A study on the Charlson comorbidity index and health-related quality of life in the middle-aged and elderly osteoporosis population / 中国骨伤

OBJECTIVE@#To explore the characteristics of comorbidities in patients with osteoporosis(OP) and factors associated health-related quality of life, so as to provide decision-making reference for improving the ability of disease co-prevention and co-treatment and the patient's life-cycle quality of life.@*METHODS@#From November 2017 to July 2018, clinical information and biological samples from residents in 10 communities in Chaoyang District and Fengtai Distric of Beijing were collected, and bone density testing was conducted. Based on the Charlson comorbidity index (CCI), the comorbidity of the population was quantified, and grouped according to factors such as gender, age, and the differences between the groups were explored. Combined with the clinical information of patients, the difference characteristics of comorbidity and non-comorbidity population were analyzed. Pearson/Spearman correlation analysis and binary Logistic regression analysis were used to explore the factors affecting the health-related quality of life in patients with OP.@*RESULTS@#Among the 521 OP patients, 121 patients had no comorbidities, and there were 153, 106, 65, and 30 patients with one, two, three, and four comorbidities, respectively, 46 patients with 5 or more kinds of comorbidites. Hypertension was the most common comorbidity in OP patients, accounting for 21.60%;followed by hyperlipidemia, accounting for 13.51%. The most common combination of the two diseases was hypertension plus hyperlipidemia (64 cases, 12.28%). Through the analysis of differences between age groups, it was found that the older patients, showed higher the CCI, and the difference between groups was statistically significant(Z=1.93, P=0.05). There were significant differences in the total EQ-5D score and the dimensions of anxiety and depression between patients with comorbidities (CCI≠0) and non-comorbidities (CCI=0) (Z=-2.67, P=0.01;Z=-2.44, P=0.02). Correlation analysis found that CCI, history of fracture, history of falls, hip bone mineral density T value and parathyroid hormone were all related to the health-related quality of life in OP patients (P<0.05). Binary Logistic regression analysis suggested that the right hip bone mineral density T value (P=0.02), CCI (P=0.01), fracture history (P=0.03) and fall history (P=0.01) were the risk factors that affect the health-related quality of life in OP patients.@*CONCLUSION@#The burden of comorbidities among middle-aged and elderly OP populations in Beijing is relatively heavy, and the health management of such populations should be further strengthened, specifically the combination of multiple comorbidities should be given high priority. Comorbid factors are of great importance for the diagnosis and treatment strategy of OP patients, which could further improve the quality of life.

Randomized controlled trial outcome indicators of postmenopausal osteoporosis treated by traditional Chinese medicine / 中国中药杂志

This study evaluated the outcome indicators of the randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) in the treatment of postmenopausal osteoporosis(PMOP) to provide a reference for the related research. Four Chinese databa-ses(CNKI, VIP, Wanfang and CBM) and three English databases(Cochrane Library, EMbase and PubMed) were searched syste-matically to screen RCTs of TCM in the treatment of PMOP according to the pre-set criteria, and the quality of the included trials was evaluated by the Cochrane risk-of-bias tool. A total of 29 627 articles were initially retrieved, and finally, 43 articles were included, including 34 in Chinese and 9 in English. As revealed by the results, the outcome indicators of 43 RCTs were mainly divided into six categories, with biochemical indicators accounting for 54.59%, bone mineral density(BMD) for 26.57%, quality of life for 6.28%, fracture for 1.94%, safety for 5.31%(including adverse reactions or events) and others for 5.31%. Biochemical indicators showed the maximum occurrence, followed by BMD. Many problems were found in the selection of outcome indicators of the TCM RCTs in the treatment of PMOP, such as the confusion of primary and secondary outcome indicators, the lack of endpoint criteria and vital clinical outcome indicators substituted by intermediate indicators, inconsistent evaluation standard of syndrome curative efficacy and neglected blinding in the measurement of subjective outcome indicators. The problems also included importance given to the efficacy indicators instead of the adverse outcome indicators, unnormalized indicator name, large quantitative range of the indicators, unconventional application of TCM efficacy criteria, seldom used confidence interval, relative effect indicator and absolute effect indicator.

