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In order to meet the clinical needs of long-acting sustained-release thienorphine, injectable thienorphine loaded microspheres were developed, and the accelerated stability study was carried out to explore the suitable storage and transportation conditions of the microspheres. Using poly(lactic-co-glycolic acid) (PLGA) as carrier material, 3 batches of microspheres were prepared in pilot scale with emulsion solvent evaporation method. By investigating the in vitro release of thienorphine loaded microspheres at 37, 45, 52, and 60 ℃, and applying the Arrhenius equation, the linear relationship between the release rate constant (lgk) and the temperature (1/T) was established to obtain the equation: lgk = -8.073/T + 24.35 (R2 = 0.985 3), which showed that the release of microspheres at high temperature can be used to predict the release in vitro at 37 ℃, and 52.0 ± 0.5 ℃ was selected as the accelerated release condition in vitro. The quality research methods were established to investigate the changes of critical quality attributes such as microsphere morphology, drug loading, particle size and distribution, polymer molecular weight, and the related substances under accelerated conditions. The difference factor f1 and similarity factor f2 were used to assess the similarity of release behavior under accelerated conditions. The results showed that under the accelerated experimental conditions of 25 ± 2 ℃ and relative humidity (RH) 60% ± 5%, the critical quality attributes of injectable thienorphine loaded microspheres had no significant change in 6 months, suggesting that the long-term storage condition could be 5 ± 3 ℃.
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A cordycipitoid fungus infecting Hepialidae sp. in Nepal was supposed to be identical to Cordyceps liangshanensis, originally described from southwestern China, and thus, transferred to the genus Metacordyceps or Papiliomyces in previous studies. However, our multi-gene (nrSSU-nrLSU-tef-1α-rpb1-rpb2) phylogenetic and morphological studies based on the type specimen and additional collections of C. liangshanensis revealed that the fungus belongs to the genus Ophiocordyceps (Ophiocordycipitaceae). Therefore, a new combination O. liangshanensis was made, and a detailed description of this species was provided.
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The freeze-drying technique, characterized by low-temperature processing, is especially suitable for sensitive volatile oils with thermal instability. However, there are few studies focusing on the retention of volatile oils in the processing of freeze-dried preparations. This study evaluated the effects of different addition methods(adsorption, emulsification, solid dispersion, and inclusion) on the retention rate of the main components in peppermint oil, aiming to explore the application feasibility of freeze-dried preparations of volatile oils. Firstly, the addition method was determined based on the retention rates of menthol in four freeze-dried preparations. Secondly, an orthogonal test was designed to optimize the preparation process based on the characteristics of the preferred addition method. The results showed that the most suitable preparation form of peppermint oil was inclusion with beta-cyclodextrin(β-CD), and the retention rate of menthol in freeze-drying was 86.36%. According to the two-step preparation process of inclusion and freeze-drying, we introduced the product of inclusion rate and retention rate, i.e., comprehensive retention rate, to determine the optimum processing parameters. The results showed that β-CD/oil ratio of 7∶1, inclusion temperature of 40 ℃, and inclusion time of 2 h were the optimum processing parameters. The product prepared with these parameter had the comprehensive retention rate of 68.41%, retention rate of 92.53%, and inclusion rate of 73.93%. The inclusion compound was white powder with significantly increased solubility. The pre-paration process based on cyclodextrin inclusion in this study is stable and reliable and provides a new idea for ensuring the efficacy and stability of volatile components in freeze-dried preparations.
Subject(s)
Cyclodextrins , Freeze Drying , Mentha piperita , Oils, Volatile , Plant Oils , Solubility , TechnologyABSTRACT
A cordycipitoid fungus infecting Hepialidae sp. in Nepal was supposed to be identical to Cordyceps liangshanensis, originally described from southwestern China, and thus, transferred to the genus Metacordyceps or Papiliomyces in previous studies. However, our multi-gene (nrSSU-nrLSU-tef-1α-rpb1-rpb2) phylogenetic and morphological studies based on the type specimen and additional collections of C. liangshanensis revealed that the fungus belongs to the genus Ophiocordyceps (Ophiocordycipitaceae). Therefore, a new combination O. liangshanensis was made, and a detailed description of this species was provided.
