Efficacy of Yigu® versus Aclasta® in Chinese postmenopausal women with osteoporosis: a multicenter prospective study.

Zoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu®) showed its clinical efficacy consistency with original ZOL (Aclasta®) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu® in Chinese population. INTRODUCTION: Yigu® has been approved its bioequivalence to Aclasta®. However, the clinical efficacy and safety of Yigu® have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu® and Aclasta® in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL. METHODS: This was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5 mg Yigu® or Aclasta®. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12 months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12 months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6 months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups. RESULTS: A total of 458 postmenopausal women with osteoporosis were enrolled (n = 227, Yigu®; n = 231, Aclasta®). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu® and Aclasta® groups after 12 months of treatment. The mean difference of BMD change at the lumbar spine after 12 months between two groups was 0.15% (95% CI: - 0.71 to 1.00, equivalence margin: - 1.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and ß-CTX showed no difference between two groups after 14 days and 6 and 12 months of treatment. As regards the whole sample, BMD significantly increased after 12 months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (ß-CTX) and procollagen 1 N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups. CONCLUSION: Intravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu® was equivalent to Aclasta® with respect to efficacy and safety.

Long-Term Efficacy of Screw Fixation vs Hemiarthroplasty for Undisplaced Femoral Neck Fracture in Patients over 65 Years of Age: A Systematic Review and Meta-Analysis.

OBJECTIVE: To compare the long-term efficacy of screw fixation and hemiarthroplasty in elderly patients with undisplaced femoral neck fractures. METHODS: We searched Cochrane Library, EMBASE, and MEDLINE from inception to 10 June 2020 to identify studies about undisplaced femoral neck fracture in elderly patients over 65 years of age. The included studies were assessed by two researchers according to the Cochrane risk-of-bias criteria and Newcastle-Ottawa Scale. Meta-analysis was performed with Revman 5.3 software. The odds ratios (OR) and mean differences (MD) were used to compare dichotomous and continuous variables. RESULTS: A total of 750 patients were included in this meta-analysis. In elderly patients, undisplaced femoral neck fracture treated with hemiarthroplasty had a lower implant-related complication rate (OR, 4.05 [95% CI, 2.38 to 6.89]; P < 0.00001; I2 = 0), lower reoperation rate (OR, 4.88 [95% CI, 2.84 to 8.38]; P < 0.00001; I2 = 0), and superior Harris score (WMD, -5.05 [95% CI, -7.30 to -2.80]; P < 0.0001; I2 = 0) in the early postoperative period. Although screw fixation was associated with shorter operative time (WMD, -36.22 [95% CI, -50.72 to -21.73]; P < 0.00001; I2 = 98%) and less blood loss (WMD, -165.84 [95% CI, -209.29 to -122.38]; P < 0.00001; I2 = 96%), there was no significant difference in long-term mortality (OR, 0.65 [95% CI, 0.28 to 1.48]; P < 0.31; I2 = 75%) between these two treatments. CONCLUSION: In elderly patients with undisplaced femoral neck fractures, hemiarthroplasty provided a lower implant-related complication rate, lower reoperation rate, superior hip function without increased long-term mortality. Hemiarthroplasty should be recommended as a better alternative in such patients compared with multiple cannulated screws.

Intramedullary Nailing Versus Minimally Invasive Plate Osteosynthesis for Distal Tibial Fractures: A Systematic Review and Meta-Analysis.

To evaluate the application, safety and efficacy of the patients treated with intramedullary nailing (IMN) and minimally invasive plate osteosynthesis (MIPO) in distal tibia fractures. Following the Preferred Reporting Items for Systematic Reviews and Meta Analysis (PRISMA) guidelines, we searched databases PubMed, Cochrane library, EMBASE and Web of Science from inception of the database up to 10 October 2018, using the keywords "distal tibia fractures", "plate", "intramedullary nailing" and "RCT" to identify randomized clinical trials about distal tibia fractures. The included studies were assessed by two researchers according to the Cochrane risk-of-bias criteria. The primary outcome of measurement included operation time, malunion rate, nonunion/delayed union rate, and wound complication. Data analysis was conducted with Review Manager 5.3 software. A total of 10 RCTs involving 911 patients fulfilled the inclusion criteria with 455 patients in the IMN group and 456 patients in the MIPO group. There were no significant differences in radiation time, nonunion or delayed union rate, union time and operation time between the two groups. Patients treated with MIPO had lower incidence of malunion compared with IMN (RR = 1.85, 95%CI: 1.21 to 2.83, P = 1.00), while IMN seemed to have lower surgical incision complications whether in closed or opening fractures (RR = 0.49, 95%CI 0.33 to 0.73, P = 0.43). But in patients classified as 43A, the result of subgroup analysis suggested that there was no significant inwound complication between the two groups. MIPO was superior in preventing malunion compared with IMN, and intramedullary nailing appeared to have lower wound complications. However, in patients with 43A distal tibial fractures, MIPO was more recommended for its prevention of malunion. No matter which method we choose, we should notice and prevent the associated complications.