Fall risk screening and related factors analysis of middle-aged and elderly population in communities:a cross-sectional study / 中国骨伤

OBJECTIVE@#To explore the potential related factors of falls and provide a reference plan for preventing falls for the middle-aged and elderly people.@*METHODS@#From November 2017 to July 2018, a total of 1 642 middle-aged and elderly people from 10 communities in @*RESULTS@#A total of 1 540 subjectswere included, including, 415 men and 1 125 women. Their average age was(63.02±7.15) years. The incidence of falls in recent one year was 12.14%(187 / 1 540). According to @*CONCLUSION@#For middle aged and elderly people, avoiding heavy drinking, eating more eggs, vegetables, and active strength exercise can effectively prevent falls. And people with family history of fracture and diabetes should pay more attention to the prevention of falls.

Clinical practice guideline for postmenopausal osteoporosis with traditional Chinese medicine / 中国中药杂志

The editorial group of the clinical practice guideline for postmenopausal osteoporosis(PMOP) with traditional Chinese medicine(TCM)(hereinafter referred to as "guideline") is composed of experts specialized in TCM orthopedics, TCM gynecology, clinical epidemiology, etc. The guideline was formulated through registration, collection and selection of clinical issues/outcome indicators, evidence retrieval and screening, preparation of systematic reviews, evaluation of evidence quality, formation of recommendations, drafting, and peer review. The syndromes and treatment of PMOP are elaborated in detail. Specifically, Liuwei Dihuang Pills and Zuogui Pills are recommended for PMOP with Yin deficiency in the liver and kidney, Qing'e Pills for PMOP with kidney deficiency and blood stasis, Yougui Pills and Jingui Shenqi Pills for PMOP with Yang deficiency in the spleen and kidney, and Er'xian Decoction for PMOP with Yin and Yang deficiency in the kidney. In addition, Duhuo Jisheng Decoction can be used to relieve pain. The commonly used Chinese patent medicines include Xianling Gubao Capsules, Qianggu Capsules, Jintiange Capsules, Gushukang Capsules, Hugu Capsules, Jinwu Gutong Capsules, and Guyuling Capsules. Acupuncture and moxibustion are also effective approaches for PMOP. The rehabilitation and daily management were carried out by exercise therapies such as Baduanjin(eight-section brocade), Wuqinxi(five-animal exercises), and Taijiquan(Tai Chi), Chinese medicine diet, health education, and fall prevention. The promotion and application of this guideline will facilitate the implementation of TCM prevention and treatment of PMOP, ensure the quality of life of PMOP patients, provide effective and safe TCM treatment measures for PMOP, and reduce the risk of fracture complications.

Analysis of adverse reactions of Xianling Gubao preparation based on real world SRS data / 中国中药杂志

From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.

Evaluation of bone mass and relevance ratio of osteoporosis among middle aged and elderly population in Beijing community / 中国骨伤

OBJECTIVE@#To investigate the relevance ratio of osteoporosis and bone mass of middle aged and elderly people in Beijing communities, in order to understand occurrence and development trend of abnormality of bone mass in high-risk population from community.@*METHODS@#Based on the method of cross-sectional investigation, the information data of 1 540 middle-aged and elderly people from 10 communities were collected, including 415 males and 1 125 females, aged from 45 to 80 years old with the average of (63.02±7.15) years old; the height was (161.34±7.24) cm, the weight was (65.90±10.19) kg, body mass index was (25.29±3.32) kg /m2. Bone mineral density (BMD) of lumbar vertebrae (L@*RESULTS@#The level of β-CTX was(0.27±0.12) ng /ml, procollanen type 1 N-terminal propeptide(P1NP) was(51.03± 22.36) ng /ml, 25(OH) D3 was (16.68±6.24) ng /ml, serum calcium was(2.34±0.09) mmol / L, blood phosphorus was (1.43± 0.37) mmol / L, and blood magnesium was (0.94±0.07) mmol / L, alkaline phosphatase was (79.28±20.48) U/ L, parathyroid hormone was (3.09±1.60) pmol / L, osteocalcin was (13.29±6.65) ng /ml. Except for blood magnesium, the other indexes had significant differences between different sex groups(@*CONCLUSION@#There are obvious differences in relevance ratio of osteoporosis and low bone mass among different sites. It is suggested that the clinical diagnosis of osteoporosis should be combined with bone mineral density and bone metabolic markers. With the increasing prevalence of osteoporosis among middle aged and elderly people in Beijing community, continuous follow-up research based on community primary health care units could promote early examination, early diagnosis, and early treatment of middle aged and elderly people at high risk of osteoporosis in community.

