スタチンを実際に使用して、副作用はどの程度起こるか? UKでのProspective コホート研究より

【文献名】

Julia Hippisley-Cox : Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database(¶1)  BMJ 2010;340:c2197



【要約】

<Objective>

To quantify the unintended effects of statins according to type, dose, and duration of use.



<Design>

Prospective open cohort study using routinely collected data. 



<Setting>
368 general practices in England and Wales supplying data to the QResearch database. 【Participants】 2 004 692 patients aged 30-84 years of whom 225 922 (10.7%) were new users of statins: 159 790 (70.7%) were prescribed simvastatin(訳注;リポバスR), 50 328 (22.3%) atorvastatin(訳注;リピトールR), 8103 (3.6%) pravastatin(訳注;メバロチンR), 4497 (1.9%) rosuvastatin(訳注;クレストールR), and 3204 (1.4%) fluvastatin(訳注;ローコール).



<Methods>

Cox proportional hazards models were used to estimate effects of statin type, dose, and duration of use. The number needed to treat (NNT) or number needed to harm (NNH) were calculated and numbers of additional or fewer cases estimated for 10 000 treated patients.



<Main outcome measure>

First recorded occurrence of cardiovascular disease, moderate or serious myopathic events, moderate or serious liver dysfunction, acute renal failure, venous thromboembolism, Parkinson’s disease,dementia, rheumatoid arthritis, cataract, osteoporotic fracture, gastric cancer, oesophageal cancer, colon cancer, lung cancer, melanoma, renal cancer, breast cancer, or prostate cancer.



<Results>

(To help reading, I added the number to the original article. See Table6 in original article.)

1.Individual statins were not significantly associated with risk of Parkinson’s disease, rheumatoid arthritis, venous thromboembolism, dementia, osteoporotic fracture, gastric cancer, colon cancer, lung cancer, melanoma, renal cancer, breast cancer, or prostate cancer. 

2.Statin use was associated with decreased risks of oesophageal cancer but increased risks of moderate or serious liver dysfunction, acute renal failure, moderate or serious myopathy, and cataract. 

3. Adverse effects were similar across statin types for each outcome except liver dysfunction where risks were highest for fluvastatin. A dose-response effect was apparent for acute renal failure and liver dysfunction. All increased risks persisted during treatment and were highest in the first year. After stopping treatment the risk of cataract returned to normal within a year in men and women. Risk of oesophageal cancer returned to normal within a year in women and within 1-3 years in men. Risk of acute renal failure returned to normal within 1-3 years in men and women, and liver dysfunction within 1-3 years in women and from three years in men.

4. Based on the 20% threshold for cardiovascular risk, for women the NNT with any statin to prevent one case of cardiovascular disease over five years was 37 (95% confidence interval 27 to 64) and for oesophageal cancer was 1266 (850 to 3460) and for men the respective values were 33 (24 to 57) and 1082 (711 to 2807).

5. In women the NNH for an additional case of acute renal failure over five years was 434 (284 to 783), of moderate or severe myopathy was 259 (186 to 375), of moderate or severe liver dysfunction was 136 (109 to 175), and of cataract was 33 (28 to 38). Overall, the NNHs and NNTs for men were similar to those for women, except for myopathy where the NNH was 91 (74 to 112).



<Conclusions>

Claims of unintended benefits of statins, except for oesophageal cancer, remain unsubstantiated, although potential adverse effects at population level were confirmed and quantified. Further studies are needed to develop utilities to individualise the risks so that patients at highest risk of adverse events can be monitored closely.

【開催日】

2011年8月3日

プラザキサの費用対効果はどれくらいか?

【文献名】

Shimoli V. Shah and Brian F. Gage. Cost-Effectiveness of Dabigatran for Stroke Prophylaxis in Atrial Fibrillation. (Circulation. 2011;123:2562-2570.)



【要約】

<Background>

Recent studies have investigated alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation (AF), but whether these alternatives are cost-effective is unknown.



