退化性關節炎之處方型態分析-包含Glucosamine sulfate使用型態及新一代NSAIDs引起消化性潰瘍的發生率

Analysis of Prescription Pattern of Osteoarthritis--Utilization Pattern of Glucosamine Sulfate and the Incidence Rate of New-Generation NSAID-Induced Gastric Toxicity

簡碧醇(Pi-Chun Chien)

指導教授 ： 顏銘宏

高雄醫學大學/藥學院/藥學研究所/碩士(2011年)

摘要

背景：退化性關節炎是一種關節退化疾病，主要會引起疼痛及功能受到限制。非類固醇消炎止痛藥(Nonsteroidal Antiinflammatory Drugs,NSAIDs)是目前最常用來緩解退化性關節炎所引起的疼痛。相較於傳統的NSAIDs，新一代NSAIDs雖然對胃腸道有較低的副作用，但因退化性關節炎需長期使用，且使用的對象為老年人，所以在使用上更需格外的謹慎小心。葡萄糖胺(Glucosamine Sulfate)安全性較高，也常見於緩解退化性關節炎的症狀。不過效果至今仍未有明確的定論。
目的：本研究主要了解目前Glucosamine Sulfate及止痛劑在治療退化性關節炎上的使用情形，及評估退化性關節炎病人使用新一代 NSAIDs後引起消化性潰瘍的發生率。
方法：本研究採用全民健康保險研究資料庫2004年到2008年承保抽樣歸人檔，ICD-9-CM符合“715”的退化性關節炎病人為研究對象。本研究主要分成三個部份進行分析：第一部份退化性關節炎藥物之處方型態中，主要利用WHO所制定的ATC系統來分析退化性關節炎在門診的藥物品項及處方頻次。第二部份Glucosamine Sulfate在門診處方的用藥型態中，研究納入條件主要是2005年以後開始服用Glucosamine Sulfate的使用者。處方型態分析包含接受人工關節置換的比例、每日處方使用劑量，及Glucosamine Sulfate的使用型態等。第三部份在新一代NSAIDs藥物引起消化性潰瘍的發生率中，主要分析有服用新一代NSAIDs (celecoxib、etoricoxib、nabumetone、meloxicam、etodolac、nimesulide)的退化性關節炎病患發生消化性潰瘍的比例及年齡分佈。使用的軟體為SAS 9.1及SPSS 12.0統計套裝軟體進行資料整理與統計分析。
結果：第一部份退化性關節炎藥物之處方型態皆以NSAIDs類比例最高，其它依序為Glucosamine、Paracetamol、Corticosteroids及Opioids。第二部份Glucosamine Sulfate在門診處方的用藥型態中，有使用Glucosamine的病人接受人工關節置換的比例高於未使用Glucosamine的退化性關節炎病人(OR=3.06，95%CI：1.58-5.95)。而在Glucosasmine的使用型態中，又以Glucosamine使用一段時間後停止使用，而改回使用止痛劑繼續治療的人數最多(69.7%)。第三部份在新一代NSAIDs藥物引起消化性潰瘍的發生率中，樣本數291人中，發生胃腸病例共有126例。所以退化性關節炎使用新一代NSAIDs之後罹患胃潰瘍的發生密度為每十萬人日142.15例。
結論：目前治療退化性關節炎藥物以NSAIDs為主。但新一代NSAIDs仍有消化性潰瘍的病例產生，所以在使用上仍需格外小心謹慎。而在Glucosamine Sulfate的使用上，雖然本研究的結果顯示，有使用Glucosamine Sulfate的病人接受人工關節置換術較高，不過因無法得知是否和病患的嚴重程度有關，所以仍需進一步探討。

關鍵字

退化性關節炎

並列摘要

Background: Osteoarthritis is a degenerative joint disease. It can result in joint pain and limited function. Nonsteroidal Antiinflammatory Drugs (NSAIDs) are the most common medications to relieve pain of Osteoarthritis. Compared with traditional NSAIDs, the new-generation NSAIDs lead to less GI adverse effects. Nevertheless, most patients with Osteoarthritis are the elders and require long-term use of NSAIDs. It must therefore be used cautiously and with careful consideration. Glucosamine Sulfate, also commonly used to relieve symptoms of Osteoarthritis, is thought to be safe. However the effect of Glucosamine Sulfate still remains controversial.

Purposes: The purposes of the present study were to examine the current uses of Glucosamine Sulfate and NSAIDs in the treatment of Osteoarthritis and to evaluate the incidence rate of new-generation NSAID-induced gastric toxicity.

Materials & Methods: The data of the present study was collected from the National Health Insurance Research Database (NHIRD) during 2004- 2008. The subjects were selected from the patients who were identified Osteoarthritis as ICD-9 codes 715, classified by International Classification Disease (ICD) coding system. The study was analyzed according to the following three parts: 1) In order to investigate the prescription pattern of Osteoarthritis, the Anatomical Therapeutic Chemical (ATC) Classification System, established by WHO, was used to assess the prescription drugs and frequency; 2) according to the prescription pattern of Osteoarthritis, the study aims to examine the patients who have started to use Glucosamine Sulfate since 2005. The analyses of the prescription pattern include the proportion of patients undergoing knee replacement surgery, prescribed daily dose of Glucosamine Sulfate and the utilization patterns of Glucosamine Sulfate; and 3) in order to investigate the incidence rate of new-generation NSAID-induced gastric toxicity, the proportion and age distribution of gastric toxicity were analyzed among the patients with Osteoarthritis who use the new-generation NSAIDS. SAS and SPSS were applied to analyze the data in the present study.

Results: First, according to Osteoarthritis prescription pattern, NSAIDs were the most commonly prescribed medications, followed by Glucosamine, Paracetamol, Corticosteroids, and Opioids. Second, according to the prescription pattern of Glucosamine Sulfate, the incidence of undergoing knee replacement surgery after Glucosamine Sulfate was significantly higher than unused(OR=3.06，95%CI：1.58-5.95). In analysis of Glucosamine Sulfate utilization patterns, it indicated that the frequency of prescribing is the highest among the patients who have stopped taking Glucosamine Sulfate and started using NSAIDs (69.7%). Finally, according to the incidence rate of new-generation NSAID-induced gastric toxicity, the incidence rate was 142.15 cases of peptic ulcers per 100.000 persons a day

Conclusion: Nowadays, NSAIDs are still the main drugs used for the treatment of Osteoarthritis. However, due to the clinical cases of new-generation NSAID-induced gastric toxicity, NSAIDs must be used with particularly careful consideration. Finally, according to the utilization patterns of Glucosamine Sulfate, the result showed that the patients using Glucosamine Sulfate have the higher incidence rate of undergoing knee replacement surgery. However, since it is lack of sufficient evidence to reveal whether the incidence rate is correlated with the patients’ degree of illness, further investigations may be necessary.

並列關鍵字

Osteoarthritis

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