Meta-analysis for Qishen Yiqi Dropping Pills in Treatment of Chronic Heart Failure with Syndrome of Qi Deficiency and Blood Stasis / 中国实验方剂学杂志

Objective: To evaluate the efficacy and safety of Qishen Yiqi dropping pills in the treatment of chronic heart failure. Method: Eight databases were searched at home and abroad, and the randomized controlled trials of Qishen Yiqi dropping pills in the treatment of chronic heart failure were screened. Literature quality of the included studies was evaluated by the bias risk assessment tool of Cochrane collaboration network, and the Meta-analysis was performed by RevMan 5.3 software. Result: A total of 606 related literature were retrieved, and 11 studies were eventually included, involving 931 patients. The quality of the included literature was generally low. Meta-analysis results showed that efficacy of Qishen Yiqi dropping pills combined with conventional western medicine was better than conventional western medicine alone in improving B-type natriuretic peptide[weighted mean difference (WMD)=-29.47, 95% confidence interval (CI) (-37.29,-21.64), PPPP=0.005], 6-minute walk test[WMD=50.13, 95%CI (22.32, 77.93), P=0.000 4]. In terms of safety indicators, one study intended to observe safety indicators, but it was not reported in the actual literature, and the remaining studies did not find adverse reactions of Qishen Yiqi dropping pills combined with conventional western medicine. Conclusion: The results of this study support the clinical use of Qishen Yiqi dropping pills combined with conventional western medicine in the treatment of chronic heart failure, but in view of the limitations in the quantity and quality of clinical studies, the positive results are only used as a reminder and reference for clinical diagnosis and treatment. In the future, more high-quality researches are needed to further confirm its efficacy.

Systematic review and Meta-analysis of Huoxiang Zhengqi Pills combined with Western medicine for acute gastroenteritis / 中国中药杂志

To systematically review the efficacy and safety of Huoxiang Zhengqi Pills combined with Western medicine in the treatment of acute gastroenteritis. Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,EMbase) were systematically and comprehensively searched from the database establishment to April 2019 to collect the randomized controlled trials( RCTs) about the treatment of acute gastroenteritis with Huoxiang Zhengqi Pills combined with Western medicine. Two investigators independently performed literature screening,data extraction and bias risk assessment. Rev Man 5. 3 software was used for data analysis. A total of 316 articles were retrieved and finally 44 studies were included in this study,involving 4153 patients. The overall quality of the included studies was generally low. Meta-analysis results showed that in the total clinical effective rate,Huoxiang Zhengqi Pills combined with conventional treatment or norfloxacin tablets was superior to conventional treatment or norfloxacin tablets alone. In terms of the time for improving clinical symptoms,Huoxiang Zhengqi Pills combined with conventional treatment or norfloxacin tablets could better relieve fever than conventional treatment or norfloxacin tablets alone. In terms of incidence of adverse reactions,there was no statistical difference between Huoxiang Zhengqi Pills combined with conventional treatment and conventional treatment alone. Other outcome measures were affected by various factors( such as inclusion of only 1 study or excessive heterogeneity among studies) and could not be concluded. Due to the limitations of the quality and quantity of included studies,this conclusion still needs to be verified by more high quality researches.