Bisphosphonates for Secondary Prevention of Osteoporotic Fractures: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.

PURPOSE: To investigate the comparative efficacies of the five most commonly used bisphosphonates for the secondary prevention of osteoporotic fractures in a Bayesian network meta-analysis. METHODS: Five databases and the reference lists of all acquired articles from inception to July 2017 were searched. A Bayesian random-effects model was employed, and vertebral, hip and nonvertebral nonhip fractures were assessed by odds ratios (ORs) and 95%credible intervals. Furthermore, with respect to each endpoint, rank probabilities for each bisphosphonate were evaluated using the surface under the cumulative ranking curve (SUCRA) value. RESULTS: Thirteen eligible studies were identified involving 11,822 patients with osteoporotic fractures. Overall in the pairwise meta-analyses, bisphosphonate use significantly reduced the risk of new vertebral, hip, and nonvertebral nonhip fractures, with ORs and 95% confidence intervals of 0.56 (0.49-0.64), 0.69 (0.48-0.98), and 0.82 (0.70-0.97), respectively. In network meta-analyses, significant differences were found between placebo and any one of the five bisphosphonates for new vertebral fractures. The rank probability plot and the SUCRA calculation results suggested that alendronate was the best intervention (14.6%) for secondary prevention of vertebral fractures, followed by zoledronate (15.3%) and etidronate (22.1%). In terms of the incidence of new hip fractures, alendronate was associated with the lowest incidence (18.5%), followed by zoledronate (43.1%) and risedronate (52.5%). However, zoledronate ranked lowest (16.6%) regarding the incidence of new nonvertebral nonhip fractures, followed by risedronate (23.8%) and alendronate (44.1%). CONCLUSIONS: Bisphosphonates show significant efficacy for secondary prevention of new vertebral fractures, and alendronate is most likely to be successful at secondary prevention of vertebral and hip fractures compared with the other four bisphosphonates.

Multicenter Study on Observation of Acute-phase Responses After Infusion of Zoledronic Acid 5 mg in Chinese Women with Postmenopausal Osteoporosis.

OBJECTIVE: It has been reported that acute-phase reactions (APR) after infusion of 5 mg zoledronic acid for the first time is common. This study surveyed the incidence and characteristics of APR in Chinese postmenopausal women receiving 5 mg zoledronic acid intravenously for osteoporosis and to evaluate the efficacy of non-steroidal anti-inflammatory drugs (NSAID) in preventing or alleviating APR following the first 5 mg zoledronic acid infusion. METHODS: A total of 2601 patients with an average age of 68.14 ± 9.89 years and a mean body mass index of 22.90 ± 3.24 kg/m2 from 62 centers in China were treated with 5 mg zoledronic acid intravenously for the first time. The incidence of fever and pain were observed in these patients, and the time of fever or pain onset and duration, and the intensity of fever and grade of pain were also recorded. The dosage, duration, and efficacy of NSAID and safety outcomes were also documented. RESULTS: At the end of the study, 18 patients are eliminated due to incomplete records of temperature. The incidence of fever was 28.65% (740/2583) within 7 days following zoledronic acid infusion; 98.34% (727/740) occurred at 1.03 ± 0.66 days after infusion and lasted 1.72 ± 0.93 days. A total of 456 (17.53%) patients had newly onset pain (312 of 1187, 26.28%) or experienced pain aggravation (144 of 1414, 10.18%), which mostly occurred within 3 days after zoledronic acid infusion. A total of 1246 (47.6%) patients had received NSAID for a median time of 2.63 ± 2.45 days. Using NSAID for at least 2 days could decrease body temperature by 0.54 ± 0.86°C, increase the percentage of pain-free patients by 6.17%, and reduce the percentage of patients with moderate to severe pain by 8.7%. CONCLUSIONS: Compared with Western populations, Chinese patients had a higher rate of fever and pain after their first zoledronic acid infusion. These symptoms were often mild to moderate in intensity and transient in duration. NSAID could effectively reduce the incidence and severity of such APR.