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Objective: To explore the prevalence and risk factors of ischemic stroke in rural areas of Liaoning province. Methods: The study was a cross-sectional survey. From September 2017 to May 2018, a total of 10 926 rural residents aged ≥40 years were investigated in Chaoyang county, Lingyuan, Liaoyang county and Donggang city of Liaoning province. The investigation included questionnaire survey, physical examination and laboratory examination.Univariate and multivariate logistic regression models were used to analyze the risk factors of ischemic stroke. Results: The prevalence of ischemic stroke in the rural areas of Liaoning province was 5.51% (602/10 926), and the standardized prevalence rate was 4.04%. The standardized prevalence rate of male (5.05%) is higher than that of female (3.44%). The prevalence of ischemic stroke increased with age in both males (P<0.01) and females (P<0.01). Multivariate logistic regression analysis showed that age increase(compared with 40-49 years old group, 50-59 years old, OR=2.08, 95%CI 1.31-3.30, P=0.02; 60-69 years old, OR=3.90, 95%CI 2.51-6.05, P<0.01; 70-79 years old, OR=5.32, 95%CI 3.37-8.34, P<0.01; ≥80 years old, OR=3.64, 95%CI 2.00-6.62, P<0.01), male(OR=2.35, 95%CI 1.95-2.84, P<0.01),family history of stroke(OR=2.18, 95%CI 1.83-2.60, P<0.01),coronary heart disease (OR=2.01, 95%CI 1.52-2.66, P<0.01), hypertension (OR=2.82, 95%CI 2.21-3.60, P<0.01), diabetes mellitus (OR=1.36, 95%CI 1.11-1.67, P=0.03) and overweight/obese (OR=1.22, 95%CI 1.02-1.47, P=0.03) were the major risk factors of ischemic stroke. Conclusions: The prevalence of ischemic stroke in rural areas of Liaoning province is high. Age, male, family history of stroke, coronary heart disease, hypertension, diabetes mellitus, overweight/obesity are the risk factors of ischemic stroke in rural areas of Liaoning province.
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Brain Ischemia/epidemiology , China/epidemiology , Cross-Sectional Studies , Hypertension , Prevalence , Risk Factors , Rural Population , Stroke/epidemiologyABSTRACT
Objective@#To explore the prevalence and risk factors of ischemic stroke in rural areas of Liaoning province.@*Methods@#The study was a cross-sectional survey. From September 2017 to May 2018, a total of 10 926 rural residents aged ≥40 years were investigated in Chaoyang county, Lingyuan, Liaoyang county and Donggang city of Liaoning province. The investigation included questionnaire survey, physical examination and laboratory examination.Univariate and multivariate logistic regression models were used to analyze the risk factors of ischemic stroke.@*Results@#The prevalence of ischemic stroke in the rural areas of Liaoning province was 5.51% (602/10 926), and the standardized prevalence rate was 4.04%. The standardized prevalence rate of male (5.05%) is higher than that of female (3.44%). The prevalence of ischemic stroke increased with age in both males (P<0.01) and females (P<0.01). Multivariate logistic regression analysis showed that age increase(compared with 40-49 years old group, 50-59 years old, OR=2.08, 95%CI 1.31-3.30, P=0.02; 60-69 years old, OR=3.90, 95%CI 2.51-6.05, P<0.01; 70-79 years old, OR=5.32, 95%CI 3.37-8.34, P<0.01; ≥80 years old, OR=3.64, 95%CI 2.00-6.62, P<0.01), male(OR=2.35, 95%CI 1.95-2.84, P<0.01),family history of stroke(OR=2.18, 95%CI 1.83-2.60, P<0.01),coronary heart disease (OR=2.01, 95%CI 1.52-2.66, P<0.01), hypertension (OR=2.82, 95%CI 2.21-3.60, P<0.01), diabetes mellitus (OR=1.36, 95%CI 1.11-1.67, P=0.03) and overweight/obese (OR=1.22, 95%CI 1.02-1.47, P=0.03) were the major risk factors of ischemic stroke.@*Conclusions@#The prevalence of ischemic stroke in rural areas of Liaoning province is high. Age, male, family history of stroke, coronary heart disease, hypertension, diabetes mellitus, overweight/obesity are the risk factors of ischemic stroke in rural areas of Liaoning province.
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Objective To develop a scale suitable for evaluating the scientific research ability of medical workers in Liaoning Province,analyze its reliability and validity to provide a scientific and objective measurement method for the evaluation of scientific research ability of medical workers in Liaoning Province.Methods A survey of 6 577 medical workers in 2 grade and up medical institutions of Liaoning province was carried out by completing a self-assessment scale form of research capacity,5 812 effective questionnaires were collected,335 out of which were used for exploratory factor analysis,5 477 were used for confirmatory factor analysis and reliability and validity analysis.Results The scale of Cronbach's a coefficient is 0.982,the retest reliability is 0.967,the cumulative contribution rate of the four factors extracted by exploratory factor analysis was 80.195％.The validation factor analysis showed that the model fit well (GFI=0.907,AGFI=0.881,CFI=0.962,RMESA=0.076,NFI=0.960,IFI=0.962).Conclusions The research capability scale for Liaoning medical workers has good reliability and validity,which can be used in the evaluation of the research capability of the medical workers in Liaoning province.