Systematic review of efficacy and safety of Lianhua Qingwen Capsules in treatment of viral influenza / 中国中药杂志

To evaluate the efficacy and safety of Lianhua Qingwen Capsules in the treatment of viral influenza in order to guide clinical medication. Randomized controlled trials(RCTs) regarding Lianhua Qingwen Capsules for treatment of viral influenza were searched in the CNKI, WanFang, VIP, SinoMed and PubMed. The quality of papers selected based on the inclusion criteria were assessed according to the Cochrane collaboration method and Meta-analysis was performed by using RevMan 5.3 software. A total of 8 articles were included, with a total sample size of 955 cases, including 478 cases in the treatment group, and 477 cases in the control group. In terms of the therapeutic effect, Lianhua Qingwen Capsules group was superior to the control group, with a total effective rate RR=1.20, 95%CI [1.09,1.32], P=0.70; recovery rate of body temperature RR=1.13, 95%CI [1.02,1.24], P=0.001; rate of symptom improvement RR=1.18, 95%CI [1.12,1.24], P=0.16. In terms of adverse reactions, the control group was superior to Lianhua Qingwen Capsules, with the incidence of adverse reactions RR=1.54, 95%CI [0.73,3.24], P=0.93. Lianhua Qingwen Capsules has a better therapeutic effect on viral influenza, but the incidence of adverse reactions is high, and its safety must be taken seriously. Given the small number of documents included and the low quality, the efficacy and safety of Lianhua Qingwen Capsules shall be confirmed by more high-quality clinical studies.

Real world study on characteristics of Maixuekang Capsules combined with traditional Chinese medicines in treating nephrotic syndrome / 中国中药杂志

To analyze the clinical characteristics of Maixuekang Capsules combined with traditional Chinese medicines in the treatment of patients with nephrotic syndrome,and provide references for improving rationality of clinical drug use. Based on the database of hospital information system(HIS) in 15 hospitals in China,the electrical medical records of the patients diagnosed as nephrotic syndrome and treated with Maixuekang Capsules were collected. Their diagnostic information and characteristics of combined traditional Chinese medicines were analyzed by using association rules. The results showed that 1 588 patients of nephrotic syndrome who used Maixuekang Capsules were often complicated with hypertension(863 cases,accounting for 7. 54%),anemia(551 cases,accounting for 4. 81%),and coronary heart disease(349 cases,accounting for 3. 05%). Maixuekang Capsules were mainly combined with Tabellae Rhei et Natrii Bicarbonatis,Baining Capsules,tanshinone,Ganmao Qingre Granule,Shuxuening Injection in treating nephrotic syndrome. The results indicated that in the real world,Maixuekang Capsules was mainly used in combination with traditional Chinese medicines such as blood-activating and stasis-removing agents,pathogens eliminating and supporting healthy Qi agents,digestants,anti-bacterial and anti-inflammatory agents,wind-dispersing and antipyretic agents for patients with nephropathy. By the pharmacological effect,it was suitable for nephropathy patients based on combined diagnosis. The association rules of combination were specific,and can provide reference for subsequent studies and rational clinical medication of traditional Chinese medicines.

Systemic review of Jintiange Capsules in treatment of postmenopausal osteoporosis / 中国中药杂志

To systemically evaluate the efficacy and safety of Jintiange Capsules in the treatment of postmenopausal osteoporosis(PMOP).Seven literature databases were retrieved systematically,and two reviewers independently searched and screened studies,extracted data,and included all the randomized controlled trials on Jintiange Capsules in the treatment of PMOP.Interventions included comparison of Jintiange Capsules with placebo and routine treatment,and the studies on Jintiange Capsules combined with routine treatment versus conventional treatment were also included.The evaluation indicators of the study included at least one of the followings:fracture,quality of life,daily living ability,clinical symptoms,death,adverse events/adverse reactions,bone density,and bone metabolism indexes.The original study quality evaluation was conducted by following the Cochrane Handbook standard and statistical analysis was performed by using Rev Man 5.2.A total of 7 randomized controlled trials were included and the study quality was low.Meta-analysis showed that as compared with conventional treatment alone,Jintiange Capsules combined with conventional treatment showed more obvious effects in pain relief(MD=-0.98,95% CI[-1.55,-0.41],P=0.000 8),increasing blood calcium levels(MD=0.05,95% CI[0.02,0.09],P=0.003) and lowering serum alkaline phosphatase levels(MD=-12.92,95% CI[-24.09,-1.75],P=0.02).In addition,the Chinese patent medicine alone or in combination with conventional treatment was relatively safe.In conclusion,Jintiange Capsules has a certain effect in treating PMOP,but the quality of evidence is low.It is necessary to conduct well designed randomized controlled trials and select recognized evaluation indicators,especially the end outcomes in order to further improve the clinical evidence.