Treatment and Management of Osteoporotic Fractures: A Nation-wide Survey of 484 Senior Orthopaedists in China.

OBJECTIVE: To investigate the treatment given to osteoporotic fracture patients by orthopaedists at major hospitals in China. METHODS: A 25-item quantitative questionnaire survey, categorized into five domains, including primary purpose of osteoporosis treatment, anti-osteoporosis therapy, calcium and vitamin D supplement, monitoring of osteoporosis, and knowledge of osteoporosis treatment, was designed to elicit information on orthopaedists' views on the treatment of osteoporotic fracture. A pre-survey test was conducted with a sample of 40 orthopaedic specialists to confirm the reliability and validity of the questionnaire. Each interview of the survey took approximately 15 min and did not directly involve any patients. The survey was conducted through face-to-face interviews at 119 tier 3 hospitals in 28 cities across Mainland China. RESULTS: A total of 484 valid responses were received. Seven in ten respondents have ≥10 years of professional practice. While two-thirds believed that osteoporosis treatment was to prevent fractures or re-fractures, 95.0% agreed that anti-osteoporosis medication should be administered to patients with a history of fragility fractures. Three in four would prescribe anti-osteoporosis medication perioperatively. Of these, 79.0% regarded bisphosphonates as the first-line drug. Approximately 86.0% of the 21-30 years cohort chose bisphosphonates compared to 71.4% for those with ≤10 years. More of the younger (≤10 years) cohort chose calcitonin compared to their older (21-30 years) colleagues (25.7% vs 11.6%). The most commonly prescribed daily dose is 800 IU for vitamin D supplements and 600 mg/day for calcium. CONCLUSIONS: Our respondents generally adhered to guidelines for the treatment and management of osteoporosis. A significant number had recommended lower dosages of vitamin D and calcium. Some differences exist between the younger cohort and their older colleagues in the prescription of pharmacological therapies. The criteria for initiating therapy should be more holistic and include other factors besides bone mineral density (BMD). Our results demonstrated that more comprehensive guidelines for osteoporosis management and a greater awareness of these guidelines by orthopaedists are needed to enable them to better manage their patients.

Association of Metabolic Factors with Symptomatic Hand Osteoarthritis in the Chinese Han Population Aged 40 Years and above.

BACKGROUND: The relationship between hand osteoarthritis (HOA) and systemic metabolic factors is unclear. The aim of this study was to investigate the prevalence of systemic metabolic factors including obesity, hypertension, diabetes mellitus, and atherosclerosis in symptomatic patients with HOA and the association between these systemic metabolic factors and symptomatic HOA in the Chinese Han population aged 40 years and above. METHODS: A cross-sectional survey was conducted on Chinese Han population aged 40 years and above in six centers in China. The sociodemographic features, lifestyle of the participants, and medical history of hypertension, diabetes mellitus, and atherosclerosis were collected. The cases with hand symptoms underwent anteroposterior radiographic examination of both hands to obtain a diagnosis. The correlations between systemic metabolic factors and symptomatic HOA were analyzed using Logistic regression analysis. RESULTS: Overweight (39.3% vs. 30.5%, P< 0.001), hypertension (34.7% vs. 18.6%, P< 0.001), diabetes mellitus (11.2% vs. 3.3%, P< 0.001), and atherosclerosis (19.8% vs. 8.3%, P< 0.001) were more prevalent in symptomatic patients with HOA than those in the population without HOA. Overweight (odds ratio [OR] = 1.35, 95% confidence interval [CI]: 1.10-1.65, P = 0.005), hypertension (OR = 1.47, 95% CI: 1.18-1.83, P < 0.001), and diabetes mellitus (OR = 2.45, 95% CI: 1.74-3.45, P< 0.001) were associated with a higher prevalence of symptomatic HOA and the OR of symptomatic HOA significantly increased with the accumulated number of the three metabolic factors. Symptomatic HOA was associated with a higher prevalence of atherosclerosis (OR = 1.39, 95% CI: 1.05-1.85, P = 0.023). CONCLUSIONS: Overweight, hypertension, and diabetes mellitus were associated with a higher prevalence of HOA, showing cumulative effects. Atherosclerosis risk should be assessed in patients with HOA.

[Evaluation of genetic diversity and population structure of Bletilla striata based on SRAP markers].