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OBJECTIVE: To investigate whether there is significant difference between the GLP-1-Fc fusion protein(YD057) that is expressed by gene recombination and the marketed drug dulaglutide(Lilly). METHODS: SDS-PAGE, SEC, CE-SDS and CIEF were used to analyze the differences in molecular weight, purity and charge heterogeneity. The amino acid sequence, biological activity and receptor binding analysis were measured to assess whether the cytological function and molecular binding capacity were consistent. Oligosaccharide distribution was measured to assess whether N-linked glycosylation modification ratio was consistent. RESULTS: There was no significant difference in physicochemical properties, amino acid primary sequence, N-linked glycosylation modification ratio, cell biology function and receptor binding capacity between the biological similar drugs(YD057) and dulaglutide. CONCLUSION: Their critical quality attributes are basically the same.
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The quality standard of Chinese herbal medicine is the key in quality control, and the establishment of rice processing technology standard of rice fried Codonopsis Radix has important significance for the overall quality control. In this study, the color brightness (L*), red-green chromaticity coordinate (a*), yellow-blue chromaticity coordinate (b*) and total color value（E*ab）were determined by colorimeter and used as the shape indexes. Ethanol extractives, polysaccharide, lobetyolin and 5-hydroxymethyl furfural contents were determined by using high performance liquid chromatography (HPLC) and ultraviolet (UV), and used as chemical indexes in the analysis by normalization distance method. The two index methods were adopted to optimize the processing technology of rice fried Codonopsis Radix by taking processing temperature, processing time, rice types and rice dosage as factors. The correlation analysis between the two index methods was carried out by SAS 9.40 and JMP 11 software. The results showed that all the four factors had significant differences, and the best processing technology was as follows: polished round-grained rice as raw material, processing temperature at 140 °C, processing time of 10min, and the ratio of Codonopsis pilosula and rice is 100:30. Chemical indexes showed significant positive correlations with shape indexes, providing basis for the quality evaluation of rice fried Codonopsis Radix in processing.
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Traditional Chinese medicine (TCM) decoction pieces refer to prescription drugs that can be used in clinical or preparation production after processing medicinal herbs. TCM decoction pieces industries are inherited from the culture of TCM and are important because of their independent intellectual property rights. The Chinese Pharmacopoeia (Ch. P) 2010 edition stipulated that "All drugs taken are decoction pieces", which raised the drug status to statutory law for the first time and clearly specified that TCM decoction pieces should be applied to TCM prescription deployment and production of proprietary Chinese medicines. It also pointed out that "The specifications of the decoction pieces used in the preparation should comply with the requirements of the actual process of the corresponding formulation type". For a long time, both the processing methods and the specification grades of the clinically used pieces of Chinese medicine were based on the inheritance and supported by the classical theory and method system centered on TCM processing. However, the theoretical research and specification standards of the decoction pieces used in the production of proprietary Chinese medicines based on modern industry are scarce, and this has led to a series of problems related to the industry, making the processing of decoction pieces becoming a limiting factor in the promotion of the Chinese medicine industry. Aiming at the existing problems of the TCM decoction pieces industry, this article was guided by the standardization system of TCM based on the concept of whole-process quality control, combined with the reference to the Japanese Kampo medicine industry's feeding mode and the reflection on the combination of traditional Chinese medicine processing and modern industry, as well as the study of the core law of the whole-process of TCM production, etc. Industrial decoction pieces and the idea of building a standardized system of TCM industry decoction pieces based on the whole-process quality control were discussed in this paper, which can provide insights for exploring the effective fusion between TCM processing theory and classic heritage and modern manufacturing and can provide the basis for the establishment of a standardized system for industrial decoction pieces based on whole-process quality control of TCM. It can also offer reference for the development of the advantages of geo-authentic crude drug and the establishment of high spots of industry decoction pieces.