Study on mechanism of Drynariae Rhizoma in treating osteoporosis with integrative pharmacology perspective / 中国中药杂志

Drynariae Rhizoma has great significance in the clinical practice of osteoporosis treatment. Based on the perspective of integrative pharmacology, the study explored the mechanism of action of Drynariae Rhizoma in the treatment of osteoporosis. Six active components in Drynariae Rhizoma were obtained, mainly including glycosides and sterols. Taking the median of 2 times of "node connectivity" as the card value, the core node of the Chinese medicine target disease gene interaction network was selected. Based on this, three topological structural eigenvalues, such as "node connectivity" "node tightness" and "node connectivity" were calculated, thereby screening out four core targets of Drynariae Rhizoma treatment for osteoporosis, including thyroid parathyroid hormone 1 receptor (PTH1R), parathyroid hormone 2 receptor (PTH2R), calcitonin receptor gene (CALCR), and SPTBN1 gene (SPTBN1). Based on the gene ontology database GO and KEGG pathway database, the molecular function, intracellular localization, and biological reactions and pathways of proteins encoded by drug target genes were determined. Combined with enrichment calculation, it is predicted that osteoporosis may play a role in biosynthetic processes, such as circulatory system, nervous system, energy metabolism, prolactin signal pathway, GnRH signaling pathway, neurotrophic factor signaling pathway and other pathway. The conclusion of this study is certain with the existing research results, and the new target and new pathway could also be used as a theoretical basis for the further verification of osteoporosis.

Correlation of circRNAs' differential expression to negative-positive symptoms of patients with schizophrenia / 解放军医学杂志

Objective To explore the correlation of circRNAs' expression level to the negative-and positive symptoms of patients with schizophrenia (SZ).Methods Gene chip screening was performed with the peripheral blood samples from each five of SZ patients and normal controls.Nine circRNAs showing differentiate expression were confirmed,and further verification was done by real-time fluorescence quantitative PCR in 102 SZ patients and 103 normal controls.All the SZ patients were assessed with Positive and Negative Symptom Scale (PANSS).Results It was revealed that the expression levels of circRNA_102101,circRNA_102315,circRNA_104597,circRNA_101835 and circRNA_101836 were significantly down-regulated (P＜0.01 or P＜0.05),and circRNA_103102 and circRNA_103704 were up-regulated in SZ group (P＜0.01).The ACT value of circRNA_102101 and circRNA_103102 was positively correlated to the positive symptoms (P＜0.01 or P＜0.05),and the ACT value of circRNA_103704 also showed positive correlation with positive symptoms and general psychopathological symptoms (P＜0.01 or P＜0.05).The ACT values of circRNA_102101,circRNA_103102,circRNA_102315,circRNA_103704 and circRNA_102802 were correlated with thinking disorder (P＜0.01 or P＜0.05),and the ACT values of circRNA_102101,circRNA_103102,circRNA_104597,circRNA_103704 and circRNA_102802 were correlated with the activation (P＜0.01 or P＜0.05).The ACT values of circRNA_102101,circRNA_103102,circRNA_103704 and circRNA_102802 were positively correlated with paranoid (P＜0.01 or P＜0.05),and of circRNA_102101,circRNA_103102,circRNA_103704 and circRNA_102802 were markedly correlated with assault (P＜0.01 or P＜0.05).Therefore,circRNA_103704 was chosen into regressive equation of positive symptoms (P＜0.01),and circRNA_103704 and circRNA_102315 were chosen into regressive equation of general pathological findings (P＜0.01 or P＜0.05).Conclusion The expression levels of circRNA_103704 and circRNA_103102 are obviously up-regulated in SZ patients than in normal controls,and markedly correlated with the negative and positive SZ symptoms,so might be the dominant regulatory factors in the pathological process of schizophrenia.