Bletilla striata has been used as traditional Chinese medicine for several centuries. In recent years, the quality and quantity of wild B. striata plants have declined sharply due to habitat deterioration and human over-exploitation. Therefore, it is of great urgency to evaluate and protect B. striata wild plant resource. In this study, sequence-related amplified polymorphism (SRAP) markers were applied to assess the level and pattern of genetic diversity in twelve populations of B. striata. The results showed a high level of genetic diversity (PPB = 90.48%, H = 0.349 4, I = 0.509 6) and moderate genetic differentiation among populations (G(st) = 0.260 9). Based on the unweighted pair-group method with arithmetic average (UPGMA), twelve populations gathered in three clusters. The cluster 1 included four populations. There are Nanjing, Zhenjiang, Xuancheng and Hangzhou. The seven populations which come from Hubei Province, Hunan Province, Jiangxi Province and Guizhou Province belonged to the cluster 2. The cluster 3 only contained Wenshan population. Moreover, Mantel test revealed significant positive correlation between genetic distances and geographic distances (r = 0.632 9; P < 0.000 1). According to the results, we proposed a series of conservation consideration for B. striata.

[Molecular identification of wild populations of Dendrobium officinale based on target region amplification polymorphism].

In this study, TRAP molecular markers were used in identification of wild populations and hybrids of Dendrobium officinale, based on the sequences of genes encoding phosphoenolpyruvate carboxylase (PEPC), UDP-glucose pyrophosphorylase (UGP) and phenylalanine ammonia-lyase (PAL). Seven polymorphic target region amplification polymorphism (TRAP) primers were selected from 54 primer combinations and used in the identification of wild populations. Moreover, hybrids had female polymorphic bands, male polymorphic bands and heterozygous bands, which suggest that seven TRAP markers are able to identify the hybrids from their parents. Furthermore, the UPGMA dendrogram revealed that when sample from Guangnan in Yunnan province was used as one parent, reciprocal hybrids grouped with them in first, and then grouped with the other parent. The results indicated that the hybrids were closer to D. officinale from Guangnan population. This study identified the wild populations and hybrids of D. officinale by TRAP molecular markers, which is useful in selection of good varieties for artificial cultivation and early identification of hybrids. The study provides a method in the control of stability of germplasm and quality of D. officinale.

Efficacy and Safety of Zhuanggu Joint Capsules in Combination with Celecoxib in Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Knee osteoarthritis (KOA) is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling, stiffness, and movement disorders. The therapeutic goal is to alleviate or eliminate pain, correct deformities, improve or restore joint functions, and improve the quality of life. This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA.</p><p><b>METHODS</b>This multi-center, randomized, double-blind, double-dummy, parallel controlled trial, started from December 2011 to May 2014, was carried out in 6 cities, including Beijing, Shanghai, Chongqing, Changchun, Chengdu, and Nanjing. A total of 432 patients with KOA were divided into three groups (144 cases in each group). The groups were treated, respectively, with Zhuanggu joint capsules combined with celecoxib capsule simulants, Zhuanggu joint capsules combined with celecoxib capsules, and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively. The improvement of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment. Intergroup and intragroup comparisons of quantitative indices were performed. Statistically significant differences were evaluated with pairwise comparisons using Chi-square test (or Fisher's exact test) and an inspection level of α = 0.0167.</p><p><b>RESULTS</b>Four weeks after treatment, the total efficacies of Zhuanggu group, combination group, and celecoxib group were 65%, 80%, and 64%, respectively, with statistically significant differences among the three groups (P = 0.005). Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu (P = 0.005) and celecoxib (P = 0.003) groups. The difference between the latter two groups was not statistically significant (P > 0.0167). Four weeks after discontinuation, the efficacies of the three groups were 78%, 95%, and 65%, respectively, with statistically significant differences (P < 0.0001). Intergroup pairwise comparisons revealed that the efficacy of the combination group was significantly better than that of the Zhuanggu and the celecoxib groups (P < 0.0001). The difference between the latter two groups was not statistically significant (P > 0.0167). The incidences of adverse events in Zhuanggu group, combination group, and celecoxib group were 8.5%, 8.5%, and 11.1%, respectively, with insignificant differences (P > 0.05).</p><p><b>CONCLUSIONS</b>Zhuanggu joint capsules alone or combined with celecoxib showed clinical efficacy in the treatment of KOA. The safety of Zhuanggu joint capsules alone or combined with celecoxib was acceptable.</p><p><b>TRIAL REGISTRATION</b>Chinese Clinical Trial Registry, ChiCTR-IPR-15007267; http://www.medresman.org/uc/project/projectedit.aspx?proj=1364.</p>

[Applylication of new type combined fragments: nrDNA ITS+ nad 1-intron 2 for identification of Dendrobium species of Fengdous].

