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Surgical Trauma and Low‑Dose Methylprednisolone Modulate the Severity of the Acute‑Phase Response Induced by Zoledronic Acid Infusion

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Surgical Trauma and Low‑Dose Methylprednisolone Modulate the Severity of the Acute‑Phase Response Induced by Zoledronic Acid Infusion 1802 EXPERIMENTAL AND THERAPEUTIC MEDICINE 14: 1802-1808, 2017 Surgical trauma and low‑dose methylprednisolone modulate the severity of the acute‑phase response induced by zoledronic acid infusion JIAN CHEN1*, LIPENG YU1*, LIXIN CHEN1, XUAN WU1,2, PENGYU TANG1, JIAN YIN1, TAO JIANG1, GUOYONG YIN1 and JIN FAN1 1Department of Orthopedics, The First Affiliated Hospital of Nanjing Medical University;2 Department of Orthopedics, Nanjing Jiangbei People's Hospital, Nanjing, Jiangsu 210000, P.R. China Received May 18, 2016; Accepted March 23, 2017 DOI: 10.3892/etm.2017.4646 Abstract. The aim of the present study was to investigate levels (r=-0.006; P<0.05). Patients treated with MP following risk factors for the development of an acute-phase response surgery and ZA infusion had a significantly lower incidence (APR) associated with the initial zoledronic acid (ZA) of APR compared with those treated with acetaminophen infusion in patients undergoing surgery, and to assess whether (6.3 vs. 62.6%; P<0.05). However, no significant differences its onset may be reduced by post-dose administration of were observed in bone mineral density between the MP and low-dose methylprednisolone (MP) or acetaminophen. A acetaminophen groups at 12 months post-surgery. The results retrospective study of patients with osteoporosis who attended of the present study suggest that surgical trauma serves a key the departments of orthopedics and endocrinology of a single role in ZA-associated APR, and low-dose MP may a suitable hospital and received 5 mg ZA was conducted; the patients post-dose treatment to manage the symptoms of APR in included surgical and non-surgical cases. A total of 450 ZA-naïve patients undergoing surgery. patients who were treated with acetaminophen following ZA infusion were stratified based on whether they suffered APR Introduction (APR+) or not (APR-). In addition, 155 of the aforementioned acetaminophen-treated patients (acetaminophen group) were Bisphosphonates (BPs) are the most commonly prescribed compared with another 32 patients from the orthopedic medication for the management of osteoporosis (1). department who were treated with MP immediately following Zoledronic acid (ZA) is a new generation BP that can be ZA infusion (MP group). Inflammatory marker levels were administered intravenously once yearly. It comprises a double significantly higher in APR+ patients than in APR- patients, nitrogen-containing structure (an imidazole ring) that results and the odds ratios of experiencing APR following minimally in a high affinity for hydroxyapatite and induces a 10‑fold invasive or open surgery were found to be 3.54 (P<0.001) increased inhibition of bone resorption compared with daily and 5.71 (P<0.001), respectively, compared with non-surgical oral BPs (2,3). However, acute-phase response (APR) is more intervention after multiple adjustments. C-reactive protein common with ZA compared with other BPs (4). APR is charac- levels prior to dosing were positively correlated with body terized by the following: Transient mild fever, malaise, flu‑like temperature (r=0.023; P<0.001). The severity of APR also symptoms, digestive symptoms, headache and dizziness, all exhibited a negative correlation with 23-hydroxyvitamin D3 occurring within 3 days of the initial drug infusion (5-8). The molecular mechanisms of APR have recently been elucidated. It has been suggested that ZA leads to the accumulation of isopentenyl pyrophosphate and dimethylallyl pyrophosphate, which are potent agonists of the γδT cell receptor, as upstream Correspondence to: Dr Guoyong Yin or Dr Jin Fan, Department metabolites of farnesyl phyrophosphate synthase in the meval- of Orthopedics, The First Affiliated Hospital of Nanjing Medical onate pathway (9-16). These agonists are naturally recognized University, 300 Guangzhou Road, Nanjing, Jiangsu 210000, by γδT cells, inducing the activation and release of tumor P. R. Ch i na E-mail: [email protected] necrosis factor (TNF)-α, TNF-β, interferon (IFN)-γ, inter- E-mail: [email protected] leukin (IL)‑2 and IL‑6, which are pro‑inflammatory cytokines involved in the development of APR (9-16). *Contributed equally It has been observed by the present authors that patients treated with ZA in the early post-operative period develop Key words: zoledronic acid, methylprednisolone, acute-phase APR more readily. To the best our knowledge, no previous response, surgical trauma, vitamin D studies have reported the risk factors for APR associated with the early administration of ZA post-surgery. However, some studies have suggested that advanced age, supplementation of