - 0.940) in the training set and 0.895 (95% CI: 0.815 - 0.974) in the test set. The prediction model also showed favourable discrimination (AUC =0.814, 95% CI: 0.715 - 0.913) , calibration (Hosmer-Lemeshow test, P = 0.068) , and accuracy (sensitivity = 0.810, 95% CI: 0.574 - 0.937; specificity = 0.786, 95% CI: 0.680 - 0.865; positive predictive value = 0.486, 95% CI: 0.317 - 0.657; negative predictive value = 0.943, 95% CI: 0.853 - 0.982) in the test set. Conclusion:A risk prediction model was constructed for diabetes mellitus in patients with vitiligo based on 6 factors (course of vitiligo, high-sugar/high-fat/high-salt diet, family history of diabetes, metabolic comorbidities, autoimmune comorbidities, and acral vitiligo) , which showed favourable discrimination, calibration and accuracy, and might provide a reference for screening the high-risk diabetic population in vitiligo patients.
7. Clinical analysis of risk factors for severe patients with novel coronavirus pneumonia
Yun LING ; Yixiao LIN ; Zhiping QIAN ; Dan HUANG ; Dandan ZHANG ; Tao LI ; Min LIU ; Shuli SONG ; Jun WANG ; Yuyi ZHANG ; Shuibao XU ; Jun CHEN ; Jianliang ZHANG ; Tongyu ZHU ; Bijie HU ; Sheng WANG ; Enqiang MAO ; Lei ZHU ; Hongzhou LU
Chinese Journal of Infectious Diseases 2020;38(0):E023-E023
Objective To analyze the clinical features of patients with coronavirus disease 2019 (COVID-19) in Shanghai and to investigate the risk factors for disease progression to severe cases. Methods The clinical data of 292 adult patients with COVID-19 hospitalized in Shanghai Public Health Clinical Center from January 20, 2020 to February 10, 2020 were retrospectively analyzed, including 21 severe patients and 271 mild patients. The demographic characteristics, epidemiological history, history of underlying diseases and laboratory examinations were compared between the two groups. Measurement data were compared using t test or Mann-Whitney U test. The count data were compared using hi-square test. The binary logistic regression equation was used to analyze the risk factors for the progression of patients to severe cases. Results Among the 292 patients, 21 were severe cases with the rate of 7.2% (21/292). One patient died, and the mortality rate was 4.8% in severe patients. The severe patients aged (65.0±15.7) years old, 19 (90.5%) were male, 11 (52.4%) had underlying diseases, 7 (33.3%) had close relatives diagnosed with COVID-19. The mild patients aged (48.7±15.7) years old, 135 (49.8%) were male, 74 (27.3%) had underlying diseases, 36 (13.3%) had close relatives diagnosed with COVID-19. The differences between two groups were all significant statistically ( t =-4.730, χ 2 =12.930, 5.938 and 4.744, respectively, all P <0.05). Compared with the mild patients, the levels of absolute numbers of neutrophils, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, creatinine, serum cystatin C, C reactive protein (CRP), procalcitonin , D -dimer, pro-B-type natriuretic peptide (proBNP), serum myoglobin, creatine kinase (CK), creatine kinase isoenzyme (CK-MB), serum troponin I (cTnI) in severe patients were all significantly higher ( U =2 091.5, 1 928.0, 1 215.5, 729.0, 1 580.5, 1 375.5, 917.5, 789.5, 1 209.0, 1 434.0, 638.0, 964.5, 1 258.0 and 1 747.5, respectively, all P <0.05), while the levels of lymphocyte count, albumin, transferrin, CD3 + T lymphocyte count, CD8 + T lymphocyte count and CD4 + T lymphocyte count in severe patients were all significantly lower ( U =1 263.5, t =4.716, U =1 214.0, 962.0, 1 167.5 and 988.0, respectively, all P <0.05). Further logistic regression analysis showed that the albumin (odds ratio ( OR )=0.806, 95% CI 0.675-0.961), CRP ( OR =1.016, 95% CI 1.000-1.032), serum myoglobin ( OR =1.010, 95% CI 1.004-1.016), CD3 + T lymphocyte count ( OR =0.996, 95% CI 0.991-1.000) and CD8 + T lymphocyte count ( OR =1.006, 95% CI 1.001-1.010) at admission were independent risk factors for the progression of COVID-19 patients to severe illness (all P <0.05). Conclusions Severe cases of patients with COVID-19 in Shanghai are predominantly elderly men with underlying diseases. Albumin, CRP, serum myoglobin, CD3 + T lymphocyte count and CD8 + T lymphocyte count could be used as early warning indicators for severe cases, which deserve more clinical attention.
