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【不良反應(yīng)】 1、少數(shù)患者用藥后出現(xiàn)惡心、泛酸、腹痛、腹瀉、大便干、腹脹、胃部不適、胃部脹滿、胸悶不適，心悸，尿痛等癥狀。 2、少數(shù)患者用藥后出現(xiàn)ALT、BUN、Scr輕度升高 3、個別患者用藥后出現(xiàn)尿紅細(xì)胞、尿蛋白、尿糖陽性、大便檢查有紅細(xì)胞。 4、個別患者用藥后出現(xiàn)頻發(fā)早搏等。 【禁忌】嚴(yán)重胃炎、胃及十二指腸潰瘍者禁用。 【注意事項】 1、 個別患者用藥后可出現(xiàn)血小板升高或者降低，但無法判斷是否與藥物有關(guān)。 2、 肝功能不全者慎用 3、 臨床用藥期間定期檢查肝腎（ALT、BUN、Scr）功能及血、尿、大便常規(guī)。 4、 現(xiàn)有的安全性是本品是以42天的安全性結(jié)果，不宜超療程使用。 【臨床試驗】本品于2000年3月由國家食品藥品監(jiān)督管理局批準(zhǔn)臨床研究，于2001年11月至2005年3月進(jìn)行了Ⅱ、Ⅲ期臨床試驗。臨床試驗采用平行對照、區(qū)組隨機(jī)、雙盲單模擬、多中心試驗設(shè)計方法，觀察了黃莪膠囊用于良性前列腺增生癥氣虛血瘀、濕熱阻滯證的有效性和安全性，對照藥為癃閉舒膠囊。Ⅱ期臨床試驗的總病例數(shù)為220例，黃莪膠囊組116例，癃閉舒膠囊組104例；Ⅲ期臨床試驗的總病例數(shù)485例，其中黃莪膠囊組323例，癃閉舒膠囊組162例。觀察療程為42天。主要療效性觀察指標(biāo)為良性前列腺增生癥相關(guān)癥狀、體征，國際前列腺癥狀評分（I-PSS）尿流率和殘余尿量等。 試驗結(jié)果顯示：Ⅱ、Ⅲ期臨床試驗的療效，I-PSS總分療效的比較，兩組積分變化差異無統(tǒng)計學(xué)意義，尿流率變化兩組差異無統(tǒng)計學(xué)意義，兩組治療前后積分改善比較，組間比較差異無統(tǒng)計學(xué)意義。殘余尿量、B超前列腺大小變化、癥狀積分的大小、不同時點排尿不禁感記分變化的統(tǒng)計學(xué)比較，兩組生活質(zhì)量指數(shù)的變化比較，兩組差異無統(tǒng)計學(xué)意義。 2009年9月-2010年4月補充了74對（試驗組和安慰劑對照組各74例）隨機(jī)、雙盲、安慰劑對照的多中心臨床試驗，療程為42天，重點觀察本品對良性前列腺增生癥氣虛血瘀、濕熱阻滯證的中醫(yī)證候療效以及相應(yīng)的安全性。結(jié)果顯示本品對中醫(yī)證候總有效率優(yōu)于安慰劑對照組，對疾病的綜合療效試驗組優(yōu)于安慰劑對照組。 黃莪膠囊組經(jīng)過約500例治療前后的血、尿、大便常規(guī)、肝功能（ALT）、腎功能（BUN、Scr），Ⅱ、Ⅲ期臨床試驗中，有8例肝功能（ALT）治療前正常治療后異常升高（56-141U/L），1例治療前異常治療后異常加重，均認(rèn)為可能與藥物有關(guān)；出現(xiàn)腎功能（BUN、Scr）相關(guān)指標(biāo)治療前正常治療后異常升高者，有3例認(rèn)為可能與藥物有關(guān)，3例與藥物的關(guān)系認(rèn)為可疑；個別患者服用后出現(xiàn)尿紅細(xì)胞，尿蛋白輕度異常，尿糖陽性、大便檢查出現(xiàn)紅細(xì)胞、血小板升高或降低，該類不良事件多數(shù)為與藥物可能有關(guān)、可疑、無法判斷。臨床試驗期間，少數(shù)患者服藥后出現(xiàn)惡心、泛酸、腹痛、腹瀉、大便干、腹脹、胃部不適、胃部脹滿、胸悶不適，心悸，尿痛，多數(shù)判斷與藥物有關(guān)或可能有關(guān)，1例患者有早搏病史，用藥后出現(xiàn)頻發(fā)早搏，患者退出試驗，認(rèn)為與藥物的關(guān)系可疑，轉(zhuǎn)歸為癥狀消失后無后遺癥，1例患者用藥后出現(xiàn)房顫，研究者認(rèn)為與藥物無關(guān)。 【藥理毒理】非臨床藥效學(xué)試驗結(jié)果顯示：本品能縮小去勢加皮下注射丙酸睪丸素大鼠模型的前列腺體積，降低前列腺濕重和干重，縮小平均腺腔，減少腺腔中蛋白物質(zhì)含量；能縮小良性前列腺增生老年犬的前列腺體積，降低前列腺組織中RNA和DNA的含量，增加腺小葉數(shù)；能抑制去甲腎上腺素所致小鼠腸系膜微血管的收縮。 |
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sltmac: 金幣-5, 違規(guī)存檔, google翻譯，初犯，扣5金幣予以警告 2012-08-12 08:05:51
sltmac: 金幣-5, 違規(guī)存檔, google翻譯，初犯，扣5金幣予以警告 2012-08-12 08:05:51
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Adverse reactions A small number of patients after treatment of nausea, pantothenic acid, abdominal pain, diarrhea, dry stools, bloating, stomach discomfort, stomach fullness, chest discomfort, palpitations, dysuria and other symptoms. 2, a small number of patients after administration of ALT, BUN and Scr mild increase Individual patients after treatment, urine red blood cells, urine protein and urine sugar positive stool examination red blood cells. Individual patients after treatment, frequent premature beats and so on. Taboo severe gastritis, gastric and duodenal ulcers disabled. [Note] Individual patients after treatment, there may be platelet increase or decrease, but can not determine whether drug-related. 2, liver dysfunction, caution 3, during the clinical use of drugs on a regular basis to check liver and kidney (ALT, BUN, Scr in) function and blood, urine, stool. 4, the safety of this product is 42 days of the security results, not ultra-treatment. Clinical trials this product in March 2000 by the State Food and Drug Administration approved clinical studies in November 2001 to March 2005, II, Ⅲ clinical trials. Clinical trials using parallel control block randomized, double-blind, single analog, multi-center trial design method to observe the yellow Curcuma capsules for benign prostatic hyperplasia blood stasis, damp heat of the efficacy and safety of the block permit, control drug for the Rongbishu capsule. Phase II clinical trial of the total number of cases to 220 cases of yellow the Curcuma capsule group 116 cases, Longbitong Capsule 