Study of Jinye Baidu granule in treatment of wind-warmth lung heat disease (heat in lung-wei pattern)： a randomized, double-blind, parallel-controlled trial / 中国中药杂志

A randomized, double-blind, active parallel controlled trial will be conducted to include patients with acute upper respiratory infection and wind-warmth lung heat disease (heat in lung-wei pattern). Patients with serious bacterial infection (white blood cell count>1.2×1010, neutrophil>80%) will be excluded.so as to further identify Jinye Baidu Granule indications of Wind-warmth lung heat disease (heat in lung-wei pattern).According to the subjects of symptoms of fever and sore throats,Patients will be divided into three blocks： fever, swelling and sore throat, combined fever and swelling and sore throat. Subjects in three blocks will be divided into treatment group and control group with stratified blocked randomization. The treatment group will be treated with Jinye Baidu Granule, and the control group will be treated with Fufang Shuanghua granule. Primary outcome measure of patients with fever will be body temperature recovery time. Primary outcome measure of patients with swelling and sore throat will be throat symptom score. Primary outcome measures of patients combined with fever and swelling and sore throat will be body temperature recovery time and throat symptom score. Before and after all of the patients in the group were collected blood and urine routine, liver and renal function, electrocardiogram (ECG) data as the safety index while observing it adverse events. A total of 623 patients were included. Compared with control group,sore throat symptoms of patients with sore throat and pharyngeal symptoms total score have significantly different. so Jinny Baidu granule have a significant advantage in the treatment of sore throat. All of the experiments showed that the safety of the drug was good. Nausea, vomiting, stomach pain, diarrhea, digestive tract symptoms may occur only occasionally. We should pay attention to the changes when using in patients with spleen deficiency cold to avoid adverse reaction.

Systemic evaluation and Meta-analysis of Xianling Gubao capsule in treatment of primary osteoporosis in randomized controlled trials / 中国中药杂志

To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of osteoporosis (OP). Eight Chinese and English databases were retrieved (from establishment to February 2017), and clinical trials were screened according to the preset inclusion criteria and exclusion criteria. Then risk assessment tools were used for quality evaluation of the studies, and data extraction and analysis were conducted by using RevMan 5.3 software for Meta-analysis. A total of 1 895 articles were retrieved, and finally 54 studies were included. The total sample number was 5 030, including 2 543 cases in experimental group and 2 487 cases in control group. As compared with CT (routine therapy) intervention, Xianling Gubao capsules showed higher SOP efficiency and improved bone mineral density in patients with OP [MD=0.08, 95%CI (0.06, 0.10)]. As compared with control group, Xianling Gubao capsule+CT showed higher efficiency in PMOP and SOP, increased bone mineral density in OP patients [MD=0.04, 95%CI (0.03, 0.05)], POP patients [MD=0.08, 95%CI (0.05, 0.10)], and SOP patients [MD=0.06, 95%CI (0.05, 0.07)], relieved osteoporotic pain in OP patients [MD=-0.93,95%CI(-1.16, -0.70), increased alkaline phosphatase level in OP patients [MD=7.53, 95%CI (5.91, 9.14), blood calcium in OP patients [MD=0.03, 95%CI (0.01, 0.06)], and osteocalcin level in OP patients [MD=4.09, 95%CI (3.20, 4.98)], and increased serum phosphorus level in SOP patients [MD=0.03, 95%CI (0.00, 0.05)]. The main adverse reactions reported were liver injury and gastrointestinal symptoms. Xianling Gubao capsule alone or combined use with other medicines had better efficacy than western medicine alone in the treatment of osteoporosis. However, because of potential bias in the included studies, more high-quality randomized controlled trials would be needed to improve the level of evidence.

Systematic review on safety of Xianling Gubao capsule / 中国中药杂志

To systemically evaluate the safety of Xianling Gubao capsule after launching. Computer retrieval of Medline, EMbase, the Web of Science, Clinical Trials. gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM was conducted to collect information on all the research types of Xianling Gubao capsule. The literature was screened according to inclusion and exclusion criteria, and the quality of the studies was assessed according to the internationally accepted quality evaluation standards for data extraction and analysis. A total of 156 papers were included in this study, including 117 randomized control trials, 11 quasi-randomized control trials, 10 non-randomized control trials, 11 case report series, and 7 individual case reports; a total of 167 studies were analyzed. Xianling Gubao capsules were used in 7 496 patients, with an accumulative 377 cases of adverse reactions (ADR) and 4 cases of severe adverse reactions, including 1 death, 1 cerebrovascular accident, 1 case of skin allergy reaction, and 1 case of gastrointestinal discomfort; gastrointestinal system damage was most common in mild ADRs. In this study, we found that the overall safety of Xianling Gubao capsule was acceptable, but it lacked the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study, so the further studies on the safety of drug use should be conducted. Meanwhile, the application scope of Xianling Gubao capsules was beyond the manual, in urgent needs of the relevant departments to formulate norms and provide better guidance for clinical medication.