8.Pharmaceutical Care for a Case of Refractory Mycoplasma Pneumoniae Pneumonia Combined with Cerebral Infarction in Child by Clinical Pharmacist
Lili HAI ; Lin ZHU ; Yiqing ZHU ; Zhiping LI ; Shuli MA
China Pharmacy 2019;30(23):3297-3301
OBJECTIVE: To introduce the pharmaceutical care for refractory mycoplasma pneumoniae (MP) pneumonia combined with cerebral infarction in child by clinical pharmacist, and to improve further understanding of MP-induced cerebral infarction and the management level of the clinical pharmacist. METHODS: Clinical pharmacist provided whole course pharmaceutical care for a child case of refractory PM pneumonia complicated with cerebral infarction admitted to the Children’s Hospital of Fudan University in Oct. 2018. The drug use in anti-infection, anti-inflammatory, treatment of cerebral infarction, possible drug interactions and suspected ADR were analyzed during treatment. RESULTS: The child admitted to the hospital for treatment due to MP pneumonia. During the treatment, the child suffered from cerebral infarction symptoms. The child was given a series of treatment programs, such as Azithromycin for injection for anti-infection, Methylprednisolone sodium succinate for injection for anti-inflammation, Nadroparin calcium injection for anticoagulation, Mannitol injection for reducing intracranial pressure, Dextran 40 glucose injection anti-thrombosis, Compound glycyrrhizin injection for protecting liver function, Hydrotalcite tablets for protecting gastric mucosa, intravenous immunoglobulin symptomatic supportive treatment. During the treatment, due to the poor therapeutic effect of Azithromycin for injection, it was considered that the patient may have cerebral infarction caused by refractory MP infection, so the patient’s prognosis was good when Azithromycin injection was replaced with Levofloxacin hydrochloride injection for anti-infection. For the increase of liver enzyme during the treatment, clinical pharmacist suggested that anti-infection combined with liver protection was provided for the child and then the liver enzyme returned to normal. During the treatment, clinical pharmacist mainly monitored the interaction and possible adverse reactions among anticoagulants, glucocorticoids, liver protecting drugs, drugs for reducing cranial pressure, antipyretic and analgesic drugs, and at the same time, made medication publicity and education for the family members of the child, and inform them of the adverse reactions of drugs to be paid attention to and the precautions for taking stomach protecting drugs, glucocorticoids and other drugs. CONCLUSIONS: Cerebral infarction caused by refractory MP pneumonia in children is because of excessive immune response directly or indirectly mediated by MP. The principle of treatment is to inhibit the inflammatory response, to solve the primary disease, and symptomatic supportive treatment. Multi-drug combination is needed in the course of treatment, so it is more necessary for the clinical pharmacist to participate in the whole process and to manage the drug refinement and ensure the safety of drug use.
