小腸術後イレウス

Nonsurgical management of partial adhesive small-bowel obstruction with oral therapy: a randomized controlled trial.
Chen SC, Yen ZS, Lee CC, Liu YP, Chen WJ, Lai HS, Lin FY, Chen WJ. 　　　Taipei, Taiwan
CMAJ. 2005 Nov 8;173(10):1165-9.

背景：小腸の癒着による閉塞は通常、保存的に、輸液と絶食で治療される。過去に行われた研究では、このアプローチでは入院期間の長期化と外科手術が遅れるリスクについて言及されてきた。本研究では、標準的内服薬の組み合わせににより手術に至る必要性や入院期間の減少ができるかRCTをおこなうこととした。
方法：144人の癒着性小腸閉塞による入院患者のうち、条件に合う128人をランダムにコントロール群（輸液、NGチュウブによる減圧、絶食）または介入群（輸液、NGチュウブによる減圧、カマグ・ガスコン・Lactobacillus acidophilusの内服）に振り分けた。主要評価項目は手術治療なしで治癒した患者数、入院期間とした。合併症や再閉塞率も記録した。
結果：128人のうち63人はコントロール群に、65人は介入群に振り分けられた。ほとんどの患者は男性であった。介入群の方が手術なしですむ可能性が高かった（59 [91%] v. 48 [76%], p= 0.03; relative risk 1.19, 95% confidence interval 1.03-1.40）。平均入院期間はコントロール群の方が長かった（4.2 [SD 2.7] v. 1.0 [SD 0.7] days, p <
0.01） 合併症や再発率は、両群で差がなかった。
結論：Oral therapy with magnesium oxide, L.acidophilus and simethicone was effective in hastening the resolution of conservatively treated partial adhesive small-bowel obstruction and shortening the hospital stay.


軽めのイレウスには、これでいいのでしょうか。

大腸癌stageII 術後5-FU+LV (QUASAR試験)

大腸癌治癒切除stageIIの術後化学療法5-FU+LVの効果　RCT：　QUASAR試験

大腸癌治癒切除stageIIに対する術後補助化学療法5FU+LV（4週毎5日間連続投与6コース）vs.　経過観察のみ
追跡期間中央値　5.5年
総死亡のRR 　0.82(95%CI 0.70-0.95) 大腸癌死のRR　0.81(95%CI 0.68-0.96)
ただし再発抑制効果は2年以内のみで、以降は差が無い。
5年死亡率の絶対的リスク減少は3.6%であった。

BACKGROUND:
To determine the size and duration of any survival benefit from adjuvant chemotherapy for patients with colorectal cancer at low risk of recurrence.

METHODS: After apparently curative resections of colon or rectal cancer, 3239 patients (2963 [91%] with stage II [node negative] disease, 2291 [71%] with colon cancer, median age 63 [IQR 56-68] years) enrolled between May, 1994, and December, 2003, from 150 centres in 19 countries were randomly assigned to receive chemotherapy with fluorouracil and folinic acid (n=1622) or to observation (with chemotherapy considered on recurrence; n=1617). Chemotherapy was delivered as six 5-day courses every 4 weeks or as 30 once-weekly courses of intravenous fluorouracil (370 mg/m2) with high-dose (175 mg) L-folinic acid or low-dose (25 mg) L-folinic acid. Until 1997, levamisole (12 courses of 450 mg over 3 days repeated every 2 weeks) or placebo was added. After 1997, patients who were assigned to receive chemotherapy were given fluorouracil and low-dose folinic acid only. The primary outcome was all-cause mortality. Analyses were done by intention to treat. This trial is registered with the International Clinical Trial Registry, number ISRCTN82375386.