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Objective To explore the feasibility of monitoring blood pressure via superficial temporal artery catheterization in neonates,which may provide more ways to monitor arterial blood pressure of neonates.Methods By lottery method,64 neonates from NICU who met inclusion criteria and needed arterial blood pressure monitoring were randomly divided into two groups.Thirty-two cases in the experimental group were treated with superficial temporal artery catheterization,while 32 cases in the control group were treated with radial artery catheterization.The success rate of one-time catheterization,indwelling time of catheter,blood pressure and the rate of complications were compared between two groups.Results There were no significant differences between two groups in the success rate of one-time catheterization,indwelling time of catheter,systolic blood pressure and the rate of complications (P＞0.05).Results showed there was significant difference in diastolic blood pressure between two groups(P＜ 0.05).Conclusion Compared with radial artery blood catheterization,neonatal superficial temporal artery catheterization showed equivalent effect,which made it more convenient for observing condition of neonates.
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Acute gangrenous cholecystitis is a histologic diagnosis,mostly diagnosed by intraoperative or postoperative pathology.In China,as the aging population increases,the incidence of the disease increases steadily.AGC is still an indication of surgical treatment for acute cholecystitis(AC),but the diagnosis and treatment of AGC remains a challenge for clinical surgeons.However,preoperative clinical data such as age, gender,hypertension,diabetes,coronary heart disease,cholelithiasis disease history,laboratory examination and radiographic results are helpful in early diagnosis and reasonable surgical timing selection.
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Objective To explore the feasibility of monitoring blood pressure via superficial temporal artery catheterization in neonates,which may provide more ways to monitor arterial blood pressure of neonates.Methods By lottery method,64 neonates from NICU who met inclusion criteria and needed arterial blood pressure monitoring were randomly divided into two groups.Thirty-two cases in the experimental group were treated with superficial temporal artery catheterization,while 32 cases in the control group were treated with radial artery catheterization.The success rate of one-time catheterization,indwelling time of catheter,blood pressure and the rate of complications were compared between two groups.Results There were no significant differences between two groups in the success rate of one-time catheterization,indwelling time of catheter,systolic blood pressure and the rate of complications (P＞0.05).Results showed there was significant difference in diastolic blood pressure between two groups(P＜ 0.05).Conclusion Compared with radial artery blood catheterization,neonatal superficial temporal artery catheterization showed equivalent effect,which made it more convenient for observing condition of neonates.
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Acute gangrenous cholecystitis is a histologic diagnosis,mostly diagnosed by intraoperative or postoperative pathology.In China,as the aging population increases,the incidence of the disease increases steadily.AGC is still an indication of surgical treatment for acute cholecystitis(AC),but the diagnosis and treatment of AGC remains a challenge for clinical surgeons.However,preoperative clinical data such as age, gender,hypertension,diabetes,coronary heart disease,cholelithiasis disease history,laboratory examination and radiographic results are helpful in early diagnosis and reasonable surgical timing selection.
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The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry.
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The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization.
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Objective To compare the recent adverse reactions caused by 131I-Metuximab (licartin) treatment via two different routes and to assess the safety and advantages of peripheral intravenous bolus of licartin for the treatment of advanced HCC.Methods Clinical data of 54 patients (45 males,9 females,age 33-80 years) with advanced HCC treated with Licartin in Tianjin Medical University Cancer Institute and Hospital from October 2010 to March 2013 were collected and analyzed.The patients were divided into vein group (n=33) with Licartin injected through peripheral vein and artery group (n =21) with Licartin injected through hepatic artery.The results of blood routine examination,liver and kidney function and thyroid function between the two groups (1 week before treatment,4 and 12 weeks after treatment) were compared.The adverse reaction rate (ARR) and adverse reaction progression rate (ARPR) were also compared between the 2 groups.Ten days after Licartin treatment,all patients underwent gamma imaging to access the drug distribution in vivo.x2 test and two-sample t test were used to analyze data.Results There were no significant differences on age,gender and TNM staging between the vein group and the artery group (t =0.721,x2=0.561 and 4.769,all P＞0.05).The vein group showed temporary drug-related leucopenia (x2=7.041,P＜0.05) and increased level of serum total bilirubin (STB;x2 =10.297,P＜0.05) 4 weeks post-treatment.Twelve weeks later,the above parameters returned to baseline.In artery group,no influence on liver and kidney functions was observed,but the numbers of WBC and PLT decreased significantly (x2 =8.949 and 8.778,both P＜0.05) and returned to baseline 12 weeks post-treatment.The ARR in patients who had normal ALT levels before treatment between the two groups was significantly different(3.33％(1/30) vs 5/19,x2=5.718,P＜0.05).No significant difference was observed on ARR in patients with normal level of other parameters,and on ARPR in patients with abnormal preoperative parameters between the two groups (x2 =0.000-2.500,all P＞0.05).The drug's in vivo biodistribution and the thyroid function between the 2 groups showed no significant difference.Conclusion The peripheral intravenous bolus administration of Licartin is safe to treat patients with advanced HCC.