<Methods and Results>

On the basis of the results from Randomized Evaluation of Long Term Anticoagulation Therapy
(RE-LY) and other trials, we developed a decision-analysis model to compare the cost and quality-adjusted survival of various antithrombotic therapies. We ran our Markov model in a hypothetical cohort of 70-year-old patients with AF using a cost-effectiveness threshold of $50 000/quality-adjusted life-year. We estimated the cost of dabigatran as US $9 a day. For a patient with an average risk of major hemorrhage (3%/y), the most cost-effective therapy depended on stroke risk. For patients with the lowest stroke rate (CHADS 2 stroke score of 0), only aspirin was cost-effective. For patients with a moderate stroke rate (CHADS 2 score of 1 or 2), warfarin was cost-effective unless the risk of hemorrhage was high or quality of international normalized ratio control was poor (time in the therapeutic range 57.1%). For patients with a high stroke risk (CHADS 2 stroke score 3), dabigatran 150 mg (twice daily) was cost-effective unless international normalized ratio control was excellent (time in the therapeutic range  72.6%). Neither dabigatran 110 mg nor dual therapy (aspirin and clopidogrel) was cost-effective.



<Conclusions>

Dabigatran 150 mg (twice daily) was cost-effective in AF populations at high risk of hemorrhage or high risk of stroke unless international normalized ratio control with warfarin was excellent. Warfarin was cost-effective in moderate-risk AF populations unless international normalized ratio control was poor.



【開催日】

2011年7月26日

風邪に対するプラセボの効果~ランダム化比較試験~

【タイトル】

風邪に対するプラセボの効果~ランダム化比較試験~



【文献名】

Barret B. Brown R. et al. Placebo Effects and the Common Cold: A Randomized Controlled Trial. Ann Fam Med. 2011; 312-322.



【要約】

<PURPOSE>

 We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open- label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all.



<METHODS>

We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echina- cea, and (4) those given open-label echinacea. Primary outcomes were illness dura- tion and area-under-the-curve global severity. Secondary outcomes included neu- trophil count and interleukin 8 levels from nasal wash at intake and 2 days later.



<RESULTS>

Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean ill- ness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global sever- ity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were ?0.16 days (95% CI, ?0.90 to 0.58 days) for illness duration and ?22 severity points (95% CI, ?70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, ?0.28 to 1.12 days) and 22 severity points (95% CI, ?19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statisti- cally significant. Among the 120 participants who at intake rated echinacea’s effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, ?4.47 to ?0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (?97.0, 95% CI, ?249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group.



<CONCLUSIONS>

Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings sup- port the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.



【開催日】

2011年7月20日

ダビガトランは患者さんにとって有用か?

【文献名】

Stuart J. Connolly, M.D. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-1151



【要約】

<Background>

Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.



<Methods>

In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran ? 110 mg or 150 mg twice daily ? or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary study outcome was stroke or systemic embolism.
  Systemic embolism was defined as an acute vascular occlusion of an extremity or organ,documented by means of imaging,surgery,or autopsy.
The primary safety outcome was major hemorrhage.



<Results>

Characteristics of the study patients was described table 1 in the original article. The three treatment groups were well balanced with respect to baseline characteristics
Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% CI, 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). 
The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051).

The only adverse effect that was significantly more common with dabigatran than with warfarin was dyspepsia(Table.4)Dyspepsia occurred in 348 patients (5.8%) in the warfarin group and in 707 patients (11.8%) and 688 patients (11.3%) in the 110-mg and 150-mg dabigatran groups, respectively (P<0.001 for both comparisons)
 110831

110831_2


 
 <Conclusions>

In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage.



【開催日】

2011年6月22日

PPIは骨折リスクを増加させる(メタアナリシス)

【文献名】

Chun-Sick Eom, Sang Min Park, Seung-Kwon Myung, Jae Moon Yun, and Jeong-Soo Ahn. Use of Acid-Suppressive Drugs and Risk of Fracture: A Meta-analysis of Observational Studies. Ann Fam Med . 2011 9: 257-267.



