akinohanayuki ブログ

学位を持っても、センスのない、感染制御専門薬剤師のブログ.  I have Ph.D. but less sense ID pharmacist.

panipenemって? メモ..._〆(゚▽゚*)

最後に使用した症例はいつの日だったのか…
おもいでの パニペネムを振り返り

パニペネムを推奨しうる使用法ないのか? 抗菌薬開発が少ない現状において、再考すべしと思いますが…論文少なく、臨床使用難しい現状ですよね。

私のハンドリサーチにおいて、死亡率を求めた検討は、レトロスペクティブ 1つだけでした。
RCT 2つは、臨床効果をoutcome設定しており客観評価が難しいです。

なお、私が求める副作用以外の情報は、以下の項目です。
  • 死亡率や再燃率
  • (臨床的改善やCRPは関節炎など長期的な治療必要な疾患以外は求めず)
  • 治療期間
  • 耐性菌化を予防出来うるか

それでは、少し復習

Pubmed検索

  • panipenem[ti] : 68件 
  • Vitroと英語以外は排除すると15件
  • なお、2013年以降なし
  • メタアナ なし
  • RCT 2件

まずは、RCT

J. Infect. Chemother. 2013 Feb; 19(1):103-11.
Prospective randomized study of cefepime, panipenem, or meropenem monotherapy for patients with hematological disorders and febrile neutropenia.

sample size
  • 300 patients (100 patients each in the CFPM, PAPM/BP, and MEPM arms). 
  • α of 0.05 and a β of 0.10,
  • efficacy rate of CFPM would be 60 % and the expected efficacy rates of PAPM/BP and MEPM would be 80 %. 
  •  sample size of 100 patients per arm.
The primary endpoint 
  • the efficacy of initial therapy with PAPM/BP and MEPM on days 3 and 7 after the start of treatment, as compared with that of initial therapy with CFPM. 
The secondary endpoints
  • (1) the efficacy of CPFX or AMK, which was added after patients proved to be unresponsive to the initial therapy
  • (2) efficacy on days 14 and 30
  • (3) safety profiles.
patients
  • 299 patients from 28 medical institutions throughout Japan
  • 299-44 : 255 patients
  • CFPM (n = 86; 33.7 %), PAPM/BP (n = 80; 31.4 %), or MEPM (n = 89; 34.9 %)
f:id:akinohanayuki:20160303213052j:image

結果は、下記の図を

f:id:akinohanayuki:20160303213057j:image
f:id:akinohanayuki:20160303213136j:image

Jpn. J. Clin. Oncol. 2008 Jan; 38(1):49-55.
Panipenem versus cefepime as empirical monotherapy in adult cancer patients with febrile neutropenia: a prospective randomized trial.

P:  adult cancer patients with febrile neutropenia
E: panipenem 
C: cefepime    
O: success rate for the panipenem group (89.1%) was similar to that of the cefepime group (91.8%) (non-inferiority, P = 0.002, 95% confidence interval: -13.48%, 10.35%)

f:id:akinohanayuki:20160303214918p:imagef:id:akinohanayuki:20160303214929j:image


続いて、RCT以外

J. Infect. Chemother. 2013 Aug; 19(4):607-14.
A retrospective cohort study of panipenem/betamipron for adult pneumococcal bacteremia at three teaching hospitals in Japan.
P: adult patients with community-acquired pneumococcal bacteremia
E : In total, 17 patients who received PAPM/BP therapy 
C : 34 treated with other carbapenems (27 with meropenem, 4 with imipenem/cilastatin, and 3 with biapenem) were identified
O : inpatient mortality rates were lower in the PAPM/BP group (12 vs. 44 %, p = 0.03). 
Multiple logistic regression analysis adjusted : other carbapenems was associated with higher in-hospital mortality : odds ratio of 6.922 (95 % CI, 1.171-40.92).

  • 良い結果ですよね。良すぎます。
  • RCTが求められます。
  • 統計にStudent’s t test を選択しています。
  • フォローチャートに背景セルが写り込んでいます⁉︎
  • サンプルサイズの根拠記載ないです。

f:id:akinohanayuki:20160306061607j:image
f:id:akinohanayuki:20160306061858j:image

J. Infect. Chemother. 2004 Aug; 10(4):242-4.
A case of listerial meningitis treated with a regimen containing panipenem-betamipron.

Although panipenem-betamipron, which is commercially available only in Japan, is recommended for treatment of pediatric bacterial meningitis by some experts, only a limited number of clinical studies have been reported. In the present report, we describe a 2-year-old boy with meningitis caused by Listeria monocytogenes who was treated with a regimen containing panipenem-betamipron and recovered without any apparent neurological sequelae. On the basis of our experience and previous reports, panipenem-betamipron appears to be effective for the treatment of listerial meningitis.

J. Infect. Chemother. 2002
Evaluation of panipenem/betamipron (PAPM/BP) in pneumonia in elderly patients.

  • Clinical response to therapy was recorded as excellent, good, fair, or poor. Clinical responses of “excellent” and “good” were defined as the resolution of physical symptoms and signs of infection within 3 and 7 days, respectively, after the beginning of PAPM/BP treatment
The present multicenter study evaluated the clinical and bacteriological efficacy and safety of panipenem/betamipron (PAPM/BP) for treating pneumonia in elderly patients. Forty-three episodes of pneumonia in 43 patients were treated with PAPM/BP as the sole antibiotic agent. All patients were 65 years of age or older, and were given PAPM/BP at a total daily dosage range of 0.5-2.0 g. The clinical efficacy rate, expressed as a percentage of the total number of excellent and good responses, was 56.4%. Of the 43 patients, 13 were evaluated bacteriologically. In these 13 patients, the eradication rate, expressed as a percentage of the total number of "eradicated" and "replaced" efficacies, was 30.8%. Adverse effects and abnormal laboratory findings occurred in 2 patients, which was 4.6% of the total number of patients evaluated. No serious adverse effects were observed. We concluded that PAPM/BP was well tolerated overall, and was effective and safe for most of the elderly patients.
  • 倫理審査の記載なし
  • サンプルサイズの根拠記載なし
  • 統計なし