9.Sleep structure of rapid eye movement sleep disorder patients and its correlations with emotional state, autonomic nerve symptom and sleep quality
Shuli CHEN ; Jinying WANG ; Linyang CUI ; Xiaodong ZHU ; Meiyun ZHANG ; Yan CHENG ; Rong XUE
Chinese Journal of Neuromedicine 2018;17(1):88-94
Objective To evaluate the sleep structure of rapid eye movement sleep disorder (RBD) patients and its correlations with emotional state,autonomic nerve system function symptoms,and sleep quality.Methods Twenty-two RBD patients examined in our hospital from October 2014 to May 2016 who complained of behavior disorders and conformed diagnosis by video-polysomnography (v-PSG) were chosen as RBD group;23 healthy gender,age and education-level matched subjects confirmed without RBD by v-PSG were selected as control group.Their emotional state,autonomic nerve function and sleep quality were assessed by center for epidemiological survey depression scale (CES-D),apathy evaluation scale (AES),scale for outcomes in PD for autonomic symptoms (SCOPA-AUT),and scale for outcomes in PD for sleep (SCOPA-SLEEP).The differences in sleep structures,periodic leg movement index (PLMI),apnea hypopnea index (AHI) and arousal index between RBD group and control group were compared.The differences of scores of emotional state,autonomic nerve system function symptoms were compared between the two groups.The correlations of sleep structure with emotional state,autonomic nerve system function symptom,and sleep quality in RBD group were analyzed.Results As compared with those of the control group,the proportion of non-rapid eye movement (NREM)-Ⅰ sleep of RBD group was significantly increased,proportions of NREM-Ⅱ sleep and NREM-Ⅲ sleep were statistically reduced,PLMI,CES-D scores,urinary and digestive system questionnaire and overall scores in the RBD group were significantly increased (P<0.05).In patients from RBD group,CES-D scores were positively correlated with proportion of NREM-I sleep (r=0.520,P=0.000);nighttime sleepiness questionnaire and overall scores were positively correlated with PLMI (r=0.465,P=0.029;r=0.444,P=0.039);daytime sleepiness scores were negatively correlated with proportion of NREM-Ⅲ sleep (r=-0.480,P=0.041);cardiovascular system symptom was correlated with PLMI (r=0.439,P=0.041).Conclusion RBD patients suffer sleep structure disturbance,depression tendency,digestive and urinary system of autonomic nerve symptoms;sleep quality scores and total scores,cardiovascular system symptoms scores are positively correlated with LMI;daytime sleepiness is negatively correlated with reducing phase Ⅲ sleep,CES-D scores are correlated with increasing NREM-I sleep and unbalanced neurotransmitter,especially,5-TH level.
10.Clinical Research on Bushen Huoxue Prescription in Treating Kidney Deficiency and Blood Stasis Type Primary Osteoporosis
Lin TIAN ; Haochen KANG ; Shuli WANG ; Ge YANG ; Jiangui ZHU
Chinese Journal of Information on Traditional Chinese Medicine 2017;24(9):11-14
Objective To observe the efficacy and safety of Bushen Huoxue Prescription in the treatment of kidney deficiency and blood stasis type primary osteoporosis. Methods Totally 50 patients with kidney deficiency and blood stasis type primary osteoporosis were collected. They were given Bushen Huoxue Prescription granules twice a day, taking with water, for 12 weeks. Before and after treatment, the femoral neck, Ward's area, L1–4 bone mineral density (BMD) were measured. VAS and TCM syndrome integrals were evaluated before and 4, 8 and 12 week of treatment. The level of serum osteocalcin (OC), β-C-terminal telopeptides of type I collagen (β-CTX) and osteoprotegerin (OPG) were detected before and after treatment. Hematuria routine, liver and kidney function were under safety testing before and after treatment. Results Bushen Huoxue Prescription could significantly increase BMD of left femoral neck and Ward's triangle (P=0.001, P=0.044). L1–4 BMD increased, without statistical significance (P=0.172). The total effective rate was 60.870% (28/46) for L1–4 and left femoral neck and 58.696% (27/46) for Ward's triangle. The VAS and TCM syndrome integral decreased significantly 4 weeks treatment compared with that before the treatment (P<0.01), and the scores decreased significantly with the prolongation of treatment time (F=159.690, P<0.001; F=163.970, P<0.001). After 12 weeks, treatment, the total effective rate for TCM syndromes was 78.26% (36/46). Serum levels of OC and β-CTX showed a tendency to increase, while serum levels of OPG showed a tendency to decrease, without statistical significance (P=0.087, P=0.091, P=0.419). There was no serious adverse reaction in hematuria routine and liver and kidney function. Conclusion Bushen Huoxue Prescription has obvious clinical efficacy for kidney deficiency and blood stasis type primary osteoporosis, which can improve the patients' BMD, improve bone metabolism, relive bone pain, with high level of safety.

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