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xuzhwei

木虫 (小有名气)

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虫号: 310305
注册: 2006-12-24
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专业: 中药学其他科学问题

[求助] 急，药品说明书翻译

【不良反应】
1、少数患者用药后出现恶心、泛酸、腹痛、腹泻、大便干、腹胀、胃部不适、胃部胀满、胸闷不适，心悸，尿痛等症状。
2、少数患者用药后出现ALT、BUN、Scr轻度升高
3、个别患者用药后出现尿红细胞、尿蛋白、尿糖阳性、大便检查有红细胞。
4、个别患者用药后出现频发早搏等。
【禁忌】严重胃炎、胃及十二指肠溃疡者禁用。
【注意事项】
1、个别患者用药后可出现血小板升高或者降低，但无法判断是否与药物有关。
2、肝功能不全者慎用
3、临床用药期间定期检查肝肾（ALT、BUN、Scr）功能及血、尿、大便常规。
4、现有的安全性是本品是以42天的安全性结果，不宜超疗程使用。
【临床试验】本品于2000年3月由国家食品药品监督管理局批准临床研究，于2001年11月至2005年3月进行了Ⅱ、Ⅲ期临床试验。临床试验采用平行对照、区组随机、双盲单模拟、多中心试验设计方法，观察了黄莪胶囊用于良性前列腺增生症气虚血瘀、湿热阻滞证的有效性和安全性，对照药为癃闭舒胶囊。Ⅱ期临床试验的总病例数为220例，黄莪胶囊组116例，癃闭舒胶囊组104例；Ⅲ期临床试验的总病例数485例，其中黄莪胶囊组323例，癃闭舒胶囊组162例。观察疗程为42天。主要疗效性观察指标为良性前列腺增生症相关症状、体征，国际前列腺症状评分（I-PSS）尿流率和残余尿量等。
试验结果显示：Ⅱ、Ⅲ期临床试验的疗效，I-PSS总分疗效的比较，两组积分变化差异无统计学意义，尿流率变化两组差异无统计学意义，两组治疗前后积分改善比较，组间比较差异无统计学意义。残余尿量、B超前列腺大小变化、症状积分的大小、不同时点排尿不禁感记分变化的统计学比较，两组生活质量指数的变化比较，两组差异无统计学意义。
2009年9月-2010年4月补充了74对（试验组和安慰剂对照组各74例）随机、双盲、安慰剂对照的多中心临床试验，疗程为42天，重点观察本品对良性前列腺增生症气虚血瘀、湿热阻滞证的中医证候疗效以及相应的安全性。结果显示本品对中医证候总有效率优于安慰剂对照组，对疾病的综合疗效试验组优于安慰剂对照组。
黄莪胶囊组经过约500例治疗前后的血、尿、大便常规、肝功能（ALT）、肾功能（BUN、Scr），Ⅱ、Ⅲ期临床试验中，有8例肝功能（ALT）治疗前正常治疗后异常升高（56-141U/L），1例治疗前异常治疗后异常加重，均认为可能与药物有关；出现肾功能（BUN、Scr）相关指标治疗前正常治疗后异常升高者，有3例认为可能与药物有关，3例与药物的关系认为可疑；个别患者服用后出现尿红细胞，尿蛋白轻度异常，尿糖阳性、大便检查出现红细胞、血小板升高或降低，该类不良事件多数为与药物可能有关、可疑、无法判断。临床试验期间，少数患者服药后出现恶心、泛酸、腹痛、腹泻、大便干、腹胀、胃部不适、胃部胀满、胸闷不适，心悸，尿痛，多数判断与药物有关或可能有关，1例患者有早搏病史，用药后出现频发早搏，患者退出试验，认为与药物的关系可疑，转归为症状消失后无后遗症，1例患者用药后出现房颤，研究者认为与药物无关。
【药理毒理】非临床药效学试验结果显示：本品能缩小去势加皮下注射丙酸睾丸素大鼠模型的前列腺体积，降低前列腺湿重和干重，缩小平均腺腔，减少腺腔中蛋白物质含量；能缩小良性前列腺增生老年犬的前列腺体积，降低前列腺组织中RNA和DNA的含量，增加腺小叶数；能抑制去甲肾上腺素所致小鼠肠系膜微血管的收缩。

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1楼 2012-07-10 14:25:49

已阅关注TA 给TA发消息送TA红花 TA的回帖

xuzhwei

木虫 (小有名气)

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在线: 173.4小时
虫号: 310305
注册: 2006-12-24
性别: GG
专业: 中药学其他科学问题

【性状】本品为硬胶囊，内容物为棕色的颗粒和粉末；气香，味苦
【功能主治】益气活血，清利湿热。用于I、II期良性前列腺增生症气虚血瘀、湿热阻滞证。症见排尿困难、尿意频急、或小腹胀满或疼痛，舌质淡紫或有淤点，苔薄黄腻，脉细。

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2楼2012-07-10 14:29:17

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linchenyu

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sltmac: 金币-5, 违规存档, google翻译，初犯，扣5金币予以警告 2012-08-12 08:05:51

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.

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