In this study, 17 kinds of Dendrobium species of Fengdous including 39 individuals were collected from 4 provinces. Mitochondrial gene sequences co I, nad 5, nad 1-intron 2 and chloroplast gene sequences rbcL, matK amd psbA-trnH were amplified from these materials, as well as nrDNA ITS. Furthermore, suitable sequences for identification of Dendrobium species of Fengdous were screened by K-2-P and P-distance. The results showed that during the mentioned 7 sequences, nrDNA ITS, nad 1-intron 2 and psbA-trnH which had a high degree of variability could be used to identify Dendrobium species of Fengdous. However, single fragment could not be used to distinguish D. moniliforme and D. huoshanense. Moreover, compared to other combined fragments, new type combined fragments nrDNA ITS+nad 1-intron 2 was more effective in identifying the original plants of Dendrobium species and could be used to identify D. huoshanense and D. moniliforme. Besides, according to the UPGMA tree constructed with nrDNA ITS+nad 1-intron 2, 3 inspected Dendrobium plants were identified as D. huoshanense, D. moniliforme and D. officinale, respectively. This study identified Dendrobium species of Fengdous by combined fragments nrDNA ITS+nad 1-intron 2 for the first time, which provided a more effective basis for identification of Dendrobium species. And this study will be helpful for regulating the market of Fengdous.

Comparative chloroplast genomes of photosynthetic orchids: insights into evolution of the Orchidaceae and development of molecular markers for phylogenetic applications.

The orchid family Orchidaceae is one of the largest angiosperm families, including many species of important economic value. While chloroplast genomes are very informative for systematics and species identification, there is very limited information available on chloroplast genomes in the Orchidaceae. Here, we report the complete chloroplast genomes of the medicinal plant Dendrobium officinale and the ornamental orchid Cypripedium macranthos, demonstrating their gene content and order and potential RNA editing sites. The chloroplast genomes of the above two species and five known photosynthetic orchids showed similarities in structure as well as gene order and content, but differences in the organization of the inverted repeat/small single-copy junction and ndh genes. The organization of the inverted repeat/small single-copy junctions in the chloroplast genomes of these orchids was classified into four types; we propose that inverted repeats flanking the small single-copy region underwent expansion or contraction among Orchidaceae. The AT-rich regions of the ycf1 gene in orchids could be linked to the recombination of inverted repeat/small single-copy junctions. Relative species in orchids displayed similar patterns of variation in ndh gene contents. Furthermore, fifteen highly divergent protein-coding genes were identified, which are useful for phylogenetic analyses in orchids. To test the efficiency of these genes serving as markers in phylogenetic analyses, coding regions of four genes (accD, ccsA, matK, and ycf1) were used as a case study to construct phylogenetic trees in the subfamily Epidendroideae. High support was obtained for placement of previously unlocated subtribes Collabiinae and Dendrobiinae in the subfamily Epidendroideae. Our findings expand understanding of the diversity of orchid chloroplast genomes and provide a reference for study of the molecular systematics of this family.

Comparison of parathyroid hormone (1-34) and elcatonin in postmenopausal women with osteoporosis: an 18-month randomized, multicenter controlled trial in China.