CHEN et al: RISK FACTORS FOR ACUTE-PHASE RESPONSE AND ITS PREVENTION 1803 vitamin D, prior use of oral BPs and nonsteroidal anti‑inflam- other orthopedic surgery methods associated with spinal and matory drugs (NSAIDs) are relieving factors for APR (5-8,16). articular implants. Patients in the endocrinology department Previous studies have reported that NSAIDs, such as acet- who had not experienced fresh fractures due to fragility aminophen, effectively alleviate the symptoms of APR (5-8), within the previous 6 months, including vertebral compres- however, the protective efficacy of NSAIDS was found to be sion fractures and hip fractures, were defined as NS subjects. unsatisfactory in patients who underwent ZA therapy soon All 450 patients received 0.3 g acetaminophen (Bayer AG, after surgery. At present, there is no evidence suggesting Leverkusen, Germany) orally twice daily on the day of the that low-dose glucocorticoids (GC), such as methylpredniso- infusion and as required for the next 3 days (5,8) (Fig. 1). lone (MP), have strong anti‑inflammatory properties for the In the second part of the study, 187 patients who had prevention of APR. Therefore, further investigation is required undergone orthopedic surgery, which included 155 of the to obtain data to ascertain whether MP may be an effective 450 patients from the first part of the study and 32 unrelated alternative to acetaminophen. cases from the orthopedics department, were further evalu- The aim of the present study was to evaluate the effects of ated to compare the efficacy and safety of acetaminophen and surgical trauma on the development of APR and to investigate low-dose MP. Patients without GC contraindications, such the efficacy of low‑dose MP in preventing APR associated as active ulcer or glaucoma, and who completed the 1-year with the early post-surgical administration of ZA using clinical follow-up were included. The 155 patients that met the above data from the orthopedics and endocrinology departments at criteria from the OS and MIS subgroups (66 and 89 patients, a single hospital. respectively) constituted the acetaminophen group. The 32 unrelated cases had been immediately treated with 40 mg MP Materials and methods (Pfizer, Inc.) in 0.9% saline daily for 2 days after ZA infusion subsequent to surgery, and constituted the MP group. The MP Patients. A total of 482 patients aged from 49 to 89 years were group included 16 patients who had undergone OS and 16 who recruited in this hospital-based, retrospective study including had undergone MIS. Fever occurring subsequently was treated 77 males and 405 females at the First Affiliated Hospital of with acetaminophen as required in the acetaminophen and MP Nanjing Medical University (Nanjing, China) from January groups (Fig, 1). 2012 to December 2014. Patients receiving their initial ZA infusion for osteoporosis (17), some of whom received ZA at Biochemical measurements and bone mass density (BMD) 1 week after orthopedic surgery, were included in the present assessment. Samples of fasting peripheral blood at rest were study. Patients with absorption fever or infection post-surgery taken as a baseline on the morning prior to ZA infusion. were excluded, as this had the potential to affect the observa- The biochemical parameters analyzed in this study were tion of APR symptoms. Exclusion criteria included a history of calcitonin (CT), type I collagen cross-linked C-telopeptide cancer, hyperparathyroidism, and previous use of parathyroid (CTx), N-telopeptide (NTx), bone gla protein (BGP), PTH, hormone (PTH), strontium, sodium fluoride, intravenous or 25-hydroxy-vitamin D3 [25(OH)D], serum Ca2+, C-reactive oral BPs, recent or chronic corticosteroid therapy, statins or protein (CRP) and erythrocyte sedimentation rate (ESR). immune therapy. Furthermore, patients with severe injuries, CT levels were assessed using a radioimmunoassay kit liver or kidney disease, or recent or scheduled dental surgery (CT-10161; Amresco LLC, Solon, OH, USA) according to the were ineligible. The present study was approved by the Ethics manufacturer's protocol. CTx and NTx were assessed using Committee of the First Affiliated Hospital of Nanjing Medical electrochemiluminescence immunoassay kits (PP-US-07407 University and written informed consent was obtained from and PP-US-05294, respectively; Roche Diagnostics) all patients. according to the manufacturer's protocol. BGP levels were assessed using a chemiluminescent microparticle immu- Study design and procedures. All subjects were treated with noassay (MAGLUMI 2000 Plus; Shenzhen New Industries cholecalciferol (Roche Diagnostics, Basel, Switzerland) Biomedical Engineering Co., Ltd., Shenzhen, China). PTH 800 IU/day and Caltrate (Pfizer, Inc., New York, NY, USA) levels were evaluated via chemiluminescence immunoassay 1,200 mg/day orally from the time of hospitalization as (Immulite 2000; Siemens AG, Munich, Germany). 25(OH) vitamin
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