104 cases; Phase III clinical trials, the total number of cases 485 cases, of which Huang Curcuma capsules group of 323 cases Longbitong Capsule group of 162 cases. The observed treatment for 42 days. The primary efficacy outcome measure was benign prostatic hyperplasia-related symptoms, signs, international prostate symptom score (I-PSS) and urinary flow rate and residual urine volume. The test results showed that: II, III clinical trial of the efficacy of the I-PSS score efficacy comparison of two sets of points difference in not statistically significant, urinary flow rate changes in two groups no significant difference between two groups before and after treatment points to improve The comparison between the two groups was no significant difference. Residual urine volume, B ultra prostate size changes, the size of the symptom score different points in time urination can not help but sense the scoring change was statistically compared the two sets of quality of life index change, the difference was not statistically significant. Supplemented in September 2009 -2010 April 74 pairs (test group and the placebo control group, n = 74) randomized, double-blind, placebo-controlled multi-center clinical trials, treatment for 42 days, focusing on observation of the goods on the benign prostatic hyperplasia blood stasis, heat block permits TCM syndromes efficacy and safety of The results show that the goods on the TCM syndromes and there is always more efficient than the placebo control group, disease efficacy trial group than the placebo control group. Huang Curcuma capsules group of about 500 cases before and after treatment the blood, urine, stool, liver function (ALT), renal function (BUN and Scr), II, III of clinical trials, 8 cases of liver function (ALT) before treatment abnormal elevation of normal after treatment (56-141U / L), abnormal pre-treatment abnormal treatment increase the view that may be drug-related; related indicators of renal function (BUN and Scr) before treatment for the treatment of abnormal elevation of three cases may be drug-related, and three cases with drugs considered suspicious; individual patients after taking the red blood cells in urine, urine protein was abnormal, positive urine, stool check red blood cells, platelets increase or decrease such The majority of adverse events with drugs that may be related, suspicious, can not determine. During clinical trials, a few patients after taking the nausea, pantothenic acid, abdominal pain, diarrhea, dry stools, bloating, stomach discomfort, stomach fullness, chest discomfort, palpitations, dysuria, the majority judgment, and drug or might be relevant, patients with premature history of frequent premature beats after treatment, the patient withdrew from the study that a suspicious relationship with the drug, and outcome of symptoms without sequelae and one patient after treatment, atrial fibrillation, the researchers believe has nothing to do with drug. Pharmacological effects of non-clinical pharmacodynamic trial results showed that: This product can reduce the castration plus subcutaneous injection of propionate testosterone rat model of prostate volume, reduce prostate wet weight and dry weight, reduce the average glandular reduce the glandular The content of protein substances; narrowing of older dogs with benign prostatic hyperplasia, prostate volume, reduce prostate tissue RNA and DNA content, and increase the number of glandular lobules; can inhibit norepinephrine-induced contraction of mouse mesenteric microvessels. |
3樓2012-07-13 19:12:50
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4樓2012-07-13 19:14:54
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