BACKGROUND: Recombinant human parathyroid hormone (1-34) (rhPTH (1-34)) is the first agent in a unique class of anabolic therapies acting on the skeleton. The efficacy and safety of long-term administration of rhPTH (1-34) in Chinese postmenopausal women had not been evaluated. This study compared the clinical efficacy and safety of rhPTH (1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. METHODS: A total of 453 postmenopausal women with osteoporosis were enrolled in an 18-month, multi-center, randomized, controlled study. They were randomized to receive either rhPTH (1-34) 20 µg (200 U) daily for 18 months, or elcatonin 20 U weekly for 12 months. Lumbar spine (L1-4) and femoral neck bone mineral density (BMD), fracture rate, back pain as well as biochemical markers of bone turnover were measured. Adverse events were recorded. RESULTS: rhPTH (1-34) increased lumbar BMD significantly more than did elcatonin after 6, 12, and 18 months of treatment (4.3% vs. 1.9%, 6.8% vs. 2.7%, 9.5% vs. 2.9%, P < 0.01). There was only a small but significant increase of femoral neck BMD after 18 months (2.6%, P < 0.01) in rhPTH groups. There were larger increases in bone turnover markers in the rhPTH (1-34) group than those in the elcatonin group after 6, 12, and 18 months (serum bone-specific alkaline phosphatase (BSAP) 93.7% vs. -3.6%; 117.8% vs. -4.1%; 49.2% vs. -5.8%, P < 0.01; urinary C-telopeptide/creatinine (CTX/Cr) 250.0% vs. -29.5%; 330.0% vs. -41.4%, 273.0% vs. -10.6%, P < 0.01). rhPTH (1-34) showed similar effect of pain relief as elcatonin. The incidence of clinical fractures was 5.36% (6/112) in elcatonin group and 3.2% (11/341) in rhPTH (1-34) group (P = 0.303). Both treatments were well tolerated. Hypercaluria (9.4%) and hypercalcemia (7.0%) in rhPTH (1-34) group were transient and caused no clinical symptoms. Pruritus (8.2% vs. 2.7%, P = 0.044) and redness of injection site (4.4% vs. 0, P = 0.024) were more frequent in rhPTH (1-34). Nausea/vomiting (16.1% vs. 6.2%, P = 0.001) and hot flushes (7.1% vs. 0.6%, P < 0.001) were more common in elcatonin group. CONCLUSIONS: rhPTH (1-34) was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months of treatment. rhPTH could improve back pain effectively. The results of the present study indicate that rhPTH (1-34) is an effective, safe agent in treating Chinese postmenopausal women with osteoporosis.

Rhizocompetence and antagonistic activity towards genetically diverse Ralstonia solanacearum strains--an improved strategy for selecting biocontrol agents.

Bacterial wilt caused by Ralstonia solanacearum is a serious threat for agricultural production in China. Eight soil bacterial isolates with activity against R. solanacearum TM15 (biovar 3) were tested in this study for their in vitro activity towards ten genetically diverse R. solanacearum isolates from China. The results indicated that each antagonist showed remarkable differences in its ability to in vitro antagonize the ten different R. solanacearum strains. Strain XY21 (based on 16S rRNA gene sequencing affiliated to Serratia) was selected for further studies based on its in vitro antagonistic activity and its excellent rhizocompetence on tomato plants. Under greenhouse conditions XY21 mediated biocontrol of tomato wilt caused by seven different R. solanacearum strains ranged from 19 to 70 %. The establishment of XY21 and its effects on the bacterial community in the tomato rhizosphere were monitored by denaturing gradient gel electrophoresis of 16S rRNA gene fragments PCR-amplified from total community DNA. A positive correlation of the in vitro antagonistic activities of XY21 and the actual biocontrol efficacies towards seven genetically different R. solanacearum strains was found and further confirmed by the efficacy of XY21 in controlling bacterial wilt under field conditions.

[Clinical results after all arthroscopic reduction and fixation of bony Bankart lesion].

OBJECTIVE: To investigate the shoulder function after arthroscopic reduction and internal fixation in patients with bony Bankart lesion. METHODS: Between May 2004 and May 2008, 45 patients with bony Bankart lesion who were treated with all arthroscopic reduction and internal fixation with metal anchors were included in this study. Among them 40 patients were male and 5 patients were female. The average age at the surgery was 27.6 years (16.5 - 50.1 years). The average duration of follow-up was 29.7 months (24.8 - 49.0 months). A history of recurrent dislocation of affected shoulder was found in all patients. Metal anchors were used to fix the bony Bankart lesion during the surgery. Hill-Sachs remplissage technique was used to treat the Engaging Hill-Sachs lesion. The preoperative American Shoulder and Elbow Society (ASES) score, Constant-Murley score, Rowe score and the VAS score for instability were 84 ± 14, 95.1 ± 4.6, 39.4 ± 2.9 and 5 ± 3 respectively. RESULTS: No significant change was found regarding active forward elevation, external rotation and internal rotation after the surgery. The ASES score, Constant-Murley score, Rowe score and the VAS score of stability were 95 ± 7, 98.3 ± 2.2, 84.5 ± 22.0 and 1 ± 2, improved significantly higher after the surgery (P < 0.01). One subluxation and 3 redislocation were happened during follow-up. The overall failure rate was 8.9% (4/45). CONCLUSIONS: All arthroscopic reduction and fixation of bony Bankart lesion can achieve a good result.