【要約】

<背景>

PPIは破骨細胞の酸生成も抑制するため骨折に予防的に働くと考えられてきたが、むしろ骨折が増えるという知見が出てきている。PPIと骨折リスクの増加についての研究は議論の一致をみておらず、これまでメタアナリシスが存在しないことからメタアナリシスを実施することとした。



<文献検索>

MEDLINE、EMBASE、Cochrane Libraryを使用。



<研究選別>

RCT、コホート内症例対照研究、症例対照研究を利用。骨折リスクのリストを作成。二人の研究者が独立して評価される研究の妥当性を評価。



<主解析>

PPI、H2ブロッカー、あるいはその両者の使用と骨折リスクとの関係



<結果>

1809の文献がヒットしたが選別の結果、最終解析に残ったのは5つの症例対照研究、3つのコホート内症例対照研究、3つのコホートであった。RCTは最終選別までに除外され残らなかった。

 

●主解析結果

PPIで骨折リスク上昇を認めた(adjusted OR 1.29: 95%CI 1.18-1.41, I2 69.8%, n=10)
H2ブロッカーで骨折リスク上昇認めず(adjusted OR 1.10: 95%CI 0.99-1.23, I2 86.3%, n=7)

●サブグループ解析結果
Table.2参照。



●出版バイアスの評価
特に影響はないと考えられた(funnel plot、Egger test)。



<Discussion>

PPIと骨折リスク増加が認められた。H2ブロッカーと骨折リスクには明らかな関係は見いだせなかったが、サブグループ解析ではhigh-quality methodology studyと5つ以上の変数について補正した解析では骨折との関連性が示唆されており今後のさらなる4研究が必要。
 限界として①観察研究が含まれるのでバイアスが含まれる可能性がるが、これについては様々なサブグループ解析を行うことで補った。②Egger testは出版バイアス評価としては信頼性が劣る。③栄養データについては評価していない。④胃の疾患の有無の評価をしていない。



<まとめ>

PPIは骨折リスクを中等度上昇させる可能性がある。H2ブロッカーに関してはその可能性は示唆されなかった。ORは2以下で僅かな影響と考えられるもののcommon diseaseでもあり社会への影響は大きい。臨床家は特に65歳以上の女性に対してこれらの処方するときには慎重に考慮をするべきである。用量についても望ましい結果得られるために必要な最低限の量にとどめることが勧められる。



【考察とディスカッション】

弱いながらもPPIと骨折リスク上昇の可能性が示唆されている。やはり制酸薬を使用する際は必要最小限のものとすることを目標とするのがよさそうである。
以下、全体でのディスカッション
NSAIDSの投与にあわせてPPIを使用している患者も多い。この文献の結果を受けて、自分自身の投薬行動を見直す機会としたい。



【開催日】

2011年6月22日

糖尿病の処方の考え方

【文献名】

辻野元祥,これで決まり!おすすめ処方 糖尿病編,日本医事新報,2011年4月9日;No.4537:42-46



【要約】


 糖尿病患者をⅠ~Ⅳの4つのグループに分けて初めて薬物治療を開始する場合および、そこからステップアップする場合の代表的な処方例をあげる。

110818_1


Ⅰ.痩せ型かつ軽中等症
 このグループに入る患者は、中等度のインスリン分泌不全、特にインスリン初期分泌障害に伴い空腹時血糖以上に食後高血糖が目立つという特徴を持つ方が多い。したがって、まずは、食後高血糖を是正する目的で最初の薬剤が選択される。
<処方例>(2~3ヶ月毎に見直し)

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Ⅱ.痩せ型かつ重症
 グループⅠよりもインスリン分泌不全がより進んだ病態。まず、HbA1cが10%以上あるいは尿ケトン体強陽性の患者はインスリンを導入すべき。HbA1cが8~10%でも可能な限りインスリン導入が勧められる。しかし、最初からインスリン導入の話をすると逃げ出してしまう患者も少なくない。インスリン導入が困難な場合の処方例を示す。
<処方例>(1~2ヶ月毎に見直し)