Systematic review on safety of sofren injection / 中国中药杂志

This systematic review aims to evaluate the drug safety of sofren injection in clinical studies. Seven databases were retrieved, and the articles were extracted by 2 researchers according to inclusion and exclusion criteria. Then the quality of all studies and extracted information was evaluated. Sixty three articles were finally included in our study, including 58 randomized controlled trials, 3 non randomized controlled trials, and 2 case reports. All studies included 5 872 patients. Intervention group had a total of 23 cases of adverse drug reaction(ADR), accounting for 0.39% of the total number of patients. ADRs mainly included headache(6 cases), palpitations(4 cases) and dizziness(4 cases). ADRs mainly occurred in the nervous system, cardiovascular system, digestive system and so on. Serious adverse events about sofren injection have not been found in the study, but it is still needed to be cautious in clinical applications. As the current systematic review is based on the previous studies, it is necessary to strengthen the safety monitoring in a long period, and regulate its clinical use as well.

Analysis of Diemailing Kudiezi injection use in real world in 7 189 patients with cerebral infarction / 中国中药杂志

This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics, use of Diemailing injection and combined use of drugs. Sixty-two percent(4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%(2 752/7 189) from western medicine hospitals; 84%(6 003/7 189) of the patients were from tertiary hospitals as compared with 16%(1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed, stash time after allocating transfusion, duration of injection, and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice, for instance, non-intravenous infusion, >14 d treatment course, use of non-designated solvent, and a single dose>40 mL or<10 mL. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China, and the other three most frequent combined drugs deproteinized calf blood extractive injection, Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing＋Aspirin＋Alprostadil was the most common combined use in our study, but the recommended clopidogrel＋Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples, providing basic reference information for clinicians and researchers. However, efficacy was not concerned in this study, so efficacy-related information could not be explained.

An introduction of RECORD and GRACE checklist for studies in real world / 中国中药杂志

Statement of the REporting of studies conducted using routinely collected data (RECORD) and evaluating checklist of good research for comparative effectiveness (GRACE) were translated and introduced in this paper. The two evaluation tools would help researchers of Chinese medicine to conduct real world study in future. RECORD statement focus on unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues. Researchers of comparative effectiveness research could refer to GRACE checklist. It was believed that researchers of Chinese medicines who were keen on real world studies would be benefited from the two tools.

Clinical manifestation and influential factors in patients with acute arsenic poisoning / 中华劳动卫生职业病杂志

<p><b>OBJECTIVE</b>To investigate the clinical characteristics of acute arsenic poisoning and its influential factors.</p><p><b>METHODS</b>Clinical data of 47 cases of arsenic poisoning were collected and analyzed. Two cases of observation, 40 cases of mild acute poisoning, and 5 severe acute poisoning were investigated in this group.</p><p><b>RESULTS</b>Myocardial enzyme activity was correlated with age and urine arsenic concentrations. Myocardial enzyme, the liver ALT, total bilirubin (TBil) and indirect bilirubin (IBil) were negatively correlated with vomiting frequency, with statistical significance (P < 0.05). Urine arsenic concentration was correlated with vomiting frequency and amount of soup drunk, with statistically significant difference (P < 0.05). Despite no statistical significance in age and amount of soup drunk, the patients with more vomiting or diarrhea had less urine arsenic concentrations, cardiac enzymes and liver enzyme concentration.</p><p><b>CONCLUSION</b>Acute arsenic poisoning can lead to multiple organ damage. The damage is relevant with amount of arsenic intake, vomiting, diarrhea and urinary frequency arsenic concentration. So early use of gastric lavage, vomiting, poison discharges, and adequate application of effective antidote (Na-DMPS) as soon as possible, symptomatic treatment and the reinforced monitoring, are the rescue key for patients with acute arsenic poisoning.</p>