[Comparative analysis of modified Dewar method versus arthroscopic double Endobutton fixation technique for the treatment of acute acromioclavicular joint dislocation].

OBJECTIVE: To compare the clinical outcomes of modified Dewar method versus arthroscopic double Endobutton fixation technique for the treatment of acute acromioclavicular joint dislocation (Rockwood types III-V). METHODS: All cases with acute acromioclavicular joint dislocation (Rockwood types III-V) were treated at our department from October 1997 to October 2009. Among them, 28 cases undergoing modified Dewar method were followed up. There were 20 males and 8 females aged 18 - 68 years old with a mean follow-up period of 6.8 years. And the arthroscopic technique of Endobutton fixation was employed for another 24 cases. There were 19 males and 5 females aged 19 - 65 years old with a mean follow-up period of 1.5 years. The radiographic findings, clinical outcomes and complications of two groups were compared. RESULTS: The good/excellent rate of modified Dewar group and arthroscopic double Endobutton group were 92.8% and 95.8% respectively. There was no significant difference between two groups. No significant difference existed between two groups as to the VAS (visual analogue scale) pain score and UCLA (University of California at Los Angeles) score. The modified Dewar group had a higher rate of ectopic ossification in coracoclavicular ligament than that of the arthroscopic double Endobutton group (25% vs 8.33%). Yet there was no statistical significance. However, the distance between clavicle and coracoid process was larger in the modified Dewar group (11.96 vs 8.54 mm, P < 0.05). CONCLUSION: Both modified Dewar method and arthroscopic double Endobutton fixation technique are both efficient therapies for acute acromioclavicular dislocation (Rockwood types III-V). The former tends to be more invasive while the latter can better maintain the relationship of coracoid process and clavicle.

Genetic diversity of Ralstonia solanacearum strains from China assessed by PCR-based fingerprints to unravel host plant- and site-dependent distribution patterns.

Bacterial wilt caused by Ralstonia solanacearum is a serious threat to crop production in China. A collection of 319 R. solanacearum strains isolated from 14 different diseased host plants collected in 15 Chinese provinces was investigated by BOX fingerprints in order to test the influence of the site and the host plant on their genetic diversity. Phylotype, fliC-RFLP patterns and biovar were determined for all strains and the sequevar for 39 representative strains. The majority of strains belonged to the Asian phylotype I, shared identical fliC-RFLP patterns and were assigned to four biovars (bv3:123; bv4:162; bv5:3; and bv6:11). Twenty strains were phylotype II, assigned to biovar 2, and had distinct fliC-RFLP patterns. BOX-PCR fingerprints generated from the genomic DNA of each strain revealed a high diversity of the phylotype I strains, where 28 types of BOX fingerprints could be distinguished. While many BOX clusters comprised isolates from different provinces and several host plants, some groups contained isolates that were plant or site specific. All phylotype II isolates originating from 10 provinces belonged to sequevar 1 and displayed identical BOX patterns as the potato brown rot strains from various regions of the world.

[A randomized, multicenter, active-controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with that of elcatonin in postmenopausal women with osteoporosis in China].

OBJECTIVE: To compare the clinical efficacy and safety between recombinant human parathyroid hormone (rhPTH) (1-34) and elcatonin in the treatment of postmenopausal women with osteoporosis in China. METHODS: This 6 month, multicenter, randomized and controlled study enrolled 205 postmenopausal women with osteoporosis. They were randomized to receive either rhPTH (1-34) 20 µg (200 U) daily or elcatonin 20 U weekly. Lumbar spine (L1-4) and femoral neck bone mineral density (BMD) and biochemical markers of bone turnover were measured. In the meantime adverse events were recorded. RESULTS: The results showed that both rhPTH (1-34) and elcatonin increased L1-4 BMD significantly at the endpoint of the study, but femoral neck BMD did not change significantly. From baseline to endpoint, BMD of L1-4 and femoral neck in the rhPTH (1-34) group increased by 5.51% (P<0.01) and 0.65% (P>0.05), but BMD of L1-4 and femoral neck in elcatonin group increased by 1.55% (P<0.05) and 0.11% (P>0.05). Moreover, the rhPTH (1-34) group had better improvement in L1-4 BMD than the elcatonin group at 3, 6 months, but there was no difference of BMD in these two groups with regard to femoral neck. There were greater mean increases of the bone markers in the rhPTH (1-34) group than those in the elcatonin group at 3, 6 months [serum bone-specific alkaline phosphatase (BSAP) 36.79% vs 0.31%; 92.42% vs -0.17%; the ratio of urine N-telopeptide of type I collagen and creatinine (NTX/Cr) 48.91% vs -5.32%; 68.82% vs -10.86%]. Both kinds of treatment were well tolerated and there were no differences between the two groups in the rates of adverse events and serious adverse events. CONCLUSION: It is concluded that rhPTH (1-34) has more positive effects on bone formation than elcatonin as shown by the greater increments of L1-4 BMD and bone formation markers and the less occurrence of adverse events as well as no significant change in hepatic, renal or hemopoietic function.