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OBJECTIVES: Some changes are found in the labyrinth anatomy during postnatal development. Although the spatial orientation of semicircular canals was thought to be stable after birth, we investigated the age-related orientational changes of human semicircular canals during development. METHODS: We retrospectively studied the computed tomography (CT) images of both ears of 76 subjects ranged from 1 to 70 years old. They were divided into 4 groups: group A (1-6 years), group B (7-12 years), group C (13-18 years), and group D (>18 years). The anatomical landmarks of the inner ear structures were determined from CT images. Their coordinates were imported into MATLAB software for calculating the semicircular canals orientation, angles between semicircular canal planes and the jugular bulb (JB) position. Differences between age groups were analyzed using multivariate statistics. Relationships between variables were analyzed using Pearson analysis. RESULTS: The angle between the anterior semicircular canal plane and the coronal plane, and the angle between the horizontal semicircular canal plane and the coronal plane were smaller in group D than those in group A (P<0.05). The JB position, especially the anteroposterior position of right JB, correlated to the semicircular canals orientation (P<0.05). However, no statistically significant differences in the angles between ipsilateral canal planes among different age groups were found. CONCLUSION: The semicircular canals had tendencies to tilt anteriorly simultaneously as a whole with age. The JB position correlated to the spatial arrangement of semicircular canals, especially the right JB. Our calculation method helps detect developmental and pathological changes in vestibular anatomy.
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Humans , Ear , Ear, Inner , Methods , Parturition , Retrospective Studies , Semicircular Canals , Tomography, X-Ray ComputedABSTRACT
Salvianolic acids and tanshinones are main hydrophilic and lipophilic extracts from Salvia Miltiorrhiza with significant anti-pulmonary fibrosis effects. The aim of this study was to prepare a co-micronized salvianolic acids-tanshinones composite powder for inhalation using a planetary ball mill. The micronization process parameters were optimized by central composite design (CCD) and response surface methodology (RSM). Treatment time, rotation speed and the ball/sample weight ratio were selected as the independent variables, and the volume fraction of particle size in 1-5 μm was taken as the dependent variable. The powder properties were evaluated by scanning electron microscopy (SEM), laser diffraction and X-ray powder diffraction (XRPD). The powder flow and hygroscopicity were determined with repose angle, compressibility index and critical relative humidity(CRH). According to the results, the salvianolic acids-tanshinones composite powder produced in optimal conditions had a narrow and unimodal particle size distribution and a smaller D₅₀ of 2.33 μm. The volume fraction of particle size in 1-5 μm was 80.82%. The repose angle was (50.60±1.13) °, and the critical relative humidity is about 77%. After being micronized, the particle size significantly reduced, and the number of amorphous substances slightly increased, with no significant changes in powder flow and hygroscopicity. These findings indicate that the grinding method with a planetary ball mill can be used to co-micronize various components with different properties and prepare composite drug powders for dry powder inhalation.
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Objective: To evaluate and compare the safety and efficiency of the combined therapy of 89Sr plus zoledronic acid and those of 89Sr-chloride alone, in patients with painful bone metastases. Methods: A total of 87 patients with osseous metastasis were ran-domly divided into treatment groups of 89Sr-chloride alone (group A, 53 patients) and 89Sr plus zoledronic acid (group B, 34 patients). A total of 17 patients in group B received zoledronic acid 2-14 days after 89Sr therapy, and 13 other patients in the group received 89Sr 4-7 days after zoledronic-acid therapy. Pain response and KPS score were evaluated after the different treatments. Results: No obvious bone marrow suppression and liver damage were found in all cases. All patients who received both 89Sr-chloride and 89Sr plus zoledronic acid showed reduced bone pain and total discomfort, as well as improved KPS score, but the response was more pronounced in group B (P=0.047; P=0.036). No statistical differences in pain score and KPS scores were observed between the groups treated with zoledronic acid first and 89Sr therapy first (P=1.000; P=0.667). Comparison of bone pain relief and changes in the KPS score of different primary tumors after treatment with 89Sr-chloride or 89Sr plus zoledronic acid showed no statistical significance. Conclusion: Compared with 89Sr-chloride, treatment with 89Sr plus zoledronic acid was more effective in patients with painful bone metastases. The safety of these two treatments are similar.