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Ⅲ.中肉~肥満型かつ軽中等症
 若干あるいは高度のインスリン抵抗性があり、グループⅠ同様にインスリン初期分泌障害があるとしても高度ではない病態。ターゲットはインスリン抵抗性、次いでインスリン初期分泌障害となる。
<処方例>(2~3ヶ月毎に見直し)



Ⅳ.中肉~肥満型かつ重症
 HbA1cが10%以上あるいは尿ケトン体陽性の患者は痩せ型でなくてもインスリンを導入すべき。HbA1cが8~10%の患者では、尿ケトン体陰性であることを確認してメトホルミンを、食事療法が可能であれば、早期からピオグリタゾンを併用するか、DPP4阻害薬を併用する。
<処方例>(1~2ヶ月毎に見直し)

110818_4



【考察とディスカッション】
糖尿病患者を4つのグループに分け、グループ毎にStepを踏んで治療を組み立てていくという考え方はこれまでも何気なくやってきたことではあったが、今回の記事を読んで、頭の中を整理する事ができた。しかも、DPP4阻害薬などインクレチン製剤も組み合わせた形で整理する事ができた。しかし、DPP4阻害薬とSU薬の併用で重篤な低血糖が起きるなど危険性も把握したうえで治療を組み立てる必要がある。
以下全体でのディスカッション。
 現時点ではDPP4阻害薬に関するエビデンスは乏しく、また多くの症例が長期で服薬した場合の副作用なども明らかにはなっていない。今回の文献はエキスパートオピニオンとして参考にすべきものであろう。
 ビグアナイド製材やSU剤が経口血糖降下薬の主役であることは当面変わらないだろう。その他の今後のエビデンスの出現に期待したい。
 ビグアナイド製剤であるメトホルミンはこれまで1日750mgまでの使用が限度であったが、2250mgまで使用可能な製剤が発売され1年が経過、長期処方が可能になったところである。こちらも注目すべき情報である。




【開催日】

2011年6月15日

変形性膝関節症の治療に関するエビデンスの整理

【文献名】
Erika Ringdahl, Sandesh Pndit. Treatment of Knee Osteoarthritis. Am Fam Physician. 2011;83(11):1287-1292.

【要約】

<Background>
Osteoarthritis is a degenerative joint disease occurring primarily in older adults. It is characterized by erosion of the articular cartilage, hypertrophy of bone at the margins (i.e., osteophytes), and subchondral sclerosis.1  Arthritis is the leading cause of disability in the United States,2 and osteoarthritis is the most common condition affecting synovial joints.3 
Despite its widespread prevalence, however, the precise etiology, pathogenesis, and progression of osteoarthritis are unknown. Several factors may make a person vulnerable to the disease (Table 1).

110818_6


<Diagnosis of Osteoarthritis>
The differential diagnosis of chronic knee pain is given in original paper (table2).
The criteria for diagnosing knee osteoarthritis are based on the presence of knee pain plus at least three of the six clinical characteristics listed in Table 3.5,6 The addition of laboratory and radiographic criteria enchances the diag- nostic accuracy; however, these tests are not necessary for all patients. In most patients, the history, physical examination, and radiography are all that is needed.

110818_7


<Treatment of Osteoarhritis>
110818_8

The evidence ratings of treatment of knee osteoarthritis are below.
# The use of braces and heel wedges may also be effective. There is some evidence that the use of a lateral heel wedge decreases the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Similar evidence suggests that a brace and lateral wedge insole may have a small beneficial effect.
# Ginger may provide some clinical benefit in patients with knee osteoarthritis; patients who took 255mg of ginger extract twice daily had a reduction in pain (63% compared with 50% in the placebo group).
# Topical NSAIDs were superior to placebo in relieving pain, but only for the first two weeks of treatment. Topical NSAIDs were less effective than oral NSAIDs.
#  Arthroscopic surgery is not an appropriate treatment unless there is evidence of loose bodies or mechanical symptoms such as locking, giving way, or catching. 
#  The main indication for total knee arhtroplasty is relief of pain associated with knee osteoarthritis if nonsurgical treatment has been ineffective. The complication rate of total knee replacement is 5.4% of patients.