Alendronate treatment does not inhibit bone formation within biphasic calcium phosphate ceramics in posterolateral spinal fusion: an experimental study in porcine model.

BACKGROUND: Biphasic calcium phosphate (BCP) ceramics has a potential advantage as an osteoconductive matrix and has an optimal resorption rate for bone formation. Using BCP ceramics as a bone graft during spinal fusion requires osteogenesis within the material and subsequent bridging between adjacent vertebrae to provide long-term support. Bisphosphonates have been reported to prolong the process of bone healing. The influence of bisphosphonate treatment on bone formation within BCP ceramics in spinal fusion remains unknown. The aim of this study was to evaluate the influence of alendronate on BCP osteogenesis in posterolateral spinal fusion. METHODS: Posterolateral spinal fusion with pedicle screw fixation was performed at the lumbar spine in twenty-two pigs. BCP ceramics were applied as a bone graft to obtain bone fusion between adjacent transverse processes. Eleven pigs in the treatment group received oral alendronate 10 mg/d for three months postoperatively. Eleven pigs in the control group did not receive treatment with alendronate. All animals underwent posterolateral spinal fusion with BCP ceramics. The fusion rate was evaluated three months after the operation. RESULTS: The fusion rates evaluated by X-ray were 27.3% in the treatment group and 20% in the control group. The fusion rates using histological evaluation were 18.2% in the treatment group and 20% in the control group. The mean volumes of fusion mass were (3.64 +/- 0.86) cm(3) in the treatment group and (4.26 +/- 0.63) cm(3) in the control group. No significant differences were found in either trabecular bone volume or residual BCP volume between treatment and control groups using histological evaluation. The new bone formation within BCP ceramics was greater in the area adjacent to transverse process (P < 0.01). CONCLUSION: Oral alendronate with a dose of 10 mg daily do not inhibit bone formation within BCP ceramics or affect the fusion rate in posterolateral spinal fusion from porcine models.

A randomized, multicenter controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with elcatonin in postmenopausal women with osteoporosis in China.

BACKGROUND: Recombinant human parathyroid hormone (1-34) (rhPTH (1-34)) given by injection is a new seventh class drug of biological products, which is prepared by adopting gene recombination technique. rhPTH (1-34) is mainly used to treat osteoporosis, especially for postmenopausal women. This study compared the clinical efficacy and safety of rhPTH (1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. METHODS: Two hundred and five women with osteoporosis were enrolled in a 6-month, multicenter, randomized, controlled study. They were randomized to receive either rhPTH (1-34) 20 microg (200 U) daily or elcatonin 20 U weekly. Lumbar spine (L1-4) and femoral neck bone mineral density (BMD), as well as biochemical markers of bone turnover were measured. Adverse events were recorded. RESULTS: rhPTH (1-34) increased lumbar BMD significantly more than did elcatonin at 3 months and 6 months (2.38% vs 0.59%, P < 0.05; 5.51% vs 1.55%, P < 0.01), but there were no significant increases of BMD in these two groups at femoral neck. There were larger mean increases in bone markers in the rhPTH (1-34) group than in the elcatonin group at 3 months and 6 months (serum bone-specific alkaline phosphatase (BSAP) 36.79% vs 0.31%; 92.42% vs -0.17%; urinary N-telopeptide/creatinine (NTX/Cr) 48.91% vs -5.32%; 68.82% vs -10.86%). Both treatments were well tolerated and there were no significant differences detected between the two groups in the proportion of any adverse events and any serious adverse events (67.0% vs 59.0%; 0 vs 0). CONCLUSIONS: rhPTH (1-34) has more positive effects on bone formation, as shown by the larger increments of lumbar BMD and bone formation markers, than elcatonin, with only mild adverse events and no significant change in the liver, kidney or hematological indices.