FINDINGS:
After a median follow-up of 5.5 (range 0-10.6) years, there were 311 deaths in the chemotherapy group and 370 in the observation group; the relative risk of death from any cause with chemotherapy versus observation alone was 0.82 (95% CI 0.70-0.95; p=0.008). There were 293 recurrences in the chemotherapy group and 359 in the observation group; the relative risk of recurrence with chemotherapy versus observation alone was 0.78 (0.67-0.91; p=0.001). Treatment efficacy did not differ significantly by tumour site, stage, sex, age, or chemotherapy schedule. Eight (0.5%) patients in the chemotherapy group and four (0.25%) in the observation group died from non-colorectal cancer causes within 30 weeks of randomisation; only one of these deaths was deemed to be possibly chemotherapy related.

INTERPRETATION:
Chemotherapy with fluorouracil and folinic acid could improve survival of patients with stage II colorectal cancer, although the absolute improvements are small: assuming 5-year mortality without chemotherapy is 20%, the relative risk of death seen here translates into an absolute improvement in survival of 3.6% (95% CI 1.0-6.0).

Quasar Collaborative Group
Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study.
Lancet. 2007 Dec 15;370(9604):2020-9. PMID: 18083404

大腸癌肝転移 FOLFOX4+Surgery vs Surgery alone （EORTC試験）

EORTC Intergroup trial

4箇所までの大腸癌肝転移に対して手術にFOLFOX4を併用することで、
術後3年目のPFSは、28.1%から35.4%に増える。HR 0.79[0.62-1.02]p=0.058


BACKGROUND:
Surgical resection alone is regarded as the standard of care for patients with liver metastases from colorectal cancer.

METHODS:
364 patients with colorectal cancer and up to 4 liver metastases were randomly assigned to either 6 cycles of FOLFOX4 before and six cycles after surgery or to surgery alone (182 in perioperative chemotherapy group vs 182 in surgery group).The primary objective was to detect a hazard ratio (HR) of 0.71 or less for progression-free survival(PFS). Primary analysis was by intention to treat. Analyses were repeated for all eligible (171 vs 171) and resected patients (151 vs 152). This trial is registered with ClinicalTrials.gov, number NCT00006479.

FINDINGS:
In the perioperative chemotherapy group, 151 (83%) patients were resected after a 6 preoperative cycles and 115 (63%) patients received a 6 postoperative cycles. 152 (84%) patients were resected in the surgery group.
The absolute increase in rate of progression-free survival(PFS) at 3 years was
7.3% (from 28.1% [95.66% CI 21.3-35.5] to 35.4% [28.1-42.7]; HR 0.79 [0.62-1.02]; p=0.058) in randomised patients;
8.1% (from 28.1% [21.2-36.6] to 36.2% [28.7-43.8]; HR 0.77 [0.60-1.00]; p=0.041) in eligible patients;
and 9.2% (from 33.2% [25.3-41.2] to 42.4% [34.0-50.5]; HR 0.73 [0.55-0.97]; p=0.025) in patients undergoing resection.
139 patients died (64 in perioperative chemotherapy group vs 75 in surgery group).
Reversible postoperative complications occurred more often after chemotherapy than after surgery (40/159 [25%] vs 27/170 [16%]; p=0.04). After surgery we recorded two deaths in the surgery alone group and one in the perioperative chemotherapy group.

INTERPRETATION:
Perioperative chemotherapy with FOLFOX4 is compatible with major liver surgery and reduces the risk of events of progression-free survival in eligible and resected patients.


Nordlinger B et al.
Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial.
Lancet. 2008 Mar 22;371(9617):1007-16. PMID: 18358928

大腸手術、腸管前処置

待機的大腸・直腸手術の機械的腸管前処置(MBP)施行群と非施行群における

縫合不全発生率
MBP施行群　32/670(4.8%)
非施行群　　 37/684(5.4%)
Risk difference 0.6% (95%CI -1.7, 2.9),P=0.69

縫合不全後の膿瘍発生率
MBP施行群　 2/670(0.3%)
非施行群　　 17/684(2.5%)
P=0.001

創離開率(13.4% vs 14.0%)、死亡率(3.0% vs 3.8%)には有意差はなかった。



Contant CM et al.
Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial.
Lancet. 2007 370:2112-7. PMID: 18156032