| 摘要: | 研究目的
探討女性乳癌病人服用tamoxifen藥品和急性胰臟炎之風險程度；及女性病人服用zolpidem藥品和急性腎盂腎炎之風險程度。
研究方法
以台灣全民健康保險研究資料庫針對前項研究目的進行4項子研究: (1)第1項子研究為病例對照研究，對象為≥20歲的乳癌婦女，研究期間 (2000至2011年) 確立了612例急性胰臟炎病例組、和6120例沒有急性胰臟炎對照組；目前、 最近、過去服用之定義分別為急性胰臟炎診斷之前0–3、3–6、≥6個月仍服用tamoxifen。(2)第2項及第3項子研究同為世代研究，對象為≥20歲、在2000至2009年初次診斷有乳癌的女性病人，從指數日(診斷為乳癌日期)追蹤至2011年底止。(3)第4項子研究對象為20–84歲女性病人，研究期間 (2000至2011年) 確立了3151例急性腎盂腎炎病例組、和6015例沒有急性腎盂腎炎對照組；現在、早期、晚期服用之定義分別為急性腎盂腎炎診斷之前0–7、8–14、≥15天仍服用zolpidem。
第1、4項子研究係以多變量邏輯斯迴歸模型計算OR，第2、3項子研究係以Cox proportional hazard model 計算 HR，並分別以 95% 信賴區間來評估藥品的影響。
研究結果
第1項子研究其目前、 最近、過去服用 tamoxifen與急性胰臟炎之風險，校正後勝算比分別為1.18 (95% CI 0.95–1.48)、1.43 (95% CI 0.87–2.35)、 0.97 (95% CI 0.79–1.19)。第2、3項子研究 (non-matching cohort, PS-matching cohort) 其服用tamoxifen與急性胰臟炎之風險，校正後HRs 分別為0.93 (95% CI 0.73–1.18), 0.94 (95% CI 0.74–1.19), 0.95 (95% CI 0.71–1.26)。第4項子研究 現在、早期、晚期服用 zolpidem與急性腎盂腎炎之風險，校正後勝算比分別為2.19 (95% CI, 1.69–2.83), 1.44 (95% CI, 0.82–2.51), 1.05 (95% CI, 0.93–1.18)。
研究結論
女性乳癌病人服用tamoxifen與急性胰臟炎之風險無統計上顯著相關；現在服用zolpidem的女性病人，相對會增加罹患急性腎盂腎炎的風險。
Objectives
To investigate whether tamoxifen use is correlated with the risk of acute pancreatitis (AP) in breast cancer female, and whether zolpidem use is correlated with the risk of acute pyelonephritis (APN) in female patients.
Methods
We conducted 4 substudies using the database of the Taiwan National Health Insurance Program. In substudy 1 (case-control study), the participants comprised 612 subjects, aged ≥ 20 years with breast cancer in females, with a first bout of AP from 2000 to 2011 as cases and 6120 randomly selected age-matched subjects without AP as the controls. Tamoxifen use was defined as “current,” ”recent,” or ”past” use if the subjects who had received the last remaining one tablet for tamoxifen filled between 0–3 months, 3–6 months, or ≥ 6 months before the date of AP diagnosis, respectively. A multivariate unconditional logistic regression model was used to estimate the odds ratio (OR) and 95% confidence interval (CI) for AP associated with the use of tamoxifen. The same model was applied in substudy 4. Both substudies 2 and 3 were cohort studies; the substudy 3 included more comorbidities than substudy 2, and the substudy 3 was employed 2 design (without PS-matching, and PS-matching designs). Their patients with new-onset breast cancer who were aged ≥20 years during 2000 to 2009 and assigned the index date as the date of cancer diagnosis. The end point was developing AP during the follow-up. Hazard ratios (HRs) and 95% CIs were assessed to determine the association between AP risk and tamoxifen use. Because the drug use varied over time, it was measured as a time-dependent covariate in the Cox proportional hazard model. In substudy 4, there were 3,151 female subjects aged 20–84 years with the first bout of APN (cases) and 6,015 controls without APN. Zolpidem use was defined as “immediate,” ”early,” or ”late,” if the last remaining one tablet for zolpidem was detected within 7 days, between 8–14 days or ≥ 15 days before the date of APN diagnosis, respectively.
Results
In substudy 1, the adjusted ORs of AP were 1.18 (95% CI 0.95–1.48), 1.43 (95% CI 0.87–2.35), 0.97 (95% CI 0.79–1.19) in subjects with current, recent, and past use, respectively. In substudy 2, and 3, the adjusted HRs of APN were 0.93 (95% CI 0.73–1.18), 0.94 (95% CI 0.74–1.19), and 0.95 (95% CI 0.71–1.26) in the substudy 2, substudy 3 (non-matching cohort), substudy 3 (PS-matching cohort), respectively. In substudy 4, the adjusted ORs of APN were 2.19 (95% CI, 1.69–2.83),1.44 (95% CI, 0.82–2.51),and 1.05 (95% CI, 0.93–1.18) in subjects with immediate, early, and late zolpidem use, respectively.
Conclusion
In substudy 1–3 we found no significant correlation between tamoxifen use and the risk of AP in females with breast cancer. In substudy 4, only female patients with immediate zolpidem use had a significantly increased relative risk of APN. |
