一個多中心實驗關於 德國欣髮源 Thymuskin 療程，對化療帶來的副作用引起的落髮，是否具有預防效果。並且研究不同抑制細胞生長的藥物，和潛在的疾病會影響病患的落髮與到什麼程度。 此研究中，共有317 位正在服用不同種抑制細胞生長藥物的患者參與。
我們用WHO 分類法，在療程前與進行期間對評估落髮狀況。在研究中，患者被分成活性實驗組和安慰劑組進行隨機雙盲實驗，安慰劑組的患者接受沒有活性成分的治療 。為了研究抑制細胞生長的療程，與潛在疾病對落髮的影響，我們將各個中心的研究結果匯總在一起。
1.德國欣髮源 THYMUSKIN 效果測試（與安慰劑組相比）
•活性實驗組 （n = 56）：41.1％患者沒有表現出落髮， 17.8％患者有可挽救的落髮現象，26.8%患者有小量的落髮，14.3%患者有中度落髮現象。
•安慰劑組（n = 40）：15％患者沒有表現出落髮，55％患者有可挽救的落髮現象，15％患者有小量或中度落髮現象。
德國欣髮源 Thymuskin 治療效果與安慰劑組落髮相比
2.化療對落髮的影響
144 名患者接受5-氟尿嘧啶（單一或聯合用藥），107 名患者接受了更侵略性的阿黴素（單一或聯合用藥）。
•接受5 氟尿嘧啶治療的患者，45%患者頭髮狀況維持不變， 掉髮狀況惡化一個等級的有15％，惡化兩個等級的有40％。
•接受阿黴素治療的患者，如預期中只有5％的患者頭髮狀能夠維持；頭髮狀況惡化一個等級的有35％，惡化兩個等級的 40％，三個等級的20％。
腫瘤病患的掉髮狀況
3. 腫瘤對落髮狀況的影響
正在接受阿黴素治療者，90％（96/107）皆為胃癌患者。接受侵略性較低的5-氟尿嘧啶治療的組，31％（44/144 ）得乳癌，23％（33/144 ）有食道癌，16％（23 / 144）有結腸癌，，11％（16/144 ）患有胰腺癌，19％（144/28）有其他惡性疾病。
•其中68％的乳癌患者、74％的結腸癌患者，3%的食道癌患者與36%患有其他癌症的患者，在接受5-氟尿嘧啶的治療過程中頭髮狀況維持不變。
•胃癌患者並接受阿黴素治療者，頭髮狀況只有2％（2/96）保持不變。而全頭禿被在70％的患者身上被消除。
左圖：接受5-氟尿嘧啶治療的組掉髮狀況；右圖：接受阿黴素治療的組掉髮狀況
4. 德國欣髮源 THYMUSKIN 在較溫和化療中的效果
進一步研究是關於 德國欣髮源 Thymuskin，足以改善因抑制細胞生長的療程，引起的落髮到什麼程度。 40 位不同腫瘤疾病（乳癌，卵巢癌，結腸癌和肺癌）的病人皆參加了這項研究。這些人主要是女性患者（男：女 比= 6:34）年紀33 歲到76 歲。取決於不同種類疾病，細胞抑制的藥物治療分配如下：
•CMF（環磷酰胺+甲氨蝶呤+ 5-氟尿嘧啶）
•諾肖林（MXO）作為單一療法或組合療法與Platinol（DDP）或長春新鹼
•環磷酰胺（環磷酰胺）+ 5-氟尿嘧啶+ Platinol（DDP）的組合
•卡鉑單藥治療
•5-氟尿嘧啶單藥治療
•Farmorubicin 聯合療法
40 位患者中的33 位接受“溫和”的單一或聯合細胞抑制藥物；出於人道主義，7 名接受侵略性”細胞抑制藥物治療（Farmorubicin 聯合療法）的患者也被包含在內。在療程中，他們每天使用 德國欣髮源 Thymuskin 養護精華凝膠，與 德國欣髮源 Thymuskin 洗髮精兩天至少一次。實驗的觀察期是一到七個月之間，一樣使用WHO 分類法（掉髮等級0-3）。為了比較實驗組與控制組的效果，對照組是從753 位選出含有50 位接受極度“溫和”的細胞抑制藥物療法。
減少接受因“溫和”化療引起的落髮
•實驗組：只有6％的患者（2/33）有微量落髮（WHO 等級1），這意味著近94％的成功率（WHO 等級0）
•控制組：22％（11/50）有落髮現象，其中8％（4/50）顯示出中度落髮（WHO等級2）
•兩組皆無觀察到完全落髮（WHO 等級3）
•實驗組落髮程度比控制組低三倍
德國欣髮源 THYMUSKIN 對抑制細胞生長的藥物（化療）引起的落髮治療效果
»德國欣髮源 Thymuskin 在治療抑制細胞生長引起的落髮效果，比安慰劑組或是控制組的可能性高三倍
»在“溫和”抑制細胞生長的治療中，德國欣髮源 Thymuskin 能讓94%的患者頭髮狀況維持
»相較於“侵略性”的細胞抑制療法（阿黴素），德國欣髮源 Thymuskin 更能顯著維持接受“溫和”抑制細胞生長的治療（5-氟尿嘧啶）病患的頭髮狀況
»德國欣髮源 Thymuskin 在乳腺癌患者或結腸癌的頭髮狀況有比較積極的效果，比食道或胃癌患者更顯著。
原文：
Cyto static drug-induced alopecia
A multicentric study11 was undertaken to investigate the extent to which hair loss as a side effect of cytostatic chemotherapy can be affected by the prophylactic application of Thymuskin alongside the treatment. It also investigated the extent to which different cytostatic drugs and underlying diseases affect hair loss. A total of 317 patients with different cytostatic drug regimens took part in the study.