【開催日】

2011年6月15日

喘息コントロール治療のファーストラインもしくは併用薬としてのロイコトリエン拮抗薬

【文献名】

David Price et al. Leukotriene  Antagonists as First-Line or Add-on Asthma-controller Therapy. The New England Journal of Medicine,May 5,2011




【要約】

<Background>

喘息治療研究のrandomized trialsa



<Methods>

・喘息治療において

①第一選択である吸入ステロイドとロイコトリエン拮抗薬(LTRA)

②すでに吸入ステロイドを導入している患者へ追加治療として
長時間作動性β刺激薬(LABA)とロイコトリエン拮抗薬(LTRA)
とを比較した。



・12歳~80歳のプライマリケア患者で喘息関連のQOLが低い人(MiniAQLQスコア6点以下)もしくは不適切な喘息コントロール患者(ACQスコア1点以上)を対象。患者をランダムに以下の2年間のopen-label治療に振り分けた。

①治療の第一選択として、LTRA使用148人と吸入ステロイド使用158人

②吸入ステロイドの追加治療として、LTRA追加170人とLABA追加182人



・Outcome

①Primary outcome ;MiniAQLQ score

②Secondary outcome;ACQscore、RCP3、MiniRQLQ、喘息悪化頻度など



<Results>

両研究①②とも2年間でMiniAQLQスコアは平均0.8-1.0点上昇。

治療2か月の時点で①②ともに、2つの治療間では効果同等(95%CI-0.3~0.3)。

治療2年後は、①-0.11(95%CI -0.35~0.13)、②-0.11点(95%CI -0.32~0.11)で同等とは言えず。

悪化率とACQスコアなどsecondary outcomeは①②とも大差なし。



<Conclusions>

治療2か月後での研究結果では、

①治療の第一選択としてLTRAは吸入ステロイドと同等。

②追加治療においてLABAと同等。
しかし治療2年後ではその同等性は証明されなかった。

グループ間の交絡因子とプラセボグループとの比較がないため結果の解釈は限定的である。




【考察とディスカッション】

・患者への治療割り付けがopen-labelでblindではなく、プラセボとの比較がない。

・喘息の診断方法や治療アドヒアランス(吸入手技/内服頻度/金銭問題など)の問題。

・小児(12歳未満)は含まれていない/小児のデータがなく成人への適応のみ。

・治療間の効果の差は小さく、解析方法により解釈結果が異なり結果を十分臨床に適応するには微妙と思われる。

・イギリスでは吸入ステロイドが第一選択で使われており医者によってはLTRAを割り当てられても他の薬剤への切り替えや追加がされやすい可能性がある。



→短期間では、吸入ステロイドとLTRAとは効果は同等でどちらを選んでも差はない。

長期的効果の同等性は証明されていないがその差は小さい可能性がある。
実際の臨床現場では、薬の効果だけでなくコンプライアンスなども複雑にかかわっているため
確実に使用できる薬剤を選択する現在の治療方針で特に問題なさそうと思われる。




【開催日】

2011年6月1日

24時間血圧測定に代わる新たな外来血圧測定法 -30分安静自動血圧測定-

【文献名】

Mark C van der Wel et al. : A Novel Approach to Office Blood Pressure Measurement: 30-Minute Office Blood Pressure vs Daytime Ambulatory Blood Pressure Ann Fam Med 2011;9:128-135.


【要約】

<Background>

Current office blood pressure measurement (OBPM) is often not executed according to guidelines and cannot prevent the white-coat effect. Moreover, large number of studies suggest the risk of cardiovascular complication correlates more closely with 24 hour or daytime ABPM than office BP.

<Purpose>

Serial, automated, oscillometric OBPM has the potential to overcome both these problems.
We therefore developed a 30-minute OBPM method that we compared with daytime ambulatory blood pressure.

