90．淋必治
出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第499页（5957字）
【中文释文】：
(大观霉素)
注射剂2g，灭菌盐酸大观霉素，用于肌肉注射。
〔性状〕
“普强”淋必治注射剂由土壤中的微生物北观链霉素(Streptomyces spectabilis)所产生之氨环多醇型抗生素。
淋必治为白色结晶含5分子结晶水双盐酸盐(dihydrochloride pentahydrate)，分子量495，在干燥状况下可保持稳定3年。
〔作用〕
淋必治可抑制细菌细胞内的蛋白质合成，其作用部位为30S核糖体亚单位。
试管试验显示，淋必治对大多数淋病奈瑟球菌株有效。
试管试验证明淋必治与青霉素对淋病奈瑟球菌绝无交互耐药性。本剂与血清蛋白无明显的结合性。
淋病奈瑟球菌对淋必治的感受性试管试验可用冻琼脂稀释法。为此种试验目的，备有淋必治感受性粉剂供用，使用前请先详阅包装内的说明书。
〔适应证〕
淋病奈瑟球菌株引起急性尿道炎、子宫颈炎及直肠炎。
〔禁忌〕
如病人对本剂曾发生过敏者不宜使用。
〔注意〕
淋必治对治疗梅毒无效，短期内使用大剂量抗生素治疗淋病时可能会掩蔽或延迟潜伏性梅毒的症状。以任何有效抗生素治疗梅毒，皆须延长疗程，故治疗淋病病人时，应仔细观察，如诊断上认为有梅毒可疑时，应每月作血清学检查，至少3个月。对孕妇、婴儿及儿童使用淋必治的安全性尚未确定。
对有过敏体质者，一般的注意事项均应遵守。
淋必治的临床功效应随时注意，以调查对淋病奈瑟球菌耐药性的发展情形。
〔副作用〕
临床试验时，注射1次剂量后曾发现有下列现象：注射部位疼痛、荨麻疹、眩晕、恶心、感冒、发热及失眠等。
对健康志愿者施行多次注射，对其慢性耐受力，亚慢性耐受性的研究，发现有血红蛋白、血细胞比容计值及肌酐清除率减低现象；以及碱性磷酸酯酶，BUN及SGPT升高现象。
正常志愿者，以单一及多次剂量试验，发现小便量减少，广泛的肾功能影响的研究结果显示，肾毒现象在注射前后均无变化。
〔用法与用量〕
本药限由医师使用。
肌肉注射剂的配制：无菌淋必治2g溶于3．2ml稀释液中，此稀释液为注射用无菌水加入0．9%(w／v)苯甲醇，在加入稀释剂后至吸取前应摇动，已调配的悬浮液可置于室温(25℃)下，但必须在24h以内使用。
注射用针头及注射器应避免青霉素残余物的污染，尤其是对青霉素特别敏感的病人更应特别注意。
〔剂量〕
注射时以使用20号针头为宜，应注射于臀肌上部外侧，深入臀肌中。
成人男性／女性：肌肉注射5ml(2g淋必冶)。
如患有淋菌性直肠炎的病人，或曾以其他抗生素治疗无效的病人，应作肌肉注射4g(10ml)，可分两部位注射。如某地区已知细菌耐药性流行时，第一次宜注射4g(10ml)。
〔贮存条件〕
未开封的产品贮于室温(15～30℃)，配制后药品应贮于室温(15～30℃)，并于24h内使用。
〔包装〕
无菌淋必治2g小瓶装，附含3．2ml／小瓶稀释液，配成5ml悬浮液，即每毫升含有400mg大观霉素。
淋必治感受性粉剂100mg。
(请详阅包装内的说明试管试验程序)。
〔人体药理学研究〕
淋必治于注射后立即吸收，一次注射2g剂量，1h后即达高血药浓度，平均100μl／m1，8h后血药浓度仍保持15μl／ml；一次注射4g剂量，2h后即达高峰血药浓度，平均为160μl／ml，8h后血药浓度仍保持31μl／ml。
〔生产厂家〕
比利时皮尔斯普强药厂
(附本品别名：壮观霉素，奇霉素，眺霉素，奇放线菌素，放线壮观霉素，治淋炎，Delspectin，Kempi，Spectam，Spectogard，Togoplus)
【外文释文】：
sterile spectinomycin hydrochloride
For intramuscular injection
Indications
Trobicin is indicated in the treatment of acute gonorrhoeal urethritis and proctitis in the male，and acute gonorrhoeal cervicitis and proctitis in the female，when due to susceptible strains of N．gonorrhoeae．Sexual contacts of individuals with known gonorrhoea should also be treated．
Contraindications
Trobicin is contraindicated in patients previously found sensitive to it．
Warnings and precautions
Trobicin is not indicated for the treatment of syphilis．Antibiotics used in high doses for short periods of time to treat gonorrhoea may mask or delay the symptoms of incubating syphilis．Thus，all patients with gonorrhoea should have a serological test for syphilis at the time of diagnosis．Patients treated with Trobicin should have a follow-up serological test for syphilis after three months．
Safety of Trobicin use during pregnancy and in infants has not been established．Trobicin has been reported to be effective in children at a dosage of 40 mg／kg．
Adverse reactions
The following reactions have been observe during single dose clinical trials：soreness at the injection site，urticaria，dizziness，nausea，chills，fever，and a reduction in urine output(without renal function changes indicative of renal toxicity)．
The following reactions have been observed during multiple-dose tolerance studies in healthy volunteers：a decrease in haemoglobin，haematocrit，and creatinine clearance；and an elevation of alkaline phosphatase，BUN，and SGPT．
Dosage and administration
The recommended dose of spectinomycin HCl in the treatment of uncomplicated gonococcal urethritis，cervicitis，or proctitis in men and women is 2．0 g in one intramuscular injection．Up to 4．0 g of spectinomycin have been administered in difficult-to-treat cases and in areas where antibiotic resistance is known to occur．
Dosage
Intramuscular injections should be made deep into the upper outer quadrant of the gluteal muscle．
Adults：inject a single 2 gram dose(5 ml)im．If a 4 gram dose(10 ml)is necessary，the 10 ml injection may be divided between two gluteal injection sites．
Preparation of drug for intramuscular injection
2 Gram sterile trobicin：reconstitute with 3．2 ml of the accompanying diluent(bacteriostatic water for injection with benzyl alcohol 0．9%w／v)．Shake vials vigorously immediately after adding diluent and before withdrawing dose．It is recommended that disposable syringes and needles be used to avoid contamination with penicillin residue，especially when treating patients，known to be highly sensitive to penicillin．Use of 20 gauge needle is recommended．
Storage conditions
Store unreconstituted product at controlled room temperature(15-30℃)．
Store prepared suspension at controlled room temperature((15-30℃)and use within 24 hours．
How supplied
Trobicin Sterile Powder(Spectinomycin hydrochloride)is available as：Trobicin Sterile Powder，2 gram vial-with one ampoule of bacteriostatic water for injection with benzyl alcohol 0．9%w／v added as preservative．When reconstituted with 3．2 ml of the accompanying diluent，each vial yields a sufficient quantity for withdrawal of 5 ml of a suspension containing 400 mg spectinomycin per ml(as the hydrochloride)．5 ml Provides 2 grams spectinomycin．For intramuscular use only．
Manufacturer
Upjohs S．a．Puurs Belgium