Hair loss was evaluated before and during the treatment using the WHO classification.
In one of the study locations, patients were split into a verum arm and a placebo arm as part of a randomised double blind study. Instead of Thymuskin, the patients in the placebo group received a preparation with no active ingredients. In order to investigate the effect of cytostatic therapy and underlying diseases on hair loss, the study results from the individual centres were compiled together.
1. Thymuski n® effectiveness compared to placebo11
• Verum group (n= 56): 41.1% of patients exhibited no alopecia, 17.8% full, reversible alopecia, 26.8% minimal hair loss and 14.3% moderate hair loss
• Placebo group (n=40): 15% of patients exhibited no alopecia, 55% full, reversible alopecia, and 15% minimal or moderate hair loss
2. Effect on chemotherapy regimen on hair loss
144 patients received 5-fluorouracil (monotherapy or combination therapy), 107 patients received the more ‘aggressive’ Adriamycin (monotherapy or combination therapy).
• Of those receiving 5-flourouracil treatment, hair condition remained the same in 45% of patients, worsened by one grade in 15% and by two grades in 40%
• Of those receiving Adriamycin treatment, as expected hair condition remained the same in only 5% of patients, worsened by one grade in 35%, by two grades in 40% and by three grades in 20%
3. Effect of tumour on hair loss
90% (96/107) of the patients being treated with Adriamycin were suffering from stomach cancer. In the group being treated with 5-fluorouracil, the less aggressive cytostatic drug regimen resulted in a different distribution: 31% (44/144) were suffering from breast cancer, 23% (33/144) from oesophageal cancer, 16% (23/144) from colon cancer, 11% (16/144) from pancreatic cancer and 19% (28/144) from another malignant disease.
• In 68% of patients with breast cancer, 74% of patients with colon cancer, 3% of patients with oesophageal cancer and 36% of patients with other cancers, hair condition remained unchanged during the treatment with 5-FU.
• Among patients with stomach cancer and undergoing Adriamycin treatment, hair condition remained unchanged in only 2% (2/96). However, alopecia totalis was prevented in 70% of patients.
4. Thymuski n® effectiveness during ‘mild’ chemotherapy
A further study13 was undertaken to investigate the extent to which Thymuskin could prevent or reduce hair loss caused by ‘mild’ cytostatic therapy. 40 patients with different underlying neoplastic diseases (breast, ovarian, colon and lung cancer) took part in the study. These were predominantly female patients (M:F ratio = 6:34) aged between 33 and 76. Depending on the underlying disease, the following cytostatic drugs were administered:
• CMF (cyclophosphamide + methotrexate + 5-fluorouracil)
• Novantrone (MXO) as a monotherapy or a combination therapy with Platinol (DDP) or Oncovin
• A combination of cyclophosphamide (Endoxan) + 5-fluorouracil + Platinol (DDP)
• Carboplatin monotherapy
• 5-fluorouracil monotherapy
• Farmorubicin combination therapies 33 of the total of 40 patients received ‘milder’ monotherapy or combination therapy with cytostatic drugs. For humanitarian reasons, seven patients undergoing ‘aggressive’ cytostatic treatment (Farmorubicin combination therapies) were also included.
The Thymuskin Scalp Serum was used daily and the Thymuskin Shampoo at least every other day alongside the treatment. The observation period was between one and seven months. The WHO classification (alopecia stages 0-3) was again used as evaluation criteria. In order to ensure that a comparison could be drawn with the treatment group, a control group was identified from a contingent of 753 cases, containing 50 patients receiving exclusively ‘milder’ cytostatic drug regimens as regards hair loss.
Reduction in hair loss for ‘mild’ chemotherapy
• Treatment group: little hair loss (WHO stage 1) in only 6% of patients (2/33),meaning a success rate of nearly 94% (WHO stage 0)
• Control group: hair loss proportion of 22% (11/50), of which 8% (4/50) exhibited moderate hair loss (WHO stage 2)
• No examples of complete hair loss (WHO stage 3) were observed in either group
• Hair loss was more than three times lower in the treatment group than in the control group
Thymuskin® effectiveness alongside treatment in cases of cytostatic drug-induced alopecia (chemotherapy)
»» Thymuskin three times more likely to prevent hair loss or total reversible alopecia under cytostatic therapy compared with placebo11 or control group
»» With ‘mild’ cytostatic therapy, Thymuskin maintains hair condition in up to 94% of patients
»» Thymuskin use can maintain hair condition significantly more often for patients undergoing ‘mild’ cytostatic therapy (5-fluorouracil) than for patients undergoing ‘aggressive’ cytostatic therapy (Adriamycin)
»» The positive effects of Thymuskin on hair condition are more significant for patients with breast or colon cancer than for patients with oesophageal or stomach cancer
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