<Methods>

Patients referred to a primary care diagnostic center for 24-hour ambulatory blood pressure monitoring (ABPM) had their blood pressure measured using the same validated ABPM device for both ABPM and 30-minute OBPMs. Known atrial fibrillation, irregular pulse, pregnancy, and night shift work were exclusion criteria.
All 30-minute measurements took place between 11 AM and 3 PM in a quiet room at the diagnostic center. The patient was sitting still 5 minutes before and during the 30-minute OBPM. The patient sat in a chair with a supported back, arm at heart level, and both feet resting flat on the floor. Blood pressure was measured on the nondominant arm at 5-minute intervals for a total of 8 measurements. The first measurement was a test measurement during the installation of the patient. The second measurement was the start of the 30-minute period; the researcher left the room after this measurement proved to be successful (no error reading).
We define 30-minute OBPM to be the mean blood pressure calculated from the 6 measurements taken at 5-minute intervals from t = 5 to t = 30 minutes. If more than 1 of these 6 measurements was erroneous (defined as an “error” reading given by the device), the entire case was excluded for analysis.
The mean 30-minute OBPM (based on t = 5 to t = 30 minutes) was compared with mean daytime ABPM using paired t tests and the approach described by Bland and Altman on method comparison.
In the absence of usual care office blood pressure measurements, we defined office blood pressure
as the mean of the first 2 measurements of the 30-minute OBPM.

<Results>

We analyzed data from 84 patients (mean age 57 years; 61% female). Patients characteristics are shown in table1 below. Systolic and diastolic blood pressures differed from 0 to 2 mm Hg (95% confidence interval, ?2 to 2 mm Hg and from 0 to 3 mm Hg) between mean 30-minute OBPM and daytime ABPM, respectively. The limits of agreement were between ?19 and 19 mm Hg for systolic and ?10 and 13 mm Hg for diastolic blood pressures.(Table2)
Both 30-minute OBPM and daytime ABPM classified normotension, whitecoat hypertension, masked hypertension, and sustained hypertension equally(Table3).

<Conclusion and discussion>

The 30-minute OBPM appears to agree well with daytime ABPM and has the potential to detect white-coat and masked hypertension. This finding makes 30-minute OBPM a promising new method to determine blood pressure during diagnosis and follow-up of patients with elevated blood pressures.

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※A device used in this study.
http://www.ciao.co.uk/Welch_Allyn_Cardioperfect_6100_Series_Ambulatory_Blood_Pressure_Monitor__6861410

【開催日】

2011年6月1日

変形性膝関節症に対する足底板の効果

【文献】

Van Raaij TM et al. Medial knee osteoarthritis treated by insoles or braces: a randomized trial. Clin Orthop Relat Res. 2010 Jul;468(7):1926-32. Epub 2010 Feb 23.


【要約】

<BACKGROUND> 

There is controversial evidence regarding whether foot orthoses or knee braces improve pain and function or correct malalignment in selected patients with osteoarthritis (OA) of the medial knee compartment. However, insoles are safe and less costly than knee bracing if they relieve pain or improve function.

<QUESTIONS/PURPOSES>

We therefore asked whether laterally wedged insoles or valgus braces would reduce pain, enhance functional scores, and correct varus malalignment comparable to knee braces.

<PATIENTS AND METHODS>

We prospectively enrolled 91 patients with symptomatic medial compartmental knee OA and randomized to treatment with either a 10-mm laterally wedged insole (index group, n = 45) or a valgus brace (control group, n = 46). All patients were assessed at 6 months. The primary outcome measure was pain severity as measured on a visual analog scale. Secondary outcome measures were knee function score using WOMAC(http://p.tl/nihq) and correction of varus alignment on AP whole-leg radiographs taken with the patient in the standing position. Additionally, we compared the percentage of responders according to the OMERACT-OARSI criteria for both groups.

<RESULTS>

We observed no differences in pain or WOMAC scores between the two groups. Neither device achieved correction of knee varus malalignment in the frontal plane. According to the OMERACT-OARSI criteria, 17% of our patients responded to the allocated intervention. Patients in the insole group complied better with their intervention. Although subgroup analysis results should be translated into practice cautiously, we observed a slightly higher percentage of responders for the insole compared with bracing for patients with mild medial OA.

<CONCLUSIONS>

Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA.

【開催日】

2011年5月25日

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